Health Canada proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations to protect against the harms caused by shortages of drugs and medical devices. The proposed amendments have been published for public consultation.
The proposed amendments will impact drug products in many ways.
Shortage prevention and mitigation plans
Drugs identified as those whose shortage could result in a serious risk of injury would be added to a Critical and Vulnerable Drugs List. Health Canada published a draft CVD List with the proposed amendments, including the methodology used to prepare it.
For drugs on the CVD List, Market Authorization Holders would be required to establish and maintain a plan that includes information such as: measures taken to identify and assess shortage risks, measures intended to be taken to prevent or mitigate shortage risks, a description of how the efficacy of the measures will be evaluated, and a strategy for communicating any significant increase in the likelihood of a shortage. Health Canada published draft guidance regarding the shortage prevention and mitigation plans.
Safety stocks
The proposed amendments create a Safety Stock List that includes drugs identified by the Minister whose shortage could present a serious and imminent risk of injury. The SS List would be a subset of the CVD List. Health Canada published a template draft SS List and draft guidance as part of the consultation.
For drugs on the SS List, MAHs would be required to keep a quantity of drug in Canada and maintain records about this stock. If the safety stock is drawn upon, the MAH would be required to replenish the stock as soon as possible. For most drugs on the SS List, the safety stock would be three months' worth of stock; however, MAHs could submit information to Health Canada to vary the quantity of safety stock they are required to keep.
Demand surge reporting
For drugs on the CVD List, importers and wholesalers would be required to report instances where sales increased by 250% or more in one month compared to the same month 1 year prior. The report would be confidential and would not be required if a shortage has already been reported for that drug. Health Canada's draft guidance on demand surge pricing is published as part of the consultation.
Other impacts
The proposed amendments would also:
- Permit the sale of drugs after their expiry if the Minister believes that it "will comply with the specifications" up to and including the extended expiration date".
- Broaden the scope of the exceptional importation and sale frameworks, allowing increased access to certain drugs.
- Create an Expanded Scope List of drugs for which a shortage or discontinuation would present a risk of injury. Drugs on the ES List would be subject to regulations regarding reporting of shortages and discontinuations and limitations on distribution outside Canada in some circumstances.
- Update the reporting frameworks for shortages and discontinuations
Next Steps
The proposed amendments are expected to come into force in three stages from 6 to 18 months after their final publication. Consultations on drugs to be included in the SS List and ES List will be held when the final regulations come into force.
The text of the proposed amendments and details regarding how to submit comments are available here. Health Canada is accepting comments until March 8, 2025.
Originally published 19 Feb 2025
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