MEDICAL MARIJUANA ACCESS IN THE UNITED STATES A PATIENT-FOCUSED ANALYSIS OF THE PATCHWORK OF STATE LAWS 2018 Annual Report prepared by Americans for Safe Access AmericansForSafeAccess.org MEDICAL MARIJUANA ACCESS IN THE UNITED STATES A PATIENT-FOCUSED ANALYSIS OF THE PATCHWORK OF STATE LAWS 2018 Annual Report prepared by Americans for Safe Access Medical Cannabis By The Numbers................................................................................................................4 PREFACE: THE STATE OF THE STATES..........6 Medical Cannabis Timeline...................................................................................................................................10 INTRODUCTION.........................................................................12 Qualifying Conditions For State Medical Cannabis Program.............................................................14 The Medical Use Of Cannabis.............................................................................................................................18 State-By-State Grades................................................................................................................................................21 How States Were Evaluated.....................................................................................................................................21 CATEGORY 1: PATIENT RIGHTS AND CIVIL PROTECTIONS FROM DISCRIMINATION...22 Arrest Protection.............................................................................................................................................................23 Affirmative Defense......................................................................................................................................................23 Parental Rights Protections.....................................................................................................................................23 DUI Protections...............................................................................................................................................................23 Employment Protections...........................................................................................................................................23 Explicit Privacy Standards........................................................................................................................................24 Housing Protections.....................................................................................................................................................24 Does Not Create New Criminal Penalties for Patients...........................................................................24 Organ Transplants.........................................................................................................................................................24 Reciprocity..........................................................................................................................................................................24 CATEGORY 2: ACCESS TO MEDICINE..........26 Allows Distribution Programs..................................................................................................................................27 Noncommercial Cultivation.....................................................................................................................................29 Explicit Right to Edibles/Concentrates/Other Forms............................................................................30 Does Not Impose Limits or Bans on THC.....................................................................................................30 Does Not Impose Limits or Bans on CBD.....................................................................................................30 Local Bans/Zoning.......................................................................................................................................................30 CATEGORY 3: EASE OF NAVIGATION..........32 Comprehensive Qualifying Conditions.............................................................................................................33 Adding New Conditions............................................................................................................................................33 Reasonable Access for Minors ............................................................................................................................33 Reasonable Caregiver Background Check Requirements..................................................................33 Number of Caregivers.................................................................................................................................................34 Patient/Practitioner-Focused Task Force or Advisory Board............................................................34 Reasonable Fees for Patients & Caregivers..................................................................................................34 Allows Multiple-Year Registrations......................................................................................................................35 Reasonable Physician Requirements................................................................................................................35 Does Not Classify Cannabis as a Medicine of Last Resort................................................................35 2 CATEGORY 4: FUNCTIONALITY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Patients Able to Access Medicine at Dispensaries or Via Cultivation. . . . . . . . . . . . . 37 No Significant Administrative or Supply Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Patients Can Receive Legal Protections Within a Reasonable Time After Receiving Recommendation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Reasonable Possession Limit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Reasonable Purchase Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Allows Patients to Medicate Where They Choose. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Covered by Insurance or State Health Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Financial Hardship (Fee Waivers/Discount Medicine). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 CATEGORY 5: CONSUMER SAFETY AND PROVIDER REQUIREMENTS. . . . . . . . . . 40 Dispensaries. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Staff Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Standard Operating Procedures and Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Recall Protocol and Adverse Event Reporting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Product Labeling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Required Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Grow/Cultivation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Staff Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Standard Operating Procedures and Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Pesticide Guidance and Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Required Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Recall Protocol and Adverse Event Reporting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Manufacturing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Staff Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Standard Operating Procedures and Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Product Labeling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Required Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 Recall Protocol and Adverse Event Reporting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Laboratory Operations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Staff Training. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Method Validation in Accordance With AHP Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Result Reporting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Independent or Third Party. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Standard Operating Procedures and Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 State Medical Cannabis Program Regulations And Oversight. . . . . . . . . . . . . . . 54 STATE REPORT CARDS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 CONCLUSION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156 Grade Comparison Chart....................................................................................160 APPENDIX 1: MODEL LEGISLATION . . . . 162 APPENDIX 2: RECOMMENDATION TO REGULATORS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 3 MEDICAL CANNABIS MARIJUANAINACCESS AMERICA IN THE UNITED STATES MEDICAL CANNABIS BY THE NUMBERS 46 0 Deaths Caused by Cannabis States with Medical Cannabis Laws 2 MIL.+ $ 500 MIL.+ Medical Cannabis Patients in the U.S. Federal Tax Dollars Spent on Federal Interference in Medical Cannabis States before Rohrabacher-Farr CJS Amendment $ 9,000 Clinical Trial Data Using Cannabis for Pain in Patient Years 50+ Qualifying Medical Conditions in Medical Cannabis Programs 4 25% 30,000 Average Drop in Opiate Related Deaths in States with Medical Cannabis Laws Studies Published on the Endocannabinoid System 89% $ 165 MIL. Americans Supporting Medical Cannabis Federal Prescription Drug Cost Savings in Medical Cannabis States in 2013 66+ 100 MIL. Known Cannabinoids 128,000 Number of Americans Suffering from Chronic Pain Annual Deaths Caused by Prescription Drugs AmericansForSafeAccess.org 5 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES PREFACE: THE STATE OF THE STATES For over fifteen years, Americans for Safe Access (ASA) has engaged state and federal governments, courts, and regulators to improve the development and implementation of state medical cannabis laws and regulations. This experience has taught us how to assess whether or not state laws meet the practical needs of patients. It has also provided us with the tools to advocate for programs that will better meet those needs. Passing a medical cannabis law is only the first step in a lengthy implementation process, and the level of forethought and advance input from patients can make the difference between a well-designed program and one that is seriously flawed. One of the most important markers of a well-designed program is whether or not all patients who would benefit from medical cannabis will have safe and legal access to their medicine without fear of losing any of the civil rights and protections afforded to them as American citizens. The current medical cannabis industry is a byproduct of a movement of doctors, scientists, patients, their families, and policymakers advocating to allow patients, under the guidance of a healthcare professional, to use cannabis therapies. This effort started at the federal level and then, after encountering a series of roadblocks, moved to the changing of laws at the state level in the late 1990s. These early laws anticipated that patients would need to obtain their medicine from a legal market but provided no framework to make that happen. Laws that regulated the production and distribution of medical cannabis were not considered until the early 2000s. By the late 2000s, state legislators were including production and distribution programs as a matter of course. The first distribution models were non-profit, member-based collectives, with members supplying their excess cannabis and cannabis products to storefront operations. This model worked with smaller populations of patients, but as the patient population grew, the member-supplied model became more of a legal designation than the actual business model for the majority of distribution centers. In 2010, Colorado was the first state to classify medical cannabis distribution as a “business” regulated under the state’s Department of Revenue, formally creating the medical cannabis industry. Patient advocates recognized this transition would require more than just regulations for business licensing, anti-diversion protocols, taxation, and zoning. Like all commercial markets in the U.S., product safety protocols would also have to be adopted. While cannabis has been proven to be a safe, non-toxic medication, many things can happen during the commercial production of cannabis and cannabis products that have a risk of contaminating them. For instance, a 2016 study entitled Study of Pesticides in Cannabis Plant Clones found that “Less than 14% of 124 randomly selected clones from different regions were free of any pesticide residue, and 77.4% of the clones tested failed current proposed California Cannabis pesticide 6 THE CURRENT MEDICAL CANNABIS INDUSTRY IS A BYPRODUCT OF A MOVEMENT OF DOCTORS, SCIENTISTS, PATIENTS, THEIR FAMILIES, AND POLICYMAKERS ADVOCATING TO ALLOW PATIENTS, UNDER THE GUIDANCE OF A HEALTHCARE PROFESSIONAL, TO USE CANNABIS THERAPIES. regulations.”1 In this new marketplace, patients have the right to know how their medicine has been produced and verify that it is free of contaminants, as with other commercial products they consume. Patients should be confident that the medicine they are receiving has been handled with the highest quality of care. In 2011, ASA teamed up with the American Herbal Products Association (AHPA), the principal U.S. trade association and voice of the herbal products industry, to create industry-wide product safety protocols for commercial cultivation, manufacturing, distribution, and laboratory testing of medical cannabis products. In 2013, the American Herbal Pharmacopoeia (AHP) issued the Cannabis Inflorescence Monograph, a comprehensive description of the plant’s botany and constituent components. This specialized study by the world’s leading experts on the plant provides scientifically valid methods of testing the identity, purity, potency, and quality of cannabis products. Both the AHPA and AHP standards are rapidly being adopted by state regulators to ensure consumer safety. Today, we have a patchwork of medical cannabis laws across the United States. Thirty states, the District of Columbia, Guam, and Puerto Rico have adopted laws that created programs that allow at least some patients legal access to medical cannabis. Most of those thirty states provide patients with protections from arrest and prosecution as well as incorporate a regulated 1 Anthony Torres, et.al., Study of Pesticides in Clones, SteepHill available at https://landing.steephill.com/ cleanclones/ 7 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES production and distribution program. Several programs also allow patients and their caregivers to cultivate a certain amount of medical cannabis themselves. While it took a long time for states to recognize the importance of protecting patients from civil discrimination (employment, parental rights, education, access to health care, etc.), more and more laws now include these explicit protections. However, as of 2017, none of the state laws adopted thus far can be considered ideal from a patient’s standpoint. Only a minority of states currently include the entire range of protections and rights that should be afforded to patients under the law, with some lagging far behind others. Because of these differences and deficiencies, patients have argued that the laws do not function equitably and are often poorly designed, implemented, or both. As production and distribution models are implemented, hostile local governments have found ways to ban such activity, leaving thousands of patients without the access state law was intended to create. Minnesota, for example, despite setting up a regulatory system for the production, manufacturing, and distribution of cannabis oil extracts, prohibits qualified patients from using the actual plant. These laws include sanctions for qualified patients who seek to use their medicine in whole plant form, unnecessarily eliminating clinically validated routes of administration used by hundreds of thousands of patients. Some states have taken years to implement their medical cannabis laws leaving patients waiting years before their medicine is available. It took Maryland nearly five years before dispensaries became operational, and Florida’s program has been delayed in implementation by numerous lawsuits and administrative delays. In addition to DC, Guam and Puerto Rico and the thirty states that are commonly recognized as having viable medical cannabis laws, another sixteen states have adopted laws that only allow the possession of certain cannabis oil extracts rich in cannabidiol (CBD), one of many active compounds in medical cannabis. CBD is among the cannabinoids that have been shown to have a positive therapeutic effect on intractable seizure disorders, especially in young children. In 2017, Indiana joined the states with CBD-focused laws, leaving only Idaho, South Dakota, Nebraska and Kansas without any form of medical cannabis law. These CBD-focused laws apply to a small subset of patients and maintain the criminalization of patients accessing medical products that use any of the other therapeutic ingredients or compounds from the plant (except for Virginia and Georgia which allow the use of tetrahydrocannabinolic acid (THCA-A). The laws are intended to serve qualified patients, but serious questions remain regarding the production, manufacturing, or distribution of cannabis oil to those patients. Only a small minority of these laws create a system that supports the implementation of quality control and quality assurance programs for in-state production and access points, with the most glaring question being: how are patients expected to obtain a steady supply of medicine if they cannot obtain it in their own state? 8 BECAUSE OF THIS NEW PATCHWORK LANDSCAPE OF MEDICAL CANNABIS LAWS, IT IS NO LONGER PRACTICAL TO ASSESS OR EVALUATE STATE LAWS ON AN “UP/DOWN” BASIS. Because of this new patchwork landscape of medical cannabis laws, it is no longer practical to assess or evaluate state laws on an “up/down” basis. For example, patient advocates debate whether or not to call Louisiana a medical cannabis state, due to the strict limitations of that state’s law, and the fact the state still does not yet have an effective distribution system. Louisiana law ostensibly protects qualified patients from arrest and prosecution, but the state’s dispensing facilities (which are both academic institutions) have failed to become operational. Likewise, patient advocates have been reluctant to count those states that have adopted CBD-only laws as medical cannabis states because the protections offered extend only to a small set of patients using a certain type of medicine that may or may not be available at some point in the future. These distinctions are subtler than just a simple “yes” or “no” classification as a medical cannabis state. Legislative proposals must be evaluated for strengths and weaknesses on a case-by-case basis within their political context. What is feasible in one state, may be impossible in another. Sometimes, even the most supportive and compassionate legislators will make the mistake of passing laws that are overly restrictive and fail to adequately meet the needs of the patients they were intended to help. Other legislative and regulatory proposals are developed or implemented in bad faith with the intent of excluding patients and serving only the narrowest segment of that population. Flawed measures like these may technically be considered medical cannabis laws but are functionally inadequate. After hosting scores of community forums across the U.S. to gather input from patients on what issues are most important to them, ASA has created a matrix to deconstruct medical cannabis laws in order to evaluate and grade each component based on patient needs. Each year, more states adopt and improve medical cannabis laws, and it is ASA’s hope that state legislators and regulators will use this matrix to help them design comprehensive, functional laws and regulations for patients. LEGISLATIVE PROPOSALS MUST BE EVALUATED FOR STRENGTHS AND WEAKNESSES ON A CASE-BY-CASE BASIS WITHIN THEIR POLITICAL CONTEXT. 9 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS TIMELINE TOTAL STATES: 8 Alaska, California, Colorado, Hawaii, Maine, Nevada, Oregon, and Washington 1996-2002 PATIENTS 50,000 FEDERAL RAIDS: 14 13 Michigan, Montana, New Mexico, Rhode Island, and Vermont 2002-2008 PATIENTS 471,438 FEDERAL RAIDS: 241 1996 – DOJ threatens licenses of any doctor recommending cannabis following passage of first medical cannabis law. 2002 – Federal court rules in Conant v. Walters that government cannot revoke physicians’ licenses for recommending medical cannabis. 1996–2002 – DOJ and DEA carry out paramilitary raids. 2007 – DEA administrative law judge recommends allowing new source of cannabis for research. 1998 – The Institute of Medicine (IOM) issues “Marijuana & Medicine: Accessing the Science Base” calling on the federal government to do formal studies on cannabis. 1998 – Congress blocks DC law. 10 TOTAL STATES: TOTAL STATES: PLUS DC 20 Arizona, Delaware, District of Columbia, New Jersey, Connecticut, Massachusetts, New Hampshire, and Illinois 2009-2013 PATIENTS 1,073,596 FEDERAL RAIDS: 262 2009 – US Attorney General announces that DOJ will not prioritize prosecution of legal medical cannabis patients. 2011 – DOJ threatens elected officials in 11 states implementing cultivation and distribution programs. 2012 – AHP issues Cannabis Monograph and AHPA issues recommendations for regulators. 2013 – DOJ issues a guidance memo to prosecutors concerning marijuana enforcement under the Controlled Substance Act (CSA). 46 TOTAL STATES: PLUS DC, PUERTO RICO, AND GUAM Arkansas, Florida, Guam, Louisiana, Maryland, Minnesota, New York, North Dakota, Ohio, Pennsylvania, Puerto Rico, West Virginia CBD-only laws: Alabama, Georgia, Indiana, Iowa, Kentucky, Mississippi, Missouri, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Utah, Virginia, and Wisconsin 2014-2017 PATIENTS 2,000,000+ FEDERAL RAIDS: 2 2014 & 2015 – Rohrabacher-Farr CJS amendment passes and prohibits the Department of Justice from spending money to prevent states from implementing medical cannabis programs. 2015 – The CARERS Act, the first medical cannabis bill in US Senate history, is introduced. 2015 – Court upholds the Rohrabacher-Farr amendment in U.S. vs Marin Alliance for Medical Marijuana. 2016 – Court extends Rohrabacher-Farr protections to individuals in U.S. vs McIntosh. 2016 – DEA announces it will not move cannabis out of its Schedule I status. 2018 – Cole memo rescinded. AmericansForSafeAccess.org 11 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES INTRODUCTION As medical cannabis programs continue to develop around the country, states have begun to approach medical cannabis from a public health perspective rather than from a compassionate use prospective. While there was an upward trend of program improvements across the country in 2017, states are still not effectively using medical cannabis to solve public health issues. Using medical cannabis to treat chronic pain is an approach that is supported by research and medical professionals, and has demonstrated positive public health outcomes. Thirty states in the U.S. have passed medical cannabis laws and another sixteen have passed more limited laws. Medical cannabis programs on average are serving 2% of the population despite a potential addressable market of 1/3 of the population that are living with chronic pain. In November 2017, Americans for Safe Access launched a campaign entitled End Pain, Not Lives (EPNL). This campaign was born from research findings that medical cannabis can be used as a tool to help combat the opioid crisis in the U.S.. The opioid epidemic continues to claim over 100 lives a day. Numerous research studies show that states with medical cannabis programs have nearly a 25% decrease in opioid overdose deaths. In fact, more recent research suggests that this number is more towards 40%. However, medical cannabis, even in states that score well under ASA’s current framework, are not available to all patients due to federal-state legal conflict, inadequacies in state law, and lack of medical professional and patient education. In order to help states better address the opioid crisis, in evaluating 2018 laws and regulations, ASA will begin scoring state programs out of 600 points rather than out of 500 points. The additional points will be assessed on how states are using their medical cannabis programs in responding to the opioid crisis and increasing patient access. Unless significant changes are made to every state program to address the opioid crisis, there is a potential for many states to lose a letter grade or more. The following is the additional matrix for 2018-2019. Due to the fact that ASA launched its EPNL campaign late in 2017, states are not scored by or penalized for this new category in this report. However, the new category of “Opioid Response” should shape the decisions of policy makers and legislatures as they propose new laws in the coming year. ASA encourages lawmakers and regulators to utilize the report Medical Cannabis as a Tool to Combat Pain and the Opioid Crisis: A Blueprint for State Policy1 as a guide to help them better address the opioid crisis in their states. 2 Available online at http://www.safeaccessnow.org/opioidblueprint 12 WHILE THERE WAS AN UPWARD TREND OF PROGRAM IMPROVEMENTS ACROSS THE COUNTRY IN 2017, STATES ARE STILL NOT EFFECTIVELY USING MEDICAL CANNABIS TO SOLVE PUBLIC HEALTH ISSUES. Opioid Response - /100 Is Cannabis Available for Treatment? - /20 • Does the state allow for chronic pain as a qualifying condition without restriction? /10 • Does the state allow for opioid use disorder? /10 Doctor Education on the Medical Use of Cannabis - /20 • Is doctor education available through the State Department of Health? /10 • Is opioid-cannabis education mandated? /10 Can Pain Patients Use Cannabis? - /10 • Has the state acknowledged the 2016 CDC guidelines on not testing for THC? /2 • Has the state issued specific guidance about testing for THC and other cannabinoids in pain patients? /8 Can Pain Patients Access Medical Cannabis? - /20 • Is there same day access with doctor’s recommendation? /5 • Are there sufficient delivery methods available? /5 • Does the state allow those with previous convictions for drug offenses to be patients and/or caregivers? /5 • Can patients use their medical cannabis in home health facilities, hospices, and treatment centers? /5 Can the Patient Afford Medical Cannabis? - /20 • Is medical cannabis exempt or taxed at the rates of other medicines? /5 • Are ID Cards affordable? /5 • Veteran discount? /2.5 • Low income discount? /2.5 • Is medicine affordable? /5 • Are the “implied” costs of medical cannabis removed? /5 Research - /10 • Are there sufficient research & development tax breaks for medical cannabis facilities? /5 • Does the state promote research? /5 13 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES QUALIFYING CONDITIONS FOR STATE MEDICAL CANNABIS PROGRAMS CONDITIONS AK AL AR AZ CA Alzheimer’s Disease (including agitation of ) X X * Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s Disease) X X Admittance into Hospice Care CO CT DE FL GA * X X X * * X * * * “Any other condition that is severe and resistant to conventional medicine” X DC * X GU HI IA IL X * X * * * * Anorexia X * * X * X LA MA ** * X ** X X ** * ** * ** * ** * ** * ** * * Arnold-Chiari Malformation KY X Anxiety Disorders such as Generalized Anxiety Disorder (GAD) Arthritis/Fibromyalgia X Autism X Cachexia or Wasting Syndrome X X X X X X * X Cancer X X X X X X * X Causalgia (Complex Regional Pain Syndrome (CRPS) Type 2) * Cerebral Palsy * Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Chronic Pancreatitis Chronic Traumatic Encephalopathy (CTE) Crohn’s Disease X X * * X X X * * * * * * * * * * * * * * X X X X ** X * X ** X X X ** * ** * ** * ** * X * X X * ** X * X ** X X X ** * ** * ** * Complex Regional Pain Syndrome (CRPS)/Reflex Sympathetic Dystrophy (RSD) * X * * Cystic Fibrosis * X * * Damage to the nervous tissue of the spinal cord w/objective neurological indication of intractable spasticity * X * * Decompensated Cirrhosis * * * ** * Degenerative or Pervasive Neurological Condition * * * ** * Dystonia * * * X ** * Fibrous Dysplasia * * * X ** * Glaucoma X Hepatitis C HIV/AIDS X X X X X X * X X X X X X * X * X * * * * * * * * * * * * * Huntington’s Disease Hydromyelia Inflammatory Bowel Disease or Irritable Bowel Syndrome (IBS) X * X X * X Hydrocephalus * California, Guam, Massachusetts, and the District of Columbia authorize X X * X X ** X X ** X X ** X ** X X ** * X ** * ** * * # Minnesota allows for cancer or terminal illness only if they produce at least one physicians to determine qualifying conditions in addition to the conditions of the following: severe or chronic pain, nausea or severe vomiting, or cachexia or explicitly stated in each state’s law. severe wasting; New Jersey treats cancer and HIV/AIDS similarly. ** Kentucky does not restrict available conditions for CBD, but does not authorize THC, and therefore might not be able to adequately treat many conditions. *** Maryland requires that physicians register for the conditions a given physician can write recommendations for, but allows that a physician could be approved to recommend for any condition if approved by the state Commission. Commission is highly encouraged to approve applications for conditions noted with an “X.” 14 * X QUALIFYING CONDITIONS FOR STATE MEDICAL CANNABIS PROGRAMS MD ME MI MN *** X X X X X MT MS NC ND NH NJ NM X X X X X X X NV NY OH X X OK OR PA X PR RI TN TX UT VA VT WA X X WV WI WY X X X X *** *** X # X X X *** X X X X *** X X *** X X X X # X X X # X X X X # X X X X X X X X X X X X X X X X X X *** *** *** *** X *** X X X X X X X X *** *** *** X X X X *** *** X *** *** X X X X X X X X X X X X X X X X X X X X X X X # X X X X X X X X X X X X X X X X X X *** *** X X X *** *** X X X Source: State Laws and Regulations available at http://www.safeaccessnow.org/state_and_federal_law 15 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES QUALIFYING CONDITIONS FOR STATE MEDICAL CANNABIS PROGRAMS (CONTINUED) CONDITIONS AK AL AR AZ CA CO CT DC DE FL GA GU Interstitial Cystitis * * * Inclusion Body Myositis * * * Lupus * Migraine X Mitochondrial Disease * Multiple Sclerosis (MS) or persistent muscle spasms, including spasms associated with MS X X X X X X X IA KY X ** * ** * MA * ** * * ** * X * ** * X X X X LA * * X IL * * X HI X X ** X * X * Muscular Dystrophy * * * X ** Nail–patella Syndrome (NPS) * * * X ** * Neurofibromatosis * * * X ** * Neuropathesis * * * ** * One or more injuries that significantly interferes with daily activities as documented by the patient’s provider * * * ** * Other conditions as determined in writing by a qualifying patient’s physician X * * ** * * ** * * ** * Obstructive Sleep Apnea Pain: Chronic Pain or Pain Pain: Severe Pain X X X Pain: Intractable Pain X * X * * X * * Parkinson’s Disease X X * * X X * * * * Polyneuropathy * * * Post Laminectomy Syndrome with Chronic Radiculopathy * X * * X * Post-Traumatic Stress Disorder (PTSD) X X Residual Limb Pain (RLP) * X * X X X * Seizure Disorders/Epilepsy X X X X X X Severe Nausea X X X X X X X X * * X * X X X X X * X X ** * X ** X ** * X ** * ** * X ** * X ** * X ** * X * Sickle Cell Disease * X * Sjogren’s Syndrome * * * Spasmodic Torticollis or Cervical Dystonia * * * Spastic Quadriplegia * * * ** Spinal Cord Injury (SCI) or Spinal Cord Disease, including but not limited to Arachnoiditis * * X Spinal Stenosis * * * Spinocerebellar Ataxia (SCA) * * Syringomyelia * Tarlov Cysts or Perineural Cysts * Terminal Illness w/less than 12 months of life * X X ** Severe Psoriasis and Psoriatic Arthritis * * * ** * * ** * ** * ** * X X * X ** ** * * X ** * * * X ** * * * X ** * * * ** * * * * X ** * * * * X ** * Traumatic Brain Injury (TBI) and Post-Concussion Syndrome * * * X ** * Ulcerative Colitis * * * ** * Terminal Illness w/less than 6 months of life Tourette Syndrome (TS) X * California, Guam, Massachusetts, and the District of Columbia authorize physicians to determine qualifying conditions in addition to the conditions explicitly stated in each state’s law. ** Kentucky does not restrict available conditions for CBD, but does not authorize THC, and therefore might not be able to adequately treat many conditions. *** Maryland requires that physicians register for the conditions a given physician 16 * * Peripheral Neuropathy X can write recommendations for, but allows that a physician could be approved to X X * recommend for any condition if approved by the state Commission. Commission is highly encouraged to approve applications for conditions noted with an “X.” # Minnesota allows for cancer or terminal illness only if they produce at least one of the following: severe or chronic pain, nausea or severe vomiting, or cachexia or severe wasting; New Jersey treats cancer and HIV/AIDS similarly. QUALIFYING CONDITIONS FOR STATE MEDICAL CANNABIS PROGRAMS MD ME MI MN MT MS NC ND NH NJ NM NV NY OH OK OR PA PR RI TN TX UT VA VT WA WV X X X X X X WI WY X X *** *** X *** *** X X *** *** X X X X X *** *** X X X X X X X X X X X X X *** *** X X X *** X *** *** X *** X X X *** X X X X X X X X X X X X X *** X X X X X X X X X *** *** *** X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X *** X X X X X X X X X X X X X X X *** *** X *** *** X *** *** X *** X X *** *** *** *** # X X *** *** *** *** X X X X X 17 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES THE MEDICAL USE OF CANNABIS TRICHOMES Resin-filled glands that contain the majority of the THC in a cannabis plant. They are typically a cloudy white color. Inflorescence Cannabis (flower) DELIVERY METHODS PATIENTS USE MANY METHODS TO TAKE CANNABIS. THE METHOD USED CAN DEPEND ON PERSONAL CHOICE, THE MEDICAL CONDITION BEING TREATED, THE AGE OF THE PATIENT, THE PATIENT’S TOLERANCE FOR THE METHODS, ETC. INHALATION Types of products: whole plant, oils, waxes, and concentrates Expected onset: 0-10 minutes Duration: 1-4 hours   INGESTION Product types: edible products, beverages, teas, capsules Expected onset: 30 to 90 minutes Duration: Up to 8 hours BENEFIT Anti-inflammatory, immunomodulatory, neuroprotective and anti-cancer THC-A BENEFIT Effective against MRSA, sedative, topical analgesic for burns, may stimulate bone growth CBN TOPICAL Product types: lotions, salves, oils Expected onset: a few minutes Duration: 1-4 hours ECS: EAT, SLEEP, RELAX, FORGET, AND PROTECT BUCCAL The endocannabinoid system is the body’s mechanism for preserving homeostasis, keeping all body functions running smoothly. This system is composed of a sophisticated group of neuromodulators, their receptors, and signaling pathways, involved in regulating a variety of physiological processes including movement, mood, memory, appetite, and pain. Product types: alcohol-based tinctures, lozenges Expected onset: 0-60 minutes Duration: 1-8 hours The endocannabinoid system is probably the most ubiquitous system in the human body, with the cannabinoid receptors CB1 and CB2 located throughout the brain and the periphery of the body. 18 CANNABINOIDS & TERPENOIDS CBD LIMONENE BENEFIT Non-psychotropic, antidepressant, anti-inflammatory, anti-convulsant, antinausea, anti-anxiety, analgesic, sedative, sleep aid and muscle relaxant LEMON Potent immunostimulant via inhalation, anxiolytic, apoptosis of breast cancer cells and acne bacteria SYNERGISTIC CANNABINOIDS: CBD, CBG, THC α-PINENE PINE Anti-inflammatory, bronchodilatory, acetylcholinesterase inhibitor (aiding memory) SYNERGISTIC CANNABINOIDS: CBD, THC β-MYRCENE THC BENEFIT Psychotropic, analgesic, anti-inflammatory, anti-microbial, muscle relaxant HOPS Blocks inflammation, analgesic, sedative, muscle relaxant, hypnotic, blocks hepatic carcinogenesis by aflatoxin SYNERGISTIC CANNABINOIDS: CBD, CBG, THC LINALOOL LAVENDER Anti-anxiety, local anesthetic, analgesic, anticonvulsant/anti-glutamate SYNERGISTIC CANNABINOIDS: CBD, THC, THCV, CBDV β-CARYOPHYLLENE CBC BENEFIT Anti-inflammatory, analgesic, anti-anxiety, antidepressant PEPPER Gastric cytoprotective, anti-malarial, selective CB2 agonist, anti-inflammatory SYNERGISTIC CANNABINOIDS: THC NEROLIDOL ORANGE CBG BENEFIT Muscle relaxant, antieurythmic, analgesic, digestive aid PHYTOL GREEN TEA YEARLY DEATHS 2017 OPIOIDS 42,249 + Over half from prescribed opioids PRESCRIPTION DRUGS 14,400 + (Source: CDC 2017) Sedative SYNERGISTIC CANNABINOIDS: THC, CBN CANNABIS 0 GABA via SSADH inhibition SYNERGISTIC CANNABINOIDS: CBG POTENTIAL SIDE EFFECTS Sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression, death POTENTIAL SIDE EFFECTS Liver failure, loss of language, cognitive decline, respiratory depression, rage, suicide, paranoia, death POTENTIAL SIDE EFFECTS Dry mouth, dizziness, increased appetite, dry eyes, sedation, euphoria, disorientation/short-term memory impairment AmericansForSafeAccess.org 19 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES 20 STATE-BY-STATE GRADES OVERVIEW STATE-BY-STATE GRADES The grade for each state’s medical cannabis program is based on how well it meets the needs of patients in five categories, worth 100 points each, described in detail in the pages that follow. Up to 35 bonus points were also awarded to states that made statutory or regulatory improvements, or prevented harmful changes from taking effect. Due to the incredible volume of bills in state legislatures, only laws passed and regulations promulgated between January 1, 2017 and December 31, 2017 were considered as additions to state programs. HOW STATES WERE EVALUATED Each state was scored based on how well their current law and regulations accommodate patient needs, as broken down in five general categories: 1. Patient Rights and Civil Protection from Discrimination 2. Access to Medicine 3. Ease of Navigation 4. Functionality 5. Consumer Safety and Provider Requirements As mentioned in the introduction, ASA developed these criteria based on a series of over 100 public meetings across the U.S. as well as surveys of our 100,000+ members. With laws and regulations changing daily, this system is a living and ever-changing document. ASA has had to amend this report several times since we began its writing, and we expect that some of this information will be out of date as soon as ink hits paper. The criteria we selected reflect the current realities of state medical cannabis laws. Definitions for each item can be found below. States that partially met the definition for certain criteria, either directly or indirectly, were eligible for partial points when appropriate. Each category was broken down into the key components and scored. On pages 25–55 are detailed descriptions of each item under the 5 categories listed above. 21 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES 4. EM ILITATIBUS EAQUE OCCUM Category Ecatempo riasse reptus min nos dem est lamet quid que porit libus. Riberna turion nat. Od ut quis dis velit et ad que voluptis reperat emporeperem ipsam est etur, quia nonsectaspid molorenda quatis sequissunt idi arionseque asit odias se nimporu pienis mollab ipsanihillab id magnis enducipsapis alit ipietur? Quiatio occus non perovid magnis am faccus magnis con coreptatem andem lam eumquis eossinc tiatur? Em et hita siminis velessunt, est es re nobit eost volesti onsendes digenducimo doluptati dolorum harcia nusandis dolessus sam rerovident hitia m quae et et experibus comnimusam alignatquiam int dolore nem volento blandicabor repudae sint verio optatem porumque parchillecae parum reped ut ipsa nihici aspiciati nitium liti aut et porit, ommos moluptatior autem velitatianis im et post illaut apedion comni arum dersperum dolupta musdam que quodio. Ut et odis ea nus. 1 PATIENT RIGHTS AND CIVIL PROTECTIONS FROM DISCRIMINATION erorepel est re, cum aut laut vel is autem cuptat et D earibus, am, et quis ea conecul laboribus, offic tempor sed quo maxime prepuda essint ut eic tem hicatur, quat laccum audamusa cor aut est, corem gentureptur simpore corunt re core non non re prae resendero cus ate porro cor sunt, dam, eicto temperum faccusam idesseq uatures aceriaeperum faccus aut et ut officimus eiunt pa qui oditaque quidendus dolut minum qui vent eicit lab intus. Em ilitatibus eaque occum ut dolor rehent quamentem ad qui totatur recullu ptibus voluptae seque volore rectin pliquid quis mosam utes et arit, ommollores conse essitio nsequae aut ut ea que quam vollupt ARREST PROTECTION – 40 PTS aerorep ediscipsant volupti nemquia adi quis doluptis AFFIRMATIVE DEFENSE dit – 15 PTSdenture esectuuae excera dollicatusam excero PARENTAL RIGHTS PROTECTIONS – 10 PTS pernam, solestibus nostisciam facee pelest qui raectat ioresti omnihit preium il ipid modiore volupti asitat DUI PROTECTIONS – 5 PTS occum quatiissam, sam, officti as maximusam, a sim ad EMPLOYMENT PROTECTIONS – 5 PTS ut atenihilici doluptur? dolupta nonse a doluptiat. EXPLICIT PRIVACY STANDARDS – 7 PTS HOUSING PROTECTIONS – 5 PTS DOES NOT CREATE NEW CRIMINAL PENALTIES FOR PATIENTS – 5 PTS ORGAN TRANSPLANTS – 5 PTS RECIPROCITY – 3 PTS 22 CATEGORY 1 Arrest Protection 40 pts DOES THE LAW SUFFICIENTLY PROTECT PATIENTS FROM ARREST? 15 pts DOES THE LAW OFFER A CLEAR AFFIRMATIVE DEFENSE IN STATE COURT? An affirmative defense refers to a criminal defendant’s right to argue medical necessity or compliance with state law as a defense in state court. With an affirmative defense, the burden is on the defendant to prove that they were not in violation of the law. Ideally, a state will afford a necessity defense for medical cannabis conduct that does not conform to the strict limits of the state law: for example, possessing amounts above the statutory limit in order to have a consistent supply of medicine. Some states have an implied affirmative defense within their arrest protection. Parental Rights DUI Protections 5 pts DOES THE LAW RECOGNIZE THAT PATIENTS MAY HAVE RESIDUAL THC METABOLITES IN THEIR BLOODSTREAM WITHOUT BEING IMPAIRED? Arrest protection refers to explicit legislative language that instructs law enforcement to refrain from arresting individuals who are in compliance with state law. Affirmative Defense PATIENT RIGHTS AND CIVIL PROTECTIONS FROM DISCRIMINATION 10 pts ARE PARENTS AT RISK OF LOSING THEIR CHILDREN IN A CHILD CUSTODY PROCEEDING BASED ON THEIR PATIENT STATUS? Most states list marijuana possession and cultivation as an indication of child abuse and/or neglect. Explicit protections against such assumptions can and should instruct state agencies and family courts to recognize that a parent’s status as a medical cannabis patient should not be a determining factor in any CPS or court intervention, including those altering parental rights. States that set an “unreasonable danger” standard or have similar provisions should include clear guidance that a patient acting in accordance with the state law is not creating an unreasonable danger. Many states allow their Driving Under the Influence (DUI) or Driving Under the Influence of Drugs (DUID) statutes to be used as a means of penalizing drivers who are medical cannabis patients, even without evidence of impairment while driving. An individual’s participation in a state medical cannabis program should not constitute probable cause for a sobriety test, nor should the presence of cannabis metabolites in the body-which can be detected days or weeks after last use-indicate actual impairment. By treating cannabis like any other medication under a state’s DUI or DUID laws, patients will still be prohibited from driving while impaired or using cannabis while driving, but patients will not be unnecessarily subjected to arrest and prosecution solely for being a medical cannabis patient or having metabolites in their bodies. Employment Protections 5 pts CAN AN EMPLOYEE BE FIRED MERELY FOR BEING A PATIENT OR FOR HAVING CANNABIS IN THEIR SYSTEM, IF IT DOES NOT AFFECT THEIR JOB PERFORMANCE? An individual’s status as a medical cannabis patient or a positive test for cannabis metabolites should not be an employer’s sole basis for either refusal to hire or dismissal of that person. Because of their regular cannabis use, most patients will test positive without being impaired. Medical cannabis use should be treated like any other prescription medication under state law. While some states have explicit protections, many laws are inadequate in providing necessary safeguards against employment discrimination. Despite concerns to the contrary, it is possible to provide workplace protections for patients while adhering to the federal drug-free workplace requirements that certain employers must meet, and many states have successfully done so. 23 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES Explicit Privacy Standards 7 pts ARE PATIENTS’ MEDICAL RECORDS KEPT PRIVATE FROM ACCESS BY LAW ENFORCEMENT AND RISK FROM EXPOSURE TO THIRD PARTIES? Medical cannabis patients deserve the same healthcare privacy rights as all other patients in the U.S. but these rights are often abridged. Information about patients, caregivers, or healthcare providers contained in a registry should be kept confidential in perpetuity and unneeded data should be destroyed. Some states explicitly protect patient information and some have even criminalized privacy violations. The unsanctioned release of registry information should carry substantial administrative penalties. Housing Protections 5 pts CAN LANDLORDS EVICT PATIENTS FROM THEIR HOMES BASED ON THEIR MEDICAL STATUS? Patients who use medical cannabis should not have to live in fear of losing their housing. Patients have routinely been evicted from public and private housing in medical cannabis states that have not created explicit protections against such discrimination. While some states do protect patients from housing discrimination, the federal government has left decisions to the discretion of local housing authorities. Does Not Create New Criminal Penalties for Patients 5 pts DOES THE MEDICAL ACCESS LAW SUBJECT PATIENTS TO NEW CRIMINAL MISDEMEANORS OR FINES? Some states create new criminal penalties related to their medical cannabis programs, including fraudulent use of the medical cannabis program (i.e. diversion), 24 violation of privacy provisions, and falsely identifying oneself as a participant in the medical cannabis program. Non-medical use or possession of cannabis is already a crime in all but nine states and the District of Columbia. Organ Transplants 5 pts ARE PATIENTS EXPLICITLY PROTECTED FROM BEING DISCRIMINATED AGAINST RECEIVING AN ORGAN TRANSPLANT? Several hospitals in the U.S. have removed medical cannabis patients from their organ transplant lists after the patients tested positive for marijuana. This exclusionary practice is based on outdated policies with no scientific basis that assume cannabis use automatically indicates substance abuse and therefore, poses a danger that the transplanted organ will be rejected. Transplant candidates should not be forced off the treatment a doctor has recommended while they wait for life-extending measures. Reciprocity 3 pts ARE PATIENTS WHO ARE LEGALLY RECOGNIZED IN THEIR HOME JURISDICTION PROTECTED WHEN VISITING THE STATE? Reciprocity refers to laws providing some measure of legal protection for non-resident medical cannabis patients. These laws generally require that patients carry documentation of their status in their home state’s program. Reciprocity is important for traveling patients, patients who are seeking specialty treatments, or those who need to stay in the care of friends or family out of state, as many state medical cannabis programs require residency for participation or legal protections. PATIENT RIGHTS AND CIVIL PROTECTIONS FROM DISCRIMINATION MEDICAL MARIJUANA ACCESS IN THE UNITED STATES 4. EM ILITATIBUS EAQUE OCCUM Category Ecatempo riasse reptus min nos dem est lamet quid que porit libus. Riberna turion nat. Od ut quis dis velit et ad que voluptis reperat emporeperem ipsam est etur, quia nonsectaspid molorenda quatis sequissunt idi arionseque asit odias se nimporu pienis mollab ipsanihillab id magnis enducipsapis alit ipietur? Quiatio occus non perovid magnis am faccus magnis con coreptatem andem lam eumquis eossinc tiatur? Em et hita siminis velessunt, est es re nobit eost volesti onsendes digenducimo doluptati dolorum harcia nusandis dolessus sam rerovident hitia m quae et et experibus comnimusam alignatquiam int dolore nem volento blandicabor repudae sint verio optatem porumque parchillecae parum reped ut ipsa nihici aspiciati nitium liti aut et porit, ommos moluptatior autem velitatianis im et post illaut apedion comni arum dersperum dolupta musdam que quodio. Ut et odis ea nus. ACCESS TO MEDICINE 2 erorepel est re, cum aut laut vel is autem cuptat et D earibus, am, et quis ea conecul laboribus, offic tempor sed quo maxime prepuda essint ut eic tem hicatur, quat laccum audamusa cor aut est, corem gentureptur simpore corunt re core non non re prae resendero cus ate porro cor sunt, dam, eicto temperum faccusam idesseq uatures aceriaeperum faccus aut et ut officimus eiunt pa qui oditaque quidendus dolut minum qui vent eicit lab intus. Em ilitatibus eaque occum ut dolor rehent quamentem ad qui totatur recullu ptibus voluptae seque volore rectin pliquid quis mosam utes et arit, ommollores conse essitio nsequae aut ut ea que quam vollupt aerorep ediscipsant volupti nemquia adi quis doluptis esectuuae excera dollicatusam dit excero denture pernam, solestibus nostisciam facee pelest qui raectat ioresti omnihit preium il ipid modiore volupti asitat occum quatiissam, sam, officti as maximusam, a sim ad ALLOWS DISTRIBUTION PROGRAMS – 40 PTS ut atenihilici doluptur? dolupta nonse a doluptiat. NONCOMMERCIAL CULTIVATION – 20 PTS EXPLICIT RIGHT TO EDIBLES/CONCENTRATES/OTHER FORMS – 10 PTS DOES NOT IMPOSE LIMITS OR BANS ON THC – 10 PTS DOES NOT IMPOSE LIMITS OR BANS ON CBD – 10 PTS LOCAL BANS/ZONING – 10 PTS 26 CATEGORY 2 Allows Distribution Programs ARE THERE LOCATIONS WHERE PATIENTS CAN LEGALLY PURCHASE MEDICINE? While most states regulate the production and distribution of medical cannabis, some states have failed to do so. ASA has found that a majority of patients rely on local dispensaries and that access to medical cannabis in states without licensed dispensaries is severely limited. Many patients do not have the time, skills, or resources to cultivate their own medicine, and cultivation is not a solution for a patient who needs medicine sooner rather than later. It is imperative that states provide for regulated distribution if they wish to have a functional, effective medical cannabis program. States that have taken measures for the implementation of dispensary programs were awarded partial points. Allows Access to Dried Flowers 40 pts 15 pts DOES THE STATE PROHIBIT ACCESS TO THE MOST COMMONLY USED FORM OF CANNABIS? A majority of medical cannabis states have allowed patients access to the dried flowers of whole-plant cannabis either for direct inhalation or to process their own medicated edibles or concentrates. However, a few states have limited access to dried flowers in favor of non-inhaled cannabis preparations. This is the most obvious flaw in the New York and Minnesota programs, but it is also part of many of the “CBD-only” laws that restrict patients to a manufactured product only. ASA’s experience shows that restricting patients from wholeplant cannabis use can prevent patients from accessing the most effective medicine for their particular condition and can make proper dosing more difficult to achieve. ACCESS TO MEDICINE Allows Delivery 5 pts DOES THE STATE LAW ALLOW FOR THE DELIVERY OF MEDICAL CANNABIS TO LEGAL PATIENTS? Many legal medical cannabis patients cannot travel to access points to receive medical cannabis due to physical, economic, or time constraints. This is especially problematic for legal patients who are in the hospital, are bedridden, or live far from an access point. Allowing for delivery of medicine is a compassionate and common-sense solution for these patients. Common-sense protocols can be used to ensure safety and discretion. There is no evidence to show that delivering medicine leads to crime or diversion of medical cannabis for nonmedical use. States should be clear that provisions allowing for “delivery” refer to home delivery rather than the criminal law context of delivery of a controlled substance. No Sales Tax or Reasonable Sales Tax 5 pts IS MEDICAL CANNABIS EXEMPT FROM SALES TAX OR IS THE TAX RATE REASONABLE? Medical cannabis is real medicine that millions of Americans use to treat serious medical conditions such as cancer, HIV/AIDS, chronic pain, and more. Unfortunately, medical cannabis is generally more expensive than other medication and not currently covered by any public or private insurance policies. Ideally, this medicine would be exempt from sales tax to ease the financial burden on legal patients. Taxation of medicine should be avoided, but when necessary, it should be reasonable. ASA recommends taxation that is comparable to similar products – herbal medicine, over-the-counter remedies, etc. Excessive sales tax is a financial hardship and may compel some patients to buy medical cannabis in the unregulated illicit market. 27 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES Allows for a 5 pts Reasonable Number of Dispensaries DOES THE STATE BURDEN PATIENTS BY PLACING SIGNIFICANT LIMITS ON THE NUMBER OF LOCATIONS WHERE THEY MAY OBTAIN THEIR MEDICINE? Ownership/ 2 pts Employ­ment Restrictions Safe, affordable access is directly related to the number of dispensaries in any given geographical area. When there are insufficient dispensaries, the cost of medical cannabis goes up while the quality of care goes down. Limitations or arbitrary caps on the number of dispensaries should be avoided. When limits are imposed, they must account for patients who live outside urban areas and those with mobility issues or who are confined to their homes. Does Not Require 2 Vertical Integration pts DOES THE STATE REQUIRE THAT DISPENSARIES MUST GROW THEIR OWN MEDICINE? Vertical integration refers to the requirement that distribution centers also cultivate and manufacture all or most of their products. While vertical integration allows producers to maximize cost effectiveness, it can also lead to supply problems and increased costs for consumers. ASA’s experience has shown that vertical integration is a decision best left to each individual provider. 28 ARE PEOPLE WITH PRIOR MARIJUANA OFFENSES OR OTHER MISDEMEANORS OR FELONIES PROHIBITED FROM BEING MEDICAL CANNABIS PROVIDERS? Ownership and employment restrictions related to cannabis businesses are commonly included in legislation. Most restrictions on ownership of medical cannabis businesses stem from background check procedures. These types of restrictions disproportionately impact people of color and have a discriminatory effect. Marijuana-related convictions should not automatically exclude a person from ownership of or employment by a medical cannabis business; instead, each individual should be considered on a case-by-case basis. Provisions for Labor 2 pts Standards ARE EMPLOYEES OF MEDICAL CANNABIS BUSINESSES AFFORDED PROTECTIONS?  Workplace safety and employment standards should be part of the development and implementation of medical cannabis laws, including consideration of such issues as living wages, sick pay, a standard 40hour work week, as well as health care coverage and other benefit packages. These provisions should also cover a neutrality, recognition, or existing collective bargaining agreement with a certified labor union. CATEGORY 2 Environmental Impact Regulations 2 pts Noncommercial Cultivation DOES THE STATE HAVE SPECIFIC REQUIREMENTS FOR MEDICAL CANNABIS PROVIDERS IN TERMS OF THEIR IMPACT ON THE ENVIRONMENT? ARE PATIENTS REQUIRED TO DESIGNATE A SINGLE DISPENSARY WHERE THEY MAY ACQUIRE MEDICINE? Some states require that patients designate a single dispensary from which they may acquire their medicine. While such an approach may be easier to regulate, it can result in patients bearing artificially high costs, reduced choice in available strains and products, and extra expense and bureaucracy. 20 pts Personal 15 pts Cultivation ARE PATIENTS ALLOWED TO GROW THEIR OWN MEDICINE? ASA places a premium on policies that encourage sustainable practices, including the implementation of best management practices that promote environmentally sound production and processing methods that reduce the potential for high-carbon footprints by allowing open air, row cover, and greenhouse methods of cultivation. States should avoid restricting the ability for cultivators to utilize natural sunlight. Choice of 2 pts Dispensary Without Restrictions ACCESS TO MEDICINE Unfortunately, states have been moving to limit personal cultivation by patients and their caregivers, restricting and, in some cases, completely obstructing access to medical cannabis. In states that have relied exclusively on regulated production and distribution programs, patients have frequently been left without any options if those programs fail to meet the basic needs of proximity, affordability, safety, or privacy. Collective 5 pts Gardening CAN SEVERAL PATIENTS FORM A GROUP TO MUTUALLY GROW THEIR MEDICINE, IN ORDER TO OFFSET COSTS AND BEST UTILIZE.SHARED EXPERTISE? Allowing experienced caregivers to cultivate for a limited number of patients can ensure adequate access to a reliable supply of safe, affordable medicine. Collective gardens intended strictly for private consumption among a small group of patients should not be subject to regulatory authority, provided the activity remains noncommercial. Collective gardening is not associated with dispensaries or other commercial businesses that engage in sales, advertising, or trade. States without explicit collective gardening rights but that do allow individual caregivers to grow for more than one patient were eligible for partial points in this category. 29 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES Explicit Right to Edibles/Concentrates/ Other Forms 10 pts ARE PATIENTS EXPLICITLY ALLOWED TO OBTAIN FORMS OF CANNABIS OTHER THAN DRIED FLOWERS? 