On June 19, 2025, Canada’s Drug Agency/L’Agence des médicaments du Canada (CDA-AMC) announced a consultation on a proposed list of essential prescription drugs and related products intended to inform the development of a national formulary. The consultation is the latest step in the implementation of national pharmacare in Canada. The consultation is open to receive submissions until July 18, 2025.
Background
On October 10, 2024, An Act respecting pharmacare (the Pharmacare Act) came into force (our report here). The Pharmacare Act sets out foundational principles for the first phase of a national, universal, single-payer, first-dollar drug coverage plan. In the first phase, the federal government is to make bilateral agreements with provincial and territorial governments to fund prescription drugs and related products for contraception and diabetes. So far, 4 bilateral agreements have been announced (our report here).
The Pharmacare Act also sets out steps for developing a national formulary. Accordingly, on December 4, 2024, the Minister of Health asked the CDA-AMC to prepare by October 10, 2025 “an initial list of essential prescription drugs, and related products where appropriate, to inform the development of a national formulary” (our report here). The CDA-AMC formed a 12-member advisory panel to develop the list.
Proposed list of essential prescription drugs and related products
The advisory panel has prepared a proposed list of 513 drugs and 6 related products across 14 therapeutic areas (available in PDF or Excel formats).
On June 19, 2025, CDA-AMC began consulting on the proposed list, the process used to develop it, and how the list should be updated in the future. To guide the consultation, the CDA-AMC has published a discussion paper and accompanying FAQs. As a brief summary:
- How the list was developed: The advisory panel’s inclusion and exclusion criteria are summarized in Table 1 of the paper. Relevant factors included: (i) being listed on the WHO Model Lists of Essential Medicines and/or the CLEAN Meds List; (ii) being commonly prescribed in Canada; (iii) adoption by at least 7 public drug plans in Canada; (iv) recommendation by a health technology assessment or clinical practice guideline; and (v) availability of biosimilar or generic products. The advisory panel’s assessment was informed by 6 previously-identified “key principles”, including equitable access (our report here). The discussion paper has specific comments on different formulations, combination products, and a “limited number of nonprescription (e.g., over the counter) products” that may be of interest.
- Phased approach: The advisory panel recommends a phased approach to developing a national formulary based on the proposed list, with the first phase generally prioritizing drugs from the CLEAN Meds List and, for oncology products specifically, oral cancer drugs.
- How the list should be updated: The advisory panel suggests that the list be regularly re-evaluated, with updates made potentially every 2 years, “to ensure that [the list] continues to be informed by up-to-date evidence, and is sustainable, effective, and of high quality.” Currently excluded drugs may be added to the list if the evidence supports such a change.
Consultation on the proposed list
In its consultation, the CDA-AMC is asking for input on 3 questions (as bolded by the CDA-AMC):
- Suggestions that could enhance the process for including and excluding products.
- Specific suggestions to support the process for updating the proposed list over time.
- The identification of commonly prescribed drugs and related products in Canada that are not already on the proposed list.
The consultation will run until July 18, 2025 at 5 pm ET. All submissions will be published and attributed.
Links:
- Canada’s Drug Agency, Canada’s Drug Agency Launches Consultation on a Proposed List of Essential Prescription Drugs and Related Products (June 19, 2025)
- Canada’s Drug Agency, Essential Prescription Drugs and Related Products Advisory Panel (June 19, 2025)
- Canada’s Drug Agency, Discussion Paper: A List of Essential Prescription Drugs and Related Products: Initial Recommendation (June 2025)
- Canada’s Drug Agency, Frequently Asked Questions – Essential Prescription Drugs and Related Products List
- Canada’s Drug Agency, List of essential prescription drugs and related products (Excel)