Emergency Access Restored for Restricted Drugs

Summary#

The federal government published the final Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program). The rules restore the possibility for practitioners to request some restricted drugs through Health Canada’s Special Access Program, and they make all forms of cocaine subject only to the Narcotic Control Regulations. These changes came into force on January 5, 2022.

What it does#

• Restores the possibility for practitioners to ask Health Canada to authorize the sale or import of a restricted drug through the Special Access Program for emergency treatment when other therapies have failed, are unsuitable, or are unavailable. Requests are still assessed case‑by‑case.
• Removes cocaine from the definition of “restricted drug,” so that all cocaine products are regulated only under the Narcotic Control Regulations (instead of being split between two different rules).
• Repeals a few definitions and related parts of Part J of the Food and Drug Regulations that were only needed because of the prior split regulation of cocaine.
• Comes into force on the date of publication in the Canada Gazette, Part II (effective January 5, 2022).

Who's affected#

• People with serious or life‑threatening conditions who might seek experimental or unapproved treatments in emergencies. Access is not automatic; clinicians must apply through the Special Access Program.
• Doctors, nurse practitioners and other clinicians who may submit applications on behalf of patients. They will need to prepare applications and report patient outcomes and any adverse reactions if authorized.
• Small medical clinics and private practices that support clinicians in preparing and tracking applications (some extra administrative time).
• Researchers, manufacturers and licensed dealers who handle cocaine. The single regulatory regime for cocaine reduces confusion about which rules apply.
• Health Canada, which will process requests, update guidance and answer questions about the change.

Why it matters#

• It reopens a narrow emergency pathway for certain restricted drugs that were barred from the Special Access Program after earlier regulatory changes. This could matter to individual patients who cannot join a clinical trial and have exhausted other treatments.
• It brings regulatory clarity by having one set of rules for all cocaine products, which should make it easier for researchers and industry to follow the law.
• The change does not legalize these drugs for general medical use or create large‑scale access. Each request will still be judged on its scientific evidence and the patient’s condition, and the Special Access Program is intended for emergency situations only.
• Practically, clinicians will see a small increase in paperwork and Health Canada expects a short‑term rise in interest and requests after the change, but not necessarily a large or permanent surge.