On June 20, 2023 the Patented Medicine Prices Review Board (PMPRB) invited stakeholders to comment on its proposed amendment for conducting interim price reviews on New Medicines per the Interim Guidance. The Interim Guidance, introduced by the PMPRB on August 18, 2022, refers to the interim period approach for reviewing the prices of patented medicines. Part of the Interim Guidance established a process where existing medicines are reviewed based on the relevant Non-Excessive Average Price (NEAP) projected in the 2021 compliance letters sent to applicable patentees by the PMPRB in March 2022.
However, the Interim Guidance also established that New Medicines, medicines without a projected a Maximum Average Potential Price (MAPP) or NEAP as of July 1, 2022, would not be subject to PMPRB price reviews during this interim period.
This approach was intended to apply until the PMPRB's final guidelines for the amended Patented Medicines Regulations could be enacted in 2022/2023. However, new guidelines have yet to be finalized and thus, the Interim Guidance has remained in effect longer than anticipated. Consequently, the Board now recognizes that this interim period has caused a growing backlog of New Medicines that have not been subject to price reviews. To address this growing issue, the PMPRB proposes an amendment to the Interim Guidance. This proposed amendment would also allow for more time for consultation over the new set of guidelines, which the PMPRB aims to establish by 2024.
The PMPRB proposes to amend the Interim Guidance by allowing New Medicines to be considered "reviewed" if their list price is below the median international price of the new basket of comparator countries (the PMPRB11 countries). Ideally, this would provide greater predictability and guidance to certain New Medicines. Medicines that do not meet this criterion will continue to be under review until the new guidelines are enacted. Furthermore, the process for patented medicines with a MAPP or projected NEAP as of July 1, 2022, would not be changed by the proposed amendment.
To allow for a consultation period, stakeholders have until Monday, August 21, 2023 to submit written feedback regarding this proposed amendment.
Co-author: Serena Nath (Summer Law Student)
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