PMPRB NEWSLetter – Special Edition - Guidelines Consultation, Phase 3

Table of Contents

• Draft Guidelines
• Overview Document
• Technical Briefings
• Next Steps
• Message from the Chairperson

Draft Guidelines

The PMPRB Draft Guidelines are now available for review. The PMPRB has launched a 90-day consultation period where stakeholders and interested Canadians are invited to read the Draft Guidelines and provide feedback by March 19, 2025.

The PMPRB Draft Guidelines are a proposal from the Board for the steps to be followed by Staff of the PMPRB to investigate if the price of a patented medicine may be excessive. The proposal sets screens that act as flags for Staff to identify cases for which detailed In-Depth Review is warranted. Following the In-Depth Review, the Staff may recommend to the Chairperson that an excessive price hearing take place. Among other things, the consultation seeks stakeholder views on whether these flags provide a transparent, predictable, and procedurally fair approach to the excessive price review.

This is the third phase in our guidelines consultation process. Phase one started in November 2023 when the PMPRB posted an initial Scoping Paper and, shortly after, hosted a two-day Policy Roundtable where stakeholders and Board Members met to discuss broad themes for the new guidelines. The second phase continued the productive conversation with the publication of the Discussion Guide, in June 2024, which provided seven topics for discussion, including hypothetical case studies, and indicating certain directions the Board was leaning to adopt for the future guidelines. The Board received submissions and held public discussion in September/October 2024. The PMPRB is now entering this third phase of consultations for the public to consider specific new Draft Guidelines which are proposed based on the factors in the Patent Act and on thefeedback received during the first two consultation phases.

Overview Document

The PMPRB has also prepared an accompanying Overview about these Draft Guidelines to explain their contents in simplified language that is easier to understand. Readers should note that the PMPRB is consulting on the contents of the Draft Guidelines and not this companion piece.

Technical Briefings

The PMRPB will hold technical briefings in February to further explain the contents of the Draft Guidelines and answer questions that interested stakeholders may have. More details will be announced soon. Follow the PMPRB on X and on LinkedIn for details.

Next Steps

Once the consultation period ends on March 19, 2025, the PMPRB will review the submitted feedback and consider any necessary changes, with the intention of publishing final guidelines later in 2025.

Message from the Chairperson

The Board is pleased to present the PMPRB Draft Guidelines for your consultation, review, and comment.

The Board continues to take the view that the best way to fulfill our mission to Canadians is to adhere closely to our enabling legislation and regulations, and to applicable court decisions, while maintaining a broadly informed view of the life sciences ecosystem which continues to evolve in Canada, and globally.

You will notice that the Board is proposing to implement significant changes from previous guidelines. Most of these changes have been considered in phase one and phase two of the current consultation. We are now providing specific Draft Guidelines which we believe are ready to be vigorously tested in the public forum. We are open to suggestions for improvements or changes, and the Board continues to take an open-minded approach to our proposal.

While it is clear that not all interested parties will agree on the paths we are proposing to take, the Board remains committed to working with all stakeholders towards the ultimate destination of protecting Canadians from excessive drug pricing, according to our statutory mandate.

We look forward to receiving your comments and critiques on these Draft Guidelines by the deadline of March 19, 2025.