10 pts DOES THE STATE REQUIRE THAT ALL FORMS OF MEDICAL CANNABIS MUST HAVE A MINIMUM CBD LEVEL? Some states explicitly provide for the manufacture and use of edible products or concentrated forms of medical cannabis. Some states do not explicitly allow these forms of medicine, but may tolerate the sale and production of such items. Edibles are important, as this form of administration is ideal or preferred for certain ailments and can offer ease of use for certain patients. States without this explicit right but that allow for availability of these products in practice were eligible for partial points. While tolerance is better than denying access to alternative forms, clear guidance is optimal, and ASA encourages states to protect and regulate the manufacturing, use, and distribution of edible and concentrated medical cannabis products. Some states have passed “CBD-enriched” or “CBDonly” legislation. The legislative intent behind this has been to eliminate the intoxicating properties of cannabis, however these preparations only benefit a small portion of a state’s patient population because CBD has been shown to work more effectively in tandem with other plant components. Even among the minority of patients who can benefit from low-THC preparations, minimum CBD requirements restrict access to the ratios of CBD to THC that may work best for them. For example, while some pediatric patients with seizure disorders benefit greatly from 30:1 ratios, other children will respond better to 1:1 ratios (and anything in between or beyond). Imposing arbitrary cannabinoid level minimum requirements are not rooted in science and provide no benefit to the public health of a state. Does Not Impose Limits or Bans on THC Local Bans/Zoning 10 pts DOES THE STATE HAVE A MAXIMUM LEVEL OF THC ALLOWED IN STRAINS OR INFUSED PRODUCTS? THC is a proven therapeutic component of the cannabis plant that the FDA has recognized for medical use and has been demonstrated to work in synergy with other important therapeutic cannabinoids such as cannabidiol (CBD). States that have passed so-called “CBD-only” legislation, which generally are better described as “low-THC” programs, have imposed arbitrary limits on the amount of THC permitted in the medical preparation or enacted outright bans. THC has far more proven medical applications than CBD alone, and CBD has been shown to work more effectively in tandem with other plant components like THC. 30 Does Not Impose Limits or Bans on CBD 10 pts DOES THE STATE LAW ALLOW LOCAL JURISDICTIONS TO BAN MEDICAL CANNABIS BUSINESSES OR TO USE ZONING LAWS TO EXCLUDE THEM? Cities and counties have a legitimate role in regulating land use within their borders. In some states, however, local governments can ban medical cannabis activity that is allowed under state law. In other cases, cities and counties have used local zoning regulations to effectively exclude medical cannabis businesses. Local bans and onerous zoning regulations are harmful to patients, because they cut off legitimate access to medicine for legal patients. Research conducted by ASA and our experience with local regulations over the last 19 years has shown that sensible regulations preserve legal access for legitimate patients, while reducing crime and complaints in communities. An ideal state law would limit or eliminate the right of local jurisdictions to ban medical cannabis activity, while preserving the city or county’s authority to adopt reasonable local zoning rules. Category EASE OF NAVIGATION 3 COMPREHENSIVE QUALIFYING CONDITIONS – 50 PTS ADDING NEW CONDITIONS – 10 PTS REASONABLE ACCESS FOR MINORS – 10 PTS REASONABLE CAREGIVER BACKGROUND CHECK REQUIREMENTS – 4 PTS NUMBER OF CAREGIVERS – 2 PTS PATIENT/PRACTITIONER-FOCUSED TASK FORCE OR ADVISORY BOARD – 2 PTS REASONABLE FEES FOR PATIENTS & CAREGIVERS – 10 PTS ALLOWS MULTIPLE-YEAR REGISTRATIONS – 2 PTS REASONABLE PHYSICIAN REQUIREMENTS – 5 PTS DOES NOT CLASSIFY CANNABIS AS A MEDICINE OF LAST RESORT – 5 PTS 32 CATEGORY 3 Comprehensive Qualifying Conditions 50 pts Reasonable Access for Minors EASE OF NAVIGATION 10 pts DOES THE STATE ALLOW DOCTORS OR POLITICIANS TO DETERMINE WHICH PATIENTS HAVE ACCESS TO MEDICAL CANNABIS? ARE YOUTH UNREASONABLY RESTRICTED FROM LEGAL PROTECTIONS FOR MEDICAL CANNABIS USE? Every state that has enacted protections for medical cannabis patients has mentioned conditions that may be effectively treated by cannabis (see Chart 1). Some states recognize the Constitutional right of physicians to recommend cannabis to any patients who could benefit from it, while other states limit the ability of physicians to certify patients for participation in their medical cannabis program with restrictive qualifying conditions lists. Many states provide for a rigorous process to expand their “approved ailment” list through the state department of health. ASA’s position is that there should be access to medical cannabis for every patient who needs it, and that the decision to use cannabis as a treatment should be left to the patients and their physicians, not the state. Though some states limit the age of a patient, many of these restrictions may be overcome through parents or guardians consenting to the treatment and agreeing to be in control of the minor patient’s acquisition and administration of medical cannabis. States that require pediatric patients to have a recommendation from multiple doctors fail to realize that the added time and expense is great challenge to meet, especially for families raising a special needs child. More research has begun around using medical cannabis to treat youth, and it is important to allow parents, along with their children’s physicians, to determine the best, most effective medication for their children. Adding New Conditions 10 pts DOES THE STATE ALLOW FOR NEW QUALIFYING CONDITIONS TO BE ADDED THROUGH RULEMAKING WITHOUT THE NEED FOR LEGISLATIVE APPROVAL? In most states that have a restrictive list of qualifying conditions, a procedure exists for the addition of new conditions to the list of approved ailments that may be effectively treated by cannabis. New studies are being published regularly, and treatments that are not contemplated by the law should be available to physicians, much like “off-label” use is available in the realm of prescription medication. It is ASA’s position that if these restrictions are imposed, then the procedure to add new conditions should be uncomplicated and timely. While many states have created such a process, the hurdles to add new conditions are impossible to meet. The scoring for this section includes 5 points for having a process in place to add new conditions, and 5 points if that system is working as intended. Reasonable Caregiver Background Check Requirements 4 pts DOES THE STATE PROHIBIT THOSE WITH MARIJUANA OFFENSES FROM BEING CAREGIVERS? A caregiver is a person who assists the patient with procuring and administering his or her medication. Some states prohibit patients from having caregivers with criminal histories related to drugs. It is ASA’s position that this type of restriction serves no purpose, as they do not protect patients from criminals; rather, they punish the patient for having a family member or trusted confidant who may have had a criminal past. Again, these provisions disproportionately impact people of color. 33 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES Number of Caregivers 2 pts DOES THE STATE RECOGNIZE THAT A SINGLE CAREGIVER PER PATIENT MAY NOT BE SUFFICIENT TO PRACTICALLY ASSIST A PATIENT WHO REQUIRES A CAREGIVER IN ORDER TO OBTAIN OR ADMINISTER THEIR MEDICINE? The number of caregivers allowed for a qualified patient varies from state to state, as well as the number of patients a caregiver may serve. Some states are very restrictive and allow only one caregiver per patient, thus putting patients who have mobility problems in a situation where they must rely on a single person to assist with their access and use of cannabis. Although ASA is mindful about diversion to the illicit market, we support patients being able to designate caregivers as determined by their unique situations, so that they always have access to cannabis when needed. For example, an elderly patient may need to have multiple family members serve as caregivers because no individual in a family has the availability to consistently assist the patient. Patient/PractitionerFocused Task Force or Advisory Board 2 pts DOES THE LAW CREATE AN OVERSIGHT BODY, AND DOES THAT BODY HAVE SUFFICIENT REPRESENTATION BY PATIENTS, CAREGIVERS, AND RELEVANT MEDICAL PROFESSIONALS? Regulatory agencies for medical cannabis programs vary by state. ASA has found that keeping the medical cannabis program within the Department of Public Health or its equivalent provides the most effective assistance to patients and their providers. States that have developed a regulated program should create task forces or advisory boards to help guide the administration of the medical cannabis program and provide assistance in developing regulations. These task forces and advisory boards can be a boon to the program by providing a voice for those most knowledgeable about its effectiveness: patients and healthcare professionals. The makeup of such task forces or boards should only include a minimal presence from law enforcement, as the priorities of police and prosecutors may be at odds promoting public health. ASA supports the development of these programs and encourages the inclusion of patients and healthcare providers in them. Reasonable Fees for Patients & Caregivers 10 pts ARE PATIENTS ASSESSED A FEE BY THE STATE SIMPLY TO HAVE LEGAL PROTECTION AND ACCESS TO MEDICINE? Fees for patient registration should be set to meet reasonable administrative costs of the registry program. Patient fees should not cover costs of medical marijuana business oversight, nor should they be looked as at a source of revenue for any other purposes. Reasonable fees are particularly important due to the lack of health insurance coverage for medical cannabis expenses. Because of the financial challenges of many chronically ill patients, ASA recommends a sliding scale fee tied to state or federal benefits for which a patient qualifies. 34 CATEGORY 3 Allows Multiple-Year Registrations 2 pts DO PATIENTS FILL OUT RENEWAL FORMS AND PAY A RENEWAL FEE ON AN ANNUAL BASIS? It makes little sense to make patients with chronic, longlasting conditions go through an annual renewal process when their condition is almost certainly going to be with them for years to come. ASA recommends that multiyear registrations be available to these patients based on the condition listed on their application. Reasonable Physician Requirements 5 pts DOES THE LAW CONTAIN PROVISIONS THAT WOULD PREVENT PHYSICIANS FROM UTILIZING MEDICAL CANNABIS AS PART OF THEIR PRACTICE? Some states require patients to have an ongoing relationship with their doctor, often referred to as a “bona fide” relationship. Generally, states define the relationship to include a complete examination and medical history, along with an ongoing expectation of care provided by the physician. Some require that physicians register with the state, or impose education requirements on physicians, which may be beneficial to patients but could be onerous to physicians and are not a requirement for writing prescriptions for more dangerous pharmaceutical medications. ASA’s position is that physicians should only treat ailments and recommend treatments that they are familiar with and feel comfortable discussing. Within the medical field, there are many specialties; prohibiting patients from choosing a doctor who specializes in medical cannabis is antithetical to the practice of medicine. Any physician in good standing with the State should be allowed to recommend the use of medical cannabis to his or her patients. Physicians who use medical cannabis themselves should not be restricted from recommending it. Because patients with chronic illnesses seek health care services from a variety of sources, ASA prefers that nurse practitioners, naturopathic doctors, and chiropractors be allowed to recommend medical cannabis, if it is not prohibited by legislation. Health care professionals who are allowed to EASE OF NAVIGATION recommend medical cannabis should not be allowed to have direct or indirect financial interest in a dispensary, manufacturer, or cultivation operation, or financially benefit from any business that might benefit from a patient’s or caregiver’s use, acquisition, or purchase of medical cannabis. Does Not Classify Cannabis as a Medicine of Last Resort 5 pts DOES THE STATE LAW CLASSIFY MEDICAL CANNABIS AS A MEDICINE OF LAST RESORT? Some state laws only allow medical cannabis as a last resort, after all other treatments have failed. This approach is harmful and interferes with the doctor-patient relationship. Doctors should be able to recommend or approve medical cannabis use at any point in a patient’s treatment. Requiring patients to try less desirable treatments first is an unnecessary burden and may cause needless suffering. Emerging science and the experience of doctors and patients all over the country indicate that cannabis is a safe, legitimate medicine with real benefits for patients. State law should respect the welfare of the patients, the doctor’s discretion, and the science of medical cannabis. 35 Category FUNCTIONALITY 4 PATIENTS ABLE TO ACCESS MEDICINE AT DISPENSARIES OR VIA CULTIVATION – 50 PTS NO SIGNIFICANT ADMINISTRATIVE OR SUPPLY PROBLEMS – 15 PTS PATIENTS CAN RECEIVE LEGAL PROTECTIONS WITHIN A REASONABLE TIME AFTER RECEIVING RECOMMENDATION – 10 PTS REASONABLE POSSESSION LIMIT – 5 PTS REASONABLE PURCHASE LIMITS – 5 PTS ALLOWS PATIENTS TO MEDICATE WHERE THEY CHOOSE – 5 PTS COVERED BY INSURANCE/STATE HEALTH AIDE – 3 PTS FINANCIAL HARDSHIP (FEE WAIVERS/DISCOUNT MEDICINE) – 7 PTS 36 CATEGORY 4 Patients Able to Access Medicine at Dispensaries or Via Cultivation 50 pts ARE THERE A SUFFICIENT NUMBER OF EASILY ACCESSIBLE RETAIL DISTRIBUTION POINTS FOR PATIENTS TO OBTAIN THEIR MEDICINE BY PURCHASING IT, AND/OR ARE PATIENTS OR THEIR DESIGNATED CAREGIVERS ALLOWED TO GROW THE MEDICINE NEEDED TO TREAT THE PATIENT ’S CONDITION?  Ideally a patient or caregiver would be able to gain access to their medicine through multiple means, including dispensaries, cooperative gardens, and personal cultivation. Personal cultivation is an important option if a state fails to expeditiously license sufficient dispensaries, if there is a change in ownership, or if there are supply issues in the commercial program. States implementing access programs were eligible for partial points. No Significant Administrative or Supply Problems 15 pts DOES THE PROGRAM WORK AS INTENDED AND PROVIDE A SUFFICIENT SUPPLY OF CANNABIS TO MEET PATIENT NEEDS? While ASA supports the creation of a statewide regulatory framework for medical cannabis, administrative oversight has become a hindrance to safe access in some states. Some states have programs that inadvertently caused shortages (and therefore disruptions) in the supply and variety of available medical cannabis. Restrictions on commercial cultivation plant numbers, the number of cultivation or access points, or over-regulation of certain areas of production and distribution can have an adverse effect on a patient population. States should consider third-party certification as a way to ease administrative burdens. ASA discourages the development of policies that unnecessarily restrict or otherwise hamper the supply. Patients Can Receive Legal Protections Within a Reasonable Time After Receiving Recommendation FUNCTIONALITY 10 pts DOES MEDICAL NEED DETERMINED BY A MEDICAL PROFESSIONAL ESTABLISH IMMEDIATE LEGAL PROTECTIONS?  Ideally, protection from arrest and prosecution should begin the moment a patient leaves the doctor’s office with a recommendation. In cases where patients must register with the state to obtain arrest protection, an affirmative defense should be granted to defendants with a valid authorization, so as not to leave patients vulnerable while their documentation is processed. Reasonable Possession Limit 5 pts DO LIMITS ACCOMMODATE ROUTE OF ADMINISTRATION AND HARVEST AMOUNTS? While it might make sense to have possession thresholds that give law enforcement guidance on personal medical use, it does not make sense for the state to determine the quantity any patient might need for his or her particular illness. The type and severity of symptoms, the strain of cannabis, and the route of administration each greatly impact the amount that a specific patient may need at any point in time. The decision of how much cannabis is sufficient to treat a patient’s illness should ultimately be an amount that allows the patient an uninterrupted supply rather than arbitrary caps that can needlessly burden seriously ill patients. In order to create safe access to a consistent supply of the medical cannabis and related products that work best for them, patients should be able to possess and maintain a 90-day supply of medicine. 37 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES Reasonable Purchase Limits 5 pts DO LIMITS ALLOW FOR AN ADEQUATE SUPPLY OF MEDICINE? When a state is considering imposing purchase limits on patients that will restrict the amount they can obtain from a dispensary, it should take into account the distance a patient must travel, the severity of an individual’s medical condition, and any patient mobility issues. Certain strains or products may have limited availability, and patients who need those products should not be denied access in favor of concerns with regulatory expediency. The best policy does not restrict patients’ ability to purchase medicine to certain windows of time, as such limits may disrupt the consistent supply for patients. Allows Patients to Medicate Where They Choose 5 pts ARE PATIENTS ALLOWED TO USE THEIR MEDICINE FREELY WITH RESPECT TO LOCATION, JUST AS PATIENTS OF RX MEDICATION? Some states restrict the locations where patients can use medical cannabis. While it may make sense to include the right to use inhaled cannabis in places where other smoking is allowed, it is abhorrent to limit locations where a sick person can use his or her medicine. Cannabis should be treated like any other medication in this regard. 38 Covered By Insurance orState Health Programs 3 pts IS MEDICAL CANNABIS COVERED BY INSURANCE OR STATE HEALTH PROGRAMS? Until federal laws regarding medical cannabis are reformed, patients will not be able to use federal medical benefits and health insurance providers will be reluctant to include coverage for medical cannabis. However, there is no reason why state law should prevent private insurance carriers from covering medical cannabis. An ideal law would require that insurance carriers and state health programs treat medical cannabis like any other legal drug. Financial Hardship (Fee Waivers/Discount Medicine) 7 pts DOES THE STATE OFFER DISCOUNTED REGISTRATION FEES OR REQUIRE DISPENSARIES TO OFFER DISCOUNTED MEDICINE FOR LOWINCOME PATIENTS? With medical cannabis not currently covered by health insurance, many patients are unable to afford treatment without experiencing undue hardship. To ease the financial burden, ASA encourages the adoption of sliding-scale fees and donation programs that cover all or part of the cost of doctor’s visits, registration fees, and medicine for patients in need. Category 5 CONSUMER SAFETY AND PROVIDER REQUIREMENTS STATES WERE EVALUATED FOR CONSUMER SAFETY AND PROVIDER REQUIREMENTS IN FOUR AREAS: DISPENSARIES – 25 PTS (1) DISPENSARIES GROW / CULTIVATION – 25 PTS (2) GROW/CULTIVATION MANUFACTURING – 25 PTS (3) MANUFACTURING LABORATORY OPERATIONS – 25 PTS (4) LABORATORY OPERATIONS 40 CATEGORY 5 DISPENSARIES Staff Training Facility Sanitary Conditions 5 pts ARE DISPENSARY WORKERS REQUIRED TO BE TRAINED IN BOTH MEDICAL CANNABIS AND THE STATE LAW? Many state governments have training requirements for the staff of dispensaries. It is ASA’s position that dispensary staff, as health care professionals, must be adequately trained in order to best understand the medication and products they sell, and be able to provide patients with the best up-to-date information. New medical cannabis patients are often unfamiliar with the strains and routes of administration available to them. A well-educated staff can and should provide answers to common questions. ASA maintains that proper training of employees is essential to deliver safe, quality cannabis products to patients and caregivers. Standard Operating Procedures and Protocols CONSUMER SAFETY AND PROVIDER REQUIREMENTS 5 pts ARE DISPENSARY FACILITIES REQUIRED TO DEVELOP AND MAINTAIN STANDARD OPERATING PROCEDURES AND PROTOCOLS? Early medical cannabis laws only provided protection from criminal prosecution. As the field of medical cannabis has developed, new laws are incorporating requirements to ensure patient and product safety. State laws should require medical cannabis businesses to develop and follow standard operating procedures and protocols to ensure product safety and industry legitimacy. Such standard operating procedures and protocols should include, at a minimum, the following considerations: IS THE FACILITY CLEAN AND SAFE?  State laws should require that medical cannabis dispensing facility operations be conducted in sanitary conditions. ASA recommends using existing sanitation standards for food packaging, storage, and distribution, as well as herbal medicine handling and storage standards, as models for sensible regulations to protect patients from contaminants. The American Herbal Products Association’s Recommendations for Regulators is a good place to start this process. Reasonable Security Protocols ARE THE SECURITY PROTOCOLS FOR MEDICAL CANNABIS REASONABLE AND EFFECTIVE? State laws or regulations should require legal medical cannabis businesses to develop and implement a reasonable and effective security plan. The plan should address physical security, loss prevention, training, etc. However, state laws should not place arbitrary or onerous restrictions on legal medical cannabis business where they are unwarranted. Storage Protocols ARE THE STORAGE PROTOCOLS ADEQUATE TO PROTECT THE QUALITY OF THE MEDICINE AND PREVENT LOSS? State laws should require medical cannabis businesses at every stage of the production and distribution chain to store medicine in a manner that is sanitary, preserves the integrity of the cannabis or derived product, and is secure. This is important to protect patients from mold, mildew, and other contaminants that may be harmful. Furthermore, state laws should require adequate loss control procedures to prevent theft or robbery. 41 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES Inventory Control DOES THE STATE LAW REQUIRE INVENTORY CONTROL MECHANISMS? State law should require reasonable inventory control protocols to ensure the integrity of the supply chain and prevent diversion of medical cannabis for non-medical use. The inventory tracking system should include a continuous chain of custody for cannabis and cannabis products, periodic inventory counts, and a procedure for dealing with lost or stolen medicine. Recall Protocol and Adverse Event Reporting 5 Product Contents Including Source Material Identification Cannabis regulations often dictate the type of packaging for raw plant material and derived products. In some cases the packaging requirements may prevent the consumer from seeing the contents or render the cannabis as part of a compound making the form of plant material (e.g., leaves, stems, seeds, flowers) unrecognizable. When this occurs, dispensaries should be required to label the product’s contents, including identifying the source plant material used or contained within. pts IS THE MEDICAL CANNABIS FACILITY REQUIRED TO DEVELOP AND IMPLEMENT A PRODUCT RECALL STRATEGY?   As with other products produced for human consumption, spoilage, human error, and the unexpected all pose the risk of contamination. As a result, ASA encourages the development of product recall and adverse-event reporting programs. Product recall strategies should include transportation guidelines that allow the patient to return recalled products to the dispensary from which the product came, and a mechanism for the dispensary to return the recalled products to the original manufacturer and/or cultivator. Additionally, the rules and regulations should require that all recall programs include the recording of consumerreported adverse events. Product Labeling 5 pts Some state government regulatory models allow or require dispensaries to obtain medical cannabis that is repackaged at the dispensary. If the dispensary can engage in such activities, then it should be required to meet these minimum standards for labeling: Allergens When labeling derived products that have been mixed with foodstuffs or known common allergens, or that have been packaged or produced in a facility that uses known common allergens, consumers should be notified. All products labeled by dispensing facilities that might contain known common allergens should be required to provide a list on the product’s label. Potency/Compound Identification Medical cannabis patients often rely on product labels to gauge the strength of the various compounds present in the medicine they consume. Labeling requirements for cannabis and cannabis-derived products should include a listing of the product’s active compounds and the potency of each. Required Testing 5 pts ARE MEDICAL CANNABIS AND MEDICAL CANNABIS PRODUCTS REQUIRED TO BE TESTED BEFORE BEING DISTRIBUTED TO A PATIENT? State government regulations are increasingly requiring laboratory testing to verify product safety and help patients understand the potency of products’ active 42 CATEGORY 5 compounds. Laboratory testing regulations should ensure that the analytical records of cannabis and derived products are made available at all levels of the supply chain, including to the dispensary should they be engaged in the processing, packaging, and labeling of medical cannabis or derived products. Such laboratory testing results should include the analytical results necessary to provide the information required to produce or verify the accuracy of a product’s label. Active Compound Identification & Potency Cannabis and cannabis-derived products vary greatly based on the strain of cannabis, as well as the technique or method used to create the cannabis products. In order to ensure that cannabis and derived products are accurately labeled, laboratory testing facilities should be required to provide analytical services that can accurately determine the presence of active compounds and the potency of all compounds determined to be in the raw cannabis and cannabisderived product. Contaminants Additionally, laboratory testing facilities should be required to utilize methodologies and provide analysis that accurately tests raw cannabis and cannabis derived products for the presence of contaminants. Staff Training order to properly maintain a compliant, safe work environment that promotes product safety. ASA maintains that the proper training of employees is essential to maintain workplace safety, regulatory compliance, and product safety. Standard Operating Procedures and Protocols 5 pts ARE CULTIVATION STAFF REQUIRED TO BE TRAINED IN BOTH MEDICAL CANNABIS KNOWLEDGE AND THE STATE LAW?  Many state governments have training requirements for the staff of cultivation facilities. It is ASA’s position that cultivation staff must be adequately trained in 5 pts ARE CULTIVATION FACILITIES REQUIRED TO DEVELOP AND MAINTAIN STANDARD OPERATING PROCEDURES AND PROTOCOLS?  As product safety guidelines have been added to many state government regulatory programs, the requirement for businesses to create and implement Standard Operating Procedures and Protocols has become a common requirement. Standard operating procedures and protocols act to ensure that the operations of a facility are conducted in a manner that is safe for all staff working in the facility as well as the surrounding environment and that the proper records are kept to ensure product safety. Written standard operating procedures and protocols also serve as internal training and resource guides for the staff and should include, at a minimum, the following key components designed to address workplace, environmental, and product safety issues. GROW/CULTIVATION CONSUMER SAFETY AND PROVIDER REQUIREMENTS Facility and Equipment Sanitary Conditions IS THE FACILITY AND THE EQUIPMENT USED CLEAN AND SAFE?  Contamination can occur at any time during the cultivation and processing of the cannabis. State laws should require that medical cannabis cultivation and processing, manufacturing, distribution, and laboratory testing be conducted in sanitary conditions. ASA recommends using existing sanitation standards for farming, food packaging, and herbal medicine processing as a model for sensible regulations to 43 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES protect patients from contaminants. The American Herbal Products Association Guidelines for Regulators is a good place to start this process. Workforce Safety Protocols Cannabis, like other crops produced for human consumption, requires the use of various types of equipment, mediums, amendments, and plant treatments during the course of its production. The proper use, storage, and personal protective equipment necessary for employees who are operating equipment and working with cultivation mediums, amendments, and plant treatments helps to ensure that the workplace is safe and accident free. Standard operating procedures and protocols addressing workplace safety are a key component to ensuring that equipment is used appropriately and that workers understand the proper use of mediums, amendments, and plant treatments. Storage Protocols (Short Term and Long Term Storage) State laws should require medical cannabis businesses at every stage of the production and distribution chain store medicine in a manner that is sanitary and appropriate for the product on hand. Cannabis is a perishable product, similar in many ways to produce, and once it is harvested and enters into the processing area to dry, cure, be graded, and possibly trimmed, various forms of storage become more appropriate to deter contamination and preserve freshness. In order to reduce the risk of spoilage and contamination, state law should allow for both short term and long term storage options as opposed to requiring that all cultivated cannabis be immediately sealed once processing is completed. 44 Batch and Lot Tracking As product safety has become more of a consideration in state government regulations and recall and adverse event reporting programs are increasingly required of cannabis facilities, lot and batch tracking has become a necessary component to ensuring product safety throughout the supply chain. The need for lot and batch tracking touches all aspects of the supply chain and must be implemented during propagation and cultivation of cannabis in order to effectively track the cannabis forward and backward through the supply chain. Successful lot and batch tracking systems allow the consumer, dispensary, manufacturer, and processor to obtain information regarding the production facility including details pertaining to the treatment and laboratory testing of the plant material or product. Reasonable Security Protocols State laws or regulations should require legal medical cannabis businesses to develop and implement a reasonable and effective security plan. The plan should address physical security, loss prevention, theft or robbery prevention, and training. However, state laws should not place arbitrary or onerous restrictions on legal medical cannabis business where they are unwarranted. Disposal/Waste Cannabis cultivation and processing facilities often have plant material that is discarded throughout the process due to disease, adulteration, or simply necessary pruning practices. How this plant material is disposed of can pose substantial risk to the safety and purity of the healthy cannabis material produced at the facility. For this reason, all cultivation and processing facilities should be required to create and implement waste disposal procedures and protocols designed to ensure that all discarded, or adulterated, plant material is disposed of in a manner that ensures the adulterated CATEGORY 5 plant material cannot accidentally get confused with healthy plant material. Such standard operating procedures and protocols should include tracking of all discarded plant material as well as a way to clearly render it as unusable. Water Management Cannabis, regardless of how it is farmed, requires the use of precious water resources and has the potential to affect the wellbeing of the environment due to the potential for wastewater discharges. To address environmental concerns surrounding the cultivation of cannabis, several state governments have developed regulatory programs to address water use and the agricultural discharges sometimes associated with cannabis cultivation. As such, cultivation facilities should be required to develop and implement a water management plan that acts to ensure that water is used appropriately and not wasted, that the water used is safe for the cultivation of the crop, and that all waste water leaving the cultivation site is safe for the surrounding environment. Pesticide Guidance and Protocols (Pesticide Guidance and Disclosure/Labeling) 5 pts WHAT TYPE OF PESTICIDES ARE USED DURING THE CULTIVATION PROCESS AND HOW DOES THE CONSUMER KNOW? The use of pesticides during the cultivation of cannabis can lead to irreversible contamination. Additionally, within the US, tolerance thresholds have not been established for pesticide products used during the cultivation of cannabis; therefore, there is no clear guidance on the appropriate use of pesticide products, nor appropriate spray protocols for such products. In order to protect consumers from encountering pesticide adulterated products, ASA encourages state governments to provide pesticide guidance to medical cannabis cultivators either through requiring that only those pesticides listed on the tolerance exempt list, Section 28 under FIFRA, be allowed or by CONSUMER SAFETY AND PROVIDER REQUIREMENTS producing a specific list of state government approved pesticide products. It is important to know the pesticides that have been used during the cultivation process. Cultivation facilities should be required to track and record pesticide use as well as offer full disclosure of pesticide products used during the cultivation of each lot and batch of cannabis produced. Such disclosures should be made available, through labeling requirements and pertain to all cannabis produced at the cultivation facility. Required Testing 5 pts ARE CULTIVATORS REQUIRED TO TEST ALL MEDICAL CANNABIS PRODUCED AND BE PREPARED TO DISCLOSE THOSE RESULTS?   In order to ensure the accurate labeling of medical cannabis and medical cannabis products, state government programs should include protocols for the proper labeling and laboratory testing of all raw medical cannabis produced. Laboratory testing protocols should be designed to verify that the product safety practices occurring at the cultivation facility are adequate and effective. Each lot and batch produced by a cultivation facility should be verified through an independent third party laboratory testing facility to ensure the proper labeling, purity, and consistency of the cannabis produced. In order to achieve this, cultivation facilities should be required to create and implement standard operating procedures and protocols that include representative lot and batch sampling that is subject to analysis to determine the active compounds in the cannabis and the potency of such compounds. Additionally, each lot and batch of raw cannabis should be screened for potential contaminants and a portion of the representative sample should be retained by the production facility for analysis at a later date, should there be a product safety concern or adverse event that occurs. 45 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES Recall Protocol and Adverse Event Reporting 5 pts Standard Operating Procedures and Protocols 5 pts IS THE MEDICAL CANNABIS FACILITY REQUIRED TO DEVELOP AND IMPLEMENT A PRODUCT RECALL STRATEGY? ARE MANUFACTURING FACILITIES REQUIRED TO DEVELOP AND MAINTAIN STANDARD OPERATING PROCEDURES AND PROTOCOLS? Product recall strategies are an integral step to ensuring the safety of medical cannabis consumers. State governmental regulations should require cultivation facilities to implement a product recall program that includes transportation guidelines that allow the consumer, a manufacturing facility, and/or a dispensary to return adulterated and recalled products to the facility from which the product originated. Additionally, the rules and regulations should require that all recall programs include the recording of consumer reported adverse events. As product safety guidelines have been added to many state government regulatory programs, the development and implementation of Standard Operating Procedures and Protocols has become a common requirement. Standard Operating procedures and protocols act to ensure that the operations of a facility are conducted in a manner that is safe for all staff working in the facility as well as the surrounding environment and that the proper records are kept to ensure product safety. Written standard operating procedures and protocols also serve as internal training and resource guides for the staff and should include, at a minimum, the following key components designed to protect workers as well as product safety, purity, and consistency. MANUFACTURING Staff Training 5 pts ARE MANUFACTURING FACILITY STAFF REQUIRED TO BE TRAINED IN MEDICAL CANNABIS KNOWLEDGE AND THE STATE LAW?  Many state governments have training requirements for the staff of manufacturing facilities. It is ASA’s position that manufacturing facility staff, should be required to successfully complete training curriculum that includes an overview of medical cannabis knowledge as well as applicable state laws and local and state regulations. Such training is essential to maintaining workplace safety, regulatory compliance, and product safety. Facility and Equipment Sanitary Conditions IS THE FACILITY AND THE EQUIPMENT USED CLEAN AND SAFE? Contamination can occur at any time during the manufacturing of cannabis-derived products. State laws should require that medical cannabis cultivation, processing, manufacturing, distribution, and laboratory testing be conducted in sanitary conditions. ASA recommends using existing sanitation standards for farming, food packaging, and herbal medicine processing as a model for sensible regulations to protect patients from contaminants. The American Herbal Products Association Guidelines for Regulators is a good place to start this process. Workforce Safety Protocols Cannabis products, like other herbal products produced for human consumption, come into contact with 46 CATEGORY 5 various types of equipment designed to assist with the extraction, mixing, development, and packaging of cannabis and cannabis derived products. The proper use, storage, and safety procedures necessary for operating equipment used during the manufacturing process helps to ensure that the workplace is safe and accident free. Standard operating procedures and protocols addressing workplace safety are a key component to ensuring that equipment is used appropriately and that workers understand the proper use, handling, and storage of materials used during the manufacturing process. Storage Protocols State laws should require medical cannabis businesses at every stage of the production and distribution chain to store medicine in a manner that is sanitary and appropriate for the product on hand. Cannabis is a perishable product, similar in many ways to produce, and upon its arrival at a manufacturing facility, should be stored in a separate incoming holding area until the raw plant material or derived product can be inspected, quality verified, logged into inventory, and moved into a storage area designated for materials ready to be used in the manufacturing process. Regulations regarding the storage of cannabis and cannabis derived products should include detailed lot and batch tracking of the product as it moves from receiving to the manufacturing floor where it may be compounded, formulated, mixed, concentrated or otherwise manipulated into a cannabis derived product. In order to reduce the risk of spoilage and contamination, storage procedures and protocols should include separate and distinct storage areas for products that are considered to be in-holding, inprocess, awaiting labels, and ready for distribution. Reasonable Security Protocols State laws or regulations should require legal medical cannabis businesses to develop and implement a reasonable and effective security plan. The plan should address physical security, loss prevention, theft or robbery prevention, and training. However, state laws should not place arbitrary or onerous restrictions CONSUMER SAFETY AND PROVIDER REQUIREMENTS on legal medical cannabis business where they are unwarranted. Batch and Lot Tracking As product safety has become more of a consideration in state government regulations, and recall and adverse event reporting programs are increasingly required of cannabis facilities, lot and batch tracking has become a necessary component to ensuring product safety throughout the supply chain. The need for lot and batch tracking touches all aspects of the supply chain and must be implemented during propagation and cultivation of cannabis in order to effectively track the cannabis forward and backward through the supply chain. Successful lot and batch tracking systems allow the consumer, dispensary, manufacturer, and processor to obtain information regarding the production facility including details pertaining to the treatment and laboratory testing of the plant material or product. Product Labeling WHAT INFORMATION SHOULD BE REQUIRED ON MEDICAL CANNABIS PRODUCT LABELS?  5 pts Consumers often have a broad range of medical cannabis products available to them. Such products can contain a broad variety of ingredients in addition raw cannabis or cannabis extracts. Often, such ingredients, including the form of medical cannabis contained within, are not easily distinguishable to the consumer who is choosing the cannabis derived product. Consumers should be able to expect clear and accurate labeling that includes the following product information. Product Contents Including Source Material Identification State government regulations should require manufacturing facilities to label each product produced in a manner that clearly discloses a list of all ingredients including the portion of cannabis plant used or source of cannabis if not raw plant material. 47 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES Allergens When labeling derived products that have been mixed with foodstuffs or known common allergens, or that have been packaged, produced, or manufactured in a facility that uses known common allergens, consumers should be notified. All products labeled by dispensing facilities that might contain known common allergens should be required to provide a list on the product’s label. Potency and Compound Identification Medical cannabis patients often rely on product labels to determine which medicinal compounds are present and the strength of the medicine they might consume. Labeling requirements for cannabis and cannabis derived products should include a listing of the products active compounds and the potency of each. Required Testing 5 Active Ingredient Identification & Potency Cannabis and cannabis derived products vary greatly based on the variety of cannabis used when creating the product as well as the technique or method used to create them. In order to ensure that cannabis and derived products are accurately labeled, manufacturing facilities should be required to test all finished products to determine the presence of active compounds and the potency of all compounds to appear on the label. Contaminants & Sample Retention Additionally, each lot and batch of cannabis derived product produced should be screened for potential contaminants and a portion of the representative sample should be retained by the production facility for analysis at a later date, should there be a product safety concern or adverse event that occurs. pts ARE MANUFACTURING FACILITIES REQUIRED TO TEST ALL MEDICAL CANNABIS PRODUCTS IN ORDER TO ENSURE THE ACCURACY OF LABELING AND VERIFY THE QUALITY, PURITY, AND CONSISTENCY OF THE PRODUCTS PRODUCED?   Contamination can occur at all points along the supply chain and the potency of active compounds may be altered during the manufacturing process. In order to ensure the accurate labeling of cannabis derived products as well as purity, quality, and consistency, state government programs should require manufacturing facilities to test all cannabis derived products with methodologies that verify the cannabis derived product is of the quality and consistency it purports to be. Shelf Life Testing Cannabis and cannabis derived products can be subject to spoilage and degradation. Manufacturing facilities should be required to conduct shelf life testing for each product produced to ensure that storage instructions and expiration dates are clearly labeled and accurate. Recall Protocol and Adverse Event Reporting 5 pts IS THE MEDICAL CANNABIS FACILITY REQUIRED TO DEVELOP AND IMPLEMENT A PRODUCT RECALL STRATEGY? Product recall strategies are an integral step to ensuring the safety of medical cannabis consumers. 48 CATEGORY 5 CONSUMER SAFETY AND PROVIDER REQUIREMENTS State governmental regulations should require all manufacturing facilities to implement a product recall program that includes transportation guidelines that allow the consumer and/or dispensary to return adulterated and recalled products to the facility from which it originated. Additionally, the rules and regulations should require that all recall programs include the recording of consumer reported adverse events. contaminant testing and standardized methodologies for cannabis analysis. Since the Monograph release, multiple state governments have adopted standards for laboratory analysis as provided by the AHP Cannabis Monograph. LABORATORY OPERATIONS IS THE LABORATORY REQUIRED TO DISCLOSE THE TYPE OF METHOD USED TO DETERMINE THE REPORTED TEST RESULTS?   Staff Training 5 pts ARE MANUFACTURING FACILITY STAFF REQUIRED TO BE TRAINED IN MEDICAL CANNABIS KNOWLEDGE AND THE STATE LAW? Many state governments have training requirements for the staff of laboratory testing facilities. It is ASA’s position that laboratory staff, should be required to successfully complete training curriculum that includes an overview of medical cannabis knowledge as well as applicable state law and local and state regulations. Such training is essential to maintaining workplace safety, regulatory compliance, and product safety. Method Validation in Accordance With AHP Guidelines 5 pts HAS THE MEDICAL CANNABIS OR MEDICAL CANNABIS PRODUCT BEEN TESTED USING A STANDARDIZED METHOD? The American Herbal Pharmacopoeia (AHP) produces critically reviewed documents called monographs that outline the quality control criteria needed for ensuring the identity, purity, and quality of botanical raw materials. In December of 2013, the AHP released a Cannabis Monograph, which serves as a guide for identifying the quality, purity, and potency of the cannabis plant and includes analytical standards to guide cannabis laboratory operations with a baseline for Result Reporting 5 pts With such a variety of medical cannabis products requiring their own specific tests to determine potency, active compounds, and the presence of contaminants for example, it is increasingly necessary for laboratory testing facilities to utilize a variety of analytical methods to provide accurate results. For example, was the presence of bacteria ruled out due to visual inspection with a microscope or was the product cultured? Laboratory testing facilities should be required to disclose the type of method used to generate the provided test result. Independent or Third Party 5 pts CAN CULTIVATORS AND MANUFACTURERS TEST THEIR OWN PRODUCTS, IN-HOUSE, TO VERIFY LABELING AND PRODUCT SAFETY?  In order for a laboratory to maintain integrity while serving as a body that can verify the quality, purity, and composition of a product, it must maintain its independence. As such, the verification of medical cannabis and medical cannabis products should be performed by independent third party entities. 49 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES Standard Operating Procedures and Protocols 5 pts ARE LABORATORY TESTING FACILITIES REQUIRED TO DEVELOP AND MAINTAIN STANDARD OPERATING PROCEDURES AND PROTOCOLS? ASA recognizes that the accuracy and consistency of laboratory analysis is dependent on a facility’s ability to implement standard operating procedures and protocols that address and standardize daily operating activities. State governments should require that laboratory testing facilities develop and implement standard operating procedures and protocols to ensure regulatory compliance and worker safety while protecting the quality, purity, and consistency of the products with which the laboratory works. Equipment and Instrument Calibration Such standard operating procedures and protocols should include the regular calibration of all equipment and instruments used in the laboratory testing facility. The regular calibration of equipment and instruments helps ensure the ongoing accuracy of analytical results. Facility and Equipment Sanitary Conditions Additionally, the testing facility and all equipment used should be subject to regular sanitation protocols designed to ensure that as new samples come into contact with equipment and instruments, they cannot become contaminated with residuals from previous test samples. 50 Sample Tracking As samples are brought into the laboratory for testing, with a portion of those samples possibly retained to verify results at a later date, state governments should require the samples be subject to detailed tracking and disposal protocol. Disposal/Waste Protocols Once a sample has been exposed to solvents or other compounds to assist in the analysis process, the laboratory dispensing facility should be required to have clear disposal protocols in place that also track the amount of waste produced on a regular basis. Storage Protocols As samples are brought in for analysis and possibly retained for analysis at a later date, laboratory facilities should be required to store the samples under appropriate environmental conditions that protect the integrity of the sample while ensuring the security of all samples stored. Workforce Safety Protocols Laboratory testing facilities should be required to develop and implement standard operating procedures and protocols that ensure workplace safety. Such protocols should address the proper use and storage of any solvents or chemicals on site and include the proper use of all equipment and instruments utilized in the facility. CATEGORY 5 CONSUMER SAFETY AND PROVIDER REQUIREMENTS MEDICAL MARIJUANA ACCESS IN THE UNITED STATES STATE MEDICAL CANNABIS PROGRAM REGULATIONS AND OVERSIGHT MEDICAL MARIJUANA REGULATORY AGENCY State agencies or group of several agencies (such as the Departments of Health, Agriculture, Consumer Affairs, etc.) are tasked with creating and monitoring regulations through all phases of the production line, issuing licenses for businesses, and coordinating patient enrollment. These agencies also conduct inspections or work with third-party accreditors to ensure compliance and monitor adverse event reporting and implement product recalls if necessary. REGULATIONS TODAY OVER 300 MILLION AMERICANS LIVE IN STATES WITH MEDICAL CANNABIS LAWS. THESE PROGRAMS ARE OVERSEEN BY LOCAL, STATE, AND FEDERAL REGULATIONS. AFTER A LAW IS ENACTED, STATE AGENCIES CREATE A SERIES OF REGULATIONS THAT GOVERN EVERYONE PARTICIPATING IN THE PROGRAM AND ALL PRODUCTS PRODUCED. ! SUPPLY CHAIN REGULATIONS BEGIN AT THE APPLICATION PROCESS WHERE CRITERIA IS SET FOR WHO CAN OWN, OPERATE, AND WORK IN MEDICAL CANNABIS BUSINESSES AND END WITH PURCHASING CRITERIA AT THE RETAIL POINT. FROM SEED TO CONSUMPTION, REGULATIONS INCLUDE TRACK AND TRACE FUNCTIONS, SECURITY REQUIREMENTS, PRODUCT SAFETY PROTOCOLS, STAFF TRAINING, AND ADVERSE EVENT REPORTING AND RECALL PROCEDURES. MEDICAL CANNABIS BUSINESSES ARE SUBJECT TO INSPECTIONS. REGULATORS NOW HAVE RESOURCES SUCH AS THE AMERICAN HERBAL PHARMACOPOEIA CANNABIS MONOGRAPH AND THE AMERICAN HERBAL PRODUCTS ASSOCIATION RECOMMENDATIONS FOR REGULATORS IN CREATING ROBUST PRODUCT SAFETY PROTOCOLS. ALL COMPANIES MUST DEMONSTRATE ABILITY TO TRACK ADVERSE EVENTS AND INITIATE A RECALL. ! ! ! TESTING LAB FACILITY All staff have proper training. Companies must adhere to Good Laboratory Practices and be accredited by an International Laboratory Accreditation Cooperation (ILAC) signatory, for ISO 17025 accreditation and related certifications. Testing laboratory must offer potency testing for a variety of cannabinoids, pesticide detections, and contaminates. Specification for these tests are set by the American Herbal Pharmacopoeia Cannabis Monograph. Ideally, laboratories are allowed to retain samples in order to assist in product recalls and public health inquires. ! ! ! CULTIVATION FACILITY MANUFACTURING FACILITY All staff have required legal compliance and product safety protocol adherence training. Companies must adhere to Good Agricultural Practices. Facilities may only use certain tolerance-exempt pesticides. Packages and labels dried flowers for retail sale or converts the dried flowers and leaf of the plant into infused products (edibles, oils, tinctures, lotions, etc.). All staff have required legal compliance and product safety protocol adherence training. Companies must adhere to Good Manufacturing Practices. Products are packaged to prevent accidental ingestion by children. AmericansForSafeAccess.org ! 52 PRODUCT SAFETY TRANSPORTATION RECALL Each batch of raw plant material and cannabis derived product must be quality assurance tested in order to ensure the integrity, purity, and proper labeling of medical cannabis products. Regulations extend to transportation of cannabis products throughout the supply chain. Regulations require drivers to be registered with the state and require paperwork at pickup and drop off locations that include weighing product. Regulations also include special instructions for dealing with waste. When a product containing contaminants, molds, mildew, or an improperly labeled product enters the supply chain, regulatory agencies trigger a product recall to prevent patient consumption. This includes alerting the manufactures, retail outlets, and the public. Recalled products are destroyed. $ DEPARTMENT OF COMMERCE DEPARTMENT OF HEALTH INSPECTIONS Medical cannabis businesses must pass inspections to maintain licenses to operate. These inspections may be conducted by the state medical cannabis regulatory agency, third party accredited agencies, law enforcement, OSHA, municipal safety inspectors, etc. DEPARTMENT OF AGRICULTURE ! ! ! OWNERS AND STAFF Regulations include legal conduct for owners and staff and often require unique IDs issued by the state. All staff and management are required to have legal compliance and product safety protocol adherence training. MEDICAL PROFESSIONALS Regulators create guidelines for medical professionals to enroll their patients into the program including forms and number of visits required. Some require medical professionals to take training and have built-in audits. ! DISPENSING/RETAIL FACILITY Staff are trained to provide guidance to patients in making the medicine purchase decisions. Regulations require the retail store to maintain certain hours and limit the scope of advertising to fit within community standards. Security cameras and increased foot traffic help deter crime. Under state laws dispensaries can only serve verified patients and caregivers. PATIENTS AND THEIR CAREGIVERS Regulators create enrollment and renewal procedures for patients that include the issuance of an ID. Rules for patients also include how much medicine a patient can posses, places where patients can legally use their medicine, and rules for transportation. QUALIFICATION MEDICAL CANNABIS PRODUCTS Products are labeled in accordance with state guidelines to display cannabinoid profile and other useful information, including expiration date if the item is perishable. REGULATORS DETERMINE REQUIREMENTS FOR PATIENTS TO PARTICIPATE IN THE MEDICAL CANNABIS PROGRAMS BASED ON AUTHORIZING STATUTE, INCLUDING GUIDELINES AND FORMS, MEDICAL PROFESSIONALS, AND RULES FOR TRANSPORTATION AND USE. 53 State Report Cards + STATE REPORT CARDS KEY FOR STATE GRADES Key for State Grades In previous versions of this report, grades for states without regulated distribution programs were calculated without factoring in the Product Safety section, then deducted a full letter grade. However, beginning in 2017, programs were scored out of 500 points whether they had a distribution system or not. Changes in letter grades from previous years, while only for a small number of states, reflect this change and highlight the importance of product and consumer safety. While the listed improvements for many states involve implementing medical cannabis solutions to resolve the opioid crisis, programs were not actually scored on how they are using medical cannabis to reduce opioid deaths. None of the CBD-focused states earned a passing grade score, indicating that the medical cannabis laws in these states must be completely overhauled to become functional in a truly meaningful way. KEY Orange - B Yellow - C Green - D Blue - F Gray - No medical cannabis program 55 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 F ALABAMA AREAS FOR IMPROVEMENT For yet another year, Alabama showed resistance to implementing a comprehensive medical cannabis program. While there was some small activity in the state legislature with a bill that would eliminate the criminal penalties associated with the possession of a small amount of cannabis, this bill did not receive a hearing. Alabama has a long way to go before it can be considered a functional jurisdiction for safe and legal access to medical cannabis therapy. Even by the standards of CBD-focused laws, the Alabama law provides little in the way of legal protections or facilitating access for its patients who have met the limited patient eligibility criteria. The state legislature needs to approve a program that allows for in-state production and distribution of medical cannabis, establish comprehensive legal protections for patients, lift artificial requirements for THC and CBD content, and adopt product safety standards. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 23/100 Arrest Protections............................................................................................................................................................................ 0/40 Affirmative Defense......................................................................................................................................................................... 10/15 Parental Rights Protections..................................................................................................................................................... 8/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 0/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 13/100 Allows Distribution Programs................................................................................................................................................ 0/40 - Allows Access to Dried Flowers.............................................................................................................................................. 0/15 - Allows Delivery................................................................................................................................................................................... 0/5 - No Sales Tax or Reasonable Sales Tax............................................................................................................................... 0/5 - Allows for a Reasonable Number of Dispensaries...................................................................................................... 0/5 - Does Not Require Vertical Integration............................................................................................................................... 0/2 - Ownership/Employment Restrictions.................................................................................................................................. 0/2 - Provisions for Labor Standards............................................................................................................................................... 0/2 - Environmental Impact Regulations....................................................................................................................................... 0/2 - Choice of Dispensary Without Restrictions...................................................................................................................... 0/2 Noncommercial Cultivation...................................................................................................................................................... 0/20 - Personal Cultivation........................................................................................................................................................................ 0/15 - Collective Gardening...................................................................................................................................................................... 0/5 Explicit Right to Edibles/Concentrates/Other Forms........................................................................................ 0/10 Does Not Impose Bans or Limits on THC..................................................................................................................... 3/10 Does Not Impose Bans or Limits on CBD..................................................................................................................... 10/10 Local Bans/Zoning.......................................................................................................................................................................... 0/10 IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 58 0 137 27.4% POINTS ISSUE EASE OF NAVIGATION 66/100 Comprehensive Qualifying Conditions............................................................................................................................ 35/50 Adding New Conditions ............................................................................................................................................................ 0/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 0/5 - System Works for Adding New Conditions...................................................................................................................... 