The European Ombudsman has told the European Medicines Agency (EMA) of her “concern” at what seems to be a significant change of EMA policy concerning public access to clinical trial data.

In a letter to EMA director Guido Rasi, Ombudsman Emily O’Reilly points out that her office had welcomed the Agency’s announcement in 2012 of a new pro-active transparency policy, giving the broadest possible public access to clinical trial data.

However, “according to documents the Ombudsman has received, EMA is planning to limit access to clinical trial data by imposing strict confidentiality requirements and by allowing data only to be seen on screen using an interface provided by EMA, as well as imposing wide restriction on the use of such data,” she writes.

“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. European citizens, doctors and researchers need maximum information about the medicines they take, prescribe and analyse,” Ms O’Reilly tells Dr Rasi.

She points out that, in the last five years, the Ombudsman has conducted over a dozen inquiries into EMA, many of which have concerned refusals to make public documents regarding the authorisation and regulation of medicines by the Agency. In response to this intervention, EMA appeared ready to adopt a pro-active approach towards transparency, she notes.

Moreover, on April 2 this year, the European Parliament voted in favour of legislative proposals to make clinical trial data public. As a consequence, the result of all future clinical trials in Europe should eventually be made publically accessible online.

Therefore, Ms O’Reilly has asked Dr Rasi to inform her, by May 31, how EMA intends to deal with requests for public access to existing clinical trials. She has also asked him to list the reasons and the legal basis for “what appears to be a significant change of policy.”

However, an EMA spokesman told the Out-Law.com website that this is a draft policy. Terms and conditions relating to access are not designed to restrict public access to the information, and these will include agreeing not to use the information “for commercial purposes such as making medicines.”

Life sciences expert Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, comments that EMA is “striving to balance the interests of all stakeholders and is adopting step-wise approach to the roll-out of its new policy.”

“In the first instance, only parts of the Clinical Study Reports (CSRs) will be released to test-drive and establish trust and confidence in the new system. The Redaction Principles clarify that only under limited circumstances may [CSRs] be considered commercially confidential information,” she says.