THE STATE OF THE STATES-A REPORT ON MEDICAL CANNABIS PROGRAMS MID YEAR MEETING AND SCIENTIFIC SEMINAR APRIL 13, 2018 NASHVILLE, TENNESSEE DEBBY MIRAN

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1 THE STATE OF THE STATES-A REPORT ON MEDICAL CANNABIS PROGRAMS MID YEAR MEETING AND SCIENTIFIC SEMINAR APRIL 13, 2018 NASHVILLE, TENNESSEE DEBBY MIRAN

2 LEARNING OBJECTIVES Participants will learn about each state s program, limitations, qualifying medical conditions Participants will learn how the laws in each state impact physicians and their practice

3 THE NATIONAL PICTURE 29 States and the District of Columbia have a full medical program Louisiana is unique 16 States have a Cannabidiol (CBD) program only 4 States have no program (Idaho, Nebraska, Kansas, and South Dakota) 46/50 states have some form of program representing ~85% of US population

4 CURRENT MAP OF THE U.S.

5 WHAT DEFINES A STATE MEDICAL PROGRAM? ASA (Americans for Safe Access) defines full medical program as the state fully legalizing use of the plant for medical purposes Symbolic Programs - states that require a provider s prescription and federal law prevents this (VA, NH, CT, WI, LA)

6 CBD ONLY STATES 16 States (AL, GA, IN, IA, KY, MS, MO, NC, OK, SC, SD, TN, TX, UT, VA, WI, WY) Low THC requirements- eliminate or reduce psychotropic properties Laws vary from NMT 0.5% THC to NMT 5% THC Hemp vs High CBD Hemp (Cannabis sativa) grown for fibrous stalks and seeds (federal definition <0.3%THC) High CBD (Cannabis sativa hybrid) strains grown for high CBD content for medicine (up to 16% CBD)

7 COMMON LIMITATIONS Flower as a finished product in dispensaries Smoking of flower not permitted Must have prescription with dosing instructions from physician Severely limited conditions such as epilepsy only Oil only as finished product

8 TENNESSEE LAW Hemp law allows for production of seed for industrial use Medical marijuana bill withdrawn on 4/3/18 by sponsor after amendments requiring a physician prescription and go out of state for oil (both federally illegal) Senate and house bill sponsors vow to introduce bill next session which would allow growing, processing, and dispensing

9 STATE BY STATE REVIEW STATE LAW/BALLOT CONDITIONS SIZE OF PROGRAM POSESSION LIMITS Alaska 1998 ballot By category* 1054 patients 1 oz, 6 plants Y Arizona 2010 ballot By category, PTSD 152, oz, 12 plants Arkansas 2016 ballot By specific disease oz per 14 days California 1996 ballot By category 1,256,550 8oz, 12 plants Y Colorado 2000 ballot By category, PTSD 93,372 2 oz, 6 plants Y Connecticut 2012 law By category, PTSD 23, oz Y Delaware 2011 law By disease, PTSD, Autism oz Y TESTING REQUIRED N, but under consideration Y

10 STATE LAW/ BALLOT STATE BY STATE REVIEW CONDITIONS Florida 2016 ballot By category and disease, PTSD Hawaii 2000 law By category, PTSD SIZE OF PROGRAM POSESSION LIMITS 74,133 TBD by physician 20,279 4 oz, 10 plants Y Illinois 2013 law By disease, PTSD 31, oz/ 14 days Y Maine 1999 ballot By disease, PTSD 41, oz, 6 plants Y Maryland 2014 law By category, PTSD 29, g/30 days Y Massachusetts 2012 ballot By disease 45, oz/ 60 days Y Michigan 2008 ballot By disease, PTSD 218, oz, 12 plants TESTING REQUIRED Y N

11 STATE BY STATE REVIEW STATE LAW/BALLOT CONDITIONS SIZE OF PROGRAM Minnesota 2014 law By disease, PTSD,Autism POSESSION LIMITS day, no flower Montana 2004 ballot By disease, PTSD 21,881 1 oz, 4 plants N Nevada 2000 ballot By condition, PTSD New Hampshire 23, oz, 12 plants 2013 law By disease, PTSD oz/ 10 days Y New Jersey 2010 law Very limited 12,514 2 oz N New Mexico 2007 law By disease, PTSD 47,840 6 oz, 12 plants Y New York 2014 law By condition, PTSD North Dakota 43, day, no flower 2016 ballot By disease Not open 3 oz/ 14 days TESTING REQUIRED Y Y Y

