On August 18, 2022, PMPRB announced its decisions regarding Price Regulation of patented medicines during the ‘Interim Period’, between July 1, 2022 and when a final set of price regulatory guidelines is published. The PMPRB has decided to move forward with earlier proposals drafted June 30th, 2022, and has provided additional clarifications:
- Existing Medicines: During the Interim Period, the price of a patented medicine will not trigger an investigation if:
- its national average transaction price (N-ATP) remains at or below the 2022 projected NEAP (Non-Excessive Average Price)
- its List Price does not increase.
- For greater clarity, an increase in the list price of a medicine will not trigger an investigation if it was taken in accordance with the CPI-based price-adjustment factors during the first filing period of 2022 (January to June).
- New Medicines: Medicines without a MAPP (Maximum Average Potential Price) or NEAP as of July 1, 2022, will not be subject to price review by PMPRB Staff during the Interim Period. Once new Guidelines are in place, no potentially excess revenues will be calculated by Staff retrospectively for any such medicines for sales made during the Interim Period.
PMPRB anticipates conducting consultation on a more permanent set of guidelines to begin in September, with a view to publishing final guidelines by the end of 2022.
This Interim Guidance outlines PMPRB’s intentions for regulating the prices of patented medicines in the “interim period” between the coming-into-force date of the new regulations (July 1st, 2022) and publication and implementation of a final set of guidelines.
For additional information, please contact Mevin Mathew at Mevin.Mathew@pdci.ca