Consulting on Proposed Amendments to the Patented Medicines Regulations

From Health Canada

Current status: Open

You're invited to provide comments on proposed amendments to the Patented Medicines Regulations.

Why

The amendments would enable the Patented Medicine Prices Review Board to better protect Canadians from paying excessive prices for patented drugs.

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

We are committed to improving the affordability, accessibility and appropriate use of prescription drugs to better meet health care system needs. This important work includes reducing the cost of prescription drugs by updating the patented drug pricing framework.

Who

We are seeking feedback on proposed amendments to the regulations, prior to their pre-publication in Part I of the Canada Gazette, from:

  • consumer groups
  • employers
  • federal drug plans
  • health professionals
  • health researchers
  • pharmaceutical industry
  • private insurers
  • provincial and territorial drug plans
  • other stakeholders
  • any interested members of the public

What

Health Canada is looking for comments on the following regulatory proposal:

Amendments are being proposed in order to provide the Patented Medicine Prices Review Board with new regulatory tools and information to better protect Canadian consumers.

The proposed amendments include:

  • revising the list of comparator countries used to determine whether a price is excessive
  • introducing other factors so that value for money and affordability can be taken into consideration
  • updating the information required from patentees

When and where

The consultation period runs from May 16, 2017 to June 28, 2017.

Further consultations on the PMPRB Compendium of Policies, Guidelines and Procedures will follow from the regulatory amendments.

How to participate

You are encouraged to read the consultation document for more information.

You may submit your comments and ideas by:

Next steps

Feedback received on or before June 28, 2017, will be considered in our regulatory proposal to protect Canadians from excessive drug prices. A summary of comments will be published in the Regulatory Impact Analysis Statement at Canada Gazette, Part I.

Related information

Contact us

Patented Medicines Regulations Consultations
Brooke Claxton Building
70 Colombine Drwy, Tunney's Pasture
Mail Stop 0910, Floor 10
Ottawa, Ontario K1A 0K9
Email: PMR-Consultations-RMB@hc-sc.gc.ca

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