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European drug agency’s attempts to improve transparency stalled by legal action from two US drug companies

BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3588 (Published 03 June 2013) Cite this as: BMJ 2013;346:f3588
  1. Clare Dyer
  1. 1BMJ

The European Medicines Agency (EMA) has been forced to put its move to greater transparency on hold in the light of legal advice, after it was taken to court by two US based pharmaceutical companies.

The agency is refusing requests for the release of trial data on drugs that have gone through the approval process after lawyers advised that its general policy of openness could expose it to more legal actions from other companies.

The advice follows an interim injunction in April from the general court of the European Union, ordering the agency not to release clinical study reports on products from two US drug companies, AbbVie and InterMune, pending a hearing …

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