HEALTH : MEDICINES AGENCY WIDENS ACCESS TO DOCUMENTS.

• Position: European Medicines Agency

The European Medicines Agency (EMA) had adopted a policy of making documents in its possession more accessible, it announced on 1 December 2010. The policy statement details the principles and terms for access to documents related to medicines for human and veterinary use.

"There is a need to establish an EMA policy on access to EMA documents in order to build a more robust system, capable of handling in a more efficient and consistent way increasing demands for access to a wide variety of EMA documents, hence facilitating the day-to-day operation of public access to EMA documents," reads the policy statement.

The EMA will from now on work from the principle that all documents in its possession must be published once the procedure concerning a medicine has been finalised, to "protect the decision making process". Documents submitted to the agency as part of a marketing authorisation application, such as clinical trial reports, can now also be released.

Certain special cases will nevertheless justify non-disclosure: the need to respect arrangements with non-EU regulators or international organisations, or to protect the privacy and integrity of a natural or legal person. In case of documents for which only parts cannot be disclosed, the agency proposes to protect the personal data and confidential commercial information and to release only the...