An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access)

This bill changes the Food and Drugs Act to make it easier for doctors to get patients access to treatments that aren't yet fully approved for sale in Canada, particularly for serious or life-threatening conditions, rare diseases, or situations where no comparable treatment is available here. It first clarifies that a licensed doctor can always use their clinical judgment to temporarily give a patient any legally available treatment in an emergency, without this being seen as breaking the law.

The main change creates a new "List of Therapeutic Products Pre-approved for Special Access," maintained by the Minister of Health. Products can be added to this list if they meet safety and quality standards and have either previously been approved in Canada or are approved by a trusted foreign regulator. Doctors, pharmacists, hospitals, and medical non-profits can request that a product be added, and the Minister must decide within 120 days. Once a product is listed, manufacturers can sell it and companies can import it specifically to fill doctor requests, with reduced regulatory red tape, though reporting and oversight rules still apply. The Minister must consult an unpaid expert advisory committee before changing the list, publish the list and any changes online, and produce an annual public report on how well the system is working. Products can be removed if safety concerns arise, if they become fully approved or commercially available in Canada, or if they're withdrawn by the manufacturer.

The bill also sets clearer rules for how the Minister decides whether to issue "letters of authorization" allowing emergency use of new drugs that aren't yet approved. It requires the Minister to weigh benefits against risks, consider a wide range of medical evidence, and publish the guidelines used for these decisions. If normal evidence is judged insufficient, two specialist doctors can jointly request authorization by submitting a treatment plan and confirming that the patient has given informed consent, and the Minister generally must grant this unless there's a real risk of misuse or public harm. If a request is refused, the Minister must give written reasons and cannot refuse solely because, for example, the drug is still in clinical trials or evidence comes from abroad. The Department of Health must also try to keep someone available at all times to help doctors get emergency authorizations quickly, and must publish an annual report on how this emergency-access system is working. These changes come into force one year after the bill becomes law.

This bill creates a List of Therapeutic Products Pre-approved for Special Access, maintained by the Minister of Health, along with rules letting practitioners, manufacturers and importers request, sell, and distribute non-marketed products outside normal regulatory approval, and sets criteria and procedures the Minister must follow when issuing emergency-use authorization letters for new drugs.

• Who holds the power — the Minister of Health decides what goes on the list, sets conditions or limitations on its use, removes products from it, and issues, refuses, or reconsiders letters of authorization for emergency drug access; a non-partisan advisory committee (unpaid, unreimbursed) must be consulted but does not have decision-making authority.
• Discretionary elements — the Minister judges what counts as "appropriate quality and safety standards," whether a foreign regulator is "comparable to Canada," whether reasons for bypassing regulatory approval are "sufficient," and whether a new drug's use poses "significant risk"; none of these terms are defined numerically or by fixed criteria in the bill.
• Exemptions created — sales, imports, and distribution of listed products made under this Part are exempted from the rest of the Food and Drugs Act and its regulations, except for this Part itself and any regulations made under it; the Minister may still specify by order which regulatory provisions (storage, transport, tracking, etc.) apply to imports.
• Obligations imposed — practitioners, manufacturers, and licence holders must submit reports or notices to the Minister within 90 days of a request, sale, or import, containing information the Minister specifies; practitioners must also report administering a new drug under emergency clinical judgment.
• Future regulation — the Act allows the Governor in Council to make regulations (under existing section 30) governing how the list is established, maintained, and published, additional criteria for adding or removing products, creation of an electronic information-exchange system, and a reconsideration process for refused authorization letters — none of these are specified in the bill itself.
• Oversight — the Minister must publish the list, any removals with reasons, and annual reports (within the first three months of each year) on the list's effectiveness and on emergency-access operations; there is no sunset clause, and decisions to refuse or remove are not subject to any appeal body other than a Minister-defined reconsideration process.