Canada Announces New Regulations for Medical Marijuana
OTTAWA, ONTARIO–(Marketwired – June 10, 2013) – Today, the Honourable Leona Aglukkaq, Minister of Health, announced new regulations that will change the way Canadians access marihuana for medical purposes. The new Marihuana for Medical Purposes Regulations (MMPR) will be published in the Canada Gazette, Part II, on June 19, 2013
“While the courts have said that there must be reasonable access to a legal source of marihuana for medical purposes, we believe that this must be done in a controlled fashion in order to protect public safety,” said Minister Aglukkaq. “These changes will strengthen the safety of Canadian communities, while making sure patients can access what they need to treat serious illnesses.”
Since its introduction in 2001, Health Canada’s Marihuana Medical Access Program (MMAP) has grown exponentially, from under 500 authorized persons to over 30,000 today. This rapid increase has had unintended consequences for public health, safety and security as a result of allowing individuals to produce marihuana in their homes. Under the new regulations, production will no longer take place in homes and municipal zoning laws will need to be respected, which will further enhance public safety.
The new Marihuana for Medical Purposes Regulations aim to treat marihuana as much as possible like other narcotics used for medical purposes. The regulations will provide access to quality-controlled marihuana for medical purposes, produced under secure and sanitary conditions, to those Canadians who need it.
The regulations will also streamline the process for applicants and health care practitioners. Under the new regime, individuals will not be required to provide personal medical information to Health Canada. Health care practitioners will be able to sign a medical document enabling patients to purchase the appropriate amount related to their conditions directly from a Licensed Producer approved by Health Canada.
In order to facilitate the transition from the current program to the new regime, both will operate concurrently until March 31, 2014. Effective April 1, 2014, Health Canada will no longer produce and distribute marihuana for medical purposes. The current Marihuana Medical Access Regulations (MMAR) will be repealed on March 31, 2014, when the new regime is fully implemented. Additional information on key dates will be provided to program participants and other stakeholders throughout the transition period.
Following broad consultations with stakeholders, the Government of Canada was concerned that the Marihuana Medical Access Program (MMAP) was open to abuse.
The MMPR represent a comprehensive response to a number of concerns raised over the past years and during the public comment period following the introduction of the draft regulations in December 2012.
The regulations aim to treat marihuana as much as possible like any other narcotic used for medical purposes by creating conditions for a new, commercial industry that is responsible for its production and distribution. The regulations will provide access to quality-controlled marihuana for medical purposes, produced under secure and sanitary conditions, to those Canadians who need it, while strengthening the safety of Canadian communities. In addition, the new regulations will also provide more choices of marihuana strains and commercial suppliers.
Under the new regulations:
-- the process for applicants and health care practitioners will be
streamlined, eliminating the need for individuals to provide Health
Canada with their personal information or apply to the department for an
Authorization to Possess;
-- personal and designated production by individuals in their homes will be
eliminated on March 31, 2014;
-- current options to access marihuana for medical purposes will be replaced
by regulated, commercial Licensed Producers who will be able to produce a
variety of strains, thereby offering more choice to individuals who use
marihuana for medical purposes;
-- Licensed Producers will have to demonstrate compliance with regulatory
requirements such as quality control standards, record-keeping of all
activities as well as inventories of marihuana, and physical security
measures to protect against potential diversion;
-- Licensed Producers will distribute marihuana for medical purposes to the
registered client via secure courier;
-- storefronts or retail outlets will not be permitted; and,
-- for the first time, nurse practitioners will be able to support access to
dried marihuana for medical purposes, if permitted within their
respective province or territory.
Under the new regulations, licensed producers will have to meet extensive security and quality control requirements. For example, when potential licensed producers apply to Health Canada for a license, they must demonstrate that:
-- They employ a quality assurance person with appropriate training,
experience and technical knowledge to approve the quality of their dried
marihuana;
-- Their production site is indoors, and not in a private dwelling. This
would reduce the risk of diversion posted by outdoor production and would
reduce health and safety risks associated with producing marihuana in a
private dwelling;
-- The production site includes restricted-access areas, which would include
all areas where a licensed activity is conducted with marihuana and
cannabis other than marihuana (i.e. lab, production room, etc);
-- Access to the production site is controlled at all times and includes
24/7 visual monitoring systems and an intrusion detection system to
detect unauthorized access;
-- Key personnel hold a valid security clearance, issued by the Minister of
Health; and,
-- They have provided a written notification of their application, providing
details regarding the location of the production site, to the local
police force, local fire authority and local government.
