Canadian Government Drops Plans for Regulatory Factors and Mandatory Net Price Reporting

Planned amendments to Canada’s Patented Medicines Regulations were dropped this week, according to a statement from the Minister of Health. The change in plans comes in response to a recent decision from the Quebec Court of Appeals, which stated that the requirements to file information on all price adjustments and implementation of new price modeling factors were unconstitutional.

According to the authors, “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.”

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(Source: Mondaq, April 19^th, 2022)