Structured frameworks to increase the transparency of the assessment of benefits and risks of medicines: Current status and possible future directions Francesco Pignatti (1), Deborah Ashby (2), Eric P. Brass (3), Hans-Georg Eichler (1), Patrick Frey (4), Hans Hillege (5), Akiko Hori (6), Bennett Levitan (7), Lawrence Liberti (8), Ragnar E. Löfstedt (9), Neil McAuslane (8), Alain Micaleff (10), Rebecca A Noel (11), Douwe Postmus (1), Ortwin Renn (12), Barbara J Sabourin (13), Tomas Salmonson (14), Stuart Walker (8). (1) The European Medicines Agency, London, United Kingdom. (2) School of Public Health, Imperial College London, London, United Kingdom. (3) Department of Medicine, Harbor-UCLA Medical Center, Torrance, California, U. S. A. (4) Food and Drug Administration, Silver Spring, Maryland, U. S. A. (5) University of Groningen, The Netherlands. (6) Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. (7) Janssen Pharmaceutical research and Development, Titusville, New Jersey, U. S. A. (8) Centre for Innovation in Regulatory Science (CIRS), London, United Kingdom. (9) Risk Research Group, Centre for Environmental Strategy, University of Surrey, Guildford, United Kingdom (10) Merck Serono, Geneva, Switzerland. (11) Eli Lilly and Company, Indianapolis, Indiana, U. S. A. (12) Institut für Sozialwissenschaften, Universität Stuttgart, Stuttgart, Germany. (13) Health Canada, Ottawa, Ontario, Canada. (14) Läkemedelsverket, Uppsala, Sweden. Address for correspondence Francesco Pignatti European Medicines Agency 7 Westferry Circus London E14 4HB United Kingdom Tel.: (44 20) 7523 7031 E-mail: francesco.pignatti@ema.europa.eu Disclaimer The views expressed in this paper are those of the authors and should not be understood or quoted as the views of their respective organisations.