Vol. 137, No. 15 — July 16, 2003

Registration
SOR/2003-261 8 July, 2003

FOOD AND DRUGS ACT

Marihuana Exemption (Food and Drugs Act) Regulations

P.C. 2003-1047 8 July, 2003

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to paragraph 30(1)(j) of the Food and Drugs Act, hereby makes the annexed Marihuana Exemption (Food and Drugs Act) Regulations.

MARIHUANA EXEMPTION (FOOD AND DRUGS ACT) REGULATIONS

DEFINITION

1. In these Regulations, "marihuana" means the substance referred to as "Cannabis (marihuana)" in subitem 1(2) of Schedule II to the Controlled Drugs and Substances Act other than marihuana sold or imported to be used for the purpose of a clinical trial, as that term is defined in section C.05.001 of the Food and Drug Regulations, involving human subjects.

EXEMPTION

2. Marihuana produced under contract with Her Majesty in right of Canada is exempt from the application of the Food and Drugs Act and the regulations made under it, other than these Regulations.

COMING INTO FORCE

3. These Regulations come into force on July 8, 2003.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

The objective of this regulatory initiative is to allow the government to implement an interim response to the decision of the Ontario Superior Court of Justice in Hitzig et al. v. Her Majesty the Queen. Although an appeal of the decision is presently before the Court of Appeal for Ontario, a request for a stay of the decision of the Superior Court pending determination of the appeal was refused. As a result, the government must, in the words of the Superior Court, "fix the Marihuana Medical Access Regulations (MMAR) or otherwise provide for a legal source and supply of the [marihuana]" for medical purposes before July 10, 2003.

As an interim response, pending clarification by the courts of the government's roles and responsibilities with respect to the source and supply of marihuana for medical purposes, the government will make dried marihuana which is produced under contract with Her Majesty in right of Canada, available to persons authorized to possess marihuana and who are unable to produce marihuana for themselves or to find a designated person to produce marihuana on their behalf. The government will also supply marihuana seeds to those authorized to produce marihuana for medical purposes.

An exemption to the Food and Drugs Act (FDA) and Food and Drug Regulations (FDR) must be made to implement this response. These Regulations will exempt marihuana produced under contract with Her Majesty in right of Canada from the application of the FDA and its regulations except when used in clinical trials.

The Legislative Framework

The Food and Drugs Act and its regulations

The FDA and its regulations regulate the sale and distribution of therapeutic drugs. The FDA provides a framework to ensure that drugs available to Canadians are safe, effective and of high quality. Pursuant to the FDR, there are only three ways in which to gain legal authority to provide or sell a drug in Canada: (1) obtain approval for general marketing through a Notice of Compliance (NOC); (2) conduct a Clinical Trial; (3) through the Special Access Program (SAP). In all three cases, substances that are regulated under the Controlled Drugs and Substances Act (CDSA) and its regulations will also have to meet the applicable requirements of that legislation.

Prior to approving a drug for general marketing through the issuance of an NOC, sufficient evidence of the safety, efficacy and quality of a product must be presented to and assessed by Health Canada. This assessment is conducted to verify that the benefits of the product outweigh the risks as presented by the scientific medical evidence. This evidence is not required to have been collected in Canada but, in all cases, it must meet international medical and scientific standards. To date, marihuana has not been approved as a therapeutic substance in Canada, or in any other country.

The testing of a drug in humans is referred to as a clinical trial. Prior to initiating a clinical trial, sponsors are required to submit a research proposal which is assessed by Health Canada to ensure that participants are not exposed to undue risk. The assessment also ensures that the clinical trial adheres to Canadian and international medical and scientific standards.

Through the SAP, practitioners can request access to drugs that are unavailable for sale in Canada in accordance with specified legislative and policy requirements. This access is limited to patients with serious or life-threatening conditions on a compassionate or emergency basis when conventional therapies have failed, are unsuitable, or are unavailable. SAP is not intended to be a mechanism to promote or encourage the early use of drugs or to circumvent the clinical trial review and approval process or the new drug approval process, but rather to provide compassionate access to drugs on a patient by patient basis.

