Patented Medicine Prices Review Board (PMPRB) Terms of Reference for Steering Committee on Modernization of Price Review Process Guidelines

1. Background

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 contemplated. 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.

The mandate of the Steering Committee is to 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 (the “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, which will be considered by the Board prior to the publication of new draft Guidelines for broader stakeholder consultation in the fall. This will result in a more focused and efficient consultation process.

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.

2. Composition of the Steering Committee

The Steering Committee will be jointly chaired by the PMPRB’s Director of Policy and Economic Analysis and the Director of Regulatory Affairs and Outreach. In addition to the co-chairs, the Steering Committee will consist of up to 17 members. Representatives from Health Canada and Innovation, Science and Economic Development (ISED) will also be present as observers. PMPRB Staff will attend meetings in order to provide administrative and other support, as required, to the Steering Committee. The members of the Steering Committee are identified below:

3. Function of the Steering Committee

The function of the Steering Committee is to assist the PMPRB in synthesizing stakeholder views on key technical and operational modalities of the PMPRB’s new, risk-based approach to regulating patented drug prices. This work will be informed in part by the analysis and recommendations of the Working Group, as per section 8 of these Terms of Reference and Appendix “A”. A report of the Steering Committee’s deliberations, and any associated advice or recommendations emerging from those deliberations, will be prepared by PMPRB staff for the Board’s consideration.

4. Governance and procedure

It is recognized that the Steering Committee is composed of members who represent organizations with divergent and even diametrically opposed points of view on the policy rationale for the proposed amendments to the Patented Medicines Regulations upon which the Guideline changes are partly based. Members who represent organizations that are opposed to that policy are nonetheless encouraged to work constructively with the Steering Committee in carrying out its function.

The co-chairs are expected to foster consensus among members but, in order to ensure that Steering Committee deliberations are as focused and productive as possible having regard to the divisive nature of the underlying policy, they shall have final say on all matters of governance and procedure. Members who disagree with a decision of the co-chairs in this regard, can request that their objection be noted on the record. The co-chairs shall make every effort to ensure that the Steering Committee’s final report accurately reflects any important points of convergence or contention between members.

5. Meetings

All Steering Committee meetings will take place at PMPRB offices in Ottawa.

The co-chairs will direct the work of the Steering Committee including calling for meetings and addressing any related scheduling issues.

An initial meeting of the Steering Committee will be held on June 25, 2018. Further meetings will be scheduled as required and, to the greatest extent possible, at dates and times to coincide with the availability of the members. It is anticipated that four meetings will be held in all, the first and last in person in Ottawa and the remainder by conference call or webinar.

6. Confidentiality

Steering Committee members may consult with their respective organizations on an ongoing basis but are expected to maintain the confidentiality of any materials specifically designated as confidential provided to them by PMPRB Staff during the course of their work. The names of the members of the Steering Committee will be published on the PMPRB’s website along with a report of its deliberations and the analysis and recommendations of the Working Group.

7. Budget

The PMPRB may cover reasonable travel and accommodation costs of members where such funding is requested and approved in advance. Where possible, the co-chairs of the Steering Committee will arrange meetings to attempt to minimize expenditures for participants.

8. Establishment of Working Group

The PMPRB will establish a Working Group which will provide analysis and recommendations on certain matters that the Steering Committee believes would benefit from expert review. Further information on the Working Group can be found in Appendix “A”.