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Micheline Gravelle and Iris Cheung of Bereskin & Parr provide an update on the final version of guidelines issued by Canada’s federal drug price regulator—and its likely implications.
The price of patented medicines in Canada is regulated by the Patented Medicine Prices Review Board (PMPRB), an independent, quasi-judicial body established under the Patent Act to ensure the prices of patented medicines are not excessive.
The PMPRB exercises its regulatory mandate by monitoring the factory gate price of patented medicines and ordering remedies when the price is determined to be excessive. It has jurisdiction only on patentees and has no regulatory power over distributors of patented medicines.
Pursuant to subsection 96(4) of the Patent Act, the PMPRB issues a set of guidelines on matters including the price review process, the commencement of investigation, hearing recommendation and ordering of remedies. The guidelines provide rules of general application but are not binding on the PMPRB.
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Bereskin & Parr, PMPRB, federal drug price, Patent Act, GDP, medicine, clinical impact, regulation, generics, innovation, pharmaceutical industry
