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European regulator confirms milestone medical-data transparency rules

Clinical trial data previously kept behind closed doors is to be released to the public by Europe’s medical regulator, after a new transparency policy was finally agreed at the European Medicines Agency (EMA).

The EMA, which is responsible for licencing drugs to be sold in European Union states, has been embroiled in a long-running debate about how it could or should release information submitted by drugs companies seeking permission to market their medicines. On 2 October, the EMA management board approved a new policy that will see it pro-actively publish clinical reports submitted to the agency in support of marketing authorisation from 1 January.

Guido Rasi, the executive director of the EMA, said the policy “sets a new standard for transparency in public health and pharmaceutical research and development” and would provide an “unprecedented level of access to clinical reports”.

This policy has been subject of fierce debate since it was first proposed, with transparency campaigners claiming the EMA was not being bold enough, and that pharmaceutical companies had previously been able to manipulate perceptions about the effectiveness of their drugs by choosing to conceal data that might paint them in a bad light. And industry has feared that commercially sensitive information would be released, and this could compromise their long-term ability to invest in research.

A key change from earlier versions of the policy is that researchers, and other members of the public, will now be able to download data. It had previously been suggested they might only be allowed to view clinical reports on screen, limiting their ability to reanalyse the huge datasets collected by pharmaceutical companies in clinical trials.

Concerns have also been raised about confidentiality, and the possibility that it might be possible to identify some individuals from the patient data in these clinical reports, particularly in the cases of rare diseases. In future the EMA will make data down to the level of individual patients available, but it wishes to consult further about how it can do this while protecting privacy.

Companies will also be able to request that parts of their data do not go into the public domain if they consider them to be ‘commercially confidential’. This has already been criticised by some transparency campaigners, but the EMA insists it will have the final say on what is redacted, and the assumption will be that information is not commercially confidential.

Information held by the agency from pre-2015 company submissions will be available under an existing policy where researchers can request access, but it will not be placed in the open.


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