Ottawa, ON – Patented Medicine Prices Review Board
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.
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.
The new Guidelines will come into force on January 1, 2021.
Major changes to the PMPRB’s Guidelines were necessary to implement Health Canada’s regulatory amendments, which come into force in January 2021.
The PMPRB consulted extensively and received feedback from a broad array of stakeholders, including pharmaceutical and biotechnology companies, their trade associations, public agencies, federal and provincial health authorities, other government bodies, patients, patient advocacy groups, unions, academics, pharmaceutical distributors, pharmacists, consultants, academics, private insurers, clinicians and other health professionals.
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.
The new Guidelines provide for an initial screening process 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.
The PMPRB has a statutory mandate to ensure that prices charged by pharmaceutical companies for patented drugs sold in Canada are not excessive.
The PMPRB also has a statutory mandate to report on pharmaceutical trends and R&D spending by pharmaceutical patentees.