0/5 Reasonable Access for Minors ............................................................................................................................................. 8/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers .................................................................................................................................................................. 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 35/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 5/50 No Significant Administrative or Supply Problems............................................................................................... 10/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 10/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 0/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 2/7 FINAL GRADE F MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 ALABAMA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 0/100 Dispensing................................................................................................................................................................................................................................................................................................................................... Grow/Cultivation ................................................................................................................................................................................................................................................................................................................... Manufacturing ......................................................................................................................................................................................................................................................................................................................... Laboratory Operations ..................................................................................................................................................................................................................................................................................................... 0/25 0/25 0/25 0/25 Dispensing 0/25 Manufacturing 0/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility and Equipment Sanitary Conditions.............................................................................................................................. - Workforce Safety Protocols.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Batch and Lot Tracking............................................................................................................................................................................ Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency and Compound Information............................................................................................................................................. Required Testing.......................................................................................................................................................................................... - Active Ingredient Identification........................................................................................................................................................... - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... - Shelf Life Testing.......................................................................................................................................................................................... - Sample Retention........................................................................................................................................................................................ Recall Protocol and Adverse Event Reporting..................................................................................................................... 0/5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1.67 0/1.67 0/1.67 Grow/Cultivation 0/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility and Equipment Sanitary Conditions.............................................................................................................................. - Workforce Safety Protocols.................................................................................................................................................................. - Storage Protocols (Short Term and Long Term Storage)................................................................................................... - Reasonable Security Protocols........................................................................................................................................................... - Batch and Lot Tracking............................................................................................................................................................................ - Disposal/Waste............................................................................................................................................................................................. - Water Management................................................................................................................................................................................... Pesticide Guidance.................................................................................................................................................................................... - Pesticide Guidance.................................................................................................................................................................................... - Pesticide Labeling....................................................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Ingredient Identification........................................................................................................................................................... - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... - Sample Retention........................................................................................................................................................................................ Recall Protocol and Adverse Event Reporting..................................................................................................................... 0/5 0/5 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/5 0/2.5 0/2.5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 0/5 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1 0/1 0/1 0/1 0/1 0/5 Laboratory Operations 0/25 Staff Training................................................................................................................................................................................................... Method Validation in Accordance with AHP Guidelines............................................................................................. Result Reporting.......................................................................................................................................................................................... Independent or Third Party................................................................................................................................................................. Standard Operating Procedures and Protocols................................................................................................................. - Equipment and Instrument Calibration......................................................................................................................................... - Sample Tracking........................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions.............................................................................................................................. - Disposal/Waste............................................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Workforce Safety Protocols.................................................................................................................................................................. 0/5 0/5 0/5 0/5 0/5 0/1 0/1 0/1 0/1 0/1 0/1 BACKGROUND In 2014, the Alabama state legislature passed SB 174, a cannabidiol (CBD) In 2016, HB 61, or “Leni’s Law”, was passed which extended the affirmative law. Officially entitled “Carly’s Law”, it offers an affirmative defense for the defense language to several conditions and removed the requirement that possession and use of CBD; however, the program is extremely limited and the patients must be enrolled in the UAB study program. Under Leni’s Law, may not be able to provide CBD-rich medicine to patients in Alabama. This patients are eligible for the affirmative defense if they are simply diagnosed law only allowed patients CBD access after a medical practitioner at the with a debilitating condition regardless of the age of the patient. However, a University of Alabama Birmingham (UAB) Department of Neurology had “prescription” is still required in order for a minor’s parents or legal guardian made a diagnosis for a “debilitating epileptic condition at which point the to be eligible for the affirmative defense. Because physicians cannot legally physician may prescribe CBD-rich preparations that are less than 3% THC write prescriptions for medical cannabis due to its Schedule I Status - only and “essentially are free from plant material.” recommendations - parents of minor aged patients may be ineligible for legal protections. 59 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 C ALASKA AREAS FOR IMPROVEMENT Although Alaska has had a long standing medical cannabis program, product safety standards still have been lacking for Alaska patients. Rulemaking associated with Alaska’s adult use program improved consumer safety and provider requirements. However, Alaska physicians still must state that they considered medications other than cannabis before providing a recommendation, making cannabis ineligible as a medicine of first resort. Alaska also falls short on providing civil protections for patients. From a product safety prospective, Alaska could improve staff training and protocols associated with recalls. Although Alaska allows for severe pain as a qualifying condition, the state is not using cannabis to its full potential in reducing the number of preventable opioid deaths. In 2016, Alaska saw 126 deaths related to opioid overdose. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 65/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 13/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 62/100 Allows Distribution Programs................................................................................................................................................ 22/40 - Allows Access to Dried Flowers............................................................................................................................................. 15/15 - Allows Delivery................................................................................................................................................................................... 3/5 - No Sales Tax or Reasonable Sales Tax.............................................................................................................................. 3/5 - Allows for a Reasonable Number of Dispensaries...................................................................................................... 1/5 - Does Not Require Vertical Integration................................................................................................................................ 0/2 - Ownership/Employment Restrictions................................................................................................................................. 0/2 - Provisions for Labor Standards.............................................................................................................................................. 0/2 - Environmental Impact Regulations...................................................................................................................................... 0/2 - Choice of Dispensary Without Restrictions..................................................................................................................... 0/2 Noncommercial Cultivation..................................................................................................................................................... 15/20 - Personal Cultivation........................................................................................................................................................................ 15/15 - Collective Gardening..................................................................................................................................................................... 0/5 Explicit Right to Edibles/Concentrates/Other Forms........................................................................................ 0/10 Does Not Impose Bans or Limits on THC..................................................................................................................... 10/10 Does Not Impose Bans on CBD ........................................................................................................................................... 10/10 Local Bans/Zoning.......................................................................................................................................................................... 5/10 IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 60 15 371 74.2% POINTS ISSUE EASE OF NAVIGATION 82/100 Comprehensive Qualifying Conditions............................................................................................................................ 44/50 Adding New Conditions............................................................................................................................................................... 7/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 2/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 74/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 40/50 No Significant Administrative or Supply Problems............................................................................................... 15/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 7/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 0/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 4/7 FINAL GRADE C MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 ALASKA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 73/100 Dispensing........................................................................................................................................................................................................................................................................................................................... 15/25 Grow/Cultivation ........................................................................................................................................................................................................................................................................................................... 18/25 Manufacturing ................................................................................................................................................................................................................................................................................................................. 20/25 Laboratory Operations ............................................................................................................................................................................................................................................................................................. 20/25 Dispensing 15/25 Staff Training................................................................................................................................................................................................... 0/5 Standard Operating Procedures..................................................................................................................................................... 5/5 - Facility Sanitary Conditions..................................................................................................................................................................1.25/1.25 - Storage Protocols........................................................................................................................................................................................ 1.25/1.25 - Reasonable Security Protocols...........................................................................................................................................................1.25/1.25 - Inventory Control......................................................................................................................................................................................... 1.25/1.25 Recall Protocol and Adverse Event Reporting..................................................................................................................... 0/5 Product Labeling......................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification.............................................................................................. 1.67/1.67 - Allergens........................................................................................................................................................................................................... 1.67/1.67 - Potency/Compound Identification................................................................................................................................................... 1.67/1.67 Required Testing.......................................................................................................................................................................................... 5/5 - Active Compound Identification........................................................................................................................................................ 1.67/1.67 - Contaminants................................................................................................................................................................................................ 1.67/1.67 - Potency............................................................................................................................................................................................................... 1.67/1.67 Grow/Cultivation 18/25 Staff Training................................................................................................................................................................................................... 0/5 Standard Operating Procedures..................................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions.............................................................................................................................. 0.71/0.71 - Workforce Safety Protocols.................................................................................................................................................................. 0.71/0.71 - Storage Protocols (Short Term and Long Term Storage)................................................................................................... 0.71/0.71 - Reasonable Security Protocols........................................................................................................................................................... 0.71/0.71 - Batch and Lot Tracking............................................................................................................................................................................ 0.71/0.71 - Disposal/Waste............................................................................................................................................................................................. 0.71/0.71 - Water Management................................................................................................................................................................................... 0.71/0.71 Pesticide Guidance.................................................................................................................................................................................... 3/5 - Pesticide Guidance.................................................................................................................................................................................... 3/2.5 - Pesticide Labeling....................................................................................................................................................................................... 0/2.5 Required Testing.......................................................................................................................................................................................... 5/5 - Active Ingredient Identification........................................................................................................................................................... 1.25/1.25 - Contaminants................................................................................................................................................................................................ 1.25/1.25 - Potency............................................................................................................................................................................................................... 1.25/1.25 - Sample Retention........................................................................................................................................................................................ 1.25/1.25 Recall Protocol and Adverse Event Reporting..................................................................................................................... 5/5 Manufacturing 20/25 Staff Training................................................................................................................................................................................................... 5/5 Standard Operating Procedures..................................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions.............................................................................................................................. 1/1 - Workforce Safety Protocols.................................................................................................................................................................. 1/1 - Storage Protocols........................................................................................................................................................................................ 1/1 - Reasonable Security Protocols........................................................................................................................................................... 1/1 - Batch and Lot Tracking............................................................................................................................................................................ 1/1 Product Labeling......................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification..............................................................................................1.67/1.67 - Allergens........................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information.............................................................................................................................................1.67/1.67 Required Testing.......................................................................................................................................................................................... 5/5 - Active Ingredient Identification........................................................................................................................................................... 1/1 - Contaminants................................................................................................................................................................................................ 1/1 - Potency............................................................................................................................................................................................................... 1/1 - Shelf Life Testing.......................................................................................................................................................................................... 1/1 - Sample Retention........................................................................................................................................................................................ 1/1 Recall Protocol and Adverse Event Reporting..................................................................................................................... 0/5 Laboratory Operations 20/25 Staff Training................................................................................................................................................................................................... 0/5 Method Validation in Accordance with AHP Guidelines............................................................................................. 5/5 Result Reporting.......................................................................................................................................................................................... 5/5 Independent or Third Party................................................................................................................................................................. 5/5 Standard Operating Procedures and Protocols................................................................................................................. 5/5 - Equipment and Instrument Calibration......................................................................................................................................... 0.83/0.83 - Sample Tracking........................................................................................................................................................................................... 0.83/0.83 - Facility and Equipment Sanitary Conditions.............................................................................................................................. 0.83/0.83 - Disposal/Waste............................................................................................................................................................................................. 0.83/0.83 - Storage Protocols........................................................................................................................................................................................ 0.83/0.83 - Workforce Safety Protocols.................................................................................................................................................................. 0.83/0.83 BACKGROUND Safe access to medical cannabis was first approved in Alaska by Measure consuming cannabis for medical use. All patients and caregivers must enroll 8 (1998), an initiative passed by 58% of voters. Alaska Senate Bill 94 was in the state registry and possess a valid identification card to be legally passed in June 1999 and modified the law created by Measure 8 to require protected. A primary caregiver must be at least 21 years old, not currently medical cannabis patients to register with the state health department on probation or parole, and have no drug related felony convictions. In 2014, and limit the amount of cannabis they and their caregivers may legally voters approved an adult use retail program, but there is no dedicated retail possess. Any patient with a valid registry card may legally use cannabis for system that regulates cannabis like a medicine. medicinal purposes and their caregiver may assist them in doing so. Patients or their caregivers may possess up to one ounce of usable cannabis and cultivate up to six cannabis plants (three mature, three immature). Patients and caregivers can possess paraphernalia associated with growing or 61 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 C ARIZONA + AREAS FOR IMPROVEMENT As of September 2017, Arizona has 143,239 qualifying patients in its medical cannabis program with nearly 85% of the patients using cannabis to treat chronic pain. While several bills were introduced by the Arizona legislature relating to medical cannabis, none of them passed with the Governor’s approval. However, Arizona did make a few small changes to its program through the rulemaking process including technical updates to the physician recommendation form and posted notices about the use of cannabis during pregnancy in dispensaries. Arizona could improve their program with additional product safety regulations, particularly when it comes to laboratory operations. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 96/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 8/10 DUI Protections.................................................................................................................................................................................. 5/5 Employment Protections............................................................................................................................................................ 5/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 5/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 4/5 Organ Transplants............................................................................................................................................................................ 5/5 Reciprocity............................................................................................................................................................................................. 2/3 ACCESS TO MEDICINE 81/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 62 10 398 79.6% 33/40 15/15 5/5 4/5 5/5 0/2 1/2 0/2 1/2 2/2 10/20 10/15 0/5 10/10 10/10 10/10 8/10 POINTS ISSUE EASE OF NAVIGATION 82/100 Comprehensive Qualifying Conditions............................................................................................................................ 46/50 Adding New Conditions............................................................................................................................................................... 9/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 4/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 1/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 3/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 4/5 FUNCTIONALITY 89/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 50/50 No Significant Administrative or Supply Problems............................................................................................... 15/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 7/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 5/7 FINAL GRADE C+ MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 ARIZONA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 39/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 15/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 10.34/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 12/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 0/25 Dispensing 15/25 Staff Training................................................................................................................................................................................................... 5/5 Standard Operating Procedures..................................................................................................................................................... 5/5 - Facility Sanitary Conditions..................................................................................................................................................................1.25/1.25 - Storage Protocols........................................................................................................................................................................................ 1.25/1.25 - Reasonable Security Protocols...........................................................................................................................................................1.25/1.25 - Inventory Control......................................................................................................................................................................................... 1.25/1.25 Recall Protocol and Adverse Event Reporting..................................................................................................................... 0/5 Product Labeling......................................................................................................................................................................................... 0/5 - Product Contents Including Source Material Identification.............................................................................................. 0/1.67 - Allergens........................................................................................................................................................................................................... 0/1.67 - Potency/Compound Identification................................................................................................................................................... 0/1.67 Required Testing.......................................................................................................................................................................................... 0/5 - Active Compound Identification........................................................................................................................................................ 0/1.67 - Contaminants................................................................................................................................................................................................ 0/1.67 - Potency............................................................................................................................................................................................................... 0/1.67 Grow/Cultivation 10.34/25 Staff Training................................................................................................................................................................................................. 5/5 Standard Operating Procedures.................................................................................................................................................. 2.84/5 - Facility and Equipment Sanitary Conditions........................................................................................................................... 0.71/0.71 - Workforce Safety Protocols................................................................................................................................................................ 0/0.71 - Storage Protocols (Short Term and Long Term Storage)................................................................................................ 0.71/0.71 - Reasonable Security Protocols........................................................................................................................................................ 0.71/0.71 - Batch and Lot Tracking......................................................................................................................................................................... 0.71/0.71 - Disposal/Waste.......................................................................................................................................................................................... 0/0.71 - Water Management................................................................................................................................................................................. 0/0.71 Pesticide Guidance.................................................................................................................................................................................. 2.5/5 - Pesticide Guidance.................................................................................................................................................................................. 2.5/2.5 - Pesticide Labeling.................................................................................................................................................................................... 0/2.5 Required Testing........................................................................................................................................................................................ 5/5 - Active Ingredient Identification........................................................................................................................................................ 1.25/1.25 - Contaminants.............................................................................................................................................................................................. 1.25/1.25 - Potency............................................................................................................................................................................................................ 1.25/1.25 - Sample Retention..................................................................................................................................................................................... 1.25/1.25 Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 Manufacturing 12/25 Staff Training............................................................................................................................................................................................. 5/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 1.67/5 - Product Contents Including Source Material Identification........................................................................................ 0/1.67 - Allergens...................................................................................................................................................................................................... 0/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 0/5 - Active Ingredient Identification..................................................................................................................................................... 0/1 - Contaminants........................................................................................................................................................................................... 0/1 - Potency......................................................................................................................................................................................................... 0/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 0/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 0/5 Laboratory Operations 0/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines..................................................................................... Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 0/5 0/5 0/5 0/5 0/5 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 BACKGROUND Arizona’s current medical cannabis program was passed in 2010 by 50.13% of voters. The Arizona Medical Marijuana Act (AMMA) allows a patient with an Arizona registry ID card to use cannabis for medical purposes. Patients may appoint a designated caregiver for assistance. Patients and their caregivers may possess up to 2.5 ounces of usable cannabis and may cultivate up to 12 plants if they live at least 25 miles away from a registered dispensary. The law recognizes out-of-state medical cannabis IDs for the purposes of criminal protections but does not permit visiting patients to obtain cannabis from Arizona dispensaries. Due to a series of lawsuits, the Arizona Department of Health Services did not post rules for the Medical Marijuana Dispensary portion of the AMMA until 2012. Since the passage of the AMMA, the legislature has passed several laws restricting the rights of patients. In 2011, HB 2541 allows an employer to fire a patient for workplace impairment solely on the word of a “reliable” colleague or a positive drug test. HB 2585 added cannabis patient data to the prescription drug monitoring program. In 2012, HB 2349 prohibited medical cannabis at schools, vocational schools, and college campuses, but a case pending before the Arizona Supreme Court, State v. Maestas, could overturn this. In 2015, HB 2346 specified that the AMMA does not require workers’ compensation benefits to include reimbursement for medical cannabis. In 2017 (HB 2061), the legislature began requiring dispensaries and doctors to warn of the potential risk of using cannabis while breastfeeding or pregnant. Arizona also opened its first drive thru dispensary in 2017. 63 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B ARKANSAS - AREAS FOR IMPROVEMENT Arkansas only allows patients to use medical cannabis to treat chronic pain if their pain has been unresponsive to ordinary medications, treatment, or surgery for more than 6 months. It is estimated that 379 individuals died from overdose in 2016, with a significant majority of these coming from prescription opioids. In May of 2017, Arkansas implemented Rules and Regulations for the Registration, Testing and Labeling of Cannabis which greatly strengthened their program. Arkansas also implemented rules governing the oversight of Medical Cannabis Cultivation facilities and dispensaries. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 91/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 10/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 3/5 Explicit Privacy Standards........................................................................................................................................................ 5/7 Housing Protections....................................................................................................................................................................... 5/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 5/5 Reciprocity............................................................................................................................................................................................. 3/3 ACCESS TO MEDICINE 69/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 64 33/40 15/15 5/5 5/5 3/5 0/2 1/2 0/2 2/2 2/2 0/20 0/15 0/5 10/10 10/10 9/10 7/10 20 411.01 82.20% POINTS ISSUE EASE OF NAVIGATION 79/100 Comprehensive Qualifying Conditions............................................................................................................................ 40/50 Adding New Conditions............................................................................................................................................................... 8/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 3/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 1/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 8/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 76/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 40/50 No Significant Administrative or Supply Problems............................................................................................... 10/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 10/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. Covered by Insurance/State Health Programs......................................................................................................... Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... FINAL GRADE B- 3/5 0/3 4/7 MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 ARKANSAS ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 75.01/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 20/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 20/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 20.01/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 15/25 Dispensing 20/25 Staff Training................................................................................................................................................................................................... 0/5 Standard Operating Procedures..................................................................................................................................................... 5/5 - Facility Sanitary Conditions..................................................................................................................................................................1.25/1.25 - Storage Protocols........................................................................................................................................................................................ 1.25/1.25 - Reasonable Security Protocols...........................................................................................................................................................1.25/1.25 - Inventory Control......................................................................................................................................................................................... 1.25/1.25 Recall Protocol and Adverse Event Reporting..................................................................................................................... 5/5 Product Labeling......................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification.............................................................................................. 1.67/1.67 - Allergens........................................................................................................................................................................................................... 1.67/1.67 - Potency/Compound Identification................................................................................................................................................... 1.67/1.67 Required Testing.......................................................................................................................................................................................... 5/5 - Active Compound Identification........................................................................................................................................................ 1.67/1.67 - Contaminants................................................................................................................................................................................................ 1.67/1.67 - Potency............................................................................................................................................................................................................... 1.67/1.67 Grow/Cultivation 20/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 0/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 5/5 2.5/2.5 2.5/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 Manufacturing 20.01/25 Staff Training............................................................................................................................................................................................. 0/5 Standard Operating Procedures............................................................................................................................................... 0/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 0/1 - Workforce Safety Protocols............................................................................................................................................................. 0/1 - Storage Protocols.................................................................................................................................................................................. 0/1 - Reasonable Security Protocols..................................................................................................................................................... 0/1 - Batch and Lot Tracking...................................................................................................................................................................... 0/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations 15/25 Staff Training.............................................................................................................................................................................................. 0/5 Method Validation in Accordance with AHP Guidelines........................................................................................ 5/5 Result Reporting..................................................................................................................................................................................... 5/5 Independent or Third Party............................................................................................................................................................ 0/5 Standard Operating Procedures and Protocols............................................................................................................. 5/5 - Equipment and Instrument Calibration..................................................................................................................................... 0.83/0.83 - Sample Tracking...................................................................................................................................................................................... 0.83/0.83 - Facility and Equipment Sanitary Conditions......................................................................................................................... 0.83/0.83 - Disposal/Waste....................................................................................................................................................................................... 0.83/0.83 - Storage Protocols................................................................................................................................................................................... 0.83/0.83 - Workforce Safety Protocols............................................................................................................................................................. 0.83/0.83 BACKGROUND In November of 2016, Arkansas voters approved a constitutional amendment that provided for a medical cannabis program. In the 12 months that followed, the Arkansas Department of Health worked diligently to create rules and regulations implementing the voter approved program. Arkansas still has areas for improvement like allowing patients to cultivate their own medicine, but the Natural State has shown significant program improvements in just its first year. Following the passage of the constitutional amendment there was a flurry of legislative activity (16 bills) that made technical and nuanced changes to the program that voters passed. 65 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B CALIFORNIA + AREAS FOR IMPROVEMENT California deserves credit for removing the sales and use tax on medical cannabis with Proposition 64. The Medicinal and Adult-Use Cannabis Regulation and Safety Act (MAUCRSA) allows improved regulations for the manufacturing of cannabis products. However, the 15% excise tax makes medicine unaffordable for many patients. Additionally, California continues to fail to provide civil protections for patients in the areas of housing and employment protections. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 79/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 13/15 Parental Rights Protections..................................................................................................................................................... 10/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 3/5 Organ Transplants............................................................................................................................................................................ 5/5 Reciprocity............................................................................................................................................................................................. 1/3 ACCESS TO MEDICINE 94/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 66 5 448 89.55% 38/40 15/15 5/5 3/5 5/5 2/2 2/2 2/2 2/2 2/2 20/20 15/15 5/5 9/10 10/10 10/10 7/10 POINTS ISSUE EASE OF NAVIGATION 93/100 Comprehensive Qualifying Conditions............................................................................................................................ 50/50 Adding New Conditions............................................................................................................................................................... 10/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 5/5 Reasonable Access for Minors ............................................................................................................................................. 10/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 95/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 50/50 No Significant Administrative or Supply Problems............................................................................................... 15/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 10/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 5/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 7/7 FINAL GRADE B+ MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 CALIFORNIA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 82/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 18.75/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 18/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 25/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 20/25 Dispensing 18.75/25 Staff Training................................................................................................................................................................................................... 5/5 Standard Operating Procedures.....................................................................................................................................................3.75/5 - Facility Sanitary Conditions.................................................................................................................................................................. 0/1.25 - Storage Protocols........................................................................................................................................................................................ 1.25/1.25 - Reasonable Security Protocols........................................................................................................................................................... 1.25/1.25 - Inventory Control......................................................................................................................................................................................... 1.25/1.25 Recall Protocol and Adverse Event Reporting..................................................................................................................... 0/5 Product Labeling......................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification.............................................................................................. 1.67/1.67 - Allergens........................................................................................................................................................................................................... 1.67/1.67 - Potency/Compound Identification................................................................................................................................................... 1.67/1.67 Required Testing.......................................................................................................................................................................................... 5/5 - Active Compound Identification........................................................................................................................................................ 1.67/1.67 - Contaminants................................................................................................................................................................................................ 1.67/1.67 - Potency............................................................................................................................................................................................................... 1.67/1.67 Grow/Cultivation 18/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 3/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 5/5 2.5/2.5 2.5/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 0/5 Manufacturing 25/25 Staff Training............................................................................................................................................................................................. 5/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations 20/25 Staff Training.............................................................................................................................................................................................. 5/5 Method Validation in Accordance with AHP Guidelines..................................................................................... 0/5 Result Reporting..................................................................................................................................................................................... 5/5 Independent or Third Party............................................................................................................................................................ 5/5 Standard Operating Procedures and Protocols............................................................................................................. 5/5 - Equipment and Instrument Calibration..................................................................................................................................... 0.83/0.83 - Sample Tracking...................................................................................................................................................................................... 0.83/0.83 - Facility and Equipment Sanitary Conditions......................................................................................................................... 0.83/0.83 - Disposal/Waste....................................................................................................................................................................................... 0.83/0.83 - Storage Protocols................................................................................................................................................................................... 0.83/0.83 - Workforce Safety Protocols............................................................................................................................................................. 