On December 28, 2024, Health Canada launched a public consultation on various measures aimed at preventing drug shortages and mitigating their impacts. Health Canada is therefore proposing regulatory amendments to the Food & Drug Regulations to enforce those changes.
These proposed amendments aim to enhance the resilience of Canada’s health product supply chains and ensure better access to essential drugs and medical devices. Key measures include:
1. Safety Stocks for Drugs: Market authorization holders would be required to maintain safety stocks for select drugs to prevent shortages, ensuring a minimum quantity is always available in Canada.
2. Shortage Prevention and Mitigation Plans: Holders would need to develop and maintain plans for drugs where a shortage could pose a serious health risk, including strategies to identify, assess, and mitigate risks.
3. Demand Surge Reporting: Drug importers and wholesalers would be mandated to report significant surges in demand to the Minister of Health for drugs where a shortage could present a serious health risk.
4. Exceptional Importation Framework: The framework would be expanded to allow the importation of foreign-authorized drugs and medical devices in shortage situations, including provisions for extending drug expiration dates.
5. Improved Reporting Frameworks: Enhanced reporting requirements for drug and medical device shortages and discontinuations would be implemented, with an earlier notice period for drug discontinuations set at 12 months in advance.
The link to the proposed amendments can be found here: Canada Gazette, Part 1, Volume 158, Number 52: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices)
This consultation is open until March 8, 2025.