As we have previously reported, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. On November 10, 2023, the PMPRB published its Scoping Paper for the Consultations on the Board’s Guidelines. The Scoping Paper asks for stakeholder feedback, posing questions organized by the following six themes:
- Efficient monitoring of prices without price setting;
- Transition to PMPRB11 – new versus existing medicines;
- Price reviews during product life cycle;
- Investigations and referral to hearing;
- Relation to pan-Canadian health partners, insurers (private and public), and alignment with broader government initiatives; and
- Engaging with patients, health practitioners, pharmacy, and other stakeholders.
Stakeholders wishing to participate in the consultation should be aware of these important upcoming dates:
- November 24: deadline to register for roundtable discussions, by filling out the registration form.
- December 5 (English) and 6 (French): roundtable discussions, both in-person (limited attendance) and virtually. There is limited availability for stakeholders to present at the roundtables.
- December 20: deadline for written submissions.
- Early 2024: PMPRB to publish a “What We Heard Report”.
The PMPRB previously advised that after this first roundtable stage, the second consultation stage in 2024 will focus on the development of new guidelines. The PMPRB anticipates finalizing the new guidelines in 2024.
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.