C-265 (45-1) - An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access)
Chamber
commons
Stage
1st Reading
Introduced
Mar 11, 2026
Progress
This bill creates a pre-approved list of unapproved drugs for faster access by patients with serious or life-threatening conditions.
Key Changes
- Creates a publicly published 'List of Therapeutic Products Pre-approved for Special Access' for unapproved drugs and devices used in serious or life-threatening conditions
- Allows manufacturers to sell and import listed products to practitioners without standard regulatory approval, subject to oversight and reporting requirements
- Sets criteria and limitations for the Minister of Health when deciding whether to issue letters of authorization for emergency use of unapproved drugs
- Allows doctors to temporarily use an unapproved drug in a genuine emergency based on clinical judgment, without prior authorization, with a requirement to notify the Minister afterward
- Requires an independent expert advisory committee (unpaid) to be consulted before the list is established or changed
- Requires annual public reports on the effectiveness of the special access list and the letter of authorization process
Gotchas
- Products sold or imported under this framework are exempt from most provisions of the Food and Drugs Act and its regulations, except those specifically created for this new Part — this is a broad regulatory carve-out that may raise safety oversight questions
- The advisory committee members receive no pay or expense reimbursement, which could limit participation and the range of experts willing to serve
- The Minister cannot refuse a letter of authorization solely because other treatments exist in Canada or because a clinical trial is currently recruiting — this limits the Minister's discretion in ways that differ from current practice
- If two expert clinicians submit a treatment plan and informed consent confirmation, the Minister is presumed to be required to issue a letter of authorization unless diversion or significant public harm is likely — this creates a near-automatic approval pathway in some cases
- The bill includes a provision allowing the Minister to investigate whether manufacturers are using the special access list to avoid the full drug approval process, and can remove products or require full approval if abuse is suspected
Who's Affected
- Patients with serious, life-threatening, or rare conditions who cannot access adequate treatment through currently approved Canadian products
- Physicians and other licensed practitioners who treat these patients
- Pharmacists and hospitals involved in obtaining or dispensing special access products
- Drug and medical device manufacturers, including foreign manufacturers whose products may be added to the list
- Health Canada and the Minister of Health, who gain new administrative responsibilities
- Pediatric and rare disease patient communities specifically mentioned as priority populations
Vibes
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Gotchas
- Products sold or imported under this framework are exempt from most provisions of the Food and Drugs Act and its regulations, except those specifically created for this new Part — this is a broad regulatory carve-out that may raise safety oversight questions
- The advisory committee members receive no pay or expense reimbursement, which could limit participation and the range of experts willing to serve
- The Minister cannot refuse a letter of authorization solely because other treatments exist in Canada or because a clinical trial is currently recruiting — this limits the Minister's discretion in ways that differ from current practice
- If two expert clinicians submit a treatment plan and informed consent confirmation, the Minister is presumed to be required to issue a letter of authorization unless diversion or significant public harm is likely — this creates a near-automatic approval pathway in some cases
- The bill includes a provision allowing the Minister to investigate whether manufacturers are using the special access list to avoid the full drug approval process, and can remove products or require full approval if abuse is suspected
Summary
Bill C-265 amends the Food and Drugs Act to create a new 'List of Therapeutic Products Pre-approved for Special Access.' This list would include drugs and medical devices that haven't gone through full Canadian approval but could be used to treat patients with serious, life-threatening, or rare conditions when no comparable approved product is available in Canada. Doctors, pharmacists, hospitals, and medical non-profits could request products be added to the list, and manufacturers could sell or import listed products to practitioners without going through the normal full approval process. The bill also sets clearer rules for when the Minister of Health can issue 'letters of authorization' — special permissions for doctors to use unapproved drugs in emergencies. It requires the Minister to weigh benefits against risks, consider a wide range of evidence, and provide written reasons if a request is denied. In true emergencies, doctors can temporarily use an unapproved drug based on their own clinical judgment, even without prior authorization, as long as they notify the Minister afterward. The bill was introduced by MP Powlowski and is intended to reduce delays and red tape that can prevent seriously ill patients — including children with rare diseases — from accessing treatments that are available in other countries but not yet approved in Canada.
Automatically generated from bill text using Claude
Vibes
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