Chapter 13

Regulating Therapeutic Use of Cannabis

As discussed in Chapter 9, cannabis has an extremely long history of therapeutic use, going back several thousands of years. It was often used for the same medical conditions it is used for today. With the development of the pharmaceutical industry in the last century, the medical community has gradually discontinued its use. Various factors may explain this. Developments in the pharmaceutical industry provided the medical community with more stable and better tested medication. The practice of medicine itself has changed and so has our conception of health. Then, at the turn of the 20^th century, the plants from which opium, cocaine and cannabis are derived were banned by the international community, except for medical and scientific purposes. In the case of cannabis, no rigorous study had been done, until recently.

Further to the social rediscovery of cannabis and the identification of its molecular composition and chemical elements in the 1960s, renewed interest in the therapeutic applications of cannabis grew in the early 1970s. More people began using the plant for its therapeutic benefits and many demanded a relaxation of the prohibitionist rules governing cannabis.

Because its safety and effectiveness have yet to be reviewed in clinical trials, cannabis has not been approved for sale in Canada as a medical product.[1][1] Despite this lack of approval, many use cannabis for its therapeutic purposes without legal authorization. In addition, because of the many claims regarding its therapeutic benefit, a growing number of people have called for a less restrictive approach and are demanding access to cannabis for people who could benefit from its use.

This chapter reviews the events that prompted the recent enactment of the Marihuana Medical Access Regulations. One of the objectives of the regulations is to provide a compassionate framework of access to marijuana for seriously ill Canadians while research regarding its therapeutic application continues. Also discussed is the implementation of these regulations, which came into force on 30 July 2001.

Background to the recent regulations

Section 56 – Controlled Drugs and Substances Act

The Controlled Drugs and Substances Act [2][2] (CDSA) prohibits a series of activities relating to psychoactive substances, including: possession; cultivation; trafficking; possession for the purposes of trafficking; importation; and exportation. These activities are illegal unless authorized by regulations made under the CDSA. For example, the Narcotic Control Regulations regulate the legal distribution of narcotic drugs.[3][3] In addition, before a drug may be marketed in Canada, it must be approved for sale under the Food and Drugs Act[4][4] (FDA) and its regulations. The regulations under that Act set out controls dealing with, among others, the safety, efficacy and quality of therapeutic products. To market marijuana as a drug in Canada, a sponsor would have to file a “New Drug Submission” with the Therapeutic Products Programme of Health Canada. Submitted data would be evaluated to assess the potential benefits and risks of the drug before the drug would be approved for sale.

Other mechanisms authorize certain otherwise prohibited activities. Pursuant to section 56 of the CDSA, the Minister of Health is authorized to grant exemptions if, in his or her opinion, such an exemption is necessary for a medical or scientific purpose or is otherwise in the public interest. Thus, any person or class of persons may be exempted from the application of all or any of the provisions of the CDSA in these specified circumstances. These circumstances include both the cultivation and possession of marijuana, activities that are otherwise prohibited by the legislation.

In response to the growing demand for access to cannabis for therapeutic purposes and to Charter challenges in relation to therapeutic use, Health Canada published an Interim Guidance Document in May 1999. This document set out a process enabling Canadians to apply for an exemption to possess and cultivate marijuana for therapeutic purposes under the authority provided in section 56 of the CDSA. Applicants were required to demonstrate that the exemption was necessary for such purposes and required a statement from a physician in support of the application, along with details of their  medical and drug therapy histories. Health Canada reviewed the applications on a case-by-case basis, taking into account the medical necessity of the applicant. The first exemption was issued in June 1999. As of 3 May 2002, 658 exemptions had been granted under the authority of section 56, and 501 were still active. With respect to the other 157 persons with exemptions, some are now authorized to possess the substance under the recently enacted Marihuana Medical Access Regulations and others may no longer need marijuana for therapeutic purposes. Under this process, persons with exemptions were required to limit their cultivation to the quantity specified in their exemption letter.[5][5]

In February 2000, as part of a commitment to public consultation in relation to the section 56 exemption program, a multi-stakeholder consultation workshop was held. The participants[6][6] identified the following issues as priorities:  

vv     Obtaining a legal source of marijuana for persons exempted under section 56;

vv     Exemptions for caregivers;

vv     Addressing the need for more information on the use of marijuana for medical purposes;

vv     Addressing concerns of law enforcement agencies;

vv     Improvement of the process and tools for section 56 applications; and

vv     Communications regarding the section 56 process and Health Canada’s activities regarding marijuana for medical purposes.[7][7]

The information gathered at these consultations was later used for the development of the Marihuana Medical Access Regulations.