Health products cost recovery initiatives

On this page

• Our approach to fees
• History of fees for health products
• Consultation and engagement
• Contact us

Our approach to fees

Health Canada's approach to cost recovery regimes for health products is guided by the principles of:

• accountability and transparency
• predictability and sustainability
• stewardship and fairness

This includes public and parliamentary reporting (financial and performance levels), financial penalties for missed performance standards and meaningful stakeholder consultations when fees are revised.

For more information on Health Canada's approach to cost recovery, please visit Cost recovery and fees for Health Canada.

History of fees for health products

Since 1995, Health Canada has been charging fees to industry to partially recover the costs associated with some regulatory activities.

Human drug and medical device fees were previously updated in April 2011 under the Fees in Respect of Drugs and Medical Devices Regulations. Fees for veterinary drugs were not updated at that time.

The Budget Implementation Act of 2017 provided the Minister of Health with the authorities to fix and adjust fees in the Food and Drugs Act (FDA). Later that year, Health Canada began engaging with stakeholders to revise fees for regulatory activities related to human drugs, veterinary drugs and medical devices. As part of the stakeholder engagement process, we proposed revised fees in October 2017. The consultation period closed in January 2018. We reviewed the comments we received and published a revised fee proposal in May 2018. Following stakeholders' comments, we published a final fee report in May 2019.

The Final Report: Fees for Drugs and Medical Devices summarizes the results of the stakeholder consultation, revised fees and performance standards for drugs and medical devices.

Revised fees were implemented under the Fees in Respect of Drugs and Medical Devices Order (Fees Order) on April 1, 2020.

Modified performance standards were also implemented on this date under the Performance Standards for the Fees in Respect of Drugs and Medical Devices Order.

The Fees Order has been recently amended as follows:

• March 2021: Order Amending the Fees in Respect of Drugs and Medical Devices Order (COVID-19 Drugs)
  • reflects a new remission provision for COVID-19 drugs that transition to the Food and Drug Regulations (FDR)
• February 2023: amendment to the Fees Order to include fees for COVID-19 medical devices
  • reflects changes to the medical device fee category definitions based on regulatory changes for COVID-19 medical devices

Consultation and engagement

Annual cost-recovery stakeholder meeting

Health Canada publishes a report on fees every fall. We then hold a meeting with stakeholders to present costs, revenues and performance for health products that fall under the cost-recovery initiative. We also develop a "what was heard" report, which is available upon request.

Fee consultations

Health Canada held the following consultations with respect to fee proposals and amendments to the Fees Order:

• Consultation on the definition of "new active substance": proposed change to the definition for a new active substance in the Fees Order to match the proposed changes to the FDR
  • consultation ran from March 6 to March 21, 2021
• Consultation on biocides fees: proposed new fees for disinfectants and sanitizers moving from the FDA and Pest Control Product Regulations to the new regulatory framework for biocides
  • biocides fee proposal consultation ran from May 7 to July 16, 2022
• Consultation on interim order transition for COVID-19 drugs: report on consultation to exclude rolling submissions for COVID-19 drugs from penalties for missed standards
  • new regulations, published in the Canada Gazette II on March 2, 2022, came into effect on February 27, 2022, following the repeal of Interim Order No. 2
• Consultation on amendments to regulations to import and sell COVID-19 medical devices: proposed changes to the definitions of fee categories to include amendments to COVID-19 medical device authorizations
  • consultation ran from May 2 to May 22, 2022
• Consultation on proposed changes to the Medical Devices Regulations to address future public health emergencies: proposed regulatory amendments to the Medical Devices Regulations (MDR) to expand the current provisions under Part 1.1 of the MDR, currently limited to COVID-19 medical devices, to apply to any future public health emergency
  • proposed amendments will also result in administrative changes to the Fees Order
    • consultation ran from March 23 to April 13, 2023
• Consultation on the Food and Drug Regulations for public health emergency drugs: proposed amendments to expand provisions introduced for COVID-19 to "COVID-19 or a condition referred to on the List of Conditions that Threaten Public Health in Canada"
  • drugs that relate to COVID-19 or a condition on this list would be referred to as public health emergency drugs
  • proposed amendments will also result in changes to the Fees Order
    • consultation ran from February 13 to April 27, 2023
• Consultation on proposed fees for natural health products: fee proposal for natural health products (NHPs)
  • consultation period ran from May 12 to August 10, 2023
• Consultation on proposed fees for veterinary drugs master files: proposed fees for veterinary drugs master files
  • consultation period ran from June 2 to August 12, 2023
  • consultation comments are posted here

Contact us

If you have a question about the cost-recovery program for health products, please contact the Cost Recovery Policy Office by email at cro-brc@hc-sc.gc.ca.