DUBLIN – As bureaucratic climbdowns go, it was pretty humiliating. The EMA has conceded to the European Ombudsman that it had no justification for a large chunk of the redactions it performed on clinical data it released to a third party under the EU's access-to-documents rules.

It marks a decisive turning point in the battle for clinical trial data transparency in Europe, as it sets down a marker for what can – and cannot – be withheld in responses to future requests for data on drugs that are already approved.

The concession was contained in a letter the EMA sent to the European Ombudsman, Emily O'Reilly, on Jan. 30, which her office released last week. O'Reilly's office had opened the investigation on April 16, 2014. In October, it sent a set of detailed questions – 76 in all – that required the EMA to justify the heavy redactions it performed on three clinical study reports (CSRs) concerning Humira (adalimumab) before releasing them. (See BioWorld Today, Nov. 13, 2014.)

North Chicago-based Abbvie Inc., which markets Humira, had agreed to a set of redactions with the EMA as part of a settlement of a court action it had taken against the agency, to prevent it from releasing the data. (See BioWorld Today, March 12, 2013.)

The ombudsman was able to do a line-by-line comparison between the original and redacted versions of the documents. "We can get access to every document in the possession of EU institutions," the ombudsman's spokesman, Gundi Gadesmann, told BioWorld Today. "That is the unique power the ombudsman has."

With respect to 19 of the 76 questions, the EMA responded that it "accepts that the information redacted should not have been redacted." The EMA pleaded that its oversights – a number of the redactions concerned information that was readily available in other parts of the same document – were due to the "massive amounts of documents reviewed" and "the time pressure to release the documents."

It has lifted most of the remaining redactions in subsequent data releases, either because it no longer deemed the information concerned to be commercially confidential or because the information has, in the interim, entered the public domain.

In setting out the agency's position, its deputy executive director, Andreas Pott, claimed "the redaction of a CSR is a dynamic process and evolves with time, taking into consideration, amongst others, the stage of development of products and the availability of information in the public domain."

The ombudsman will issue its formal response to the EMA in a matter of weeks. Its powers of sanction are strictly limited – it operates by persuasion rather than coercion. In exceptional situations, it can refer a case to the European Parliament, but this is usually a last resort. "That is really only something we use where there is an important question of principle at stake," Gadesmann said.

The present movement does not signal that CSRs will henceforth be released without any redactions. Article 4 of the relevant regulation, (EC) No. 1049/2001, allows for data to be withheld on several grounds, which included personal privacy and commercial interests, including intellectual property.

"There are very limited exceptions to the access-to-documents rules," Gadesmann said. "The ombudsman is never calling for 100 percent transparency, if there are legitimate reasons for withholding the information." Nor is it permitting the EMA to interpret the rules as it sees fit. "This is now the reality check on what EMA is actually doing to these documents," Gadesmann said. "They know that all eyes are on it."

The EMA argues that a degree of latitude is necessary, given the absence of any formal legal guidance. "While the EU legislation provides ample guidance on the protection of personal data, there is no agreed or binding definition of commercially confidential information, either in the EU legislation or in the case-law of the Court of Justice of the EU," an EMA spokeswoman stated. "Based on experience and stakeholder feedback [including this particular case], the agency is continuously improving its understanding of what can and cannot be considered confidential."

The EMA, she added, will accept suggested redactions from drug firms, but "only if the information is not already in the public domain and if companies are able to justify that disclosure of the information in question would undermine their competitive position."

Releasing CSRs under the access-to-documents rules concerns the vast bulk of drugs that are approved in Europe. Since the beginning of the year, however, the EMA has introduced a new policy of proactive release of CSRs, which derives its legal authority from Article 80 of Regulation (EC) No 726/2004, the legal foundation on which the EMA rests.

This applies to clinical data filed with the EMA after Jan. 1, 2015, but it is being implemented in a stepwise fashion, which will initially exclude individual patient-level data. Finding a way of including it is ongoing.