European Medicines Agency widens public access to documents

The European Medicines Agency (EMA) yesterday published its new policy on access to documents related to medicines for human and veterinary use. The new policy is part of the Agency's response to increasing public demand for more openness and transparency. It will give wider access than ever before to documents held by the Agency, while it ensures that personal data and commercial confidential information remain adequately protected.

The decision to do so also follows a request from European Ombudsman Nikiforos Diamandouros for the Agency to review its policy after it refused to give access to documents related to a drug used to treat severe forms of acne which was linked with a rise in suicidal tendencies (The Pharma Latter May 12). At that time, the EMA 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 EMA.

"Openness and transparency are enshrined as fundamental values in the Agency's regulatory framework," says Noel Wathion, head of patient health protection at the EMA. "They allow our stakeholders to understand the basis for the Agency's scientific decision-making and provide for the basis on which patients and health care professionals can have confidence in our opinions and information relating to medicines."