Meeting minutes - June 25 Steering Committee meeting

The first meeting of the PMPRB Steering Committee on Modernization of Price Review Process Guidelines was held June 25, 2018 in Ottawa.

The Terms of Reference were agreed upon by all members present. PMPRB clarified that the term “respective organizations” in the Confidentiality section included, as applicable, companies who are members of the Steering Committee association, and advisors to the members. IMC noted for the record that it is opposed to many of the proposed regulatory changes to the Patented Medicines Regulations, and that its participation in the Steering Committee did not imply support for the aforementioned proposed changes.

Members discussed the proposed timelines for implementation of the changes to the Regulations and the PMPRB’s development of Guidelines. Several members expressed the view that the PMPRB’s consultations were premature before CG2 publication. Board Staff responded that January 1, 2019 remains the implementation date until the Minister of Health directs otherwise, but that any changes resulting from the CG2 process would necessarily be addressed before the issuance of draft Guidelines for additional consultation.

Board Staff presented the proposed PMPRB framework modernization structure for discussion by members. Discussion focused on the potential impact of the proposed framework on patient access to new and existing medicines; the interface between the PMPRB, health technology assessment agencies, and the pCPA; and the PMPRB’s proposed use of pharmacoeconomic value in price review.

A list of suggested questions related to the framework was proposed to the Steering Committee to encourage targeted feedback; it was agreed that this list may expand as the Steering Committee considers appropriate. A Technical working group will be formed to answer specific economic and clinical questions, and additional working groups to address specific topics may be considered by the Committee as needed. The Steering Committee’s next meeting will be scheduled in July.