The PMPRB – An Overview
The Patented Medicine Prices Review Board, or PMPRB, is a federal agency with a mandate to determine if patented drugs are being or have been sold at an excessive price in any market in Canada. The Board is required to apply factors set out in the Patent Act and to comply with Canadian laws regulating the operation of administrative tribunals.
There are two main aspects of the Board’s jurisdiction: reporting and enforcement.
Reporting obligations: Any rights holder for an invention pertaining to a medicine, e.g, patentee or CSP holder, is required to disclose the following information to the Board at prescribed times:
The Human Drug Advisory Panel (HDAP) created by the Board provides recommendations to Board Staff regarding the categorization of new drug products and the selection of comparable drug products for pricing purposes.
Enforcement: Board Staff has the power to investigate whether a rights holder has contravened the Patent Act and/or Patented Medicines Regulations. Investigations may arise, for instance, if the rights holder has failed to report documents and information to the Board, or if Board Staff believes that the rights holder has sold a medicine in any market in Canada at an excessive price. If Board Staff is of the view that there has been an infraction, it will generally ask the rights holder to provide a voluntary compliance undertaking (VCU) to remedy the situation.
If a VCU cannot be reached, Board Staff may refer the matter to the Board to determine whether to issue a Notice of Hearing. Hearings are quasi-judicial proceedings based on oral and documentary evidence in which the parties are represented by legal counsel. Cases are heard in public by a three-member panel that has all the powers of a superior court. If the Board finds that a rights holder has failed to report, or has sold a patented medicine in any market in Canada at a price that is excessive, the Board may order the rights holder to do the following things:
If the Board is of the opinion that the rights holder has engaged in a policy of selling a medicine at an excessive price, then it may order the rights holder to offset up to twice the amount of the excess revenues that would otherwise be payable.
Board decisions are reviewable by the Federal Court. Judicial review decisions are appealable to the Federal Court of Appeal, without leave, and to the Supreme Court of Canada, with leave.