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Court annuls EMA data decision

Published on 05/12/13 at 05:12pm
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The European Court of Justice has annulled interim injunctions against the European Medicines Agency issued earlier this year after AbbVie and InterMune sought to prevent the release of clinical trial information.

In March AbbVie issued injunctions against the EMA to prevent the regulator revealing data about rheumatoid arthritis drug Humira.

US firm InterMune brought a similar case against the EMA regarding third party access to information about its lung disease drug Esbriet.

The vice president of the Court of Justice (the higher of the two entities making up the European Court) has now in effect cancelled the ‘interim measure orders’ and told the General Court (the lower body) to look again at their judgment.

“The Court has sent it back and told the General Court to reconsider the interim measures,” an EMA spokesman told Pharmafocus. “The vice president has outlined the points of law which the interim measures now have to be decided on. He hasn’t thrown them out.”

In many ways this means we are back to square one: the EMA says it is not going to release the documents in question - even though the injunctions against doing so have been annulled. Instead it will wait to see the court’s next judgment on them - for which there is no timeline.

The Court of Justice is due to publish further documents on its decision to annul either today (Thursday) or Friday.

Transparency body AllTrials says that the new decision means AbbVie and InterMune “must provide proof of the serious and irreparable harm the release of these documents will cause”.

Dr Ben Goldacre, AllTrials co-founder and author of Bad Pharma, told Pharmafile: “We can only hope that the European Court will come to its senses, and recognise that it took a huge backwards step in forcing the EMA to hide these documents from doctors and researchers.”

He went on: “This is an extraordinary and shameful case that has inflicted huge reputational damage on the pharmaceutical industry.”

While others have been moving forwards towards greater transparency, AbbVie and InterMune have “actively sued the EMA, forcing them to withhold the very information that doctors, researchers and patients need to make informed decisions about which treatment is best”, he concluded.

Yet as far as Abbvie is concerned, it is a clear issue of protecting intellectual property, pure and simple. The company says the EMA’s rejection of its ‘compromise proposals’ led to the injunctions in the first place.

Of the annulment decision, a spokeswoman said: “The vice president of the Court of Justice has not provided a judgment on the EMA’s appeal and has referred the matter back to the General Court for further consideration. Until the conclusion of this additional assessment by the General Court, there can be no final outcome.”

The company is confident that the ruling will eventually go in its favour, with the original injunction upheld, “as the Court of Justice has acknowledged that the clinical study reports do contain commercially confidential information”, the spokeswoman said.

AbbVie insists it will continue to promote a data sharing process that “allows qualified researchers access to confidential information without undermining our ability to innovate and develop new medicines for patients”.

In a statement InterMune says: “We remain confident that a re-examination of the evidence submitted by InterMune will confirm that interim measures should be granted in this case while the main proceedings are pending.”

Making available “confidential information about InterMune’s only marketed product would be likely to cause the company serious and irreparable economic harm for various reasons, including because it could jeopardize InterMune’s ability to protect certain intellectual property for Esbriet”.

The company adds it has “already extensively published a series of manuscripts relating to the safety and efficacy data from its clinical trials”. 

Meanwhile the EMA reiterates that it has carried on releasing data throughout the court process and will continue to do so - just not the AbbVie and InterMune documents yet.

“We continue to receive requests for information all the time,” the spokesman said. “And we continue to release documents. We are assessing every request.”

Next week the regulator’s management board meets (11-12 December) after which it will issue more detail - and timings - on its own delayed plans to release a data transparency policy.

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