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PMPRB releases proposed amendment to Interim Guidance for comment

Authored byMalcolm Harvey

Update: On September 27, 2023, the Board adopted the Amended Interim Guidance as originally proposed.

On June 20, 2023, the Patented Medicine Prices Review Board (PMPRB) released a proposal to amend the Interim Guidance, which sets out the approach for reviewing the prices of patented medicines under the July 1, 2022 amendments to the Patented Medicines Regulations pending the release of new guidelines (anticipated in 2024). Comments are due by August 21, 2023.


The PMPRB has proposed that provisions of the Interim Guidance related to patented medicines without a Maximum Average Potential Price or projected Non-Excessive Average Price as of July 1, 2022 (“New Medicines”) be amended to indicate that these medicines will be considered reviewed if their list price is below the median international price for the PMPRB11 countries. New Medicines that do not meet this criterion would continue to be under review until new guidelines are in place.

Separately, on June 6, 2023, the PMPRB released its June 2023 NEWSletter. The June 2023 newsletter contains updates on:

  • PMPRB staffing (including the February 2023 appointment of new Chairperson Thomas J. Digby);
  • investigations commenced according to criteria set out in the Interim Guidance; and
  • recent and upcoming presentations and publications of the National Prescription Drug Utilization Information System (NPDUIS).

Amongst the featured NPDUIS publications is the recently released Market Intelligence Report: Antidiabetic Drugs, 2012-2021, which explores trends in antidiabetic drug market shares and utilization in Canada and internationally. According to the report:

  • the growth in spending on antidiabetic drugs in Canada from 2012 to 2021 outpaced that of the overall drug market, primarily due to sales of new-generation/non-insulin subclasses; and
  • although insulin sales remained relatively stable, there were shifts in the utilization of specific long-acting insulins due to provincial drug plan policies (including biosimilar switching policies) and the listing in most provinces of insulin degludec (Novo Nordisk’s TRESIBA). 

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.