Scientific Expertise and National Interest

"The attribution of marketing authorizations (MAs) is the principal measure though which public authorities try to ensure the safety and effectiveness of drugs. Between the mid-1960s and the establishment of the European Medicines Agency in 1995, the conditions in which this public control was exercised changed radically. Whereas the evaluation of medicines used to take place at a national level, today it is primarily carried out on a European scale. This paper demonstrates that to fully understand this evolution it is necessary to consider three closely related phenomena: the growing interdependency between national entities; the emergence of a field of scientific expertise specifically related to the assessment of drugs and the transformation of its relationship to national representation; and finally the increasing autonomy of MAs and the incorporation of the decision-making process into scientific evaluation. "