Health Canada has proposed additional regulations intended to prevent, mitigate, and respond to drug shortages. The proposed amendments to the Food and Drug Regulations (Regulations) include new requirements for drug market authorization holders to develop shortage prevention and mitigation plans, report surges in demand, and maintain safety stocks for certain drugs. Health Canada is accepting comments on the proposed amendments and related drug lists and guidance until March 8, 2025.

Background: Existing Regulations

A drug “shortage” is defined in the Regulations as “a situation in which the manufacturer… is unable to meet the demand for the drug in Canada”.  Manufacturers holding a drug identification number (DIN-holders) as well as entities holding a drug establishment licence (DEL-holders), such as importers and wholesalers, have obligations under the current Regulations to address drug shortages. For instance, DIN-holders must post information online about existing or likely drug shortages and impending drug discontinuations. DEL-holders are prohibited from distributing a drug outside Canada if doing so could cause or exacerbate a shortage in Canada.

New Proposed Regulations

Critical and Vulnerable Drug List

The proposed amendments to the Regulations add new requirements for drugs for which a shortage “could present a serious risk of injury to human health”. In particular, for each such drug:

  • The DIN-holder would be required to establish and maintain a plan to prevent and mitigate shortages. The plan would need to be updated every three years or after a significant change in the likelihood of a shortage. Health Canada has published a draft Guide to shortage prevention and mitigation plans for consultation.
  • DEL-holders who are an importer or wholesaler of the drug would be required to report demand surges to the Minister of Health (Minister).  A demand surge would occur when the monthly volume of sales increases by at least 250% compared to the same month in the previous calendar year. Health Canada has published a draft Guide to reporting drug demand surges for consultation.

To assist industry in identifying drugs subject to these new requirements, Health Canada intends to develop a Critical and Vulnerable Drug List. A draft list and guidance is available for consultation. The draft list has approximately 160 active ingredients and product groups listed.

Safety Stock List

The proposed amendments to the Regulations add a further requirement for drugs for which a shortage “could present a serious and imminent risk of injury to human health” (our emphasis). Such drugs would be a subset of the Critical and Vulnerable Drug List and would be listed separately by the Minister (the Safety Stock List). Health Canada will hold a future consultation for drugs to be added to the Safety Stock List, but has provided 10 examples in a draft list and guidance. Health Canada anticipates that up to 70 drugs would eventually be added to the list.

DIN-holders of drugs on the Safety Stock List would be required to stock a minimum quantity of the drug inside Canada and keep related records.  As a default, the minimum quantity would be 3 months of average monthly demand, but the Minister may specify a different amount where, for example, a drug’s physical characteristics make the default quantity impractical. Health Canada has published a draft Guide to safety stocks for consultation.

Extended Expiration Dates

Under the proposed amendments to the Regulations, the Minister would publish a list of drug lots/batches with extended expiration dates (the Extended Expiration Dates List).  The Minister could add a drug to the list where there is a shortage (or risk thereof) that “could present a risk of injury to human health” and the lot/batch will comply with the drug’s specifications until the extended expiration date.  Health Canada has published a skeleton draft list and guidance (without any listed drugs) and a Guide on extending expiration dates for consultation.

Other proposed changes

The proposed amendments to the Regulations would make other changes, including:

  • Broadening the framework for exceptional importation and sale of drugs (e.g., sourcing an acceptable alternative of any drug whose shortage could present a risk of injury to human health).
  • Requiring DIN-holders to provide earlier notice of a decision to discontinue a drug (e.g., at least 12 months in advance of the discontinuation date instead of the current 6 months).

Additionally, Health Canada is proposing certain changes to the Medical Devices Regulations to address shortages of medical devices (e.g., clarifying the scope of the exceptional importation framework for medical devices).

Coming into force

The proposed amendments to the Regulations would come into force 6 to 18 months after their final publication. For instance, the requirements to develop prevention and mitigation plans and to report demand surges would come into force 1 year after publication, while the requirement to maintain safety stocks would come into force 18 months after publication.

Stakeholder feedback

Comments on the proposed amendments to the Regulations and the related draft lists and guidance must be submitted by March 8, 2025.

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