The Patented Medicine Prices Review Board (PMPRB) has announced a framework for the launch of its consultation on new guidelines, beginning with a scoping paper to be published in advance of Policy Roundtable sessions to be held December 5 (English) and December 6 (French), 2023.
The PMPRB has not had a full set of guidelines since July 1, 2022, when amendments to the Patented Medicines Regulations came into force. As we reported, the PMPRB has been operating under an Interim Guidance, which was recently amended to provide additional guidance on new medicines introduced during the Interim Period until new guidelines are introduced.
In its news release, the PMPRB indicated that it is seeking feedback on the following themes that will be outlined in the scoping paper:
- 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
- Engaging with Patients, Health Practitioners, Pharmacy, and other Stakeholders
The Board also indicated that the scoping paper will include details on participating in the Policy Roundtable, and that a “what we heard” report will be published after the first phase of consultations is complete. The Board previously indicated that the second stage of consultation, focused on the development of new guidelines, will take place in 2024.