The European Ombudsman has welcomed the European Medicines Agency (EMA)’s release of adverse reaction (AR) reports related to the combination antibiotic Septrin (co-trimoxazole).
The move follows a complaint from an employee of a Greek law firm, who had asked EMA on September 21 2007 for public access to a range of documents including AR reports connected to Septrin and, specifically, for information “on the negative effect to human health related to Septrin as noted in the last 10 years.”
The Agency replied to him on September 27 2007, refusing to grant such access on the grounds that it needed to protect commercial interests, and it confirmed this decision in November after the complainant appealed the original decision.
He then took his case to the Ombudsman, P Nikiforos Diamandouros, whose investigation of the issues 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.
During 2010, Mr Diamandouros had criticised the EMA twice for failing to provide European Union (EU) citizens with access to documents in its possession, In May, he called on the Agency to reconsider its refusal to provide an Irish citizen with information on suspected ARs associated with Roche’s acne treatment Roaccutane (isotretinoin), which the EMA said was based on its belief that EU transparency rules did not apply to reports of serious ARs.
Then in June 2010, the Ombudsman criticised the Agency for rejecting a 2007 request by Danish researchers for clinical study reports and trial protocols relating to the obesity drugs orlistat (Roche’s Xenical and GlaxoSmithKline’s over-the-counter product Alli) and rimonabant (Sanofi’s now-withdrawn Acomplia). Providing this information would undermine the commercial interests of the drugs’ manufacturers, the Agency had said.
At the end of 2010, the EMA adopted a new policy which it said would provide the public with wider access than ever before to documents in its possession related to medicines for human and veterinary use.
The Agency added however that it would ensure that personal data and commercial confidential information would remain adequately protected, and that, as a general rule, it would release documents once a procedure concerning a medicine had been finalised, in order to protect the decision-making process.
Commenting last Friday on the long-running Septrin case, the Ombudsman said: “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.”
