Bill C-265 Aims to Streamline Canada’s Special Access Program
This article was originally published by Law360 Canada, part of LexisNexis Canada Inc.
The Special Access Program (SAP) provides a regulatory mechanism under the Food and Drug Regulations, Part C, Division 8, sections C.08.010 and C.08.011, and Food and Drugs Act, allowing practitioners to request access to drugs not authorized for sale in Canada.
Comparatively, Canada’s SAP is analogous to the United States’ expanded-access program and the European Medicines Agency’s compassionate-use framework. Both allow patients with serious or life-threatening conditions to access unapproved therapies under defined conditions.
Under Canada’s SAP, access is permitted on a compassionate basis for a medical emergency, interpreted by Health Canada as serious or life-threatening conditions where conventional therapies have failed, are unsuitable, or unavailable.
Therapies may be unavailable for several reasons: they are not approved or marketed in Canada, are subject to shortage, or have been discontinued from the Canadian market. In circumstances of drug shortage or discontinuation, the SAP will consider requests on a case-by-case basis for alternatives to otherwise marketed drugs to address a medical emergency.
SAP is not intended to circumvent the drug approval process, but rather to provide compassionate access in exceptional cases. Health Canada evaluates SAP requests on a case-by-case basis, exercising statutory discretion in deciding whether to authorize or deny access.
Requesting a Drug Previously Authorized through the SAP
Health Canada receives about 12,000 SAP requests annually, most involving drugs previously authorized through SAP.
In 2020, amendments to the Food and Drug Regulations reduced the regulatory burden on practitioners seeking access to a drug that has been previously authorized through SAP for use in emergency treatment.[1]
The amendments permit practitioners to submit a request for a drug previously authorized by the SAP without information on the use, safety and efficacy where:
The drug has been previously authorized by the SAP for the same medical emergency;
The drug is authorized for sale without terms and conditions (i.e. without any further restrictions placed on the drug) by the European Medicines Agency or the United States Food and Drug Administration to address the same use for which the drug is requested; and
Any drug identification number previously issued for the drug has not been cancelled.[2]
While these reduced information requirements were intended to expedite access, the practical impact may be constrained by the need for the practitioner to contact Health Canada to find out if the drug has been previously authorized. Health Canada has indicated that maintaining a continuously updated list presents a challenge due to the dynamic nature of SAP authorizations.
To promote transparency, Health Canada publishes a list of drugs most frequently accessed through SAP updated annually, including request volumes and therapeutic areas.[3] However, future requests for a drug appearing on the list are not guaranteed to be approved.
Private Member’s Bill C-265: Pre-Approved Therapies for Special Access
On March 11, 2026, Private Member’s Bill C-265, An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access) was introduced at first reading in the House of Commons by Dr. Marcus Powlowski.[4]
Bill C-265 proposes establishing a list of therapeutic products pre-approved for special access to allow streamlined access to treatment for patients with serious or life-threatening conditions or where there is an unmet need.
A pre-approved therapeutic products list for SAP may address practical limitations arising from the 2020 regulatory amendment in expediting access. It may also represent a limited recalibration of discretionary authority, by providing practitioners with a more active role in facilitating access to unapproved therapies in life-threatening situations.
Notably, Bill C-265 also proposes expanding SAP eligibility beyond “emergency treatment” by broadening access where unmet medical need is demonstrated.
Next Steps and Considerations
Health Canada’s published data on volume of SAP requests — particularly for therapies which may be considered first-line treatments in other jurisdictions — may reflect structural considerations within Canada’s drug approval and launch environment. Continued reliance on SAP for therapies already established in comparable jurisdictions may reflect regulatory and commercial considerations affecting Canadian market entry timelines and launch sequencing decisions.
[1]Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment): SOR/2020-212, Canada Gazette, Part II, Volume 154, Number 21.
[2]Food and Drug Regulations, C.08.010 (1)(a)(iii) and C.08.010 (2).
[3]Health Canada’s special access programs: Most often requested drugs.
[4]Private Member’s Bill C-265, An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access), First Reading, House of Commons, March 11, 2026.
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