EMA releases new document disclosure policy
Says it will ensure widest possible access to 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 Ombudsman Nikiforos Diamandouros in two similar cases. In one, an Irish citizen had asked for reports concerning suspected adverse reactions to an acne drug. EMA had initially refused access, arguing that EU transparency rules do not apply to adverse reaction reports, but the Ombudsman did not agree. EMA later released the reports.