The Patented Medicine Prices Review Board (PMPRB) holds public hearings on two types of matters:
- to determine whether the price of a medicine is excessive; and
- to determine whether a rights holder has failed to file the required information set out in the Patent Act and the Patented Medicines Regulations.
On March 5, 2026, the PMPRB published seven proposed Practice Directions aiming to provide clarity on procedural matters related to these hearings. The proposed Practice Directions, summarized below, seek to align with modern approaches and technologies in addition to promoting consistency, efficiency and procedural fairness.
- Mode of Hearings: The PMPRB proposes to make “paper hearings” the default for evidentiary matters (e.g., written testimony, paper cross-examinations/transcripts) while generally reserving oral hearings for the argument portion.
- Facilitating Document Exchange: Disclosure of documents will be standardized through affidavits of documents.
- Standardizing Motions: A structured approach to motions is proposed and the default format for all motions will be in writing.
- Electronic Filing and Page Limits: The proposed Practice Direction sets out page limits for written submissions and expert witness reports. Electronic filing is the default format.
- Expediting Failure-to-File (FTF) Proceedings: The proposed Practice Direction outlines an expedited process for FTF proceedings that adopts an abbreviated paper format. Such expedited proceedings will be case managed and require early delivery of written evidence on a compressed (90-day) schedule.
- Use of Artificial Intelligence (AI) in Proceedings: Counsel and parties will be required to disclose the use of AI in preparation of any materials used in hearings. This should be done by including a declaration in the first paragraph of any document which utilizes AI, specifying which sections of the document were generated using AI.
- Virtual Proceedings: Oral arguments will be conducted virtually unless an exception applies.
The PMPRB is seeking feedback on the proposed Practice Directions by Monday, May 4, 2026. Following the consultation, the final Practice Directions will be published on the PMPRB website with a specified coming-into-effect date.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation 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.