The Patented Medicine Prices Review Board (PMPRB) has announced new details regarding the progress of its consultation on new price review Guidelines.

Phase 2: Discussion Guide

The next phase of the PMPRB’s consultation will begin in summer 2024 with the release of a Discussion Guide. As we reported, the first phase of the consultation launched with a Scoping Paper in November 2023, followed by the release of a “What We Learned” Report in February 2024. Building on this first phase, the Board’s announcement states that the Discussion Guide “will indicate a direction on certain issues and provide a range of options on others.” Stakeholders will then have an opportunity to provide feedback to the Board.

Phase 3: Draft Guidelines

Following the publication of the Discussion Guide, PMPRB plans to publish new draft Guidelines before the end of 2024. According to the Board’s announcement, they “will be open for a Notice and Comment period before finalization and implementation, which is anticipated in 2025.”

The PMPRB’s announcement also includes a message from the Chairperson describing the Board’s approach to the new Guidelines. In the message, the Chairperson notes that the Board has discretion on how to implement its enabling legislation and states that these consultations are “designed to seek feedback from stakeholders on their views about what the Board should emphasize and de-emphasize in the Guidelines.”

Interim Guidance remains in effect

The PMPRB’s Interim Guidance, as amended on September 27, 2023, will continue to govern patented medicine drug pricing until new Guidelines are implemented.