12 STATE BY STATE REVIEW STATE LAW/BALLOT CONDITIONS SIZE OF PROGRAM POSESSION LIMITS Ohio 2016 law By disease, PTSD Not open 90 day, no flower Oregon 1998 ballot By condition 24 oz, 6 plants Y Pennsylvania 2016 law By disease, PTSD, Autism day, no flower Rhode Island 2006 law By condition 19, oz/ 12 plants Vermont 2004 law By condition oz, 9 plants N Washington 1998 ballot By condition, PTSD Washington DC West Virginia 2017 law 2010 law Conditions controlled by MD By condition, PTSD 27,240 8 oz, 6 plants Y TESTING REQUIRED Y Y N oz N Not open 30 day, no flower Y

13 PAIN AS A CONDITION Chronic and/or severe- 12 states Intractable- 10 states Not included- 2 states (CT and MA) Provider discretion- 4 states and DC (CA AR, MD, MA)

14 MOST COMMON CONDITIONS Arthritis HIV/AIDs Chronic pain Severe nausea Epilepsy Cancer Glaucoma Multiple Sclerosis Crohn s Disease Fibromyalgia

15 STATE LAWS AND IMPACT TO PROVIDERS Providers are typically MDs and DOs who hold CDS licenses Some states like Maryland expanded definition to include any provider who holds a CDS license including MDs, DOs, NPs, Dentists, Podiatrists, and Nurse Midwives Some states protect providers under specific provisions in their law (i.e. Ohio) th Circuit Court Decision Conant v Walters. Physicians are protected under first amendment freedom of speech to have conversation about cannabis with a patient

16 REQUIREMENTS FOR PROVIDERS Most states require a bona fide relationship between patient and physician Must maintain patient records, provide follow up Many states require providers to be registered with program Registries may or may not be publically available Must hold current state license to practice and be in good standing Shall not have any financial relationship with grower, processor, dispensary, or testing lab Some states require provider CME training on cannabis science and medicine

17 REQUIREMENTS FOR PATIENTS Most states require in person patient evaluation Must be recommended for a listed condition by provider Must be registered with program (required in most states) May have a caregiver(s) and minors (under age 18) must have caregiver All states have some limit on supply (30-90 day, with specified maximum) Most states require a patient/caregiver ID card

18 THE INTERNATIONAL PICTURE North America Canada- full medical use since 2001, adult use in 2018, able to export US- no national laws; states only. Interstate commerce and export prohibited Mexico law legalizing medical use, final regulations pending Central America Costa Rica bill proposed for medical use which would include legal cultivation and distribution, and clinical research at universities

19 SOUTH AMERICA MANY COUNTRIES LEGALIZED FOR MEDICAL USE Argentina law for medical use allows for import of oil and state cultivation for research Brazil law allows for medicinal CBD only importation and dispensing Chile decree removed cannabis from list of dangerous drugs. Largest state grown farm in SA. Allowed to import oil and other processed products. Clinical studies ongoing Columbia decree allows for licensing of cultivation and sale of medical products Ecuador bill proposed for medical cultivation, processing, and dispensing Peru law legalizing medical use just signed by president

20 URUGUAY A MODEL PROGRAM Medical and scientific use permitted since 2013 First to legalize and regulate domestic non-medical use Business entities have full banking privileges Wide access through pharmacies, dispensaries, clubs Goal to eliminate all black market

21 EUROPE The Netherlands- one of the first to decriminalize for medical use. One company grows for all national use Italy law for medical use and dispensed through pharmacies. Allows imports and state-controlled domestic cultivation Germany law for medical use and dispensed through pharmacies. Import and domestic cultivation permitted Denmark approval for 4 year trial for medical access under Rx by physician Czech Republic law for medical use. Local cultivation and export permitted. Created major center for research Greece, Poland laws allowing medical use with prescription

22 ISRAEL Medical use permitted since 1990s Regulatory revisions in 2016 eased access for patients (~30,000 enrolled) Home of famous researcher, Raphael Mechoulam who isolated and identified THC in 1964 Currently 100+ research and clinical trials ongoing; including big autism study Local production and export permitted

23 OTHER MAJOR INTERNATIONAL MEDICAL PROGRAMS Australia- National law passed in 2016 with slow roll out (~only 600 enrolled patients). Many restrictions on local cultivation, distribution, and patient access. Importation allowed South Africa- National law passed in 2017 decriminalizing possession and cultivation for personal medical use. Licenses to cultivate will be issued Jamaica law allows for cultivation and dispensing for medical use, medical tourism. and religious use by Rastafarians

24 THE WORLD VIEW

25 SUMMARY Each state is unique and laws and regulations must be carefully studied No national physician Standards of Care (CA and Puerto Rico have drafted documents) Some states require provider CME training; many do not Approximately 14 colleges/universities offer some course work or electives in pharmacy or medical schools on the science and medicine of cannabis AOA position (H-419-A/2016)- supporting well controlled conical trials on use of cannabis in patients with significant medical conditions

26 THANK YOU FOR YOUR ATTENTION I look forward to your questions

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