Health Canada says it has approved 354 Special Access requests for psilocybin since 2022.

The yearly figures in Health Canada’s reply to Parliament, Sessional Paper 8555-451-1384 (opens in new tab), add up to 354 Special Access applications for psilocybin approved from 2022 into 2026.

The table records 28 denials, and withdrawn requests are outside it: Health Canada’s guidance (opens in new tab) says a practitioner “may choose to withdraw the request rather than receiving a denial”.

For 157 of the applications the table counts as received, it records neither an approval nor a denial, and it does not say why.

From 2 October 2013 the Food and Drug Regulations barred Health Canada (opens in new tab) from issuing a letter of authorization for any restricted drug, a category that included psilocybin. An amendment published on 5 January 2022 (opens in new tab) repealed the bar.

Only a practitioner can apply, for a patient under their care. Health Canada’s information for patients (opens in new tab) says applicants are “typically physicians” and that “Patients cannot apply directly.” A request has to be for a serious or life-threatening condition where conventional treatments have failed, are unsuitable or are unavailable in Canada.

The department decides each request case by case. Its notice on psychedelic requests (opens in new tab) says the Program considers whether conventional treatments “have been tried and have failed or have been considered and deemed not appropriate for that patient”. It adds that Health Canada’s role “is not to question the practitioner’s diagnosis or recommended treatment option”.

Health Canada’s psilocybin page (opens in new tab) says “There is no guarantee that a request for psilocybin, or any other unauthorized drug, will be granted”. The reply to Parliament gives no breakdown by condition.

One request is not one patient. The Program’s patient request form, Form A, in the guidance’s words “is used to request access to a drug for immediate use for one or multiple patient(s)”. For psychedelic requests the notice asks for a patient-specific form, and “new or repeat requests” both need one.

An approval, in the notice’s words, “is not a broad statement or opinion that the drug is safe, efficacious or of high quality, rather, that the sale is justifiable in the context of a medical emergency”. The Program asks the manufacturer named in the request to confirm it is “able and willing to sell the drug”. The guidance says Health Canada “cannot compel a manufacturer” to sell.

Health Canada says (opens in new tab) that “In some circumstances, with the support of a regulated health care practitioner, it may be possible for individuals to legally access psilocybin through one of three pathways”. This count covers one of them.

The Program remains a lawful route. Its letter of authorization is still issued under the Food and Drug Regulations (opens in new tab), and since 1 October 2026 the Controlled Substances Regulations (opens in new tab) let the practitioner named in it sell, provide or administer a restricted drug to the patient they are treating. Canada’s entry in the register carries the rest of the law.

Two sets of yearly figures were published before the reply, and neither matches it in any year. In June 2025 CBC News printed (opens in new tab) yearly counts of authorized requests without stating their source. In a comment in the July 2025 issue of Nature Mental Health (opens in new tab), Quebec researchers published figures released to them under an access-to-information request. Unlike the reply, those figures were broken down by condition.

CBC reported on 16 June 2026 (opens in new tab) that a Health Canada spokesperson said the department had issued 354 authorizations for psilocybin since January 2022, the same total the reply’s yearly figures add up to.

Health Canada ends each approval with a letter, faxed to a manufacturer and copied to a practitioner. The yearly figures in its reply to Parliament add up to 354 approvals. How many patients they covered, the reply does not say.