Health Canada’s proposed regulatory changes to address health product shortages

On June 25, 2024, Health Canada published a notice of intent and Building resilience: Health Canada’s plan to address health product shortages from 2024 to 2028relating to Health Canada’s plan for the next 4 years to address health product shortages, including proposed changes to Food and Drug Regulations AND Medical Device RegulationsConsultation on both matters was open until July 25, 2024. Amendments to the regulations will be published in Canada Gazette Part I this fall for additional comment.

Health Canada’s plan includes measures to: (1) identify and address the risk of shortages; (2) improve and share supply chain information (for example, by improving regulatory responses and reporting requirements); and (3) improve access to health products by modernizing the regulatory framework.

As set out in the Notice of Intent, the proposed measures contained in the amended regulations will help prevent shortages of medicines and medical devices for human use and limit the effects of shortages that cannot be prevented.

Proposed changes to Food and Drug Regulations switch on:

application of shortage regulations to additional drugs or drug classes
expanding the use of the exceptional import framework
allowing exceptional sales of a foreign-approved drug produced domestically to address shortages, and
requiring manufacturers to ensure that a three-month safety stock is maintained in Canada for critical and shortage-prone drugs, based on historical demand data.

Proposed changes to Medical Device Regulations switch on:

using the exceptional import framework in a more targeted way to help reduce security risks, for example by specifying that the framework can be used to address a shortage or risk of shortage that could cause harm, and
requiring importers to notify Health Canada of the suspension or cancellation of a foreign authorisation for an exceptionally imported medical device.

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