EMA releases new document disclosure policy

The European Medicines Agency (EMA) has endorsed a new policy on handling written requests for access to its scientific documents.

Faced with criticism from the European Ombudsman over a lack of openness, the European Medicines Agency (EMA) has endorsed a new policy on handling written requests for access to its scientific documents. The details should be released next month (November) and come into force immediately.

‘This policy takes into account the outcome of the EMA public consultation and recommendations made by the European Ombudsman and will ensure the widest possible access to EMA documents,’ EMA said.

However, the agency warned that there would be no automatic release of requested material. ‘Some documents or part of them may have to be redacted prior to disclosure, to protect commercially confidential information and personal data,’ it said.

EMA added that when it responded to requests for access to documents, it would apply the principle of proportionality to avoid jeopardising the performance of the agency’s core tasks.

The move follows calls for more openness from