Is EMA Back-Tracking on Open Data Promises?

Published on: May 20, 2014

Applied Clinical Trials

Concerns are emerging among researchers that the European Medicines Agency is not following through with its pledge to open clinical trials data to public scrutiny.

Concerns are emerging among researchers that the European Medicines Agency (EMA) is not following through with its pledge to open clinical trials data to public scrutiny. Draft documents containing details about how the agency plans to make data available contains small print that may severely limit access and that constitutes a turnaround from earlier promises for openness, according to a report published on May 19 by ScienceInsider.

For example, the plan stipulates that registered users would only be allowed to view trial information on screen, making it more difficult to analyze data, and they would not be permitted to download, save, edit, photograph, print, distribute or transfer the information.

“This is a stunning and surprising reversal,” according to Tom Jefferson, a reviewer at the Cochrane Acute Respiratory Infections Group in Rome, and Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy in Baltimore and associate editor at BMJ.

The European ombudsman, Emily O'Reilly, has echoed these worries, noted the ScienceInsider report. “I am now concerned about what appears to be a significant change in EMA's policy, which could undermine the fundamental right of public access to documents established by EU law,” she said, adding that EMA did not make the documents public but shared them with representatives of patients, consumers, health care professionals, the pharmaceutical industry, academia, and medical journals a part of targeted discussions to finalize the draft policy.

Researchers have also expressed concerns that some data in clinical study reports may be blacked out. Although EMA says that much of the information in the reports is not commercially confidential, the draft policy does list a series of items that may be redacted before the data is shared. This could be necessary in the case of novel statistical or other analytical methods, as well as results about potential off-label uses of medicines, say the draft redaction principles.

According to ScienceInsider, EMA spokesman Martin Harvey-Allchurch denies that the agency is reneging on its promises. “We're not going backwards,” he said. “It's about facilitating access.” He stressed that the plans are still open for discussion before EMA presents the revised draft policy to its managing board on 12 June.