As previously reported, the Patented Medicine Prices Review Board (PMPRB) proposed amendments in June 2023 to its Interim Guidance ("Amended Interim Guidance") for reviewing the prices of patented medicines pending the release of new guidelines relating to the July 1, 2022 amendments to the Patented Medicines Regulations.
On September 27, 2023, the PMPRB adopted the Amended Interim Guidance substantively as proposed. Thus, patented medicines without a MAPP (Maximum Average Potential Price) or NEAP (Non-Excessive Average Price) as of July 1, 2022 ("New Medicines") are considered reviewed if their list price is below the median international price for the PMPRB11 countries. New Medicines that do not meet this criterion are considered "under review" until new guidelines are in place. Once new guidelines are in place, no potential excess revenues will be calculated by staff retrospectively for any New Medicines for sales made during the Interim Period (i.e., from July 1, 2022 to the publication of new guidelines).
The PMPRB has also announced that it intends to launch a consultation on themes relevant to new guidelines. This consultation will be conducted in two stages: the first will be based on themes selected from issues and trends impacting health care and pharmaceuticals in Canada and internationally, and the second (in 2024) will focus on the development of new guidelines.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.