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Status and purpose

• Bill C-265 is at second reading. It would amend the Food and Drugs Act to create a list intended to streamline special access to certain therapeutic products and change how emergency access to new drugs is assessed.
• It would affect patients, practitioners, pharmacists, hospitals, medical non-profit organizations, manufacturers, licensed importers and the Minister of Health.

Clinical judgment

• The bill clarifies that, in an emergency, a person entitled to practise medicine under provincial law may temporarily administer an available therapeutic product to a patient in their care if it was lawfully manufactured in or imported into Canada and is, in their clinical judgment, the best available treatment.

Part I.1: Pre-approved special-access list

• The Minister would have to establish and publish a list of non-marketed products or product classes for serious or life-threatening conditions, including rare diseases, and where no comparable product is available on the Canadian market. Significant differences in cost, formulation, efficacy, contraindications or adverse-event rates in specific populations make products non-comparable.
• The Minister could add products meeting quality and safety standards if they satisfy specified prior authorization or foreign-approval criteria. The list must state authorized uses and any practitioner or setting limitations. The Minister could impose conditions or remove products or uses for specified reasons, publishing the reasons for removal.
• Practitioners, pharmacists, hospitals and medical non-profit organizations could propose additions. The Minister would have 120 days to decide.
• Subject to list restrictions, practitioners could request listed products from manufacturers for listed uses without knowing the patient’s identity when making the request. Manufacturers could sell, and appropriately licensed holders could import, products in response to or in anticipation of requests.
• These sales, imports and distributions would be exempt from other Food and Drugs Act and regulatory provisions, except Part I.1 and its regulations. For imports, the Minister could also apply specified regulatory provisions concerning storage, transportation, quality control, tracking and records.
• Practitioners, manufacturers and importers would have reporting or notification duties generally due within 90 days of the relevant request, sale or import. The Minister could demand additional information, restrict or prohibit a practitioner’s use where it poses a significant health or safety risk, and question manufacturers suspected of using the list to circumvent approval.
• The Minister would have to consult a non-partisan expert committee before establishing or changing the list. Committee members would receive no remuneration or expense reimbursement. A public report on the list’s effectiveness would be required within the first three months of each calendar year.

Emergency access to new drugs

• When deciding whether to issue an existing regulatory letter of authorization, the Minister would have to weigh benefits and risks, including the risk of not authorizing treatment, and consider specified forms of medical evidence. The Minister’s guidelines would have to be published and kept current.
• If the Minister considers the evidence insufficient, authorization would generally be required when two qualified expert clinicians provide a treatment plan and specified statements about appropriateness, likely benefits and informed consent. The Minister could refuse if use is likely to cause diversion or other significant public harm.
• Refusals would require written reasons and information about reconsideration. The bill also specifies grounds that cannot alone justify refusal, including an active clinical trial, foreign or off-label evidence, or the availability of other Canadian treatments.
• The Minister would have to make every effort to ensure departmental assistance is available at all times for urgent authorization requests.
• In an emergency, a practitioner could temporarily administer an available new drug without a letter if it was lawfully manufactured in or imported into Canada and is the best available treatment in their clinical judgment. The practitioner must notify the Minister; continued use without a letter is not authorized.
• A public annual report on the emergency-access provisions would be required within the first three months of each calendar year, including request and refusal numbers, average response times and proposed improvements.

Regulations and commencement

• The bill would enable regulations on the list, an electronic information exchange and reconsideration of authorization refusals.
• It would come into force one year after royal assent.