C-265, An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access), would amend the federal Food and Drugs Act. Its stated goal is to streamline access to treatment for serious or life-threatening conditions and where there is an unmet need. These are proposed changes, not provisions in force; if enacted, the bill would come into force one year after royal assent.
The Minister of Health would have to establish and publish a list of certain non-marketed therapeutic products, including products for serious or life-threatening conditions or where a comparable product is unavailable in Canada.
The Minister could add products, set limits or conditions on their use, and remove products or uses for listed reasons. Practitioners, pharmacists, hospitals and medical non-profit organizations could submit products for consideration; the Minister would have to decide within 120 days.
Practitioners could request listed products from manufacturers for patients in their care. Manufacturers could sell them, and certain licence holders could import and distribute them, under exemptions from other provisions of the Act and its regulations.
Practitioners, manufacturers and importers would have reporting duties. The Minister could also require information or restrict a practitioner’s use of a product if it poses a significant health or safety risk.
For requests to use a new drug in an emergency, the bill would set decision rules for the Minister, require written reasons for refusals, and require every effort to make a Health Canada employee available at all times to help practitioners obtain authorization.
In an emergency, practitioners could temporarily administer certain lawfully manufactured or imported products without prior authorization, based on clinical judgment. For new drugs, the practitioner would have to notify the Minister; this would not authorize continued use without a letter of authorization.
Patients: The bill could provide a route to request certain products that are not marketed in Canada. It does not require a manufacturer to sell a product, guarantee that a product will be available, or create a general entitlement to receive one.
Practitioners: You could request a listed product for a patient without knowing the patient’s identity when making the request. You would have to report within 90 days and provide information the Minister requires. For emergency use of a new drug without a letter, you would have to notify the Minister; continued use would still require a letter.
Manufacturers and importers: A manufacturer could sell a listed product in response to a request or, subject to Minister-set limits or conditions, in anticipation of one. Licensed importers could import products on the same basis and distribute them in response to requests. Sales and imports would have to be reported within 90 days.
Health Canada: The Minister would have to consult an expert committee before establishing or changing the list, publish the list and changes, and prepare annual reports. The committee’s members would not be paid or reimbursed.
General public: The bill would not change drug prices, require manufacturers to supply products, or create a new independent agency. The supplied text does not establish a new front-line treatment service.
The bill assigns duties to the Minister and Health Canada, including maintaining the list, deciding submissions, publishing information and reports, and making every effort to provide an employee available at all times for emergency assistance. It gives no staffing or cost estimate.
Advisory committee members could not receive pay or expense reimbursement.
The bill does not define important terms such as “appropriate quality and safety standards,” “serious” condition, or “significant” difference between products.
It does not set out the full application or review process for adding a product, beyond allowing submissions and requiring a decision within 120 days. The scope of information the Minister may require is also left to the Minister.
Manufacturers may sell products, but the bill does not require them to do so. It does not explain how product supply, pricing, or shortages would be handled.
The exemptions from other provisions of the Act and regulations are broad; some import-related rules could later be specified by ministerial order. The supplied text does not explain how the new route would interact with existing special-access processes.
The supplied material does not show the bill’s current parliamentary status or provide the parent Act and regulations, so current-law details and overlap cannot be verified.
The bill appears intended to make some non-marketed products easier to access when a comparable Canadian-market product is unavailable or a patient has a serious condition.
A public list, published reasons for removals, and annual reports could make this access route more visible.
The bill directs the Minister to consider different kinds of medical evidence, including clinical practice, studies and data recognized by foreign regulators.
For emergency new-drug requests, the bill requires the Minister to weigh the risks of not authorizing treatment and, in specified circumstances, to issue a letter when two expert practitioners provide a treatment plan and informed-consent statements.
A listing would not guarantee access: manufacturers may sell, but are not required to, and the bill does not set supply or pricing rules.
The Minister’s quality and safety standards and some key eligibility terms are not defined in the bill, leaving important decisions to later rules or judgment.
Products sold or imported through this route would be exempt from other provisions of the Act and regulations except the new Part and rules made for it. The bill allows some import controls by order but does not set out a full oversight system in the text.
The reporting rules can require patient-identifying information, including a name and address for shipments, but the bill does not explain how that information would be protected.
The bill requires emergency administration of a new drug without a letter to be temporary, but does not define “temporary” or set a specific time limit.