The Patented Medicine Prices Review Board (PMPRB) published its new Guidelines for PMPRB Staff on June 30, 2025, marking a significant milestone in Canada's pharmaceutical pricing oversight. The guidelines, which will take effect on January 1, 2026, establish a comprehensive two-step process for monitoring and reviewing drug prices and represent a substantial departure from previous PMPRB guidelines.
New Two-Step Review Framework
The updated guidelines introduce a structured approach to drug price evaluation. The Initial or Annual Review serves as a screening process, comparing drug prices to those in other countries or to similar treatments available in Canada. If this initial assessment raises concerns, or if a complaint is received from an approved individual or organization, the PMPRB will initiate a more comprehensive In-Depth Review.
During the In-Depth Review phase, PMPRB staff conduct detailed comparisons of the drug under review to similar drugs and treatments available for the same medical conditions. This tiered approach aims to provide a more efficient and targeted review process while maintaining rigorous oversight of patented medicine pricing.
Completion of Regulatory Modernization
These new guidelines complete the process of updating the PMPRB Guidelines to operationalize the July 1, 2022 amendments to the Patented Medicines Regulations. Acting Chairperson Anie Perrault had previously confirmed in the PMPRB's June 2025 NEWSletter that the board planned to publish its final Guidelines in summer 2025.
The comprehensive consultation process leading to these guidelines included stakeholder written submissions and webinar materials, all of which are now available on the PMPRB's website. The board emphasized that these guidelines have been established "after much consideration from the Board" and following extensive stakeholder engagement.
Strategic Planning and Governance Updates
The PMPRB is also developing a five-year Strategic Plan, with more details expected once the plan is finalized. The board has maintained active governance through regular meetings, with sessions occurring between September 23, 2024 and May 1, 2025, each accompanied by summary documentation.
Market Analysis Through NPDUIS Report
Concurrent with the guidelines release, the National Prescription Drug Utilization Information System (NPDUIS) initiative published the ninth edition of the Meds Entry Watch Report in June 2025. This comprehensive analysis focuses on medicines that received first-time approval from Canada, the United States, and Europe in 2022 and 2023.
The report analyzes multiple aspects of pharmaceutical market dynamics, including uptake patterns, pricing structures, sales data, and availability metrics as of the fourth quarter of 2023. This data provides crucial context for understanding how new medicines enter and perform in the Canadian market.
Regulatory Impact and Transparency
The PMPRB emphasized that these guidelines provide "a transparent and predictable process to be used by PMPRB staff to review drug prices once they enter the market." This transparency is designed to give pharmaceutical companies and other stakeholders clear expectations about how their products will be evaluated.
The board's role remains focused on ensuring that prices of patented medicines are not excessive, maintaining its unique position within the Canadian health system. The new guidelines are intended to strengthen this oversight while providing clearer pathways for both routine monitoring and more detailed investigations when warranted.
