Summary: European legislation regulating the marketing authorisation of medical products states that results from clinical trials that do not meet the ethical requirements of Good Clinical Practice, cannot legally be used by an applicant to justify its application, irrespective of whether the trial was done inside or outside the EU. However, earlier studies indicate that this legislation is not always properly observed: these studies identified trials with an unethical design that were part of approved EU marketing applications. Clinical trials that are no longer accepted by Western European ethics committees are approved by the local ethics committees in countries like India, China, Argentina and Russia. Once officially approved by an ethics committee, there are no obstacles to including the trial in the technical dossier of a marketing application. In particular the ethical principles which are of utmost importance for developing countries, as reflected in the Declaration of Helsinki, are ignored by companies and regulatory authorities. The main objective of this paper is to provide the European Parliament with concrete recommendations, both at legislative and enforcement level, aimed to guarantee that trials conducted in third countries are done so in conformity with EU and international ethical standards. [...]
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