Veterinary drug approval ‘severely eroded’

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Published: July 16, 1998

Canada’s veterinary drug industry is complaining the federal government is failing to meet its commitment to quickly review and approve drugs which meet scientific standards.

The Guelph,Ont.,-based Canadian Animal Health Institute, representing companies that develop and manufacture vet drugs and feed additives, has complained to Ottawa that Health Canada’s bureau of veterinary drugs is in crisis.

It blames “personnel issues” within the bureau. Some scientists have created a political uproar by publicly alleging the companies have too much influence over the drug regulatory system.

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The companies have a different view.

In terms reminiscent of farmer complaints about the Pest Management Regulatory Agency, also under Health Canada, the industry complains about bureaucratic delays which keep animal drugs off the Canadian market long after they are available to farmers in other countries.

The long delay in deciding on the dairy growth hormone bovine somatotropin often is cited as an example.

“The BVD’s ability to ensure timely availability of safe and effective veterinary drug products has been severely eroded over the past three years,” the animal health institute complained late last month. “Canada’s drug approval process is experiencing a drastic downward swing as far as efficiency is concerned.”

The institute noted it takes regulators more than half a year to assess as many as half the applications for drug approvals. Before 1995, average product assessments were much faster.

The industry says this is a direct violation of a commitment the government made to improve the system after cost recovery was introduced.

Drug companies have proposed to Ottawa a 10-point plan for “improving” the veterinary drug regulatory process.

It would include better performance goals, efforts to make the Canadian system equivalent to systems in competitor countries and a timetable for completion of reviews.

It also calls for better management and more training for staff.

“It is only by addressing (such) recommendations … that Canada’s veterinary drug program will begin to function more effectively,” said the industry lobby.

Last week, health minister Allan Rock announced a two-to-three-year review of his department’s health protection branch, including the veterinary drug bureau.

Political critics and the union representing scientists have said the review must include allegations that the drug companies have too much influence in the drug approval and regulatory system, rather than too little.

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