Health Canada Proposes Regulations to Mitigate Drug and Medical Device Shortages

Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices) (Proposed Regulations) would amend the Food and Drug Regulations and the Medical Devices Regulations under the Food and Drugs Act.

In the Regulatory Impact Analysis Statement accompanying the Proposed Regulations, Health Canada reports that since 2017, 10-15% of drugs marketed in Canada are in shortage at any given time, and over half of marketed drugs have experienced at least one shortage. Similarly, Health Canada states that since 2020, it has received reports of nearly 550 medical device shortages across 18 different clinical categories of devices specifically monitored by the department.

Health Canada has stated that the Proposed Regulations are intended to better protect Canadians from the potential harms posed by shortages, and to provide the regulator with additional methods to prevent, mitigate and respond to drug and medical device shortages.

Industry stakeholders have until March 8, 2025, to comment on the Proposed Regulations and related draft guidance documents that were published to support the proposal.

The Proposal

Five key requirements are set out in the Proposed Regulations:

1. Drug Market Authorization Holders (MAHs) would be required to develop and maintain shortage prevention and mitigation plans for drugs where a shortage could present a serious risk of injury to human health.
   • Health Canada would publish a list of drugs that are critical and vulnerable to shortage (the Critical and Vulnerable Drug List) where a shortage plan is required.
2. MAHs would be required to assess the effectiveness of the measures outlined in their shortage prevention and mitigation plan every three years or when there is a significant change in the likelihood that a shortage of their drug could occur. MAHs would also be required to submit their plan to the Minister of Health (Minister) within 24 hours upon the Minister’s request.
3. Certain importers and wholesalers would be required to report to Health Canada surges in demand for drugs they sell where a shortage could present a serious risk of injury to human health.
4. MAHs would be required to maintain safety stocks in Canada for select drugs that could present a serious and imminent risk of injury to human health if in shortage.
   • The Minister would have the authority to add a drug to a Safety Stock List, which would be a subset of the Critical and Vulnerable Drug List.
   • The required safety stock would be determined using a formula set out in the Proposed Regulations.
5. MAHs and manufacturers of specified Class I-IV devices and importers of specified Class I devices would be subject to improved and expanded reporting of drug and medical device shortages and discontinuations.
   • The Minister could add a new drug or class of drugs (the Expanded Scope List), such as non-prescription drugs, that are not currently subject to any shortage regulations. Drugs added to the Expanded Scope List would be subject to shortage-related regulatory requirements.
   • In the case of medical devices, provisions would be added that require manufacturers of specified Class I-IV devices and importers of specified Class I devices to establish and maintain documented procedures that enable them to:
     • monitor their ability to meet demand for the medical device in Canada;
     • identify when shortages of the medical device occur; and
     • provide shortage-related information to the Minister upon request.

The Proposed Regulations would also allow the Minister to increase the supply of a drug available to address a shortage by extending the expiration date for the drug in certain circumstances and improve the exceptional importation and sale frameworks for drugs and medical devices to address shortages.

Timing

The Proposed Regulations would come into force in three phases to allow stakeholders time to implement the requirements:

• The provisions related to the Expanded Scope List, expiration date extensions, and exceptional import and sale would come into effect six months after final regulations are published.
• The provisions related to the requirement for importers and wholesalers to report demand surges, the requirement for drug MAHs to maintain shortage prevention and mitigation plans, and the expanded requirements to report drug and medical device shortages and discontinuations would come into effect one year after final regulations are published. 
• The provisions related to safety stocks of drugs would come into effect 18 months after final regulations are published.

The Proposed Regulations and related guidance documents are currently open for consultation. Stakeholders and the public can submit comments here until March 8, 2025.

If you have any questions, please do not hesitate to contact the authors or any member of the Blakes Health & Product Regulatory group.