Reports of possible lethal side effects of a medicine for bacterial infections were released by the European Medicines Agency (EMA). It marked a second victory for transparency on medicine control, won by the European Ombudsman, P. Nikiforos Diamandouros.
The Septrin reports released
EMA, a London-based EU agency, agreed to release to a Greek law firm reports of adverse reactions to Septrin, a medicine used to treat bacterial infections. The decision followed a recommendation by the European Ombudsman, who had investigated the case. "Hopefully the EMA in the future will be more easily inclined to release information. This could be a breakthrough for journalists wishing to report about the side effects of medications," said Marleen Teugels, a Belgian reporter who had previously experienced problems obtaining data from EMA. In a press release the Ombudsman commended the progress EMA had recently made in improving the transparency of its work, saying such improvements would ensure that citizens had greater trust in the agency, increasing both its legitimacy and its effectiveness in its important public-health work.
Broader implications
Although targeted at a law firm in a specific legal case, the decision to release the reports had broader implications. The existing EU rules for access to documents (regulation 1049/2001) applied to the content of the EudraVigilance database, which was held and administered by EMA; the data stored in EudraVigilance constituted "documents"; and providing the requested access did not impose a disproportionate administrative burden on the agency.
These conclusions had already been drawn in a draft recommendation by the Ombudsman in 2010, relating to another, similar case concerning reports of side effects of Roaccutane, an anti-acne medicine. The investigation in the Roaccutane case had yet to be concluded.
The agency's arguments rejected
In the Septrin case the agency argued that the reports contained commercially confidential information and should therefore not be disclosed; that they should be withheld under data-protection rules; and that it was for the applicant to prove that there was an overriding public interest in access. The Ombudsman rejected two of the three claims: it was not obvious that commercial interests were at stake, and this had in any case not been shown by the agency; and the agency itself had an obligation to consider a possible overriding public interest. As for data protection, it was suggested that the names of, and data relating to, natural persons could be blanked out — a solution to which the applicant had no objection.
A wider win for reporters
Besides convincing EMA to change its attitude and behaviour, the Ombudsman also strengthened his role as a guardian of transparency. In 2008, Danish journalist Brigitte Alfter, Belgian reporter Marleen Teugels and Dutch reporter Joop Bouma had obtained side-effect information under national legislation, working as a Danish-Dutch-Belgian team. While Denmark and the Netherlands opened the reports following requests, Teugels had had difficulty getting access at national level in Belgium and to documents held by EMA; with the new decision, Alfter and Teugels noted, all citizens in Europe now had the same conditions. Alfter argued that the reports on side effects were the only control tool available to the public once a medicine was on the market, that they should not be kept secret — which the Ombudsman had confirmed — and that the decision would allow journalists acting on behalf of European patients to focus on reporting the content rather than spending time trying to obtain key information, as had previously been necessary. The two reporters agreed that transparency in Europe was a delicate matter, because there were so many different traditions, but that those traditions should not be allowed to put patients in danger; they noted that the Ombudsman provided inexpensive help, whereas taking EU cases to court could cost a fortune if a case was lost. The broader principle that the public has a right to know is examined in what EU judges told the public about its interest in knowing.
Frequently asked questions
What did the European Medicines Agency agree to release?
It agreed to release to a Greek law firm reports of adverse reactions to Septrin, a treatment for bacterial infections, following a recommendation by the European Ombudsman.
Why did the decision matter beyond the single case?
The Ombudsman found that regulation 1049/2001 applied to the EudraVigilance database, that its stored data counted as "documents", and that disclosure was not a disproportionate burden — conclusions with implications for future access requests. For background, see how to use European freedom-of-information laws.
Which arguments by the agency did the Ombudsman reject?
He rejected the claims that commercial confidentiality was at stake, which the agency had not shown, and that the applicant had to prove an overriding public interest, since the agency itself had a duty to weigh that interest; personal data could be blanked out.