Notice and Comment - Incremental Reforms to Compendium of Policies, Guidelines and Procedures

December 4, 2015 – The Patented Medicine Prices Review Board (PMPRB) invites stakeholders to comment on two proposed amendments to the Compendium of Policies, Guidelines and Procedures (Guidelines): the “Reasonable Relationship Test (Schedule 4)” and the “List Price Relative to Maximum Average Potential Price (MAPP) Verification (section C.11)”. These changes would be effective for all drugs introduced in Canada after January 1, 2016.

The deadline to submit written comments has been extended. Written comments must now be submitted by January 29, 2016 to:

Guillaume Couillard
Director, Board Secretariat, Communications and Strategic Planning
Box L40
333 Laurier Avenue West
Suite 1400
Ottawa, Ontario K1P 1C1
Guillaume.Couillard@pmprb-cepmb.gc.ca

A detailed review and side-by-side comparison of the proposed amendments are available on the PMPRB website.

The PMPRB will take into consideration all comments received from stakeholders in finalizing the proposed amendments.

About the proposed amendments

For the Reasonable Relationship Test (Schedule 4) amendment, it is proposed that if the new drug and the comparator are both owned by the same patentee, Board Staff will use the non-excessive National Average Transaction Price of the comparable drug product to establish the Maximum Average Potential Price, instead of the current practice of using the lowest of the six publicly available prices.

For the List Price Relative to MAPP Verification (section C.11) amendment, it is proposed that, at introduction, the list prices of the new product, as defined by the current six publicly available price sources, not exceed the Maximum Average Potential Price.