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09 December 2020
On 23 November 2020 Innovative Medicines Canada (IMC) and numerous research-based pharmaceutical companies commenced an application for judicial review (T-1419-20) of the final Patented Medicine Prices Review Board (PMPRB) Guidelines, which were released on 23 October 2020 (for further details please see "Few significant changes made in final PMPRB guidelines"). The guidelines aim to operationalise amendments to the Patented Medicines Regulations scheduled to come into force on 1 January 2021.
The amendments themselves have already been subject to judicial scrutiny: on 10 September 2020 the Federal Court struck a price calculation provision that would have expanded the reporting requirements in current Subsection 4(4) of the regulations to encompass information beyond the first point of sale (eg, confidential third-party rebates; for further details please see "Federal Court strikes price calculation provision of amendments to Patented Medicines Regulations"). The court 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.
In the new application for judicial review, the applicants seek a declaration that the guidelines are ultra vires the Patent Act, on the basis that:
The hearing of a 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 (ie, the guidance that operationalises the regulations that are currently in force) was completed on 20 November 2020 and a decision was taken under reserve.
For further information on this topic please contact Abigail Smith at Smart & Biggar by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
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