The Patented Medicines Prices Review Board (PMPRB) has launched the first phase of consultations on its new Guidelines, inviting feedback through upcoming policy roundtables or through written submissions.
Previously, we discussed the amendments made to the Patented Medicines Regulations, which govern PMPRB activity, and how the most controversial parts of those amendments were later struck down by the Federal Court as being ultra vires the Patent Act. The remaining amendments changed the basket of comparator countries from 7 to 11, while also removing the United States and Switzerland.
In early fall, the PMPRB announced that it would adopt the Amended Interim Guidance during the consultation period, indicating that it would "approach the consultation with a fresh and open mind."
The PMPRB published a scoping paper for the consultations on the Board's Guidelines, which sets out the themes on which it is seeking stakeholder views:
- 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
More detail on each of these themes, as well how to submit feedback and information about the roundtable, can be found in the scoping paper at the link above,.
To participate in one of the roundtables, you must complete the Policy Roundtable Registration Form by Nov. 24, 2023. Written submissions are being accepted until Dec. 20, 2023.
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