PMPRB NEWSletter – Special Edition - Guidelines Consultation Update

Contents

• Upcoming Discussion Guide
• Message from the Chairperson – The Board’s Approach
• Guideline Consultation Process – A Three-Phase Approach
  • Phase 1 – Policy Roundtable and What We Learned
  • Phase 2 – Discussion Guide
  • Phase 3 – Draft Guidelines
• Interim Guidance

Upcoming Discussion Guide

As part of the ongoing process to update its Guidelines, the PMPRB will publish a Discussion Guide in the summer of 2024. Building from the progress made at the Policy Roundtable in December 2023 and the feedback received in response to the Scoping Paper, the Discussion Guide will provide material to continue an informed, focused, and productive consultation. Stakeholders will gain an insight into the Board’s perspective on issues that the Board needs to consider in addressing the upcoming Guidelines. The Discussion Guide will indicate a direction on certain issues and provide a range of options on others.

Stakeholders will be invited to provide feedback in writing and in limited cases by in-person, on the record, meetings. Further details will be provided when the Discussion Guide is released.

Message from the Chairperson – The Board’s Approach

The PMPRB is in the process of updating our Guidelines to give effect to amendments to the Patented Medicines Regulations (SOR/94-688), which came into force on July 1, 2022. As Chairperson, I would like to take this opportunity to share with you the Board’s approach to the new Guidelines.

PMPRB staff use the Guidelines to review prices of patented medicines and to identify instances of potential excessive pricing which the Chairperson could consider bringing to a public hearing. The procedures laid out in the Guidelines are drawn from factors set out in s. 85(1) of the Patent Act, as interpreted by the Patented Medicines Regulations. They are meant to frame how staff are to interpret the complex price data received from pharmaceutical manufacturers who hold the rights for the patented medicines under our jurisdiction.

It is the Board, comprised of appointed Board Members, that has the authority to establish the Guidelines. The Board has discretion on how to implement the legislation. The current Guidelines consultation process is designed to seek feedback from stakeholders on their views about what the Board should emphasize and de-emphasize in the Guidelines.

While the Guidelines are non-binding, it is our view that Guidelines which are clear, predictable and procedurally fair provide an efficient way for rights-holders to manage risk. Historically, over 99% of the investigations conducted by staff have been resolved within the scope of the Guidelines without the need for a hearing. To this extent, it is clear that Guidelines are an important concern for stakeholders and they can be an efficient tool in achieving the PMPRB’s legislative mandate.

With these thoughts and concerns in mind, the Board has implemented a three-phase Guidelines consultation process, which started in September 2023. The publication of a Discussion Guide in the summer will mark the beginning of the second phase. So far, the Board is encouraged by the participation of the diverse stakeholders who have various perspectives about the prices of patented medicines in Canada. We encourage you to continue to work with us in this important process and share your perspectives on what the PMPRB should address going forward.

Thank you,

Guideline Consultation Process – A Three-Phase Approach

Phase 1 – Policy Roundtable and What We Learned

In the first phase of the consultation process, the PMPRB published a Scoping Paper with six key themes designed to encourage a productive conversation between stakeholders and the PMPRB. In December 2023, the PMPRB hosted a two-day Policy Roundtable where stakeholders were invited to present their feedback in person. The written feedback can be read on the PMPRB website, and a summary of the in-person feedback can be reviewed in the What We Learned Report. The PMPRB thanks all those who took the time to provide their thoughts. We are using that feedback to inform the upcoming Discussion Guide.

Phase 2 – Discussion Guide

Information on the Discussion Guide, to be released in the summer of 2024, is provided in the introductory section titled Upcoming Discussion Guide.

Phase 3 – Draft Guidelines

The Board intends to publish new draft Guidelines before the end of 2024 following due consideration of the feedback received on the two previous phases. These Guidelines will be open for a Notice and Comment period before finalization and implementation, which is anticipated in 2025.

Interim Guidance

As a reminder to all stakeholders, the Interim Guidance, amended on September 27, 2023, remains in effect until further notice.