PMPRB NEWSLetter – Special Edition - Guidelines Consultation, Phase 2 

Discussion Guide 

The Patented Medicine Prices Review Board is pleased to launch the second phase of the consultation on new Guidelines with the release of the Discussion Guide. The Discussion Guide continues the informed, focused, and productive consultation based on the Policy Roundtable in December 2023 and the feedback received in response to the Scoping Paper.

In order to further explore the concerns and the potential impact of new Guidelines that were raised in the first phase, the Board has published a Discussion Guide. The Guide provides 7 topics for discussion with stakeholders, including hypothetical case studies for your consideration and comments. It also indicates certain directions the Board is leaning to adopt for the future Guidelines.

We invite all stakeholders to review the Discussion Guide and submit feedback by September 11, 2024. 

You are also invited to submit questions and register to the Webinar that will be held in August. The webinar intends to explain the approach taken by the Board and answers any questions submitted in advance by stakeholders on any topics of the Discussion Guide.

The Board will consider feedback received on the Discussion Guide to draft its new Guidelines. The PMPRB intends to publish a set of draft Guidelines for a final round of consultation later this year. 

Message from the Chairperson - Important Issues Beyond the Guidelines 

After extensive internal discussions in light of judicial decisions, and after an initial open discussion with stakeholders, I’m very pleased to report that the Board is now proposing a framework to implement the PMPRB11 basket of countries through its Guidelines.

Stakeholders will note numerous proposed changes from previous Guidelines adopted by the Board.  Among the most important changes are:

  • All patented medicine list prices will be reviewed on an approximately annual basis.
  • List prices of new medicines which are a low risk of excessive pricing based on international price comparison will receive initial review from the Board within 60 days and no further consideration will be given until the annual review or if a complaint is filed; 
  • A streamlined process whereby in-depth review using therapeutic class comparison (TCC) will be required only if the list price is at risk of being excessive based on international price comparison or if a complaint is filed;
  • If Canada is the first launch country for a new medicine in the PMPRB11, the Board will not require an in-depth review that year;
  • A greater emphasis on complaints as a way to identify situations in which an in-depth review using TCC should be warranted.

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

You will see in the Discussion Guide that the Board proposes to adopt certain specific directions, but we have not yet finalized our position on multiple other significant questions.  We believe this Discussion Guide is the best method to carry forward our consultations in an informed, focused and productive conversation.

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

We look forward to receiving your feedback on this Discussion Guide and the Phase 2 Consultation by the deadline of September 11, 2024. 

Thomas Digby, Chairperson, Patented Medicine Prices Review Board

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