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Clinical-trial transparency hits judicial roadblock

The European Medicines Agency (EMA) has been forced to scale back its programme to make more clinical-trial data available, owing to ongoing legal action.

The EMA is attempting to make available more of the data submitted to it by drug companies seeking approval for their medicines (see ‘Drug-company data vaults to be opened’). However, the companies AbbVie of North Chicago, Illinois, and InterMune of Brisbane, California, took the agency to court earlier this year to try to prevent the release of some of their trial data. An interim decision from the European General Court in April blocked the EMA from releasing the documents in question.

Now the Sense About Science campaign group says that this ruling has spread to restrict other document release by the EMA. Researchers have this week been receiving letters from the EMA saying that it cannot release documents they have requested while this legal case is ongoing. Around 100 such requests are pending.

“Nearly 2 million pages of Clinical Study Reports and other documents have been released by EMA, and only two companies … have challenged EMA’s releases in court,” Peter Doshi, a medical researcher at Johns Hopkins University in Baltimore, Maryland, said in a statement distributed by Sense About Science. “If AbbVie and InterMune win their cases, there is a real chance that EMA’s revolution in data transparency will come to an abrupt end, returning us to the old status quo of data secrecy.”

Martin Harvey-Allchurch, head of communications at the EMA, says that the requests that have been denied are all for documents similar to those involved in the two court cases. Owing to the court’s decision, the agency is currently unable to provide access to documents similar to those in the court cases.

“We just can’t operate the policy [on access to documents] the way we had in the past. It’s not a decision we have taken lightly,” Harvey-Allchurch says.

He adds that the EMA has released other documents since the court case, and that a public consultation on future access to clinical-trial data continues.


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