PMPRB publishes Scoping Paper for the Consultations on the Board’s Guidelines to streamline Policy Roundtable

The Patented Medicines Prices Review Board (“PMPRB”) is responsible for ensuring that the prices of patented medicines in Canada are not excessive. In fulfilling this mandate, Guidelines issued in 2010 provided transparency to the PMPRB’s approach to patented medicines price monitoring, including the price review process and investigations, and were meant to be read in conjunction with the Patent Act and Regulations.

With the recent coming into force of amendments to the Patented Medicines Regulations in July 2022, the PMPRB is in the process of updating the Guidelines. As part of the updating process, the PMPRB will host a Policy Roundtable on December 5 (English) and 6 (French) during which interested parties are invited to voice their opinions and concerns regarding the future Guidelines.

To streamline the Roundtable consultation, the PMPRB published a Scoping Paper for the Consultations on the Board’s Guidelines, which outlines six themes up for discussion at the Roundtable, with each theme containing several questions for stakeholders to consider.

The following six themes are up for discussion:

1. Efficient monitoring of prices without price setting: the questions under this theme include which elements of the 2010 Guidelines should remain, how medicines should be categorized (i.e., by therapeutic class comparator characteristics), weight given to the various factors under s. 85 of the Patent Act, and treatment of international price comparators.
2. Transition to PMPRB11 – New versus existing medicines: there were no grandfathering clauses contemplated with the coming into force of the amendments and consequently, the questions under this theme include whether medicines that existed prior to the July 2022 amendments should be treated differently than new medicines when evaluating pricing cut-offs.
3. Price reviews during product life cycle: the PMPRB will consider frequency of pricing evaluations throughout a patent’s lifecycle and fairness in evaluation frequency (i.e., impact of Consumer Price Index increases on pricing cut-offs).
4. Investigations and referral to hearing: the PMPRB is aiming for the Guidance to include more transparency for rightsholders related to investigation triggers, what happens once an investigation is opened, and closure mechanisms (i.e., voluntary undertakings such as price reductions and repayment of potential excess revenues).
5. Relation to pan-Canadian Health Partners, insurers (private and public); and alignment with broader government initiatives: the questions under this theme include what efficiencies could be gained by co-ordinating the PMPRB’s decisions and timelines with other Canadian Health Partners and how the PMPRB can optimize its presence within the Canadian bio/pharmaceutical ecosystem to support a whole of government approach to issues relating to patented medicines.
6. Engaging with patients, health practitioners, pharmacy, and other stakeholders: the PMPRB intends to also seek feedback from stakeholders who are not rightsholders, particularly in the context of high-priced drugs for the treatment of rare diseases.

Geoffrey Mowatt and Gabriella Levkov of DLA Piper Canada will attend the December 5 Policy Roundtable.