Viehbacher claims EMA transparency initiative threatens R&D investment in EU

A decision by Europe’s drug regulator to release detailed data on drugs once a medicine is approved could discourage critical investment in crisis-hit Europe, Sanofi’s chief executive said to news agency Reuters.

Chris Viehbacher, who took over as president of the European Federation of Pharmaceutical Industries and Associations (Efpia) on Monday, said companies would invest in regions where they felt welcome.

“If you, on the other hand, say, ‘you guys are bad actors, we want to cut your prices, we want to take your confidential data and share it with any one of your competitors’, you don’t get the same feeling of encouragement,” he told reporters.

His comments coincide with publication of a draft policy from the European Medicines Agency (EMA) that would see the regulator proactively release detailed clinical trial data on newly approved drugs from 2014. The controversy over clinical data transparency compounds a situation where drugmakers are already reluctant to invest in Europe because of a wave of austerity-driven cuts in drug prices.

As an interesting contrast, David-Alexandre Gros, Chief Strategy Officer of Sanofi, said at an FT conference in December 2012 that “the pharmaceutical industry should have nothing to fear about publishing raw data from clinical trials”