Making regulation responsive to commercial interests: streamlining drug industry watchdogs

Has the pharmaceutical industry skilfully managed to achieve an unhealthy influence over European drug regulatory agencies?

New prescription drugs are developed and tested for quality, safety, and efficacy by the pharmaceutical industry, and little or no drug testing is conducted by governments in modern industrialised countries. Governments have regulatory authorities which have a legal duty to protect public health by ensuring that new drugs are not licensed unless they are of adequate quality, safety, and efficacy (box 1). The thousands of birth deformities and deaths caused by thalidomide focused public and professional concerns on how the commercial interests of pharmaceutical companies may diverge from, or conflict with, the interests of patients and public health. The reasoning behind the creation of new government regulatory authorities in the post-thalidomide era was therefore that they should be “entirely independent” of the commercial interests of the pharmaceutical industry and should act on behalf of the public interest by checking the adequacy of the test data produced by the industry.1^–3 I explain how these government regulatory authorities in the European Union, which were initially established to provide independent scrutiny of pharmaceutical firms in the interests of public health, have become increasingly responsive to the commercial interests of the industry (box 2).