Information for patients on the Special Access Program

On this page

• About the Special Access Program
• Who can apply
• How decisions are made
• Other steps and requirements
• Expected timelines
• Following up on requests

About the Special Access Program

The Special Access Program (SAP) can help patients get access to drugs and medical devices that are not yet sold in Canada.

The SAP is only intended for medical emergency situations. It may be used for patients with serious or life-threatening conditions, but only when conventional therapies have failed, are not medically suitable, or are unavailable in Canada.

Who can apply

Only health or dental practitioners, typically physicians, can apply to the SAP. They must make the request on behalf of a patient under their care.

Patients cannot apply directly.

The practitioner is responsible for ensuring that the request is complete and is supported by credible evidence for the proposed use of the drug or medical device.

How decisions are made

We review each request as quickly as possible. Every request is assessed individually, based on the patient’s situation and the information provided.

The review checks:

• if the request fits within the scope of the SAP
• if there is sufficient evidence that the proposed treatment may work and
• if the proposed treatment poses any unnecessary risks to the patient

An authorization under the SAP is not the same as full market approval. Drugs and medical devices approved under the SAP have not gone through our full review for safety, efficacy/effectiveness, or quality.

After the evaluation of the request, the practitioner is informed of the decision. The information is confidential and cannot be shared with anyone else. If a request is approved, a formal letter is sent to the manufacturer allowing the sale of the drug or medical device. A copy of that letter is also sent to the practitioner.

Most SAP approvals are for drugs and medical devices available in other countries who have similar regulations, such as the United States or the European Union.

Other steps and requirements

If we approve a SAP request, the drug or medical device manufacturer must also agree to provide the health product through the program. We cannot require them to do so.

The practitioner is responsible for explaining the possible risks and benefits to the patient. In the case of drugs, practitioners are also responsible for reporting treatment results, including any side effects experienced by the patient, to Health Canada.

Expected timelines

SAP reviews urgent requests as quickly as possible. Each request to the SAP is unique and reviewed on a case-by-case basis. Timelines for decisions vary depending on the nature of the medical emergency, the availability of marketed alternatives, and the information provided in support of the request regarding the use, safety and efficacy/effectiveness of the drug or medical device.

Following up on requests

Since SAP requests are confidential, only the practitioner who made the request can contact the SAP about it.

Patients should communicate with their practitioner if they have any questions regarding the status of the request.