The European Medicines Agency will release adverse reaction reports

The European Ombudsman has welcomed the announcement of the European Medicines Agency (EMA) accepting to release documents about adverse reactions related to a drug used to treat acne. This announcement follows the recommendations made in the framework of one of the Ombudsman's inquiry.

In April 2008, an Irish citizen asked the European Medicines Agency (EMA) for the release of reports concerning suspected adverse reactions to one drug, because his son had committed suicide after taking it. The European Medicines Agency, which approves and monitors medicines placed on the EU market with a view to protecting public health, initially refused access arguing that EU transparency rules do not apply to adverse reaction reports.

Following his investigation into the Irish citizen's complaint, the European Ombudsman concluded that EU rules on access to documents apply to all documents held by EMA and he, therefore, recommended that EMA review its refusal. He also suggested that, as part of a proactive information policy, EMA could provide additional clarifications to make it easier for the public to understand such data and their significance.

EMA accepted the Ombudsman's recommendation to give access to the documents by announcing the release of the adverse reaction reports.

Transparency in the European Union and access to public information

Nearly two decades ago, in the Treaty of Maastricht, the European Union recognised that transparency (or openness) helps to build and maintain public trust in the institutions and strengthens their democratic nature. Subsequent developments include the recognition of public access to documents as a fundamental right of Union citizenship, guaranteed by the Charter of Fundamental Rights and by the Treaty on the Functioning of the Union. This right empowers citizens to monitor and scrutinise effectively the exercise of the powers vested in the institutions.

There are two ways of putting the principle of transparency into effect in relation to public access to documents and information. The first is to react to requests for access. The second is to be proactive in putting material into the public domain. The reactive and proactive approaches are complementary and reinforce each other. They are not alternatives, except in the sense that it is unnecessary to request access to something that is already in the public domain.