0.83/0.83 BACKGROUND In 1996, California became the first medical cannabis state when voters approved Prop In 2015, the state passed the Medical Cannabis Regulation and Safety Act (MCRSA), a 215, the Compassionate Use Act. That law allows doctors to recommend cannabis for any trio of bills that creates a state regulated cultivation and dispensary system and protects serious or persistent medical condition, and allows patients to legally use, possess, and medical cannabis patients in need of an organ transplant. Voters approved the Adult Use grow cannabis and designate caregivers to assist them. In 2003, the California legislature of Marijuana Act (Proposition 64) in 2016 that expanded rights for patients by adding passed the Medical Marijuana Program Act, establishing a voluntary ID card program, parental right protections, enhancing patient privacy rules, prohibiting cities from banning protections for transporting cannabis, and a legal framework to protect not-for-profit personal cultivation, and exempting card holding patients from sales tax. dispensing collectives and cooperatives. The voluntary registry issues ID cards that offer protection from arrest for patients and caregivers in possession of no more than eight In July of 2017, the Governor signed the MAUCRSA Act. On November 16, 2017 California ounces of cannabis, or cultivating no more than six mature or 12 immature plants. Patients published emergency rules and regulations that implemented Prop. 64 and MAUCRSA. and designated caregivers without a state ID card, or those in possession of larger These emergency regulations also impacted the state’s medical program, particularly in quantities, are afforded an affirmative defense. Qualified patients on probation or parole regards to how businesses are licensed, purchasing limits for patients, and much needed may legally use medical cannabis with the consent of their probation or parole officer. regulations for the manufacturing of cannabis products. 67 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B COLORADO - AREAS FOR IMPROVEMENT Colorado continues to do well in most aspects of providing safe and legal access to its medical cannabis patients. In terms of the law, the biggest oversight is lack of civil protections in the areas of housing, employment, and parental rights. On the regulatory side of things, the state should improve its product safety requirements by having the state evenly enforce regulations across the state instead of at the county level. The state should create a better system for adding qualifying conditions or follow states like Maryland, Massachusetts, and the District of Columbia and replace condition lists with granting physicians the right to recommend medical cannabis to any patient for whom the benefits outweigh the risks. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 62/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 0/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 88/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 68 10 401.67 80.33% 35/40 15/15 5/5 4/5 5/5 2/2 2/2 0/2 0/2 2/2 15/20 15/15 0/5 10/10 10/10 10/10 8/10 ISSUE POINTS EASE OF NAVIGATION 86/100 Comprehensive Qualifying Conditions............................................................................................................................ 46/50 Adding New Conditions............................................................................................................................................................... 7/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 2/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 1/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 10/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 4/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 92/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 50/50 No Significant Administrative or Supply Problems............................................................................................... 15/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 9/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 6/7 FINAL GRADE B- MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 COLORADO ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 63.67/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 18.33/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 14/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 11.33/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 20/25 Dispensing 18.33/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 0/5 3.33/5 1.67/1.67 1.67/1.67 0/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 14/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 0/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 4/5 2/2.5 2/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 0/5 Manufacturing 11.33/25 Staff Training............................................................................................................................................................................................. 0/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 3.33/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 0/1.67 Required Testing.................................................................................................................................................................................... 3/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 0/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 0/5 Laboratory Operations 20/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines..................................................................................... 5/5 0/5 Result Reporting..................................................................................................................................................................................... 5/5 Independent or Third Party............................................................................................................................................................ 5/5 Standard Operating Procedures and Protocols............................................................................................................. 5/5 - Equipment and Instrument Calibration..................................................................................................................................... 0.83/0.83 - Sample Tracking...................................................................................................................................................................................... 0.83/0.83 - Facility and Equipment Sanitary Conditions......................................................................................................................... 0.83/0.83 - Disposal/Waste....................................................................................................................................................................................... 0.83/0.83 - Storage Protocols................................................................................................................................................................................... 0.83/0.83 - Workforce Safety Protocols............................................................................................................................................................. 0.83/0.83 BACKGROUND Colorado’s original medical cannabis initiative, Amendment 20, was a citizens’ initiative passed in 2000, and amended the state constitution to authorize patients to use and possess up to two ounces of medical cannabis, cultivate up to six plants (3 mature, 3 immature), and be assisted by a caregiver. Colorado’s second medical cannabis law, the Colorado Medical Marijuana code (C.R.S. 12-43-101 et. seq.), was enacted by the legislature in the summer of 2012 to establish a dual licensing mechanism that regulates Colorado medical cannabis businesses at both the state and local level. Colorado allows local governments to adopt regulations regarding medical cannabis businesses and caregiver conduct, which has led to an uneven application of the law. In addition, the Colorado Medical Marijuana Code permits various state agencies to continuously enact new regulations for the medical cannabis community. In 2016 the legislature passed two bills pertaining to the medical cannabis program. HB 1371 created protections for children and their parents from being punished for possessing and consuming medical cannabis on campus or as a reason for not being admitted into a school. SB 40 extends ownership rights of cannabis businesses to non-Colorado residents. In 2017, SB 192 was passed which allowed for delivery of cannabis and single instance transfers between adult use dispensaries and medical dispensaries. SB17-017 also added PTSD and other stress-related conditions to the state’s list of qualifying conditions. 69 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B CONNECTICUT - AREAS FOR IMPROVEMENT Connecticut did not make any improvements to its program in 2017 through the legislature. A court case (Noffsinger v. SSN Nitanic Operating Co. LLC) reaffirmed employee rights for medical cannabis patients by holding that employees cannot be fired just because they test positive during a drug screening. This court case treats medical cannabis like any other prescription, which is a positive move for Connecticut’s opioid crisis. Connecticut patients would benefit from not being restricted to one dispensary. Additionally, Connecticut’s program could be improved by adding protections for parental rights, creating financial hardship exemptions, and adding pain conditions to its list of qualifying conditions. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 74/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 13/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 5/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 5/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 4/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 66/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 70 25 400 80.03% 26/40 15/15 0/5 4/5 4/5 2/2 1/2 0/2 0/2 0/2 0/20 0/15 0/5 10/10 10/10 10/10 10/10 POINTS ISSUE EASE OF NAVIGATION 81/100 Comprehensive Qualifying Conditions............................................................................................................................ 42/50 Adding New Conditions............................................................................................................................................................... 10/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 5/5 Reasonable Access for Minors ............................................................................................................................................. 7/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers ........................................................................................................ 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 4/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 77/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 45/50 No Significant Administrative or Supply Problems............................................................................................... 14/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 3/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 0/7 FINAL GRADE B- MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 CONNECTICUT ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 77/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 23/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 19/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 18/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 17.49/25 Dispensing 23/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 2.67/5 1.67/1.67 0/1.67 1/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 19/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 0/5 4/5 0.71/0.71 0/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0/0.71 0/0.71 5/5 2.5/2.5 2.5/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 Manufacturing 11.33/25 Staff Training............................................................................................................................................................................................. 0/5 Standard Operating Procedures............................................................................................................................................... 4/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 0/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 4/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations 17.49/25 Staff Training.............................................................................................................................................................................................. 5/5 Method Validation in Accordance with AHP Guidelines..................................................................................... 0/5 Result Reporting..................................................................................................................................................................................... 5/5 Independent or Third Party............................................................................................................................................................ 5/5 Standard Operating Procedures and Protocols............................................................................................................. 2.49/5 - Equipment and Instrument Calibration..................................................................................................................................... 0/0.83 - Sample Tracking...................................................................................................................................................................................... 0.83/0.83 - Facility and Equipment Sanitary Conditions......................................................................................................................... 0.83/0.83 - Disposal/Waste....................................................................................................................................................................................... 0/0.83 - Storage Protocols................................................................................................................................................................................... 0.83/0.83 - Workforce Safety Protocols............................................................................................................................................................. 0/0.83 BACKGROUND In 2012, Connecticut became the 17th medical cannabis state with the signing of HB 5380, an Act Concerning the Palliative use of Marijuana. HB 5389 provides registered patients with protection from arrest when using or possessing up to a one-month supply of medical cannabis in accordance with the law and allows them to designate caregivers to assist them. Patients and caregivers registered with the Department of Consumer Protection may purchase medical cannabis from state licensed dispensaries, but no personal cultivation is allowed. Final regulations were issued in 2013 and dispensaries began offering medicine in September 2014, with six dispensaries opening throughout the state. In 2016, three additional dispensaries were licensed; six new conditions were added to the program; and the legislature passed HB 5450, which allows minors to qualify for the medical cannabis program under some restrictions, creates protections for nurses to administer medical cannabis in health care facilities, and allows dispensaries to provide medical cannabis to medical facilities serving registered medical cannabis patients. 71 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 C DELAWARE + AREAS FOR IMPROVEMENT The Delaware medical cannabis program would be greatly improved with an overhaul of product safety protocols and the issuance of more distribution licenses to increase access in the state. An additional Compassion Center is scheduled to open in early 2018. In 2017, Delaware and a third party organization entered into a partnership for the testing of cannabis. Two petitions to add qualifying conditions of anxiety and pediatric autism were filed in 2017, but the Department of Health has not issued a final decision on these petitions. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 92/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 13/15 Parental Rights Protections..................................................................................................................................................... 10/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 5/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 5/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 4/5 Organ Transplants............................................................................................................................................................................ 5/5 Reciprocity............................................................................................................................................................................................. 3/3 ACCESS TO MEDICINE 66/100 Allows Distribution Programs.................................................................................................................................................. 33/40 - Allows Access to Dried Flowers............................................................................................................................................... 15/15 - Allows Delivery..................................................................................................................................................................................... 5/5 - No Sales Tax or Reasonable Sales Tax................................................................................................................................. 5/5 - Allows for a Reasonable Number of Dispensaries........................................................................................................ 4/5 - Does Not Require Vertical Integration................................................................................................................................... 0/2 - Ownership/Employment Restrictions.................................................................................................................................... 1/2 - Provisions for Labor Standards................................................................................................................................................. 0/2 - Environmental Impact Regulations......................................................................................................................................... 1/2 - Choice of Dispensary Without Restrictions........................................................................................................................ 2/2 Noncommercial Cultivation....................................................................................................................................................... 0/20 - Personal Cultivation.......................................................................................................................................................................... 0/15 - Collective Gardening........................................................................................................................................................................ 0/5 Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... 5/10 Does Not Impose Bans or Limits on THC....................................................................................................................... 9/10 Does Not Impose Bans on CBD ............................................................................................................................................. 9/10 Local Bans/Zoning............................................................................................................................................................................ 10/10 IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 72 10 386.26 77.25% POINTS ISSUE EASE OF NAVIGATION 85/100 Comprehensive Qualifying Conditions............................................................................................................................ 46/50 Adding New Conditions............................................................................................................................................................... 8/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 3/5 Reasonable Access for Minors ............................................................................................................................................. 8/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 4/5 FUNCTIONALITY 78/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 42/50 No Significant Administrative or Supply Problems............................................................................................... 10/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 5/7 FINAL GRADE C+ MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 DELAWARE ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 55.26/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 15.92/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 18.84/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 12.67/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 7.83/25 Dispensing 15.92/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 2/5 3.25/5 0/1.25 1/1.25 1.25/1.25 1/1.25 3/5 2.67/5 1/1.67 0/1.67 1.67/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 18.84/25 Staff Training................................................................................................................................................................................................. 3/5 Standard Operating Procedures.................................................................................................................................................. 2.84/5 - Facility and Equipment Sanitary Conditions........................................................................................................................... 0.71/0.71 - Workforce Safety Protocols................................................................................................................................................................ 0/0.71 - Storage Protocols (Short Term and Long Term Storage)................................................................................................ 0.71/0.71 - Reasonable Security Protocols........................................................................................................................................................ 0.71/0.71 - Batch and Lot Tracking......................................................................................................................................................................... 0.71/0.71 - Disposal/Waste.......................................................................................................................................................................................... 0/0.71 - Water Management................................................................................................................................................................................. 0/0.71 Pesticide Guidance.................................................................................................................................................................................. 4/5 - Pesticide Guidance.................................................................................................................................................................................. 2/2.5 - Pesticide Labeling.................................................................................................................................................................................... 2/2.5 Required Testing........................................................................................................................................................................................ 5/5 - Active Ingredient Identification........................................................................................................................................................ 1.25/1.25 - Contaminants.............................................................................................................................................................................................. 1.25/1.25 - Potency............................................................................................................................................................................................................ 1.25/1.25 - Sample Retention..................................................................................................................................................................................... 1.25/1.25 Recall Protocol and Adverse Event Reporting.................................................................................................................. 4/5 Manufacturing 12.67/25 Staff Training............................................................................................................................................................................................. 3/5 Standard Operating Procedures............................................................................................................................................... 4/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 0/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 2.67/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1/1.67 - Potency and Compound Information....................................................................................................................................... 0/1.67 Required Testing.................................................................................................................................................................................... 3/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 0/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 0/5 Laboratory Operations 7.83/25 Staff Training.............................................................................................................................................................................................. 2/5 Method Validation in Accordance with AHP Guidelines..................................................................................... 0/5 Result Reporting..................................................................................................................................................................................... 0/5 Independent or Third Party............................................................................................................................................................ 5/5 Standard Operating Procedures and Protocols............................................................................................................. 0.83/5 - Equipment and Instrument Calibration..................................................................................................................................... 0/0.83 - Sample Tracking...................................................................................................................................................................................... 0/0.83 - Facility and Equipment Sanitary Conditions......................................................................................................................... 0/0.83 - Disposal/Waste....................................................................................................................................................................................... 0/0.83 - Storage Protocols................................................................................................................................................................................... 0.83/0.83 - Workforce Safety Protocols............................................................................................................................................................. 0/0.83 BACKGROUND In 2011, the Delaware state legislature approved Senate Bill 17, the Delaware Medical Marijuana Act, making it legal for a patient with a registration identification card to use and possess cannabis for medical purposes and designate a caregiver. Registered patients and designated caregivers may possess up to six ounces of usable cannabis; however, no personal cultivation is allowed. Qualifying patients and caregivers are protected from discrimination in employment, education, housing, parental rights, or medical care, including organ transplants. Delaware lawmakers adopted regulations for the Medical Marijuana Program in 2012; however, before the regulations were finalized, the program was suspended by Governor Jack Markell as the result of a letter sent to him from the U.S. Attorney for Delaware threatening legal action against state employees. In August 2013, Gov. Markell lifted the suspension, and the Department of Health and Social Services completed the process of implementing regulations. The state’s first Compassion Center was opened in 2014. In 2015, three legislative updates were made to the program. SB 7 made technical changes to the oversight commission and SB 138 authorized research studies in the state. The most notable change was SB 90, which allowed pediatric access to cannabis extract oils with less than 7% THC. In 2017 HB 219 was passed which allowed minors access to the same petition process as adults to add qualifying conditions and SB 24 which removed the requirement of a psychiatrist recommendation for PTSD patients. 73 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 DISTRICT OF COLUMBIA AREAS FOR IMPROVEMENT B Washington, D.C., has a very strong program and deserves credit for being the first jurisdiction to introduce portions of Americans for Safe Access’ ACT NOW legislation, which looks at cannabis as an option to fight the opioid crisis. However, the District still needs to overhaul regulations for manufacturers and provide civil protections for patients in the areas of employment protections, housing protections, and parental rights. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 78/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 3/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 5/5 Reciprocity............................................................................................................................................................................................. 3/3 ACCESS TO MEDICINE 78/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 74 20 416.2 83.24% 29/40 15/15 0/5 4/5 5/5 2/2 1/2 0/2 0/2 2/2 11/20 10/15 1/5 10/10 10/10 10/10 8/10 POINTS ISSUE EASE OF NAVIGATION 93/100 Comprehensive Qualifying Conditions............................................................................................................................ 50/50 Adding New Conditions............................................................................................................................................................... 10/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 5/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 2/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 8/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 81/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 40/50 No Significant Administrative or Supply Problems............................................................................................... 15/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 5/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 5/7 FINAL GRADE B MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 DISTRICT OF COLUMBIA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 66.2/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 16.01/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 17.5/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 12.67/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 20/25 Dispensing 16.01/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 0/5 3.34/5 1.67/1.67 0/1.67 1.67/1.67 2.67/5 1.67/1.67 0/1.67 1/1.67 17.5/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 3/5 2/2.5 1/2.5 2.5/5 1.25/1.25 0/1.25 1.25/1.25 0/1.25 2/5 Manufacturing 12.67/25 Staff Training............................................................................................................................................................................................. 5/5 Standard Operating Procedures............................................................................................................................................... 4/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 0/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 2.67/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1/1.67 - Potency and Compound Information....................................................................................................................................... 0/1.67 Required Testing.................................................................................................................................................................................... 1/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 0/1 - Potency......................................................................................................................................................................................................... 0/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 0/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 0/5 Laboratory Operations 20/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 5/5 0/5 5/5 5/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND The voters of Washington, D.C. first approved medical cannabis in 1998 with the passage of Initiative 59 (I-59), but the law was blocked by Congressional action through a budget rider that was attached to the District’s budget every year until 2009. Once Congress dropped its opposition, the D.C. Council passed B18-0622: Legalization of Marijuana for Medical Treatment of 2010 Initiative which replaced I-59. Registered patients can possess up to two ounces of usable cannabis or its equivalent in other forms (i.e. edibles, tinctures, topicals, etc.). Registered cultivation centers supply medical cannabis dispensaries. Patients whose income is less than 200% of the federal poverty level are entitled to purchase medicine at a reduced rate. In July 2014, the D.C. Council passed emergency legislation to lift the physician restrictions on determining qualifying conditions and to increase the cultivation center plant limit from 95 to 500 plants. In 2015, they increased the plant limit to 1,000 plants. In November 2016, the Council passed B21-210 which requires the Department of Health (DOH) to license independent laboratories for product testing, removes drug conviction restrictions on individuals allowed to work in dispensaries, and required the DOH to create a District-wide tracking system that, once implemented, will allow reciprocity of medical cannabis card holders in other states, and patients to visit any dispensary in D.C. In 2017, D.C. increased its number of dispensaries from 6 to 7. 75 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 C FLORIDA - AREAS FOR IMPROVEMENT Florida passed several improvements to its program in 2017 as it continued to move through the implementation of Amendment 2, which created a comprehensive medical cannabis program. In bill 8A, the Florida legislature removed access to dried flowers, prohibited the smoking of cannabis, and reinforced a prohibition on home cultivation. Access to dried flowers, smoking, and home cultivation are currently being challenged in the Florida court system (Redner v. DOH, et. al., People for United Medical Marijuana v. DOH). The state also lacks a financial hardship waiver. The Florida Legislature adversely changed what voters decided and should return to language passed in Amendment 2. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 69/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 13/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 5/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 4/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 49/100 Allows Distribution Programs.................................................................................................................................................. 19/40 - Allows Access to Dried Flowers............................................................................................................................................... 0/15 - Allows Delivery..................................................................................................................................................................................... 5/5 - No Sales Tax or Reasonable Sales Tax................................................................................................................................. 5/5 - Allows for a Reasonable Number of Dispensaries........................................................................................................ 4/5 - Does Not Require Vertical Integration................................................................................................................................... 0/2 - Ownership/Employment Restrictions.................................................................................................................................... 1/2 - Provisions for Labor Standards................................................................................................................................................. 2/2 - Environmental Impact Regulations......................................................................................................................................... 0/2 - Choice of Dispensary Without Restrictions........................................................................................................................ 2/2 Noncommercial Cultivation....................................................................................................................................................... 0/20 - Personal Cultivation.......................................................................................................................................................................... 0/15 - Collective Gardening........................................................................................................................................................................ 0/5 Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... 9/10 Does Not Impose Bans or Limits on THC....................................................................................................................... 9/10 Does Not Impose Bans on CBD ............................................................................................................................................. 4/10 Local Bans/Zoning............................................................................................................................................................................ 8/10 IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 76 20 354.83 70.97% POINTS ISSUE EASE OF NAVIGATION 75/100 Comprehensive Qualifying Conditions............................................................................................................................ 45/50 Adding New Conditions............................................................................................................................................................... 7/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 2/5 Reasonable Access for Minors ............................................................................................................................................. 8/10 Reasonable Caregiver Background Checks................................................................................................................ 0/4 Number of Caregivers................................................................................................................................................................... 0/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 5/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 0/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 71/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 40/50 No Significant Administrative or Supply Problems............................................................................................... 10/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 5/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 0/7 FINAL GRADE C- MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 FLORIDA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 70.83/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 21.34/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 21/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 21/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 7.49/25 Dispensing 21.34/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 3.34/5 1.67/1.67 0/1.67 1.67/1.67 3/5 1/1.67 1/1.67 1/1.67 21/25 5/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 4/5 2/2.5 2/2.5 2/5 1/1.25 0/1.25 1/1.25 0/1.25 5/5 Manufacturing 21/25 Staff Training............................................................................................................................................................................................. Standard Operating Procedures............................................................................................................................................... - Facility and Equipment Sanitary Conditions........................................................................................................................ - Workforce Safety Protocols............................................................................................................................................................. - Storage Protocols.................................................................................................................................................................................. - Reasonable Security Protocols..................................................................................................................................................... - Batch and Lot Tracking...................................................................................................................................................................... Product Labeling.................................................................................................................................................................................... - Product Contents Including Source Material Identification........................................................................................ - Allergens...................................................................................................................................................................................................... - Potency and Compound Information....................................................................................................................................... Required Testing.................................................................................................................................................................................... - Active Ingredient Identification..................................................................................................................................................... - Contaminants........................................................................................................................................................................................... - Potency......................................................................................................................................................................................................... - Shelf Life Testing.................................................................................................................................................................................... - Sample Retention.................................................................................................................................................................................. Recall Protocol and Adverse Event Reporting............................................................................................................... Laboratory Operations 5/5 5/5 1/1 1/1 1/1 1/1 1/1 2/5 1/1.67 0/1.67 1/1.67 4/5 1/1 1/1 1/1 0/1 1/1 5/5 7.49/25 Staff Training.............................................................................................................................................................................................. 0/5 Method Validation in Accordance with AHP Guidelines........................................................................................ 0/5 Result Reporting..................................................................................................................................................................................... 5/5 Independent or Third Party............................................................................................................................................................ 0/5 Standard Operating Procedures and Protocols............................................................................................................. 2.49/5 - Equipment and Instrument Calibration..................................................................................................................................... 0.83/0.83 - Sample Tracking...................................................................................................................................................................................... 0.83/0.83 - Facility and Equipment Sanitary Conditions......................................................................................................................... 0/0.83 - Disposal/Waste....................................................................................................................................................................................... 0/0.83 - Storage Protocols................................................................................................................................................................................... 0.83/0.83 - Workforce Safety Protocols............................................................................................................................................................. 0/0.83 BACKGROUND In 2014, the Florida Legislature passed SB 1030, which created a registry ID card system for patients with cancer, seizure disorders, or severe or persistent muscle spasms that would allow them to possess and use only cannabis products rich in cannabidiol (CBD) and low in THC. SB 1030 created state licensing of dispensing organizations, and the legislature passed HB 307, which expanded the program to terminally ill patients and allowed dispensing organizations to produce products outside the THC cap. In November 2016, voters approved Amendment 2, which created a comprehensive medical cannabis program with significantly expanded qualifying conditions. In 2017, the legislature passed SB 8A in an emergency session which provides a framework for patients to access cannabis more quickly. On July 3, 2017 the Florida Department of Health promulgated rules for implementing SB 8A. 77 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 GEORGIA F AREAS FOR IMPROVEMENT In May of 2017 through SB 16, Georgia greatly expanded its list of qualifying conditions by adding AIDS, Alzheimer’s, epidermolysis bullosa, peripheral neuropathy, Tourette syndrome, and autism. Georgia is one of the few states to list autism as a enumerated qualifying condition. SB 16 also slightly increased labeling requirements. However patients in Georgia still have great difficulty accessing medicine because there is no state distribution system. Georgia could greatly improve its program by allowing patients to access medicine within the state, increase product safety standards, and remove arbitrary limits on THC percentage. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 54/100 Arrest Protections............................................................................................................................................................................ 30/40 Affirmative Defense......................................................................................................................................................................... 10/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 2/3 ACCESS TO MEDICINE 15/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 78 20 187 37.40% 0/40 0/15 0/5 0/5 0/5 0/2 0/2 0/2 0/2 0/2 0/20 0/15 0/5 3/10 5/10 7/10 0/10 POINTS ISSUE EASE OF NAVIGATION 73/100 Comprehensive Qualifying Conditions............................................................................................................................ 40/50 Adding New Conditions............................................................................................................................................................... 0/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 0/5 - System Works for Adding New Conditions...................................................................................................................... 0/5 Reasonable Access for Minors ............................................................................................................................................. 8/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 1/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 10/10 Allows Multiple-Year Registrations ................................................................................................................................... 2/2 Reasonable Physician Requirements ............................................................................................................................ 4/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 2/5 FUNCTIONALITY 25/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 0/50 No Significant Administrative or Supply Problems............................................................................................... 10/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 0/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 0/7 FINAL GRADE F MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 GEORGIA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 0/100 Dispensing...................................................................................................................................................................................................................................................................................................................... Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... Manufacturing ............................................................................................................................................................................................................................................................................................................ Laboratory Operations ........................................................................................................................................................................................................................................................................................ 0/25 0/25 0/25 0/25 Dispensing 0/25 Manufacturing 0/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Staff Training............................................................................................................................................................................................. Standard Operating Procedures............................................................................................................................................... - Facility and Equipment Sanitary Conditions........................................................................................................................ - Workforce Safety Protocols............................................................................................................................................................. - Storage Protocols.................................................................................................................................................................................. - Reasonable Security Protocols..................................................................................................................................................... - Batch and Lot Tracking...................................................................................................................................................................... Product Labeling.................................................................................................................................................................................... - Product Contents Including Source Material Identification........................................................................................ - Allergens...................................................................................................................................................................................................... - Potency and Compound Information....................................................................................................................................... Required Testing.................................................................................................................................................................................... - Active Ingredient Identification..................................................................................................................................................... - Contaminants........................................................................................................................................................................................... - Potency......................................................................................................................................................................................................... - Shelf Life Testing.................................................................................................................................................................................... - Sample Retention.................................................................................................................................................................................. Recall Protocol and Adverse Event Reporting............................................................................................................... 0/5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1.67 0/1.67 0/1.67 Grow/Cultivation 0/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 0/5 0/5 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/5 0/2.5 0/2.5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 0/5 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1 0/1 0/1 0/1 0/1 0/5 Laboratory Operations 0/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 0/5 0/5 0/5 0/5 0/5 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 BACKGROUND In 2015, the Georgia legislature passed HB1 which created a patient ID card registry and established a list of eight qualifying conditions so that patients may legally possess and use low-THC medical cannabis products. The law places a 5% cap on THC and requires products to have a least a 1:1 ratio of THC to CBD. The law does not allow for in-state production or access, but it did create the Georgia Medical Cannabis Commission, which was tasked with investigating other state programs to come up with a legislative proposal. In Dec. 2015, the commission voted against in-state production of cannabis. In May of 2017, SB 16 added six more qualifying conditions to be eligible for the program and allowed patients in hospice care to possess oil. 79 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 GUAM C - AREAS FOR IMPROVEMENT Guam deserves credit for allowing physicians to recommend for any qualifying condition. However, it needs to open dispensaries and remove administrative delays to effectively serve patients. Guam illustrates that a good program on paper does not necessarily translate to patient access. It needs to improve its staff training in cannabis cultivation, dispensing, and manufacturing and increase civil rights protections in the areas of housing, organ transplants, and employment. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 75/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 9/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 4/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 63/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 80 10 357.18 71.44% 27/40 15/15 0/5 3/5 5/5 2/2 0/2 0/2 0/2 2/2 0/20 0/15 0/5 10/10 10/10 10/10 6/10 POINTS ISSUE EASE OF NAVIGATION 91/100 Comprehensive Qualifying Conditions............................................................................................................................ 50/50 Adding New Conditions............................................................................................................................................................... 10/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 5/5 Reasonable Access for Minors ............................................................................................................................................. 8/10 Reasonable Caregiver Background Checks................................................................................................................ 2/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 57/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 30/50 No Significant Administrative or Supply Problems............................................................................................... 7/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 9/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 0/7 FINAL GRADE C- MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 GUAM ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 61.18/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 15.09/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 13.09/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 16/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 17/25 Dispensing 15.09/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 0/5 3.75/5 0/1.25 1.25/1.25 1.25/1.25 1.25/1.25 3/5 5/5 1.67/1.67 1.67/1.67 1.67/1.67 3.34/5 1.67/1.67 0/1.67 1.67/1.67 13.09/25 Staff Training................................................................................................................................................................................................. 0/5 Standard Operating Procedures.................................................................................................................................................. 2.84/5 - Facility and Equipment Sanitary Conditions........................................................................................................................... 0.71/0.71 - Workforce Safety Protocols................................................................................................................................................................ 0/0.71 - Storage Protocols (Short Term and Long Term Storage)................................................................................................ 0.71/0.71 - Reasonable Security Protocols........................................................................................................................................................ 0.71/0.71 - Batch and Lot Tracking......................................................................................................................................................................... 