Act, Regulations and Guidelines

The Patented Medicine Prices Review Board operates within the boundaries of various legislation, regulations and guidelines.

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

The Patented Medicines Regulations outline data reporting requirements, including patentees´ revenues and research and development expenditures, which all patentees must adhere by in order to be in compliance with the Patent Act. The Patentee´s Guide to Reporting is a reference document to help patentees complete their filing requirements. The Guide explains each element of information to be reported, how and when the information is to be submitted to the PMPRB.

Rules of Practice and Procedures for Hearings – govern proceedings before the Board.

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.

Regulatory Management

• Forward Regulatory Plan
• Service Standards
• Departmental Actions to respond to the Red Tape Reduction Commission´s Recommendation Report
• For more information
  • Government-Wide Forward Regulatory Plans
  • The Cabinet Directive on Regulatory Management
  • The Red Tape Reduction Action Plan
  • The Canada-United States Regulatory Cooperation Council

To learn about upcoming or ongoing consultations on proposed federal regulations, visit the Canada Gazette and Consulting with Canadians websites.