Since the 1990s, Health Canada has been charging user fees to industry to cover a portion of the costs of its regulatory programs for drugs and medical devices. This is common practice amongst international regulators of therapeutic products.
In this section you will find information about the existing fees related to human drugs, medical devices and veterinary products; as well as information about efforts to update some of these fees.
Cost recovery is a federal government policy intended to promote more business-like and equitable management of government programs. The policy stipulates that specific individuals or firms, who benefit directly from or cause government activity should bear some or all of the cost of those activities.
Many of Health Canada's regulatory activities represent a direct benefit to or are triggered by companies selling therapeutic products on the Canadian market; therefore, these activities are considered appropriate for cost recovery.
The current cost recovery regime for human drugs Fees, medical devices Fees and veterinary products Fees covers pre-market review, post-market surveillance, as well as inspection and licensing of regulated establishments.
In 2004, the Health Products and Food Branch (HPFB) undertook a significant project to update its cost recovery framework - the Cost Recovery Initiative. Consultations have been undertaken with industry, health professionals, patients and consumers, and independent advisory panels reviewed complaints that had been raised. The culmination of this work has resulted in Health Canada's Proposal to Parliament for User Fees and Service Standards for Human Drugs and Medical Devices Programs (User Fees Proposal). The proposal was developed in accordance with the User Fees Act, responds to a changing marketplace, and better reflects the benefits received by Canadians and industry. It sets out updated fees for Health Canada's human drugs and medical devices programs, as well as fee mitigation measures and provision for an annual adjustment of fees.
On April 12, 2010, the Minister of Health tabled Health Canada's User Fees Proposal in the House of Commons. The Proposal was tabled in the Senate the following day.
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 are required to go through the Canada Gazette process. The regulatory proposal was published in the Canada Gazette, Part I on November 13, 2010 for a 75-day consultation period. A summary of stakeholders' comments and Health Canada's responses were published in Canada Gazette, Part II, as part of the Regulatory Impact Analysis Statement that accompanies the regulations.
The updated fees came into force on April 1, 2011.
Regulations published on the Justice Canada website:
Financial Administration Act
Food and Drugs Act