PsyCan Discovers Sharp Decline in Health Canada Approvals for Doctors Seeking Legal Psychedelic Therapy for Patients
TORONTO, Sept. 08, 2025 (GLOBE NEWSWIRE) -- PsyCan, the trade association representing Canada’s medical psychedelics industry, is calling for urgent reforms to the way Canadians access psychedelics for medical purposes following a release of Health Canada Special Access Program (SAP) records under the Access to Information Act.
The release shows psilocybin and MDMA approvals dropping dramatically under the Carney government with only half as many SAP requests for psychedelic-assisted therapy being approved compared to last year. Timelines on decisions have also been growing dramatically. [1]
Reports from doctors and patients suggest a bureaucratic nightmare, citing 15-page rejection letters, often followed by mandamus applications being accepted by the government following extensive legal back-and-forth. Courts have begun overruling a number of these refusals, creating additional administrative burden and legal costs within Health Canada and for frustrated and confused patients and doctors – all while underscoring the government’s overly restrictive approach. [2]
The unsealed records confirm that requests by doctors for life-saving therapies under the SAP are slow, unpredictable, and fundamentally unsuited to meeting the urgent and growing need for novel mental health treatments. Restricted legal access drives desperate patients to seek these drugs on the black market as evidenced by the proliferation of illicit psilocybin stores online and on the main streets of ~1/3 of Canada’s major urban centres. [3]
“The Special Access Program has become the hallway medicine of mental health care.”
“For veterans and first responders with PTSD, people with treatment‑resistant depression or addiction, and those facing end‑of‑life distress, weeks and months matter,” said PsyCan Board Chair and Bluestem President Austin Miller. “The Special Access Program has become the hallway medicine of mental health care.”
“Conventional treatments are often inaccessible, unaffordable, or harmful. Canadians need a predictable pathway to these novel therapies without bureaucrats standing between doctors and patients.”
Parliament has already spoken. The bipartisan Senate Subcommittee on Veterans Affairs has urged the federal government to immediately launch and fund a large‑scale research program and to ensure equitable access for veterans with post-traumatic stress disorder (PTSD) [4] (watch PsyCan’s 2024 parliamentary press conference to learn more).
In the US, government is already taking action. The Department of Veterans Affairs has moved forward with significant research [5], and psilocybin is currently under review for potential reclassification at the U.S. Department of Health and Human Services. Meanwhile, Canada remains mired in regulatory red tape.
PsyCan’s recent submission to the Department of Finance as part of the 2025 pre-budget consultations recommends that the Carney government create a section 56 class exemption under the Controlled Drugs and Substances Act allowing any qualified mental health professional with prescribing powers to prescribe psilocybin and MDMA for qualifying mental health conditions.
“This would realize significant legal and administrative cost savings and ease regulatory burden while putting Canada in line with other jurisdictions like Australia and New Zealand,” said PsyCan Executive Director Liam Bedard.
“Provinces aren’t waiting: Alberta passed psychedelic-assisted psychotherapy regulations in 2023, and Quebec has already established billing codes for psychedelic-assisted therapy.”
The broader costs of inaction on this file are enormous. A 2024 report from the Canadian Mental Health Association revealed that 1 in 5 Canadians suffer from mental illness, while 2.5 million suffer inadequate access to treatment. [6] More than 50,000 Canadians die each year from substance use and over 3 million Canadians use substances problematically. [7] All of the resulting ER visits, law enforcement, and lost productivity drains ~$100 billion CAD from the economy each year. [8]
As the home of the world’s most promising psychedelic medicine companies, Canada and has the opportunity to rise to these challenges and become a global leader in this emerging sector (projected to be worth over 8 billion USD by 2028). [9] Beyond eliminating the black market and offering new hope for patients in need, this could mean thousands of new jobs, billions of dollars in new investment, an expanded tax base, and myriad indirect economic multipliers across the country.
The vast majority of Canadians agree. In a time of political division, a remarkable ~68% of citizens are “open to Canadians being allowed to use mushroom-based psilocybin-assisted psychotherapy”, rising to 84% supporting psilocybin for people who are suffering from a terminal illness. [10]
The Government of Canada should reflect society’s consensus and act on this economic, and moral imperative. We have the science and regulatory tools. What we need now is political will.
Media Contact
Liam Bedard
PsyCan Executive Director
(364) 297-6127
admin@psychedelicscanada.org
About PsyCan
Incorporated as the Psychedelics Businesses Association, PsyCan is the not-for-profit trade association of legally operating psychedelic medicine and therapy companies in Canada. PsyCan is dedicated to working collaboratively to advance government regulation, scientific research, and the specific needs of the growing sector. Its member companies represent research, development, manufacturing, and clinic operations. At the time of incorporation, PsyCan was the first national-level trade association for the legal psychedelic medicine and therapy sector anywhere in the world.
psycan.org
admin@psychedelicscanada.org
1 Adelaide Street East Suite 801 Toronto, ON M5C 2V9
[1] Release package (A-2025-000569). Health Canada. August 13, 2025. 3 pages. Records released under the Access to Information Act; administrative cover pages. PDF on file with PsyCan.
[2] Judicial review decision (T‑1881‑23). Federal Court of Canada, Trial Division. June 2025. 36 pages. A decision concerning Dr. Davenport’s request under the Special Access Program (SAP) for psilocybin to treat cluster headaches, highlighting administrative review of the SAP redetermination. Link | Letter to Dr. Davenport (redacted). Health Canada, Pharmaceutical Drugs Directorate. June 7, 2024. A five‑page letter regarding the redetermination of J.L.’s SAP request for psilocybin following a Federal Court decision, including Health Canada’s confirmation of additional evidence received late in the process. Link.
[3] Psilocybin Dispensaries and Online Health Claims in Canada. JAMA Network Open. April 1, 2025. Link.
[4] The Time is Now: Granting equitable access to psychedelic-assisted therapies. Senate of Canada, Subcommittee on Veterans Affairs. November 8, 2023. Link.
[5] Congress must continue to support the VA’s research into psychedelics for PTSD. STAT. August 21, 2025. Link.
[6] The state of mental health in Canada? It’s alarming, a new CMHA report finds. CMHA Ottawa. November 20, 2024. Link
[7] Canadian Substance Use Costs and Harms 2007–2020. Canadian Centre on Substance Use and Addiction. 2023. Link | Mental and substance use disorders in Canada. Statistics Canada. November 27, 2015. Link.
[8] Canadian Substance Use Costs and Harms 2007–2020. Canadian Centre on Substance Use and Addiction. 2023. Link. Making the Case for Investing in Mental Health in Canada. Mental Health Commission of Canada. 2013. Link.
[9] Psychedelic Therapeutics Market worth $8.31 billion by 2028 - Exclusive Report by InsightAce Analytic. InsightAce Analytic. July 18, 2022. Link
[10] National Omnibus Survey. Abacus Data. March 2023. Link.
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
