Canada’s Intellectual Property Firm

PMPRB to strike Working Group on Guideline reform in June, anticipates concurrent release of guidance on operationalization of anticipated regulatory changes

In its May 2018 NEWSletter, the Patented Medicine Prices Review Board (PMPRB) announced that the next step in its Guideline reform would be the inception of a multi-stakeholder Working Group intended to gather stakeholder input on key technical aspects of the new regime (see our prior articles on the proposed amended Patented Medicines Regulations and scoping paper here and here). The PMPRB anticipates concurrently releasing more specific guidance on how it foresees operationalizing the anticipated regulatory changes. The report of the Working Group will be presented to the PMPRB for consideration prior to the publication of draft Guidelines in the fall, followed by a further period of consultation.

Separately, in its 2018 Special 301 Report, the Office of the United States Trade Representative placed Canada on its Priority Watch List, based in part on the proposed changes to the PMPRB regime, concluding that they “fail to appropriately recognize the value of innovative medicines in both the private and public markets, and would make Canada’s pricing policies an outlier among similarly situated countries.”