Further discussion required on wording and practical arrangements
The European Medicines Agency's (EMA) Management Board has postponed the formal adoption of its policy on publication of clinical trial data to its meeting on 2 October.
Further clarifications on wording and practical arrangements will be discussed by Board members, who 'have confirmed their general support of the overall aims and objectives of the policy', including the more user-friendly amendments proposed by EMA Executive Director Guido Rasi that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes.
Further to the agreement reached with the European Commission in accordance with Article 80 of Regulation (EC) No 726/2004, the Board 'was not able to conclude on the final wording of the policy through a written procedure'. Members of the Board have offered additional contributions which will now be considered and addressed in the next few weeks, the Agency says.
The Agency also acknowledges the complexity of the debate on both political and technical aspects which have emerged during the previous general and more targeted consultation phases. Over the last 12 months, the Agency says it has tried to strike a balance between proactive data disclosure and the need to protect personal data and commercially confidential information.
The EMA management remains committed to introducing this additional measure towards transparency as soon as possible.
The new clinical trial Regulation (EC) No 536/2014 will become applicable in 2016 at the earliest and will apply to only clinical trials conducted in the European Union.
The Agency says it will continue to work with the Management Board and the European Commission ahead of the 2 October meeting to ensure that members receive the clarifications requested and to facilitate the adoption of the policy.