Innovative Medicines Canada (IMC) and a number of pharmaceutical companies have jointly commenced an application for judicial review of the final Patented Medicine Prices Review Board (PMPRB) guidelines.
The guidelines were released on October 23, 2020 and scheduled to be implemented on January 1, 2021. The current application is seeking for the guidelines to be declared ultra vires the Patent Act, based on:
- The price review process described in the guidelines considers certain rebates, specifically the ‘maximum rebated price’, which may be considered at the investigation stage, notwithstanding the federal court decision deeming rebates beyond the first point of sale to be ultra vires the Patent Act
- The guidelines purport to be non-binding on their face but effectively and improperly prescribe the ceiling prices for patented medicines in Canada
- The guidelines exceed the PMPRB’s statutory price-review mandate, which is limited to regulating excessive prices.
A separate judicial review for amendments to the guidelines commenced on September 10, 2020, ruled that because the new price calculation provision exceeded the first point of sale, it was ultra vires the Patent Act. An appeal and cross-appeal are pending. Another separate court challenge in the Quebec Superior Court to the constitutionality of the PMPRB provisions of the Patent Act, the regulations, the amended regulations and the Compendium of Policies, Guidelines and Procedures was completed on November 20, 2020 with a decision taken under reserve.
Read the case documents, provided by Smart and Biggar, for more information.