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Health Canada Explains Revised Fees for Drugs and Devices

Posted 16 May 2019 | By Zachary Brennan 

Health Canada Explains Revised Fees for Drugs and Devices

Following extensive stakeholder engagement, Health Canada announced Thursday its plan to revise the fees paid by pharmaceutical and medical device companies. The plan will be implemented 1 April 2020.

Presently, Health Canada recovers 43% of its costs for regulatory activities from industry, while the remaining costs are covered by Canadian taxpayers. But the revised fees will increase that percentage and better align Canada with other jurisdictions, like Australia and Europe, where industry fees recover 100% of their costs leaving no burden on their tax payers.

In the US, meanwhile, user fees make up 70% of the US Food and Drug Administration’s budget for drugs, and about 35% for devices.

Here’s the rundown of what some of Health Canada’s fees will look like:

Pre-market Evaluation:
Drugs/Devices: Fees set at 75% of costs (phased in over four years)
Veterinary: Fees set at 50% of costs (phased in over seven years)

Right to Sell: 
Fees set at 67% of costs for all products (human and veterinary drug fees phased in over four years)
Drug Right to Sell: 3 tiers of fees: Prescription; Non-Prescription; Disinfectants

Establishment Licenses:
Fees set at 100% of costs; one fee to be charged per establishment, regardless if Human or Veterinary Drug activities (fees for human drugs phased in over four years, veterinary drugs over seven years)

For small businesses, Health Canada also revised its strategy to provide help for both pre- and post-market activities to companies that meet the Treasury Board Secretariat definition:
  • “First pre-market submission or application reviewed for free for new small businesses that have never previously filed with Health Canada
  • A 50% reduction in all fees for subsequent pre-market submission or applications
  • A 25% reduction of all right to sell fees and Establishment Licence fees.”
Final Report: Fees for Drugs and Medical Devices

Performance Standards for the Fees in Respect of Drugs and Medical Devices Order

Categories: Regulatory News

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