Notice on Proposed Amendments to the Patented Medicines Regulations

From Health Canada

Current status: Open

Health Canada is committed to improving the affordability, accessibility and appropriate use of prescription medicines to better meet health care system needs. This important work includes reducing the cost of prescription medicines by updating the patented medicines pricing framework.

We are now seeking feedback on proposed amendments to the Patented Medicines Regulations. 

Why

The amendments would 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 is encouraging representations from:

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

What

Amendments are being proposed in order to 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

You are encouraged to read the proposed amendments to the regulations.

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

Send your comments to:

Patented Medicines Consultations
Karen Reynolds, Executive Director, Office of Pharmaceuticals Management Strategies,
Strategic Policy Branch, Health Canada
10th Floor, Brooke Claxton Building
70 Colombine Driveway, Tunney's Pasture, Ottawa, Ontario K1A 0K9
email: PMR-Consultations-RMB@hc-sc.gc.ca.

Learn more

  1. Sign up for a webinar to learn more about the proposed regulations
  2. Find out more about the Patent Act, the Patented Medicines Regulations, and the Patented Medicine Prices Review Board
  3. Question and Answers on the Proposed Amendments to the Patented Medicines Regulations
  4. 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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