In August 2019, the federal government published controversial amendments to the Patented Medicines Regulations. These amendments expand the role of the Patented Medicines Prices Review Board (PMPRB) in a way that is intended to drastically reduce the price ceilings applicable to patented medicines in Canada.
All present and future medicines are affected.
Fasken filed a constitutional challenge in the Superior Court of Québec. This challenge attacks both the amendments and the validity of the existing PMPRB regime under the Patent Act.
Two previous legal challenges to the PMPRB’s constitutional validity in the Federal Courts have failed, as has a third attack in the Manitoba Superior Court. Fasken’s constitutional challenge adopts a novel approach. Fasken has argued not only that the PMPRB encroaches on provincial jurisdiction over property and civil rights, but also that it encroaches on provincial powers over healthcare and local matters. Fasken’s constitutional challenge is also the first case to introduce evidence of how the PMPRB actually operates in practice. All previous challenges were conducted in the abstract, without evidence of the PMPRB’s day-to-day functioning.
The Superior Court of Québec ruled that the PMPRB Regime is largely constitutional. However, for the first time, part of the PMPRB regime was invalidated for constitutional reasons. The Superior Court struck down the parts of the amendments that authorized the PMPRB to gain access to confidential pricing and rebate information provided by drug manufacturers to the provinces. The Court also highlighted that the evidence of the PMPRB’s day-to-day functioning was “troubling” and it set limits on the scope of the PMPRB’s constitutionally-permissible regulations going forward.
This matter is the first one in which a Court provided substantial analysis of the scope of the federal patent power. It is also the first case to strike down any part of the PMPRB regime on constitutional grounds. It will have multi-billion dollar ramifications to the Canadian pharmaceutical industry.
A Fasken team comprised of Julie Desrosiers, Marc-André Fabien, Michael Shortt, Eliane Ellbogen, Mathieu Gagné, Dara Jospé, Marc-André Boucher, Marie Lafleur, Chris Semerjian and David McLauchlan advised Merck Canada Inc., Janssen Inc., Servier Canada Inc., Boehringer Ingelheim Canada Ltd/Ltée, Bayer Canada Inc., Theratechnologies Inc., and an additional (Confidential) pharmaceutical company in connection with this case.