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Clinical trials

Concerns remain over EMA proposals on access to clinical trial data


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. Its president Roberto Frontini said: “Transparency is needed for the purposes of scrutiny.

“We hope the agency will listen to what the European Ombudsman and stakeholders are saying: the transparency policy should go further.”

Ben Goldacre, physician, scientist and author of Bad Science and Bad Pharma, has also joined the debate. In a guest post on the USvsth3M blog he urged users to complain to Paola Testori, head of the European Commission’s directorate for health and consumers, which oversees the EMA.

He described the EMA’s proposals as an “affront to evidence-based medicine” which puts lives at risk. “They fly in the face of changes to EU legislation … exposing the regulator to justified mockery.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065541

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