On March 5, 2026, the Patented Medicine Prices Review Board (PMPRB or Board) published a series of proposed Practice Directions to streamline its hearing process. The proposed Practice Directions signal an important procedural shift away from live in-person, “action”-style hearings in favour of paper-based “application”-style hearings. This change, to facilitate shorter and less complex hearings, suggests the Board is preparing to hold more enforcement hearings under its new Guidelines process, which just came into force on January 1, 2026. The PMPRB is accepting feedback on the proposed Practice Directions until May 4, 2026.

Background

Under the Patent Act, the PMPRB monitors the prices of patented medicines sold in Canada to ensure that rights holders do not abuse their patent rights by charging an “excessive” price. On June 30, 2025, the PMPRB released the final version of its new guidelines (Guidelines), which establish the new price-review process to be used by the Board’s Staff (our report here). Those Guidelines took effect on January 1, 2026 and set out a new two-step process designed to identify and prioritize cases recommended for a public price hearing.

In its almost 40-year history, the Board has presided over relatively few hearings. Since 1993, the PMPRB has issued 31 notices of hearing, 14 of which were resolved through settlements prior to the hearing on the merits, and 17 of which were subject to a full public hearing (ten related to allegations of excessive pricing, and seven related to allegations of failure-to-file (FTF)).[1] Historically, Board proceedings have been lengthy, with an average hearing duration of nine days, and a trend toward longer hearings in the most recent cases (closer to 20 days).

Practice Directions

The PMPRB has published seven proposed Practice Directions for consultation. The Practice Directions are part of the PMPRB’s Strategic Plan for 2026-2030, to “provide organized and efficient administrative services”. The Board wants to “ensure that Rights Holders have clear expectations” and hold efficient hearings that are both timely and procedurally fair.

The Practice Directions are non-binding and supplemental, providing guidance on procedural matters that are not already specifically addressed in the PMPRB’s Rules of Practice and Procedure (Rules). The guidance describes the “default” for the Board’s hearing procedures, which the PMPRB hearing panels may depart from at any time, at their discretion.

The key takeaways from each of the proposed Practice Directions are summarized below.

  1. Mode of PMPRB Hearings: The PMPRB is seeking to promote the increased use of “paper hearings” for the evidentiary portion of price hearings. The proposed default will be that the “live” portion of the hearing is heard virtually and reserved for oral argument, with all evidence (e.g., written testimony and transcripts of cross-examinations of witnesses) going in by paper. This resembles an application-style procedure before the Federal Court. Either the Board or the parties may request that oral testimony and/or cross-examinations be heard “live”, or that the hearing be in-person. Any oral hearing of evidence will be limited to five hours a day over 5-7 days, with 1-2 additional days for oral argument. Upon party agreement, the Board may also adopt a six-month expedited hearing process.
  2. Facilitating Document Exchange: Disclosure of all relevant documents will be made through affidavits of documents, which should be supplemented or corrected if new documents or information come to light. The timing for service and filing of affidavits of documents and expert witness reports will be set at a case management conference, or via Board direction. Parties may bring paper motions to contest confidentiality claims, object to experts or their reports, or request productions.
  3. Standardizing Motions: The Board routinely hears pre-hearing motions (e.g., for document disclosure, confidentiality, objections to expert reports, leave to intervene). All motions will be determined in writing, by default, but parties can request an oral hearing (either in-person or virtual). Motion timelines are short: within two business days of receiving a moving party’s motion record, the responding party must indicate whether or not they will respond, and file their responding motion record within five business days of service of the motion record. Any reply must be filed within two business days of service of the response. Extensions of time may be granted, on request, in exceptional circumstances.
  4. Electronic Filing and Page Limits: Electronic filing is the Board’s preferred filing format.  Parties no longer need to file three paper copies of e-filed documents. Any written submissions on the merits are limited to 30 pages, with any reply limited to 20 pages. Motion submissions are limited to ten pages, with five pages for any reply. Finally, expert witness reports can be no longer than 15 pages. Requests for additional pages can be made to the Board, with justification (e.g., where the case is particularly complex).
  5. Expediting Failure-to-File Proceedings: The PMPRB can issue FTF orders under subsection 81(1) of the Patent Act, requiring rights holders to file pricing and other information with the PMPRB. The Board proposes to adopt an abbreviated, paper format for FTF proceedings. The Board explains that these proceedings “have different consequences for rights holders” than proceedings on excessive pricing, “often do not involve complex legal questions”, and “may be based on smaller evidentiary records”. Unless ordered otherwise, written submissions are limited to 15 pages, with 10 pages for any reply. Oral hearings can be requested, but will only be granted in exceptional circumstances. FTF cases will have a 90-day, compressed schedule and will be case managed to help streamline the process and establish a timetable for filings. 
  6. Use of Artificial Intelligence (AI) in Proceedings: Counsel and parties must disclose any use of AI in preparing their materials.
  7. Virtual Proceedings: By default, oral arguments will be heard virtually. Virtual hearings will be open to the public.

Consultation

The PMPRB is seeking feedback on the proposed Practice Directions until May 4, 2026. Once finalized, the Practice Directions will be issued with a coming-into-effect date, and will be published on the PMPRB’s website.

Link:

[1] PMPRB, Annual Report 2024 at “Summary”.