0.71/0.71 - Disposal/Waste.......................................................................................................................................................................................... 0/0.71 - Water Management................................................................................................................................................................................. 0/0.71 Pesticide Guidance.................................................................................................................................................................................. 3.5/5 - Pesticide Guidance.................................................................................................................................................................................. 2.5/2.5 - Pesticide Labeling.................................................................................................................................................................................... 1/2.5 Required Testing........................................................................................................................................................................................ 3.75/5 - Active Ingredient Identification........................................................................................................................................................ 1.25/1.25 - Contaminants.............................................................................................................................................................................................. 1.25/1.25 - Potency............................................................................................................................................................................................................ 1.25/1.25 - Sample Retention..................................................................................................................................................................................... 0/1.25 Recall Protocol and Adverse Event Reporting.................................................................................................................. 3/5 Manufacturing 16/25 Staff Training............................................................................................................................................................................................. 0/5 Standard Operating Procedures............................................................................................................................................... 4/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 0/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 4/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 3/5 Laboratory Operations 17/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 2/5 0/5 5/5 5/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND In 2013, Guam passed Public Law 33-220, known as the “Joaquin Concepcion, II Compassionate Use of Cannabis Act” which allowed for the medical use of cannabis. Applications for businesses to obtain medical cannabis licenses will be available beginning January 18, 2017. The Joaquin Concepcion Act has been amended twice since its enactment, once in 2016 and once in 2017. The 2017 amendments related to the fees and taxation of medical cannabis cultivation, manufacturing, and laboratory facilities and created ownership restrictions for non-residents of Guam. Guam requires each of its dispensaries to be certified by Patient Focused Certification, a standards project of Americans for Safe Access. Patients or caregivers may possess up to 2.5 ounces of dried or prepared cannabis from a dispensary. However, administrative barriers and procedural delays have prevented the program from effectively serving patients. 81 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 HAWAI’I B + AREAS FOR IMPROVEMENT After a slow start to its program, Hawai’i seems to be headed in a great direction in terms of effectively serving patients. Despite being one of the strongest programs in the country, Hawai’i still has room for improvement, particularly in the area of product recall standards. Also, in light of the ongoing opioid crisis, it is critical for Hawai’i to add chronic pain as a qualifying condition. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 91/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 10/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 5/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 5/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 4/5 Organ Transplants............................................................................................................................................................................ 5/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 82/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 82 15 439.18 87.84% 27/40 15/15 0/5 4/5 5/5 0/2 1/2 0/2 0/2 2/2 18/20 15/15 3/5 10/10 10/10 10/10 7/10 POINTS ISSUE EASE OF NAVIGATION 92/100 Comprehensive Qualifying Conditions............................................................................................................................ 48/50 Adding New Conditions............................................................................................................................................................... 9/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 4/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 9/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 4/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 81/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 45/50 No Significant Administrative or Supply Problems............................................................................................... 12/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 7/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 4/7 FINAL GRADE B+ MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 HAWAI’I ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 78.18/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 18.34/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 18.50/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 17.34/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 24/25 Dispensing 18.34/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 0/5 3.34/5 1.67/1.67 0/1.67 1.67/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 18.50/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 3.5/5 2.5/2.5 1/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 0/5 Manufacturing 17.34/25 Staff Training............................................................................................................................................................................................. 5/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 3.34/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 0/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 4/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 0/5 Laboratory Operations 24/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 5/5 5/5 4/5 5/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND In 2000, Hawai’i passed SB 862/HD 1, making it the first state legislature to legalize allows more to be licensed in 2017. SB 1291 clarified anti-discrimination protections for medical cannabis via the legislative (rather than the voter initiated) process. The patients. In 2016, the legislature passed HB 2707 which created a legislative oversight legislature amended the law in 2013 with two bills. HB 668 moved the medical cannabis group to monitor the program and report back to the legislature before the 2018 session. program from the Department of Public Safety to the Department of Health and The bill also expanded the allowed delivery methods and protections for medical cannabis established a Medical Marijuana Registry special fund. SB 642 defined “adequate supply,” paraphernalia. “medical use,” “primary caregiver,” “usable marijuana,” and “written certification. SB 642 amended registration requirements and created a mechanism for law enforcement to 2017 brought significant improvements for Hawai’i’s medical cannabis program, including immediately verify registration status 24 hours a day, seven days a week. Registered legislation that expanded the number of plants an individual can grow, laboratory medical cannabis patients and their registered caregivers may possess up to three certification standards, and added four new qualifying conditions. In 2017, Hawai’i also ounces of usable cannabis and cultivate up to ten plants. Registered patients and improved its petition process for adding qualifying conditions, provided clarifications caregivers are entitled to an affirmative defense in court. In 2015, the legislature passed about patient privacy, and developed a state sanctioned cashless purchasing system two more bills that improved the medical cannabis program. HB 321 created a program for medical cannabis. Hawai’i also deserves credit for making technical changes to its allowing eight medical marijuana dispensaries with two cultivation licenses each and program by replacing the word “marijuana” with cannabis in their statutes. 83 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 ILLINOIS B + AREAS FOR IMPROVEMENT Illinois remains one of the strongest programs in the country. However, 2017 brought no substantive changes to the state’s medical cannabis program. The state should add chronic pain as a qualifying condition in light of the ongoing opioid crisis and remove restrictions for qualifying patients. In 2016, 1,191 individuals in Illinois lost their lives to opioid analgesics including fentanyl, morphine, and semi-synthetic opioids such as oxycodone. The state should work to remove its fingerprinting requirements for background checks which serve no purpose in improving the lives of patients. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 94/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 13/15 Parental Rights Protections..................................................................................................................................................... 10/10 DUI Protections.................................................................................................................................................................................. 5/5 Employment Protections............................................................................................................................................................ 5/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 5/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 4/5 Organ Transplants............................................................................................................................................................................ 5/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 68/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 84 10 438.83 87.77% 30/40 15/15 0/5 3/5 5/5 2/2 1/2 2/2 2/2 0/2 0/20 0/15 0/5 10/10 10/10 10/10 8/10 POINTS ISSUE EASE OF NAVIGATION 90/100 Comprehensive Qualifying Conditions............................................................................................................................ 47/50 Adding New Conditions............................................................................................................................................................... 10/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 5/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 2/2 Reasonable Physician Requirements ............................................................................................................................ 4/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 4/5 FUNCTIONALITY 86/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 45/50 No Significant Administrative or Supply Problems............................................................................................... 15/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 6/7 FINAL GRADE B+ MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 ILLINOIS ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 91/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 25/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 25/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 25/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 15.83/25 Dispensing 25/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 5/5 1.67/1.67 1.67/1.67 1.67/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 25/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 5/5 2.5/2.5 2.5/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 Manufacturing 25/25 Staff Training............................................................................................................................................................................................. 5/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations 15.83/25 Staff Training.............................................................................................................................................................................................. 5/5 Method Validation in Accordance with AHP Guidelines........................................................................................ 5/5 Result Reporting..................................................................................................................................................................................... 0/5 Independent or Third Party............................................................................................................................................................ 5/5 Standard Operating Procedures and Protocols............................................................................................................. 0.83/5 - Equipment and Instrument Calibration..................................................................................................................................... 0/0.83 - Sample Tracking...................................................................................................................................................................................... 0.83/0.83 - Facility and Equipment Sanitary Conditions......................................................................................................................... 0/0.83 - Disposal/Waste....................................................................................................................................................................................... 0/0.83 - Storage Protocols................................................................................................................................................................................... 0/0.83 - Workforce Safety Protocols............................................................................................................................................................. 0/0.83 BACKGROUND In 2013, The Compassionate Use of Medical Cannabis Pilot Program Act (HB 1) was enacted to create a temporary statewide distribution program for qualifying patients. HB 1 specifies 35 qualifying conditions, but excludes chronic pain, the leading indication for use of medical cannabis. HB 1 allows patients to possess up to 2.5 ounces of cannabis every two weeks from one of the 60 dispensing organizations that are supplied by the 22 cultivation centers. Cultivation by patients or their caregivers is prohibited. Public safety officials, school bus and commercial drivers, police and correctional officers, firefighters, and anyone convicted of a drug-related felony, are not eligible for the program. The Joint Committee Administrative Rules approved final rules for the pilot program on July 15, 2014 with input from the Departments of Agriculture, Financial and Professional Regulation, Public Health, and Revenue. The state’s first dispensaries began serving patients in November 2015. In 2016, the legislature passed SB 10 that extended the sunset clause for the program to 2020, added PTSD and terminal illness as qualifying conditions, established a petition process for adding new conditions, and made changes in the regulations for physicians recommending process including a 3-year renewal option for patients. 85 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 INDIANA F AREAS FOR IMPROVEMENT Despite bordering three states with fairly effective programs, Indiana did not provide any access at all for medical cannabis until the spring of 2017. Although Indiana implementing a program for certain patients suffering from epilepsy is a step in the right direction, thousands of patients are excluded by the limiting the use of cannabidiol to only those suffering from epilepsy. If Indiana wants to get on par with neighboring states like Michigan, Illinois, and Ohio the program needs to include more qualifying conditions and not be so limited in its access points. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 23/100 Arrest Protections............................................................................................................................................................................ 0/40 Affirmative Defense......................................................................................................................................................................... 12/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 2/5 Explicit Privacy Standards........................................................................................................................................................ 4/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 9/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 86 10 106 21.2% 0/40 0/15 0/5 0/5 0/5 0/2 0/2 0/2 0/2 0/2 0/20 0/15 0/5 3/10 1/10 5/10 0/10 POINTS ISSUE EASE OF NAVIGATION 36/100 Comprehensive Qualifying Conditions............................................................................................................................ 10/50 Adding New Conditions............................................................................................................................................................... 0/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 0/5 - System Works for Adding New Conditions...................................................................................................................... 0/5 Reasonable Access for Minors ............................................................................................................................................. 7/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 1/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 10/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 3/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 1/5 FUNCTIONALITY 28/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... No Significant Administrative or Supply Problems............................................................................................... Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. Reasonable Possession Limits.............................................................................................................................................. Reasonable Purchase Limits................................................................................................................................................... Allows Patients to Medicate Where They Choose................................................................................................. Covered by Insurance/State Health Programs......................................................................................................... Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... FINAL GRADE F 0/50 5/15 8/10 4/5 0/5 4/5 0/3 7/7 MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 INDIANA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS Dispensing...................................................................................................................................................................................................................................................................................................................... Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... Manufacturing ............................................................................................................................................................................................................................................................................................................ Laboratory Operations ........................................................................................................................................................................................................................................................................................ Dispensing Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 0/25 0/5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1.67 0/1.67 0/1.67 0/25 0/5 0/5 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/5 0/2.5 0/2.5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 Manufacturing Staff Training............................................................................................................................................................................................. Standard Operating Procedures............................................................................................................................................... - Facility and Equipment Sanitary Conditions........................................................................................................................ - Workforce Safety Protocols............................................................................................................................................................. - Storage Protocols.................................................................................................................................................................................. - Reasonable Security Protocols..................................................................................................................................................... - Batch and Lot Tracking...................................................................................................................................................................... Product Labeling.................................................................................................................................................................................... - Product Contents Including Source Material Identification........................................................................................ - Allergens...................................................................................................................................................................................................... - Potency and Compound Information....................................................................................................................................... Required Testing.................................................................................................................................................................................... - Active Ingredient Identification..................................................................................................................................................... - Contaminants........................................................................................................................................................................................... - Potency......................................................................................................................................................................................................... - Shelf Life Testing.................................................................................................................................................................................... - Sample Retention.................................................................................................................................................................................. Recall Protocol and Adverse Event Reporting............................................................................................................... Laboratory Operations Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 0/100 0/25 0/25 0/25 0/25 0/25 0/5 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/25 0/5 0/5 0/5 0/5 0/5 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 BACKGROUND In April 2017, Governor Eric Holcomb signed a bill into law that provided patients who were suffering from treatment resistant epilepsy to enroll into the state’s medical cannabis program with approval from their neurologist. The Indiana program limits patients to use cannabidiol with 0.3% or less THC. After passing the law, Indiana State Excise Police confiscated over 3500 CBD items from 57 stores across state, creating access problems that were even more significant than before the law passed. 87 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 IOWA F AREAS FOR IMPROVEMENT While Iowa’s program remains limited, 2017 showed an improvement. House File 524, which was signed into law, expanded access to those with Parkinson’s, cancer, Multiple Sclerosis, seizures, HIV/AIDS, Crohn’s disease, ALS, most terminal illnesses with life expectancy less than one year, and untreatable pain. Adding untreatable pain is a step in the right direction for those affected by the opioid crisis, but the definition of pain remains limited. The law also allows for the production of low-THC cannabis products in the state creating a framework for growing, manufacturing, and distribution companies to submit proposals to the state. Iowa could still vastly improve on developing robust product safety regulations and increasing accessibility to medicine. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 55/100 Arrest Protections............................................................................................................................................................................ 20/40 Affirmative Defense......................................................................................................................................................................... 12/15 Parental Rights Protections..................................................................................................................................................... 8/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 3/3 ACCESS TO MEDICINE 24/100 Allows Distribution Programs.................................................................................................................................................. 8/40 - Allows Access to Dried Flowers............................................................................................................................................... 0/15 - Allows Delivery..................................................................................................................................................................................... 3/5 - No Sales Tax or Reasonable Sales Tax................................................................................................................................. 0/5 - Allows for a Reasonable Number of Dispensaries........................................................................................................ 5/5 - Does Not Require Vertical Integration................................................................................................................................... 0/2 - Ownership/Employment Restrictions.................................................................................................................................... 0/2 - Provisions for Labor Standards................................................................................................................................................. 0/2 - Environmental Impact Regulations......................................................................................................................................... 0/2 - Choice of Dispensary Without Restrictions........................................................................................................................ 0/2 Noncommercial Cultivation....................................................................................................................................................... 0/20 - Personal Cultivation.......................................................................................................................................................................... 0/15 - Collective Gardening........................................................................................................................................................................ 0/5 Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... 3/10 Does Not Impose Bans or Limits on THC....................................................................................................................... 3/10 Does Not Impose Bans on CBD ............................................................................................................................................. 10/10 Local Bans/Zoning............................................................................................................................................................................ 0/10 IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 88 15 253.09 50.62% POINTS ISSUE EASE OF NAVIGATION 85/100 Comprehensive Qualifying Conditions............................................................................................................................ 50/50 Adding New Conditions............................................................................................................................................................... 5/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 0/5 Reasonable Access for Minors ............................................................................................................................................. 6/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 10/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 3/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 3/5 FUNCTIONALITY 56/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 20/50 No Significant Administrative or Supply Problems............................................................................................... 12/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 0/5 Allows Patients to Medicate Where They Choose................................................................................................. 5/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 7/7 FINAL GRADE F MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 IOWA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 18.09/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 8.09/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 5/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 5/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 0/25 Dispensing 8.09/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... 0/5 4.75/5 1.25/1.25 1.25/1.25 1.25/1.25 1/1.25 0/5 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1.67 0/1.67 0/1.67 Grow/Cultivation 5/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 0/5 0/5 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/5 0/2.5 0/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 0/5 Manufacturing Staff Training............................................................................................................................................................................................. Standard Operating Procedures............................................................................................................................................... - Facility and Equipment Sanitary Conditions........................................................................................................................ - Workforce Safety Protocols............................................................................................................................................................. - Storage Protocols.................................................................................................................................................................................. - Reasonable Security Protocols..................................................................................................................................................... - Batch and Lot Tracking...................................................................................................................................................................... Product Labeling.................................................................................................................................................................................... - Product Contents Including Source Material Identification........................................................................................ - Allergens...................................................................................................................................................................................................... - Potency and Compound Information....................................................................................................................................... Required Testing.................................................................................................................................................................................... - Active Ingredient Identification..................................................................................................................................................... - Contaminants........................................................................................................................................................................................... - Potency......................................................................................................................................................................................................... - Shelf Life Testing.................................................................................................................................................................................... - Sample Retention.................................................................................................................................................................................. Recall Protocol and Adverse Event Reporting............................................................................................................... Laboratory Operations Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 5/25 0/5 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/1.67 0/1.67 0/1.67 5/5 1/1 1/1 1/1 1/1 1/1 0/5 0/25 0/5 0/5 0/5 0/5 0/5 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 BACKGROUND In 2014, the Iowa legislature passed the “Medical Cannabidiol Act” which allows licensed neurologists and other health care practitioners to certify patients with intractable epilepsy to use cannabidiol (CBD) with 3% or less THC content. Qualifying patients must obtain a registry card to be eligible to receive legal protection; patients may designate a caregiver to assist them. The law does not impose a minimum amount of CBD, but does not extend legal protections to those with products that have more than 3% THC. In 2017, HF 524 expanded the qualifying conditions list and created a distribution system for the state. 89 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 KENTUCKY F AREAS FOR IMPROVEMENT Unfortunately, Kentucky’s program has remained limited and unchanged over the last year. In September of 2017, a Kentucky judge ruled that Kentucky has a good reason to “curtail citizens’ possession of a narcotic, hallucinogenic drug.” (Seum et. al, v. Bevin) On the other hand, Kentucky Secretary of State Alison Lundergan Grimes has called for a taskforce to look into possible medical cannabis legalization, but the task force itself has no legislative authority. Kentucky has one of the highest opioid overdose rates in the country at a rate of 29.9 per 100,000, and the state’s population could be tremendously helped by a medical cannabis program that included chronic pain. Kentucky needs to expand its limited program and increase availability of medicine. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 41/100 Arrest Protections............................................................................................................................................................................ 20/40 Affirmative Defense......................................................................................................................................................................... 9/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 10/100 Allows Distribution Programs.................................................................................................................................................. 0/40 - Allows Access to Dried Flowers............................................................................................................................................... 0/15 - Allows Delivery..................................................................................................................................................................................... 0/5 - No Sales Tax or Reasonable Sales Tax................................................................................................................................. 0/5 - Allows for a Reasonable Number of Dispensaries........................................................................................................ 0/5 - Does Not Require Vertical Integration................................................................................................................................... 0/2 - Ownership/Employment Restrictions.................................................................................................................................... 0/2 - Provisions for Labor Standards................................................................................................................................................. 0/2 - Environmental Impact Regulations......................................................................................................................................... 0/2 - Choice of Dispensary Without Restrictions........................................................................................................................ 0/2 Noncommercial Cultivation....................................................................................................................................................... 0/20 - Personal Cultivation.......................................................................................................................................................................... 0/15 - Collective Gardening........................................................................................................................................................................ 0/5 Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... 0/10 Does Not Impose Bans or Limits on THC....................................................................................................................... 0/10 Does Not Impose Bans on CBD ............................................................................................................................................. 10/10 Local Bans/Zoning............................................................................................................................................................................ 0/10 IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 90 0 156 31.2% POINTS ISSUE EASE OF NAVIGATION 77/100 Comprehensive Qualifying Conditions............................................................................................................................ 50/50 Adding New Conditions............................................................................................................................................................... 0/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 0/5 - System Works for Adding New Conditions...................................................................................................................... 0/5 Reasonable Access for Minors ............................................................................................................................................. 10/10 Reasonable Caregiver Background Checks................................................................................................................ 0/4 Number of Caregivers................................................................................................................................................................... 0/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 10/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 2/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 3/5 FUNCTIONALITY 28/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 0/50 No Significant Administrative or Supply Problems............................................................................................... 10/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 10/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 0/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 0/7 FINAL GRADE F MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 KENTUCKY ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS Dispensing...................................................................................................................................................................................................................................................................................................................... Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... Manufacturing ............................................................................................................................................................................................................................................................................................................ Laboratory Operations ........................................................................................................................................................................................................................................................................................ Dispensing 0/25 Manufacturing Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Staff Training............................................................................................................................................................................................. Standard Operating Procedures............................................................................................................................................... - Facility and Equipment Sanitary Conditions........................................................................................................................ - Workforce Safety Protocols............................................................................................................................................................. - Storage Protocols.................................................................................................................................................................................. - Reasonable Security Protocols..................................................................................................................................................... - Batch and Lot Tracking...................................................................................................................................................................... Product Labeling.................................................................................................................................................................................... - Product Contents Including Source Material Identification........................................................................................ - Allergens...................................................................................................................................................................................................... - Potency and Compound Information....................................................................................................................................... Required Testing.................................................................................................................................................................................... - Active Ingredient Identification..................................................................................................................................................... - Contaminants........................................................................................................................................................................................... - Potency......................................................................................................................................................................................................... - Shelf Life Testing.................................................................................................................................................................................... - Sample Retention.................................................................................................................................................................................. Recall Protocol and Adverse Event Reporting............................................................................................................... Grow/Cultivation Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 0/5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1.67 0/1.67 0/1.67 0/25 0/5 0/5 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/5 0/2.5 0/2.5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 Laboratory Operations Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 0/100 0/25 0/25 0/25 0/25 0/25 0/5 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/25 0/5 0/5 0/5 0/5 0/5 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 BACKGROUND In 2014, the Kentucky legislature revised the definition of marijuana Although the law does not limit the use of CBD to one particular under state law to create legal protections for patients who use condition, rather letting physicians recommend to anyone where the cannabidiol (CBD) as part of an approved clinical trial or on the benefits outweigh the risks, Kentucky fails to provide any production written order of “a physician practicing at a hospital or affiliated with a or distribution system making the program completely ineffective. Kentucky public university having a college or a school of medicine.” 91 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 D- LOUISIANA AREAS FOR IMPROVEMENT As of December 2017, six doctors have signed up to participate in the program. Only agricultural centers at Louisiana State University and Southern University are allowed to grow medical cannabis, and access to medical cannabis could happen by mid2018. Due to the limited number of access points, many patients are left without an opportunity to obtain medicine. Louisiana’s program did see a significant boost due to the Department of Agriculture promulgating consumer safety and provider regulations. The state’s restriction of only allowing two state universities to dispense medical cannabis is overly restrictive and patients continue to not have access in Louisiana. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 62/100 Arrest Protections............................................................................................................................................................................ 35/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 46/100 Allows Distribution Programs.................................................................................................................................................. 0/40 - Allows Access to Dried Flowers............................................................................................................................................... 0/15 - Allows Delivery..................................................................................................................................................................................... 0/5 - No Sales Tax or Reasonable Sales Tax................................................................................................................................. 0/5 - Allows for a Reasonable Number of Dispensaries........................................................................................................ 0/5 - Does Not Require Vertical Integration................................................................................................................................... 0/2 - Ownership/Employment Restrictions.................................................................................................................................... 0/2 - Provisions for Labor Standards................................................................................................................................................. 0/2 - Environmental Impact Regulations......................................................................................................................................... 0/2 - Choice of Dispensary Without Restrictions........................................................................................................................ 0/2 Noncommercial Cultivation....................................................................................................................................................... 0/20 - Personal Cultivation.......................................................................................................................................................................... 0/15 - Collective Gardening........................................................................................................................................................................ 0/5 Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... 5/10 Does Not Impose Bans or Limits on THC....................................................................................................................... 3/10 Does Not Impose Bans on CBD ............................................................................................................................................. 10/10 Local Bans/Zoning............................................................................................................................................................................ 10/10 IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 92 25 313 62.56% POINTS ISSUE EASE OF NAVIGATION 66/100 Comprehensive Qualifying Conditions............................................................................................................................ 40/50 Adding New Conditions............................................................................................................................................................... 2/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 2/5 - System Works for Adding New Conditions...................................................................................................................... 0/5 Reasonable Access for Minors ............................................................................................................................................. 10/10 Reasonable Caregiver Background Checks................................................................................................................ 0/4 Number of Caregivers................................................................................................................................................................... 0/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 4/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 3/5 FUNCTIONALITY 53/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 25/50 No Significant Administrative or Supply Problems............................................................................................... 10/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 5/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 5/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 0/7 FINAL GRADE D- MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 LOUISIANA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 60/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 14.59/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 12.46/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 17/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 16/25 Dispensing 14.59/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 0/5 3.25/5 0/1.25 1/1.25 1.25/1.25 1/1.25 3/5 5/5 1.67/1.67 1.67/1.67 1.67/1.67 3.34/5 1.67/1.67 0/1.67 1.67/1.67 12.46/25 Staff Training................................................................................................................................................................................................. 0/5 Standard Operating Procedures.................................................................................................................................................. 0.71/5 - Facility and Equipment Sanitary Conditions........................................................................................................................... 0/0.71 - Workforce Safety Protocols................................................................................................................................................................ 0/0.71 - Storage Protocols (Short Term and Long Term Storage)................................................................................................ 0/0.71 - Reasonable Security Protocols........................................................................................................................................................ 0.71/0.71 - Batch and Lot Tracking......................................................................................................................................................................... 0/0.71 - Disposal/Waste.......................................................................................................................................................................................... 0/0.71 - Water Management................................................................................................................................................................................. 0/0.71 Pesticide Guidance.................................................................................................................................................................................. 4/5 - Pesticide Guidance.................................................................................................................................................................................. 2/2.5 - Pesticide Labeling.................................................................................................................................................................................... 2/2.5 Required Testing........................................................................................................................................................................................ 3.75/5 - Active Ingredient Identification........................................................................................................................................................ 1.25/1.25 - Contaminants.............................................................................................................................................................................................. 1.25/1.25 - Potency............................................................................................................................................................................................................ 1.25/1.25 - Sample Retention..................................................................................................................................................................................... 0/1.25 Recall Protocol and Adverse Event Reporting.................................................................................................................. 4/5 Manufacturing 17/25 Staff Training............................................................................................................................................................................................. 3/5 Standard Operating Procedures............................................................................................................................................... 3/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 0/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 0/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 3/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 0/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 3/5 Laboratory Operations 16/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHPA Guidelines..................................................................................... Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 3/5 0/5 5/5 3/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND The state first passed medical cannabis legislation in 1978; however, the program has never functioned. The state tried to resuscitate it with the passage of SB 143. While this was a good step for the state it does not do anything to help patients access cannabis in a safe and legal way. The original bill used the term “prescribe” rather than “recommend,” but due to its classification as a Schedule I controlled substance, no physician can currently write prescriptions for cannabis. In 2016, the state passed and signed a pair of bills, SB 271 and SB 180 which fixed the “prescription” language issue, established legal protections for patients, and expanded the qualifying conditions. In June of 2017, Governor John Bel Edwards signed SB 35 into law which extended arrest protections to employees of the medical cannabis industry, including those who would be dispensing at pharmacies, research facilities, and laboratories, moving the program one step closer to serving patients. 93 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B MAINE AREAS FOR IMPROVEMENT Maine provides a strong program for patients and was an early leader in implementing product safety guidelines. However, Maine could improve its program by further expanding its product safety regulations in the areas of dispensing and manufacturing. Maine also made national news when a medical cannabis patient was denied an organ transplant due to their patient status, and this shows a clear opportunity for a program improvement through expanding civil protections. No patient should be denied medical care because of the medication they choose. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 90/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 10/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 5/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 5/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 3/3 ACCESS TO MEDICINE 87/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 94 10 426.56 85.31% 31/40 15/15 5/5 5/5 3/5 0/2 1/2 0/2 0/2 2/2 18/20 15/15 3/5 10/10 10/10 10/10 8/10 POINTS ISSUE EASE OF NAVIGATION 87/100 Comprehensive Qualifying Conditions............................................................................................................................ 