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AbbVie drops EMA legal case after compromise

Published on 04/04/14 at 09:48am
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AbbVie will no longer seek to stop the European Medicines Agency from releasing data on its blockbuster arthritis treatment Humira.

The US firm was suing the European Medicines Agency (EMA) after the regulator tried to publish data around Humira (adalimumab), currently the biggest-selling drug in the world.

But in a statement released this week the EMA says AbbVie has now “withdrawn both its court cases brought against the Agency concerning access to clinical trial data.”

The EMA was initially ruled not to release the data in April last year, but managed to appeal against this decision. 

When bringing the court case against the EMA in 2013, AbbVie said that it “objected to detailed patient data being made available to rivals”, and filed the legal actions in a bid to “protect AbbVie’s confidential and commercially-sensitive information”.

But in a compromise decision, the EMA was requested to consider an entirely new set of redacted documents from AbbVie, that had limits proposed by the company on what could be seen.

The EMA says: “The very limited redactions proposed by AbbVie were consistent with the Agency’s redaction practices and also had no significant impact on the readability of the reports. Therefore, a decision accepting that new set of documents was notified to the company.”

AbbVie was one of two firms suing the EMA, InterMune being the other. The US biotech brought a similar case against the EMA last year regarding third-party access to information about its lung disease drug Esbriet (pirfenidone). Unlike AbbVie, however, it has not dropped its case.

This all comes just one day after the European Parliament voted for greater clinical trial transparency to be imposed across Member States.

This new law will mean that from 2016 the EU will no longer see study data as ‘commercially confidential’, thus removing any legal barriers for bodies like the EMA to publish trial information.

Ilaria Passarani, of the EU consumer organisation BEUC that was an intervener organisation in the case, says: “We don’t know what are the reasons that led AbbVie to withdraw its applications in the cases they filed against the EMA but we hope InterMune will do the same.

“The new Clinical Trials Regulation, adopted yesterday by a large majority in the European Parliament […] clearly shows that the time for secrecy is over. In this context the court cases against EMA seem really anachronistic.”

Dr Ben Goldacre, co-founder of the AllTrials campaign, adds: “These efforts by AbbVie to impose secrecy on European regulators were scandalous. More than that, they have inflicted huge and unnecessary reputational harm on the pharmaceutical industry as a whole, which ultimately undermines all of medicine.

“It cannot make sense for the pharmaceutical industry to continue campaigning against transparency. The world has moved on.”

Ben Adams 

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