The Patented Medicines Review Board (PMPRB) has unveiled the final version of the PMPRB guidelines, which have come after five years of work devoted to strengthen the Canadian framework governing patented drug prices.
Updated after Health Canada’s August 2019 amendment to the Patented Medicines Regulations, the new guidelines include changes following two successive rounds of consultations.
The PMPRB received comments from a broad spectrum of stakeholders including pharmaceutical and biotechnology firms, trade associations, public agencies, federal and provincial health authorities, private insurers, patients, and patient advocacy groups, among others.
Under the new guidelines, the PMPRB said, it will compare Canadian list prices with those in Australia, Belgium, Japan, Netherlands, Norway, Spain, the UK, Sweden, France, the UK and Italy.
The new guidelines also include an initial screening process to determine which drugs are likely to face higher risks of excessive pricing (“Category I” medicines), particularly those that come with high annual treatment costs or are expected to take hold of a sizeable share of the Canadian market. Those products, the PMPRB said, will be the ones it will focus its new powers on.
Following the announcement, the Canadian Life and Health Insurance Association (CLHIA) issued a statement welcoming the new guidelines.
“Through workplace benefit plans, insurers provide employers and their employees with access to over 11,000 patented medicines – which include an increasing number of high cost drugs,” said CLHIA President and CEO Stephen Frank. “Lower drug costs will help to keep these plans sustainable.”
Declaring its continued support of the amendments, CLHIA said it will work with the government on implementing the reforms as well as any future measures to better take control of rising prescription drug costs.
The new guidelines will take effect on January 1, 2021.