[Dictionary] 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 an unauthorized drug, biologic, or medical device for a named patient with a serious or life-threatening condition when conventional therapies have failed, are unsuitable, or are unavailable in Canada. It runs as two administratively separate streams -- drugs/biologics and medical devices -- each with its own request form. SAP is explicitly not a research pathway: Health Canada's own guidance states it cannot be used to bypass a Clinical Trial Application, run a research study, or promote early product adoption. The practitioner (not the patient) sources the product and submits the request; time-sensitive, life-threatening cases are typically resolved within hours, while cost is set by the manufacturer and may fall to the hospital, an insurer, or the patient.