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Drug Coverage: The Special Access Programme (SAP)

All prescription drugs need to be approved for sale in Canada in order for you to access them. But what if you have a serious health condition and have exhausted all of the current available treatment options? If your doctor strongly advises a medication that is not yet approved for sale in Canada, you may be able to access the drug through the Special Access Programme (SAP).

What is the SAP?
How do I access medication through the SAP?
Are the medications safe?
Who pays for these drugs?

What is the SAP?

Developed by Health Canada, the SAP gives physicians access to medications that are not currently available in Canada—but only under special circumstances. When conventional therapies have failed or are deemed unsuitable, a doctor can request access to an otherwise unauthorized drug to treat patients with serious or life-threatening conditions. The SAP can help patients get additional medications for conditions like seizures, terminal cancer, AIDS, as well as hemophilia and other blood disorders.

Visit the Health Canada website to find more information about the SAP. You can also learn more about special access programs offered by your province or territory.

How do I access medication through the SAP?

To initiate a request, your physician must fill out the required Special Access Request forms, and must also agree to provide a report on the results of the use of the drug, including any adverse reactions.

The manufacturer of the drug reserves the right to decide whether or not to supply it, and can impose strict guidelines to ensure that it is used as intended, based on clinical evidence.

SAP requests are granted according to need and decisions are based on whether or not other treatments are advisable. If the request is approved by Health Canada’s Therapeutic Products Directorate, the medications will be shipped directly to your doctor or to an inpatient pharmacy. Your doctor can request a dosage that will last up to six months for chronic treatments, but must re-submit a SAP form for more.

Are the medications safe?

Health Canada does not guarantee that a drug accessed through the SAP is safe or effective. The SAP does not conduct a comprehensive investigation into the effectiveness of the available drugs, nor do they request proof of drug quality or safety from the manufacturer.

Physicians have a responsibility to consider all variables both when recommending a drug and when considering the risks and benefits. If your doctor is requesting a drug on your behalf, he should have credible evidence to support the use of that particular drug, and should inform you of both the benefits and the possible risks.

Who pays for these drugs?

Some manufacturers may provide medications released through the SAP free of charge, though they are not required to. If there is a charge for the medication, the patient or a public drug plan must cover the cost.

If you have questions about the SAP, including processing and authorization information, you can contact them directly at:

Special Access Programme
Therapeutic Products Directorate
2nd Floor, Holland Cross, Tower A
11 Holland Ave., A.L. 3002C
Ottawa, ON, K1A 0K9

Phone: (613) 941-2108
Fax: (613) 941-3194
E-Mail: SAPdrugs@hc-sc.gc.ca

Key Websites:

• Health Canada: The Special Access Programme

Related Articles:

• Special Medication Access: Locating provincial programs
• Publicly Funded Drug Plans: Know your options
• Private Drug Insurance: Your coverage explained

References