At the 2024 Market Access Summit on October 29, Guillaume Couillard, Director General, presented an update on the Patented Medicine Prices Review Board (PMPRB), its evolving mandate, and the development of new guidelines to ensure Canada’s patented drug prices remain fair and transparent.
Key Points
Mandate:
- Established in 1987 under the Patent Act as an independent, quasi-judicial body.
- Monitors patented drug prices to ensure they are not excessive.
- Does not generally set price ceilings or block market entry.
- “Excessive price” is determined case by case, considering domestic prices, prices abroad, similar drugs, and the Consumer Price Index.
Organizational Updates:
New President, Vice-President, Board members, and Director General appointed since February 2023.
The Chairperson directs operations; only the Board can determine if a price is excessive.
New Guidelines:
Non-binding guidelines help prioritize which cases may require a hearing.
Changes to the Patented Medicines Regulations in 2022 introduced new comparator countries (PMPRB11) and reduced reporting for low-risk drugs.
Consultations to update the guidelines launched in October 2023 and follow three phases:
- Phase 1: Scoping paper and policy roundtable (complete).
- Phase 2: Draft technical framework in development (underway).
- Phase 3: Release of draft guidelines for stakeholder input (expected soon).
Proposed updates include shorter reviews for lower-risk drugs, automatic review for first-to-market launches, in-depth reviews for higher-risk cases, annual monitoring, and possible complaint mechanisms.
Final guidelines are expected in the first half of 2025, pending consultation results.
The PMPRB remains focused on modernizing its framework and engaging stakeholders as it works to balance innovation and fair pricing in Canada’s pharmaceutical market.
Read more: Guillaume Couillard’s Presentation Slides
