So on we go—Canada’s PMPRB proposes interim guidance

On June 20, 2023, Canada’s Patented Medicines Prices Review Board (PMPRB) published a proposed interim guidance intended to apply until new guidelines are developed and finalized. PMPRB is asking for comments from stakeholders, and the deadline to provide comments is August 21, 2023.

The PMPRB is a quasi-judicial body that regulates the prices of patented medicine in Canada by determining whether they are being sold at an excessive price. The Patented Medicines Regulations were amended on July 1, 2022 to create a new basket of 11 comparator countries to reference (referred to as the PMPRB11) when assessing whether a proposed list price in Canada is excessive.

New patented medicines approved since then have not had their pricing reviewed, creating much uncertainty regarding compliance and a significant backlog. A proposed interim guidance would remove that uncertainty for many new patented medicines and continue the status quo for existing patented medicines, while the PMPRB consults on yet another set of new proposed guidelines.

What you need to know

• Interim guidance is different from guidelines. Both are not law but are intended to clarify the PMPRB’s views on when the pricing of patented medicines is likely to be regarded as excessive.
• The proposed interim guidance would be a temporary measure to provide some clarity while a more comprehensive set of guidelines is finalized.
• There is a substantial backlog of reviews on the pricing of new patented medicines. (New patented medicines are those that received marketing authorization from Health Canada after July 1, 2022). None of these new patented medicines have been subject to price reviews by PMPRB staff. This proposed interim guidance is intended to provide certainty to patentees regarding which new patented medicines would be regarded as being reviewed by PMPRB and which would be regarded as still pending PMPRB review.
• The PMPRB indicates that approximately 55% of new patented medicines have Canadian list prices that are below the median list prices of the PMPRB11.
• The PMPRB intends to consult on a new set of guidelines in the coming months, anticipating that such guidelines will be finalized in 2024.

What the interim guidance says

The following proposed amendments were introduced under the proposed interim guidance:

• The price of a new patented medicine
  • will be considered as reviewed if the list price is below the median international price for PMPRB11; or
  • will remain under review if the list price is above the median international price for PMPRB11, but the review by PMPRB staff will not take place during the consultation on the new guidelines. Once the guidelines are finalized and the review takes place, PMPRB indicates that there will be no clawback of revenues for sales of such new medicines made during the interim period.
• The pricing for existing patented medicines (those that were issued marketing authorizations before July 1, 2022) would be regarded as non-excessive if the price is at or below the non-excessive average price as communicated to patentees in 2021, with allowable CPI adjustments.

More on the interim guidance

The intent of the proposed interim guidance is to allow for an expedited assessment of the prices of new patented medicines that have Canadian list prices below the median international price of PMPRB11 while a fulsome consultation on the new guidelines takes place.

The amendments to the Patented Medicines Regulations came into force on July 1, 2022, and on August 18, 2022, the PMPRB published an interim guidance (current interim guidance) for reviewing the prices of patented medicines. This proposed interim guidance under consultation until August 21, 2023 would replace the current interim guidance if adopted. The PMPRB has indicated that it does not anticipate in-person submissions or meetings relating to this consultation given its limited scope.