Across Pharma, Few Open Arms For Trial Data Sharing

Alex Philippidis | Genetic Engineering & Biotechnology News (GEN) | July 9, 2013

Industry inches toward consensus on limited sharing as EMA, GSK press for open access.

When it comes to sharing clinical trial data, at one end of the spectrum is the European Medicines Agency (EMA), which has drawn a proverbial line in the sand with its public draft of Policy 70, requiring the same open access through which it has released some two million pages of documents related to agency-approved drugs since 2010.

At the other end, Sanofi CEO Christopher A. Viehbacher has drawn his own line, raising the specter that his company—and possibly others—will cut back on investment in Europe if authorities insist on such open access.