On December 28, 2024, the Government of Canada published the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (the “Proposed Amendments”). The Proposed Amendments aim to mitigate shortages that negatively impact Canadians’ access to drug and medical devices.
The previous 2016 and 2021 amendments had sought to address this issue, but given the ongoing disruptions in the global medical supply chains, Health Canada emphasized the need for additional proactive measures.
A 70-day consultation period regarding the Proposed Amendments is open until March 8, 2025.
Scope of Drugs Subject to Shortage Regulations
Currently, market authorization holders ("MAHs") are subject to shortage and discontinuation reporting requirements and a prohibition against exporting drugs if doing so could cause or exacerbate a shortage.
The Proposed Amendments would expand the scope of the current regulations by creating a list of drugs, which allows Health Canada to impose certain additional regulatory obligations, including shortage prevention and mitigation plans, demand surge reporting, and safety stocking (the "Expanded Scope List").
Health Canada would be permitted to add drugs to the Expanded Scope List if their shortage or discontinuation of sale could pose a risk of injury to human health. Changes to the list would follow stakeholder consultation, and notice would be given to regulated parties to allow time to comply.
The Proposed Amendments would also permit Health Canada to request information about drug shortages for any drug that could pose a risk of injury to human health if in shortage.
Shortage Prevention and Mitigation Plans
There are currently no legal requirements in Canada for organizations to have drug-specific shortage prevention and mitigation plans.
Following the Proposed Amendments, Health Canada would create a list of drugs for which a shortage could pose a serious risk of injury to human health, and are critical and vulnerable to shortage (the "Critical and Vulnerable Drug List").
MAHs would be required to develop prevention and mitigation plans for their drugs appearing on this list. The plans would need to identify and assess shortage risks, and outline measures to be taken to prevent and mitigate those risks. The plans would need to be maintained for the entire time that the MAH sells the drug on the Canadian market.
To assist MAHs with compliance, Health Canada would publish additional guidance.
Demand Surge Reporting
The Proposed Amendments would also impose reporting requirements on importers and wholesalers of drugs that could pose a serious risk of injury to human health if in shortage. Reporting would be required where the monthly volume of sales of these drugs increases by at least 250% compared to the sales in the same month of the previous calendar year.
Drugs on the Critical and Vulnerable Drug List would be subject to this requirement.
These reports would not be published in order to protect confidential business information, unlike shortage reports under the current shortage regulations.
Safety Stocks
There are currently no legal requirements for MAHs to retain safety stocks in Canada for the drugs they sell. The Proposed Amendments would allow Health Canada to create and update a list of drugs for which it has reasonable grounds to believe that a shortage, if it were to occur, could present a serious and imminent risk of injury to human health (the “Safety Stock List”, a subset of the Critical and Vulnerable Drug List).
MAHs of drugs on this list would be required to ensure that a minimum quantity of the drug be held inside Canada. In particular, MAHs would be required to maintain at least 3 months' supply of drugs on this list and keep detailed records of safety stocks for a minimum of 3 years. Health Canada would be able to adjust stock quantity requirements based on specific drug characteristics and unusual demand patterns.
Authority to Extend Drug Expiration Dates
The Proposed Amendments would allow Health Canada to extend the expiration dates of drugs to increase supply during shortages, if there are reasonable grounds to believe that there is an actual or risk of shortage posing a risk of injury to human health. Lots or batches of drugs added would be permitted for sale until the extended expiration date specified on this list.
Additional Updates
Finally, in respect of both drugs and medical devices, the Proposed Amendments would update exceptional importation frameworks to allow them to be used in a broader range of circumstances while mitigating safety risks to the greatest extent possible.
Moreover, the timeframes for reporting of drug and medical device shortages and discontinuations would be revised. New obligations would also be imposed on specified device manufacturers to establish procedures, monitor demand, identify shortages, and provide information to Health Canada upon request.
Coming into Force
The Proposed Amendments' implementation would take place in three phases:
Effective six months after publication:
- Health Canada’s authority to expand the scope of drugs subject to shortage regulations,
- Health Canada’s authority to extend drug expiration dates to address shortages; and
- The update of the exceptional importation and sale frameworks for drugs and medical devices.
Effective one year after publication:
- The new requirement for importers and wholesalers to report demand surges under certain conditions,
- Regulations mandating MAHs to maintain plans; and
- Updates to the reporting frameworks for drug and medical device shortages and discontinuations.
Effective 18 months after publication:
- Regulations requiring MAHs to maintain safety stocks in certain circumstances.
Conclusion
As the Proposed Amendments are still undergoing consultation, Fasken's Life Sciences group is actively tracking new developments. We remain available to assist stakeholders in navigating these changes.
