New PMPRB rules restrict who can trigger reviews and shift focus to inflation and global price gaps
Only federal and provincial health ministers and public drug plans can now file complaints about excessive drug prices—marking a significant shift in oversight as Canada’s Patented Medicine Prices Review Board (PMPRB) finalises new pricing rules.
According to the final guidelines published by the PMPRB on June 30, complaints from private insurers will no longer initiate in-depth price reviews, a reversal from the December 2023 draft that included them.
As reported by The Globe and Mail, this change came after pharmaceutical companies argued private insurers could use the process as leverage during price negotiations.
Lawyers from Fasken Martineau DuMoulin LLP, on behalf of Merck, Janssen, Boehringer Ingelheim, Bayer, and Servier, opposed allowing private health plans to submit complaints.
The Canadian Life and Health Insurance Association called the move an “unexpected decision.”
Its president, Stephen Frank, told the Globe and Mail that “the ability to file complaints directly with the PMPRB is a critical tool to help avoid excessive drug prices for the millions of Canadians who depend on access to affordable medication.”
The PMPRB guidelines—set to come into force on January 1, 2026—outline a two-step framework to monitor prices of patented medicines.
As per the PMPRB’s publication, the first stage is a screening mechanism (Initial or Annual Review) to identify pricing concerns, followed by an In-Depth Review if triggered by data or a valid complaint.
Staff may then recommend a hearing to the chair, who alone can decide whether to proceed.
Under the new structure, staff will only escalate a drug to in-depth review if its Canadian price exceeds the highest international price among the 11 comparator countries (PMPRB11), or if the price rises faster than inflation.
During annual reviews, PMPRB staff will also compare price changes against the Consumer Price Index, as published by Statistics Canada.
As per The Globe and Mail, the PMPRB will no longer review drugs without international price data during initial screening—these are deemed to have passed unless flagged in future annual checks.
Guillaume Couillard, the PMPRB’s director general, said the process is intended to clarify “how do we continue our mandate of monitoring pricing, and how do we identify cases where we should put our resources and focus.”
The guidelines reflect the final phase of a years-long federal reform process launched in 2017 to strengthen the PMPRB’s authority.
A 2019 reform proposal would have expanded the board’s mandate to include confidential pricing data and additional economic factors in excessive pricing reviews.
However, that package was largely rolled back after legal opposition and industry lobbying during the pandemic.
Ultimately, the only surviving regulatory change was the update to the PMPRB11 reference countries, which notably excludes the US—home to some of the world’s highest drug prices.
This change came into effect in July 2022, as confirmed in both the guidelines and reporting by The Globe and Mail.
According to the PMPRB, these new rules aim to enhance predictability and transparency for all parties involved in drug pricing. The board plans to hold learning sessions ahead of implementation to assist stakeholders in understanding the changes.
