LONDON – The EMA is once again embroiled in legal action over its plans to release data contained in marketing authorization applications, just weeks before its new policy on automatically releasing clinical study reports once a product has approval comes into effect.

In the latest chapter, the agency is appealing rulings telling it not to release data on two approved products, following requests for access from unnamed third parties.

The first case relates to PTC Therapeutics Inc.'s Translarna (ataluren) treatment for Duchenne muscular dystrophy, which currently has conditional approval in the EU. The second is Merck Animal Health's Bravecto (fluralaner), a treatment for cat and dog fleas, approved by the FDA in July and the EMA in May.

Both companies claim that releasing the requested documents would infringe their right to protect commercially confidential information.

EMA said it is appealing the rulings in order to have legal clarity from the European Court of Justice on its policy on data release.

"These court cases are a good opportunity to test our rules on making available to the general public the documents on which EMA's scientific opinions on medicines are based," said Stefano Marino, head of the EMA's legal department.

The EMA has been here before; its policy of allowing access on request, first implemented in November 2010, has been contested previously. However, earlier cases have been settled out of court and the cases withdrawn, leaving a legal vacuum.

The most high-profile case was brought by Abbvie Inc. in 2013 to prevent the EMA from releasing three clinical study reports relating to the world's best-selling drug, Humira (adalimumab). In 2014, before the conclusion of the court proceedings, Abbvie agreed EMA could provide access to redacted versions of the reports, and the case was withdrawn.

The matter did not rest there however, because the European Ombudsman, the EU public interest watchdog, which has taken a close interest in the development of EMA's transparency policy, decided to check if the redactions agreed between Abbvie and EMA were justified. (See BioWorld Today, May 27, 2014, and June 16, 2014.)

After opening in April 2014, that investigation did not report until June of this year. The Ombudsman's conclusion was that redactions to protect personal patient data were justified, but redactions to protect information deemed by Abbvie to be commercially confidential were not.

"The public interest in disclosure will generally defeat any claim of commercial sensitivity," the Ombudsman said.

Whilst the Ombudsman was looking at the specific case of the Humira clinical study report redactions, the EMA was busy drawing up new rules on redaction. Those will be applied later this year, once the agency starts automatically releasing clinical study reports on approval of a product, and not as currently, when a third party makes a request for access.

The EMA guidance, published in March, made it clear that the vast majority of the information contained in clinical reports is not considered commercially confidential, but that in the limited circumstances in which clinical reports might contain such information, companies can make a case for redactions.

'the Whole matter needs clearing up'

With the European Court ruling against the release of the ataluren phase IIb study report on the grounds that it contains commercially sensitive information, the EMA is now stuck between a rock and two hard places.

Its own guidance acknowledges that "in limited circumstances clinical study reports may contain commercially confidential information." The Ombudsman's edict in June begs to differ. And the European Court ruling in favor of PTC, handed down in July, clearly challenges both.

Marino maintains that the EMA's position – that clinical study reports are not confidential per se, but may contain "residual" commercially sensitive information that can be redacted – is confirmed in the new EU regulation on clinical trials, which is the process of being implemented.

"However, a sort of blanket protection from disclosure for documents supporting an authorization for a medicine seems neither consistent with the legislation, nor advocated by our stakeholders, including an overwhelming majority of pharmaceutical companies," Marino said.

The European Court is at odds with the EMA on that point, saying the agency did not take the contested decision to release the ataluren clinical study report on the basis of the new clinical trials regulation.

PTC argued that the ataluren phase IIb study report contains information that could help competitors developing other exon-skipping treatments for Duchenne and could also undermine its efforts to develop similar products for other indications.

The European Court concurred, saying that "it is foreseeable with a sufficient degree of probability that the vulnerable situation in which [PTC] would be placed in the event of disclosure of that report would become one entailing financial damage to it."

Until the EMA was forced by transparency campaigners and political pressure into an abrupt change of policy in November 2010, it too held that clinical study reports were commercially confidential. The European Court said it is, therefore, "not in any way unreasonable" for PTC to make the same case over ataluren.

It is also the case that the majority of requests for access to clinical study reports received since the EMA changed its stance have come from companies with a competitive interest in the files, rather than academics pursuing the public interest. From that perspective, it is disingenuous for the EMA to talk about making data available to the general public.

The EMA and the European Court do agree on one thing: The whole matter needs clearing up. The EMA has a new, more liberal policy on disclosure, but the lawfulness of that policy and the question of possible confidentiality have not yet been ruled on.

"The two cases are an opportunity to receive clarity from the Court of Justice as to whether its approach is correct or not, and to eliminate operational uncertainties for the agency or the stakeholders using its system," the EMA said.