On December 28, 2024, Health Canada published proposed amendments to the Food and Drug Regulations and Medical Devices Regulations to address therapeutic product shortages (see our previous article regarding Health Canada’s notice of intent and Health Canada’s four-year plan to address health product shortages).
The proposed amendments are intended to help address and mitigate the harm to public health caused by shortages by (1) imposing obligations on market authorization holders which, if not complied with, would threaten public health by contributing to or exacerbating shortages; and (2) help Health Canada and others respond to shortages when they occur.
The proposed amendments include enacting the following for select drugs for which a shortage could present a serious risk of injury to human health:
- requirements for safety stocks of select drugs;
- requirements to develop and maintain shortage prevention and mitigation plans;
- requirements to report surges in demand;
- extending the expiration dates for Canadian-authorized drugs in certain circumstances; and
- updating the scope and framework for exceptional importation and sale, including:
- to allow sale of a domestically manufactured drug authorized in a foreign jurisdiction;
- to allow sourcing of acceptable alternatives;
- to allow sourcing of substitutes for drugs discontinued in Canada, for a period of up to 36 months after discontinuation; and
- allowing the Minister to limit sale of specific drugs on the List of Drugs for Exceptional Importation and Sale to practitioners, pharmacists, hospitals or other persons that hold an establishment licence in respect of the drug.
The proposed amendments to the Medical Devices Regulations include updates to the requirements for reporting shortages and discontinuations.
The estimated cost to industry in the first year is over $70 million.
Consultation on the proposed amendments is open until March 8, 2025.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.