June 20, 2011
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Earlier this week, the Canadian Institute held its 5th annual Drug Pricing and Reimbursement Conference in Toronto. The conference highlighted a number of key issues including market access for pharmaceutical companies, Federal and Provincial regulatory and reimbursement policies, and global trends that may affect Canada’s pharmaceutical landscape. Attendees included both innovative and generic drug manufacturers, public and private payers, policy makers and lawyers. One recurring theme at the meeting was a focus on patients as the target/end-users of the regulatory and pricing initiatives being discussed.
Of particular interest was the Patented Medicine Prices Review Board’s (“PMPRB”) session, one year after the new guidelines were released. Michelle Boudreau, Executive Director of the PMPRB, gave an update in light of the impact of the guidelines and touched on the future directions of the board. She focused on the issue of transparency in drug pricing including access to public information and open hearings for the PMPRB. In terms of moving forward, she commented on the Board’s new direction in trying to become more aligned with our international counterparts. In the coming months, the PMPRB’s transparency initiative will be exemplified through ongoing monitoring and evaluation, and increased public information made available on their web site. A consolidated version of the guidelines was promised to be available on the website by the end of June. A pdf of the presentation is available here.
Special thanks to the Canadian Institute for the conference pass and to Norton Rose summer student Karen Sie for this report.
January 8, 2010
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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.