The Controlled Drugs and Substances Act and its regulations

Cannabis (marihuana) is controlled under the CDSA, the Narcotic Control Regulations (NCR), and the MMAR. The CDSA provides a legislative framework for the control of substances that can alter mental processes and that may produce harm to the health of an individual and to society when distributed or used without supervision.

Except as authorized under the NCR or the MMAR, the possession, possession for trafficking, trafficking, importation, exportation, possession for exporting and production of marihuana is prohibited under the CDSA.

The NCR authorize various persons (e.g., licensed dealers, pharmacists, physicians and hospitals) to carry out certain activities which are otherwise illegal under the CDSA by creating a legal chain of distribution for controlled substances, including marihuana, to permit, among other things, their use for medical purposes.

The MMAR which were promulgated on July 30, 2001, provide seriously ill patients residing in Canada with a process by which they can obtain an authorization to possess and/or a licence to produce marihuana for medical purposes. There are two main components to the MMAR: "authorization to possess" and "licence to produce". An authorization to possess marihuana for medical purposes is issued on compassionate grounds to persons ordinarily resident in Canada who, with the advice and support of their medical practitioner(s), can demonstrate medical need.

A licence to produce marihuana is issued to either the patient or a representative that the patient designates in the application to grow on their behalf if they meet the applicable regulatory requirements. The licence permits the designated person to produce, store, transfer and, if necessary, transport specified maximum quantities of marihuana for medical purposes dependent upon the patient's daily dosage.

As of June 2003, 487 persons in Canada were authorized to possess and in 337 of those cases, licenced to produce marihuana for their own medical needs; 38 persons were licensed to act as a designated person to produce marihuana for an authorized person.

International Framework

Internationally, the drug control system is governed by a series of conventions adopted under the aegis of the United Nations, which require that governments exercise control over production and distribution of narcotic and psychotropic substances (including marihuana), combat drug abuse and illicit trafficking, maintain the necessary administrative machinery, and report to international organizations on their actions.

The existing conventions are: the Single Convention on Narcotic Drugs, 1961 (as amended, 1972), the Convention on Psychotropic Substances 1971, and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances 1988. Canada has signed and ratified these Conventions.

The Issues

On January 9, 2003, the Ontario Superior Court of Justice rendered its decision in the case of Hitzig et al. v. Her Majesty the Queen. The applications were brought jointly by eleven individuals, nine of whom suffered from various medical conditions. The applicants challenged the constitutionality of the process for the issuance of authorizations to possess and the lack of availability of a safe, licit and continuous source and supply of marihuana under the MMAR.

The Court essentially upheld the constitutionality of the MMAR for the issuance of authorizations to possess marihuana for medical purposes, finding that the regulations address the shortcomings of the section 56 exemption scheme (i.e., section 56 of the CDSA) identified by the Court of Appeal for Ontario in R. v. Parker that led to the establishment of the MMAR.

Nevertheless, the Court declared the MMAR unconstitutional and invalid on the grounds that the framework failed to adequately resolve issues related to source and supply. The Court suspended the declaration of invalidity for 6 months to give the government "time to fix the MMAR or otherwise provide for a legal source and supply of the drug [that] the MMAR authorize seriously ill individuals to possess or produce, consistent with their section 7 (Charter) rights".

The Government has appealed the Superior Court decision in Hitzig et al; the appeal is scheduled to be heard on July 29-30, 2003. A stay of the decision was requested by the Crown pending the appeal. The Court refused to grant the stay.

Failure to sufficiently address the issues raised by the Court by July 10, 2003 would result in the MMAR becoming invalid in Ontario. If the MMAR were to become invalid, it follows, as a result of R. v. Parker, that the prohibition on the possession of marihuana in section 4 of the CDSA would also be of no force and effect in Ontario. This would create a regulatory vacuum with respect to marihuana that would exacerbate existing concerns with respect to the availability of marihuana for medical purposes and the risks associated with its misuse and diversion.

The Government has decided that it is in the best interests of those seriously ill Canadians for whose benefit the MMAR were enacted to ensure that the MMAR remain valid by providing access, on an interim basis, to a licit source and supply of marihuana seeds and dried marihuana.

