Letter to the President and Chief Executive Officer of Canada's Drug Agency

Dear Ms. McGurn:

I would like to open by expressing my gratitude and appreciation for your organization's ongoing partnership and support, including assuming the additional responsibilities associated with the transformation to Canada's Drug Agency-L'Agence des médicaments du Canada (CDA-AMC). You are well positioned to provide expert advice in support of the Government of Canada's advancement of national pharmacare.

As you are aware, on October 10, 2024, royal assent was given for Bill C-64, An Act Respecting pharmacare (the Act), which sets out a path for the federal government to work in partnership with the provinces and territories to implement national, universal pharmacare in Canada. The first phase aims to provide Canadians with universal, single-payer, first-dollar coverage for a range of contraception and diabetes medications.

The Government is committed to improving health equity and outcomes in the Canadian health care system, and the Act will help to ensure that Canadians can access the prescription drugs and related products they require, regardless of where they live or their ability to pay. The Act builds from ongoing initiatives, such as the National Strategy for Drugs for Rare Diseases, the Improving Affordable Access to Prescription Drugs initiative with Prince Edward Island, and strengthening the supply of health products in Canada under Health Canada's new action plan to prevent and reduce health product shortages.

As set out in the Act, I am requesting the CDA-AMC's expert advice with respect to:

1. A List of Essential Prescription Drugs and Related Products

   In accordance with section 8 (1), and in collaboration with partners and stakeholders, I am requesting that the CDA-AMC prepare an initial list of essential prescription drugs, and related products where appropriate, to inform the development of a national formulary. This list is to be delivered no later than October 10, 2025, the first anniversary of the day on which this Act received royal assent. Furthermore, a report on the progress of the work should be provided to Health Canada no later than April 10, 2025, six months from the day of royal assent.

   Given the instrumental support that the then-Canadian Agency for Drugs and Technologies in Health provided to the pan-Canadian Advisory Panel on a Framework for a Prescription Drug List, the CDA-AMC is well placed to undertake this project.

   Using the CLEAN Meds List developed at Toronto's St. Michael's Hospital as a starting point, and in alignment with the lists of covered contraceptives and treatments for diabetes published alongside the tabling of the Act, the list should be developed to include a range of recommended drugs and related products for each of the therapeutic classes. As you know, the CLEAN Meds List (approximately 130 medications in 12 therapeutic classes) was adapted from the World Health Organization (WHO) Model List of Essential Medicines, for the Canadian context.

   Additions or modifications to the list should include drugs and related products that are commonly prescribed, with an emphasis on those that have been proven to be safe, effective and of good value. It may be developed with reference to Canadian clinical practice guidelines, expert guidance from clinicians, scientists and patients, among others. The WHO's Essential Medicines List should also inform this work as appropriate.

   In addition to the list, a report should be prepared outlining the methodology used to determine the list, including assessment and selection criteria, that would guide future updates to the list so a consistent approach can be applied to make the list evergreen and responsive to the development of national pharmacare.

2. A National Bulk Purchasing Strategy

   In accordance with section 9, I further request that, in collaboration with partners and stakeholders, the CDA-AMC develop advice on a national bulk purchasing strategy for prescription drugs and related products, where appropriate, to support the principles set out in paragraphs 4(a) to (d) of the Act, also by no later than October 10, 2025, the first anniversary of the day on which this Act received royal assent.

   It is our expectation that the proposed strategy includes options and approaches that would strengthen the collective purchasing power of Canada's pharmaceutical management system and work in conjunction with two existing system features, the collaboration of public drug plans to collectively negotiate drug prices through the pan-Canadian Pharmaceutical Alliance's (pCPA) and the protection against excessive patented drug prices through the Patented Medicine Prices Review Board's (PMPRB) regulatory framework. The proposed strategy should also consider and make recommendations on how national bulk purchasing will impact all stakeholders in Canada, including hospital formularies and beneficiaries of private drug insurance plans. It should, in addition, seek to consider how the strategy could impact the management or mitigation of drug shortages in Canada.

   A description of the methodology and approach should be a part of the submitted report, including to support its update and application as national pharmacare evolves, should this be the outcome of future consultations with the provinces, territories, Indigenous Peoples, patients and stakeholders, as set out in the Act.

The Government is committed to consulting and working with the provinces, territories, Indigenous Peoples and other partners and stakeholders, as we work to expand the implementation of national, universal pharmacare beyond the initial phase. I am certain that the CDA-AMC will undertake this important work in collaboration and consultation with the appropriate stakeholders, in your usual fashion.

Thank you for your attention to this important matter. I trust that the CDA-AMC will continue to demonstrate its leadership and technical proficiency in fulfilling these critical tasks. Your efforts will be instrumental in informing the provinces, territories, Indigenous Peoples and other partners and stakeholders on ways forward toward establishing a robust national pharmacare system that ensures equitable access to essential prescription drugs and related products for all Canadians.

Please accept my best wishes.

Yours sincerely,
The Honourable Mark Holland, P.C., M.P.