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CVMA Responds to Health Canada's Proposed Veterinary Pre-market Evaluation Fee Structure

August 2, 2019

The Canadian Veterinary Medical Association (CVMA) feels the proposed Veterinary Pre-market Evaluation Fee Structure would result in an increase in drug review and maintenance fees over the next few years.

Based on its analysis (July 2019) of the proposal, the Canadian Animal Health Institute (CAHI) concluded: “The new veterinary drug fees are not competitive and will have a significant negative impact on the availability of veterinary drugs when fully implemented. Specifically, when taken together the service fees for veterinary drug reviews, drug establishment licenses (DEL), and maintenance in the market by one Canadian veterinary drug company found that if implemented as is:

  • sales for 58 per cent of the current livestock products will not support a new registration due to review, DEL and maintenance fees; and
  • 52 per cent of companion animal product sales will not support being introduced and/or maintained in the Canadian market for the same reasons.
  • If innovation costs of 5 per cent of the total research and development (R&D) costs are included in the calculation
    • 79 per cent of the livestock products; and
    • 74 per cent for companion animal

fall below the financial threshold to support product registration and launch in Canada.”

The CVMA is concerned Canadian veterinarians could lose access to animal health products that are currently available and would not gain access to products licensed in countries such as the USA since registration and maintenance costs in Canada’s relatively small market would be prohibitive. Such a situation would have negative implications for both Canada’s livestock and pets.

The current proposal could undermine the Government of Canada’s efforts to coordinate stakeholder initiatives under the federal Pan-Canadian Framework on Antimicrobial (AM) Resistance and associated federal Action Plan. The CVMA has a particular interest in this initiative given the recent approval by the Minister of Agriculture and Agri-Food Canada of its proposal for a four-year project for a National Veterinary Oversight System for Antimicrobial Use (NVOS) which will focus on AM Stewardship and AM Use Surveillance. The CVMA is concerned that without enough available, safe and effective antimicrobials and alternatives, other less desirable options may be sought by some including increased use of compounded drugs, extra-label drugs use, or even illegal importation.

Read the complete letter here.