The European Medicines Agency (EMA) is coming under increasing pressure over what critics claim is a U-turn in its approach to handling the charged issue of clinical trial data transparency.

In a statement issued to BioWorld Today on Friday, the European Ombudsman Emily O'Reilly, the European Union's public interest watchdog, said she was not satisfied with the EMA's response, which it issued last Thursday, in response to concerns she had raised on May 13. "It does not give an answer to the key question of why EMA has changed its policy in a way that does not give effect to the fundamental citizens' right of public access to documents," she stated.

Also on Friday, Germany's health technology assessment agency, the Cologne-based Institute for Quality and Efficiency in Health Care (IQWIG), which has participated actively in the EMA's policy development process, published a damning commentary in the British Medical Journal (BMJ) Friday, suggesting the EMA's data transparency initiative may now amount to no more than a "placebo intervention."

The criticism follows the circulation earlier this month of proposals – as yet unpublished – that would reverse the EMA's position on treating clinical trial data on an open-access basis. The three coauthors, all IQWIG officials, stated: "In our opinion, the data sharing model now suggested by EMA is jeopardizing what could have been a major improvement in health care. We call on EMA to return to the approaches outlined in the initial draft policy on data transparency."

A major bone of contention is the EMA's proposal to limit researchers' access to clinical study reports (CSRs) to "view-on-screen only" mode. This represents a major shift from the EMA's draft policy, published in June 2013. That document stated that, in the absence of personal data protection concerns, all clinical trial data and documents are "open access" and that "such data will be available as downloads from the agency's website, at the time of publication of the European Public Assessment Report (EPAR) for positive decisions, negative decisions or withdrawals."

The ombudsman said she "remains disappointed that EMA has clearly stepped back from enabling independent review of the evidence used by them in an analyzable format. The restrictive 'look-but-don't-touch' approach to allow researchers to view the data on screen only does not meet the standards of transparency expected in today's world."

"Independent researchers," she continued, "need to be able to download, save, print and be able to re-use the data. Furthermore, the restrictions and legal warnings placed around the usage of the new approach places hurdles so high, as to make it near meaningless."

IQWIG has conducted in-depth, quantitative analyses of the value of CSRs to its own work in weighing up the benefits and harms of different drugs. In terms of supplying complete information on both methods and on patient outcomes, CSRs are far superior to both journal papers and registry reports, its officials stated in the BMJ paper. It is also critical of the EMA's plans to redact parts of the CSRs on commercial confidentiality grounds, which, they stated, could run counter to the European Union's new rules on clinical trials. IQWIG is also critical of restrictions on the use of trial data not directly used to support a label claim, on the grounds that this will hamper comparative effectiveness research and health technology assessments.

Whatever provisions on proactive data release the new policy will contain, they will be additional to the existing practice of releasing clinical trial documents, including CSRs, on request, once an applicant can demonstrate that the release has an overriding public health interest.

"We're not trying to subvert or to change the right of people to access documents," an EMA spokesman told BioWorld Today.

Since 2010, it has released 1.5 million pages in total.

"People lose sight of the fact that what we did in 2010 was quite ground-breaking," he said. Academic and medical researchers account for more than 80 percent of successful applications, but the spokesman was unable to disclose what percentage of applications are successful.

This remains a contentious issue. Indeed, the ombudsman recently opened an investigation into how the agency handled an access-to-documents request for CSRs associated with the approval of Abbvie Inc.'s, Humira (adalimumab) in treating Crohn's disease. The move followed shortly after North Chicago-based Abbvie – and Brisbane, Calif.-based Intermune Inc. – dropped their cases on clinical data release they'd brought against the EMA last year.

Publication of the EMA's final policy, which was originally due to be implemented at the start of 2014, is still some weeks off.

"The plan is to go the management board on June 12," the spokesman said. "We aim to publish it as soon as is practically possible after that."

Implementation will follow either late this year or early next year – unless the ombudsman succeeds in politically escalating the dispute.

"The ombudsman will ask the European Commission to publish its opinion as regards transparency in this area as EMA needs the commission's agreement for the adoption of its pro-active policy," she stated. She also plans to consult "concerned" members of the European Parliament.