Investigations

An investigation is an in-depth review of the price of a patented medicine conducted by Board Staff. Board Staff will open an investigation into the price of a patented drug product when any of the following criteria are met:

• the list price of any dosage form or strength of a medicine appears to be above the corresponding applicable “interim Maximum List Price” (iMLP) or the “Maximum List Price” (MLP) by more than 5%; or
• the potential excess revenues appear to exceed $50,000 for the medicine (i.e., across all dosage forms and strengths) in a calendar year; or
• A complaint is received.

When Board Staff start an investigation, the patentee will be notified, and the medicine will be reported in the PMPRB’s Annual Report as “Under Investigation”.

An investigation could result in:

• A Voluntary Compliance Undertaking (“VCU”), as described in section VIII;
• The issuance of a Notice of Hearing if, upon the recommendation of Staff, the Chairperson considers it to be in the public interest; and/or
• The closure of the investigation.

For more information on the investigation process, please see the Compendium of Policies, Guidelines and Procedures.
Information on how to make a complaint.