Health Care Professionals Forum May 19, 2016
Statistics Update
Licensed Producers There are currently 31 licenses for the production of marijuana for medical purposes There are approximately 400 applications to become a Licensed Producer (LP) being reviewed by Health Canada Three new licenses to produce have been issued since our last meeting (WeedMD, Whistler Medical Marijuana Corp., THC Biomed Ltd.) 3
Current Status of the Marijuana for Medical Purposes Regime LPs are required to submit monthly statistics to Health Canada including production, sale, and inventory amounts. LPs do not provide information pertaining to patient data to Health Canada Authorized licensed production totals 27,000 kg/year or 2,250 kg/month 11,700 kg of dried marijuana has been sold under MMPR licenses since 2013 March 2016 numbers demonstrate that there is sufficient supply of dried marijuana to meet current demand: 1,150 kg sold 1,790 kg produced 10,700 kg in inventory Average authorized amount per day is declining. In March 2016 the average amount authorized was 2.7 grams/day 4
Dried Marijuana As of April 2016: Prices range from $1.75/g to $15/g The average price of dried marijuana is $8.22/g There are approximately 300 strains/product offerings available Most strains are higher in THC/low in CBD, with the highest level of THC observed at 31% 5
Cannabis Oil There are currently 9 licenses to sell oil Authorized licensed production of cannabis oil in Canada is up to 5,000 kg/year or 420 kg/month Approximately 600 kg of cannabis oil has been sold under MMPR licenses since December 2015 As of March 31, 2016, there is sufficient supply of cannabis oil to meet current demand: 400 kg sold 600 kg produced 1,400 kg in inventory As of April 2016: Prices range from $0.95/ml to $4.17/ml The average price of cannabis oil is $2.61/ml There are approximately 30 cannabis oil offerings 6
Patient Access As of March 31, 2016, nearly 54,000 patients are registered under the MMPR. This number has been increasing at an average rate of 9% each month. 7
Marijuana for Medical Purposes Authorization: December Snap Shot December 2015 Average amount of marijuana authorized: 2.9 g/day 68% of medical practitioners supported one patient The average patient to Healthcare practitioner ratio was 5:1 The highest number of patients per doctor was 305 16 physicians authorized more than 100 patients 13 of the 16 are located in Ontario 8
Health Care Practitioners As of January 2016, approximately 6,400 health care practitioners have authorized patient access; under the former MMAR regime (2001-2014) 7,116 physicians supported patient access On average, health care practitioner authorizations increase at a rate of 7% per month Health Canada s summary of peer-reviewed evidence in the Information for Health Care Professionals: Cannabis (marihuana, marijuana) and the cannabinoids, 2013 is in the process of being updated Health Canada is developing a Request for Proposals (RFP) to design Continuing Medical Education (CME) on Marijuana for Medical Purposes RFP is scheduled to be launched in summer 2016 9
Adverse Reactions Hanan Abramovici
Adverse Reaction Reporting - Current status Health Canada collecting Adverse Reaction (AR) reports through the Canada Vigilance Program Spontaneous reporting program for suspected adverse reactions Collects mandatory reports from industry; voluntary reports from HCP and consumers The total number of ARs for a health product cannot be estimated, nor can the numbers of ARs for one health product be compared with those of another, because the number of people using a health product is not known, and not all ARs are reported Caution around data interpretation and causality Monthly line-listings for AR reports sent from Marketed Health Products Directorate (MHPD) to Office of Medical Cannabis (OMC) OMC reviews AR report Compares info in report to Health Canada s cannabis monograph, literature OMC takes action as required 11
Update January 01 2014 April 27 2016 129 Adverse Event Reports (AERs) (serious + non-serious) 105 serious reports 24 non-serious reports 449 AE occurrences in total 5 deaths (from non-medical use) Likely not related to marijuana use only Principally associated with polysubstance abuse (i.e. opioids, depressants) 3 life-threatening 2 unclear if used for medical or non-medical purposes, other false report 12 hospitalizations 10/12 associated with unclear, possible, or confirmed use for medical purposes 94 reports associated with non-medical use 325 AE occurrences 35 reports associated with possible or confirmed use for medical purposes 124 AE occurrences 12
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Current Issues
Updated Daily Amount Fact Sheet In April 2016, the Office of Medical Cannabis released an updated version of the daily Amount Fact Sheet Fact sheet now includes information on cannabis oil, including a section on the Equivalency Factor that the licensed producer must apply to determine the amount of oil is equivalent to one gram of dried marijuana Includes a section on the onset, peak, and duration of effects depending on how the product was administered Includes references to dosing amounts based on recent studies Includes a section on reporting adverse reactions to Health Canada 16
Health Canada s Stakeholder Registry Health Canada wants to know who you are, how to get a hold of you, and what topics you are interested in being consulted on A web-based, centralized information management system for stakeholders and public engagement activities Created to improve the openness and transparency of stakeholder engagement and consultations and allow Canadians to have a stronger say in our departmental/agency priorities and policies Identify the areas in which you want to be consulted, as well as in the level of interaction you wish to have Register online at: http://www.hcsc.gc.ca/ahc-asc/publicconsult/stakeholder-intervenants/indexeng.php 17
Current Issues AG Report on VAC, legalization Auditor General Report on Veterans Affairs Canada On May 3, 2016 the Auditor General released a report on the Department of Veterans Affairs drug benefit program. This report makes a number of recommendations regarding VAC s policy pertaining to reimbursement for marijuana for medical purposes. Impending Legalization The Government of Canada is committed to legalizing, regulating and tightly restricting access to marijuana in order to keep it away from children and to stop criminals from profiting from the illicit trade In the short term, a Task Force will be launched to study every aspect of legalization, and to advise on the design of a new legalized system. Experts, provincial and territorial governments and the public will have an opportunity to provide input. The Government has committed to introducing legislation in Spring 2017 18
Current Issues: New Regulations On March 24, 2016, the Minister of Health confirmed that the Government of Canada would propose changes to the Marihuana for Medical Purposes Regulations (MMPR) to respond to the Federal Court s judgment in Allard v. Canada The Government has until August 24, 2016 to address the limits to reasonable access to marijuana for medical purposes identified by the Federal Court 19