Marihuana for Medical Purposes Regulations. October 16, 2014

Transcription

1 Marihuana for Medical Purposes Regulations October 16, 2014

2 Overview Provide an overview of the evolution of marihuana for medical purposes regulations in Canada Status of the old program/ Allard Injunction Describe the key elements of the new Marihuana for Medical Purposes Regulations (MMPR) Update on Role of Healthcare Practitioners, Daily Authorized Amounts, Information Sharing Regulations 2

3 Background Since 2001, Health Canada had operated a program to provide court mandated access to marihuana Health Canada selling directly to Canadians Home production in approximately 30,000 sites High average physician-authorized daily doses (18g) and number of plants (91) per licence This program was open to abuse leading to strong public health and safety concerns from law enforcement, fire and other municipal authorities Following extensive consultations, in June 2013, new regulations to address public safety issues came into force Health Canada regulates licensed producers, including rigorous security checks, inspection and compliance and enforcement Commercial licensed producers responsible for all aspects of production and distribution Clients continue to require the authorization of a health professional to access marihuana The regulations governing the old program were repealed on March 31,

4 Status of the Old Program The Marihuana Medical Access Regulations (MMAR) were repealed on March 31, 2014 Allard injunction: Federal Court interim injunction March 21, 2014 People previously authorized to possess and grow marihuana under MMAR, who meet the terms of the Court order, may continue on an interim basis until the Court issues a final decision Authorization to Possess valid on March 21, 2014 Personal-Use Production License or Designated-Person Production License on, or after, September 30, 2013 (plus an associated valid ATP as of March 21, 2014) The Government of Canada is appealing the order 4

5 Overview of the New Regulations New regulations treat marihuana, as much as possible, like other narcotics used for medical purposes by: Eliminating risky production of marihuana by individuals in their homes Ending Health Canada's role in authorizing individuals to possess and produce marihuana and in supplying and distributing marijuana Creating conditions for the establishment of a regulated commercial market of licensed producers responsible for the production and distribution of marihuana for medical purposes Patients would obtain a medical document, similar to a prescription, and purchase marihuana directly from a licensed producer Individuals would be able to obtain a medical document from a licensed medical practitioner, or, if permitted by provincial or territorial governments, from a nurse practitioner 5

6 Old Program vs New Program Old Program New Program Support for Access Physician Physician or nurse practitioner* Authorization Application to Health Canada Registration with Licensed Producer Production Distribution Health Canada Role 1) Purchase from Health Canada 2) Personal use production 3) Designated-person production Health Canada supply sent through secure courier; designated producer could distribute in person or by mail Authorized and licensed individuals with medical support; administered production contract Licensed Producer only Licensed Producer (secure direct delivery) Regulate licensed producers, including licensing, audit and inspection * If authorized by individual provinces and territories 6

7 Status of New Program Currently, there are 22 licensed producers, serving 10,858 registered clients. The regulations do not specify a maximum number of licensed producers As of August 31, 2014: 725 physicians (1% of 74,800) authorized patient access to marihuana in August A total of 7,116 physicians (9.5%) had ever supported the old regime P/T medical colleges have issued prescriber guidelines in BC, AB, SK, MB, QC, NB, NL, NS, PE Sufficient supply to meet current demand in August: 1,417 kg in inventory; 874 kg produced; 194 kg sold Currently-approved licensed producers are collectively licensed to produce 45,000 kg/year or 3,750 kg/month Less than 1,000 kg sold since the MMPR came into force in June Average authorizations: 3.8 g/day; shipped amount (daily consumption ): 1.1 g/day In contrast, under old program average authorization was 17.7 g/day 7

8 Licensed Producers As of August 27, 2014 Province Number of LPs British Columbia 6 Saskatchewan 2 Ontario 11 Manitoba 1 Quebec 1 New Brunswick 1 TOTAL 22 8

9 Key Features of the MMPR Personnel Security Enhanced clearance for key staff to reduce risk of criminal activity Physical Security Strengthening the safety of Canadian communities Licensing & Inspection Regular audits and inspections to verify compliance Production Standards Providing access to quality controlled marihuana Objectives - Reasonable Access - Public Health - Public Safety Record Keeping LPs required to track all activities with marihuana Anti-Diversion Source of starting material & possession limits regulated reduce the risk of diversion to the illicit market Notice to Local Authorities Know where production sites are located in communities Medical Documentation Support from practitioner in a simplified format 9

