Safety standards: an urgent need for Evidence-Based Regulation

"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). 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. Given the probable and predictable negative impacts on costs and innovation, both in developed and developing countries – particularly in the latter where the needs are huge and the resources highly limited – we contend that such a move is urgently needed.