Amendments to the Patented Medicines Regulations delayed six months, until July 1, 2022

Canada's recently appointed Minister of Health, the Honourable Jean-Yves Duclos, just announced the deferral of the coming into force of recent amendments to the Patented Medicines Regulations by six months, until July 1, 2022. The new Patented Medicine Prices Review Board (PMPRB) Guidelines, which operationalize the Patented Medicines Regulations, are also expected to take effect at the same time. We have previously reported on the Coming-into-Force of the amendments here (Amendments to the Patented Medicines Regulations delayed by 6-months, until July 1, 2021) and here (Amendments to the Patented Medicines Regulations delayed by a further six months, until January 1, 2022).

As previously reported, the amendments would introduce new economic factors when determining excessive pricing including pharmacoeconomic value, market size and GDP; change the basket of countries the PMPRB uses as a benchmark for pricing (most significantly removing the US and Switzerland); and introducing a new price calculation for determining non-excessive sale price. The changes would also increase the administrative burden on companies.

A statement by Minister Duclos explains that the impact of new COVID-19 variants of concern required urgent action and a further delay to the coming into force of the amendments. Specifically, this delay would allow industry and government "to continue to focus their efforts on responding to the unprecedented challenges presented by the COVID-19 pandemic." Further, in his announcement, the Minister stated that to bring these amendments into force in the context of a global pandemic "requires preparedness and consultation" and stated that a delay "also allows the Government to further engage stakeholders on the application of these amendments within the changing pharmaceutical landscape."