Cost Recovery Renewal Initiative
Health Canada's cost recovery framework for fees set under the Food and Drugs Act (FDA) follows a principled approach to fees that is agile and responsive to a changing regulatory landscape. A key pillar of the framework is Health Canada's commitment to accountability, transparency and stakeholder engagement. This includes public and parliamentary reporting (financial and performance levels), financial penalties for missed performance standards, and meaningful stakeholder consultations when fees are revised.
Revised Fees under the Food and Drugs Act (2020)
Health Canada has been charging fees to industry to recover partial costs since 1995. Fees for veterinary drugs had not been updated since that time, human drugs and medical device fees were last updated in April 2011 Fees in Respect of Drugs and Medical Devices Regulations.
In 2017, Health Canada began engaging with stakeholders to revise fees for regulatory activities related to human drugs, veterinary drugs, and medical devices. The Fee Proposal for Drugs and Medical Devices was published for a 75 day consultation period in October 2017 and closed on January 4, 2018.
After analyzing all the comments received from stakeholders, Health Canada developed a Revised Fee Proposal for Drugs and Medical Devices in May 2018 and accepted stakeholder feedback until June 14, 2018.
The revised fees will be implemented on April 1, 2020. The Final Report: Fees for Drugs and Medical Devices includes a summary of consultations, including stakeholders’ views and Health Canada's responses, revised fees and performance standards. The Final Report includes significant fee reductions for small business and fee exemptions for publicly funded health care institutions. The Performance Standards for the Fees in Respect of Drugs and Medical Devices Order outlines the performance standards to be used to determine whether a remission should be granted for a missed performance standard effective April 1, 2020.
Additional fee proposals to introduce new fees for new regulatory pathways or to revise existing fees will be posted here.
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