The Patented Medicine Prices Review Board (the PMPRB or Board) is an independent, quasi‑judicial body, responsible for ensuring that the prices of patented medicines in Canada are not excessive during the period of market exclusivity granted to patentees. In 2015, certain reports called into question the effectiveness of the PMPRB’s regime in meeting its policy objective to curb excessive drug prices. Despite ongoing efforts since 2016 to reform the Board’s regulatory framework, a new regime has yet to be implemented. After legal challenges and multiple delays, certain amendments to the Patented Medicines Regulations came into force in 2022. However, the active application of these regulatory amendments is contingent on the issuance of new PMPRB Guidelines.

The PMPRB published a draft of its new Guidelines in October 2022 and opened a 60‑day consultation period. The resignations of the Acting Chairperson, a Board member and the Executive Director of the PMPRB in the months following the end of this consultation period raised concerns regarding the Board’s operations and its ongoing efforts to implement drug pricing reforms. Two of the people involved made public their varied motivations for resigning. Some of these reasons seemed to call into question the integrity of the Guidelines reform process.

To better understand the events that led to these three resignations, the House of Commons Standing Committee on Health (the Committee) undertook a study of the PMPRB. Over two meetings, it heard from the Minister of Health and government officials, as well as the three individuals who had resigned. Among the themes that emerged from the testimony were communication issues between the PMPRB and Health Canada; allegations of ministerial interference in the PMPRB’s Guidelines consultation process; the pharmaceutical industry’s influence on Canadian drug policy; and ambiguities in the PMPRB’s operating procedures. Witnesses put forward different reasons for the PMPRB’s difficulties in carrying out its reforms. Some blamed pressures exerted on the Board by the Minister of Health and pharmaceutical industry, while others pointed to problems within the PMPRB, such as resistance to meaningful stakeholder engagement or unclear operating procedures.

As of April 2024, the PMPRB has yet to issue new PMPRB Guidelines, and the regulatory reform process that was begun in 2016 remains incomplete. In this report, the Committee presents 10 recommendations on how the Government of Canada can enable the PMPRB to more effectively carry out its mandate and implement its reforms. Some of the actions recommended include:

• establishing a clear communications protocol between the Minister of Health and the Chairperson and the members of the PMPRB;
• reviewing how the federal government interacts with the pharmaceutical industry;
• reviewing the PMPRB’s internal operating procedures to ensure that they are clear and transparent; and
• clarifying the PMPRB’s mandate.