Health care practitioners will sign a medical document enabling patients to purchase the appropriate amount for their medical condition from a Licensed Producer approved by Health Canada.
To help health care practitioners, Health Canada has updated and will soon publish the “Information for Health Care Professionals – Cannabis (marihuana, marijuana) and the cannabinoids” on its web site. The document will present a summary of the peer-reviewed scientific and medical literature concerning potential therapeutic uses and harmful effects of cannabis (marihuana) and cannabinoids.
In order to facilitate the transition from the MMAP to the new regime, both will operate concurrently until March 31, 2014. Program participants can continue to produce marihuana for medical purposes, designate someone to produce for them, or purchase it from Health Canada until that date.
Effective October 1, 2013, new applications for personal or designated production licences will no longer be accepted by Health Canada. At any time during the transition period, individuals can move from their current means of accessing marihuana for medical purposes to purchasing it from Licensed Producers under the new regime.
The current program costs Canadian taxpayers millions of dollars each year because the $5/gram charged to program participants who choose to purchase from Health Canada is heavily subsidized. Under the new regime, Licensed Producers will set the price for marihuana for medical purposes. Once the first established Licensed Producers have set a price for dried marihuana, Health Canada will align the price of its supply with the market price so as not to undermine the creation of this new industry.
Transitioning to the New System
The Government of Canada has introduced new regulations that will change the way Canadians access marihuana for medical purposes. The new Marihuana for Medical Purposes Regulations (MMPR) will be published in Canada Gazette, Part II, on June 19, 2013. The current Marihuana Medical Access Regulations (MMAR) will be repealed on March 31, 2014. During this transition period, both regulations will be in force. Below are some key dates during the transition period.
June 19, 2013
-- The Application Form to Become a Licensed Producer, Guidance Document for
Applications to Become a Licensed Producer, and Security Clearance
Application Form for parties interested in applying to become a Licensed
Producer of marihuana for medical purposes will be posted to the Health
Canada website.
-- Additional information such as guidance documents on product quality and
security requirements will also be posted to help Licensed Producers
comply with the MMPR.
June 19, 2013 – March 31, 2014
-- During the transition period, individuals who have the support of their
health care practitioner have the choice of:
-- Continuing to access dried marihuana through the Marihuana Medical
Access Program (MMAP) until March 31, 2014;
-- Registering with, and ordering directly from, an available
Licensed Producer under the new regime; or,
-- Applying under the MMAP and transferring to the new regime by
March 31, 2014.
October 1, 2013
-- New applications for personal-use and designated-person production
licences, and applications to change the location of a production site or
the number of plants are no longer accepted by Health Canada. However,
Health Canada will continue to renew personal-use and designated-person
production licences under the MMAP.
-- New applicants to the current program will either have to obtain dried
marihuana from Health Canada, or go directly to an approved Licensed
Producer.
-- Individuals who obtain support from their health care practitioner by
means of a medical document under the new system can only obtain their
supply of dried marihuana from a Licensed Producer.
March 31, 2014
-- The MMAR are repealed and the MMAP ends.
-- All Authorizations to Possess (ATP), Personal-Use Production Licenses
(PUPL) or Designated-Person Production Licences (DPPL) expire.
April 1, 2014
-- Health Canada will no longer sell and distribute marihuana for medical
purposes.
-- Personal and designated production is no longer permitted. All PUPL or
DPPL holders must safely dispose of all dried marihuana and marihuana
plants.
-- The only legal source to obtain marihuana for medical purposes for
Canadians is from Licensed Producers under the new regime.
-- ATPs issued under the MMAR cannot be used by an individual as a valid
authorization to possess dried marihuana for medical purposes.
-- ATPs are valid for registration with a Licensed Producer until the
validity date (the latest date specified on the document).
For a copy of the new regulations in advance of the June 19 publication date, please email: mmap-pamm@hc-sc.gc.ca.
Media Inquiries:
Health Canada
613-957-2983
Cailin Rogers
Office of the Honourable Leona Aglukkaq
Federal Minister of Health
(613) 957-0200
Public Inquiries:
613-957-2991
1-866-225-0709
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(Canada Announces New Regulations for Medical Marijuana)