The central EU drugs regulator, the European Medicines Agency, has taken a major step forward in its policy to publish clinical data. In a move that anticipates the introduction of the transparency provisions in the new Clinical Trials Regulation (discussed here), the EMA will publish selected data in support of drug approval applications that are filed from January 2015 onwards.
Transparency is a central plank of the new clinical trials regime. But that will not be adopted until May 2016 or later to allow for development of the new EU Portal. Meanwhile, the EMA has been consulting widely to implement an earlier move toward transparency with the twin objectives of increasing public trust in the system and enabling independent analysis of the data. Its new policy brings in the first phase of publication.
The new rules will apply to new applications for central marketing approval made from the start of next year. Once a decision on whether to approve the medicine for marketing has been reached, the clinical reports will be made public. A later date is relevant for applications for line extension or extension of indications - those filed from July 2015 will fall within the new regime.
Announcing the move, Guido Rasi, EMA Executive Director said “The adoption of this policy sets a new standard for transparency in public health and pharmaceutical research and development. This unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia and industry.”
Reaching this point has not been easy. An analysis of the public consultation outcomes shows that key industry concerns were the disclosure of commercially confidential material and protection from unfair commercial use, while researchers objected to proposed limits on accessing the data.
The EMA has accepted that allowing competitors to piggyback on the research efforts of drug companies would be unfair, and the policy deals with redaction to remove confidential material. The applicant will have to identify the material it considers to be confidential and explain why (for example, revealing details of assays not known to competitors, or disclosing details of regulatory strategies). But the final decision on redaction will be carried out by EMA staff, and the policy kicks off that debate by saying that "generally the information contained in clinical reports should not be considered [commercially confidential information]".
The EMA is currently consulting on making available individual patient data. Given EU sensitivities around the personal data of individuals, this promises to be an even trickier task.