Update: See our January 26, 2021 article, which links to the Canada Gazette copy of the further amendments and discusses proposed consequential modifications to the Guidelines definition of “gap medicine” and compliance timelines.
While scheduled to come into force on January 1, 2021 (see here), in recognition of the fact that the COVID-19 pandemic continues to challenge all stakeholders, the amendments to the Patented Medicine Prices Review Board Regulations (formally, the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements)) will now come into force on July 1, 2021. The amendments delaying the coming-into-force date (see here) will be published in the Canada Gazette II on January 20, 2021. Accordingly, the reporting requirements due by January 31, 2021 of sales and pricing information for the period from July 1, 2020 to December 31, 2020 will be governed by the current Regulations.
These new regulations - officially titled Regulations amending the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements), No. 2 - push back the timelines for reporting a cost-utility analysis prepared by a publicly funded Canadian organization under new section 4.1(4) and estimated maximum use of the medicine under new section 4.2(4) by six months. Similarly, section 4.4 will require the Board to consider excessive pricing based on the three new pharmacoeconomic factors for sales in Canada after June 30, 2021, and not after December 31, 2020.
Notably, new section 4(4) (section 3(4) of the Amending Regulations), which would have required price and revenue reporting to take into account confidential rebates provided to provincial payers, is to come into force on a day to be fixed by a separate amendment. As previously reported, this provision has been found invalid by the Federal Court (see here) and unconstitutional by the Quebec Superior Court (see here).