The Patented Medicine Prices Review Board (PMPRB) has released a new Discussion Guide for consultation on new price review Guidelines. The Discussion Guide outlines a proposed new price review process and requests stakeholder feedback on several specific topics, including the manner in which excessive-price factors such as the international price comparison (IPC) test will be applied during price review by Board Staff.

Written submissions on the Discussion Guide are required to be submitted by September 11, 2024.


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. The release this week of the Discussion Guide for consultation marks the beginning of the second phase. The third phase will be publication of new draft guidelines, based on the feedback received during consultation.

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 Discussion Guide

In the Discussion Guide, the PMPRB outlines a proposed new four-part process for price review by Board Staff. In summary:

  • A. Initial Price Review – Staff would compare list prices against the IPC criteria to flag medicines that may be at risk of excessive pricing for “in-depth review”.
  • B. Post-Initial Price Review – Staff would conduct ongoing monitoring of medicines that have already undergone the initial price review, based on the IPC and Consumer Price Index criteria, in order to flag medicines that may be at risk of excessive pricing for in-depth review. Medicines that do not meet any identification criteria for in-depth review would be considered reviewed at this time, with no further action by Staff until the following year’s review, or if a complaint is received.
  • C. Special Provisions – Addresses the role of complaints in determining which medicines are subjected to an in-depth review by Staff.
  • D. In-depth Review – Staff would conduct an analysis based on all of the excessive-price factors in subsection 85(1) of the Patent Act.

The proposed price review process does not include different criteria for medicines that were subject to review under the previous guidelines (i.e., “Existing Medicines”), as compared to newer medicines that were not. Instead, the Board has proposed a transitional period of one to three years to adapt before an in-depth review may be commenced for Existing Medicines that exceed the IPC criteria.

While the Board has indicated that it is accepting feedback on any aspect of the Discussion Guide, it has identified seven specific topics of primary interest:

  1. Price level within the PMPRB11 to be used in the initial and post-initial price review
  2. The length of time Staff should wait, following the implementation of the Guidelines, to determine whether the IPC identification criterion for an Existing medicine is met
  3. In-depth review based on CPI increase criteria
  4. The individuals/groups permitted to submit a complaint
  5. Expanding the list of products that would only be subject to an in-depth review following a complaint to include biosimilars and/or vaccines
  6. Use of clinical evidence to contextualize the degree of similarity of comparators identified for the therapeutic class comparison (TCC)
  7. Future role of Human Drug Advisory Panel (HDAP)

Next Steps

The Board requests written stakeholder submissions providing feedback on the Discussion Paper by September 11, 2024. The Board states that “in the coming weeks”, the Board “will be hosting a multi-stakeholder webinar where the PMPRB will provide an overview of the proposed framework and address any questions.”

The Board also addresses the anticipated timeline for new Guidelines to come into effect in 2025:

The Board intends to publish new draft Guidelines by the end of 2024 after considering the feedback received on the two previous phases. These Guidelines will be open for a Notice and Comment period before finalization and implementation, which is anticipated in 2025 unless further consultation on an amended draft is necessary.