Letter to the acting Chairperson and Chief Executive Officer of the Patented Medicine Prices Review Board
The original letter was sent in French only.
November 28, 2022
Dear Ms. Bourassa Forcier:
I would like to provide you with perspectives regarding the current consultation on the new draft Guidelines, in accordance with the Patent Act.
Thank you for your continued leadership as the Acting Chairperson and Chief Executive Officer of the Patented Medicine Prices Review Board (PMPRB).
The amendments to the Patented Medicines Regulations (PMR) came into force on July 1, 2022. In anticipation of this coming into force, the PMPRB issued interim Guidelines for establishing non-excessive prices for medicines launched during the period of time between the coming into force of the Regulations and the publication of its final Guidelines. The consultation process for the interim Guidelines, launched in June 2022, proposed that once the draft Guidelines were published there would be a targeted consultation process with key stakeholders to develop final Guidelines. Subsequently, the draft Guidelines were published on October 6, 2022 with a 60-day Notice and Comment Period ending on December 5, 2022. In its consultation documents, the PMPRB states that it would like to issue its final Guidelines by the end of the year. Following which, they would come into effect on January 1, 2023, and compliance monitoring and implementation by Board staff would begin in January 2024.
The proposed new Guidelines incorporate the new Schedule of 11 comparator countries (“PMPRB11”), as per the amendments to the PMR, as well as contain a number of substantive changes that form part of the modernization efforts that the Board has been undertaking for several years. Importantly, this new version of the Guidelines signal a pivotal change from a long-standing practice of including price tests and price ceilings, to instead including investigation criteria.
Given the new direction set out in the proposed new Guidelines, it is critical that all stakeholders understand fully how the new Guidelines will be implemented. Many stakeholders have raised concerns and questions associated with the new Guidelines, and are looking for more information about the potential impacts and on the operationalization of some of the key technical aspects of the Guidelines. It is only with this more detailed understanding that stakeholders can engage meaningfully in the consultation process. In parallel, the Board will benefit in receiving the considered views and feedback of stakeholders as part of its decision-making.
Furthermore as Minister of Health, I am especially interested in understanding any potential impacts respecting drug shortages, which affect the availability of medicines for Canadians. In addition, given the role of provinces and territories in the pharmaceutical management system, I would like to consult with my colleagues to understand their views on these draft Guidelines.
Based on these considerations, I respectfully ask that the Board consider pausing the consultation process, so as to allow time to work collaboratively, with all stakeholders, to understand fully the short and long-term impacts of the proposed new Guidelines. During this time, I understand that the interim Guidelines currently in place could continue to be in force.
Please accept my best wishes.
The Honourable Jean-Yves Duclos, P.C., M.P.
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