European Medicines Agency releases adverse reaction report

European Ombudsman Nikiforos Diamandouros has welcomed the European Medicines Agency's release of adverse reaction reports related to Septrin (co-trimoxazole), a now off patent drug for the treatment of bacterial infections originally developed by Glaxo Wellcome. This follows a complaint from a law firm, whose request for access to these reports had been refused. EMA eventually followed the Ombudsman's recommendation to release the adverse reaction reports.

The Ombudsman stated: "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."

A Greek law firm asked EMA for public access to a range of documents, including adverse reaction reports related to Septrin. The 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.