The European Medicines Agency released the adverse reaction reports related to Septrin
The European Medicines Agency (EMA) eventually followed the European Ombudsman's recommendation to release the adverse reaction reports related to Septrin, a medicine for the treatment of bacterial infections. EMA disclosed the documents after removing personal data.
The European Ombudsman, P. Nikiforos Diamandouros, welcomed the European Medicines Agency's (EMA) decision to following Ombudsman recommendation to release the adverse reaction reports related to Septrin, a medicine for the treatment of bacterial infections. The recommendation made by Diamandouros follows a complaint from a Greek law firm asked EMA for public access to a range of document. The follow-up report recently published by the Ombudsman showed that in 2010 received a positive reply from the EU institutions in 78% of cases.
The complaint was made by a Greek law firm which asked EMA for public access to a range of documents, including adverse reaction reports related to Septrin, a medicine for the treatment of bacterial infections. EMA refused, arguing that it needed to protect commercial interests. The Ombudsman’s investigation led him to conclude that the documents in question did not contain commercially confidential information, but that personal data contained in the reports needed to be removed before disclosure. EMA eventually followed the Ombudsman's recommendation to disclose the documents, after removing personal data.
Mr Diamandouros therefore welcomed 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.