Europe Eyes Open Access To Drug Trial Data

A proposal by Europe’s drug regulatory authority to make data from clinical trials public met with immediate criticism from industry when it was announced last week. The head of the European Federation of Pharmaceutical Industries & Associations, a trade group known as EFPIA, warned that the European Medicines Agency’s proposal could expose competitively sensitive data on research done in Europe to drugmakers around the world.

At a press conference in Brussels, Christopher A. Viehbacher, CEO of the French drugmaker Sanofi who was elected president of EFPIA last week, questioned whether European taxpayers want publicly supported research and development “suddenly available to all and at a disadvantage to European companies. ... We’re certainly open to doing things in a different way, but let’s do it intelligently.”

In releasing the draft policy, EMA said it is acting to “balance out the commitment to give widest possible access to data for independent scrutiny with the need to protect personal data as well as legitimate commercially confidential information.” The draft will be open for public comment for three months, and EMA says it expects enactment by Jan. 1, 2014.

Some European drugmakers—GlaxoSmithKline, for example—have already committed to publishing clinical trial data. GSK claims to have information on its website on all clinical trials under way, with about 5,000 trial summaries currently available.

And in the U.S., the Food & Drug Administration is developing a framework to make available to the public safety and effectiveness data that have been masked to protect patient privacy. The agency already makes clinical summaries of its extensive drug reviews available to the public on its website. And FDA’s advisory committee process provides previews of its initial interpretation of submitted drug ­information.

Meanwhile, EFPIA is at work on its own plan for publishing clinical trial data. “We are currently studying the [EMA] proposal, and at the same time we are finalizing an industry commitment to share patient-level and study-level data with researchers,” the association said in a statement.