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 therapeutic products that doctors can access more easily for 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 licensed practitioners to order products directly from manufacturers once a product is on the list, without a separate special access application each time
- Sets criteria and limits on when the Minister can refuse to issue a letter of authorization for emergency use of a new drug
- Allows doctors to use an unapproved drug in a true emergency based on clinical judgment, with a requirement to notify the Minister afterward
- Requires the Minister to consult an unpaid expert advisory committee before adding or changing the list, and to publish annual reports on the program's effectiveness
- Gives the Minister power to remove products from the list for safety concerns, misuse, diversion, or if a manufacturer appears to be avoiding the full approval process
Gotchas
- Advisory committee members are explicitly unpaid and not reimbursed for expenses, which could limit participation from some experts, particularly those in private practice or from underrepresented regions
- Manufacturers can sell or importers can import products 'in anticipation' of a practitioner request, which could lead to stockpiling of unapproved products under certain conditions
- The bill exempts listed products from most of the Food and Drugs Act and its regulations during sale, import, and distribution — oversight relies primarily on the new Part I.1 provisions and ministerial orders
- The Minister can refuse a letter of authorization if use of the drug is likely to cause 'diversion or other significant public harm,' but this term is not defined in the bill
- The bill comes into force one year after royal assent, giving Health Canada time to establish the list and processes, but creating a gap period before the new system is operational
- A manufacturer suspected of using the list to avoid full regulatory approval can be required to justify their decision, and the Minister can remove their product — but the bill does not set a timeline for this process
Who's Affected
- Patients with serious, life-threatening, or rare conditions who need access to unapproved treatments
- Physicians and other licensed practitioners who treat such patients
- Pharmacists and hospitals involved in obtaining or dispensing special access products
- Manufacturers and importers of therapeutic products
- Health Canada and the Minister of Health, who must administer the new list and reporting requirements
Vibes
0 responses
Gotchas
- Advisory committee members are explicitly unpaid and not reimbursed for expenses, which could limit participation from some experts, particularly those in private practice or from underrepresented regions
- Manufacturers can sell or importers can import products 'in anticipation' of a practitioner request, which could lead to stockpiling of unapproved products under certain conditions
- The bill exempts listed products from most of the Food and Drugs Act and its regulations during sale, import, and distribution — oversight relies primarily on the new Part I.1 provisions and ministerial orders
- The Minister can refuse a letter of authorization if use of the drug is likely to cause 'diversion or other significant public harm,' but this term is not defined in the bill
- The bill comes into force one year after royal assent, giving Health Canada time to establish the list and processes, but creating a gap period before the new system is operational
- A manufacturer suspected of using the list to avoid full regulatory approval can be required to justify their decision, and the Minister can remove their product — but the bill does not set a timeline for this process
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 regulatory approval but meet certain safety and quality standards. Doctors, pharmacists, hospitals, and medical non-profits could request products be added to the list, and once on it, licensed practitioners could order those products for their patients without going through the usual case-by-case special access application process. The bill also sets clearer rules for when the Minister of Health must issue a 'letter of authorization' — a document allowing a doctor to use an unapproved drug for emergency treatment. It limits the reasons the Minister can use to refuse such requests and requires written explanations when a request is denied. In true emergencies, doctors would be allowed to 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 to reduce bureaucratic delays for patients with serious or rare conditions who need treatments not yet approved or available in Canada. It aims to streamline access while maintaining oversight through reporting requirements, an advisory committee, and ministerial powers to remove products from the list if safety concerns arise.
Automatically generated from bill text using Claude
Vibes
0 responses