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Drug approvals slow, redundant

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Published: April 3, 2008

Too little, too late is how many in the livestock industry describe the pace of veterinary drug approvals by Canadian authorities.

“It leaves us in an uncompetitive position. Our government is hampering our ability to compete with our American neighbours by denying us the tools of this North American trade,” said Rick Paskal. The southern Alberta cattle feeder was describing Canada’s system, which can take six to 10 years to approve a new veterinary drug.

Paskal’s frustration was echoed by cattle producers attending a recent beef and forage symposium in Saskatoon.

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Canadian Cattlemen’s Association president Brad Wildeman said Health Canada’s Veterinary Drug Directorate has been underfocused, underfunded and poorly staffed to meet the needs of the Canadian livestock industry.

“(In the U.S.) they can have a new drug approved within a year or two. If we even are an attractive enough market to get the drug makers to invest in the additional costs of testing and registration (in Canada), it takes six years or more,” he said.

Wildeman said many new drugs available to American producers are less expensive and safer for the public and the animals treated.

“These newer products are not just going to improve returns to producers and allow us to compete. They are better products that produce healthier animals and that is good for all Canadians,” he said.

Jean Szkotnicki, president of the Canadian Animal Health Institute, said Canadian producers need to have the same health tools as their competitors.

The institute represents veterinarians, drug companies, feed additive makers and researchers.

“This is an animal welfare issue. You are the original animal welfare activists. You are taking care of your animals every day. You want the best for them. You are about healthy animals more than anyone else. You are about the best husbandry. And you aren’t able to access all of the tools that are available to your competitors to achieve those goals,” she said.

Szkotnicki said rules that require new drugs and vaccines to be retested in Canada add about $100 million to each new major product release in Canada and take up to 10 years to achieve.

Rules for drug approval requirements often mirror those in the U.S. system, but Canadian authorities tend not to accept third party research done in other countries, she said.

Szkotnicki said 82 percent of her member companies find Canadian regulations an obstacle to the release of new products, even those developed in Canada.

“We have researchers in Canada creating new animal health products that will be released in the U.S. half a decade before they are available to Canadian producers.”

Canada has similar safety and regulatory requirements to Australia but that country’s drug approval system accepts the research submitted to other countries for approvals. The U.S., the European Union and Japan all have some form of reciprocal acceptance of research for product approvals.

“But not Canada. Why is that? I wish we had all of those answers,” she said.

In some cases drug makers will seek Canadian approval for only swine or cattle and leave out other species, such as sheep, because of additional testing costs related to other animals.

Szkotnicki said she has been asked by staff at the veterinary drug directorate why the number of applications for new products is dropping when there are so many new drugs being reviewed in the U.S. and elsewhere.

“Simple. The companies aren’t applying for Canadian approvals,” she said.

The institute has asked the federal government to create a streamlined system that would provide approvals within six months of registration in the U.S.

The organization suggested a post product release surveillance system would provide follow-up health security.

About the author

Michael Raine

Managing Editor, Saskatoon newsroom

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