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Germany opposes EU plans for regulating clinical trials owing to lack of ethical standards

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e6640 (Published 02 October 2012) Cite this as: BMJ 2012;345:e6640
  1. Annette Tuffs
  1. 1Heidelberg

The German Medical Association, several German members of parliament (MPs), and the German pharmaceutical industry have criticised the European Union’s (EU) plans for a new directive on clinical drug trials because they exclude the current ethical standards for safeguarding patients’ health.

The EU directive aims to speed up clinical drug trials by streamlining procedures in the 27 member states.

The main criticisms are that the proposals do not include the obligatory involvement of an ethics committee for approving a clinical trial, and that once a member state has taken over leadership in a clinical trial, other member states have no say …

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