Psychedelic appeal: FCA rules that government must explain policy change on psilocybin access

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 concerned a decision of the Minister of Mental Health and Addictions, courts are likely to take the same approach with other regulators, such as Health Canada and the Canadian Food Inspection Agency.
• Timing for appeal. The Minister has until early in the fall to seek leave to appeal the decision to the Supreme Court of Canada.

Background: the request for exemption to possess and consume psilocybin

Psilocybin is the psychoactive compound in hallucinogenic mushrooms. Possessing psilocybin is prohibited under the Controlled Drugs and Substances Act. The federal Minister of Mental Health and Addictions, however, has discretion to grant exemptions where possession “is necessary for a medical or scientific purpose or is otherwise in the public interest”².

Healthcare practitioners in this case sought to possess and consume psilocybin mushrooms for a psilocybin-assisted psychotherapy (PSAP) training program. The program was run by a not-for-profit patient advocacy group dedicated to helping Canadians access PSAP. It requires healthcare practitioners to undergo “experiential training” wherein they personally consume psilocybin and experience its effects so that they can “deliver the safest and most effective treatment to their patients”³.

In 2020, Health Canada had granted an exemption to a group of healthcare practitioners completing the training program. But in 2022, the Minister denied nearly identical requests. The Minister’s 2022 reason for the denial was that the healthcare practitioners could obtain access through a clinical trial and, therefore, an exemption was not necessary. The Minister described the change in approach as “an evolution” in the Office of Clinical Trial’s position on the issue but did not provide further details⁴.

The healthcare practitioners, together with prospective patients and other third parties, brought an application for judicial review. They challenged the decision on several grounds, including alleging that it was unreasonable for a number of reasons and did not comply with the Charter.

The Federal Court dismissed the application for judicial review⁵. The applicants appealed.

The Federal Court of Appeal decision

The Federal Court of Appeal allowed the appeal. Although the Court rejected most of the healthcare practitioners’ grounds for review, it concluded that the Minister’s decision was unreasonable. The Minister had failed to explain why its 2022 decision was different from its 2020 decision. The Court acknowledged that “[i]t is a truism that science does not stand still, and decision-makers engaged with science are not expected to stand still either—and hopefully they never will—rather, they make their decisions in real time based on the evidence before them”⁶. But the mere acknowledgement that there had been an “evolution” in the Office of Clinical Trial’s position on the issue was a conclusion, not a justification. The failure to provide justification fell short of the necessary transparency for a reasonable decision under the Supreme Court of Canada’s controlling authority on judicial review, Vavilov⁷. The decision was remitted to the Minister for redetermination⁸.

The Charter grounds were rejected because the healthcare professionals’ interest in delivering optimum results was not a recognized Charter right, and even if Charter interests were engaged, the decision reflected a proportionate balancing⁹. The remaining grounds invited the Court to adjudicate the merits of a scientific debate (whether experiential training is necessary for successful PSAP), which is not the role of the Court on judicial review¹⁰.

Implications

Toth has potential application in all highly regulated contexts. Government administrators cannot “fetter” their discretion by purporting to be bound by their own policies and prior determinations. But Toth demonstrates that consistency matters. When administrators render decisions that conflict with their own prior decisions, they must discharge a “justificatory burden” to explain their shift in position. Otherwise, their determinations are ripe for challenge on judicial review.

When advocating before regulators, the regulator’s past practice can be an important tool to argue for a particular outcome. Absent good reason and a compelling explanation, regulators should generally be guided by their past decisions and arrive at similar conclusions in similar situations.