From reviews to hearings: PMPRB guidelines come into effect
The Patented Medicines Prices Review Board (“PMPRB”) monitors and reviews the prices of patented medicines in Canada. Rights holders provide information to the staff of the PMPRB, who review that information and recommend hearings for certain products. Following a hearing, the PMPRB may require that the price of a patented medicine be reduced to a “non-excessive” level.
To guide PMPRB staff and provide transparency to rights holders regarding the process by which potential cases are identified for hearings before the PMPRB, the PMPRB published guidelines in June 2025 titled “Administrative Process for Excessive Price Hearing Recommendation”. These guidelines come into effect on January 1, 2026, and are available here.
The Guidelines outline a two-step process to be followed by PMPRB staff to identify cases suitable for a hearing before the PMPRB.
1) Initial Review and Annual Review
Drugs first sold in Canada on or after July 1, 2022, will immediately be subject to an initial review. PMPRB staff will use pricing information submitted by rights holders to the PMPRB to conduct an International Price Comparison (“IPC”). If the Canadian list price of a patented medicine is higher than the highest international price of that medicine in the comparator countries identified in the Patented Medicines Regulations, the patented medicine will be subjected to the second step of the review, as will all other patented medicines covered by the same patent.
All drugs will also be subject to an annual review. The annual review includes an IPC based on the data most recently filed by the rights holder as well as a consideration of the Consumer Price Index (“CPI”). If the price of the patented medicine has increased by more than the CPI in a given year, an in-depth review is triggered unless the price of the patented medicine was not increased in the previous year and the price increase was not more than the total change in the CPI in the previous two years. For drugs first sold in Canada before July 1, 2022, the first annual review will be conducted in 2028.
The PMPRB aims to complete initial and annual reviews within 60 days.
2) In-Depth Review
In-depth reviews may be triggered by initial and annual reviews and may also be triggered by complaints made to the PMPRB by federal, provincial, or territorial Ministers of Health or by senior officials authorized to represent publicly funded drug plans.
As part of an in-depth review, PMPRB staff will identify comparator medicines through a therapeutic class comparison (“TCC”). The TCC may include input from rights holders as well as consultations with the independent Human Drugs Advisory Panel. PMPRB staff will then consider pricing information and submissions from the rights holder to determine whether to recommend a hearing be conducted for a patented medicine.
The PMPRB expects that in-depth reviews could take between 12 and 28 months. The PMPRB may defer in-depth reviews depending on its internal resources; importantly, any excess revenues that a rights holder may ultimately be required to pay continue to accrue during a deferral.
