European Medicines Agency pledges to publish clinical reports

The European Medicines Agency, after widespread pressure from scientists and the public, will soon publish the clinical reports that underpin market authorisation requests for new drugs.

The decision, taken unanimously by the agency’s management board on 2 October, is part of its more proactive policy on transparency. It will apply to all centralised marketing authorisations submitted after 1 January 2015.

Announcing the commitment, Guido Rasi, the agency’s executive director, said, “The adoption of this policy sets a new standard for transparency in public health and pharmaceutical research and development. This unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia, and industry.”

The policy overturns the agency’s previous insistence that clinical data would be made available through a read only format that could be viewed only on screen, making it hard to digest, process, and share large volumes of complex information.1 Under the new arrangements the data may be downloaded, printed, and saved.2

The agency has insisted that the reports may not be used for commercial purposes. Although it maintains that their contents do not normally contain commercially confidential information, it retains the right to redact elements if it agrees with a company’s arguments for doing so. The agency also plans to make individual patient data available, after first consulting widely on how to protect the privacy of the individuals involved.

Campaigners for greater transparency have welcomed the policy change but believe it does not go far enough. Carl Heneghan, director of the Centre for Evidence Based Medicine at Oxford University and a cofounder of the AllTrials campaign (www.alltrials.net), described the announcement as “a major step forward” that represented a “real shift in favour of ensuring research is shared routinely and reused effectively in the public interest.” However, he said that clinical study reports (CSRs) for all drugs in use today should also be made available, including those submitted before 1 January 2015.

Ben Goldacre, another cofounder of the AllTrials campaign and author of Bad Science, emphasised the point. He said, “The EMA [European Medicines Agency] records are woefully incomplete for informed decision making. The EMA only holds CSRs for a small proportion of all the trials done on all medicines we use today. We need a radical overhaul giving retrospective transparency on all CSRs from industry and clear transparency on methods and results from all trials done by academics.”

The European Federation of Pharmaceutical Industries and Associations, while pointing out that its member companies were already committed to sharing study results with the public and individual patient data with researchers, gave the commitment a cautious welcome. “The new policy appears to strike a more appropriate balance between enhancing data sharing, whilst protecting patient privacy and commercially confidential information,” it said in a statement.

Emily O’Reilly, the European Union ombudsman, who is making transparency in European public administration a key theme of her tenure, welcomed the agency’s commitment. “This is an important step towards ensuring the transparency that is vital in order to build and maintain citizens’ trust in the reliability of the EU’s system of making sure that the medicines placed on the market in the EU are safe and effective,” she said.

However, O’Reilly confirmed that she would continue to investigate how the European Medicines Agency dealt with requests for access to documents in the past, to determine whether it was justified in redacting certain information. She is also examining in detail whether the terms to which users are required to sign up before gaining access to documents published by the EMA are justified.