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PMPRB “What We Learned Report” Released

02/16/2024

The Patented Medicine Prices Review Board Canada (PMPRB) published its “What We Learned Report” (Report) on February 15, 2024, which summarizes Policy Roundtable Discussions (Policy Roundtable) held in December 2023. A separate report will be released on the analysis of the written submissions.

The Policy Roundtable invited participants to join in-person and virtually and 34 stakeholder presentations were accepted to participate. Stakeholder groups included: rights holders, industry, and industry associations; patients and patient advocacy groups; distributors, pharmacies, and pharmacy associations; civil society groups and unions; academics; a health practitioner; an individual; and a research funding organization.

Stakeholders focused on topics and issues such as:

  • The PMPRB mandate;
  • Assessing excessive pricing;
  • Considerations for PMPRB Guidelines;
  • Understanding the life sciences ecosystem;
  • Alignment of PMPRB Guidelines with broader government initiatives; and
  • Stakeholder engagement.

For further details, please see the report here.

Background

As we reported, the Patented Medicine Prices Review Board (PMPRB) adopted its Amended Interim Guidance (Interim Guidance) on September 27, 2023. The Interim Guidance provides information on how the PMPRB reviews the prices of patented medicines in Canada and will be in force until the New Guidelines are developed and implemented.

The Policy Roundtable, as we reported, was to focus on:

  • Efficient Monitoring of Prices without Price Setting;
  • Transition to PMPRB11 – New versus Existing Medicines;
  • Price Reviews during Product Life Cycle;
  • Investigations and Referral to Hearing;
  • Relation to pan-Canadian Health Partners, Insurers (Private and Public) and Alignment with Broader Government Initiatives; and
  • Engaging with Patients, Health Practitioners, Pharmacy, and other Stakeholders.

As previously reported, the PMPRB also published a Scoping Paper for the Consultation on the Board’s Guidelines (Scoping Paper) outlining further details on the consultation process and aimed to facilitate the consultation process in an informed, focused and productive manner.

Next Steps

The PMPRB is continuing to review feedback it has received and will be announcing next steps soon. The Report was released after the first phase of consultations.

Please reach out to any member of our life sciences team if you would like to discuss the Amended Interim Guidance or the consultations to develop the new guidelines.

This publication is a general summary of the law. It does not replace legal advice tailored to your specific circumstances.

For more information, please contact the authors of this article or any member of our Intellectual Property Group.