Reports of possible lethal side effects of a medicine for bacterial infections, have been released by the European Medicines Agency (EMA). This is a second victory for transparency on medicine control, won by the European Ombudsman P. Nikiforos Diamandouros.

EMA, a London based EU-agency has accepted to release reports to a Greek law firm of adverse reactions to Septrin, a medicine for the treatment of bacterial infections.
The decision follows a recommendation by the European Ombudsman who has made an investigation of 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,” says Marleen Teugels, a Belgian reporter who previously experienced problems with getting data from the EMA.

The Ombudsman P. Nikifouros Diamandouros, commented in a press release:
”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.”

Although targeted to a law firm in a specific legal case the decision to release the reports has broader implications:
* The present EU-rules for access to documents (regulation 1049/2001) applies to the content of the EudraVigilance database, held and administrated by the EMA.
* Data stored in EudraViligance constitute ”documents”
* It does not impose a disproportionate administrative burden for the EMA to provide the requested access.

 These conclusions were already drawn in a draft recommendation by the Ombudsman in 2010, related to another, but similar case concerning reports of side effects of Roaccutane, an anti-pimple medicine. The investigation in the Roaccutane case is yet to be concluded.
In the Septrin case the agency advocated that the reports contained commercially confidential information, and should thus not be disclosed. It was also argued that the reports should be withheld due to data protection rules. And finally the agency argued that it was the applicant who had to prove that there was an overriding public interest in access.
The Ombudsman rejected two of these three claims:

 * It was not obvious that commercial interests were at stake, and this was anyway not shown by the agency.
* The agency has itself an obligation to consider a possible overriding public interest, the Ombudsman said.
As for data protection it was suggested that the names of natural persons and data related to natural persons could be blanked out.

The applicant had no objection to this solution.

 Besides having successfully convinced the EMA to change its attitudes and behaviour the Ombudsman has also strengthens his own role as a guardian of transparency, argues Brigitte Alter, co-editor of this website.
With Belgian Marleen Teugels, and Dutch reporter Joop Bouma, Brigitte Alfter wobbed out information under national legislation in a Danish-Dutch-Belgian team in 2008.
However while Denmark and the Netherlands opened the reports following wob-requests, Marleen Teugels had difficulties getting access to documents on national level in Belgium and documents held by EMA.
“Now all citizens in Europe have the same conditions,” Alfter and Teugels notes.

 ”These reports on side-effects are the only control tool of the public once a medicine is on the market. Of course they may not be kept secret – and the Ombudsman fortunately confirms that. This decision will hopefully allow journalists on behalf of European patients to focus on actually reporting about the content, rather than spending a lot of time on trying to get access to key-information, as we had to do previously,” Brigitte Alfter concludes.
”Transparency in Europe is a delicate matter, because there are so many different traditions. However these different traditions should not be allowed to bring patients in danger. This is important to journalists as the Ombudsman provides a non expensive help where as it can cost a fortune to take EU-cases to court if you loose,“ the two reporters agree.

Staffan Dahllöf