46/50 Adding New Conditions............................................................................................................................................................... 7/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 2/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 9/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 92/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 50/50 No Significant Administrative or Supply Problems............................................................................................... 14/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 9/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 7/7 FINAL GRADE B MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 MAINE ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 60.56/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 14.42/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 14.14/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 11/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 21/25 Dispensing 14.42/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 4/5 3.75/5 0/1.25 1.25/1.25 1.25/1.25 1.25/1.25 0/5 3.67/5 1.67/1.67 1/1.67 1/1.67 3/5 1/1.67 1/1.67 1/1.67 14.14/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 3/5 2.14/5 0/0.71 0/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0/0.71 0/0.71 3/5 2/2.5 1/2.5 3/5 1/1.25 1/1.25 1/1.25 0/1.25 3/5 Manufacturing 11/25 Staff Training............................................................................................................................................................................................. Standard Operating Procedures............................................................................................................................................... - Facility and Equipment Sanitary Conditions........................................................................................................................ - Workforce Safety Protocols............................................................................................................................................................. - Storage Protocols.................................................................................................................................................................................. - Reasonable Security Protocols..................................................................................................................................................... - Batch and Lot Tracking...................................................................................................................................................................... Product Labeling.................................................................................................................................................................................... - Product Contents Including Source Material Identification........................................................................................ - Allergens...................................................................................................................................................................................................... - Potency and Compound Information....................................................................................................................................... Required Testing.................................................................................................................................................................................... - Active Ingredient Identification..................................................................................................................................................... - Contaminants........................................................................................................................................................................................... - Potency......................................................................................................................................................................................................... - Shelf Life Testing.................................................................................................................................................................................... - Sample Retention.................................................................................................................................................................................. Recall Protocol and Adverse Event Reporting............................................................................................................... Laboratory Operations 3/5 3/5 0/1 0/1 1/1 1/1 1/1 2/5 1/1.67 0/1.67 1/1.67 3/5 1/1 1/1 1/1 0/1 0/1 0/5 21/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 5/5 5/5 1/5 5/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND In 1998, voters enacted the Maine Medical Marijuana Act to protect patients who use medical cannabis at the advice of their doctor. In 2002, the Maine legislature approved SB 611, which increased the medical cannabis possession limit for those who could legally acquire medicine under the 1998 act. In 2009, the voters of Maine modified the 1998 act with the initiative Question 5. Question 5 added several qualifying conditions and created a statewide distribution program and registry system. In 2012, the Maine legislature amended the law to provide better patient privacy. Registered patients, or their designated caregivers, may possess up to 2.5 ounces of usable cannabis and cultivate up to six mature plants. In 2013, the Maine legislature passed HP755/LD 1062, which added PTSD to the list of qualifying conditions. In 2016, LD 726 was passed, which authorized 3rd party testing labs. In 2016 voters approved an adult use program, but disagreements between Governor LePage and the legislature have delayed implementation. Maine has approved regulations that will allow physicians to diagnose conditions through telemedicine beginning in 2018. A case is currently pending before Maine’s Supreme Court that could allow medical cannabis to be covered by the state Workers’ Compensation Fund. 95 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B MARYLAND AREAS FOR IMPROVEMENT After nearly 4 years of waiting, patients in Maryland finally have access to medicine through a total of 21 dispensaries (as of December 2017) in the state. Maryland has been thoughtful in their adoption of consumer safety and provider requirements, earning them a perfect score in this category, but still needs to provide civil protections for patients including parental rights, employment protections, and organ transplants. While Maryland’s affirmative defense provision has been used in limited instances to protect patients growing their own medicine, the state should explicitly provide for patients and caregivers to grow their own medicine. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 63/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 13/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 0/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 3/3 ACCESS TO MEDICINE 76/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 96 10 419 83.8% 39/40 15/15 5/5 5/5 5/5 2/2 1/2 2/2 2/2 2/2 0/20 0/15 0/5 10/10 10/10 10/10 7/10 POINTS ISSUE EASE OF NAVIGATION 89/100 Comprehensive Qualifying Conditions............................................................................................................................ 44/50 Adding New Conditions............................................................................................................................................................... 9/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 4/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 9/10 Allows Multiple-Year Registrations ................................................................................................................................... 2/2 Reasonable Physician Requirements ............................................................................................................................ 4/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 81/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 45/50 No Significant Administrative or Supply Problems............................................................................................... 12/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 9/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 3/7 FINAL GRADE B MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 MARYLAND ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 100/100 Dispensing...................................................................................................................................................................................................................................................................................................................... Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... Manufacturing ............................................................................................................................................................................................................................................................................................................ Laboratory Operations ........................................................................................................................................................................................................................................................................................ Dispensing 25/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 5/5 1.67/1.67 1.67/1.67 1.67/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 25/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0/0.71 0/0.71 3/5 2/2.5 1/2.5 3/5 1/1.25 1/1.25 1/1.25 0/1.25 3/5 25/25 25/25 25/25 25/25 Manufacturing 11/25 Staff Training............................................................................................................................................................................................. Standard Operating Procedures............................................................................................................................................... - Facility and Equipment Sanitary Conditions........................................................................................................................ - Workforce Safety Protocols............................................................................................................................................................. - Storage Protocols.................................................................................................................................................................................. - Reasonable Security Protocols..................................................................................................................................................... - Batch and Lot Tracking...................................................................................................................................................................... Product Labeling.................................................................................................................................................................................... - Product Contents Including Source Material Identification........................................................................................ - Allergens...................................................................................................................................................................................................... - Potency and Compound Information....................................................................................................................................... Required Testing.................................................................................................................................................................................... - Active Ingredient Identification..................................................................................................................................................... - Contaminants........................................................................................................................................................................................... - Potency......................................................................................................................................................................................................... - Shelf Life Testing.................................................................................................................................................................................... - Sample Retention.................................................................................................................................................................................. Recall Protocol and Adverse Event Reporting............................................................................................................... Laboratory Operations 3/5 3/5 0/1 0/1 1/1 1/1 1/1 2/5 1/1.67 0/1.67 1/1.67 3/5 1/1 1/1 1/1 0/1 0/1 0/5 21/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 5/5 5/5 1/5 5/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND Maryland’s first legal protections for patients were established in 2003 with the Darrell Putman Compassionate Use Act, which created an affirmative defense for patients possessing less than one ounce of cannabis that reduced convictions to a misdemeanor offense with a maximum $100 fine. In 2011, Maryland passed SB 308 to recognize specific medical conditions and remove the misdemeanor penalty but not the $100 fine. In 2013, HB 180 expanded the affirmative defense to caregivers, while HV 1101 allowed “Academic Medical Centers” to conduct medical cannabis research studies and established the Natalie M. LaPrade Medical Marijuana Commission to create regulations. In 2014, the Maryland Legislature approved HB 881/SB 923, a comprehensive medical cannabis program that expanded and clarified legal protections for patients, caregivers, and physicians and created a distribution system. Registered patients and their designated caregivers are allowed to obtain and possess a 30 day supply of cannabis, but personal cultivation is prohibited. There are no explicit qualifying conditions in Maryland under HB 881; instead, physicians must apply for permission to write recommendations for conditions they specify, though the Commission may add conditions through rulemaking. In 2016, HB 104 was passed which expanded the type of healthcare practitioners that could recommend cannabis. In 2017, certain dispensaries began distributing medicine, but quickly ran into supply shortages. 97 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B MASSACHUSETTS AREAS FOR IMPROVEMENT After nearly a year long delay, Massachusetts implemented a number of regulations that improve patient access. Under the new rules, certified nurse practitioners can apply for permission to issue medical cannabis recommendations. The new rules also allows for employees of nursing homes, hospice centers, and other medical facilities to administer medical cannabis. In addition, the regulations fixed some supply issues by allowing dispensaries to grow cannabis from clippings instead of just seeds, which could boost plant yields and ensure that strains stay consistent over multiple harvests. Despite these improvements, Massachusetts still needs to protect patients in the areas of housing and employment discrimination. The Department of Health also needs to strengthen laboratory testing regulations, and expedite the process for dispensary licensing. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 80/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 13/15 Parental Rights Protections..................................................................................................................................................... 10/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 5/5 Reciprocity............................................................................................................................................................................................. 3/3 ACCESS TO MEDICINE 86/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 98 5 423 84.66% 36/40 15/15 5/5 5/5 5/5 1/2 1/2 0/2 2/2 2/2 10/20 10/15 0/5 10/10 10/10 10/10 10/10 POINTS ISSUE EASE OF NAVIGATION 90/100 Comprehensive Qualifying Conditions............................................................................................................................ 50/50 Adding New Conditions............................................................................................................................................................... 10/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 5/5 Reasonable Access for Minors ............................................................................................................................................. 8/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 8/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 4/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 83/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 45/50 No Significant Administrative or Supply Problems............................................................................................... 10/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 5/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 6/7 FINAL GRADE B MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 MASSACHUSETTS ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 79/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 25/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 23/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 23/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 8.32/25 Dispensing 25/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 5/5 1.67/1.67 1.67/1.67 1.67/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 23/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0/0.71 0/0.71 3/5 2/2.5 1/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 Manufacturing 23/25 Staff Training............................................................................................................................................................................................. 5/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 3/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 0/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations 8.32/25 Staff Training.............................................................................................................................................................................................. 5/5 Method Validation in Accordance with AHP Guidelines........................................................................................ 0/5 Result Reporting..................................................................................................................................................................................... 0/5 Independent or Third Party............................................................................................................................................................ 0/5 Standard Operating Procedures and Protocols............................................................................................................. 3.32/5 - Equipment and Instrument Calibration..................................................................................................................................... 0/0.83 - Sample Tracking...................................................................................................................................................................................... 0.83/0.83 - Facility and Equipment Sanitary Conditions......................................................................................................................... 0.83/0.83 - Disposal/Waste....................................................................................................................................................................................... 0/0.83 - Storage Protocols................................................................................................................................................................................... 0.83/0.83 - Workforce Safety Protocols............................................................................................................................................................. 0.83/0.83 BACKGROUND In 2012, 63% of Massachusetts voters approved Question 3, “An Initiative Petition for a Law for the Humanitarian Medical Use of Marijuana”, establishing legal protection for patients, caregivers, physicians, medical professionals, cultivators, and providers. Registered patients and their designated caregivers may possess up to a 60-day supply of usable cannabis, defined as 10 ounces. Some protections for patients began January 1, 2013, including limited rights to cultivate their own medicine. In 2014, the Department of Health (DOH) began issuing ID cards for patients and granting licenses for dispensaries. “Registered Marijuana Dispensaries” are licensed to both grow and sell medical cannabis and are required to provide medicine at discounted rates for low income residents. DOH issues hardship cultivation licenses to patients who qualify. In 2016, DOH announced it will accept applications for dispensaries on a rolling basis. Voters in Massachusetts have passed Question 4, an adult use initiative which added some rights for patients including parental rights and organ transplant rights. 99 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B+ MICHIGAN AREAS FOR IMPROVEMENT If Michigan makes its emergency rules permanent, it will have one of the strongest program in the country. However, good laws on paper do not always translate to quality patient access. Michigan, as shown in ASA’s opioid state policy blueprint, has hundreds of thousands of potential patients that are barred from access. Michigan still needs to provide civil discrimination protections in the areas of housing, employment, and organ transplants and create stronger regulations for laboratory testing. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 82/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 8/10 DUI Protections.................................................................................................................................................................................. 4/5 Employment Protections............................................................................................................................................................ 2/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 3/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 3/3 ACCESS TO MEDICINE 78/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 100 30 439 87.74% 26/40 15/15 0/5 1/5 5/5 2/2 1/2 0/2 0/2 2/2 15/20 15/15 0/5 10/10 9/10 10/10 8/10 POINTS ISSUE EASE OF NAVIGATION 88/100 Comprehensive Qualifying Conditions............................................................................................................................ 46/50 Adding New Conditions............................................................................................................................................................... 9/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 4/5 Reasonable Access for Minors ............................................................................................................................................. 8/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 8/10 Allows Multiple-Year Registrations ................................................................................................................................... 2/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 81/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 45/50 No Significant Administrative or Supply Problems............................................................................................... 12/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 4/7 FINAL GRADE B+ MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 MICHIGAN ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 80/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 21/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 21/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 21.34/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 16/25 Dispensing 21/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 4/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 4/5 3.34/5 1.67/1.67 0/1.67 1.67/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 21/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 3/5 1/2.5 2/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 3/5 Manufacturing 21.34/25 Staff Training............................................................................................................................................................................................. 4/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 3.34/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 0/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations 16/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 3/5 0/5 3/5 5/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND In 2008, Michigan voters passed the Michigan Medical Marihuana Act, which allows qualifying patients or their designated caregivers to cultivate up to 12 cannabis plants and possess up to 2.5 ounces of usable cannabis. Patients certified by their doctor and registered with the Department of Licensing and Regulatory Affairs (LARA) are not subject to arrest or prosecution and are protected from civil penalty or disciplinary action by a business, occupational, or professional licensing board or bureau. Although dispensaries were not expressly permitted by law, several local jurisdictions have allowed them to provide access to patients. In September 2016, the governor signed three bills to improve the medical cannabis program. HB 4210, which went into effect immediately, clarified that patients may possess cannabis extracts and infused products. The Medical Marihuana Facilities Licensing Act creates a program to license and regulate the cultivation, processing, transport, and distribution of medical cannabis. The Medical Marihuana Licensing Board and LARA issued emergency rules were issued in December 2017, and are in place for six months until final rules are approved. 101 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 C- MINNESOTA AREAS FOR IMPROVEMENT Minnesota did not make any legislative changes to its medical cannabis program in 2017. However, the Department of Health did approve sleep apnea and autism to be added to the list of qualifying conditions. Petitions to add dried cannabis flower and vaporizing were dismissed. However, the state’s program currently faces steep challenges in appropriately serving the state’s medical cannabis patients. The program has a small number of dispensaries, which lost over $11 million dollars in the first two years and the state’s approach to product safety lack clear training requirements. Increasing the number of cultivators and dispensaries as well as lifting the restriction on methods of delivery would ensure more patients being able to access medicine. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 84/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 12/15 Parental Rights Protections..................................................................................................................................................... 10/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 5/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 5/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 0/5 Organ Transplants............................................................................................................................................................................ 5/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 48/100 Allows Distribution Programs.................................................................................................................................................. 13/40 - Allows Access to Dried Flowers............................................................................................................................................... 0/15 - Allows Delivery..................................................................................................................................................................................... 0/5 - No Sales Tax or Reasonable Sales Tax................................................................................................................................. 5/5 - Allows for a Reasonable Number of Dispensaries........................................................................................................ 3/5 - Does Not Require Vertical Integration................................................................................................................................... 0/2 - Ownership/Employment Restrictions.................................................................................................................................... 1/2 - Provisions for Labor Standards................................................................................................................................................. 0/2 - Environmental Impact Regulations......................................................................................................................................... 2/2 - Choice of Dispensary Without Restrictions........................................................................................................................ 2/2 Noncommercial Cultivation....................................................................................................................................................... 0/20 - Personal Cultivation.......................................................................................................................................................................... 0/15 - Collective Gardening........................................................................................................................................................................ 0/5 Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... 7/10 Does Not Impose Bans or Limits on THC....................................................................................................................... 10/10 Does Not Impose Bans on CBD ............................................................................................................................................. 10/10 Local Bans/Zoning............................................................................................................................................................................ 8/10 IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 102 10 359 71.78% POINTS ISSUE EASE OF NAVIGATION 85/100 Comprehensive Qualifying Conditions............................................................................................................................ 47/50 Adding New Conditions............................................................................................................................................................... 8/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 3/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 3/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 4/5 FUNCTIONALITY 72/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 35/50 No Significant Administrative or Supply Problems............................................................................................... 12/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 5/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 5/7 FINAL GRADE C- MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 MINNESOTA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 60/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 21/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 12.25/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 18.67/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 8.32/25 Dispensing 21/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 3/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 2.67/5 1.67/1.67 0/1.67 1/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 12.25/25 Staff Training................................................................................................................................................................................................. 3/5 Standard Operating Procedures.................................................................................................................................................. 0/5 - Facility and Equipment Sanitary Conditions........................................................................................................................... 0/0.71 - Workforce Safety Protocols................................................................................................................................................................ 0/0.71 - Storage Protocols (Short Term and Long Term Storage)................................................................................................ 0/0.71 - Reasonable Security Protocols........................................................................................................................................................ 0/0.71 - Batch and Lot Tracking......................................................................................................................................................................... 0/0.71 - Disposal/Waste.......................................................................................................................................................................................... 0/0.71 - Water Management................................................................................................................................................................................. 0/0.71 Pesticide Guidance.................................................................................................................................................................................. 3/5 - Pesticide Guidance.................................................................................................................................................................................. 2/2.5 - Pesticide Labeling.................................................................................................................................................................................... 1/2.5 Required Testing........................................................................................................................................................................................ 1.25/5 - Active Ingredient Identification........................................................................................................................................................ 1.25/1.25 - Contaminants.............................................................................................................................................................................................. 0/1.25 - Potency............................................................................................................................................................................................................ 0/1.25 - Sample Retention..................................................................................................................................................................................... 0/1.25 Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 Manufacturing 18.67/25 Staff Training............................................................................................................................................................................................. 3/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 2.67/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 0/1.67 - Potency and Compound Information....................................................................................................................................... 1/1.67 Required Testing.................................................................................................................................................................................... 3/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 0/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations 8.32/25 Staff Training.............................................................................................................................................................................................. 0/5 Method Validation in Accordance with AHP Guidelines........................................................................................ 0/5 Result Reporting..................................................................................................................................................................................... 0/5 Independent or Third Party............................................................................................................................................................ 5/5 Standard Operating Procedures and Protocols............................................................................................................. 3.32/5 - Equipment and Instrument Calibration..................................................................................................................................... 0/0.83 - Sample Tracking...................................................................................................................................................................................... 0.83/0.83 - Facility and Equipment Sanitary Conditions......................................................................................................................... 0.83/0.83 - Disposal/Waste....................................................................................................................................................................................... 0.83/0.83 - Storage Protocols................................................................................................................................................................................... 0.83/0.83 - Workforce Safety Protocols............................................................................................................................................................. 0/0.83 BACKGROUND In 2014, the Minnesota legislature passed SF 2470, which provides legal protections for patients with certain debilitating medical conditions who obtain a physician’s recommendation for the use of medical cannabis products. Minnesota law does not provide access to medical cannabis in its most common form, dried flower. Patients may only legally obtain and use medical cannabis products such as oils, pills, or liquids which may be consumed by a means other than smoking. The law does not impose concentration requirements for THC or CBD. The law contains strong privacy protections for patients, though they do collect medical data from physicians on the patients for whom they recommend medical cannabis. In 2016, intractable pain and PTSD were officially added as qualifying conditions through HF 3142, which also improved transportation laws for testing and disposal and allowed pharmacists to video-conference with patients. In 2017, the Minnesota Department of Health added sleep apnea and autism disorders as qualifying conditions. 103 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 F MISSISSIPPI AREAS FOR IMPROVEMENT Despite being home of the National Institute on Drug Abuse’s only facility where cannabis is grown by the federal government, patients in Mississippi still face tremendous access problems. While the state deserves credit for including parental right protections, the program fails to help patients on nearly all other fronts. Until a robust set of qualifying conditions, including chronic pain, and strong product safety guidelines are developed the patients of Mississippi will be denied a functional medical cannabis program. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 62/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 9/15 Parental Rights Protections..................................................................................................................................................... 8/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 0/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 7/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 104 0 153 30.6% 0/40 0/15 0/5 0/5 0/5 0/2 0/2 0/2 0/2 0/2 0/20 0/15 0/5 3/10 1/10 3/10 0/10 POINTS ISSUE EASE OF NAVIGATION 46/100 Comprehensive Qualifying Conditions............................................................................................................................ 20/50 Adding New Conditions............................................................................................................................................................... 0/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 0/5 - System Works for Adding New Conditions...................................................................................................................... 0/5 Reasonable Access for Minors ............................................................................................................................................. 6/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 1/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 10/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 2/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 3/5 FUNCTIONALITY 38/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 5/50 No Significant Administrative or Supply Problems............................................................................................... 15/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 0/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 2/7 FINAL GRADE F MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 MISSISSIPPI ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS Dispensing...................................................................................................................................................................................................................................................................................................................... Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... Manufacturing ............................................................................................................................................................................................................................................................................................................ Laboratory Operations ........................................................................................................................................................................................................................................................................................ Dispensing Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 0/25 0/5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1.67 0/1.67 0/1.67 0/25 0/5 0/5 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/5 0/2.5 0/2.5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 Manufacturing 0/100 0/25 0/25 0/25 0/25 0/25 Staff Training............................................................................................................................................................................................. Standard Operating Procedures............................................................................................................................................... - Facility and Equipment Sanitary Conditions........................................................................................................................ - Workforce Safety Protocols............................................................................................................................................................. - Storage Protocols.................................................................................................................................................................................. - Reasonable Security Protocols..................................................................................................................................................... - Batch and Lot Tracking...................................................................................................................................................................... Product Labeling.................................................................................................................................................................................... - Product Contents Including Source Material Identification........................................................................................ - Allergens...................................................................................................................................................................................................... - Potency and Compound Information....................................................................................................................................... Required Testing.................................................................................................................................................................................... - Active Ingredient Identification..................................................................................................................................................... - Contaminants........................................................................................................................................................................................... - Potency......................................................................................................................................................................................................... - Shelf Life Testing.................................................................................................................................................................................... - Sample Retention.................................................................................................................................................................................. Recall Protocol and Adverse Event Reporting............................................................................................................... Laboratory Operations 0/5 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 0/5 0/5 0/5 0/5 0/5 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 BACKGROUND In 2014, Mississippi passed HB 1231, which creates an affirmative defense for the possession and use of CBD oil in very limited circumstances. Known as “Harper Grace’s Law,” the bill only provides legal protections to patients diagnosed with a debilitating epileptic condition, and only if the CBD oil was either obtained from or tested by the National Center for Natural Products Research at the University of Mississippi and dispensed by the Department of Pharmacy Services at the University of Mississippi Medical Center. The law requires that CBD oil must have at least 15% CBD and no more than 0.5% THC. Patients with conditions other than a debilitating epileptic condition are not entitled to any legal protections, nor are there any legal protections for the possession and use of any other type of cannabis. In 2017, the legislature passed SB 2610 which clarifies the use of cannabidiol in research for the treatment of seizures. 105 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 F MISSOURI AREAS FOR IMPROVEMENT Although Missouri decriminalized possession of cannabis this year, they did little to improve their medical cannabis program. Missouri’s limited medical cannabis program has a long way to go before it will adequately serve Missouri’s population. There were 908 opioid overdose deaths in Missouri in 2016, which exceeded the number of traffic fatalities. The state needs to adopt and implement laws that allow for instate production of medical cannabis without restrictions on THC or CBD, create civil protections for patients, designate chronic pain as a qualifying condition, and adopt product safety guidelines. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 47/100 Arrest Protections............................................................................................................................................................................ 30/40 Affirmative Defense......................................................................................................................................................................... 12/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 0/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 11/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 106 0 130 26% 0/40 0/15 0/5 0/5 0/5 0/2 0/2 0/2 0/2 0/2 0/20 0/15 0/5 3/10 1/10 7/10 0/10 POINTS ISSUE EASE OF NAVIGATION 43/100 Comprehensive Qualifying Conditions............................................................................................................................ 20/50 Adding New Conditions............................................................................................................................................................... 0/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 0/5 - System Works for Adding New Conditions...................................................................................................................... 0/5 Reasonable Access for Minors ............................................................................................................................................. 6/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 1/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 2/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 3/5 FUNCTIONALITY 29/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 0/50 No Significant Administrative or Supply Problems............................................................................................... 12/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 0/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 2/7 FINAL GRADE F MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 MISSOURI ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS Dispensing...................................................................................................................................................................................................................................................................................................................... Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... Manufacturing ............................................................................................................................................................................................................................................................................................................ Laboratory Operations ........................................................................................................................................................................................................................................................................................ Dispensing Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 0/25 0/5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1.67 0/1.67 0/1.67 0/25 0/5 0/5 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/5 0/2.5 0/2.5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 Manufacturing Staff Training............................................................................................................................................................................................. Standard Operating Procedures............................................................................................................................................... - Facility and Equipment Sanitary Conditions........................................................................................................................ - Workforce Safety Protocols............................................................................................................................................................. - Storage Protocols.................................................................................................................................................................................. - Reasonable Security Protocols..................................................................................................................................................... - Batch and Lot Tracking...................................................................................................................................................................... Product Labeling.................................................................................................................................................................................... - Product Contents Including Source Material Identification........................................................................................ - Allergens...................................................................................................................................................................................................... - Potency and Compound Information....................................................................................................................................... Required Testing.................................................................................................................................................................................... - Active Ingredient Identification..................................................................................................................................................... - Contaminants........................................................................................................................................................................................... - Potency......................................................................................................................................................................................................... - Shelf Life Testing.................................................................................................................................................................................... - Sample Retention.................................................................................................................................................................................. Recall Protocol and Adverse Event Reporting............................................................................................................... Laboratory Operations Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 0/100 0/25 0/25 0/25 0/25 0/25 0/5 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/25 0/5 0/5 0/5 0/5 0/5 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 BACKGROUND In 2014, Missouri passed HB 2238, which creates a legal right for certain patients to obtain, possess, and use “hemp extracts” in limited circumstances. The law defines a “hemp extract” as a preparation of cannabis that contains at least 5% CBD and no more than 0.3% THC. Only patients with a seizure disorder and a recommendation from a neurologist can obtain a “hemp registration card,” which entitles them to access and limited legal protections. Patients are allowed to purchase hemp extracts from two state-regulated “cannabidiol oil care centers.” In 2015, the Department of Agriculture granted two licenses, and in 2016, the centers began serving patients. A ballot initiative for the state to develop a comprehensive medical cannabis program has momentum (over 70,000 of the approximately 160,000 signatures needed), but it is too early to tell if this measure will be successful. 107 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B- MONTANA AREAS FOR IMPROVEMENT Montana does well in serving patients and has moved through its implementation of its medical cannabis program quickly. However, Montana needs a better system for adding qualifying conditions or should allow physicians to recommend cannabis for any condition. Montana also should create strong civil protections for patients including employment protections, protections for parents, housing protections, and organ transplants ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 63/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 13/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 3/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 0/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 78/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 108 30 401 80.14% 26/40 15/15 0/5 4/5 3/5 2/2 1/2 0/2 0/2 1/2 15/20 15/15 0/5 10/10 10/10 10/10 7/10 POINTS ISSUE EASE OF NAVIGATION 79/100 Comprehensive Qualifying Conditions............................................................................................................................ 47/50 Adding New Conditions............................................................................................................................................................... 3/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 3/5 - System Works for Adding New Conditions...................................................................................................................... 0/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 2/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 8/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 3/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 77/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 40/50 No Significant Administrative or Supply Problems............................................................................................... 13/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 9/10 Reasonable Possession Limits.............................................................................................................................................. 3/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 4/7 FINAL GRADE B- MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 MONTANA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 74/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 19/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 20/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 16.34/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 18/25 Dispensing 19/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 1/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 5/5 1.67/1.67 1.67/1.67 1.67/1.67 3.34/5 1.67/1.67 0/1.67 1.67/1.67 20/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 0/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 5/5 2.5/2.5 2.5/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 Manufacturing 16.34/25 Staff Training............................................................................................................................................................................................. 