ARTICLE
14 June 2023

Patented Medicines Regulations: The Problem Is Not In Collecting The Data, But In How You Use It! (June, 2023)

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Smart & Biggar

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The Federal Court of Appeal recently heard a constitutional challenge to the new Patented Medicines Regulations that came into force on July 1, 2022.
Canada Food, Drugs, Healthcare, Life Sciences

Melanie Szweras and Chantalle Briggs' article "Patented Medicines Regulations: The Problem is Not in Collecting the Data, but in How You Use It!" was published in Health Law in Canada, Volume 43 (3).

Abstract:

The Federal Court of Appeal recently heard a constitutional challenge to the new Patented Medicines Regulations that came into force on July 1, 2022. Several appellants, including Innovative Medicines Canada, challenged the validity of the new list of comparator countries used by the Patented Medicines Price Review Board (PMPRB) in its price calculations to combat excessive prices on patented medicines. They alleged that the Government was pursuing the purpose of setting reasonable prices of patented medicines generally, rather than specifically policing excessive pricing in accordance with excessive price provisions of the Patent Act. However, the Court accepted the Government's argument that the list of comparator countries was updated to modernize the tools available to the PMPRB. Changing the list of comparator countries only changes the pricing information collected; if the PMPRB were to improperly set reasonable prices generally, this would amount to a misuse of the information collected.

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