On September 29, 2021, the Attorney General of Canada applied for leave to appeal to the Supreme Court of Canada concerning the Federal Court of Appeal’s (FCA) July 2021 decision in Alexion Pharmaceuticals Inc v Canada (Attorney General). On March 24, 2022, the Supreme Court of Canada has denied this application.
Background: On July 29, 2021, the FCA rendered its decision in Alexion Pharmaceuticals v. Canada (Attorney General), 2021 FCA 157 – PMPRB Alexion / Soliris excessive-pricing case. The FCA overturned the decisions of the Federal Court and the PMPRB hearing panel, deeming the decisions to be unreasonable and remitted the matter for redetermination by the Patented Medicine Prices Review Board (PMPRB).
What does this (now confirmed) FCA decision mean? While the decision is specific to the Alexion Soliris case, it has far reaching implications for PMPRB’s mandate and the future its Regulations and new Guidelines, currently scheduled to come into force July 1, 2022.
- July 2021 FCA decision stands: Soliris will return to PMPRB for redetermination. Unless there is a settlement between PMPRB and Alexion, a new hearing will be required more than six years after the first notice of hearing.
- PMPRB’s price regulation mandate is limited to product-specific, case-by-case regulation of excessive prices, not consumer protection generally or lower prices writ large
- Aspects of new PMPRB guidelines including pharmacoeconomic factors and third-party rebates are outside the PMPRB’s mandate
- Going forward, PMPRB will be even harder pressed to step outside the limits of its guidelines (e.g. by using price tests not in guidelines). In this regard, the FCA decision said PMPRB was “asking the Court to sign a blank cheque in its favour. But this Court does not sign blank cheques.” Today’s decision is consistent with PDCI’s long-standing position and efforts supporting patentees to push back on such cases of PMPRB mandate overreach.
- July 2022 implementation is very unlikely. All of the abovefurther undercut timelines to implement amended Regulations and new Guidelines on July 1, 2022. Today’s decision, and other recent legal decisions (e.g. Quebec Court of Appeal), combined with the government’s apparent growing recognition of the importance of access to medicines, suggests there may be a sea change with respect to the Federal Government’s thinking when it comes to the PMPRB and the federal role in price regulation.
SAVE THE DATE: These implications and more will be discussed during a PDCI Webinar on April 6, 2022 from 8:30 a.m. to 9:15 a.m.
Stay tuned for more information on how to register for this event.
Please contact John-Paul Dowson, Director of Strategic Consulting & Policy Research at firstname.lastname@example.org for any questions or further information.