0/5 Standard Operating Procedures............................................................................................................................................... 4/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 0/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 3.34/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 0/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 4/5 Laboratory Operations 18/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 5/5 0/5 5/5 3/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND In 2004, 62% of Montana voters passed initiative I-148, allowing registered patients to In November 2016, Montana voters passed I-182 which not only restored many of the use, posses, and cultivate medical cannabis and designate a caregiver to assist them. rights granted to patients in I-148, but also added PTSD and removed restrictions on Currently, registered patients and their designated caregivers may possess up to one chronic pain for qualifying conditions. In 2017, the legislature passed SB 333 which ounce of usable cannabis and cultivate up to four mature plants and 12 immature. created detailed regulations and allowed for the additional manufacture of cannabis In 2011, the Montana legislature introduced several laws to create regulations for a products. statewide licensing program, but instead the legislature passed SB 423 that repealed much of the rights granted under I-148. SB 423 was challenged in state court blocking Currently, comprehensive rules regarding requirements for cardholders, cannabis many of the worst provisions before it could be implemented. Following a lengthy court products, dispensaries, quality assurance, and testing laboratories are pending final battle, the Montana Supreme Court ruled in favor of allowing SB 423 to be implemented adoption which is expected in early 2018. While these rules could potentially affect in early 2016, which cut off almost all access for patients. possession limits and patient fees, these regulations develop a strong system for product labeling, testing, and standard operating procedures for employees at cannabis businesses. 109 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B+ NEVADA AREAS FOR IMPROVEMENT Nevada is one of the strongest programs in the country and demonstrates the value of keeping medical and adult use programs legislatively separate. Although the Nevada Department of Agriculture made decisions about recalls at certain cannabis facilities, the legislature needs to develop stronger language about recalls and adverse event reporting. Nevada’s opioid overdose rate is 21.6 deaths for every 100,000 people, making it the leading cause of death in the state. Nevada needs to better use its medical cannabis program to help decrease the number of preventable opioid deaths. Nevada also needs to provide civil protections for cannabis patients receiving organ transplants, protecting parental rights, and improve housing protections. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 72/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 13/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 2/5 Employment Protections............................................................................................................................................................ 3/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 4/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 3/3 ACCESS TO MEDICINE 89/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 110 15 437 87.40% 36/40 15/15 4/5 5/5 5/5 2/2 1/2 0/2 2/2 2/2 15/20 15/15 0/5 10/10 10/10 10/10 8/10 POINTS ISSUE EASE OF NAVIGATION 89/100 Comprehensive Qualifying Conditions............................................................................................................................ 46/50 Adding New Conditions............................................................................................................................................................... 7/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 2/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 1/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 9/10 Allows Multiple-Year Registrations ................................................................................................................................... 1/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 89/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 50/50 No Significant Administrative or Supply Problems............................................................................................... 15/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 4/7 FINAL GRADE B+ MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 NEVADA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE Dispensing...................................................................................................................................................................................................................................................................................................................... Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... Manufacturing ............................................................................................................................................................................................................................................................................................................ Laboratory Operations ........................................................................................................................................................................................................................................................................................ Dispensing 21/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 1/5 5/5 1.67/1.67 1.67/1.67 1.67/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 21/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 5/5 2.5/2.5 2.5/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 1/5 Manufacturing POINTS 83/100 21/25 21/25 21/25 20/25 21/25 Staff Training............................................................................................................................................................................................. 5/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 1/5 Laboratory Operations 20/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 5/5 0/5 5/5 5/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND In 2000, 65% of Nevada voters approved Question 9, amending the state constitution to allow use, possession, and cultivation of cannabis by qualifying patients who participate in a confidential state run registry that issues identification cards. Patients may possess up to 2.5 ounces of cannabis in a single 14 day period, cultivate up to 12 plants (if they are more than 25 miles away from a dispensary), and present a medical necessity defense in court if they possessed over the legal limit. In April 2014, Senate Bill 374 was enacted, establishing a statewide medical cannabis distribution system. The law allows for the creation of up to 66 dispensaries and 200 production facilities as regulated by the Department of Health and Humans Services (DHHS). The law added the 25 mile restriction but also increased patient possession limits and allowed out of state patients to register and participate in the state program. In 2016, DHHS put patient applications online and began issuing temporary cards allowing patients to enroll and access medicine more quickly. In November of 2016, voters approved an adult use market in Nevada. As Nevada adopted regulations surrounding the state’s adult use market in 2017, employment protections were increased and sales tax on medical cannabis was removed. 111 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B NEW HAMPSHIRE AREAS FOR IMPROVEMENT New Hampshire’s program saw several small but significant changes to its program in 2017. A change in regulations allowed a “support person” who is not necessarily a caregiver to enter a dispensary and obtain medicine for a qualifying patient. New Hampshire’s program also added chronic pain, PTSD, Ehlers-Danlos Syndrome, and Hepatitis C. Last year, New Hampshire had the second highest opioid overdose rate in the country, so the addition of chronic pain as a qualifying condition will hopefully help improve health outcomes for individuals suffering from pain. New Hampshire also added a more effective petition process for adding new qualifying conditions. New Hampshire could improve its program by adding employment discrimination protections, allow delivery and/or home cultivation, and allow for patients to have multiple year registrations. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 84/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 10/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 4/5 Organ Transplants............................................................................................................................................................................ 5/5 Reciprocity............................................................................................................................................................................................. 3/3 ACCESS TO MEDICINE 62/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 112 15 428 85.6% 25/40 15/15 0/5 5/5 3/5 0/2 1/2 0/2 1/2 0/2 0/20 0/15 0/5 10/10 10/10 10/10 8/10 POINTS ISSUE EASE OF NAVIGATION 87/100 Comprehensive Qualifying Conditions............................................................................................................................ 45/50 Adding New Conditions............................................................................................................................................................... 8/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 3/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 8/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 87/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 50/50 No Significant Administrative or Supply Problems............................................................................................... 13/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 7/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 5/7 FINAL GRADE B MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 NEW HAMPSHIRE ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE Dispensing...................................................................................................................................................................................................................................................................................................................... Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... Manufacturing ............................................................................................................................................................................................................................................................................................................ Laboratory Operations ........................................................................................................................................................................................................................................................................................ Dispensing 25/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 1/5 5/5 1.67/1.67 1.67/1.67 1.67/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 23/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 3/5 2/2.5 1/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 1/5 Manufacturing POINTS 93/100 25/25 23/25 25/25 20/25 25/25 Staff Training............................................................................................................................................................................................. 5/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 1/5 Laboratory Operations 20/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 5/5 0/5 5/5 5/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND In 2013, New Hampshire became the 19th medical cannabis state with the passage of HB 573, Use of Cannabis for Therapeutic Purposes, after similar bills had been vetoed twice before. Patients and caregivers registered with the New Hampshire Department of Health and Human Services’ (DHHS) medical cannabis program, in possession of a registry ID card, who possess no more than two ounces of cannabis, are protected from arrest or prosecution. If charged, registration provides an affirmative defense for patients or caregivers in compliance with the law. Patients and caregivers may not be denied any right or privilege based on their status. At this time, personal cultivation is prohibited, but bills have already been filed for the 2018 legislative session to address this. Medicine may be obtained by the patient, a registered caregiver, or in some cases a “support person” from one of the state’s Alternative Treatment Centers. Up to two ounces may be purchased every 10 days. A patient may only designate one caregiver, but a caregiver may assist up to five patients. In November 2015, DHHS began issuing ID cards and licensing businesses. In 2016, dispensaries began serving patients. 2017 brought several important changes that made navigating the program easier for patients. 113 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 NEW JERSEY AREAS FOR IMPROVEMENT New Jersey’s Medical Marijuana Review panel recommended that chronic pain related to musculoskeletal disorders, migraines, anxiety, chronic pain of visceral origin, and Tourette’s Syndrome be added to the list of conditions for enrollment in the medical cannabis program. However, these recommendations are not final, and the Commissioner of the Department of Health has until late April 2018 to approve or deny the panel’s recommendations. Outside of these positive recommendations, New Jersey’s program did little to improve over 2017. Perhaps the greatest victory for New Jersey’s medical cannabis program was Governor Christie, a member of the President’s Commission on Opioids and a fierce opponent to medical cannabis reform, leaving office. The state still needs to improve its production and supply base so more patients can benefit from the program. New Jersey also needs to add civil discrimination protections in the areas of housing, employment, parental rights and organ transplants. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 65/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 13/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 58/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 114 5 380 76% 23/40 15/15 0/5 4/5 3/5 0/2 1/2 0/2 0/2 0/2 0/20 0/15 0/5 10/10 7/10 10/10 8/10 C POINTS ISSUE EASE OF NAVIGATION 92/100 Comprehensive Qualifying Conditions............................................................................................................................ 46/50 Adding New Conditions............................................................................................................................................................... 10/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 5/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 8/10 Allows Multiple-Year Registrations ................................................................................................................................... 2/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 4/5 FUNCTIONALITY 81/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 43/50 No Significant Administrative or Supply Problems............................................................................................... 12/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 3/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 1/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 6/7 FINAL GRADE C MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 NEW JERSEY ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 76.43/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 19.67/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 20.09/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 19.67/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 17/25 Dispensing 19.67/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 2.67/5 1.67/1.67 0/1.67 1/1.67 2/5 1/1.67 0/1.67 1/1.67 20.09/25 Staff Training................................................................................................................................................................................................. 5/5 Standard Operating Procedures.................................................................................................................................................. 2.84/5 - Facility and Equipment Sanitary Conditions........................................................................................................................... 0.71/0.71 - Workforce Safety Protocols................................................................................................................................................................ 0/0.71 - Storage Protocols (Short Term and Long Term Storage)................................................................................................ 0.71/0.71 - Reasonable Security Protocols........................................................................................................................................................ 0.71/0.71 - Batch and Lot Tracking......................................................................................................................................................................... 0.71/0.71 - Disposal/Waste.......................................................................................................................................................................................... 0/0.71 - Water Management................................................................................................................................................................................. 0/0.71 Pesticide Guidance.................................................................................................................................................................................. 4/5 - Pesticide Guidance.................................................................................................................................................................................. 2/2.5 - Pesticide Labeling.................................................................................................................................................................................... 2/2.5 Required Testing........................................................................................................................................................................................ 3.25/5 - Active Ingredient Identification........................................................................................................................................................ 1.25/1.25 - Contaminants.............................................................................................................................................................................................. 1/1.25 - Potency............................................................................................................................................................................................................ 1/1.25 - Sample Retention..................................................................................................................................................................................... 0/1.25 Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 Manufacturing 19.67/25 Staff Training............................................................................................................................................................................................. 5/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 2.67/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 0/1.67 - Potency and Compound Information....................................................................................................................................... 1/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 1/5 Laboratory Operations 17/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 3/5 0/5 5/5 4/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND On January 18, 2010, Governor Jon Corzine signed the New Jersey Compassionate Use Marijuana Act, SB 119 into law on his last day in office. Governor Chris Christie subsequently made several attempts to delay the program. After a series of legislative and bureaucratic battles, the New Jersey Department of Health (DOH) adopted rules for the program in 2011. These rules included changes to the licensing process for cultivators and distributors, prohibited home delivery, and required a recommending physician to certify that a patient’s qualifying condition is “resistant to conventional medical therapy” and must be recertified every 90 days. Patients must obtain medicine from one of six Alternative Treatment Centers. The certifying physician must indicate the quantity a registered patient can obtain, not to exceed two ounces in a 30-day period. The first patient registrations were accepted in August 2012, and the first Alternative Treatment Center (ATC) opened in December 2012, with the most recent ATC opening in Secaucus in 2017. In August 2013, SB 2842 lifted the limits on the number of cannabis strains that may be cultivated and allowed for the manufacture and distribution of edible cannabis solely to minors. In 2016, the legislature passed AB 457 adding PTSD as a qualifying condition, and the DOH finally appointed a panel of physicians and health professionals with the authority to add more conditions. 115 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B NEW MEXICO AREAS FOR IMPROVEMENT New Mexico did not pass any legislative or regulatory improvements to the medical cannabis program in 2017. However, research from the University of New Mexico showed a strong correlation between use of medical cannabis and reduction of opioid use, making the state more poised to adopt opioid use disorder in 2018, despite a veto from Governor Martinez on this condition in 2017. New Mexico remains a strong program for patients; however, the state still needs to add civil protections for patients including housing, employment, parental rights, and organ transplants. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 65/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 13/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 90/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 116 10 424.34 84.87% 34/40 15/15 5/5 4/5 5/5 0/2 1/2 0/2 2/2 2/2 18/20 15/15 3/5 10/10 9/10 10/10 9/10 POINTS ISSUE EASE OF NAVIGATION 86/100 Comprehensive Qualifying Conditions............................................................................................................................ 46/50 Adding New Conditions............................................................................................................................................................... 10/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 5/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 9/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 4/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 3/5 FUNCTIONALITY 85/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 45/50 No Significant Administrative or Supply Problems............................................................................................... 13/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 2/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 4/7 FINAL GRADE B MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 NEW MEXICO ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 88.34/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 22.67/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 23/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 22.67/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 20/25 Dispensing 22.67/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 2.67/5 1.67/1.67 0/1.67 1/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 23/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 3/5 2/2.5 1/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 Manufacturing 22.67/25 Staff Training............................................................................................................................................................................................. 5/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 2.67/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 0/1.67 - Potency and Compound Information....................................................................................................................................... 1/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations 20/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 5/5 0/5 5/5 5/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND In March 2007, the New Mexico legislature passed SB 523, the “Lynn and Erin Compassionate Use Act.” The law allowed patients and their caregivers to collectively possess up to six ounces of usable cannabis and, after obtaining a separate permit, cultivate up to four mature plants and 12 seedlings. The Department of Health (DOH) oversees the rules and regulations for patient and caregiver IDs and Personal Production Licenses (PPLs) for patients or caregivers to grow medical cannabis for personal use. Thirty-nine licensed non-profit producers serving medical cannabis patients were relicensed for 2018. The DOH has updated the regulations several times to expand plant numbers and clarify requirements. New Mexico’s program includes a Medical Advisory Board that can approve new qualifying conditions and was the first to approve PTSD. The Board also removed restrictions on chronic pain patients from qualifying for the program. In 2016, the DOH extended the expiration date for many patients so they could improve their ability to turn around more applications more quickly. This period of extension ended in April of 2017 after the DOH believed it sufficiently addressed its backlog. 117 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 C+ NEW YORK AREAS FOR IMPROVEMENT New York made several improvements to its program in 2017 including the addition of PTSD and chronic pain as qualifying conditions. Between 2010 and 2015, the opioid overdose rate doubled in New York, so the addition of chronic pain to the state’s medical cannabis program will be a welcome addition. Regulations made it easier for healthcare practitioners to register for the program, increased available doctor education, increased the variety of products, and added five new registered manufacturing and dispensing organizations. Despite these improvements New York still should continue to better its program. Given the size and geography of the state, 25 dispensing facilities is not enough to adequately serve the population. New York needs to focus on developing civil protections for housing, parental rights, and organ transplant discrimination. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 72/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 5/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 57/100 Allows Distribution Programs.................................................................................................................................................. 22/40 - Allows Access to Dried Flowers............................................................................................................................................... 5/15 - Allows Delivery..................................................................................................................................................................................... 3/5 - No Sales Tax or Reasonable Sales Tax................................................................................................................................. 3/5 - Allows for a Reasonable Number of Dispensaries........................................................................................................ 4/5 - Does Not Require Vertical Integration................................................................................................................................... 0/2 - Ownership/Employment Restrictions.................................................................................................................................... 1/2 - Provisions for Labor Standards................................................................................................................................................. 2/2 - Environmental Impact Regulations......................................................................................................................................... 2/2 - Choice of Dispensary Without Restrictions........................................................................................................................ 2/2 Noncommercial Cultivation....................................................................................................................................................... 0/20 - Personal Cultivation.......................................................................................................................................................................... 0/15 - Collective Gardening........................................................................................................................................................................ 0/5 Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... 10/10 Does Not Impose Bans or Limits on THC....................................................................................................................... 7/10 Does Not Impose Bans on CBD ............................................................................................................................................. 10/10 Local Bans/Zoning............................................................................................................................................................................ 8/10 IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 118 25 389.67 77.93% POINTS ISSUE EASE OF NAVIGATION 91/100 Comprehensive Qualifying Conditions............................................................................................................................ 50/50 Adding New Conditions............................................................................................................................................................... 10/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 5/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 9/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 3/5 FUNCTIONALITY 70/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 35/50 No Significant Administrative or Supply Problems............................................................................................... 12/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 3/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 5/7 FINAL GRADE C+ MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 NEW YORK ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 74.67/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 20.67/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 21/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 23/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 10/25 Dispensing 20.67/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 3/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 2.67/5 1.67/1.67 1/1.67 0/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 21/25 3/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 3/5 2/2.5 1/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 Manufacturing 23/25 Staff Training............................................................................................................................................................................................. 3/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations 10/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 5/5 0/5 0/5 0/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND In June 2014, the New York Assembly passed S7923, which created legal protections for patients and caregivers and authorized the Department of Health (DOH) to license and regulate “registered organizations” to cultivate and sell medical cannabis to patients. Upon receiving written certification from their physician, patients must obtain a registration identification card. The law requires physicians to complete educational requirements and state the “dosage” patients should use, which then is used to determine the amount that constitutes a 30-day supply of medicine that the patient may possess. The law forbids the smoking of cannabis but does not explicitly ban patients from access to cannabis in its dried flower form. The DOH granted five licenses in July 2015 and began issuing patient ID cards in December 2015. In January 2016, dispensaries began serving medical cannabis patients. In 2016, the DOH added chronic pain as a qualifying condition and updated the regulations to allow nurse practitioners to recommend medical cannabis, home delivery, and registered organizations to sell “wholesale” products to other registered organizations to prevent shortages. The program was improved again in 2017 with the addition of PTSD and chronic pain as well more registered organizations and an increased variety of products. 119 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 F NORTH CAROLINA AREAS FOR IMPROVEMENT North Carolina still lacks many of the components that make a state medical cannabis program effective, including the lack of in-state production and dispensing systems. North Carolina’s Department of Health has issued an Opioid Action Plan to reduce opioid overdose deaths by 20% by the year 2021, but this plan does not include using medical cannabis as a tool. There are no civil protections for patients included in the areas of housing, organ transplants, employment rights, and parental rights. The program could benefit by expanding the list of qualifying conditions and removing the arbitrary limits on THC and CBD. North Carolina also needs to develop rigorous product safety regulations. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 43/100 Arrest Protections............................................................................................................................................................................ 24/40 Affirmative Defense......................................................................................................................................................................... 9/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 5/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 11/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 120 0 149.34 29.87% 0/40 0/15 0/5 0/5 0/5 0/2 0/2 0/2 0/2 0/2 0/20 0/15 0/5 3/10 1/10 7/10 0/10 POINTS ISSUE EASE OF NAVIGATION 46/100 Comprehensive Qualifying Conditions............................................................................................................................ 20/50 Adding New Conditions............................................................................................................................................................... 0/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 0/5 - System Works for Adding New Conditions...................................................................................................................... 0/5 Reasonable Access for Minors ............................................................................................................................................. 6/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 1/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 9/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 3/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 3/5 FUNCTIONALITY 25/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... No Significant Administrative or Supply Problems............................................................................................... Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. Reasonable Possession Limits.............................................................................................................................................. Reasonable Purchase Limits................................................................................................................................................... Allows Patients to Medicate Where They Choose................................................................................................. Covered by Insurance/State Health Programs......................................................................................................... Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... FINAL GRADE F 0/50 8/15 7/10 5/5 0/5 3/5 0/3 2/7 MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 NORTH CAROLINA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 24.34/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 5.67/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 8/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 10.67/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 0/25 Dispensing 5.67/25 Staff Training................................................................................................................................................................................................... 0/5 Standard Operating Procedures..................................................................................................................................................... 0/5 - Facility Sanitary Conditions.................................................................................................................................................................. 0/1.25 - Storage Protocols........................................................................................................................................................................................ 0/1.25 - Reasonable Security Protocols........................................................................................................................................................... 0/1.25 - Inventory Control......................................................................................................................................................................................... 0/1.25 Recall Protocol and Adverse Event Reporting..................................................................................................................... 0/5 Product Labeling......................................................................................................................................................................................... 2.67/5 - Product Contents Including Source Material Identification.............................................................................................. 1.67/1.67 - Allergens........................................................................................................................................................................................................... 0/1.67 - Potency/Compound Identification................................................................................................................................................... 1/1.67 Required Testing.......................................................................................................................................................................................... 3/5 - Active Compound Identification........................................................................................................................................................ 1/1.67 - Contaminants................................................................................................................................................................................................ 1/1.67 - Potency............................................................................................................................................................................................................... 1/1.67 Grow/Cultivation Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 8/25 0/5 0/5 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/5 0/2.5 0/2.5 3/5 1/1.25 1/1.25 1/1.25 0/1.25 5/5 Manufacturing 10.67/25 Staff Training............................................................................................................................................................................................. 0/5 Standard Operating Procedures............................................................................................................................................... 0/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 0/1 - Workforce Safety Protocols............................................................................................................................................................. 0/1 - Storage Protocols.................................................................................................................................................................................. 0/1 - Reasonable Security Protocols..................................................................................................................................................... 0/1 - Batch and Lot Tracking...................................................................................................................................................................... 0/1 Product Labeling.................................................................................................................................................................................... 2.67/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 0/1.67 - Potency and Compound Information....................................................................................................................................... 1/1.67 Required Testing.................................................................................................................................................................................... 3/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 0/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 0/25 0/5 0/5 0/5 0/5 0/5 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 BACKGROUND In July 2014, North Carolina enacted HB 1220, known as North Carolina Epilepsy Alternative Treatment Act, creating a pilot program that allows medical use of CBD-rich oil only for registered patients diagnosed by a neurologist at one of four universities as having intractable epilepsy (that has not been responsive to at least three other treatment options). Access is to be only through a registered caregiver who must be a parent, guardian, or legal custodian who must obtain the CBD oil in a state with reciprocity to purchase medical cannabis products. Most medical cannabis jurisdictions that honor reciprocity for other state registration cards do not allow patients/caregivers from out of state to purchase any medical cannabis products. The CBD-rich oil must contain at least 10% CBD, no more than 0.3% THC, and must have no other psychoactive components. In July of 2015, House Bill 766 was signed by Governor McCory, amending HB 1220 to expand qualified positions to include any board certified physician certified in neurology and affiliated with any state-licensed hospital. The bill also changed the required THC/CBD percentages for medical cannabis from greater than 10% CBD and less than 0.3% THC to greater than 5% CBD and less than 0.9%THC. There were also changes to enhance patient privacy as well as the addition of a sunset clause, ending the medical cannabis program in 2021 if studies fail to show therapeutic relief from CBD. 121 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 C NORTH DAKOTA AREAS FOR IMPROVEMENT North Dakota appears to be moving at a good pace in implementing their medical cannabis program as they signed implementation legislation in April of 2017 and are currently holding implementation hearings with public input. As North Dakota continues to implement its medical cannabis program, adopting the proposed rules would lead to the implementation of strong product safety protocols. North Dakota could also improve its program by adding affirmative defense as well as civil discrimination protections in the areas of housing, patients, organ transplants, and parental rights. Note: North Dakota had a scoring error in 2016 and should have received 69.2% rather than 74% ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 34/100 Arrest Protections............................................................................................................................................................................ 30/40 Affirmative Defense......................................................................................................................................................................... 0/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 4/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 0/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 81/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 122 25 378 75.62% 34/40 15/15 5/5 5/5 5/5 1/2 1/2 0/2 0/2 2/2 10/20 10/15 0/5 10/10 10/10 10/10 7/10 POINTS ISSUE EASE OF NAVIGATION 81/100 Comprehensive Qualifying Conditions............................................................................................................................ 42/50 Adding New Conditions............................................................................................................................................................... 8/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 3/5 Reasonable Access for Minors ............................................................................................................................................. 10/10 Reasonable Caregiver Background Checks................................................................................................................ 1/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 1/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 8/10 Allows Multiple-Year Registrations ................................................................................................................................... 1/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 3/5 FUNCTIONALITY 76/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 45/50 No Significant Administrative or Supply Problems............................................................................................... 12/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 5/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 5/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 0/7 FINAL GRADE C MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 NORTH DAKOTA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 81.11/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 19.25/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 23/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 24/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 15/25 Dispensing 19.25/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 3.25/5 1/1.25 1/1.25 0/1.25 1.25/1.25 5/5 2.67/5 1.67/1.67 0/1.67 1/1.67 3/5 1.67/1.67 0/1.67 1.67/1.67 23/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 3/5 0.71/0.71 0/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0/0.71 0/0.71 5/5 2.5/2.5 2.5/2.5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 Manufacturing 24/25 Staff Training............................................................................................................................................................................................. 5/5 Standard Operating Procedures............................................................................................................................................... 4/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 0/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations 15/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 5/5 0/5 5/5 0/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND In 2016, 64% of North Dakotans voted in favor of the North Dakota Medical Marijuana Legalization initiative creating a comprehensive cannabis program for patients of the state. The program allows access for patients at retail dispensaries, but also allows patients to grow up to 8 plants if they live 40 or more miles away from the nearest dispensary. The program is one of the strictest in the nation as it allows the ND Department of Health to conduct in person interviews in order to determine eligibility. Implementation legislation for this program became effective on April 18, 2017. As of December 2017, the ND Department of Health was hosting implementation meetings and accepting public comment on its proposed medical cannabis rules. The proposed rules could be effective as early as April 1, 2018. 123 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B+ OHIO AREAS FOR IMPROVEMENT Ohio has moved well through the implementation process, but the state’s program is still a long way from being fully functional and serving patients. In 2016, Ohio had 4,050 drug overdose deaths, so it is clear that even though Ohio does well on paper, there is still room for improvement. Ohio has some of the worst employment language in the country, making employment discrimination against patients lawful and explicitly denying patients a cause of action in court to challenge employment discrimination cases. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 84/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 10/15 Parental Rights Protections..................................................................................................................................................... 10/10 DUI Protections.................................................................................................................................................................................. 5/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 4/7 Housing Protections....................................................................................................................................................................... 4/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 5/5 Reciprocity............................................................................................................................................................................................. 1/3 ACCESS TO MEDICINE 63/100 Allows Distribution Programs.................................................................................................................................................. 30/40 - Allows Access to Dried Flowers............................................................................................................................................... 15/15 - Allows Delivery..................................................................................................................................................................................... 0/5 - No Sales Tax or Reasonable Sales Tax................................................................................................................................. 5/5 - Allows for a Reasonable Number of Dispensaries........................................................................................................ 5/5 - Does Not Require Vertical Integration................................................................................................................................... 2/2 - Ownership/Employment Restrictions.................................................................................................................................... 1/2 - Provisions for Labor Standards................................................................................................................................................. 0/2 - Environmental Impact Regulations......................................................................................................................................... 0/2 - Choice of Dispensary Without Restrictions........................................................................................................................ 2/2 Noncommercial Cultivation....................................................................................................................................................... 0/20 - Personal Cultivation.......................................................................................................................................................................... 0/15 - Collective Gardening........................................................................................................................................................................ 0/5 Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... 9/10 Does Not Impose Bans or Limits on THC....................................................................................................................... 9/10 Does Not Impose Bans on CBD ............................................................................................................................................. 10/10 Local Bans/Zoning............................................................................................................................................................................ 5/10 IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 124 25 437.01 87.4% POINTS ISSUE EASE OF NAVIGATION 84/100 Comprehensive Qualifying Conditions............................................................................................................................ 45/50 Adding New Conditions............................................................................................................................................................... 8/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 3/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 8/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 86/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 45/50 No Significant Administrative or Supply Problems............................................................................................... 12/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 7/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 5/5 Allows Patients to Medicate Where They Choose................................................................................................. 5/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 7/7 FINAL GRADE B+ MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 OHIO ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 95.01/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 23.01/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 22/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 25/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 25/25 Dispensing 20.67/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 5/5 1.67/1.67 1.67/1.67 1.67/1.67 3/5 1/1.67 1/1.67 1/1.67 21/25 5/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 4/5 2/2.5 2/2.5 3/5 1/1.25 1/1.25 1/1.25 0/1.25 5/5 Manufacturing 25/25 Staff Training............................................................................................................................................................................................. 5/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations 25/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 5/5 5/5 5/5 5/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND Ohio’s medical cannabis program was created by HB 523 (2016), which went into effect on September 8, 2016. The law allows patients in Ohio to obtain legal protections to possess and use medical cannabis. The law contains 23 qualifying conditions and the state can add more conditions through rulemaking. The Ohio Medical Marijuana Control Program is comprised of several state agencies that regulate the program. Patients who meet certain requirements are eligible for an affirmative defense for possession and use of medical cannabis. Ohio promulgated rules for a variety of areas in 2017, including dispensing, cultivation, manufacturing, and laboratory standards. 125 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 F OKLAHOMA AREAS FOR IMPROVEMENT Now that a medical cannabis ballot initiative will appear on the 2018 ballot, it may be possible that the legislature will implement the will of the voters by adopting a full program. However, in the meantime, Oklahoma still has considerable work to do before becoming a functional program. Oklahoma’s current law fails to address instate production and access for patients, places arbitrary caps on THC, and fails to protect patients from civil discrimination in the areas of housing, employment, organ transplants, and parental rights. The state could also improve by increasing product safety regulations. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 39/100 Arrest Protections............................................................................................................................................................................ 25/40 Affirmative Defense......................................................................................................................................................................... 9/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 0/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 14/100 Allows Distribution Programs.................................................................................................................................................. 0/40 - Allows Access to Dried Flowers............................................................................................................................................... 0/15 - Allows Delivery..................................................................................................................................................................................... 0/5 - No Sales Tax or Reasonable Sales Tax................................................................................................................................. 0/5 - Allows for a Reasonable Number of Dispensaries........................................................................................................ 0/5 - Does Not Require Vertical Integration................................................................................................................................... 0/2 - Ownership/Employment Restrictions.................................................................................................................................... 0/2 - Provisions for Labor Standards................................................................................................................................................. 0/2 - Environmental Impact Regulations......................................................................................................................................... 0/2 - Choice of Dispensary Without Restrictions........................................................................................................................ 0/2 Noncommercial Cultivation....................................................................................................................................................... 0/20 - Personal Cultivation.......................................................................................................................................................................... 0/15 - Collective Gardening........................................................................................................................................................................ 0/5 Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... 