Notice on Proposed Amendments to the Patented Medicines Regulations

From Health Canada

Current status: Closed

This consultation ran from December 1 2017, to February 14, 2018.

Health Canada benefited from considerable stakeholder input since pre-publication of the regulatory proposal in Canada Gazette, Part I in 2017. Comments were received from a diverse range of stakeholders including patient groups, industry, academics, health partners, and the provinces and territories.

Why

The amendments will enable the Patented Medicine Prices Review Board (PMPRB) to better protect Canadians from excessive prices for patented medicines.

The regulations have not changed in over 20 years, despite major changes in the pharmaceutical market. Canadians are now paying some of the highest patented medicine prices in the developed world. This impacts patients and the sustainability of Canada’s health care system.

Who

Health Canada heard from :

  • Canadians
  • Consumer and patient groups 
  • Employers
  • Health professionals
  • Health researchers
  • Other levels of government
  • Pharmaceutical industry
  • Private insurers

What

Amendments will provide the Patented Medicine Prices Review Board (PMPRB) with new regulatory tools and information to better protect Canadian consumers.

This proposal has three key measures that would:

  1. provide the PMPRB with new factors to enable it to consider the price of a patented medicine in relation to its value and impact on the health care system.
  2. update the list of countries that the PMPRB uses to compare prices to include countries with similar consumer protection measures, economic standing and pharmaceutical markets as Canada.
  3. change current reporting requirements to:
    1. add new reporting requirements to support the new factors as described above,
    2. alter price and revenue information to include all third-party price adjustments, and
    3. remove the reporting requirements for patented medicines that have the lowest risk of being priced excessively.

How to participate

The deadline to provide written comments was February 14, 2018.

Learn more

  1. Find out more about the Patent Act, the Patented Medicines Regulations, and the Patented Medicine Prices Review Board
  2. PMPRB Guidelines Scoping Paper – High Level Overview of Potential New Framework (Canada Gazette, Part I)

Related information

Contact us

Patented Medicines Regulations Consultations
Brooke Claxton Building, Room 1009A
70 Colombine Drwy, Tunney's Pasture
Mail Stop 0910, Floor 10
Ottawa, Ontario K1A 0K9

Email: PMR-Consultations-RMB@canada.ca

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