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Image header Agence Europe
Europe Daily Bulletin No. 10525
Contents Publication in full By article 15 / 25
SECTORAL POLICY / (ae) health

EMA sheds light on adverse effects of Septrin

Brussels, 05/01/2012 (Agence Europe) - On Thursday 5 January, European Ombudsman Nikiforos Diamandouros hailed the fact that the European Medicines Agency (EMA) had released adverse reaction reports related to Septrin, a medicine for the treatment of bacterial infections. This followed a complaint from a law firm, whose request for access to the reports had been refused for reasons pertaining to the protection of commercial interests. Further to an inquiry, the Ombudsman said that EMA should unveil the documents in question, as they did not contain confidential commercial information, but that personal data contained in the reports needed to be removed before disclosure. This was effectively done by EMA. “I commend the important progress that EMA has recently made in improving the transparency of its work. Such improvements ensure that citizens will have greater trust in EMA, thus increasing both its legitimacy and its effectiveness in carrying out its important work in the field of public health”, Diamandouros said. (IL/transl.jl)

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