PMPRB NEWSletter: September 2026, Volume 30, Issue 3

Message from the Chairperson

I’m pleased to share the latest edition of the PMPRB Newsletter, which highlights the organization’s continued progress on several important fronts. We recently concluded a 30-day consultation on proposed Practice Directions designed to clarify procedural matters and improve the efficiency of PMPRB hearings. I have also accepted the first Undertaking under the new Guidelines, which you can read more about in this edition.

At the same time, we continue to engage actively with rights holders, patient groups, and other interested partners through conferences, meetings, and stakeholder engagement sessions. These discussions have made it clear that questions and misconceptions remain about the PMPRB, its mandate, and the new Guidelines. I would therefore like to take this opportunity to reiterate a few key points.

It is important to understand that the PMPRB does not set or negotiate the price of patented medicines, nor does it establish price ceilings. We also do not decide whether a medicine should be reimbursed by public or private drug plans. Those responsibilities rest with other organizations.

Instead, our role is to determine, based on the factors set out in the Patent Act, whether an excessive price constitutes an abuse of patent rights. If there are concerns that a price may be excessive, the PMPRB may review the matter and, where appropriate, hold a public hearing. This clear division of responsibilities allows each organization to fulfill a complementary role without duplication or overlap, contributing to a balanced and effective pharmaceutical policy framework.

The PMPRB has the legislative authority to conduct quasi-judicial hearings and issue legally binding orders requiring a reduction in the price of a patented medicine or requiring the rights holder to offset excess revenues resulting from excessive pricing.

The new Guidelines are administrative in nature and provide greater clarity on how PMPRB staff conduct price reviews, including when an in-depth review will begin and, importantly, how the Highest International Price (HIP) test is applied. To be clear, the applicable test is the HIP test—not a mid-price or average-price test based on the PMPRB11 countries. I want to emphasize this distinction because there may still be some confusion about which test applies.

The Guidelines are intended to help PMPRB staff carry out their price review responsibilities consistently, efficiently, and transparently. They are not legally binding on rights holders and do not create any new legal obligations beyond those established under the Patent Act and the Patented Medicines Regulations.  Their primary objective is to promote administrative efficiency by focusing the PMPRB's resources on medicines that present a greater potential risk of excessive pricing, while allowing lower-risk cases to proceed through a streamlined review.

I look forward to continuing these conversations as we advance the PMPRB’s important work.

Board updates

New appointments to the Board 

The Honourable Marjorie Michel, Minister of Health, announced on June 16, 2026 the appointment of Peter Moreland-Giraldeau as the new Vice-Chairperson and Conor McCourt as a member of the Board. 

Mr. Moreland-Giraldeau is a lawyer by training with eight years of professional experience across multiple jurisdictions. He has served on the Board as a member since October 2023, and in his new position as Vice-Chairperson he will support the recently appointed Chairperson, Anie Perrault.   

Mr. McCourt is a retired lawyer with extensive experience in the practice of pharmaceutical patent law and agency, health regulatory affairs, and pharmaceutical and biologics market access and pricing. 

Undertakings

The Chairperson has accepted the first Undertaking under the PMPRB’s new Guidelines, which led to closure of the In-Depth Review.

An undertaking is a unilateral promise made by a Rights Holder to resolve an In-Depth Review. It is submitted by Rights Holders in view of the specific facts and underlying context of a particular In-Depth Review and is purely administrative in that it is only used to close the In-Depth Review. As such, undertakings are not intended to have precedential value.

Under the PMPRB’s new Guidelines, an Undertaking may be submitted at any point during an In-Depth Review between its commencement and two months after the Chairperson has received Staff’s recommendation for the issuance of a Notice of Hearing. Rights Holders are notified by Staff when such a recommendation is made, granting Rights Holders a final opportunity to resolve the In-Depth Review prior to the Chairperson’s decision. When an Undertaking is received, Staff’s analysis under the 85(1) factors may be paused. All Undertakings received by Staff are presented to the Chairperson for decision.

Imcivree (setmelanotide) - Rhythm Parmaceuticals
Imcivree is indicated for weight management in adult and pediatric patients 6 years of age and older with obesity due to:

• Bardet-Biedl syndrome (BBS) 
• Genetically confirmed biallelic pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency due to variants interpreted as pathogenic, likely pathogenic, or of uncertain significance

On August 10, 2026, the Chairperson accepted an undertaking by Rhythm Pharmaceuticals regarding Imcivree.
Rhythm Pharmaceuticals committed to maintain the current Canadian list price for Imcivree and not to increase it based on the consumer price index (CPI) for a period of two years from the initial review of the medicine (i.e. until January 1, 2028). 

Events

The PMPRB have participated in or are planning to participate in the following events:

• May 20, 2026 – A Board Meeting was held in Ottawa.
• June 4, 2026 – Chairperson, Anie Perrault, attended the Small Departments and Agencies Community General Assembly.
• August 23-25, 2026 – Chairperson, Anie Perrault, attended the Victoria Forum 2026 in Victoria, British Columbia.
• October 6 & 7, 2026 – Chairperson, Anie Perrault, will attend and present at the Market Access Summit in Toronto. Director General, Guillaume Couillard, will also attend.
• October 19 & 20, 2026 – Chairperson, Anie Perrault, will attend the Canadian Life and Health Insurance Association’s (CLHIA) Healthcare Forum in Toronto. Director General, Guillaume Couillard, will also attend.
• October 23, 2026 – A Board meeting will be held in Ottawa.
• November 24-25 – Chairperson, Anie Perrault and Director General,  Guillaume Couillard, will attend the Forum de l’industrie de la santé de Québec (FISQ) in Québec City.

NPDUIS Research Initiative Activities

The PMPRB continues to publish a number of analytical studies for the Minister of Health through the NPDUIS research initiative.

NPDUIS Advisory Committee Meeting

The NPDUIS Advisory Committee reconvened virtually in July 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 October 2026.

Conference Participation

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

• Canadian Association for Population Therapeutics (CAPT), Toronto, ON (September 28-29, 2026) – 30th annual conference presenting “The Legacy of CAPT-ACTP: Three Decades of Shaping Canadian Health Systems”

NPDUIS Research Initiative: New and Upcoming Publications

New Releases

Coming Soon

Several studies are slated for publication in the coming months:

Meds Entry Watch, 10^th Edition

The Meds Entry Watch report explores the market entry of new medicines in Canada and other countries. Building on a retrospective analysis of trends since 2021, this report focuses 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 to 2025 inclusive, and analyzes 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 provides sales and pricing information on medicines that received their first Health Canada approval between 2021 and 2024, as well as a retrospective review of approvals 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.