Rolling with it: Health Canada proposes inclusion of psychedelics in Special Access Program

Life Sciences Update


On December 11, 2020, Health Canada announced that it intends to repeal amendments to the Food and Drug Regulations (Parts C and J) and the Narcotic Control Regulations made in 2013 that, among other things, prohibit access to controlled drugs through the Special Access Program (the “SAP”). Currently, health care professionals can apply to the SAP for approval to use drugs that are not available for sale in Canada in order to treat patients who have serious or life-threatening conditions. To qualify for such a request, conventional treatments for the patient’s condition must have failed, been found unsuitable, or be unavailable in Canada.

Since MDMA and psilocybin are controlled substances that meet the definition of “restricted drug” under the Food and Drugs Act, they have been excluded from the SAP for the last number of years (for a primer on psychedelics in Canada, please see our article here). As such, the only legal means by which a patient could access these drugs has been through: (a) seeking a Section 56(1) exemption, which is granted if the Minister deems the exemption necessary for a medical or scientific purpose, or otherwise in the public interest (these exemptions have thus far been centred around use of psilocybin to manage end of life distress); or (b) participating in a clinical trial. Health Canada is considering reversing its position on the use of restricted drugs given the growing body of research showing their therapeutic potential.

If Health Canada moves forward with its initiative, physicians will be able request access to these restricted drugs for qualifying patients through a simpler avenue: the SAP. In addition, Canada will cement its status as an early mover in the psychedelics renaissance, joining the ranks of a small number of other jurisdictions taking steps toward making psychedelic therapies more accessible. As one example, on November 4, 2020, Oregon became the first state to approve a legal framework for the therapeutic use of psilocybin. While this vote will not allow the general population to purchase psilocybin from dispensaries the same way they can purchase cannabis, it means that regulated treatment facilities will be able to offer psilocybin-assisted therapies to patients.

Based on Health Canada’s announcement regarding revisions to the SAP and its grant of numerous Section 56(1) approvals this year (including an especially notable approval for 17 healthcare professionals associated with TheraPsil to possess and use psilocybin for clinical training), it appears the movement towards therapeutic psychedelics is gaining momentum. Against the backdrop of a year that has exacerbated the mental health struggles of so many Canadians, it is perhaps not entirely surprising to see the Government of Canada begin to more fully explore the possibilities of these alternative medicines.

The 60-day public comment period on Health Canada’s intention to include restricted drugs in the SAP ends on February 10, 2021. More information regarding the proposal and how to submit comments can be found here.

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