On June 19, 2025, Canada’s Drug Agency (CDA) opened a public consultation on a proposed process for preparing a list of essential prescription drugs and related products.
As required by the Pharmacare Act, the CDA must develop a list of essential prescription drugs and related products to inform the development of a national formulary. Accordingly, the Essential Prescription Drugs and Related Products Advisory Panel has developed a discussion paper (see also FAQs) which outlines the methodology used for developing the proposed list of 664 drugs and products, with 519 recommended for inclusion and the balance to be excluded.
The consultation seeks input primarily on:
- suggestions that could enhance the process for including and excluding products on the proposed list of essential prescription drugs and related products;
- specific suggestions to support the process for updating the proposed list over time; and
- identification of commonly prescribed drugs and related products in Canada that are not already on the proposed list (including products identified for both inclusion and exclusion), such as high-use prescription drugs in Canada that are listed on most public drug plans.
Comments on the discussion paper may be provided until July 18, 2025.
CDA intends to open a separate consultation on draft advice on a national bulk purchasing strategy for prescription drugs and related products in early to mid-July 2025, and intends to summarize and present feedback received from both consultations during a webinar this fall.
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.