The European Medicines Agency (EMA) has now closed its three-month public consultation on a draft policy for access to, and publication of, clinical-trial data.
EMA’s proposals, which envisage a tiered system of access to clinical study reports and raw trial data once the agency has published its European Public Assessment Report on an application for centralised marketing authorisation, has been challenged by industry on legal, technical and ethical grounds.
More than 150 individuals and organisations submitted over 1,000 comments during the consultation period, EMA noted. Healthcare professionals, academics and the pharmaceutical industry responded “in broadly similar numbers and together represented almost half of all contributors”.
There was also significant input from patient organisations, regulatory authorities, health-technology assessment bodies and payers, EMA said, adding: “A large proportion of respondents were individual citizens expressing their support for the EMA’s initiative to increase clinical-trial data transparency”.
The agency intends to finalise its disclosure policy before the end of the year. Pending an endorsement by the EMA Management Board at its meeting on 12 December 2013, the finalised policy will be published on the EMA website together with an overview of comments received.
The agency expects the policy to come into force on 1 January 2014. “An implementation plan is under preparation,” EMA stated.