Bill C-265 Therapeutic Products
C-265 An Act to Amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access)
Bill Type: Private Member’s Bill
Bill Sponsor: Marcus Powlowski (Thunder Bay—Rainy River)
What is Special Access?
Canada's Special Access Program allows doctors to request unapproved or non-marketed drugs for patients with serious or life-threatening conditions when no approved treatment is available or working. Right now the process is slow, paperwork-heavy and entirely at the Minister's discretion. This Bill creates a pre-approved list of therapeutic products that can be accessed faster, sets rules for how the Minister must decide on emergency drug requests and protects doctors who use their clinical judgment in a genuine emergency.
- ⚠️ Every decision in this Bill flows through a single point of control — the Minister of Health — what gets listed, who can use it, what standards apply, what the advisory committee recommends and whether a patient's doctor can access a treatment are all Ministerial calls with no parliamentary oversight, no patient appeal mechanism and no binding external check
Status: 2nd Reading — debate May 8, 2026. This Bill hasn't passed yet.
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WHO GAINS POWER
- The Minister of Health gains the authority to establish and maintain the pre-approved list, add or remove products, limit which practitioners can use them and impose conditions on their use
- The Minister gains the power to require manufacturers to explain why they are not seeking full regulatory approval — and to remove products from the list if the explanation is not satisfactory
- ⚠️ The Minister decides what "appropriate quality and safety standards" means — that standard is not defined in the Bill and is left entirely to Ministerial discretion
- An advisory committee of unpaid experts gains a formal consultative role — but their recommendations are not binding on the Minister
WHO LOSES POWER
- Manufacturers lose the ability to use the special access list indefinitely as a substitute for full regulatory approval
- ⚠️ The advisory committee has no binding authority — the Minister consults them but is not required to follow their advice
- ⚠️ Patients have no direct role in the process — access to a pre-approved therapeutic product depends entirely on their practitioner making a request; patients cannot apply directly, appeal a refusal or request that a product be added to the list
WHO GAINS MONEY
- Manufacturers of non-marketed therapeutic products gain a streamlined pathway to sell products in Canada without full regulatory approval
- Manufacturers may sell in anticipation of requests — not just in response to them — opening a pre-stocking market
- ⚠️ Sales made under this Bill are exempt from most provisions of the Food and Drugs Act — manufacturers operating under the list face a lighter regulatory burden than those seeking full approval
WHO LOSES MONEY
- Manufacturers who have invested in full regulatory approval face competition from products on the pre-approved list that bypassed that process
- No compensation or liability framework is established for patients harmed by products accessed through the list
THE CATCH
- ⚠️ The pre-approved list is built and controlled entirely by the Minister — what goes on it, what comes off it and who can use it are all Ministerial decisions with no Parliamentary oversight mechanism written into the Bill
- ⚠️ Products authorized by a foreign regulatory authority can be added to the list even if the uses are not approved by that foreign authority — the uses only need to be supported by "generally accepted guidelines or clinical evidence," a standard the Minister interprets
- ⚠️ Advisory committee members are unpaid and not reimbursed for expenses — the Bill explicitly prohibits remuneration, which limits who can realistically serve and raises questions about who will actually sit on the committee
- The Bill comes into force one year after Royal Assent — meaning the list, the committee and the reporting framework all need to be built from scratch within that window
- ⚠️ No liability framework is established — if a patient is harmed by a product accessed through the pre-approved list, the Bill does not address who is responsible
- Practitioners can administer a new drug in an emergency without authorization but must notify the Minister afterward — the Bill does not specify consequences if they do not
- ⚠️ The exemption from the Food and Drugs Act for sales and imports under this Bill is broad — only the provisions of this Part and its regulations apply, which is a significantly lighter standard than full regulatory approval