On November 10, 2023, the Patented Medicine Prices Review Board (“PMPRB”) launched the first phase of stakeholder consultations on new PMPRB Guidelines.[1]

As we have previously reported, controversial amendments to the Patented Medicines Regulations changing the basket of comparator countries considered by the PMPRB took effect July 1, 2022.[2] Changes to the PMPRB Guidelines are necessary to implement these regulatory amendments.

The first stage of consultations will focus on six themes identified by the PMPRB in a newly published Scoping Paper for Consultations on the Board’s Guidelines, and will be followed by the release of a “What We Heard document” in early 2024. The second stage of consultation will take place in 2024, and will focus on the development of the new PMPRB Guidelines. The PMPRB’s goal is to finalize the new PMPRB Guidelines during 2024.

How Interested Stakeholders Can Get Involved

• Register to participate at a Policy Roundtable by completing the Registration Form by November 24, 2023; 
• Participate in person or virtually at a Policy Roundtable scheduled for December 5, 2023 (in English) and December 6, 2023 (in French); 
• Make a presentation to the PMPRB; and/or
• Submit written submissions by December 20, 2023.

The PMPRB is Seeking Stakeholder Views on Six Topics

The PMPRB outlines six themes for which it is interested in hearing stakeholders’ views to inform the PMPRB’s development of new PMPRB Guidelines:

• 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 governmental initiatives; and 
• Engaging with patients, health practitioners, pharmacy and other stakeholders who are not rights holders. 

For more information, please contact the McCarthy Tétrault Intellectual Property Litigation group in Toronto.

[1] https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/scoping-paper-board-guidelines.html

[2] These amendments replaced the schedule of PMPRB7 countries with the PMPRB11 schedule, which (i) maintains France, Germany, Italy, Sweden, and the UK; (ii) adds Australia, Belgium, Japan, Netherlands, Norway, and Spain; and (iii) removes Switzerland and the US.