Parliamentary Committee Issues Report on PMPRB Reform. Calls for “Comprehensive Response” by the Government
On May 6, 2024, Canada’s Standing Committee on Health (“HESA”) issued a report containing “ten recommendations on how the Government of Canada can enable the Patented Medicine Prices Review Board (“PMPRB”) to more effectively carry out its mandate and implement its reforms” (“Report”). HESA has called on the government to “table a comprehensive response to this report” within 120 days.
Links to the Report and the record of proceedings are provided below.
What is HESA?
HESA is a federal Parliamentary committee. Its mandate is to “study and report on all matters relating to the mandate, management and operation of Health Canada”, to provide oversight of four agencies that report to Parliament through the Minister of Health, including the PMPRB, and to study other matters that it chooses to examine. HESA makes public its findings and recommendations on these topics by presenting a report to the House of Commons. The current HESA chair is a member of the governing Liberal party.
Purpose of the Study
The purpose of this study was to assess “concerns regarding the Board’s operations and its ongoing efforts to implement drug pricing reforms” that have been under consideration since 2016. HESA was particularly interested in events giving rise to the delayed implementation of Guidelines that were expected to come into force in January 2023, and the sudden resignations of the Acting Chairperson, a Board member, and the Executive Director shortly thereafter (“Resignations”).
Committee Hearings
In April-May 2023, the Committee heard testimony from seven witnesses, including the (now former) Minister of Health, who provided “contrasting accounts” of the events leading up to the Resignations. HESA noted that “[s]ome blamed pressures exerted on the Board by the Minister of Health and pharmaceutical industry, while others refuted the existence of external interference and pointed to problems within the PMPRB, such as resistance to meaningful stakeholder engagement or ambiguities in operating procedures.” Seven health-related organizations also submitted briefs to the committee.
The Report
HESA released its Report on May 6, 2024. The Report summarizes the relevant evidence and presents ten recommendations “to enable the PMPRB to more effectively carry out its mandate of protecting Canadian consumers against excessive drug pricing and ensure that the Board is successful in reforming its approach to evaluating drug prices”.
- Recommendation 1
That the Government of Canada implement a clear communications protocol between the Minister of Health and the Chairperson and members of the PMPRB.
- Recommendation 2
That the Government of Canada review the process by which it enacts PMPRB regulatory reform.
- Recommendation 3
That the Government of Canada review the way in which it interacts with the pharmaceutical industry as a regulated sector with monopolistic patent pricing power.
- Recommendation 4
That the mandate of the PMPRB be clarified. The Board “should be mandated to ensure that the prices of patented medicines are not excessive while also ensuring that pricing does not ultimately limit patient access, particularly in the case of rare diseases.”
- Recommendation 5
That the PMPRB review its internal operating rules to ensure that they are clear and transparent. In addition, members appointed to the organization should be provided with independent, external support to help them in the event of misunderstandings and issues.
- Recommendation 6
That the PMPRB consider case studies to gain insight into how its future Guidelines would be applied in practice and to have a firmer idea of their potential consequences on patients and the life sciences ecosystem.
- Recommendation 7
That the PMPRB include a broader range of stakeholders in policy development.
- Recommendation 8
That the members of the PMPRB always have real-time access to the contents of submissions presented in consultations.
- Recommendation 9
That a registry be created to track drug penetration rates in Canada and compare them with similar countries.
- Recommendation 10
That the Government of Canada maintain a public registry of publicly funded innovations, alone or in partnership with the industry, and ensure that what it funds is available in the Canadian marketplace.
Next Steps
HESA has asked the Government to “table a comprehensive response to this report”. The applicable standing order requires a response to be presented to the House of Commons within 120 days.
Relevant Links
Record of Proceedings: HESA – Patented Medicine Prices Review Board (ourcommons.ca)