Thalidomide, BSE and the single market: An historical‐institutionalist approach to regulatory regimes in the European Union

Abstract

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 the European Food Safety Agency in 2002. This article adopts an historical‐institutionalist 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.

Agency Autonomy Actually: Managerial Strategies, Legitimacy, and the Early Development of the European Union's Agencies for Drug and Food Safety Regulation

“…The creation of EMA, on July 22, 1993 (Council of the European Communities 1993), was the culmination of 30 years of EU pharmaceutical legislation (Hancher 1990;Vos 1999;Krapohl 2007). The failure of the decentralized approach spurred the emergence of a supranational regulatory regime of which the industry and the Commission were the prime beneficiaries.…”

“…In fact, regulating pharmaceuticals is not completely different from regulating food, and there does not seem to be anything systematic about the regulatory domain that would explain a difference in agency autonomy. 2 At least part of the reason why drugs have become so homogenous lies in the fact that they have undergone strict regulation at the EU level for much longer than food products (Krapohl 2007). 3 As the focus has for a long time been on abolishing frontiers between countries, food agencies in Europe have only been invested with the powers to police the internal market since the 1990s, ''safety'' being a relatively new concern at the European level.…”

“…One could argue that regulating pharmaceuticals is something completely different from regulating foodstuffs because of the different nature of the products and the way the scientific community is structured in each domain. Whereas pharmaceuticals are relatively homogenous products and can therefore be more easily authorized before sale, food products are relatively heterogeneous, which makes it difficult to subject them to pre-market authorization (Krapohl 2007).…”

Reforming pharmaceutical regulation: A case study of generic drugs in Brazil

“…For example, the scandal of thalidomide in Europe caused many children to be born with malformations led several states to create National Regulatory Authorities (cf. Krapohl, 2007). Periods of uncertainty can create discrepancies from expected behaviour making it impossible to predict what political actors want, without knowing the content and structure of social relations (Woll, 2008).…”

Scandals, Ethics, and Regulatory Change in Biomedical Research

“…Such a model has been applied to regulatory systems in general (Krapohl 2007) and in the context of ethics review systems it is reasonable to argue that the punctuated equilibrium model of institutional change is the dominant theoretical resource.…”