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 (for further details please see "PMPRB releases scoping paper concerning proposed amended regulations"). The PMPRB anticipates concurrently releasing more specific guidance on how it foresees putting the anticipated regulatory changes into operation. 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 the proposals "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".

For further information on this topic please contact Abigail Smith at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smart-biggar.ca.

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