On June 30, 2025, the Patented Medicine Prices Review Board (PMPRB or Board) released the final version of its new guidelines (the Guidelines).

The Guidelines outline a new process for Board Staff to evaluate and make hearing recommendations on patented medicine prices, with an initial screening based on a comparison to the highest international price (HIP) of the patented medicine across the PMPRB11 comparator countries.[1] There have been few changes made to the final Guidelines, which closely resemble the draft version that was released for consultation in December of 2024 (the Draft Guidelines).

The PMPRB has also updated its website with revised information for rights holders in connection with the Guidelines.

Background

The PMPRB has not had a full set of Guidelines since July 1, 2022, when amendments to the Patented Medicines Regulations came into force implementing the new “PMPRB11” list of foreign reference price countries. The PMPRB has been working on this new iteration of the Guidelines since 2023, and was accepting feedback on the December 2024 Draft Guidelines (reported here) into early 2025. In the meantime, the PMPRB has been operating under an Interim Guidance, as amended on September 27, 2023. The new Guidelines will take its place when they come into effect on January 1, 2026. 

The Guidelines

The Guidelines set out a price-review process that will be used by the Board’s Staff. Staff will undertake a two-step screening process along the following lines:

  • First Step: An Initial Review and Annual Reviews comparing the Canadian list price reported by the rights holder to the HIP of the same medicine across the PMPRB11 comparator countries. In Annual Reviews, Staff will also consider changes in the consumer price index (CPI). If the Canadian list price exceeds the HIP or the applicable CPI measurement, the medicine will progress to the second step. As explained below, transitional measures are included for Existing Medicines (defined as those first sold before July 1, 2022 – i.e., prior to PMPRB11 implementation).
  • Second Step: An In-Depth Review based on a broader range of price factors set out in subsection 85(1) of the Patent Act, which could take 12–28 months depending on the complexity of the analysis. An In-Depth Review can be triggered by exceeding the threshold established for an Initial or Annual Review, or by a complaint filed with the Board by an “authorized individual or organization”. At the conclusion of the In-Depth Review, Staff will have discretion whether to recommend that a notice of hearing be issued. This could lead to a hearing and, in turn, an order under section 85 of the Patent Act in respect of any prices that the hearing panel found to be “excessive”.

The Guidelines also address a range of other topics, including the PMPRB’s structure and jurisdiction; the criteria for identifying a “medicine” and determining whether a patent pertains to it; filing requirements; and the general process for resolving issues with the Board by making a voluntary undertaking or settling a proceeding.

Changes since the Draft Guidelines

The overall structure of the final Guidelines is largely the same from the Draft Guidelines, with few changes. These include:

  • Annual Review: grace period for Existing Medicines. The Draft Guidelines included a one-year transitional period for Existing Medicines before they would become subject to the Annual Review process. The final Guidelines extend this transitional period to two years:

54. Transitional measures: For the first Annual Review for existing medicines, occurring two (2) years from the date these Guidelines go into effect, Staff will only apply the IPC identification criterion (the HIP). The application of the Consumer Price Index (CPI) identification criterion will begin during the following Annual Review. Existing medicines will only become subject to In-Depth Review during this two-year period if they are the subject of a complaint (set out below under “Special Provisions on Complaints”) or if they are an Associated DIN of a medicine that is subject to In-Depth Review.

Guidelines at para. 54
  • Complaints: approved individuals or organizations. The Draft Guidelines identified three categories of “approved individuals or organizations” whose complaints could trigger an In-Depth Review: (1) the Federal Minister of Health or any of their Provincial or Territorial counterparts; (2) publicly funded drug programs; and (3) Canadian life and health insurance companies and their trade association(s). The final guidelines eliminate the third category of complainant from the list.
  • Patent-pertaining considerations. Changes were made to the section on when a patent pertains to a medicine for the purposes of Board jurisdiction (e.g., removing a reference to establishing the required link based on “clinical similarities”). This appears to reflect the Federal Court of Appeal’s recent decision on the patent-pertaining test, which we reported on here.  

Next steps

The Guidelines are scheduled to come into effect on January 1, 2026. The PMPRB has also indicated that it intends to announce opportunities to learn more and ask questions about the new Guidelines. Interested stakeholders should stay tuned.

[1] The “PMPRB11” countries, which were established by amendments to the Patented Medicines Regulations, are: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, and the United Kingdom.