Canadian Court Sides with Psychedelic Therapy Advocates in Psilocybin Exemption Case

LOS ANGELES- A Canadian federal court has ordered Health Canada to revisit its denial of psilocybin exemptions for health-care professionals, marking a significant development in the country’s evolving drug policy landscape. The ruling stems from a lawsuit filed by Therapsil, a non-profit advocating for legal access to psilocybin-assisted psychotherapy.

Therapsil initially received exemptions under the Controlled Drugs and Substances Act in 2020, permitting 19 clinicians to undergo experiential training involving psilocybin. However, a 2022 application seeking the same exemptions for an additional 93 health-care workers was denied. In June 2025, the Federal Court of Appeal ruled that Health Canada failed to adequately explain its policy reversal, ordering a new decision on the matter.

The decision reflects growing legal and public scrutiny over access to psychedelics for therapeutic purposes. Psilocybin therapy is currently under investigation in Canada for applications in palliative care and for treating mental health disorders such as treatment-resistant depression and substance use disorder. Health Canada has granted over 300 individual exemptions for psilocybin therapy but continues to apply a case-by-case approach through its Special Access Program.

Therapsil argues that clinicians require firsthand experience with the substance to administer effective therapy. The group likens its legal strategy to past cannabis litigation that ultimately expanded access and contributed to Canada’s eventual recreational cannabis legalization in 2018.

As interest in psychedelic-assisted therapy rises, Health Canada faces pressure to adapt its regulatory framework. The agency has not confirmed whether it will appeal the court’s ruling or issue new guidance. Meanwhile, unregulated sales of psilocybin continue across Canada, raising concerns about patient safety and the limitations of current enforcement.

The outcome of this case could have lasting implications for the structure and regulation of psychedelic therapies in Canada, echoing legal precedents set during the country’s path to medical and recreational cannabis reform.