Voluntary Compliance Undertakings

A Voluntary Compliance Undertaking (VCU) is a written commitment by a patentee to comply with the Board’s Guidelines, including adjusting the price of the patented drug in question to a non-excessive level and offsetting any excess revenues that may have been received as the result of having sold the patented drug at an excessive price in Canada. Patentees are given the opportunity to submit a VCU when Board Staff concludes, following an investigation, that the price of a patented drug product sold in Canada appears to have exceeded the Guidelines. A VCU can also be submitted following the issuance of a Notice of Hearing, but must then be approved by the Hearing Panel. VCUs represent a compromise between the PMPRB and the patentee as a result of negotiations between the parties geared towards a satisfactory resolution of an investigation initiated by Board Staff as per the Guidelines. VCUs take into account the specific facts and underlying context of a particular case. As such, VCUs are not intended to have precedential value.

The PMPRB publishes VCUs on the web (below) once they are approved by the Chairperson of the Board or by the Hearing Panel, as the case may be. As soon as a patentee has been informed that the terms of a VCU have been accepted, the document becomes public and is reported in the PMPRB quarterly NEWSletter and the Annual Report.

Older VCUs

2021 - 1993