Newspaper article The Canadian Press

Should Health Canada Rely on Foreign Assessment of New Drugs?

Newspaper article The Canadian Press

Should Health Canada Rely on Foreign Assessment of New Drugs?

Article excerpt

Should Health Canada rely on foreign assessment of new drugs?

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This article was originally published on The Conversation, an independent and nonprofit source of news, analysis and commentary from academic experts. Disclosure information is available on the original site.

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Author: Joel Lexchin, Professor Emeritus of Health Policy and Management, York University and Associate Professor of Family and Community Medicine, University of Toronto

Health Canada is proposing a new way of allowing certain drugs that Canadians need into the country.

Instead of conducting a detailed review of the evidence -- to make sure the product meets acceptable standards for safety, efficacy and quality of manufacturing -- the regulator would rely on decisions made by drug regulators in a small number of other regions, including the United States and Europe.

In a notice about this proposal, Health Canada explicitly states that it would only "conduct a cursory clinical review of the submission package."

These are drugs that are on an "urgent public health needs" list, particular formulations for children, the elderly and those made available to individuals with serious or life-threatening conditions through Health Canada's Special Access Programme.

They are drugs that would not otherwise make it onto the Canadian market. Usually, this is because the company making the product doesn't think enough people will use the drug to justify the cost of getting it through the regulatory system and then marketing it.

Is this a good idea? Should Canada rely on what regulators in the United States or Europe have to say about drugs?

On the surface it seems fine. The standards these countries use are comparable to those in Canada. But there are some issues that Health Canada's announcement does not address, and some information that raises serious questions about this proposal.

Increased exposure to harms

One study from the U.S. has examined what would happen if a policy similar to Health Canada's was adopted there.

The study lists 110 new drugs that were approved in Europe and/or Canada before the United States between 2001 and 2010. A number of those drugs had been examined by the U.S. Food and Drug Administration and rejected for safety reasons. Two of the drugs approved in Europe were subsequently withdrawn because of unacceptable side effects.

The conclusion of the study was that "reciprocal approval legislation would most likely benefit only a small number of U.S. patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms. …

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