The Canadian federal pathway that lets physicians request psilocybin and MDMA for individual patients with serious or life-threatening conditions.
Health Canada's Special Access Program gives licensed practitioners a legal way to request unauthorized drugs for patients who have no other options. The program has existed for decades for drugs like thalidomide and certain antivirals. The 2022 amendment extended it to include psilocybin, MDMA, and other restricted drugs for the first time in nearly a decade.
The SAP is not a prescription pathway. It is a case-by-case authorization process managed by Health Canada's Therapeutic Products Directorate. A physician or nurse practitioner submits a request, Health Canada reviews it, and — if approved — the practitioner receives authorization to obtain the drug from a licensed supplier and administer it to that specific patient.
Access is granted to the practitioner, not the patient. Patients cannot apply on their own behalf, and approval for one patient does not set a precedent for others.
Canada has no approved psilocybin or MDMA drug product. Clinical trials are the only other legal route, and not every patient qualifies. The SAP fills the gap for people with serious conditions who cannot wait for trial enrollment or a future drug approval.
Organizations like TheraPsil — the nonprofit that first coordinated SAP access for palliative patients — have helped dozens of patients through the process since 2020, when the program first opened to individual ministerial exemptions before the 2022 class-level amendment.
The Food and Drug Regulations amendment (SOR/2022-86), effective January 5, 2022, reversed a 2013 policy that had blocked SAP access to restricted drugs — a category that includes psilocybin and MDMA under Canada's Controlled Drugs and Substances Act.
Health Canada first proposed the amendment in December 2020 and held a 60-day public comment period that closed February 10, 2021. The final rule came into force more than a year later on January 5, 2022.
At the same time, Health Canada issued a Section 56(1) class exemption under the Controlled Drugs and Substances Act for psilocybin and MDMA specifically. The class exemption means that when Health Canada approves an SAP request for one of these two drugs, the practitioner and patient are automatically covered without needing a separate individual exemption filed in parallel.
Health Canada reviews psilocybin SAP requests mainly for two conditions: end-of-life distress and treatment-resistant major depressive disorder. MDMA requests are reviewed primarily for post-traumatic stress disorder.
These are not rigid gatekeeping categories — the SAP assesses each case on its clinical merits. A patient must have a serious or life-threatening condition, and standard treatments must have failed, been unsuitable, or be unavailable. The practitioner's submission must include the patient's diagnosis, treatment history, and a rationale for why the requested drug is the appropriate next step.
In practice, palliative applications have the highest approval rates. Published data from the journal Nature Mental Health (July 2025) found that palliative-care applications were approved at consistently higher rates than depression applications — a pattern researchers attributed to the clinical urgency being clearer and the risk-benefit calculus more accepted at end of life.
Only physicians and nurse practitioners licensed in their province or territory can submit SAP requests for psilocybin and MDMA. Psychologists, social workers, and other therapists who may provide the psychotherapy component of treatment cannot submit requests — they must work alongside a prescribing practitioner who does.
This is an operational detail many applicants miss. A clinic with a licensed psychedelic therapist on staff still needs a physician or nurse practitioner to be the named requester and the authorized administering provider.
Health Canada has issued approximately 301 psilocybin SAP authorizations from the program's launch in early 2022 through mid-2025. The annual breakdown: 56 in 2022, 106 in 2023, 104 in 2024, and 35 in the first half of 2025.
Approval rates peaked around February 2024 when Health Canada was approving roughly 78% of submitted requests. That rate then dropped sharply. By mid-2025, PsyCan — the Canadian Psychedelic Association, using records obtained under the Access to Information Act — reported that psilocybin and MDMA approvals had fallen to about half their 2024 volume under the Carney government.
MDMA approvals have always been fewer than psilocybin approvals, reflecting both the smaller pool of licensed practitioners comfortable requesting MDMA and the heightened regulatory caution following the US FDA's August 2024 rejection of Lykos Therapeutics' MDMA-assisted therapy application. See our MDMA therapy guide for the FDA decision in detail.
Submitting an SAP request for psilocybin or MDMA requires a licensed physician or nurse practitioner to complete Health Canada's SAP request form and submit it through the Therapeutic Products Directorate. The standard service target is one to two business days, though actual review times have proven significantly longer.
The submission must include the patient's diagnosis, a complete medical and treatment history showing that standard options have been tried or are contraindicated, a description of the proposed treatment protocol, and information about the drug source (typically a licensed supplier or compounding pharmacy authorized for the substance).
Practitioners must also hold or arrange for a drug supply. This is a separate step: SAP authorization permits the use of the drug but does not provide it. TheraPsil and a small number of licensed producers have helped practitioners navigate this step since 2022.
Health Canada's stakeholder notice on psychedelic-assisted psychotherapy makes clear the agency expects SAP requests to be embedded in a therapeutic support structure — preparation, supervised dosing, and integration. The SAP form does not enforce a specific therapy protocol, but practitioners who submit requests with detailed psychotherapy plans tend to receive more favorable reviews.
For patients seeking this pathway, our guide to psychedelic therapy training explains which professionals are qualified to provide the therapy component.
