EU Agency Lifts Lid on Drug Data Secrets

Ben Hirschler | Reuters | July 15, 2012

Europe's medicines regulator, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information. The change is a landmark in transparency that puts Europe ahead of the United States, according to critics of the $1 trillion-a-year global drugs industry, who have long argued for full access to trial data.

Such information is a treasure trove for scientists wanting to test drug company claims and potentially expose product deficiencies. As part of a process of opening up, the European Medicines Agency (EMA) plans to hold a conference in November to consider ways of making large data sets available rapidly and routinely to outside investigators.

The shift chimes with a widespread push in many fields to treat scientific data as a public rather than a private resource as the world grapples with a growing flood of information. It is blow for the pharmaceutical industry, which guards its commercial secrets fiercely and has not before been required to share its data with independent researchers or academics. Companies however have little choice in the matter since they must submit their data to the regulator to get drugs approved...