PMPRB NEWSletter: May 2026, Volume 30, Issue 2

Message from the Chairperson

I’m pleased to share this latest edition of the PMPRB Newsletter with you.

It’s a particularly active time at the PMPRB. Our new Guidelines are now in force, initial reviews have now been completed in the 60-days delay promised, some In-Depth reviews are starting, the latest Meds Pipeline Report has just been released, and we are amid completing a public consultation on proposed Practice Directions aimed at making hearings more efficient.

Over the past few months, I’ve also had the opportunity to meet with a wide range of stakeholders and to speak at several events. These exchanges are invaluable—they allow us to connect directly with those affected by our work. In doing so, I’ve noticed that certain aspects of the PMPRB remain unclear: some misconceptions persist, and questions continue to arise about our mandate, the changes introduced by the new Guidelines, and even my role as Chair.

As you know, our new 2026–2030 Strategic Plan places a strong emphasis on more transparent and modern communication. In line with that commitment, we’ve taken concrete steps by developing new tools and materials designed to better explain our role and demystify our work. I’m pleased that these new communications resources are now available—not only to clarify our mission, but also to address some of the more persistent myths.

To be clear, the PMPRB is a drug price watchdog—it does not set drug prices. Our role is to review the prices set by manufacturers to ensure they are not excessive. Our Guidelines outline the process used by staff to identify cases that may, in the public interest, warrant a hearing to determine whether a price is excessive.

The PMPRB is also not a barrier to market entry. We only review the price of a medicine after it has been sold in Canada. We are not involved in the approval of drugs, nor in decisions about reimbursement by public drug plans across provinces and territories. Manufacturers remain free to set their prices; the PMPRB intervenes only where there may be concerns about excessive pricing.

These are just a few of the questions and misconceptions addressed in our new communications tools, which I invite you to explore on our website and social media platforms.

I look forward to continuing these conversations with rights holders, patient groups, and other partners as we advance the important work of the PMPRB.

Implementation of the New Guidelines

The new Guidelines for PMPRB Staff came into effect on January 1, 2026. Building on the preparatory work outlined in the January 2026 newsletter, the PMPRB has now completed its first activities under the new framework. 

In late January 2026, Rights Holders submitted the required information for the July to December 2025 reporting period. This was the first semi‑annual filing reviewed entirely under the new Guidelines. PMPRB staff assessed these submissions in accordance with the updated processes, ensuring that the Initial Review of new medicines was carried out consistently and in line with the revised approach. 

All medicines with a first date of sale on or after July 1, 2022, underwent an Initial Review. Rights Holders were notified of the status of their medicines within the 60‑day service standard. Existing medicines, those first sold before July 1, 2022, will undergo their first review under the new framework in January 2028. Until then, they will continue to be included in bi-annual information reports.  

The PMPRB remains focused on supporting a clear and efficient transition period. Rights Holders who still have questions about their filing obligations or the review status of a DIN are encouraged to contact their assigned Senior Regulatory Officer for assistance. 

As implementation continues, the PMRPB will maintain its emphasis on transparency, predictability, and consistent application of the Guidelines, ensuring a stable regulatory environment as the new framework matures. 

New proposed Hearing Practice Directions

On March 5, 2026, the PMPRB published proposed Practice Directions for a 60-day consultation period where stakeholders and interested Canadians were invited to read the proposed PMPRB Practice Directions and provide feedback. 

The Practice Directions are intended to modernize and improve the efficiency, consistency, and fairness of PMPRB hearings. They are meant to be followed alongside the existing PMPRB Rules of Practice and Procedure.  

The PMPRB is proposing seven Practice Directions for hearings: 

1. Mode of Hearings 
2. Facilitating Document Exchange 
3. Standardizing Motions 
4. Electronic Filing and Page Limits 
5. Expediting Failure to File Proceedings 
6. Use of Artificial Intelligence in Proceedings 
7. Virtual Proceedings                 

The deadline to submit feedback was Monday, May 4, 2026. The PMPRB is reviewing the feedback that was submitted and will share next steps soon.

