The European Medicines Agency (EMA) says it may have to delay finalising its draft policy on disclosing clinical-trial data for newly licensed medicines, citing the volume and level of detail in comments received during its public consultation on the proposals.
The three-month consultation on the draft policy, which envisages a tiered system of access to clinical study reports and raw trial data for products approved centrally in the European Union, concluded at the end of September.
More than 150 individuals and organisations submitted over 1,000 comments during the consultation period. The original aim was to finalise the disclosure policy before the end of this year, in time for the planned implementation on 1 January 2014.
The EMA now says it needs more time to review and analyse the comments in depth, “which may therefore delay the finalisation of the policy initially planned for the end of 2013”.
The agency will provide an update on timelines “at the latest” following the EMA Management Board meeting on 11-12 December 2013, it adds.
The public consultation drew input from an “unprecedented range” of stakeholders, including patients, healthcare professionals, the pharmaceutical industry, researchers, transparency campaigners, academic and public institutions, and health-technology assessment bodies, the EMA noted.
Many of these contributors “provided detailed in-depth comments, some of them substantial, some of them technical, including suggestions relating to methodological and technical aspects of the implementation of the policy”.
As part of its “collaborative approach” to developing a methodology for the release of clinical-trial data, the agency is “currently devoting attention to all comments received and reaffirms its commitment to transparency and the principles of publication and access to clinical-trial data”, it stated.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has raised a number of objections to the draft policy, in particular relating to commercially confidential information, patient privacy, informed consent, and the need for a robust review-and-appeal system before clinical-trial data are released.