Health Canada Special Access Program (SAP)

Health Canada’s Special Access Program (SAP) is the federal mechanism that lets a licensed health, dental, or veterinary practitioner request a drug, biologic, or medical device that is not authorized for sale in Canada, on behalf of a specific patient with a serious or life-threatening condition for whom conventional therapies have failed, are unsuitable, or are unavailable. It runs as two related but administratively separate streams — drugs (including biologics) and medical devices — each with its own request form and review path, both governed under the Food and Drug Regulations and the Medical Devices Regulations respectively.

Not a clinical-trial pathway

SAP is explicitly outside the research framework: Health Canada’s own guidance states the program cannot be used to bypass a Clinical Trial Application, run a research study, or promote early adoption of a product ahead of its formal authorization. It exists for individual-patient treatment access, not for generating trial data. A research administrator most often encounters SAP at the edges of a trial — when a study closes to enrollment but a participant is still benefiting and has no other option, or when a sponsor is evaluating whether continued access after a trial’s end should run through SAP rather than a protocol amendment.

How a request moves through SAP

The practitioner — not the patient — sources the product first, identifying a manufacturer willing to supply it, then submits a signed SAP request form to Health Canada. Time-sensitive, life-threatening requests are prioritized and are commonly resolved within hours; other requests can take longer. Cost is not standardized: the manufacturer sets the price, and depending on the case it may be covered free of charge, by the requesting hospital, by a private or public insurer, or by the patient or family directly — SAP authorizes access, it does not fund it.

Worked examples

Example 1. A Phase III oncology trial closes to enrollment, but two participants are still responding well to the investigational drug and have no comparable alternative. Rather than extending the trial protocol to keep supplying them, the sponsor and treating physicians arrange continued access through an SAP drug request — the product remains unauthorized in Canada, so post-trial access still needs its own authorization route separate from the now-closed trial.

Example 2. A specialist wants to treat a patient with a device approved in the EU or US but not yet licensed for sale in Canada, and no Canadian trial program exists for it. Because the goal is treating this one patient rather than generating research data, the specialist applies through the SAP medical-devices stream rather than waiting for the manufacturer to complete a full Medical Device Licence application.

What SAP is not

A sponsor wanting to supply an investigational drug to participants enrolled in a new, Health Canada–authorized trial is not an SAP matter — that is governed by the Clinical Trial Application process itself, plus Research Ethics Board approval at each site. SAP applies only to individual-patient access outside a trial; conflating the two is a common source of confusion for anyone new to the Canadian regulatory landscape.