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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.
pharmaceutical lawyer
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 identity of the medicine
  • The name and address of the rights holder
  • The identity of any patents and certificates of supplementary protection (CSP) pertaining to the medicine
  • The nature of the rights under each patent
  • The date on which the first notice of compliance was issued to the rights holder
  • The drug identification number for each strength and dosage form of the medicine
  • The proposed introductory sale price of the medicine in Canada
  • The date on which the medicine was first sold in Canada
  • The quantity of medicine sold
  • The price at which the medicine was sold in any market in Canada and elsewhere
  • The prices at which other medicines in the same therapeutic class have been sold in countries other than Canada
  • The gross revenue from all sales of the medicine in Canada
  • The revenues received from all licensees from the sale of the medicine in Canada
  • The costs of making and marketing the medicine
  • Any other related matters that the Board may require.
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:
  • Report the price at which the medicine is sold in any market in Canada
  • Reduce the price at which the medicine is sold in any market in Canada
  • Reduce the price at which other medicines are sold in any market in Canada
  • Require the rights holder to pay to His Majesty in right of Canada an amount that is specified in the order to offset excess revenues.
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.