Forward Regulatory Plan 2019-2021: Cost Recovery for Drugs and Medical Devices

Title of Regulatory Initiative

Cost Recovery for Drugs and Medical Devices

Enabling Act

Food and Drugs Act

Description

Health Canada is modernizing its cost recovery regime for drugs and medical devices.

The Budget Implementation Act, 2017 amended the Food and Drugs Act to provide Health Canada with new authorities to establish an agile cost recovery system capable of supporting regulatory system delivery and transformation, while maintaining transparency and accountability principles.

Applicable fee regulations currently under the Financial Administration Act will be repealed and new fee regulations will be established under the Food and Drugs Act. Health Canada will be utilizing these new authorities to update and revise existing fees for human drugs, veterinary drugs and medical devices to better reflect current costs of program delivery.

Regulatory cooperation efforts (domestic and international)

Not applicable

Potential impacts on Canadians, including businesses

The Regulations will impact the fees to be paid by companies for regulatory services, but is not expected to increase the costs of health products to consumers.

Consultations

Health Canada published its Fee Proposal for Drugs and Medical Devices and launched its consultation with Canadians and stakeholders on October 11, 2017. The consultation closed on January 4, 2018. During this time the department met and engaged with a range of stakeholders. A Revised Fee Proposal was published May 24, 2018, addressing many stakeholder concerns, and the Feedback Process closed June 14, 2018.

The timing of publication in Canada Gazette, Part II and implementation of the revised fees is to be determined.

Further information

Additional information can be requested from the Departmental contact

Departmental contact information

Bruno Rodrigue
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone: 613-946-6586
Email: hc.lrm-mlr.sc@canada.ca

Date the regulatory initiative was first included in the Forward Regulatory Plan

April 1, 2017

Consult Health Canada's acts and regulations web page for:

  • a list of acts and regulations administered by Health Canada
  • further information on Health Canada's implementation of government-wide regulatory management initiatives

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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