Healthy Skepticism Library item: 20547

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Abbasi K, Herxheimer A
The European Medicines Evaluation Agency: open to criticism
BMJ 1998 Oct 3; 317:(7163):898-900
http://www.bmj.com/content/317/7163/898

Abstract:

The European Medicines Evaluation Agency has been in existence since 1995 and has authorised the marketing of 62 drugs in the European Union.1 Now fully operational, the agency has furthered its ambition of transparency by starting a public dialogue with the International Society of Drug Bulletins. Rather than quell fears about the agency’s activities, however, a recent meeting of the two bodies in London raised a further set of questions about both transparency and rigour.

Although the licensing decisions of national bodies like the Medicines Control Agency in the United Kingdom remain secretive, the European Medicines Evaluation Agency produces a European public assessment report, which attempts to increase openness by outlining the reasons for each licensing decision.2 Concerns, however, surround the rigour of the agency’s appraisal of applications for drug licences and the extent to which it is prepared to withhold information from the public that it has been persuaded to treat as …