The Proposed Approach

In response to the Superior Court's decision in Hitzig et al, and the Court of Appeal's refusal to grant a stay of the decision pending determination of that appeal, Health Canada has secured marihuana seeds and will on an interim basis make these seeds available to holders of Personal-Use Production Licences and Designated-Person Production Licences issued under the MMAR and to persons authorized under section 56 of the CDSA to possess and cultivate marihuana for medical purposes. In addition, Health Canada will on an interim basis provide a licit source and supply of dried marihuana to patients authorized to possess marihuana for medical purposes who are unable to produce marihuana themselves or find a person who can produce on their behalf.

Marihuana provided for medical purposes meets the definition of a drug under the FDA and is, therefore, subject to the requirements of the FDA and the FDR. A regulation to exempt marihuana produced under contract with Her Majesty in right of Canada from the application of the FDA and FDR is necessary, in the absence of a NOC, to be able to make dried marihuana available to patients who are unable or unwilling to participate in a clinical trial, and where the criteria to have access to a drug under the SAP cannot be met.

Alternatives

The options outlined below provide an overview of the alternatives that were considered.

Option 1: Maintain the status quo.

Failure to sufficiently address the issues raised by the Court by July 10, 2003, would result in the MMAR becoming invalid. Further, the prohibition on the possession of marihuana in section 4 of the CDSA would also become invalid. Perhaps of greater practical concern is the possibility that if the MMAR and prohibition on possession become invalid, the CDSA prohibitions on production (section 7), and possibly traffic (section 5) may also be challenged and invalidated. This would create a regulatory vacuum with respect to marihuana and impact adversely on the administration of the criminal justice system, making this option unacceptable.

Option 2: Provide marihuana seeds on an interim basis to persons licenced to produce marihuana who do not have plants at any stage of production.

Health Canada is able to make marihuana seeds available to persons licenced to produce marihuana for medical purposes. Although the provision of seeds resolves the issue of licit source and supply for all persons licensed to produce, it is argued that some authorized persons are unable to produce for themselves or find a designated person to grow on their behalf. Therefore, this option is considered to be an inadequate interim response pending clarification by the Courts of the government's roles and responsibilities with respect to the source and supply of marihuana for medical purposes. This could result in the MMAR becoming invalid with the same potential outcome as option 1.

Option 3: Provide dried marihuana on an interim basis to all persons authorized to possess marihuana for medical purposes.

Health Canada could make dried marihuana available on an interim basis to persons authorized to possess marihuana for medical purposes from supplies produced for the Medical Marihuana Research Program (MMRP). A form of cost-recovery system would be implemented. The quantity of dried marihuana that is available from the research supply is, however, limited. One of Health Canada's priorities with respect to marihuana is to continue to support research on the safety and efficacy of marihuana when used for medical purposes and to supply dried marihuana for related clinical trials. Provision of dried marihuana to all authorized persons could, therefore, compromise the MMRP. Further, some patients will continue to produce marihuana for themselves or have a designated person produce on their behalf. Therefore, without the provision of seeds, this option is considered to be inadequate.

Option 4: Provide on an interim basis marihuana seeds to persons licensed to produce for medical purposes who do not have plants at any stage of production and dried marihuana to authorized persons unable to produce marihuana for themselves or to find a designated person to produce on their behalf.

Dried marihuana would be made available, on an interim basis, only to those authorized persons who are unable to produce marihuana for themselves or to find a designated person to produce on their behalf. Persons who are currently producing for themselves would not be eligible to have access. Should a person who currently holds a Designated-Person Production Licence decide to no longer supply an authorized person, the latter will be required to make diligent and reasonable efforts to find another designated person before applying to have access to the Health Canada supply of dried marijuana.

This option is the preferred one in the context of the current Court decisions and as an interim measure until the Government of Canada's roles and responsibilities with respect to a source and supply of marihuana for medical purposes are clarified by the Courts. The supply of dried marihuana and the provision of marihuana seeds will provide for a licit source and supply of marihuana for authorized persons. A form of cost-recovery system will be implemented. This option will address the issues raised by the Court thereby maintaining the integrity of the MMAR and preserving the prohibitions with respect to marihuana under the CDSA.

