The Patented Medicine Prices Review Board (PMPRB) released its new draft Guidelines today and launched a 60-day consultation period with stakeholders and interested members of the public.
This consultation follows Health Canada’s recent amendments to the Patented Medicines Regulations, which strengthen and modernize Canada’s pricing framework for patented drugs so that the PMPRB can better protect Canadian consumers from excessive prices in an era marked by increasingly high-cost drugs.
Major changes to the PMPRB’s Guidelines are necessary to implement the regulatory amendments.
“The PMPRB is committed to hearing from Canadians on how it can continue to ensure they are protected from excessively priced patented drugs,” Dr. Mitchell Levine Chairperson, of the PMPRB said. “And looks forward to receiving constructive and meaningful feedback on the proposed changes to its Guidelines.”
The Guidelines explain the steps taken by staff at the PMPRB in assessing whether a patented drug appears to be priced excessively in Canada. It also explains what information patent-holding pharmaceutical companies must provide to the PMPRB to enable it to make that assessment.
The PMPRB ensures that prices charged by pharmaceutical companies for patented drugs sold in Canada are not excessive. On August 9, 2019, Health Canada announced amendments to the Patented Medicines Regulations which will come into force on July 1, 2020.
The deadline for providing written submissions to [email protected] is January 20, 2020. The PMPRB consultation plan also provides for multiple feedback opportunities and formats. Full details are available on the PMPRB’s website.
The PMPRB also reports on pharmaceutical trends and R&D spending by pharmaceutical patentees.