Steering Committee on Modernization of Price Review Process Guidelines
The PMPRB is consulting with its stakeholders on changes to its non-binding guidelines (the “Guidelines”), as contemplated by subsection 96(4) of the Patent Act. The purpose of these changes is to modernize the PMPRB’s approach to carrying out its mandate to protect Canadian consumers from excessive patented drug prices. Two main types of changes are considered. The first type would operationalize Health Canada’s proposed amendments to the Patented Medicines Regulations in order to make patented drugs more affordable for Canadians. The second would enable the PMPRB to make more efficient use of its resources by adopting a risk-based approach to how it regulates drug prices that simplifies and streamlines compliance for patentees.
In order to do this, the PMPRB will be establishing a multi-stakeholder Steering Committee, which will meet for the first time in June 2018, in order to discuss aspects of the new regime and assist the PMPRB in synthesizing stakeholder views on key technical and operational modalities of new draft Guidelines that would give effect to these changes. This work will be based in part on the analysis and recommendations of a technical Working Group which will examine certain issues that the Steering Committee believes would benefit from the review of experts in health technology assessment and other economic and scientific matters.
A report of the Steering Committee’s deliberations will be produced by PMPRB staff and considered by the Board prior to the publication of new draft Guidelines for broader stakeholder consultation in fall 2018.
Any analysis or recommendations emanating from the Working Group’s review or from the Steering Committee’s deliberations will not be binding on the Board.
Below you will find reference materials from the Steering Committee’s meetings:
- June 25 Steering Committee meeting