The European Medicines Agency (EMEA) represents a new type of supranational regulation. Formally, it merely advises the Commission and a member state committee on the authorization of pharmaceuticals. In practice, however, it dominates decision-making and operates much like an independent agency. Based upon a brief discussion of the merits of independent regulation and the necessity to control regulatory activities, the article explores the institutional arrangement in which the EMEA is embedded and seeks to explain how tight oversight is compatible with quasi-independent action. It argues that the multi-tiered oversight mechanism restricts the non-scientific actors involved in the authorization of pharmaceuticals more than the agency -as long as the agency adheres to its mandate of producing scientifically convincing decisions.
This article argues that regional integration can follow three different developmental paths, depending on the centrality of external economic actors and economic asymmetries in regional trade networks. The first path causes intra-regional interdependence, the second path reinforces dependence on extra-regional actors, and the third path reinforces asymmetries in the region. The article illustrates this argument using diachronic network visualization of trade networks in three world regions. The European Union (EU) corresponds to the first path, the Association of Southeast Asian Nations (ASEAN) to the second and the Southern African Development Community (SADC) to the third. The theoretical argument and empirical analysis in the article demonstrate how regional organizations get locked into these developmental paths, and how regional integration reinforces rather than changes existing economic structures.
The creation of more and more supranational regulatory agencies has been one of the most significant institutional developments in the European Union during the last decade. Usually, these agencies evolve from EU committees and take over most of their structures. Accordingly, like most EU committees and the Commission, regulatory agencies are not independent, but act under the control of the member states. The question is, how far do they indicate a credible commitment of the Member States to long-term policy goals like health and consumer protection. This article compares the institutional structures and decision-making rules of the European Agency for the Evaluation of Medicinal Products and of the newly established European Food Safety Authority, in order to clarify the extent of credible commitment that the Member States show through the setting-up of these agencies. It concludes that the commitment of the Member States in the foodstuff sector is not as deep as in the pharmaceutical sector, and that the creation of the European Food Safety Authority will not lead to a success story similar to that of the European Agency for the Evaluation of Medicinal Products.
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.
This article analyses decision-making within the EU's committee system for BSE regulations during the latest phase of the mad cow scandal between Spring 2000 and Spring 2001. As the empirical analysis shows, the two concepts which dominate the academic discussion -the principal-agent theory and the concept of deliberative supranationalism -each focus on different committees within this complex institutional framework. While the principal-agent theory emphasizes the intergovernmental character of oversight committees, the concept of deliberative supranationalism stresses the supranational character of scientific committees. However, this article demonstrates that there is a differentiation within the decision-making system and a functional division of labour between the different kinds of committees. The oversight committees fulfil the control function in the interests of the member states, whereas the scientific committees advise the Commission during the policy formulation process. Under specific circumstances the scientific committees gain significant influence over the decisions in the oversight committees and, thereby, on the final policy outcome. In this way, the different committees help to increase the EU's problem-solving capacity.
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