Changes to the Patented Medicine Prices Review Board (PMPRB) regime, contained in pending amendments to the Patented Medicines Regulations, have been delayed until January 1, 2022. These amendments form the basis for new PMPRB Guidelines, which are scheduled to come into force at the same time as the amendments.

The amendments contain a number of changes affecting the PMPRB’s review of patented medicine prices. These include new mandatory factors to be considered by the Board, such as pharmacoeconomic value; a requirement to include “adjustments” when computing average transaction prices reported to the Board; and a revised basket of international comparator countries for reference pricing that omitted the United States and Switzerland.

As we reported, the amendments were introduced in August 2019. At that time, they were set to come into force on July 1, 2020. The coming-into-force date of the amendments has since been delayed three times: first to January 1, 2021, then to July 1, 2021, and most recently to January 1, 2022. In addition, the coming-into-force date of the amendment regarding average transaction prices has been delayed to an unspecified future date, pending the outcome of litigation regarding its validity.

The RIAS indicates that the purpose of the most recent six-month delay to the amendments is “to provide industry stakeholders with additional time to adapt to the new reporting obligations given the unexpected impact of the third wave of the COVID-19 pandemic.”

These amendments are separate from recent changes that bring Certificates of Supplementary Protection (CSPs) into the PMPRB regime, which came into force on June 30, 2021.