Canada: The first two patients got governmental approval to use
marijuana -- Research plan for clinical studies and cultivation of
cannabis
The federal government has given permission for the cultivation
and use of marijuana for medical purposes for the first time in
Canadian history to two patients, Jim Wakeford of Toronto and
Jean-Charles Pariseau of Vanier, both of whom have AIDS.
In a press release of 9 June Health Minister Allan Rock
announced that "he has exercised his authority under Section 56
of the Controlled Drugs and Substances Act and has granted two
individuals exemptions for the possession and cultivation of
marijuana for medical purposes." He tabled, in the House of
Commons, a status report entitled Health Canada's Research Plan
for the Use of Marijuana for Medicinal Purposes.
The plan includes the possibility to apply for further approvals
under Section 56 of the Controlled Drugs and Substances Act.
The Department will review each application within 15 working
days of receiving all the necessary information. On 6 May Health
Canada released an Interim Guidance Document that outlines the
information to be provided by applicants seeking an exemption.
Rock said he has received 30 applications from individuals wishing
to use marijuana for medical purposes.
There are three components of the research plan relating to
clinical trials:
1. Funds have been committed to The Community Research
Initiative of Toronto in association with the Canadian HIV Trials
Network to conduct short-term clinical trials in which marijuana is
smoked. Health Canada will be working with Canadian
researchers to obtain access to research-grade marijuana
cigarettes from U.S. National Institute of Drug Abuse (NIDA).
2. The Medical Research Council of Canada will receive funding
to sponsor a variety of research activities, including clinical trials
pertaining to marijuana, marijuana extracts and related products.
Requests for proposals will be posted later in June with research
proposals due by September 15.
3. Health Canada is negotiating with GW Pharmaceuticals from
the United Kingdom to develop clinical trials using a non-smoked
form of marijuana (using an inhalation device). These trials would
be undertaken in Canada using the research grade product being
developed.
In addition to moving forward on the development of clinical trials,
Health Canada is developing a business plan for the creation of a
government-approved domestic source of supply of research-
grade marijuana in Canada.
(Sources: Press release of Allan Rock, Canadian Health Minister,
of 9 June 1999)
