Consultation on the revised PMPRB proposed Practice Directions

Canada’s Patented Medicine Prices Review Board (PMPRB or the Board) is developing non-binding Practice Directions to guide procedural matters in Board hearings that are not already covered by its existing Rules of Practice and Procedure¹.

After an initial 60-day public consultation period in Spring 2026, the Board received support for modernization and transparency, but also constructive feedback on its proposed Practice Directions. The PMPRB responded to this feedback by revising the proposed Practice Directions in August 2026. The revised Practice Directions² are now subject to a further 30-day consultation period.

What you need to know

• The PMPRB is a quasi-judicial body that regulates the prices of patented medicine in Canada by determining whether they are being sold at an excessive price.
• The revised version acknowledges and responds to stakeholder submissions, including from patient groups, pharmaceutical companies, and the Canadian Bar Association, who raised concerns about fairness, achievable timelines, and harmonization with Federal Court guidance.
• The proposed Practice Directions are not legally binding, and do not replace or amend the Board’s Rules. Rather they present a base “default” for hearing procedures which may be departed from at any time by PMPRB hearing panels at their discretion to ensure the fair and expeditious conduct of any proceeding.
• The Practice Directions should be read in conjunction with the Board’s Rules, the Patent Act³, and the Patented Medicines Regulations⁴.
• The deadline to submit feedback on the revised Practice Directions is Thursday, September 24, 2026. The PMPRB will consider all feedback received before the Practice Directions are finalized.

Notable changes

• “Default” to “preferred” mode of hearings. Following industry feedback, the PMPRB changed paper from the “default” to “preferred” mode for the evidentiary portion of Board proceedings. It added that the mode to be used for each proceeding will be confirmed at a case management conference on a case-by-case basis. We note that some stakeholders, in the initial consultation period, wanted to abandon any stated preference for paper proceedings entirely. The Board also changed reserving the live portion of the hearing for oral argument from “default” to “preferred”.
• Extending the expedited hearing process. The revisions permit a twelve-month expedited hearing process, up from the initially proposed six months, in situations where all parties agree during case management.
• Removing hour limits on “Chess Clock” process. The revised Practice Directions remove all specific time constraints from the “Chess Clock” provision for oral hearings. Rather, the parties must confer and agree upon a hearing schedule with time provided by the Board during case management. The requirement to show “exceptional circumstances” when requesting additional time for an oral hearing has been removed. While this change addresses some stakeholder concerns, the hearing schedule is not expressly contingent on party consent, and the Board retains authority to set the final schedule.
• Clarifying document exchange disclosure and confidentiality concerns. The revised Practice Directions replaced the broad standard of “relevant to any matter in issue” for documentary production to an "intends to rely" formulation. This revision directly responds to stakeholder concerns by clarifying that the PMPRB should not be expanding discovery obligations beyond existing requirements. The revisions also address stakeholders’ concerns regarding confidentiality by ensuring that such issues are addressed early and that disputed materials remain confidential pending a decision.
• Extending motion timelines. The Board fulfilled demands to increase the five-business-day deadline for motion responses to ten business days, and the deadline for replies from two to five business days. The Board also lowered the threshold for granting extension for the motion filing schedule from if “exceptional circumstances arise” to if “more time is required”.
• Expanding page limits. The PMPRB addressed concerns that the proposed page limits were insufficient for proceedings by increasing the applicable page limits to fit the demands of stakeholders. These changes include increasing the page limit of written submissions on the merits in a proceeding, an abbreviated failure-to-file (FTF) proceeding, and on a motion, as well as replies to each of these submissions, to 30 pages. Additionally, the PMPRB removed the 15-page limit for expert witness reports. Such reports are now proposed to have page limits be set on a case-by-case basis during a case management conference, with a required 10-page executive summary.
• FTF proceedings not expedited by default. The proposed default abbreviated paper format for FTF proceedings has been removed. The abbreviated process may be selected during case management on consent of all parties, but it is not mandatory. This consent-based approach addresses concerns that FTF proceedings can raise jurisdictional and liability issues and should not be compressed by default.
• Providing information on the use of AI in proceedings. The revised Practice Directions provide clarity on AI disclosure. The revisions align more closely with the Federal Court’s May 2024 AI notice, which was requested by stakeholders, and require a declaration when AI has functioned as a co-author of filed materials. However, the revisions disregarded the feedback that these AI policies should explicitly apply to Board Staff.

Feedback from stakeholders not addressed in the revised Practice Directions

The revised Practice Directions do not address calls from industry stakeholders to set out what parties can expect in terms of the Board’s response times. Additionally, the PMPRB did not define key terms and cross-reference them against the existing Rules of Practice and Procedure, such as “notice”, “response”, and “reply”, as requested by stakeholders for clarity.

What’s next

Once finalized after this consultation period, the Practice Directions will be issued with a coming-into-effect date and will be published on the PMPRB’s website. Certain aspects of the final Practice Directions may be revisited in the future by the PMPRB as circumstances change. If any changes to the Practice Directions are contemplated because of an internal review, interested parties will be consulted by the PMPRB as per subsection 96(5) of the Patent Act.

Historically, there have not been many hearings before the PMPRB. According to the PMPRB’s 2024 Annual Report⁵, since the PMPRB’s inception in 1993, 31 notices of hearing have been issued, 14 of which were resolved through settlements prior to the hearing. Only 3 hearings have been undertaken in the last 10 years. Many patentees choose to enter into voluntary compliance undertakings (VCUs) before a notice of hearing is issued. The PMPRB website⁶ reports that 3 VCUs were completed in 2023, 10 in 2022 and 2 in 2021.

We previously reported on the changes to the PMPRB’s pricing review framework⁷, the draft guidelines operationalizing the amended regulations⁸, the final guidelines implementing the framework that came into effect on January 1, 2026⁹, and now the PMPRB’s revised proposed Practice Directions which respond to stakeholder feedback and may shape the conduct of future Board proceedings. It will be interesting to see whether there is more activity before the Board under this new regime.