New rules on procedure and practice before the Patented Medicine Prices Review Board were published in the Canada Gazette today to codify existing procedures.
The proposed regulations were published in the Canada Gazette in June for consultation (see my earlier post) and no comments were received. The rules, entitled “Patented Medicine Prices Review Board Rules of Practice and Procedure” are enabled under Section 92(2)(b) of the Patent Act.
The objectives of the rules, as identified in the preamble published in the Gazette are to enhance:
- the transparency of the Board’s activities;
- consistency in the exercise of its formal powers;
- fairness to all parties appearing before the Board; and
- the timely completion of hearings.
In other PMPRB news, the Board published notice that it has accepted to Voluntary Compliance Undertakings of Eisai Limited for Banzel (rufinamide) and of Pfizer Canada Inc. for Lyrica (pregabalin).