On August 18, 2022, PMPRB announced its Decision resulting from the consultation on the PMPRB Price Review Approach During the Interim Period following publication of Amendments to the Patented Medicines Regulations – Canada.ca
The 'Interim Period' is from July 1, 2022 until a final set of price regulatory guidelines is published (expected for end of 2022).
In short, the Board has decided to proceed with the interim guidance as initially proposed in the June 30, 2022 Notice and Comment, with two important clarifications. That guidance is summarized below, with the clarifications underlined:
1. Existing Medicines
During the Interim Period, the price of a patented medicine will not trigger an investigation if:
A. its national average transaction price (N-ATP) remains at or below the 2022 projected NEAP (Non-Excessive Average Price) – this price would have been reported to patentees in February/March 2022 in letters received from Board Staff.
B. 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).
2. New Medicines
Medicines which do not have 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.
At first glance, the clarifications seem largely favorable to industry. However, the interim period is intended to last for only a few months. So the material impact of the reform will largely depend on content of the PMPRB's upcoming draft guidelines, which have been promised for September.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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