On August 11, 2016, Health Canada announced the Access to
Cannabis for Medical Purposes Regulations (ACMPR), replacing
the Marihuana for Medical Purposes Regulations (MMPR) as
the regulations governing Canada's medical cannabis program.
The new regulations will come into force August 24, 2016 and seek
to address the issues raised by the Federal Court in Allard v.
Canada (2016 FC 236) by allowing for reasonable access to
cannabis for medical purposes for Canadians who have been
authorized for such use by their health care practitioner.
Why Replace the MMPR?
The Federal government introduced the MMPR in April 2014 with
the stated goal of creating a regulated, commercial, medical
marihuana industry. Through the enactment of the MMPR, the Federal
government sought to repeal all existing Authorizations to Possess,
Personal-Use Production Licenses and Designated-Person Production
Licenses and instead require that all medical marihuana users
purchase their marihuana from authorized, large-scale
The Federal Court ruled the MMPR unconstitutional in
Allard and gave the Federal government six months to
redraft regulations governing Canada's medical cannabis
program. The decision centred on the fact that under the MMPR
scheme, the quantity, strain or quality of marihuana could not be
guaranteed at an acceptable price compared to the personal
production options that were being repealed by the MMPR. As a
result, some individuals could lose access to their medical
marihuana supply or be forced to break the law by continuing to
produce their own. The Court found this to be an infringement of
medical marihuana users' section 7 Charter rights and
a violation of our principles of fundamental justice.
What Has Changed Under the ACMPR?
Under the ACMPR, Canadians who have been authorized by their
health care practitioner to access cannabis for medical purposes
will be able to produce a limited amount of cannabis for their own
medical purposes, or designate someone to produce it for them.
Persons wishing to do so will need to register with Health Canada
in addition to receiving authorization from their health care
practitioner. Further details regarding this process will be
released August 24, 2016. They will also be able to continue
purchasing cannabis from one of the producers licensed by Health
How Will the ACMPR Affect Licensed Producers?
The 34 licensed producers across Canada are expected to continue
to be the main source of cannabis for medical purposes. The
licensed producers will now also be the only legal source of
starting materials (seeds or plants) and interim supply to
individuals who are registered with Health Canada to produce, or
designate someone to produce for them, a limited amount of cannabis
for their own purposes.
Do the New Regulations Allow for Storefront Operations?
No, storefront operations selling marihuana — commonly
known as "dispensaries" and "compassion clubs"
— are not authorized to sell cannabis for medical or any
other purpose. These operations that sell, supply or distribute
marihuana remain illegal and subject to law enforcement action.
What Does the Future Hold?
These regulations are meant only to provide an immediate
solution to the issues raised by the Court in Allard and
should not be interpreted as the long-term strategy for the
regulation of access to medical marihuana. The Government is
continuing to review and develop their long-term strategy with
respect to medical marihuana and, as a result, many questions
relating to the industry remain.
Participants in the medical marihuana industry—or those
that may be interested in becoming participants in the industry
— should continue to pay close attention to how these
regulations are implemented and interpreted moving forward.
On June 30, 2016, the Minister of Justice and Attorney General of Canada, the Minister of Public Safety and Emergency Preparedness, and the Minister of Health announced the creation of a nine-member Task Force on Cannabis Legalization and Regulation (the "Task Force").
Pharma in Brief reported on many legal and regulatory developments of interest to the pharmaceutical industry in 2016. Looking back on 2016 as the new year begins, we have compiled our list of the past year's top headlines below. These include, in no particular order, key developments that affect the pharmaceutical industry and we will continue to monitor in 2017.
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