This initiative also offers a balance between facilitating patient access to a marihuana supply for medical purposes as required by certain court decisions, and ensuring protection against diversion and misuse of marihuana. While this option provides an interim remedy for problems of source and supply, it raises issues associated with the Government producing and distributing an unapproved drug product to Canadians outside of a research context.

A regulation to exempt marihuana produced under contract with Her Majesty in right of Canada from the application of the FDA and FDR is necessary to be able to make dried marihuana available to patients outside of a clinical trial context. Although such marihuana will be exempted from provisions of the FDA and FDR other than the clinical trial regulations, it will continue to be regulated under the CDSA, the MMAR and the NCR, which provide for control over the distribution of marihuana to minimize the risk of diversion and misuse of this substance. The exemption from the FDA and FDR will not apply to marihuana used within clinical trials to ensure that the requirements of Division 5 of the FDR which pertain to drugs for Clinical Trials Involving Human Subjects will continue to apply and the objectives of the MMRP can be met.

The continued existence of the MMAR and related provisions and policies will be evaluated on an ongoing basis with reference to the relevant medical and scientific literature as this may exist from time to time, and amended or repealed accordingly.

Benefits and Costs

These regulatory amendments are expected to impact on the following sectors:

Public

In accordance with the Court's direction, these Regulations will allow on an interim basis for access to an alternative licit source and supply of marihuana for authorized persons who may otherwise have no legal access to the substance. The dried marihuana available through Health Canada will be research grade. The existing control measures to prevent marihuana diversion and misuse will continue to apply.

The dried marihuana will be provided on a form of cost-recovery basis. Although it is usual to have to pay for drug therapy, some persons may express dissatisfaction. In addition, as with other unapproved drug products, the cost may not be covered by provincial drug plans or private insurance.

Medical Practitioners

It is anticipated that medical practitioners may be more comfortable supporting patients' applications for access to marihuana for medical purposes knowing that their patients will have access to research grade marihuana. However, it may increase the burden on medical practitioners as the result of their anticipated role in the distribution of dried marihuana to their patients.

Law Enforcement Agencies

By addressing the concerns of the Court, these Regulations will maintain the integrity of the MMAR and preserve the prohibitions in respect of marihuana under the CDSA. The ongoing availability of offences for possession, production and traffic will allow law enforcement agencies to continue to take enforcement action when unauthorized possession, production, and traffic of marihuana is identified.

Health Canada

This interim initiative will have resource implications due to the requirement to establish a distribution system for dried marihuana and marihuana seeds. A form of cost-recovery system will be implemented.

Consultation

An exemption from pre-publication of these Regulations in the Canada Gazette, Part I, is requested in order to have these amendments promulgated in the Canada Gazette, Part II, before July 10, 2003, the date on which the MMAR would become invalid if no action is taken. These regulatory amendments are necessary in order to:

— allow the government to implement an interim source and supply policy for marihuana for medical purposes in response to the decision of the Ontario Superior Court of Justice in Hitzig et al. v. Her Majesty the Queen before the Court imposed deadline of July 9, 2003, ensuring that the MMAR remain in effect pending clarification by the Courts of the roles and responsibilities of the government; and

— help protect public health and safety by ensuring that the possession, production and distribution of marihuana for medical purposes occur within a regulatory framework aimed at minimizing the risk of diversion and misuse of controlled substances.

Once these Regulations are published in the Canada Gazette, Part II, stakeholders will be notified by direct mail and Web site announcements, or may be invited to information sessions with Health Canada.

Compliance and Enforcement

Because these Regulations will exempt only marihuana produced under contact with Her Majesty in right of Canada, the impact on existing compliance and enforcement mechanisms under the provisions of the FDA, the CDSA and their regulations will be minimal.

Contact

Cynthia Sunstrum
Drug Strategy and Controlled Substances Programme
Healthy Environments and Consumer Safety Branch
Address Locator: 3503D
Ottawa, Ontario
K1A 1B9
Telephone: (613) 946-0125
FAX: (613) 946-4224
E-mail: OCS_Policy_and_Regulatory_Affairs@hc-sc.gc.ca

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