The Court Grants An Appeal In Favour Of Psychedelic Assisted Psychotherapy ' Toth v. Canada, 2025 FCA 119

• Published date: 21 July 2025
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: McMillan LLP
• Author: Ms Leila Rafi, Sasa Jarvis and Anica Villamayor

A ruling from the Federal Court of Canada has resulted in an appeal of prior government refusals to permit access to psilocybin in connection with psilocybin assisted psychotherapy ("PSAP").¹

Psilocybin, a psychoactive compound, is classified as a drug under the Food and Drugs Act, and controlled substance under the Controlled Drugs and Substances Act ("CDSA").² Possession of psilocybin is criminally prohibited unless authorized by an exemption. Subsection 56(1) of the CDSA grants an exemption for the possession of prohibited substances if it is necessary for medical or scientific purposes, such as a clinical trial, or if it is in the public interest ("Exemption").

In June 2022, the Minister of Mental Health and Addictions and Associate Minister of Health (the "Minister") made a decision to refuse to grant an Exemption for PSAP (the "Decision").³ The applicants who sought the Exemption challenged the Decision, and sought judicial review on a number of grounds, which are discussed below.

Background

In 2022, a not-for-profit patient advocacy organization (the "Organization"), along with 96 healthcare professionals ("HCPs") and eight patient appellants (collectively, the "Appellants") sought an Exemption. Central to the proceedings was whether HCPs should be able to access psilocybin for experiential training for PSAP. The Appellants argued that experiential training was essential to provide effective treatment to patients with serious medical conditions. The Appellants also argued that denial of the Exemption would violate their rights under section 7 of the Canadian Charter of Rights and Freedoms (the "Charter"), which aims to protect those in its jurisdiction from the government depriving them of a "life, liberty, or security interest."⁴ The Minister denied the request for an Exemption on the basis that HCPs could access psilocybin through clinical trials, and that there was no scientific evidence HCPs who had experiential training were more capable at administering PSAP to patients.

The Appellants applied for judicial review with the Federal Court regarding the Decision. The application for judicial review was dismissed. The Federal Court concluded that the Appellants did not have standing regarding private or public interest. The Federal Court also held that the Appellants' Charter rights were not engaged. The judge stated that clinical trials are a suitable alternative for HCPs to access psilocybin and provide an avenue that balanced the Charter...