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The Patented Medicine Price Review Board (PMPRB) has opened a public consultation on proposed Practice Directions governing PMPRB hearings. While the proposed Practice Directions are expressly non‑binding, they are intended to operate as the Board's default procedural framework and reflect how PMPRB panels expect hearings to be conducted in practice. Taken together, the proposals emphasize written-record proceedings, defined timelines, and electronic filing. The consultation arises against the backdrop of the PMPRB's new Guidelines, which came into force on January 1, 2026, and the PMPRB's 2026–2030 Strategic Plan, which commits the Board to conducting hearings that are more efficient, predictable, and procedurally fair.
Consultation Details
Stakeholders have until May 4, 2026 to provide written submissions. Companies that may face PMPRB price reviews or hearings should consider whether the proposed Practice Directions merit comment, especially where streamlined procedures may reduce flexibility in complex or high‑stakes cases.
The Proposed Practice Directions
Historically, PMPRB hearings have involved live testimony, in‑person cross‑examinations, and procedural issues, often leading to expensive, lengthy, and logistically complicated hearings. To address these challenges, the PMPRB has released seven proposed Practice Directions aimed at standardizing and streamlining hearing procedures.
The proposed Practice Directions aim to significantly restructure the conduct of PMPRB hearings, with an emphasis on written processes, standardization, and upfront control of hearing procedures.
The PMPRB proposes to move away from trial‑style hearings by making hearings on the written record the default for the evidentiary phase, reserving live hearings primarily for oral argument and generally conducting any live components virtually.
The proposals also introduce a more formalized and predictable approach to document exchange, replacing ad hoc production practices with sworn affidavits of documents, defined mechanisms for asserting and challenging confidentiality, ongoing disclosure obligations, and structured procedures for seeking additional production or addressing expert evidence.
Motion practice would likewise be standardized through prescribed timelines, a default written format, and expectations that parties attempt to resolve issues informally before bringing motions.
Electronic filing will become the norm, supported by uniform formatting requirements and page limits intended to promote proportionality and efficiency, with limited opportunities to seek exceptions.
For failure‑to‑file proceedings, which the Board characterizes as narrower in scope, the proposals contemplate an abbreviated, written-record process designed to resolve such matters within a compressed timeframe, with oral hearings reserved for exceptional cases.
The proposed Practice Directions also codify procedural expectations for virtual proceedings and establish explicit disclosure and responsibility requirements where parties use artificial intelligence in preparing submissions. Collectively, the proposals reflect a structured, written, and time‑bound process for PMPRB hearings.
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