UPDATE: See our article providing an overview of the proposed price review framework. See also new Draft Guidelines.
On June 26, 2024, the Patented Medicine Prices Review Board (PMPRB) released a Discussion Guide for its Phase 2 Consultations on its New Guidelines. The deadline for comments is September 11, 2024, and details of a related webinar will be released soon.
According to the PMPRB, the Guidelines are being updated to reflect the July 1, 2022 amendments to the Patented Medicines Regulations (which updated the schedule of comparator countries to the PMPRB11 and reduced reporting requirements for medicines at the lowest risk of excessive pricing; see our related article), to reflect recent jurisprudence, and to increase efficiency.
A three-phase Guidelines consultation process started in September 2023:
- Phase 1 – Scoping Paper and Policy Roundtable
- Phase 2 – Discussion Guide, now released
- Phase 3 – Draft Guidelines which are anticipated by the end of 2024 for comment, with implementation anticipated in 2025
According to the Discussion Guide, “The Board intends these Guidelines to achieve two main objectives: a) enhance the Board’s administrative efficiency, and b) provide transparency and predictability to Rights Holders regarding the process typically engaged in by PMPRB staff (“Staff”) in identifying patented medicine [sic] that may be at a greater risk for excessive pricing for an in-depth review or a potential hearing”.
We will release a further article with more details on the Discussion Guide.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.