TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal (FCA) to overturn the refusal of the Minister of Mental Health and Addictions and Associate Minister of Health (Minister) to allow the HCPs to possess and consume psilocybin mushrooms for experiential training in supervised consumption of psilocybin in psychotherapy.
In Toth v Canada (Mental Health and Addictions), 2025 FCA 119, the FCA allowed the appeal from a Federal Court (FC) dismissal of the appellants’ application for judicial review of the Minister’s decisions (2023 FC 1283), but did not direct the Minister to grant exemptions under the Controlled Drugs and Substances Act (CDSA). The HCPs’ exemption requests are remitted to the Minister for redetermination in accordance with the FCA’s reasons.
Psilocybin prohibition and exemption under the Controlled Drugs and Substances Act
Psilocybin is a psychoactive compound found in certain mushrooms and is a controlled substance in Schedule III of the CDSA.
Possession is an offence under section 4 of CDSA, including possible imprisonment, unless otherwise authorized. The Minister (with powers, duties and functions transferred from the Minister of Health) has discretion under section 56 to grant an exemption:
if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest.
2022 exemption requests and refusal decisions
TheraPsil provides a training program for psilocybin-assisted psychotherapy (PSAP). The program’s experiential training requires HCPs to consume psilocybin to experience the altered state of consciousness patients experience during PSAP.
In 2022, the 73 HCPs – including doctors, psychologists, nurses, social workers, and counsellors – submitted requests to Health Canada for section 56 exemptions to allow them to possess, transport, and consume psilocybin mushrooms for TheraPsil’s program. The HCPs had made extensive submissions that their rights and the rights of patients under section 7 of the Canadian Charter of Rights and Freedoms (Charter) would be violated if their requests were denied.
Health Canada denied the requests in identical letters to each of the HCPs in June 2022. Without mentioning the Charter arguments, the decisions denied the requests on the basis that access to psilocybin could be obtained through a clinical trial:
…there is an option available under the [Food and Drug Regulations] through which the sale of the drug for the purposes of a clinical trial may be authorized, and therefore, an exemption under the [CDSA] is not necessary.
The HCPs and TheraPsil sought judicial review. Assessing for reasonableness, the FC concluded that the decisions did not engage the Charter and, in any event, demonstrated that the Minister reasonably and proportionately balanced Charter values with the statutory objectives of the CDSA.
Charter rights not engaged
During the pendency of the appeal, the Supreme Court of Canada released York Region District School Board v Elementary Teachers’ Federation of Ontario, 2024 SCC 22, which clarified that whether the Charter is engaged is a constitutional question that is reviewed for correctness.
In light of this guidance, the FCA found the Minister’s decisions do not deprive the HCPs or prospective patients of a life, liberty or security interest. There was therefore no requirement that the Charter be expressly addressed.
Reasonableness analysis
The FCA accordingly considered the Minister’s decisions from an administrative law perspective for reasonableness. The FCA concluded that two of the appellants’ three challenges were, at their core, matters of medical debate; however, the decisions were unreasonable based on the third.
Existence of a clinical trial or other regulatory option
First, the appellants’ premise – that experiential training is necessary for PSAP – was reasonably rejected by the Minister. Therefore, the Minister was reasonable in disagreeing with the arguments that a clinical trial is not compatible with TheraPsil’s training objectives and that it would be unethical to conduct a clinical trial for therapist training.
Second, the FCA found no reviewable error in the Minister’s assessment of the public interest. While the decisions could be understood to be stating an invariable rule, which would constitute an improper fettering of discretion, fairly and globally read they provided a reasoned consideration of why it was not in the public interest to grant an exemption and the corresponding advantages of a clinical trial.
Inconsistency with 2020 exemptions
Health Canada had, two years earlier, granted 19 substantively identical exemption requests for HCPs to possess and consume psilocybin-containing mushrooms for the purpose of completing TheraPsil’s experiential training.
As the FCA noted, inconsistencies in the Minister’s positions in 2020 and 2022 included the importance of experiential training for HCPs, the propriety of a clinical trial, and the evidentiary requirements for a section 56 exemption. While also noting that scientific or clinical trial developments could explain the policy shift, the FCA declined to “connect the dots”; it was incumbent on the Minister to explain the change:
It would be an uncomfortable stretch of judicial reasoning to connect the dots here. The shift in policy between 2020 and 2022 and the Minister’s appreciation of the relevant factors are significant, if not abrupt, and call for some explanation. This is a critical part of the Decisions, and it is the role of the Minister and not the Court to make the required connections.
The FCA accordingly concluded that the Minister’s refusals to grant the HCPs’ exemption requests failed to demonstrate the necessary transparency for a reasonable decision.
The HCPs’ exemption requests were therefore remitted to the Minister for redetermination in accordance with the FCA’s reasons. The Minister may seek leave to appeal to the Supreme Court of Canada.