On November 10, 2023, the Patented Medicine Prices Review Board (PMPRB) released its Scoping Paper for the Consultation on the Board’s Guidelines (Scoping Paper) and opened registration for stakeholders to participate in Policy Roundtable Discussions on December 5, 2023 (in English) and December 6, 2023 (in French).
As previously reported, the PMPRB recently adopted its Amended Interim Guidance to evaluate the pricing of patented medicines. Additionally, we reported that the PMPRB announced the launch of the first phase of consultations for preparing new guidelines and informed stakeholders of the upcoming Policy Roundtable Discussions.
The Scoping Paper aims to facilitate the consultation process and lead to more informed, focused, and productive feedback for the PMPRB in developing its new guidelines. The Scoping Paper is to be used for discussion purposes to advance consultation rather than a “definitive articulation of the PMPRB’s position on these issues.” The discussion themes in the Scoping Paper include:
- efficient monitoring of prices without price setting;
- transition to PMPRB11 – new versus existing medicines;
- price reviews during product life cycle;
- investigations and referral to hearing;
- relation to pan-Canadian health partners, insurers (private and public) and alignment with broader government initiatives; and
- engaging with patients, health practitioners, pharmacy, and other stakeholders.
How Can Stakeholders Participate in the Policy Round Table?
Stakeholders are invited to participate in Policy Round Table discussions scheduled for December 5, 2023 (in English) and December 6, 2023 (in French). Both sessions will be held both in person and virtually.
To register, interested parties are invited to complete the Policy Round Table Registration Form by November 24, 2023. There are limited in-person attendance spots, but all interested persons can register to participate online.
Interested parties are also invited to make presentations, however, only limited spots are available. Presenters will be chosen in a way that ensures a diversity of opinions is reflected.
Additionally, interested parties are invited to submit written submissions on questions raised by the Scoping Paper as well as any other relevant topics. The deadline for written submissions is December 20, 2023.
The PMPRB will release a “What we Heard Report” in early 2024 after the conclusion of the Policy Round Table discussions and aims to finalize new Guidelines during 2024.
Please reach out to any member of our life sciences team if you would like to discuss the Amended Interim Guidance or the upcoming consultations to develop the new guidelines.