Emergency Access to Unauthorized Drugs

Summary#

These final regulations create a new pathway in the Food and Drug Regulations called Division 11. It lets certain public health officials apply to the Minister of Health to buy a specific quantity of a drug that is not authorized for sale in Canada for immediate use or for stockpiling in a public or Canadian Armed Forces health emergency. The regulations came into force on February 15, 2023.

What it does#

• Sets up Division 11 in the Food and Drug Regulations to allow an application to the Minister to authorize a manufacturer to sell a specified quantity of an unauthorized drug to a public health official for:
  • immediate use in a public or military health emergency, or
  • stockpiling in anticipation of such an emergency.
• Allows drugs that are not approved in Canada, that are approved abroad, or that are still under development to be considered for these authorizations.
• Requires the application to include basic contact details, a description of the emergency, the intended use, the quantity requested, and key drug information (name, ingredients, strength, dosage form, recommended dose and route, storage, known safety information, and foreign approvals if known).
• Requires clear labelling or an accompanying document in English and French with specified information (manufacturer, intended use, dosing, storage, warnings, lot and expiry info, net contents).
• Assigns responsibilities to the initial public health official who receives the drug (they must update recipients if information changes, monitor use and adverse reactions, keep records and report to the Minister on request).
• Keeps mandatory serious adverse drug reaction (SADR) reporting in place; hospitals report SADRs under existing rules and the Surgeon General of the Canadian Armed Forces must report military SADRs within 30 days of becoming aware.
• Requires record retention for 15 years for sales and use records related to the authorization.
• Allows the Minister to cancel an authorization if the drug appears to pose a serious or imminent health risk.
• Amends the Natural Health Products Regulations so that quantities sold under this authorization are not treated as natural health products.
• Amends the Certificate of Supplementary Protection Regulations (under the Patent Act) so Division 11 authorizations are not counted as an “authorization for sale” eligible for extra patent-like protection.
• Includes a transitional rule that treats some existing Special Access Program (SAP) authorizations for public/military health emergencies as if issued under Division 11.
• Does not require manufacturers to sell a drug; manufacturers may still refuse.

Who's affected#

• Public health officials who can apply or receive stockpiled drugs, including:
  • the Chief Public Health Officer,
  • provincial and territorial Chief Medical Officers of Health,
  • municipal Medical Officers of Health (or equivalents),
  • the Surgeon General of the Canadian Armed Forces, and
  • the Chief Medical Officer of Public Health for the Department of Indigenous Services.
• Government stockpilers and users such as the Public Health Agency of Canada (PHAC) and the Canadian Armed Forces (CAF).
• Drug manufacturers that might be asked to sell quantities to those public health officials.
• Hospitals, practitioners and the people who receive or administer these drugs (they will get extra information and reporting duties).
• Health Canada, which will review applications, may inspect stockpiles, and can cancel authorizations.
• The regulations estimate government costs and implementation impacts: a net present value cost to government of $677,607 (annualized $96,476). The CAF and PHAC expect to procure a combined 39 different drugs over the next ten years and have identified per-drug fixed and monitoring costs.

Why it matters#

• It gives public health authorities a clear legal path to obtain drugs that are not on the Canadian market during a public or military health emergency. That can speed up access in a fast-moving crisis.
• These drugs will not have gone through full Canadian market approval. The rules therefore put extra labelling, tracking and monitoring duties on public health officials to protect people who receive them.
• The pathway balances quicker access with safeguards: required information, reporting, record-keeping, and a power for the Minister to cancel an authorization if safety concerns arise.
• Manufacturers are not forced to sell, and drugs supplied this way do not qualify for certain patent-based extensions. That matters for industry decisions and for whether a product might later receive the same commercial protections as a fully authorized Canadian drug.
• There will be some ongoing costs and administrative work for stockpiling and monitoring, mainly for government stockpilers and public health bodies.