Thalidomide, BSE and the Single Market: A Historical-Institutionalist Approach to Regulatory Regimes in the European Union

Abstract

The success of the European Union in regulating the safety of products in the single market differs widely. In the last decade, the regulatory regime for pharmaceuticals has functioned without raising public concerns.The establishment of a European agency for pharmaceuticals in the early 1990s has been evaluated positively by both producers and consumers, and there have been no large scandals so far.At the same time, the food sector was subject to a whole range of crises, of which the BSE scandal was certainly the most significant one. In reaction to this, the regulatory regime for foodstuffs was reformed by setting up a European Food Safety Agency in 2002. This article adopts an historical-instituionalist approach, and thus tries to give an explanation for the striking differences between the two regulatory regimes. Accordingly, the development of supranational regulatory regimes is distinguished by two critical junctures: a crisis of consumer confidence and the establishment of a single market. It is crucial which of these occurred first. If a crisis of consumer confidence leads to the establishment of national regulatory authorities, these authorities act as stakeholders, which could be an obstacle for harmonization, but also ensures a necessary commitment to health and consumer protection once a single market is set up. If national regulatory authorities are missing, it might be easier to set up a single market, but a regulatory deficit is more likely to occur and, in case of a crisis, the whole regulatory regime has to be established at the supranational level.