10 Licensed Producers Activities and Requirements Produce and sell dried marihuana only Indoors and not in a dwelling place Local authorities must be notified on application, issuance, renewal, amendment, suspension, reinstatement or revocation of the licence Notifications must: Be addressed to a senior official of the local authority (municipality, fire and law enforcement) Specify the activities, address of the site 10

11 Licensed Producers Interaction with Municipal Bylaws Comply with all federal, provincial and municipal laws and bylaws, including municipal zoning bylaws Municipality s responsibility to conduct relevant inspections for compliance with bylaws such as zoning MMPR does not include zoning requirements Municipalities with viable applicant(s) are contacted by Health Canada to confirm they received notification from the potential licensed producer(s) 11

12 Licensed Producers Personnel Security Required for key personnel and alternates, officers and directors of corporation: Background checks for links with individuals or organizations that pose an unacceptable risk, including risk of diversion to illicit market or use Research undertaken by RCMP, clearance issued by Health Canada Validity period is 5 years and in accordance with level of risk posed Clearance can be suspended or cancelled by Health Canada 12

13 Licensed Producers Physical Security Measures Demonstrate security requirements: Visual monitoring 24/7 to detect attempted or unauthorized access Intrusion detection system operating 24/7 and monitored by personnel Record kept for every person entering and exiting restricted areas Air filtration system to prevent escape of pollen and odours Licensed producers are subject to audits and inspections by Health Canada to verify compliance with the MMPR 13

14 Inspection Pre-licence inspection Compliance & Enforcement Regime of the MMPR Compliance inspections Increased number of dedicated inspections within the first year to establish a C&E regime Non-compliance calls for corrective action plan If non-compliance persists, immediate action may be taken including seizure of product, suspension, or revocation of licence To help ensure decreased opportunity for diversion to illicit market or use Reporting Licensed producers submit a detailed report, initially on a monthly basis Information analysed and fed into ongoing C&E planning 14

15 Packaging Packaging and Shipping Not more than 30g of dried marihuana in the immediate container Child-resistant Tamper evident Shipping o Assurance to consumers that the container has not been opened prior to receipt Direct shipping of dried marihuana to registered client Must be traceable during transport (e.g. chain of signature) Secure packaging to avoid identification of contents (i.e. no smell, no release of content) No more than 150g per shipment 15

16 Possession of Dried Marihuana and Cannabis The MMPR authorize possession of: Dried marihuana by a person who has obtained it from a licensed producer, a healthcare practitioner or a hospital, provided it is the lesser of: o 30 x daily amount supported by their practitioner, or o 150 g Dried marihuana by a healthcare practitioner or hospital employee in the context of their employment Cannabis by licensed producers or licensed dealers o Plants, dried marihuana, chemical preparations such as THC (for analytical testing) It is prohibited to seek or obtain dried marihuana from more than one source at a time from the same medical document Proof of legal possession Client label and/or separate document provided by the licensed producer 16

17 Role of Healthcare Practitioners MMPR The responsibility to assess a patient and decide on an appropriate treatment continues to rest with healthcare practitioners The information that the physicians must provide under the MMPR is: Patient's given name, surname and date of birth Daily quantity of dried marihuana to be used by the patient Healthcare practitioner's given name, surname and profession Healthcare practitioner's business address and address of the location at which the patient consulted the health care practitioner (if different ) Phone number of the healthcare practitioner Province(s) authorized to practice in Healthcare practitioner's licence number Support from an additional specialist is no longer required, instead, it is at the discretion of the healthcare practitioner 17

18 Daily Authorized Amount Marihuana is not an approved drug or medicine in Canada and has not gone through the necessary rigorous scientific trials to establish efficacy or safety There are concerns around the use of marihuana as a treatment, including the limited clinical information available, the lack of dosage guidelines, and lack of information on adverse effects associated with the use of marihuana for medical purposes Health Canada's examination of the current available information suggests most individuals use up to 3 grams of dried marihuana daily for medical purposes, whether it is taken orally, or inhaled or a combination of both 18

19 Commitment to Improve Information- Sharing The medical community has asked that Health Canada work with them and improve information sharing Minister of Health directed Health Canada to work with licensed producers of marihuana to enhance information-sharing with healthcare licensing authorities on how doctors and nurse practitioners are supporting the use of marihuana Amendments to the MMPR are in development to provide provincial and territorial healthcare licensing authorities with the same information available in the best prescription monitoring program models 19

20 For More Information on the MMPR Marihuana for Medical Purposes Regulations Frequently Asked Questions Information for Health Care Professionals Sample Medical Document for the Marihuana for Medical Purposes Regulations 20

21 Questions?