Events

The PMPRB participated in the following events:

• January 12, 2026 – Director General, Guillaume Couillard, delivered a presentation to the CAPDM Executive Conference Panel in Montreal.
• January 30, 2026 – A Board Meeting was held in Ottawa.
• February 12, 2026 – Director General, Guillaume Couillard, participated in the Canada Drug Agency International Trade Policy Impacts on Canada’s Drug System Workshop in Toronto.
• February 19, 2026 – Chairperson, Anie Perrault, met with patient groups for an update on PMPRB projects. This meeting is now intended to be an annual event.
• March 24 & 25, 2026 – Director General, Guillaume Couillard, delivered two presentations to the Canadian Institute, 11th Annual Forum, Pathways to Access & Reimbursement Workshop and Conference.
• April 8, 2026 – Chairperson, Anie Perrault, presented at The Canadian Association for Healthcare Reimbursement conference in Montreal. Director General, Guillaume Couillard, also attended.
• April 22-24, 2026 – Chairperson, Anie Perrault, and Director General, Guillaume Couillard, attended the Canada’s Drug Agency symposium in Ottawa.
• April 29, 2026 – Chairperson, Anie Perrault, presented at the Rare Disease Day 2026 conference in Toronto. Director General, Guillaume Couillard, also attended.

NPDUIS Research Initiative Activities

The PMPRB continues to publish a number analytical studies for the Minister of Health through the NPDUIS research initiative. In addition, the PMPRB hosted information sessions to share the results of its recent reporting.

NPDUIS Advisory Committee Meeting

The NPDUIS Advisory Committee reconvened virtually in March 2026 for a quarterly meeting led by PMPRB and Canadian Institute for Health Information (CIHI) representatives. The NPDUIS Advisory Committee advises and supports the PMPRB on research priorities, the development of research methodologies, and the interpretation of analytical results. It is composed of public drug plan representatives and participants from Health Canada, CIHI, Canada’s Drug Agency (CDA-AMC) and the pan-Canadian Pharmaceutical Alliance (pCPA) Office.

The Committee will reconvene for its next meeting in Summer 2026.

Conference Participation

NPDUIS research initiative analysts were invited to present research briefs at the following conferences:

• Canada’s Drug Agency (CDA) Symposium 2026 in Ottawa, ON (April 22–24, 2026)
• Canadian Association for Health Services and Policy Research (CAHSPR) 2026 conference in Ottawa, ON (May 25–28, 2026)

NPDUIS Research Initiative: New and Upcoming Publications

New Releases

Meds Pipeline Monitor 2026

The Meds Pipeline Monitor (MPM) is a horizon scanning report that features new medicines undergoing clinical evaluation or in pre-registration that may gain market authorization in Canada in the future. The 2026 edition identifies a broad range of late-stage medicines in the pipeline and reviews those featured in the previous edition of the MPM to report on changes to their status in the pipeline. A section focused on Canada highlights medicines currently under review by Health Canada.

Research Briefs

The following research briefs, summarizing projects presented by PMPRB staff at various conferences and symposia, are now available:

• Insight into approvals, marketing, and pricing of emerging and innovative medicines 2021-2025
• Cost drivers in Canada’s public and private drug plans: a comparative study using real-world evidence

Coming Soon

Several studies are slated for publication in the coming months:

Meds Entry Watch, 10^th Edition

The Meds Entry Watch report series explores the market entry of new international approvals from a Canadian lens. Building on a retrospective analysis of trends since 2021, the tenth edition will focus on medicines that received first-time approval from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada from 2021 through 2025, and analyze their uptake, pricing, sales, and availability as of the last quarter of 2024 (Q4-2024). In addition to the international analysis, a Canadian-focused section will provide trend analysis of medicines that received their first Health Canada approval from 2021 to 2025.

Generics360

Generics360 reports on the latest trends in the Canadian generic drug market within an international context. Canada has established one of the strongest generic markets in the industrialized world, though domestic prices have historically been much higher than international levels. To inform policy discussions and support evidence-based decision making, the PMPRB has been monitoring changes in the generic landscape in Canada since 2007. Building on these previous analyses, future editions of Generics360 will review the decades-long impact of generic pricing policies in Canada.

CompassRx, 11^th Edition: Annual Public Drug Plan Expenditure Report, 2023/24

The PMPRB’s flagship CompassRx report monitors and analyzes the cost pressures driving changes in prescription drug expenditures in Canadian public drug plans. The eleventh edition of the report will provide insight into the factors driving growth in drug and dispensing costs in 2023/24, as well as a retrospective review of trends in public drug plan costs and utilization.