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European drug agency backtracks on plan to give researchers access to clinical trial reports

BMJ 2014; 348 doi: (Published 21 May 2014) Cite this as: BMJ 2014;348:g3432
  1. Ingrid Torjesen
  1. 1London

The European Medicines Agency has watered down its plans for allowing public access to clinical trial reports as part of its drive towards greater transparency, angering researchers and the European ombudsman.

A document on the draft terms of use for access to clinical trial reports, seen by The BMJ and set to be endorsed by the agency’s management board on 12 June, says that trial reports, instead of being published proactively by the agency, will be available only to registered users. Furthermore, these users would be able to view the information only in a “view on screen only” mode, using an interface provided by the agency, and will not be permitted to “download, save, edit, photograph, print, distribute, or transfer the information.”

In addition, the draft terms impose strict confidentiality requirements and wide restrictions on the use of the data.

A further draft document on redaction principles, also seen by The BMJ, outlines the range of information that the EMA would be able to withhold “where disclosure may undermine the economic or competitive position of the owner of the information.”

The agency’s change …

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