Psychedelic Appeal: FCA Rules That Government Must Explain Policy Change On Psilocybin Access

• Published date: 30 June 2025
• Subject Matter: Litigation, Mediation & Arbitration, Food, Drugs, Healthcare, Life Sciences, Trials & Appeals & Compensation, Food and Drugs Law
• Law Firm: Torys LLP
• Author: Amanda Wolczanski, Jon Silver and Yael Bienenstock

As science evolves, policies may evolve as well. But when policy changes affect how a decision-maker exercises their discretion, those decision-makers must explain why they are taking a new approach. If they fail to do so, their decisions are vulnerable to challenge on judicial review. That was the conclusion of the Federal Court of Appeal in Toth v. Canada¹'where the Court set aside decisions denying access to psilocybin, the psychoactive compound in hallucinogenic mushrooms.

What you need to know

• Court sets aside decision denying request for access to psilocybin. The Federal Court of Appeal set aside the Minister of Mental Health and Addictions' decision denying an exemption to a group of healthcare practitioners who were seeking to use psilocybin in experiential training. The decision did not meet the Vavilov standards of justification and transparency because the Minister had previously granted nearly identical requests but failed to explain the change in the Minister's position here.
• Decision-makers must justify departures from past practice. This case demonstrates the principle that regulators cannot make contradictory decisions without explanation If they fail to provide adequate justification for departing from past practice, their decisions risk being set aside on judicial review.
• Past practice is a useful tool when making submissions to regulator. Past practice and past decisions can be useful tools when advocating before a regulator. While they are not binding, past decisions will be a constraint on and inform the regulator's future decisions. While the case...