Important New Procedural Guidelines From the PMPRB

The Patented Medicine Prices Review Board (PMPRB) is a Canadian federal agency that regulates the prices of patented medicines in Canada. The PMPRB is established and empowered under the federal jurisdiction over patents in subsection 91(22) of the Constitution Act, 1867. Under sections 79-83 of the Patent Act, the PMPRB makes sure that the exclusivity granted by patents for medicines in Canada is not abused. The PMPRB works with a consumer protection objective and aims to guard Canadians from medicines deemed excessively priced.

Under the Patent Act and the Patented Medicine Regulations, pharmaceutical patent rights holders are required to file price and sales information about their patented medicines within a prescribed period after their first sale in Canada, and subsequently twice a year. The PMPRB reviews the prices using the PMPRB’s Guidelines as a procedural framework.

On June 30, 2025, the PMPRB released new Guidelines to monitor and review drug prices in Canada. The new Guidelines will take effect on January 1, 2026.

The new Guidelines are not intended to determine what constitutes an “excessive price,” to set drug prices, or to encourage compliance tests or price ceilings. The new Guidelines are designed to provide transparency for patent rights holders on the process PMPRB staff uses to identify potentially excessively priced patented drugs and to recommend those cases to the PMPRB Chairperson for consideration of a hearing.

The process described in the new Guidelines provides two screening steps intended to prioritize the cases that are recommended for a hearing. The PMPRB states that the goal of the new Guidelines is to allow the PMPRB to use its limited hearing-related resources efficiently.

The new Guidelines provide a two-step process:

Step 1: Initial / Annual Review. This serves as a screening process to determine if an In-Depth Review will be required. The PMPRB service standard is 60 days from the filing deadline for the patented medicine’s first semi-annual filing for both the Initial and Annual Review. The same International Price Comparison identification criteria (the highest international price (HIP)) and methodology is used for both the Initial Review and the Annual Review, but the Annual Review focuses on the most recent domestic and international pricing data.

Patented medicines whose prices are above the HIP threshold are subject to an In-Depth Review. During an Annual Review, the PMPRB will also compare price changes against the consumer price index as a criterion to warrant an In-Depth Review.

Step 2: In-Depth Review. During an In-Depth Review, the PMPRB analyzes information and prepares a recommendation to the Chairperson on whether the matter should be brought to a hearing. The In-Depth Review includes both a scientific review and a price review. The result of the In-Depth Review may be a recommendation to the Chairperson to issue a Notice of Hearing.

The determination of whether the price of a patented medicine is excessive or not can only be made by a Hearing Panel at a hearing. A hearing is commenced by the issuance of a Notice of Hearing by the Chairperson.

The PMPRB prepared a visual depiction of the timeline described above and the relevant service standards. This figure is available for review here.

The new Guidelines have been established following consultations and consideration from the PMPRB. The new Guidelines are a significant departure from the previous Guidelines (which were challenged in Federal Court). While the goal of these amendments is to provide better transparency for patent rights holders, it will be important for patent rights holders to become familiar with the new procedures as they come into effect in 2026. 

Please contact the authors or a member of the Intellectual Property Group at Aird & Berlis LLP if you have any questions or require assistance in regard to the new PMPRB Guidelines.