Proposed new regulations formalizing procedures before the Patented Medicine Prices Review Board were published in yesterday’s Canada Gazette.

The proposed regulations, entitled “Patented Medicine Prices Review Board Rules of Practice and Procedure” and enabled under Section 92(2)(b) of the Patent Act, would formalize procedures before the Patented Medicines Prices Review Board including the role of the adjudicator and define “Board Staff” as a party to proceedings, formalize expert reports, fix timelines for filing of materials and the filing of reply submissions.

The impact statement notes that the rules primarily codify existing informal procedures.

The enacting portions of the Patent Act, require that procedures before the Board be “informally and expeditiously as the circumstances and considerations of fairness permit” (s.97) but rulings of the Board may also be enforced as equivalent to orders of the Federal Court or a superior court of a province (s.99).

In 2011, orders of the Board were entered as orders of the Federal Court on three instances – T-243-11, T-1705-11, and T-1707-11.

Parties have 30 to make submissions on the proposed regulations although the Board notes that earlier versions have already been published and submissions received on the earlier versions.