The agency said it will wait until its October 2 meeting to further clarify wording and practical arrangements, though Board members “have confirmed their general support to 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.
Rasi’s recommendations represent an about face from the agency’s previous moves to keep data relatively restricted, which was previously a sticking point for the EU ombudsman.
The EMA in May seemed to be cowering to industry pressure and shifting away from increased transparency, saying that it would only allow data to be seen via an interface provided by the agency. But since then, the agency has investigated more user-friendly ways for users to view the data, which has drawn accusations from industry and the US Chamber of Commerce that the efforts might discourage pharma R&D.
The US CoC specifically took issue with the fact that commercially confidential information could not only go public in the EU, but also on an international level, which could spur copycats from foreign countries that seek to replicate the transparency efforts, the CoC contends.
Delays
This latest delay comes as the EMA’s 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. And over the last year, the EMA says it has tried to balance proactive data disclosure with the need to protect patient data and commercially confidential information.
The new clinical trial regulation will become applicable in 2016 at the earliest and will apply only to clinical trials conducted in the European Union.
“The Agency 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,” the EMA said.