Investigations

Board Staff will open an investigation into the price of a patented drug product when any of the following criteria are met:

• The National Average Transaction Price or any Market-Specific Average Transaction Price of a new drug product exceeds the Maximum Average Potential Price during the introductory period by more than 5%
• Excess revenues are $50,000 or more
• The PMPRB receives a complaint

When the price of a patented drug product appears to be excessive and one of the criteria above are met, the patentee will be notified that an investigation has been opened and the patented drug will be reported on the PMPRB website as “Under Investigation.”

The investigation includes an analysis of the pricing history of the medicine, including national average price, provincial/territorial average prices and market-specific prices, i.e., for each class of customer (hospital, pharmacy, wholesaler).

An investigation could result in:

• closure of the file if the price is found to be within the Guidelines
• a Voluntary Compliance Undertaking by the patentee to reduce the price and offset excess revenues through a payment and/or a reduction in the price of another patented drug
• a public hearing to determine whether the price is excessive

For more information on the investigation process, please see the Compendium of Policies, Guidelines and Procedures.

Information on how to make a complaint.