Concerns remain over EMA proposals on access to clinical trial data | PJ Online 2014-06-27


"The European Medicines Agency (EMA) has altered its draft policy on access to clinical trial data after the European Ombudsman complained that recent changes had made the policy too restrictive. The agency had proposed that researchers and the wider public should have access to an 'on-screen only' version of clinical trial data, preventing the printing, distribution or circulation of the information.  But Emily O’Reilly, the ombudsman, wrote to the EMA’s director, Guido Rasi, saying the restrictions on data undermine a 'fundamental right of public access to documents established by European Union law'. The EMA has now indicated that it intends to make changes to its draft policy to allow the possibility of downloading documents for academic and non-commercial research purposes. However, O’Reilly is still concerned that the EMA has imposed broad legal conditions on the access to and use of data and that it will allow only limited access to clinical trial data by redacting significant information. In a statement, she says: 'The Ombudsman 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.' The European Association of Hospital Pharmacists has also written to the EMA board expressing concerns about the proposals ..."


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Tags: oa.comment oa.ema oa.europe oa.clinical_trials oa.policies oa.medicine oa.biomedicine oa.pharma

Date tagged:

06/27/2014, 06:49

Date published:

06/27/2014, 02:49