On June 30, 2025, the Patented Medicine Prices Review Board (PMPRB) published its new Guidelines for PMPRB Staff, which will come into force on January 1, 2026.
The finalized Guidelines maintain the proposed two-step review process which we have previously described in our review of the Draft Guidelines, with minimal changes overall. The material changes between the final and draft Guidelines are summarized below:
- Update regarding the jurisdiction of the PMPRB in view of the decision by the Federal Court of Appeal re: Galderma: the Guidelines have removed the reference to the ability to consider clinical similarities when determining whether a patent pertains to a given medicine.
- Application of the Guidelines to “Existing medicines” and “New Medicines”:
- Patented medicines first sold before July 1, 2022—“Existing medicines”—will be subject to a first Annual Review two years (rather than one year in the draft Guidelines) after the Guidelines are in force, i.e., January 1, 2028. For the first Annual Review, PMPRB Staff will only apply the International Price Comparison, using the highest international price (HIP) criterion. Subsequent annual reviews will also apply the Consumer Price Index criterion. During the two-year transition period, Existing medicines will only be subject to an In-Depth Review if they are the subject of a complaint or if they are an Associated DIN of a medicine that is subject to an In-Depth Review. “Associated DINs” are those that a Rights Holder has identified as pertaining to the same patented invention(s).
- Patented medicines first sold on or after July 1, 2022—“New medicines”—will be subject to an Initial Review process when the Guidelines come into force on January 1, 2026. The Initial Review applies the International Price Comparison, using the HIP criterion. New medicines with prices above the HIP, and all Associated DINs, will be subject to an In-Depth Review.
- Complaints process: Complaints by an approved individual or organization will lead to an In-Depth Review. The approved individuals or organizations who may use the complaints process once the Guidelines come into force are limited to (a) the Federal Minister of Health or their Provincial or Territorial counterparts, and (b) senior officials authorized to represent Canadian publicly funded drug programs. While included in the Draft Guidelines, Canadian life and health insurance companies and their trade association(s) will not be an approved individual or organization.
We have prepared a version of the Guidelines that tracks changes over the Draft 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 life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.