New Guidelines For Patented Medicine Prices Review Board Released

On June 30, 2025, the Patented Medicine Prices Review Board (PMPRB) released new non-binding guidelines (the Guidelines) which come into effect on January 1, 2026. The Guidelines are a further step in the long and highly controversial process following from attempts to change some of the criterion for price controls, in particular the list of comparator countries (as reported by the E-TIPS® newsletter here).

The Guidelines seek to: (i) address prior amendments to the Patented Medicines Regulations; (ii) direct PMPRB staff on identifying candidates to recommend to the Chairperson for a hearing; and (iii) provide transparency to Rights Holders on the recommendation process followed by PMPRB staff. They also purport to incorporate guidance from the Courts that has arisen from the extensive litigation over the proposed changes.

The general review process for patented medicines is separated into two steps: (i) an Initial Review or Annual Review; and (ii) if required, an In-Depth Review. The second step is only required for patented medicines that have been referred for an In-Depth Review in step one.

The Initial Review will apply to “new medicines” (patented medicines first sold on or after July 1, 2022) immediately after the Guidelines come into effect. All patented medicines in Canada will be subject to an Annual Review of their list price beginning in January of each year. Annual Reviews for “existing medicines” (patented medicines first sold before July 1, 2022) will only begin two years after the Guidelines come into effect, unless the patented medicines are the subject of a complaint during this transitional time.

The Initial Review will compare a patented medicine’s first semi-annual price filing against the highest international price (HIP) among Schedule Countries filed as per section 85(1)(c) of the Patents Act. The Annual Review follows the same process with the most recently filed pricing data. Patented medicines with prices exceeding the HIP threshold will be referred for an In-Depth Review. Referral for an In-Depth Review does not presuppose that prices above the HIP threshold are excessive or non-excessive.

If referred for an In-Depth Review, PMPRB staff will collect information on the patented medicine and its comparators to prepare a recommendation to the Chairperson to either close the review or hold a hearing. Rights Holders can expect an In-Depth Review to take between 12 and 28 months to complete, depending on the complexity.

The Appendices to the Guidelines contain sample case studies to further illustrate the steps described above. The internal guidance will be of use to those seeking to set prices for new and already marketed pharmaceuticals in Canada.

Summary By: Amy Ariganello