Bloomberg News

European Drug Regulator Delays Trial-Data Policy Until March

December 17, 2013

The European Medicines Agency is continuing discussions on a policy for expanding disclosure of clinical-trial data submitted with applications for drug approval.

The regulator’s management board will discuss the matter in March after receiving more than 1,100 comments from pharmaceutical makers, patient advocates, health-care professionals, consumer groups and members of the public, said Martin Harvey-Allchurch, a spokesman.

The EMA said in November it might have to delay the final policy, which was expected to be published by Nov. 30 and to take effect on Jan. 1. The agency promised in 2010 to bolster transparency by disclosing, on demand, clinical trial data for every drug reviewed and has been reviewing how to expand that disclosure. It published a draft proposal in June and accepted comments until Sept. 30.

EMA Executive Director Guido Rasi said in 2012 that it’s not a matter of whether the regulator will publish the clinical trial data but rather how. The delayed policy will probably benefit patients, said Peter C. Goetzsche, director of the Nordic Cochrane Centre, a non-profit health research and information center in Copenhagen.

“I believe they have by and large turned all the industry’s arguments down,” he said. “All this secrecy is now over.”

The EMA is also awaiting a European Parliament vote on clinical-trial legislation later this week and the outcome of pending lawsuits over its disclosure of trial data brought by AbbVie Inc. (ABBV:US) and InterMune Inc. (ITMN:US), Harvey-Allchurch said.

The EMA is continuing to release clinical-study reports for which it receives requests in the interim, the spokesman said.

To contact the reporter on this story: Andrea Gerlin in London at agerlin@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net


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