Canada's SAP and Australia's TGA Authorised Prescriber scheme are the two most developed national pathways for physician-led psychedelic access outside of clinical trials, but they differ in scope, prescriber eligibility, and how indications are defined.
| Feature | Canada — Health Canada SAP | Australia — TGA Authorised Prescriber |
|---|---|---|
| Effective date | January 5, 2022 | July 1, 2023 |
| Eligible prescribers | Licensed physicians and nurse practitioners | Psychiatrists only |
| Psilocybin indication | End-of-life distress and treatment-resistant depression (case by case) | Treatment-resistant depression only (fixed indication) |
| MDMA indication | PTSD (case by case) | PTSD only (fixed indication) |
| Review process | Case-by-case by Health Canada | HREC ethics review, then TGA final approval per prescriber |
| Drug scheduling | Restricted drug (CDSA); class exemption for SAP use | Reclassified to Schedule 8 (controlled medicine) for these indications |
| Approval volume (2023–2024) | ~210 psilocybin authorizations in that window | Approximately 60 registered Authorised Prescribers as of late 2024 |
| Prescriber-level vs patient-level | Patient-level authorization (each patient requires a new request) | Prescriber-level authorization (approved psychiatrist can treat multiple patients) |
When Canada's SAP fits better: if the patient is a non-psychiatrist's client, if they have a palliative condition, or if they are seeking care under a nurse practitioner. When Australia's TGA scheme fits better: if the prescriber is a psychiatrist who wants to treat multiple patients under a single authorization without re-applying each time. The patient-level vs prescriber-level distinction is the most operationally important difference and is rarely discussed in news coverage of either program.
For the full picture of where MDMA is accessible worldwide, see our guide to where MDMA is legal.
Bill C-286, introduced in Parliament on June 16, 2026 by Conservative MP Corey Tochor of Saskatchewan, is the first private member's bill to propose a statutory medical-access framework for psilocybin in Canada.
The bill is named Thomas' Bill after Thomas Hartle, a Saskatchewan father with stage IV colon cancer who became Canada's first patient to receive a legal psilocybin exemption in 2020, through a ministerial exemption before the SAP amendment. Hartle died in 2022.
If enacted, Bill C-286 would amend the Controlled Drugs and Substances Act and the Food and Drugs Act to remove psilocybin and psilocin from the restricted-drug category, place them in a standard controlled-drug medical framework, and require priority review status for new drug submissions involving these compounds. This would give practitioners a clearer, more predictable access route than the current SAP.
The SAP is active and accepting requests. Despite falling approval rates, it remains the most accessible legal route for psilocybin or MDMA outside a clinical trial in Canada.
Practitioners who want to submit an SAP request should document the patient's treatment history thoroughly, embed the request within a structured psychotherapy protocol, and plan for a review period longer than the two-business-day target.
For patients, the first step is finding a physician or nurse practitioner willing to submit a request. TheraPsil maintains a list of practitioners trained in the SAP process. For more on what legal psychedelic access looks like internationally, see our guide to legal psychedelics and our psilocybin therapy explainer.
Health Canada's Special Access Program (SAP) lets licensed physicians and nurse practitioners request psilocybin or MDMA for individual patients with serious or life-threatening conditions when standard treatments have failed. The program was amended on January 5, 2022 to include restricted drugs like psilocybin and MDMA. Each request is reviewed case by case, and approval is not guaranteed.
Health Canada reviews SAP requests for psilocybin primarily for patients with end-of-life distress or treatment-resistant major depressive disorder. MDMA access is reviewed mainly for post-traumatic stress disorder. All patients must have a serious or life-threatening condition and must have tried or been unable to tolerate standard treatments. Only a licensed physician or nurse practitioner can submit the request — patients cannot apply directly.
Health Canada has issued approximately 301 SAP authorizations for psilocybin since the 2022 amendments — 56 in 2022, 106 in 2023, 104 in 2024, and 35 in the first half of 2025. Approval rates peaked at roughly 78% of submitted requests in early 2024, then declined sharply in 2025 under the Carney government.
Along with the January 2022 regulatory amendment, Health Canada issued a Section 56(1) class exemption under the Controlled Drugs and Substances Act specifically for psilocybin and MDMA. This means practitioners and their patients do not need separate individual exemptions each time — the SAP authorization itself covers the legal basis for access. It does not guarantee approval of any individual request.
Both programs allow physician-led access to psilocybin and MDMA outside of clinical trials. The key difference is eligibility: Canada's SAP accepts requests from any licensed physician or nurse practitioner, while Australia's TGA Authorised Prescriber scheme is limited to psychiatrists only. Australia also reclassified both drugs as Schedule 8 substances with fixed indications, while Canada reviews each case individually without a fixed indication list. Australia's scheme is also prescriber-level rather than patient-level, meaning one approval covers multiple patients.
Bill C-286, known as Thomas' Bill after the late Thomas Hartle — Canada's first legal psilocybin patient — is a private member's bill introduced in June 2026 by Conservative MP Corey Tochor. It would amend the Controlled Drugs and Substances Act and the Food and Drugs Act to remove psilocybin and psilocin from the restricted-drug category and place them in a standard controlled-drug medical framework, requiring priority review for new drug submissions. If passed, it would replace the SAP with a more predictable regulatory pathway. The bill is at first reading as of June 2026.
The Health Canada SAP, Australia's TGA scheme, and US clinical trial pathways are all moving at different speeds. Our legalization tracker logs every significant policy move — approvals, declines, new bills, and court rulings — as they happen.
→ Psychedelic legalization tracker · Where is MDMA legal worldwide?
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