Pharma industry launches court challenge of federal regulatory changes

Pharma industry launches court challenge of federal regulatory changes


A Canadian pharmaceutical lobby group and 16 of its members have filed a lawsuit against Ottawa’s overhaul to how it regulates the costs of patented medicines.

Health Canada announced long-awaited amendments last month to patented medicine regulations, which include allowing the arm’s-length Patented Medicine Prices Review Board (PMPRB) to consider whether the price of a drug reflects the value it has for patients.

The list of countries that the review board uses to compare prices and gauge its own levels will no longer include the United States and Switzerland, both of which are home to some of the highest drug prices in the world.

The judicial review application in the Federal Court of Canada is being led by Innovative Medicines Canada.

The lobby group’s president, Pamela Fralick, said that it’s a necessary step for the industry because the regulations will have a significant impact on patient access to medicines and on the country’s life sciences sector, which includes companies researching and developing drugs, medical devices and other medical services.

Fralick said the industry tried to work with Health Canada for nearly two years to find policy alternatives to lower the cost of drugs without hurting industry investments in Canada.

“As a result, IMC has filed this judicial review application on the basis that the federal government does not have the authority to fundamentally alter the role of the PMPRB through the recent changes to the Patented Medicines Regulations,” she said.