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The Hypocrisy Of Own-Use Import Rules

The double standard established by the federal government over the issue of own-use import rules has created many inequalities and hard feelings in the cattle industry.

Under the rule veterinarians, animal health suppliers and distributors in Canada cannot bring in cheaper pharmaceuticals from south of the border yet producers can bring them in for their “own use.” While this loophole was created originally, I believe for human pharmaceuticals producers have made widespread use of it, especially for heavily used feedlot products like endectocides and implants.

The obvious answer is for Canada to get rid of the bureaucratic red tape that only adds huge costs and lengthy delays to getting pharmaceuticals licensed in Canada.

As Dr. Joyce Van Donkersgoed and Rick Paskal accurately stated in the June-July 2009 edition of CANADIAN CATTLEMEN, these regulatory impediments and our much smaller market make pharmaceuticals more expensive in Canada. As a result, producers have sought out supplies of cheaper U.S. products.

This flow has ebbed recently as prices came more into balance but for the future we need a new system. There is a very logical way to keep all parties happy.

Similar to the collaboration on pharmaceutical licensing between New Zealand and Australia, we need a North American veterinary drug directorate, or at the very least a joint Canada-USA one. Currently Canada and the U.S. do their own thing. Product approvals in the U.S. take an average 180 days compared to 1,200 days or 3.29 years in Canada. There is no accountability for this spread. Companies are often reluctant to even inquire about their submissions, even though a six-figure fee is attached to it, for fear that it will only slow the process. This huge difference in time caused by a totally redundant system drives up costs and limits the drugs available in Canada.

With all the meat and live cattle Canada and the U.S. sell to each other wouldn’t a joint organization make sense?

The Americans are no better. Canadian cattle treated with Canadian products are consumed south of the border and vice-versa. Yet the Americans don’t allow the import of pharmaceuticals or biologicals from Canada. Even when our dollar was low and Canadian pharmaceuticals were cheaper they could not be exported to the U.S. Why do we have this double standard?

If there were safety concerns such as different withdrawal dates, it might be different, but in reality drugs that are ruled safe in the U.S., are just as safe in Canada.

Allowing Canadian veterinarians and their suppliers to access, prescribe and market these same products would level the playing field, and create a larger overall market and lessen the overall costs to the system. Otherwise pharmaceutical companies will soon stop investing in Canada and our products will have to be purchased elsewhere.

At the end of the day, producers apply all pharmaceutical products to their own animals. If I as a veterinarian purchase a product through a distributor and prescribe it to a producer that is still “own use” as far as I am concerned. By forcing pharmaceutical companies to distribute only Canadian approved products while producers can purchase U.S. products the Canadian government is being hypocritical and essentially driving this business south of the border. Generics can be licensed faster in the U.S. once a patent runs out so more of them are available making that market more competitive.

A George Morris Center study found the costs to the Canadian economy from these long delays in drug approvals were staggering in terms of lost jobs and profits in the cattle industry. All this because the federal government refuses to consider eliminating a small department and co-operating with our U.S. counterparts. This could all happen with the stroke of a pen.

These products are already being used up here under the own use provision so there is no question that they are safe. So why not grant the same products complete access to the Canadian market?

One of the big issues with licensing of products in Canada, believe it or not, is bilingual labelling. One would think conversion from English to French would be easy and require no more than a few hours work by a translator. However, translations are not that easy when it comes to medical terms and disease conditions and products in the past have been delayed simply because of these rather complicated labelling issues. This ignores the fact that the vast majority of cow-calf and fed cattle are found in Western Canada where a single English label, as is found on the U.S. products, will do quite well.

Extra French labels could simply be inserted to satisfy market areas such as Quebec where they are required. This is done now in the U.S where training documents and posters on pharmaceutical products are published in Spanish for use in southern feedlots and ranches where the majority of workers are Spanish-speaking Mexican immigrants. The same sort of thing could be done in Canada where necessary.

A solution has to be found to harmonize our two systems of approving drugs, and soon, otherwise the investment by the pharmaceutical industry in Canada will spiral down.

I can’t blame cattle producers for seeking the best deal any more than I can blame the pharmaceutical companies for trying to recoup their investment. What I do blame is a redundant government bureaucracy that drags out the approval process and makes the pharmaceutical industry uncompetitive in Canada.

For once let’s learn from the rest of the world and stop reinventing the wheel.

Dr. Lewis is a private veterinary practitioner in Westlock, Alta.

About the author

Contributor

Roy Lewis is an Alberta-based veterinarian specializing in large-animal practice. He is also a part-time technical services vet for Merck Animal Health.

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