List of Act and Regulations

Patent Act

The Patent Act establishes the Patented Medicine Prices Review Board (PMPRB) with a mandate to regulate the prices of patented medicines sold in Canada to ensure that they are not excessive; and to report to Parliament annually through the Minister of Health. The PMPRB operates within sections 79 to 103 of the Act.

Sections 90, 92, 102 and 103 of the Act authorize the Minister of Health to: instruct the Board to inquire into any matter and report back; make recommendations respecting the appointment of Members of the Board; enter into agreements with provinces respecting the distribution of excess revenues collected by the Board; and convene formal meetings on matters relating to how the PMPRB administers this Act as it applies to patented medicine prices.

Patented Medicines Regulations (SOR/94-688)

Guidelines

• Compendium of Policies, Guidelines and Procedures – outlines how Board Staff reviews the prices of patented drug products, and proceeds when a price appears to be excessive. This Compendium has been issued to promote awareness and facilitate compliance.
• Monitoring and Evaluation Plan for the Major Changes in the Guidelines – provides information on how the impact of the Guidelines, as revised in 2010, will be measured. This Plan will also be examined on an ongoing basis and updated annually.