PMPRB Update: Canadian Government Announces It Will No Longer Seek To Implement Price Regulatory Factors Or Requirement To Report Net Prices

Yesterday, the Canadian government announced it will no longer seek to implement certain controversial amendments to the Patented Medicines Regulations.1 A statement from the Minister of Health declared that Health Canada will not move forward with implementing amendments related to economic drug price regulatory factors, nor with the requirement to report net prices.

Canada's decision to abandon these amendments follows the Quebec Court of Appeal's recent decision in Merck Canada inc. c. Procureur general du Canada, 2022 QCCA 240, in which the court found that amendments that would add new economic factors to consider when assessing whether a drug price is excessive (namely pharmacoeconomic value, market size in Canada, and GDP and GDP per capita in Canada), and a requirement to file information net of all price adjustments were unconstitutional. See our recent article on this decision for more information.

Health Canada announced that it will be moving forward with the implementation of the new basket of comparator countries (Australia, United Kingdom, Belgium, France, Germany, Italy, Japan, Netherlands, Norway, Spain, and Sweden) and reduced reporting requirements for those medicines at lowest risk of excessive pricing (for example, vaccines and biosimilars). These changes will take effect July 1, 2022.

What does this mean for the pharmaceutical industry in Canada?

In a short time this year there have been number of important wins for the pharmaceutical industry in Canada. As we previously reported, Canadian appeal courts have sent strong signals that general price control and consumer protection is not within the PMPRB's jurisdiction, and are not part of balance struck in the Patent Act between incentivizing research and development of patented medicines in Canada and protecting against patent abuse.

In light of yesterday's announcement it is likely that the long awaited updated PMPRB guidelines will come into force in July 2022.



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