Sweeping New Powers Given To Canada's Drug Watchdog

Sweeping New Powers Given To Canada’s Drug Watchdog

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Canada’s drug price watchdog PMPRB ready to apply new powers to protect Canadians from surging high cost drugs

The Patented Medicine Prices Review Board (PMPRB) today released the final version of the PMPRB Guidelines. The release of the Guidelines is the culmination of a five-year process to strengthen and modernize the pricing framework for patented drugs in Canada, and follows on the heels of Health Canada’s August 2019 amendment to the Patented Medicines Regulations.

The Guidelines have been updated following two successive rounds of intensive consultation with Canadians, patentees and other stakeholders which took place over the past year.

Sweeping New Powers Given To Canada's Drug Watchdog

The new Guidelines provide for a risk-based approach to regulating ceiling prices for patented pharmaceuticals by focusing the PMPRB’s new powers on products that pose a greater risk of excessive pricing because of their high cost or market size.

Under the new rules, the PMPRB will compare Canadian list prices to prices in Australia, Belgium, Japan, Netherlands, Norway, Spain, the UK, Sweden, France, the UK and Italy. This will help to identify drugs that are likely to be at higher risk of excessive pricing (“Category I” medicines), namely drugs that have a very high annual treatment cost or are expected to capture a sizeable share of the Canadian market.

Sweeping New Powers Given To Canada's Drug Watchdog

The PMPRB has a statutory mandate to ensure that prices charged by pharmaceutical companies for patented drugs sold in Canada are not excessive.

The new Guidelines will come into force on January 1, 2021.

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