Canada’s Intellectual Property Firm

PMPRB releases scoping paper relating to proposed amended Regulations

Authored byKatie Lee

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:

  1. Interim international price reference test;
  2. Screening;
  3. High priority drugs;
  4. Medium and low priority drugs; and
  5. 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.