The Patented Medicine Prices Review Board (PMPRB or Board) has released a draft of its new price review Guidelines (the Draft Guidelines) for consultation. The Draft Guidelines outline a proposed new price-review process for Board Staff, with an initial screening based on a comparison to the highest international price (HIP) of the patented medicine across the PMPRB11 comparator countries.1

Written submissions on the Draft Guidelines are due before March 19, 2025.

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 a new list of foreign reference price countries (PMPRB11).

As we reported, the PMPRB is currently engaged in a three-phase process to develop new price review guidelines. The first phase of the consultation launched with a Scoping Paper in November 2023, followed by the release of a “What We Learned” Report in February 2024 and a Discussion Guide in June 2024. The release this week of the Draft Guidelines for consultation marks the beginning of the third phase.

The PMPRB’s Interim Guidance, as amended on September 27, 2023, will continue to govern patented medicine drug pricing until new Guidelines are implemented.

The Draft Guidelines

The Draft Guidelines set out a price-review process that would be used by the Board’s Staff. Staff would 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 patentee to the HIP of the same medicine across the PMPRB11 comparator countries. In Annual Reviews, Staff would also consider changes in the consumer price index (CPI). If the Canadian list price exceeded the HIP or the applicable CPI measurement, the medicine would progress to the second step. Notably, Existing Medicines (defined as those first sold before July 1, 2022 – prior to PMPRB11 implementation) would be subject to Annual Reviews based on the PMPRB11 starting one (1) year from the date the Guidelines are brought into force.
  • 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. At the conclusion of the In-Depth Review, Staff would 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 Draft 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.

Next steps

In an email to stakeholders announcing the consultation, the PMPRB indicated that the consultation will be open for 90 days. Written submissions can be filed through the PMPRB website, and are due before March 19, 2025.

In line with previous statements, the PMPRB’s email to stakeholders also indicated that it intends to release final guidelines in 2025.

  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. ↩︎