European Ombudsman criticises European Medicines Agency over access to documents

The initial complaint to the European Ombudsman came in 2007 and was lodged by two Danish researchers who questioned the reliability and independence of analysis conducted on the drugs and sought to validate the evidence themselves. The European Medicines Agency refused access to the documents on the grounds that they contain commercially sensitive information and that disclosure would undermine the manufacturers’ interests.

During his investigation, the Ombudsman inspected all the relevant reports and protocols and concluded that they did not contained any information on the composition of the drugs and therefore could not be considered commercially sensitive. Referring to the Agency’s refusal as a "maladministration" [1], he called for the disclosure of the documents or a written explanation by 31 August 2010.

Last month, the European Medicines Agency came under similar pressure after it refused to release documents relating to a controversial acne medication: After reports that it might be linked to suicidal tendencies, an Irish citizen requested access to the drug’s clinical reports, but was refused on the basis that transparency rules do not apply to adverse reactions [2]. The Ombudsman disagreed and the Agency has until 31 July 2010 to respond or disclose the reports.