HTTP/1.0 200 OK Content-Type: text/html Minister Rock Announces Intention To Develop New
Pubdate: Thu, 14 Sep 2000
Source: Health Canada
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releases. Below the press release is a fact sheet from the website.
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News Release


OTTAWA - Health Minister Allan Rock today announced Health Canada's 
intention to develop a new regulatory approach for Canadians to access 
marihuana for medical purposes. This will address some of the issues 
relating to transparency of the process and a clear definition of medical 
necessity that stemmed from the decision by the Court of Appeal for Ontario 
in the case of R. v. Parker, rendered on July 31, 2000. The new regulatory 
approach will define the circumstances, and the manner in which the use of 
marihuana for medical purposes will be authorized.

"We want to bring greater clarity to the process for those Canadians who 
may request the use of this drug to alleviate symptoms. We want to do so in 
recognition of a need for a more defined process for those in pain and 
suffering," said Minister Rock.

The matter of an appeal on the narrow legal issues raised by the Parker 
decision is still under consideration. Whether or not leave to appeal the 
case is sought, the move to establish this new regulatory approach will go 

Until the new regulatory approach is in place, Canadians can continue to 
apply for an exemption for medical purposes under Section 56 of the 
Controlled Drugs and Substances Act with the support of their medical 
practitioner. An interim guidance document and application form are 
available online. To date, 71 Canadians have received exemptions.

Consultation is a vital part of the process in determining how to deal with 
regulatory issues. Issues raised by key stakeholders will be considered as 
the regulatory process is developed.

To date, marihuana is not approved as a drug in any country in the world. 
Health Canada is funding research activities which will lead to the 
scientific data necessary to evaluate the safety and effectiveness of 
marihuana for medical purposes in the future.

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Media inquiries: Roslyn Tremblay, Health Canada (613) 957-1588
Public inquiries: (613) 957-2991

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New Regulatory Approach

Why is Health Canada developing a new regulatory approach now?

On July 31, 2000, the Court of Appeal for Ontario rendered its decision in 
the case of Terrance Parker who uses marihuana to help control his 
epilepsy. The Court dealt exclusively with the issue of medical use of 
marihuana. In a companion case, the same Court concluded that Parliament 
can validly prohibit marihuana where used for recreational purposes.The 
Court upheld a 1997 lower court decision to stay the charges against Mr. 
Parker on constitutional grounds and raised issues related to the section 
56 process, such as the broad discretion given by the law to the Minister 
of Health to grant exemptions, transparency of the process and what 
constitutes medical necessity. As a result, the Court declared the 
prohibition on the possession of marihuana in the Controlled Drugs and 
Substances Act (CDSA) to be unconstitutional and of no force and effect. 
The declaration of invalidity was suspended for a year, however, to avoid 
leaving a gap in the regulatory scheme.

Will the Government of Canada appeal the decision of R. v. Parker?

The decision on whether or not to appeal lies with the Attorney General of 
Canada. September 29, 2000 is the deadline to file a motion seeking leave 
to appeal to the Supreme Court of Canada.

It is important not to confuse the issues. The possible need to seek leave 
to appeal on the narrow legal issues that do not relate directly to the 
medical use of marihuana does not detract from the Government's commitment 
to create a framework that will support those who need marihuana for 
medical purposes. The announcement today relates to the creation of such an 
approach irrespective of whether an appeal has to be launched or not.

Will concerns from key stakeholders be considered?

When making the regulatory changes, Health Canada has and will continue to 
take into account concerns raised by key stakeholders such as health care 
providers, pharmacists, hospitals, provincial licensing authorities, care 
givers, law enforcement officials and their agencies, addiction agencies, 
and those using the drug for medical purposes.

When will the new regulatory approach be in place and what is the process 
for amending or developing regulations?

Health Canada intends to have the new regulatory approach in place by July 
31, 2001. Key steps in developing or amending regulations include:

New draft regulations are prepared based on the policy developed (which 
takes into account issues and concerns raised by key stakeholders).

