European Ombudsman tells EMEA to review refusal to release reports on adverse drug reactions; Council adopts animal research legislation

The European Ombudsman, Nikiforos Diamandouros, has called on the European Medicines Agency (EMEA) to reconsider its refusal to give access to documents related to a drug used to treat severe forms of acne.

The complainant, an Irish citizen, specifically asked for reports on suspected adverse reactions to the drug, such as reactions giving rise to suicidal tendencies. The EMEA refused access, arguing that European Union transparency rules do not apply to adverse reaction reports. The Ombudsman did not agree. In his view, the EU transparency rules apply to all documents held by EMEA.