PMPRB Releases New Guidelines for Drug Price Monitoring Effective January 1

The PMPRB has released comprehensive new guidelines governing its staff procedures for monitoring and reviewing patented medicine prices. These guidelines establish the administrative process for excessive price hearing recommendations and update the framework for how the Board conducts compliance activities. The new guidelines take effect on January 1, 2025, replacing previous guidance.

Pharmaceutical manufacturers and patent holders selling drugs in Canada will need to familiarize themselves with these updated procedures to ensure continued compliance with PMPRB requirements. The guidelines affect how drug prices are evaluated against comparators and the processes that may lead to excessive price hearings. Companies should review their pricing strategies and documentation practices in light of these changes.