Notice: Clarifications Regarding Access to Restricted Drugs through the Special Access Program (SAP)

Date: July 23, 2021
Our file number: 21-113500-270

Key messages

Drugs are authorized for sale in Canada once they have successfully gone through the drug review process, which includes the assessment of the safety, efficacy and quality of the drug. However, Health Canada's SAP allows practitioners to request access to drugs that are not available in Canada for the emergency treatment of patients with serious or life-threatening conditions who have exhausted other treatment options.

Due to regulatory changes made in 2013, restricted drugs cannot currently be accessed through the SAP. Although restricted drugs do not generally have authorized medical uses, the science regarding the efficacy and safety of certain restricted drugs has continued to advance. In December 2020, Health Canada published a Notice of Intent that proposed to reverse the regulatory changes made in 2013, and thereby restore potential access to restricted drugs through the SAP.

In practice, this would mean that practitioners could request access to restricted drugs through the SAP on a patient-by-patient basis on behalf of patients with serious or life-threatening conditions, in instances where other therapies have failed, are unsuitable or are not available in Canada. However, it is important to note that the proposed amendments would not guarantee that restricted drugs would be approved through the SAP. The proposed amendments would simply treat restricted drugs like all other drugs for the purposes of the SAP. The SAP is a science-based program that only grants access to an unapproved drug where scientific evidence is available to support the potential effective and safe use of the drug for the treatment of the underlying medical condition. All requests will continue to be assessed on a case-by-case basis taking into consideration the level of evidence regarding the safety and efficacy for the proposed use, the quality of the drug, as well as the patient's condition and their clinical status.

Next steps

Should Health Canada proceed with these proposed changes, the regulatory amendments will be published in the Canada Gazette.

Contact us

For questions about SAP, please contact us at:

Special Access Program
Health Canada

Telephone: 613-941-2108
Fax: 613-941-3194
E-mail: hc.sapd-pasm.sc@canada.ca

Related links

Footnote 1

Restricted drugs are controlled substances listed in the Schedule to Part J of the Food and Drug Regulations (FDR) (https://laws-lois.justice.gc.ca/eng/regulations/c.r.c.,_c._870/page-189.html#docCont).

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Footnote 2

Section C.01.001. of the FDR (https://laws-lois.justice.gc.ca/eng/regulations/c.r.c.,_c._870/page-94.html#h-574670) defines a practitioner as "a person who (a) is entitled under the laws of a province to treat patients with a prescription drug, and (b) is practising their profession in that province".

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Footnote 3

In accordance with Section C.08.002 of the FDR (https://laws-lois.justice.gc.ca/eng/regulations/c.r.c.,_c._870/page-142.html#docCont)

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