2020-21 Operating Context

In June 2020, the PMPRB released draft Guidelines for consultation with its stakeholders. The PMPRB took advantage of the original delay in the implementation of the amendments to the Patented Medicines Regulation (Regulations) from July 1, 2020, to January 1, 2021 and extended the period for stakeholders to comment on the June 2020 draft of the Guidelines. Consequently, in October 2020, the PMPRB issued new Guidelines. The Guidelines, which are non-binding, implement the amendments to the Regulation, which come into force January 1, 2022.

Also, in June 2020, the Federal Court issued its decision in respect of Innovative Medicines Canada’s application for judicial review of the recent amendments to the Patented Medicines Regulations. The new section 85(1) excessive pricing factors and new comparator countries was upheld but amendments relating to the calculation of net prices, subsection 3(4) of the Amended Regulations, were deemed outside the PMPRB’s jurisdiction. The Quebec Superior Court issued a similar decision. Considering these decisions, the PMPRB extended its deadline for comments on the June 2020 draft Guidelines and published new Guidelines in October 2020. The new Guidelines, which give effect to the amended Patented Medicines Regulations, are now scheduled to come into force on January 1, 2022.