Regulatory Focus™ > News Articles > In Major Reversal, EMA Ordered by EU Court to Halt Clinical Trials Transparency Initiative

In Major Reversal, EMA Ordered by EU Court to Halt Clinical Trials Transparency Initiative

Posted 30 April 2013 | By Alexander Gaffney, RAC

Plans by the European Medicines Agency (EMA) to make clinical and non-clinical data available to the public have been dramatically put on hold after the General Court of the EU today issued an interim order that the agency is not to publish the documents until a final order is passed down.

EMA has been moving toward a policy of transparency since at least November 2010, when it first announced its intent to eventually publish all research data provided to it in support of a regulatory dossier or application.

That plan has won rave reviews from some transparency advocates, including those behind the AllTrials campaign, which is campaigning for the release of all clinical data. Industry, however, has been far less supportive, with at least two-AbbVie (formerly of Abbott Laboratories) and InterMune-suing the agency to stop it from releasing what they called "commercially confidential information."

Those arguments evidently held enough weight with the General Court of the EU to merit an interim order barring the agency from moving forward with its transparency plan, at least for the time being.

In a statement, the agency noted that it is currently evaluating whether it will appeal the interim decisions.

"The EMA remains committed to transparency and openness of information to meet the legitimate public interests to enable scrutiny of the Agency's recommendations on medicines," it added.

In a separate statement on the social media network Twitter, Martin Harvey, head of communications at EMA, said that the ruling was "disappointing, but not the end."

As an interim measure, the agency said it plans to allow select access to the contested documents on a "case-by-case" basis-a measure already in place and responsible for the release of nearly 2 million documents since November 2010 when its access-to-documents policy first began.

EMA: European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information

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