EU ombudsman takes issue with trial transparency moves by EMA

The EMA seems to be planning to limit access to clinical trial data by imposing strict confidentiality requirements and by allowing data only to be seen using an interface provided by EMA, according to the letter​.

O'Reilly said: "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​."

The shift in strategy by the EMA seems to be revealed in documents obtained by O’Reilly, and “envisages to make available clinical-trial data, with the exception of what it considers to constitute ‘Commercial confidential Information,’ to natural or legal persons or organisations that have registered with EMA and that agree to the conditions for such access that are set down in the ‘Terms of use.​’”

She also notes that under the draft regulations, as opposed to the documents provided by the EMA, people requesting access to trial data do “not have to state any reasons for his or her application​,” while the EMA seems to be requesting certain terms and conditions under which people requesting data would have to abide by.

Background ​

On April 2, the European Parliament passed draft regulations​ that mandate the publication of data from all trials. The draft regulations are expected to be finalized in June and come into force in 2016. Some proprietary information may be redacted by sponsors, which is what the EMA is still ironing out.

The EMA, in collaboration with the EU countries, would manage and maintain the EU portal and database where the trial information would be collected.

With that power, the EMA seems to be taking a step back on transparency with its latest moves.

“[​F]rom the documents that I received, it appears that EMA now envisages a policy that very much differs from what I had understood to be EMA's initial approach​,” O’Reilly writes.

She has since asked EMA Director Guido Rasi to inform her by May 31 of how EMA intends to deal with requests for public access to existing clinical trial data. She also asked him to list the reasons and the legal basis for what she’s considering to be a significant change of policy.