Amendment Allows Canadian Physicians to Request Access to Psychedelic Treatments

Health Canada, the federal agency responsible for the nation’s health policy, announced this month it has amended its Special Access Program (SAP) to allow qualified physicians to request access to psychedelic treatments for serious, treatment-resistant or life-threatening health conditions when other therapies have failed or are deemed unsuitable or unavailable, and data supports the safety and efficacy for a patient’s specific condition.

The amendment, a reversal from a regulatory change made in 2013 that prohibited access to psychedelics and other drugs, received widespread support, with the department reporting that opposition made up less than 2% of public responses.

Canada Gazette, Part II, the section of the national government newspaper that contains enacted regulations and statutory instruments, notes that the regulatory change “will not result in large-scale authorization for access to restricted drugs,” and that requests to the SAP will continue to be evaluated case-by-case. Also of note is that the SAP differs from the country’s Section 56 exemption, as the SAP applies to patient care while the S56 exemption relates to clinical trials and research purposes.

In separate emails sent to Psych Congress Network, Canadian psychedelics companies Numinus Health and Mindcure each identified the amendment as a critical move toward expanding access to mental healthcare through psychedelic-assisted psychotherapy.

“Amending the SAP and righting a historical wrong based on stigma highlights Canada's commitment to making psychedelic-assisted therapies a possibility for the many Canadians who struggle with mental wellness,” Payton Nyquvest, Numinus founder and CEO, said in a news release. “While we believe this is only the beginning of greater change to come, it signifies an important step towards creating expanded safe access to treatment and care in the mental health sector through psychedelic medicine. I am proud of our team who have had a longstanding role in advocating for this reform.”

Toronto-based Field Trip Health is among the organizations that have indicated they will begin making applications on behalf of patients who are interested in accessing psilocybin-assisted and MDMA-assisted therapy for the treatment of depression, anxiety, post-traumatic stress disorder, and other disorders affecting the central nervous system.

“It has always been a central thesis to our business model that legal access to psychedelic-assisted therapies using psilocybin and MDMA would happen much sooner than most people would have expected,” added Field Trip Executive Chairman Ronan Levy said in a news release. “While these amendments to the SAP do not yet achieve our hope of generalized medical access to these therapies, it is an encouraging development and we commend Health Canada for being a clear leader in this regard. The amendments to the SAP will provide hope to Canadians who have suffered with these debilitating conditions for too long.”