The Patented Medicine Prices Review Board (PMPRB), a federal entity that ensures patented drug prices in Canada are not excessive, has launched a 60-day consultation period on a new interim set of guidelines.
The PMPRB invites pharmaceutical companies and the public, among others, to comment on its proposed interim approach by August 21, 2023.
The new approach would amend the interim guidelines published by the PMPRB on August 18, 2022. These guidelines were intended to serve as a temporary measure following amendments made by Health Canada to the Patented Medicines Regulations, which came into effect on July 1, 2022.
The new approach would allow the PMPRB to review the prices of new drugs under Health Canada's new regulations until the final guidelines are put in place. The PMPRB adds that it will soon announce its forward-looking plan on the matter.
Accelerating price reviews
The PMPRB says it is conducting the consultation in response to the increasing number of new drugs it has not yet been able to review.
It is proposing to modify the interim approach to accelerate price assessment and extend the time allowed for a thorough consultation on the new guidelines.
Under Health Canada's regulations, the PMPRB changed the basket of countries it uses as a benchmark to review the prices of new drugs, increasing that number from seven to 11 countries for comparison. It also excluded the United States and Switzerland where the PMPRB judged drug prices to be much higher than in other countries. (In Switzerland, the gross domestic product (GDP) per capita is almost double that of Canada.)
Other measures remain pending in the wake of the proposed changes to the interim approach. The PMPRB had planned to publish its new guidelines at the end of 2022. However, it had indicated in December that it would not be able to implement them on January 1, 2023, as planned.
The sale of expensive drugs occupies a large part of the total drug sales in Canada. In its annual report submitted to the Senate and the House of Commons on November 18, 2022, the PMPRB indicates that sales of patented medicines in Canada amounted to $17.4 billion in 2021.
This is a decrease of 1.7 per cent when compared to 2020 figures. Medicines with an annual treatment cost of at least $10,000 represented 57 per cent of patented drug sales in Canada in 2021, while five per cent of total sales are attributable to 29 drugs with an annual cost of over $100,000.