Policy-making and scientific expertise: European regulations of medicines

A study of the EU system for regulating medicinal products is used to show the usefulness of distinguishing between policy-making and scientific expertise when analyzing political decision-making. This approach presupposes identifying the characteristics of scientific expertise. The experts responsible for assessing drugs have to combine knowledge and action. Questions are raised about how work is shared between decision-makers and experts. In the case of medicinal products, the work of experts has absorbed decision-making. Lest we waver between explanations in terms either of science or else of politics, it is necessary to substantively identify expertise's political dimensions. Two conceptions - the "healthy man's" and the "sick man's" - of the purpose of assessing medicinal products stand out in debates; but political authorities pay no heed to them. (c) 2005 Publie par Elsevier SAS.