The Patented Medicine Prices Review Board (PMPRB) has launched a 30-day public consultation on its updated draft pricing guidelines. These guidelines have been significantly changed in response to stakeholder feedback on an earlier draft that was released in November 2019 for an 85-day consultation period.
The guidelines explain the steps taken by staff at the PMPRB in assessing whether a patented medicine 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.
Amendments meant to modernize pricing framework
This consultation follows Health Canada's amendments to the Patented Medicines Regulations, which strengthen and modernize Canada's pricing framework for patented medicines 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 guidelines are necessary to implement the regulatory amendments.
These regulations are set to come into force on January 1, 2021.
The deadline for providing written submissions is July 20, 2020. The PMPRB will be hosting a series of webinars to discuss the draft guidelines with stakeholders.
