The Patented Medicine Prices Review Board (PMPRB) has launched a 60-day consultation on proposed changes to the price-review process set out in its Interim Guidance of August 18, 2022 (Interim Guidance). The proposed changes would affect products classified as “New Medicines” with list prices that are below the median of prices in the basket of 11 comparator countries set out in the Patented Medicines Regulations (the PMPRB11). The Board has also provided an update on a forthcoming consultation regarding new Guidelines.
Proposed Amendments to the Interim Guidance
Background. The Interim Guidance that is currently in force replaces the Board’s previous Guidelines, effective for the period beginning July 1, 2022 and until further notice (the Interim Period). The proposed amendments to the Interim Guidance are specific to “New Medicines”, defined as those medicines without a PMPRB ceiling price (either a “Maximum Average Potential Price” (MAPP) or projected “Non-Excessive Average Price” (NEAP)) under the Board’s previous Guidelines, as of the start of the Interim Period (i.e., July 1, 2022).
Price review based on “below” the median of PMPRB11. Currently, New Medicines are not subject to price review by Board Staff during the Interim Period. Under the proposed amendments, Board Staff would begin reviewing prices of certain eligible New Medicines on the following terms:
- New Medicines are considered reviewed if the list price is below the median international price for the PMPRB11 countries.
- The rights holders of these New Medicines will receive a Status Report letter once the assessment is completed.
- New Medicines that do not meet this criterion, are considered “under review” until new Guidelines are in place.
- Once new Guidelines are in place, no potentially excess revenues will be calculated by Staff retrospectively for any New Medicines based on sales made during the Interim Period.
The deadline to submit written feedback on the proposed amendments to the Interim Guidance is Monday August 21, 2023. The PMPRB states that “no in-person submissions or meetings are anticipated” in view of “the limited scope of proposed update”.
Other updates: Guidelines consultation and HESA hearings
In its news release on the proposed amendments to the Interim Guidance, the PMPRB has signaled that it “intends to re-engage its stakeholders in the coming months and consult on a new set of guidelines, which are anticipated to be finalized in 2024”. The PMPRB previously consulted in late 2022 on new Guidelines, which were intended to take the place of the Interim Guidance as of January 1, 2023. Following that consultation, the PMPRB instead decided to extend the Interim Guidance until further notice.
As we reported, the events surrounding the Board’s previous Guidelines consultation process have been a primary focus of a study being conducted by the Standing Committee on Health (HESA). Since our last report, the HESA website has been updated with additional submissions to the Committee by various stakeholders. In addition, HESA adopted a motion requiring witnesses to produce correspondence that they consider relevant to support their testimony. Correspondence submitted by former Acting Chairperson Melanie Bourassa Forcier, former Executive Director Douglas Clark, former Board Member Matthew Herder, and the Department of Health has been posted to the HESA website.
 The PMPRB11 countries are: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, and the United Kingdom.