September 6-8. San Francisco, California 1. CLEAR 2012 Annual Educational Conference Medical Marijuana: Politics Meets Regulation



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Medical Marijuana: Politics Meets Regulation Presenters: Dr. Heidi Oetter, MD President, Federation of Medical Regulatory Authorities of Canada Richard Morales, Section Director Colorado Division of Professions & Occupations Promoting Regulatory Excellence Colorado Background State Constitutional Change Designed to benefit persons suffering from a debilitating medical condition Regulatory Environment MMJ Patient Registry MMJ Vendors, Retailers & Caregivers Physicians 2 Social & Political Environment Change in Federal Stance on MMJ Legislative Bills & Hearings Medical Marijuana Advocates & Activities Law Enforcement Experiences 3 San Francisco, California 1

Canada 4 Health Care Single payor First dollar coverage 91% hospital services publicly funded 99% physician services publicly funded Fewer physicians per population 99% of physicians belong to one mutual defense organization 5 Licensing and regulation Provincial Colleges or territorial government Colleges have delegated authority No DEA, colleges have oversight of doctors prescribing practices 6 San Francisco, California 2

Federal versus Provincial Responsibilities Health Canada: drug scheduling Criminal law is a federal responsibility Medical marijuana: regulation under the Controlled Drugs and Substances Act 7 Medical Marijuana Ontario Court of Appeal 2000 Violation of Charter of Rights and Freedoms Gravely ill patients denied access to symptom relief 8 Medical Marijuana Access Regulations Made possession of small amounts of marijuana legal if for medical purposes Patients could also grow their own or have someone grow it for them Access limited to patients suffering from grave and debilitating illness for whom conventional therapy failed Patients needed physician to submit forms to Health Canada Physician confirmed diagnosis, need and dose 9 San Francisco, California 3

More Court Rulings Unconstitutional to not supply marijuana "Prairie Plant Systems Incorporated" 10 Relaxed Physician Obligations Provide diagnosis, no longer provide dose 11 Headlines! 12 San Francisco, California 4

Statistical Data from the MMJ Registry Sex Percent on Registry Average Age Males 68% 41 Female 32% 43 Reported Condition # of Patients Percent Chachexia 1,201 1% Cancer 2,553 3% Glaucoma 1,022 1% HIV/AIDS 627 1% Muscle Spasms 17,035 17% Seizures 1,668 2% Severe Pain 92,704 94% Severe Nausea 11,471 12% 13 140,000 120,000 100,000 Active Registry Cards 2009-2012 80,000 60,000 40,000 2009 2010 2011 2012 20,000 0 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Working with Board to Manage Reactions It s not evidenced based! This isn t right! Not in my practice! But we ll look stupid if we don t do anything! I want to make a stand! We re not equipped to fight the proliferation of MMJ! 15 San Francisco, California 5

It s all about the medicine. Should someone seeking medical marijuana receive substandard medical treatment? Focus on the medicine and safety to practice 16 Complaints Received by the Colorado Medical Board Inappropriate MMJ Certifications Physician Using MMJ 17 Current Concerns HC has difficulty growing enough marijuana Compassions clubs operate under radar to provide supply 15,000 licensed growers, never inspected by HC 18 San Francisco, California 6

Current Reality Regulation was intended to authorize access for a small number of patients Demand has exceeded supply 2005-805 patients 2011-12,264 patients Ontario court judgment: estimate 400,000 users of "medical marijuana" 19 Parallels with Medical Alcohol Lawful possession and use of alcohol during prohibition 20 BC Bud High potent marijuana grown in BC 6 billion dollar illegal industry, 95% exported to USA Majority operated by gangs 20,000 homes growing it 21 San Francisco, California 7

Regulatory Enforcement Issues Specific to MMJ Safety to Practice Identifying Experts Complainants vs. Patients Witnesses Investigative Intense 22 Enforcement Issues Continued Grand Standing Legal Service Resources 23 Regulatory Experience Physicians remain reluctant gatekeepers HC limited resources to scrutinize use Very few complaints to regulators High societal tolerance of recreational use Serious concerns with criminal supply/distribution 24 San Francisco, California 8

HC Proposed Regulations Essentially remove HC from any enforcement or oversight Physicians become authorizing agent HC no longer does supply and distribution 25 FMRAC's Position on Amendments Maintain status quo, or Treat it like a pharmaceutical, schedule it and supply is through pharmacies, or Decriminalise it 26 FMRAC's Position on Medical Marijuana The practice of medicine should be evidence based Physicians should not be asked to prescribe or dispense substances or treatment for which there is little evidence of efficacy or safety 27 San Francisco, California 9

Speaker Contact Information Richard Morales, Section Director Colorado Division of Professions & Occupations Richard.Morales@dora.state.co.us Dr. Heidi Oetter Registrar, CPSBC President, FMRAC hoetter@cpsbc.ca 28 San Francisco, California 10