PMPRB Proposes Practice Directions for Hearings and Seeks Feedback

JD Supra Intellectual Property

Published March 5th, 2026

Detected March 28th, 2026

Summary

The Patented Medicine Prices Review Board (PMPRB) has published seven proposed Practice Directions for its hearings, seeking public feedback by May 4, 2026. These proposals aim to modernize procedures, standardize document exchange, and expedite certain proceedings, including the use of AI.

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What changed

The Patented Medicine Prices Review Board (PMPRB) is seeking feedback on seven proposed Practice Directions designed to enhance clarity, efficiency, and fairness in its hearing processes. Key proposals include making "paper hearings" the default for evidentiary matters, standardizing document disclosure via affidavits, adopting a written format for motions, setting page limits for submissions, and expediting Failure-to-File (FTF) proceedings with a 90-day schedule. Notably, the proposals require disclosure of AI use in any submitted materials.

Regulated entities, particularly drug manufacturers, should review these proposed directions and submit feedback by May 4, 2026. The PMPRB intends to publish final Practice Directions after the consultation period, which will come into effect on a specified date. Compliance officers should prepare for potential changes in procedural requirements for PMPRB hearings, including electronic filing and AI disclosure mandates.

What to do next

Review proposed PMPRB Practice Directions
Submit feedback by May 4, 2026

Source document (simplified)

March 27, 2026

PMPRB consults on proposed Practice Directions for PMPRB hearings

LinkedIn Facebook X Send Embed 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. [View source.]

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Named provisions

Mode of Hearings Facilitating Document Exchange Standardizing Motions Electronic Filing and Page Limits Expediting Failure-to-File (FTF) Proceedings Use of Artificial Intelligence (AI) in Proceedings Virtual Proceedings