More Loss Your Private Health Info...Internationally

EMA, EU TO SHARE DATA: The European Medicines Agency and DG SANTE sealed a deal with the Swiss regulatory agency to share non-public information on the safety and effectiveness of medicines. The move is in line with a growing trend towards data sharing among regulators, driven by the twin needs to maximize safety and to speed development of useful medicines. The EMA has had confidentiality arrangements with the U.S. Food and Drug Administration since September 2003, allowing the exchange of confidential information as part of their regulatory and scientific processes. It also exchanges information on pre- and post-authorization applications with Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency. The new agreement with Switzerland consolidates existing agreements from 2002 on quality and manufacturing, and cooperation during the H1N1 influenza pandemic in 2010.

The announcement immediately attracted suspicion from those who have long campaigned against undue secrecy. The clinical data transparency advocate AllTrials co-founder Ben Goldacre told POLITICO: “I would expect both Swiss and EU staff to be able to give clear and unambiguous justifications for secrecy on this kind of information. Have they?” http://bit.ly/1g4LbsO