Has drug regulation abandoned its public health mission?

November 14, 2002

Over the past 20 years, the pharmaceutical industry has skilfully managed to achieve an unhealthy influence over drug regulatory agencies, which may be threatening the public health needs of the European Union, according to an article in this week's BMJ.

Professor John Abraham argues that European regulatory authorities, which were initially established to provide independent scrutiny of pharmaceutical firms in the interests of public health, have been overly influenced by the industry's desire for rapid drug approvals.

He explains how the industry has undermined the credibility of regulatory agencies. As a result, agencies have become increasingly dependent on industry fees for their survival and now compete with each other for regulatory work.

This is of major concern because doctors and patients need to be able to rely on the commitment of the regulatory system in their country to put the interests of public health above the commercial interests of industry, he concludes.

These views are reiterated in the first of three accompanying commentaries. Danielle Bardelay and Christophe Kopp write: "One thing is clear: the public needs of the European Union can no longer be neglected and the regulatory agencies left to operate largely for the benefits of the drug industry."

In the second commentary, J D Kleinke argues that making drug regulation responsive to commercial interests has not put patients and the public health at risk. In the final commentary, Emma Bennion, who has Parkinson's Disease, describes how the drug she needs has suffered at the hands of the regulators.
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BMJ

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