The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Special Access Program

The Long Arm of Canada’s Patented Medicine Prices Review Board (PMPRB)

In Canada, the Patented Medicine Prices Review Board (PMPRB)’s mandate is to (1) “ensure that prices charged by patentees for patented medicines sold in Canada are not excessive,” and (2) “report on pharmaceutical trends of all medicines, and on the R&D spending by pharmaceutical patentees. ” It has jurisdiction over any patented medicine “sold in any market in Canada.”

In a recent case, Canada (Attorney General) v. Celgene Corporation (A-177-09), the Federal Court of Appeal restored the PMPRB’s order that  a patented medicine sold by a U.S. company and shipped F.O.B. the U.S.A. to physicians in Canada was nevertheless “sold in any market in Canada” and subject to the jurisdiction of the Board, despite shipment, invoicing and payment all occuring directly to the U.S. in U.S. currency.  In this case, Celgene was shipping THALOMID to Canadians under Health Canada’s Special Access Programme (“SAP”).

This decision means that SAP drugs will be subject to the PMPRB’s jurisdiction whether they’re manufactured in Canada or not.

For the full story, check out the Ogilvy Renault bulletin on the case.

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