3/10 Does Not Impose Bans or Limits on THC....................................................................................................................... 1/10 Does Not Impose Bans on CBD ............................................................................................................................................. 10/10 Local Bans/Zoning............................................................................................................................................................................ 0/10 IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 126 0 141 28.2% POINTS ISSUE EASE OF NAVIGATION 60/100 Comprehensive Qualifying Conditions............................................................................................................................ 30/50 Adding New Conditions............................................................................................................................................................... 0/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 0/5 - System Works for Adding New Conditions...................................................................................................................... 0/5 Reasonable Access for Minors ............................................................................................................................................. 8/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 10/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 3/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 3/5 FUNCTIONALITY 28/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 0/50 No Significant Administrative or Supply Problems............................................................................................... 8/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 10/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 0/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 2/7 FINAL GRADE F MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 OKLAHOMA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS Dispensing...................................................................................................................................................................................................................................................................................................................... Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... Manufacturing ............................................................................................................................................................................................................................................................................................................ Laboratory Operations ........................................................................................................................................................................................................................................................................................ Dispensing Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 0/25 0/5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1.67 0/1.67 0/1.67 0/25 0/5 0/5 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/0.71 0/5 0/2.5 0/2.5 0/5 0/1.25 0/1.25 0/1.25 0/1.25 0/5 Manufacturing Staff Training............................................................................................................................................................................................. Standard Operating Procedures............................................................................................................................................... - Facility and Equipment Sanitary Conditions........................................................................................................................ - Workforce Safety Protocols............................................................................................................................................................. - Storage Protocols.................................................................................................................................................................................. - Reasonable Security Protocols..................................................................................................................................................... - Batch and Lot Tracking...................................................................................................................................................................... Product Labeling.................................................................................................................................................................................... - Product Contents Including Source Material Identification........................................................................................ - Allergens...................................................................................................................................................................................................... - Potency and Compound Information....................................................................................................................................... Required Testing.................................................................................................................................................................................... - Active Ingredient Identification..................................................................................................................................................... - Contaminants........................................................................................................................................................................................... - Potency......................................................................................................................................................................................................... - Shelf Life Testing.................................................................................................................................................................................... - Sample Retention.................................................................................................................................................................................. Recall Protocol and Adverse Event Reporting............................................................................................................... Laboratory Operations Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 0/100 0/25 0/25 0/25 0/25 0/25 0/5 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/1.67 0/1.67 0/1.67 0/5 0/1 0/1 0/1 0/1 0/1 0/5 0/25 0/5 0/5 0/5 0/5 0/5 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 0/0.83 BACKGROUND In April of 2015, Governor Fallin signed HB 2154, Katie and Cayman’s Law, which allows physicians in Oklahoma to recommend a high-CBD cannabis oil (less than 0.3%) to minors suffering from a severe epilepsy disorder like Lennox-Gastaut or Dravet Syndrome. In 2016, the state adopted HB 2835, which expanded legal protections to patients of all ages and added several new qualifying conditions including spasticity due to Multiple Sclerosis or paraplegia, intractable nausea and vomiting, and appetite stimulation with chronic wasting diseases. In March of 2017, a lawsuit was resolved that will allow question 788, the “Medical Marijuana Legalization Initiative” to appear on the June 2018 Ballot. 127 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 B+ OREGON AREAS FOR IMPROVEMENT Laws passed in 2017 helped Oregon continue to have one of the strongest programs in the country. An average of three Oregonians die every week from prescription opioids, so there is still room for growth in using medical cannabis as an option for pain. While Oregon improved testing procedures, it still needs to develop better recall and adverse event reporting protocols. Additionally, Oregon needs to provide patients additional civil protections including in the areas of employment, improved protections for housing, and parental rights. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 78/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 3/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 5/5 Reciprocity............................................................................................................................................................................................. 3/3 ACCESS TO MEDICINE 90/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 128 15 440.50 88.10% 37/40 15/15 5/5 5/5 5/5 2/2 1/2 0/2 2/2 2/2 17/20 15/15 2/5 10/10 9/10 10/10 7/10 POINTS ISSUE EASE OF NAVIGATION 87/100 Comprehensive Qualifying Conditions............................................................................................................................ 47/50 Adding New Conditions............................................................................................................................................................... 7/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 2/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 6/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 91/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 50/50 No Significant Administrative or Supply Problems............................................................................................... 15/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 5/5 Reasonable Purchase Limits................................................................................................................................................... 2/5 Allows Patients to Medicate Where They Choose................................................................................................. 5/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 6/7 FINAL GRADE B+ MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 OREGON ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 79.50/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 19.67/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 17.84/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 18.67/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 23.32/25 Dispensing 19.67/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 5/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 2/5 2.67/5 1.67/1.67 0/1.67 1/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 17.84/25 Staff Training................................................................................................................................................................................................. 5/5 Standard Operating Procedures.................................................................................................................................................. 2.84/5 - Facility and Equipment Sanitary Conditions........................................................................................................................... 0.71/0.71 - Workforce Safety Protocols................................................................................................................................................................ 0/0.71 - Storage Protocols (Short Term and Long Term Storage)................................................................................................ 0.71/0.71 - Reasonable Security Protocols........................................................................................................................................................ 0.71/0.71 - Batch and Lot Tracking......................................................................................................................................................................... 0.71/0.71 - Disposal/Waste.......................................................................................................................................................................................... 0/0.71 - Water Management................................................................................................................................................................................. 0/0.71 Pesticide Guidance.................................................................................................................................................................................. 3/5 - Pesticide Guidance.................................................................................................................................................................................. 2/2.5 - Pesticide Labeling.................................................................................................................................................................................... 1/2.5 Required Testing........................................................................................................................................................................................ 5/5 - Active Ingredient Identification........................................................................................................................................................ 1.25/1.25 - Contaminants.............................................................................................................................................................................................. 1.25/1.25 - Potency............................................................................................................................................................................................................ 1.25/1.25 - Sample Retention..................................................................................................................................................................................... 1.25/1.25 Recall Protocol and Adverse Event Reporting.................................................................................................................. 2/5 Manufacturing 18.67/25 Staff Training............................................................................................................................................................................................. 4/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 2.67/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 0/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 5/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 1/1 - Sample Retention.................................................................................................................................................................................. 1/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 2/5 Laboratory Operations 23.32/25 Staff Training.............................................................................................................................................................................................. 5/5 Method Validation in Accordance with AHP Guidelines........................................................................................ 5/5 Result Reporting..................................................................................................................................................................................... 5/5 Independent or Third Party............................................................................................................................................................ 5/5 Standard Operating Procedures and Protocols............................................................................................................. 3.32/5 - Equipment and Instrument Calibration..................................................................................................................................... 0/0.83 - Sample Tracking...................................................................................................................................................................................... 0.83/0.83 - Facility and Equipment Sanitary Conditions......................................................................................................................... 0.83/0.83 - Disposal/Waste....................................................................................................................................................................................... 0/0.83 - Storage Protocols................................................................................................................................................................................... 0.83/0.83 - Workforce Safety Protocols............................................................................................................................................................. 0.83/0.83 BACKGROUND In 1998, Oregon voters approved the Oregon Medical Marijuana Act (OMMA), allowing a patient with a valid ID to use, possess, and cultivate cannabis for medical purposes, and designate a primary caregiver to assist them. Qualifying patients may possess up to twenty-four ounces of usable cannabis, and individuals may cultivate up to six mature plants and twelve immature plants or four plants if they belong to a non-OMMP cardholder. To be protected from arrest, patients must enroll in the Oregon Health Authority patient registry and possess a valid Oregon Medical Marijuana Program (OMMP) identification card. Non-registered patients with a valid recommendation who are within the possession or cultivation limits set by the OMMA are entitled to an affirmative defense. In August 2013, HB 3460 established regulations for state-licensed medical cannabis facilities. In March 2014, SB 1531 granted cities and counties the right to pass moratoriums on the opening of medical marijuana facilities until May 1, 2015. There are currently over 300 state licensed dispensaries serving patients. In 2016 the legislature passed HB 1404 allowing out of state ownership/ investment in medical cannabis businesses. Also passed was SB 1524 which reduces the paperwork requirement for veterans. New rules in Oregon became effective January 1, 2018 due to the passage of SB 56, SB 1057 and HB 2198 in 2017. These rules changed the plant limits to twelve at grow sites, introduced new testing procedures and environmental and zoning regulations, and allowed for caregivers to assist patients with the production of cannabis or processing of concentrates. 129 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 C PENNSYLVANIA AREAS FOR IMPROVEMENT Pennsylvania was able to launch its program this fall, with full implementation expected by early 2018. Pennsylvania adopted temporary regulations in early 2017, and these show the state’s dedication to developing a robust program that is effective for patients. There is still room for improvement. Pennsylvania should add housing and organ transplant protections, allow patients to participate in personal cultivation, and improve the training of staff at medical cannabis facilities. Pennsylvania should also remove harsh restrictions on access to dried flowers. Note: Pennsylvania was not graded on consumer safety in 2016, so while their letter grade dropped, they obtained more total points. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 71/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 7/15 Parental Rights Protections..................................................................................................................................................... 10/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 5/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 2/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 60/100 Allows Distribution Programs.................................................................................................................................................. 24/40 - Allows Access to Dried Flowers............................................................................................................................................... 5/15 - Allows Delivery..................................................................................................................................................................................... 5/5 - No Sales Tax or Reasonable Sales Tax................................................................................................................................. 4/5 - Allows for a Reasonable Number of Dispensaries........................................................................................................ 5/5 - Does Not Require Vertical Integration................................................................................................................................... 2/2 - Ownership/Employment Restrictions.................................................................................................................................... 1/2 - Provisions for Labor Standards................................................................................................................................................. 0/2 - Environmental Impact Regulations......................................................................................................................................... 0/2 - Choice of Dispensary Without Restrictions........................................................................................................................ 2/2 Noncommercial Cultivation....................................................................................................................................................... 0/20 - Personal Cultivation.......................................................................................................................................................................... 0/15 - Collective Gardening........................................................................................................................................................................ 0/5 Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... 9/10 Does Not Impose Bans or Limits on THC....................................................................................................................... 10/10 Does Not Impose Bans on CBD ............................................................................................................................................. 10/10 Local Bans/Zoning............................................................................................................................................................................ 7/10 IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 130 25 380 76% POINTS ISSUE EASE OF NAVIGATION 81/100 Comprehensive Qualifying Conditions............................................................................................................................ 46/50 Adding New Conditions............................................................................................................................................................... 6/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 1/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 2/4 Number of Caregivers................................................................................................................................................................... 0/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 2/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 9/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 3/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 4/5 FUNCTIONALITY 84/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 45/50 No Significant Administrative or Supply Problems............................................................................................... 14/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 7/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 5/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 5/7 FINAL GRADE C MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 PENNSYLVANIA ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 59/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 15.67/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 18/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 13.67/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 11.66/25 Dispensing 15.67/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 3/5 5/5 1.25/1.25 1.25/1.25 1.25/1.25 1.25/1.25 5/5 1.67/5 1.67/1.67 0/1.67 0/1.67 1/5 1/1.67 0/1.67 0/1.67 18/25 Staff Training................................................................................................................................................................................................. Standard Operating Procedures.................................................................................................................................................. - Facility and Equipment Sanitary Conditions........................................................................................................................... - Workforce Safety Protocols................................................................................................................................................................ - Storage Protocols (Short Term and Long Term Storage)................................................................................................ - Reasonable Security Protocols........................................................................................................................................................ - Batch and Lot Tracking......................................................................................................................................................................... - Disposal/Waste.......................................................................................................................................................................................... - Water Management................................................................................................................................................................................. Pesticide Guidance.................................................................................................................................................................................. - Pesticide Guidance.................................................................................................................................................................................. - Pesticide Labeling.................................................................................................................................................................................... Required Testing........................................................................................................................................................................................ - Active Ingredient Identification........................................................................................................................................................ - Contaminants.............................................................................................................................................................................................. - Potency............................................................................................................................................................................................................ - Sample Retention..................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting.................................................................................................................. 0/5 5/5 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 0.71/0.71 5/5 2.5/2.5 2.5/2.5 3/5 1/1.25 1/1.25 1/1.25 0/1.25 5/5 Manufacturing 13.67/25 Staff Training............................................................................................................................................................................................. 0/5 Standard Operating Procedures............................................................................................................................................... 3/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 0/1 - Storage Protocols.................................................................................................................................................................................. 0/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 2.67/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 0/1.67 - Potency and Compound Information....................................................................................................................................... 1/1.67 Required Testing.................................................................................................................................................................................... 3/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 1/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 0/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 5/5 Laboratory Operations 11.66/25 Staff Training.............................................................................................................................................................................................. 0/5 Method Validation in Accordance with AHP Guidelines........................................................................................ 0/5 Result Reporting..................................................................................................................................................................................... 5/5 Independent or Third Party............................................................................................................................................................ 5/5 Standard Operating Procedures and Protocols............................................................................................................. 1.66/5 - Equipment and Instrument Calibration..................................................................................................................................... 0/0.83 - Sample Tracking...................................................................................................................................................................................... 0/0.83 - Facility and Equipment Sanitary Conditions......................................................................................................................... 0/0.83 - Disposal/Waste....................................................................................................................................................................................... 0/0.83 - Storage Protocols................................................................................................................................................................................... 0.83/0.83 - Workforce Safety Protocols............................................................................................................................................................. 0.83/0.83 BACKGROUND The Pennsylvania Medical Marijuana Act (Act 16, 2016), signed on April 17, 2016, created the state’s medical marijuana program. The program will ultimately allow patients to obtain medical cannabis from state-licensed dispensaries. The program initially includes 17 qualifying conditions. has offered the public the opportunity to comment on them. The program allows for 25 “grower/processor” licenses and 50 dispensary licenses. Each dispensary license may have up to three locations, meaning there is a potential maximum of up to 150 dispensaries throughout the state. The program should be prepared to distribute medicine in early 2018. Prior to the opening of dispensaries (and presumably after) pediatric patients and the parent/legal guardian caregivers can apply for safe harbor exemptions from possessing and using medical cannabis. The state Department of Health (DOH) has provided guidelines for patients seeking safe harbor. Physicians must take a training course before being eligible to recommend medical cannabis under Act 16. The state DOH has issued temporary regulations for dispensaries and 131 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 C- PUERTO RICO AREAS FOR IMPROVEMENT Puerto Rico clearly indicates that it wants its program to, above all, be patient focused. Puerto Rico’s program also explicitly provides for research and development for new medical cannabis products. It could improve its program by adding civil protections for patients including employment protections, housing protections, and parental rights. Note: Puerto Rico is scored on a translated version of regulations meaning there may be some legislative intricacies that were omitted which could result in a change in score. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 61/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 8/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 0/5 Employment Protections............................................................................................................................................................ 0/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 3/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 3/3 ACCESS TO MEDICINE 56/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 132 25 351 70.17% 19/40 5/15 5/5 0/5 5/5 0/2 1/2 1/2 0/2 2/2 0/20 0/15 0/5 10/10 10/10 10/10 7/10 POINTS ISSUE EASE OF NAVIGATION 75/100 Comprehensive Qualifying Conditions............................................................................................................................ 40/50 Adding New Conditions............................................................................................................................................................... 5/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 0/5 Reasonable Access for Minors ............................................................................................................................................. 7/10 Reasonable Caregiver Background Checks................................................................................................................ 4/4 Number of Caregivers................................................................................................................................................................... 1/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 1/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 7/10 Allows Multiple-Year Registrations ................................................................................................................................... 0/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 66/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 40/50 No Significant Administrative or Supply Problems............................................................................................... 10/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 8/10 Reasonable Possession Limits.............................................................................................................................................. 3/5 Reasonable Purchase Limits................................................................................................................................................... 2/5 Allows Patients to Medicate Where They Choose................................................................................................. 3/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 0/7 FINAL GRADE C- MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 PUERTO RICO ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 68/100 Dispensing...................................................................................................................................................................................................................................................................................................................... 17/25 Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... 16.84/25 Manufacturing ............................................................................................................................................................................................................................................................................................................ 18/25 Laboratory Operations ........................................................................................................................................................................................................................................................................................ 16/25 Dispensing 17/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..................................................................................................................................................... - Facility Sanitary Conditions.................................................................................................................................................................. - Storage Protocols........................................................................................................................................................................................ - Reasonable Security Protocols........................................................................................................................................................... - Inventory Control......................................................................................................................................................................................... Recall Protocol and Adverse Event Reporting..................................................................................................................... Product Labeling......................................................................................................................................................................................... - Product Contents Including Source Material Identification.............................................................................................. - Allergens........................................................................................................................................................................................................... - Potency/Compound Identification................................................................................................................................................... Required Testing.......................................................................................................................................................................................... - Active Compound Identification........................................................................................................................................................ - Contaminants................................................................................................................................................................................................ - Potency............................................................................................................................................................................................................... Grow/Cultivation 3/5 3/5 0/1.25 1/1.25 1/1.25 1/1.25 1/5 5/5 1.67/1.67 1.67/1.67 1.67/1.67 5/5 1.67/1.67 1.67/1.67 1.67/1.67 16.84/25 Staff Training................................................................................................................................................................................................. 3/5 Standard Operating Procedures.................................................................................................................................................. 2.84/5 - Facility and Equipment Sanitary Conditions........................................................................................................................... 0/0.71 - Workforce Safety Protocols................................................................................................................................................................ 0.71/0.71 - Storage Protocols (Short Term and Long Term Storage)................................................................................................ 0.71/0.71 - Reasonable Security Protocols........................................................................................................................................................ 0.71/0.71 - Batch and Lot Tracking......................................................................................................................................................................... 0.71/0.71 - Disposal/Waste.......................................................................................................................................................................................... 0/0.71 - Water Management................................................................................................................................................................................. 0/0.71 Pesticide Guidance.................................................................................................................................................................................. 5/5 - Pesticide Guidance.................................................................................................................................................................................. 2.5/2.5 - Pesticide Labeling.................................................................................................................................................................................... 2.5/2.5 Required Testing........................................................................................................................................................................................ 3/5 - Active Ingredient Identification........................................................................................................................................................ 1/1.25 - Contaminants.............................................................................................................................................................................................. 1/1.25 - Potency............................................................................................................................................................................................................ 1/1.25 - Sample Retention..................................................................................................................................................................................... 0/1.25 Recall Protocol and Adverse Event Reporting.................................................................................................................. 3/5 Manufacturing 18/25 Staff Training............................................................................................................................................................................................. 3/5 Standard Operating Procedures............................................................................................................................................... 5/5 - Facility and Equipment Sanitary Conditions........................................................................................................................ 1/1 - Workforce Safety Protocols............................................................................................................................................................. 1/1 - Storage Protocols.................................................................................................................................................................................. 1/1 - Reasonable Security Protocols..................................................................................................................................................... 1/1 - Batch and Lot Tracking...................................................................................................................................................................... 1/1 Product Labeling.................................................................................................................................................................................... 5/5 - Product Contents Including Source Material Identification........................................................................................ 1.67/1.67 - Allergens...................................................................................................................................................................................................... 1.67/1.67 - Potency and Compound Information....................................................................................................................................... 1.67/1.67 Required Testing.................................................................................................................................................................................... 2/5 - Active Ingredient Identification..................................................................................................................................................... 1/1 - Contaminants........................................................................................................................................................................................... 0/1 - Potency......................................................................................................................................................................................................... 1/1 - Shelf Life Testing.................................................................................................................................................................................... 0/1 - Sample Retention.................................................................................................................................................................................. 0/1 Recall Protocol and Adverse Event Reporting............................................................................................................... 3/5 Laboratory Operations 16/25 Staff Training.............................................................................................................................................................................................. Method Validation in Accordance with AHP Guidelines........................................................................................ Result Reporting..................................................................................................................................................................................... Independent or Third Party............................................................................................................................................................ Standard Operating Procedures and Protocols............................................................................................................. - Equipment and Instrument Calibration..................................................................................................................................... - Sample Tracking...................................................................................................................................................................................... - Facility and Equipment Sanitary Conditions......................................................................................................................... - Disposal/Waste....................................................................................................................................................................................... - Storage Protocols................................................................................................................................................................................... - Workforce Safety Protocols............................................................................................................................................................. 3/5 0/5 3/5 5/5 5/5 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 0.83/0.83 BACKGROUND Puerto Rico’s program was first passed in 2015; however, due to administrative delays, it hasn’t been functioning until this year. On July 8, 2016, Reglamento 8766 (Regulation 8766) was adopted which outlines the rules and regulations for Puerto Rico’s medical cannabis program. Reglamento 8766 repealed Reglamento 155 of 2015. Reglamento 8766 removed restrictions on individuals with prior convictions from serving as medical cannabis employees. Reglamento 8766 also allows for reciprocity for patients who do not permanently reside on the island. On July 9, 2017, the Governor of Puerto Rico signed into law the Act to Manage the Study, Development and Investigation of Cannabis for Innovation, and Applicable Norms and Limitations (Ley 42-2017) which set up a framework for dealing with medical cannabis, establishing research protocols, and creating a Regulatory Board. 133 MEDICAL MARIJUANA ACCESS IN THE UNITED STATES MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 C RHODE ISLAND AREAS FOR IMPROVEMENT Rhode Island deserves credit for protecting employee rights through the courts in Callaghan v. Darlington Fabrics Co. et. al., (R.I. Super. Ct. 2017). However, barring this victory for patients, Rhode Island did not pass any legislation or adopt any regulations in 2017 to improve the medical cannabis program. Rhode Island had 257 opioid overdose deaths in 2017, and the state should adjust its medical cannabis program to serve those affected by the opioid crisis. Rhode Island could also improve its program greatly by adopting strict consumer and provider safety requirements, particularly in the area of laboratory testing. ISSUE POINTS PATIENT RIGHTS AND CIVIL PROTECTIONS 76/100 Arrest Protections............................................................................................................................................................................ 40/40 Affirmative Defense......................................................................................................................................................................... 15/15 Parental Rights Protections..................................................................................................................................................... 0/10 DUI Protections.................................................................................................................................................................................. 5/5 Employment Protections............................................................................................................................................................ 4/5 Explicit Privacy Standards........................................................................................................................................................ 7/7 Housing Protections....................................................................................................................................................................... 0/5 Does Not Create New Criminal Penalties for Patients........................................................................................ 5/5 Organ Transplants............................................................................................................................................................................ 0/5 Reciprocity............................................................................................................................................................................................. 0/3 ACCESS TO MEDICINE 81/100 Allows Distribution Programs.................................................................................................................................................. - Allows Access to Dried Flowers............................................................................................................................................... - Allows Delivery..................................................................................................................................................................................... - No Sales Tax or Reasonable Sales Tax................................................................................................................................. - Allows for a Reasonable Number of Dispensaries........................................................................................................ - Does Not Require Vertical Integration................................................................................................................................... - Ownership/Employment Restrictions.................................................................................................................................... - Provisions for Labor Standards................................................................................................................................................. - Environmental Impact Regulations......................................................................................................................................... - Choice of Dispensary Without Restrictions........................................................................................................................ Noncommercial Cultivation....................................................................................................................................................... - Personal Cultivation.......................................................................................................................................................................... - Collective Gardening........................................................................................................................................................................ Explicit Right to Edibles/Concentrates/Other Forms.......................................................................................... Does Not Impose Bans or Limits on THC....................................................................................................................... Does Not Impose Bans on CBD ............................................................................................................................................. Local Bans/Zoning............................................................................................................................................................................ IMPROVEMENT BONUS TOTAL OUT OF 500 SCORE PERCENTAGE 134 10 378.13 75.63% 28/40 15/15 5/5 4/5 3/5 0/2 1/2 0/2 0/2 0/2 16/20 15/15 1/5 9/10 10/10 10/10 8/10 POINTS ISSUE EASE OF NAVIGATION 89/100 Comprehensive Qualifying Conditions............................................................................................................................ 48/50 Adding New Conditions............................................................................................................................................................... 7/10 - Laws/Regulations Allow for New Conditions................................................................................................................. 5/5 - System Works for Adding New Conditions...................................................................................................................... 2/5 Reasonable Access for Minors ............................................................................................................................................. 9/10 Reasonable Caregiver Background Checks................................................................................................................ 3/4 Number of Caregivers................................................................................................................................................................... 2/2 Patient/Practitioner-Focused Task Force or Advisory Board...................................................................... 0/2 Reasonable Fees for Patients and Caregivers........................................................................................................... 8/10 Allows Multiple-Year Registrations ................................................................................................................................... 2/2 Reasonable Physician Requirements ............................................................................................................................ 5/5 Does Not Classify Cannabis as a Medicine of Last Resort............................................................................. 5/5 FUNCTIONALITY 87/100 Patients Able to Access Medicine at Dispensaries or by Cultivation.................................................... 45/50 No Significant Administrative or Supply Problems............................................................................................... 15/15 Patients Can Receive Legal Protections Within Reasonable Timeframe of Recommendation.............................................................................................................................................................................. 9/10 Reasonable Possession Limits.............................................................................................................................................. 4/5 Reasonable Purchase Limits................................................................................................................................................... 4/5 Allows Patients to Medicate Where They Choose................................................................................................. 4/5 Covered by Insurance/State Health Programs......................................................................................................... 0/3 Financial Hardship (Fee Waivers/Discount Medicine)...................................................................................... 6/7 FINAL GRADE C MEDICAL CANNABIS ACCESS STATE REPORT CARD 2018 PAGE 2/2 RHODE ISLAND ISSUE POINTS CONSUMER SAFETY AND PROVIDER REQUIREMENTS ISSUE POINTS 35.13/100 Dispensing...................................................................................................................................................................................................................................................................................................................... Grow/Cultivation ...................................................................................................................................................................................................................................................................................................... Manufacturing ............................................................................................................................................................................................................................................................................................................ Laboratory Operations ........................................................................................................................................................................................................................................................................................ Dispensing 10/25 Staff Training................................................................................................................................................................................................... Standard Operating Procedures..........................................................................................................................