On January 5, 2022 the Canadian Government amended the Food and Drug Regulations to allow healthcare practitioners to apply, on a case-by-case basis, to the Minister of Health (the “Minister“) for special access to a certain class of “restricted drugs” including amphetamines, psilocybin and lysergic acid diethylamide (LSD). Further, the January 5, 2022 amendments simplify the framework of regulation over all forms of cocaine in Canada, thereby reducing complexity for stakeholders applying to conduct activities with cocaine (e.g. research).
The Canadian Government regulates the possession, sale, importation/exportation and use of controlled substances through the Controlled Drugs and Substances Act and the Food and Drugs Act. Between the Controlled Drugs and Substances Act and the Food and Drugs Act, and their associated regulations, controlled substances in Canada are sub-divided into four categories of substances, consisting of narcotics, targeted substances, controlled drugs and restricted drugs.
Restricted drugs are regulated under the Food and Drug Regulations. Examples of drugs in this category include amphetamines, psilocybin, and lysergic acid diethylamide (LSD), amongst others. Restricted drugs are controlled substances that generally do not have approved medical uses in Canada. Given the lack of approved medical uses for restricted drugs, the Food and Drug Regulations do not permit the sale of restricted drugs to healthcare practitioners for use in the treatment of their patients. Practitioners are therefore effectively barred from prescribing or using restricted drugs in the treatment of their patients. In Canada, restricted drugs are only permitted to be used for scientific and/or research purposes (e.g. clinical trials). Therefore, the only way for patients to access restricted drugs is through participation in clinical trials
The Special Access Program:
Part C of the Food and Drug Regulations sets out a process by which a “practitioner”1 can apply to the Minister for a letter of authorization permitting the sale of a drug which would otherwise be unavailable to patients in Canada. Where a letter of authorization is granted, a manufacturer may sell requested quantities of a drug directly to a practitioner for the emergency treatment of a patient. This process is known as the Special Access Program (the “SAP“).
Letters of authorization may be requested where the patient suffers from a serious or life-threatening condition, and where conventional therapies have failed, are unsuitable or are unavailable in Canada. Where a request is made by a practitioner, the Minister will consider the “level of scientific evidence” behind the drug, which includes evidence pertaining to safety and efficacy. The Canadian Government’s Regulatory Impact Analysis Statement, released concurrently with the January 5, 2022 amendments, notes that requests to the SAP are normally only considered where positive results of Phase II or Phase III clinical trials are readily available.
Medical Access to Restricted Drugs through the SAP:
Since 2013, the Food and Drug Regulations explicitly barred the Minister from granting access to restricted drugs through the SAP. Restricted drugs were the only category of controlled substances that were barred from being accessed through the SAP. However, on January 5, 2022 the Canadian Government amended the Food and Drug Regulations to remove this prohibition. The Food and Drugs Act now permits the Minister to grant practitioners access to restricted drugs through the SAP, and practitioners can now apply to the Minister for special access to restricted drugs on a case-by-case basis.
Prior to 2013, all forms of cocaine were classified as narcotics and were available through the SAP. In 2013, the Canadian Government amended the Narcotic Control Regulations, made under the Controlled Drugs and Substances Act, and the Food and Drug Regulations. Pursuant to the amendments, any form of cocaine that was:
- assigned a drug identification number by Health Canada;
- offered for sale through a clinical trial; or
- compounded by a pharmacist pursuant to a prescription;
remained classified as a narcotic under the Narcotic Control Regulations. However, all other forms of cocaine became classified as restricted drugs and were to be regulated under the Food and Drugs Act. As a result, any form of cocaine which now became classified as a restricted drug could not be accessed through the SAP.
On January 5, 2022, the Canadian Government reversed those amendments. Any references to any form of cocaine in the Food and Drug Regulations is now removed. The ultimate effect of these amendments being that all forms of cocaine will now be classified as narcotics, and will only be subject to regulation under the Narcotic Control Regulations. The Regulatory Impact Analysis Statement notes that the object of these amendments is to eliminate complexity for stakeholders (e.g. researchers) applying to conduct or conducting activities with cocaine.
The Future of Medical/Recreational Psychedelics in Canada:
While the amendments seem to be a step in the right direction for advocates of medical psychedelics, the Canadian Government stressed in its Regulatory Impact Analysis Statement that these amendments will not create large-scale access to restricted drugs. Requests for restricted drugs through the SAP, like all other requests, will be considered only on a case-by-case basis. The government further stressed that these amendments do not signal an intent towards decriminalizing or legalizing restricted drugs in Canada.
1 “Practitioner” is defined in the Food and Drug Regulations as a person who: (a) is entitled under the laws of a province to treat patients with a prescription drug; and (b) is practicing that profession in that province.