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European regulator is ordered not to release clinical study documents

BMJ 2013; 346 doi: (Published 02 May 2013) Cite this as: BMJ 2013;346:f2846
  1. Zosia Kmietowicz
  1. 1BMJ

Europe’s medicines regulator has said that it remains committed to transparency despite an order from a European court telling it not to release documents it holds on the safety and efficacy of drugs made by two pharmaceutical companies.

Campaigners for full transparency of clinical trial data have condemned the ruling, saying that there is no justification for withholding information that would allow patients to make fully informed decisions about the medicines that they take. One called the decision “a disgrace” and “absurd.”

The United States company AbbVie took out an injunction against the European Medicines Agency (EMA) earlier this year to stop it from releasing detailed information it held on its drug Humira (adalimumab) for rheumatoid arthritis.1 …

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