Once approved by the Governor in Council, the draft regulations are 
published in the Canada Gazette Part I and comments from the public are 

The regulations are amended where appropriate and re-submitted to the 
Governor in Council for approval and publication in Canada Gazette Part II.

The new regulations take effect on the date specified in the regulations or 
on the date of registration.

Is this the first step towards the legalization of marihuana?

No. The regulatory approach centers around the process of providing access 
to marihuana for medical purposes. Marihuana still remains an illegal drug 
in Canada.

How does this verdict affect other provinces and territories?

This verdict only applies to Ontario. However, the new regulatory approach 
developed by Health Canada will apply to individuals in all provinces.

The Current Process For Marihuana For Medical Purposes

How can Canadians access marihuana for medical purposes?

Currently and until the new regulatory approach is in place, individuals 
who wish to use marihuana for medical purposes can still apply under 
section 56 of the CDSA to obtain an exemption.

What is section 56 of the Controlled Drugs and Substances Act (CDSA)?

Section 56 of the CDSA gives the Minister of Health the authority to grant 
exemptions if, in the opinion of the Minister, such an exemption is 
necessary for a medical or scientific purpose or is otherwise in the public 
interest. Such an exemption permits certain activities that are otherwise 
prohibited by the Act or its Regulations (e.g. the cultivation and 
possession of marihuana).

How does an individual apply for an exemption to use marihuana for a 
medical purpose?

An application for an exemption must be submitted in writing to the 
Minister of Health and specify the activity for which the exemption is 
sought. A statement from the treating physician in support of the 
application along with details on the patient's medical and drug therapy 
histories must also be included with the application. An interim guidance 
document and application form are available online.

How are applications reviewed?

Because the circumstances of each applicant are unique, applications are 
reviewed on a case-by-case basis. The review takes into consideration the 
medical necessity of the applicant.

How does the R. v. Parker verdict affect current exemptees?

Exemptions granted under the CDSA remain valid. The Court suspended its 
declaration of invalidity with respect to the possession of marihuana. As 
the marihuana prohibition remains in full force and effect, exemptees 
should continue to carry their letters of exemption with them at all times.

Clinical Trials and Canadian Supply

Is marihuana a safe and effective drug?

Marihuana is not approved as a drug in any country in the world. Health 
Canada is sponsoring a variety of research activities to evaluate the 
safety and efficacy of smoked marihuana and of cannabinoids. In this 
regard, a request for proposal (RFP) was jointly developed by Health Canada 
and the Canadian Institutes of Health Research. This research is expected 
to span five years.

Where will the marihuana come from for the research?

Health Canada recognizes the need for standardized quality marihuana for 
research purposes from a Canadian legal supplier. Through Public Works and 
Government Services Canada (PWGSC), a request for proposal (RFP) was 
released on May 5, 2000. The RFP looks to establish a Canadian source of 
quality, standardized, affordable, research-grade marihuana. The 
requirement for this source was originally outlined in Health Canada's 
Research Plan for Marijuana for Medical Purposes, released June 9, 1999.

A number of proposals were received by the closing date of June 28, 2000 
and Health Canada is aiming to have the five-year contract in place by the 
fall of 2000.

Who will be receiving the marihuana from the legal supplier?

The RFP was designed to produce quality, standardized, affordable, 
research-grade marihuana to be used for scientific research in Canada. 
Therefore, the marihuana will be made available to qualified, approved 
scientists for research.

How soon will the marihuana be made available to the eligible 
recipients/participants in the research projects?

The first production quantities should be made available for qualified 
research projects within one year after awarding the contract, as 
stipulated in the RFP.

Why can't marihuana that is seized by law enforcement be used for research 

As the source and quality of the drug is seldom known, the risks to humans 
cannot be easily evaluated. There is uncertainty about contaminants such as 
herbicides and pesticides which could be detrimental to health. In 
addition, the Commission of Narcotic Drugs General Assembly has adopted a 
resolution to encourage countries, including Canada, to refrain from 
supplying confiscated drugs for any purpose.

Who can I contact for more information?

More information on marihuana for medical purposes is available online, or 
by calling (613) 954-6540. 
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MAP posted-by: Richard Lake