ARCHIVED - User Fees Proposal

Health Canada's Proposal to Parliament for User Fees and Service Standards for Human Drugs and Medical Devices Programs (User Fees Proposal) sets out updated fees, as well as fee mitigation measures and provision for an annual adjustment of fees.

In April 2010, Health Canada's proposal was tabled in both Houses of Parliament for review. In May 2010, the Senate Standing Committee on Social Affairs, Science and Technology reviewed the proposal. The Committee provided a report to the Senate indicating their support for the proposal with no observations or modifications. The Senate subsequently adopted the report of its committee on May 26, 2010, thereby concluding the Parliamentary review of Health Canada's proposal.

As user fees are set in regulations, any changes to update them were required to go through the Canada Gazette process. The regulatory proposal was published in Canada Gazette Part I for a 75-day consultation period, and in Canada Gazette Part II. The new fee regulations and updated fees came into effect on April 1, 2011.

This marks the first time that the Department has updated user fees for human drugs and medical devices since their introduction between 1995 and 2000.

Consultation Activities and Results

Health Canada held consultations on a Cost Recovery Framework in 2007, and issued a report highlighting the results. Input received through these consultations was incorporated into a revised HFPB Cost Recovery Framework, which was posted as an official notice of a fee proposal in accordance with the  User Fees Act.

Background Documents

  1. Consultation Document, March 2007
  2. Stakeholder Consultation Report, July 2007
  3. Official Notice of Fee Proposal for Human Drugs and Medical Devices, July 2007
  4. International Comparison of Fees and Service Standards for Human Drugs, August 2007
  5. International Comparison of Fees and Service Standards for Medical Devices, August 2007
  6. Cost Development in Support of HPFB User Fees, August 2007
  7. Business Impact Test Survey Results (Executive Summary), April 1, 2008
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