EMA was planning that interested parties would only be allowed to access the data in a ‘view on screen only’ mode, and would not have been allowed to download, save, edit, photograph, print, distribute or transfer the information. These conditions had been criticized by the German Institute for Quality and Efficiency in Health Care (IQWiG) as making scientific analysis of study data impossible [1].

However, after EMA’s management board meeting on 12 June 2014 agreed on ‘more user-friendly amendments’ proposed by EMA Executive Director, Dr Guido Rasi. The amendments give the possibility to download, save and print trial data for academic and non-commercial research purposes.

The European Ombudsman, Ms Emily O’Reilly welcomed the change regarding on-screen access. However, the Ombudsman expressed concern that EMA had not mentioned whether there would be any change regarding the legal conditions for access to and use of data and the significant redacting of information.

The Ombudsman added that she ‘remains puzzled as to why EMA abandoned its original draft disclosure policy from 2012 and substituted it with a different draft policy, more in line with the pharmaceutical industry’s wishes.’

EMA will now adapt the wording of the policy to include practical arrangements for academic and non-commercial research users. The policy is expected to be finalized with a view to its adoption by the management board through written procedure by mid-July 2014 and will be effective from 1 October 2014.

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Reference
1. GaBI Online – Generics and Biosimilars Initiative. EMA criticized for change in data transparency plans [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 27]. Available from: www.gabionline.net/Policies-Legislation/EMA-criticized-for-change-in-data-transparency-plans

Source: www.gabionline.net