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 interests and the objectives of the CDSA. After the Federal Court dismissed the judicial review, the Appellants commenced an appeal to the Federal Court of Appeal ("FCA").
FCA
The FCA highlighted the Minister's failure to justify the shift in policy from previous exemptions that recognized the necessity for experiential training for HCPs. The Decision did not provide adequate explanation, and thus failed to demonstrate the necessary transparency for a reasonable Decision. The FCA's analysis considered the standard of review, Charter rights, and the reasonableness of the Decision. The Appellants raised three arguments.
1. Did the Minister establish too many limitations?
The Appellants argued that the Minister fettered her discretion by limiting the Exemptions under subsection 56(1) of the CDSA to situations where no other options, such as a clinical trial, are available. The Minister disagreed that an Exemption in addition to ongoing clinical trials would be useful in this situation and also provided that:5
- A clinical trial offers greater protections to HCPs by ensuring compliance with good manufacturing practices and ethical standards. 6
- An Exemption would only be granted in the case that it was in the public interest to grant one, and the Minister gave reasons in the Decision why she did not think this was the case.7
2. Was the Decision unreasonable because it failed to address relevant concerns?
The Appellants argued that the time and structure required for a clinical trial would delay patient care and conflict with the educational goals and timing of their training program. They also argued that conducting a clinical trial solely for therapist training would breach Canadian ethical guidelines, which prohibit trials conducted primarily for commercial or educational reasons. However, the FCA found that the Minister's reasons are clear and sufficient for this argument, emphasizing the following reasons:
- PSAP can be delivered without personally experiencing the substances involved, and that there is insufficient high-quality evidence to support the necessity of experiential training.8
- The experiential component was a requirement imposed by the Organization itself, not an established medical necessity.9 As a result, the incompatibility of a clinical trial with the Organization's program no longer held weight in evaluating the Exemption request.10
3.Was the Decision inconsistent with other decisions in the past?
The FCA rejected the Appellants' first two arguments, but allowed the appeal based on the third argument. In 2022, the Minister stated there was no expert consensus on experiential training and that clinical trials were preferred; however, the Minister granted Exemptions in 2020 based on expert support for experiential training and concerns about the feasibility of clinical trials. The FCA found that the Minister did not provide sufficient justification for the shift in the reasoning, emphasizing the following:
- A mere acknowledgment of a shift was not enough.11
- The Decision lacked transparency and failed to justify the inconsistency with past practice.12
The Minister had not met the required burden and the FCA allowed the appeal on this ground.
h3>The CharterIn addition to addressing the Appellants' arguments, the FCA made notable conclusions about the engagement of section 7 Charter rights within the context of the Exemption for the use of psilocybin in experiential training for PSAP. The FCA held that there was no deprivation of liberty or security rights based on the following reasons:
- The HCPs voluntarily chose to apply for the Exemption to possess psilocybin and any legal jeopardy they face arises from that voluntary decision.13
- The HCPs were not required by law or employment to possess psilocybin, as experiential training is not a sanctioned medical service.14
- The FCA differentiated the current case from past cases where HCPs risked prosecution for providing sanctioned medical services.15
- The HCPs cannot rely on hypothetical future patients' Charter rights to consume psilocybin themselves to strengthen their own claims for their education.
- Charter rights are individual and cannot be asserted by proxy unless a direct legal relationship or deprivation exists.16
Conclusion
The FCA allowed the appeal, remitting the Exemption requests back to the Minister for redetermination in accordance with the FCA's reasons. The FCA held that while the Decision was not unreasonably limited, addressed the Charter arguments, and provided reasons for why neither an Exemption nor a clinical trial was strictly required for the medical care of the patients, the Decision failed to explain the shift in policy regarding experiential training for HCPs. This failure of explanation ultimately undermined the transparency necessary to meet the standard of reasonableness in the Decision.
Footnotes
1 Toth v. Canada (Mental Health and Addictions), 2025 FCA 119 [Toth].
2 Health Canada, "Notice to Stakeholders – Clarification of Requirements under the Food and Drug Regulations and the Controlled Drugs and Substances Act When Conducting Clinical Research with Psilocybin" (11 January 2022). See also Food and Drugs Act, RSC 1985, c F-27 and the Controlled Drugs and Substances Act, SC. 1996 c 19, Schedule III.
3 Toth v. Canada (Mental Health and Addictions), 2023 FC 1283 at para 14.
4 Canadian Charter of Rights and Freedoms, s 7, Part I of the Constitution Act, 1982, being Schedule B to the Canada Act 1982 (UK), 1982, c 11.
5 Toth, supra note 1 at 78.
6 Ibid at 79.
7 Ibid at 80.
8 Ibid at 68.
9 Ibid at 71-72.
10 Ibid.
11 Ibid at 89.
12 Ibid at 95.
13 Ibid at 83.
14 Ibid at 44.
15 Ibid at 43-44, 83. See also Canada (Attorney General) v PHS Community Services Society, 2011 SCC 44.
16 Ibid at 46.
The foregoing provides only an overview and does not constitute legal advice. Readers are cautioned against making any decisions based on this material alone. Rather, specific legal advice should be obtained.
© McMillan LLP 2025
