As we have previously reported, controversial amendments to the Patented Medicines Regulations changing the basket of comparator countries considered by the Patented Medicine Prices Review Board (“PMPRB”) took effect July 1, 2022. These amendments replaced the schedule of PMPRB7 countries with the PMPRB11 schedule, which (i) maintains France, Germany, Italy, Sweden, and the UK; (ii) adds Australia, Belgium, Japan, Netherlands, Norway, and Spain; and (iii) removes Switzerland and the US.
On June 30, 2022, the PMPRB published Proposed Interim Guidance on the price test to apply during the period between July 1, 2022, when the amended Regulations came into force, and the final publication of a corresponding set of updated PMPRB Guidelines to operationalize same (the “Interim Period”). In summary, the Board proposed adopting a “status quo” approach to carrying out its regulatory mandate, and provided the following specific guidance:
- an existing patented medicine will not trigger an investigation provided
- its national average transaction price remains at or below its most recent non-excessive average price established under the existing Guidelines, OR if higher, excess revenues do not exceed $50,000; and
- its list price does not increase during the Interim Period.
- The PMPRB will not conduct a price review of any new patented medicines or open any investigations in respect of them until the new guidelines come into effect.
The PMPRB has invited stakeholders comments on its proposed approach for conducting interim price reviews. The deadline for submissions is July 18, 2022.
Consultation on a new set of PMPRB Guidelines is expected to take place in September with the goal of arriving at a final set of guidelines by the end of this year.