Canada delivers landmark ruling in favour of big pharma

The  Quebec Court of Appeal in Canada has ruled that the 2019 amendments to the Patented Medicines Regulations, governing the country’s Patented Medicine Prices Review Board (PMPRB) are partially invalid.

The landmark win for the Canadian pharmaceutical industry, handed down on February 18, saw the court affirm the Quebec Superior Court’s decision to remove the provisions compelling patentees to reveal confidential rebates negotiated with insurers.

According to a  blog post by Canadian firm  Fasken, this case joins a growing number “questioning the price control reasoning by the PMPRB” and that it was “therefore an optimal time for patentees to reconsider their patented medicines pricing strategy”.

The Fasken team led by Marc-André Fabien, Julie Desrosiers, Michael Shortt, Eliane Ellbogen, Mathieu Gagné and Dara Jospé represented the pharmaceutical companies including MSD, Janseen, Bayer and Boehringer Ingelheim.

The case began in August 2019, when Canada’s federal government enacted amendments to the Patented Medicine Regulations.

The regulations introduced new, economics-based price regulatory factors to reflect a drug’s value and Canada’s ability to pay for patented medicines; and also required patentees to report price and revenue information net of all price adjustments.

The pharmaceutical industry issued a constitutional challenge to the amendments, arguing that the federal government is not legally entitled to regulate drug prices without a proven incidence of patent abuse.

It held that only the provincial governments are constitutionally permitted to regulate prices, and because the amendments are a form of price control, they are consequently outside the parliament’s remit.

The court on Friday agreed with the industry’s argument that the majority of the amendments were not related to excessive pricing or patent abuse but to price control and the regulation of an industry.