As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations for comment. On December 11, 2017, the Patented Medicine Prices Review Board (PMPRB) released the PMPRB Guidelines Scoping Paper – High Level Overview of Potential New Framework (Canada Gazette, Part I). According to the paper, the purpose is to provide a non-binding outline of preliminary thoughts on how to best operationalize the proposed changes, and is to be read in conjunction with the proposed amendments and Regulatory Impact Analysis Statement.
The scoping paper describes the framework as a risk-based approach to pricing review that is broken down into five main parts:
- Interim international price reference test;
- Screening;
- High priority drugs;
- Medium and low priority drugs; and
- Re-benching.
The paper concludes that the proposed amendments would allow the PMPRB to move to a risk-based framework that scrutinizes drugs with the greatest potential for excessive pricing to take into account their value and financial impact on consumers when setting prices. Finally, the paper encourages specific questions to be considered in consultations with the new proposed Guidelines, and states that it is expected that a first draft of new PMPRB Guidelines will be made public in the spring of 2018, with technical roundtables to follow, with a view to having new Guidelines in place by early 2019.
Related Publications & Articles
-
Update on biosimilars in Canada – March 2024
In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access).Read More -
Minister of Health proposes legislation for first phase of national universal pharmacare
On February 29, 2024, the Minister of Health announced the introduction of Bill C-64, An Act respecting pharmacare (Pharmacare Act).Read More -
PMPRB releases 2022 Annual Report and March 2024 NEWSletter
On February 16, 2024, the Minister of Health tabled the 2022 Annual Report of the Patented Medicine Prices Review Board (PMPRB).Read More