Surveys and Perspectives Integrating Environment and Society www.surv-perspect-integr-environ-soc.net 1993-3800 1993-3819 1 2 2008 10.5194/sapiens-1-105-2008 http://www.surv-perspect-integr-environ-soc.net/1/105/2008/ http://www.surv-perspect-integr-environ-soc.net/1/105/2008/sapiens-1-105-2008.html http://www.surv-perspect-integr-environ-soc.net/1/105/2008/sapiens-1-105-2008.pdf 105 115 2008-11-03 Safety standards: an urgent need for Evidence-Based Regulation P. Kourilsky philippe.kourilsky@college-de-france.fr I. Giri Collège de France, Collège de France, 11 place Marcelin Berthelot, 75231 Paris Cedex 05, France Access conseil, 20 avenue Henri Grellou, 91370 Verrières-le-Buisson, France "Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients." (Sackett et al., 1996). <br><br> This opinion article describes and analyses some of the consequences of the ever-growing stringency of regulatory standards in the field of drugs and vaccines for human health, with distinct issues in the developed and developing countries. It is argued that the cost and benefit of safety standards, prior and after implementation, are not sufficiently evaluated, nor sufficiently informed by science. We suspect that, as a result, significant amounts of public and private money might be misspent, because assessments of risks/benefits are often questionable, sometimes out of context and inadequate. It is suggested that, just as it happened in medicine 30 years ago, a move towards Evidence-Based Regulation should be promoted. 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