III-1.2 : Risk Regulation in the single Market: the Governance of Pharmaceuticals and Foodstuffs in the European Union

Introduction: The Need for a Systematic Analysis of Supranational Risk Regulation
PART I: AN INSTITUTIONALIST APPROACH TO SUPRANATIONAL RISK REGULATION
Functional Pressure and Path-Dependencies: The Emergence and Development of Supranational Regulatory Regimes
Efficiency and Legitimacy: The Evaluation of Supranational Regulatory Regimes
PART II: THE AUTHORIZATION OF PHARMACEUTICALS IN THE EU
From National Crises to a Strong Supranational Regime: The Development of Pharmaceutical Authorization in Europe
A Strong Regulatory Network: The Evaluation of the European Regulatory Regime for Pharmaceuticals
PART III: THE REGULATION OF FOODSTUFFS IN THE EU
From an Early Single Market to a Crisis of Consumer Confidence: The Development of Foodstuff Regulation in Europe
A Weak Supranational Agency: The Evaluation of the European Regulatory Regime for Foodstuffs
PART IV: CONCLUSION
A Comparison of Pharmaceutical and Foodstuff Regulation in Europe

                This book is divided into three parts. The first part presents the institutionalist approach to supranational risk regulation. Here, the author first analyses the need for, and the historical development of, EU risk regulation and the pressure to develop of supranational regulatory regimes. Such regimes were not originally part of the EU’s scope of activities, but functional pressure has required centralising risk regulation at the supranational level in order to achieve the Single Market. In the next chapter the author develops analytic tools for evaluating the performance of emerging supranational regulatory regimes. Theoretically contemplating the interests of consumers and industry, the author concludes that the long-term interests of both market players call for appropriate risk regulation. To achieve this, through the functional pressure to establish strong regulatory regimes at the EU level, member states must make a credible commitment, and delegate their lawmaking power to independent agents. This, on the other side, necessitates a credible commitment to supranational risk regulation and accountability mechanisms, which would strengthen the legitimacy of this ‘chain of delegation’, which is becoming more and more important for legitimising delegations of power and day-to-day operations.

                 The second part of the book is a case study of the EU regulatory regime for pharmaceuticals. The author, in the fourth chapter, first analyses the history of European pharmaceutical legislation from the 1950s onwards and analyses its development, which was significantly influenced by the thalidomide case. Not only member states, but also the EU itself, became active in the field of pharmaceutical regulation after that scandal. The failure of mutual recognition of national pharmaceutical authorisations led to a failure of market integration in the pharmaceutical sector, but the European pharmaceutical industry had a strong interest in the establishment of a single market and urged for centralisation in 1990s, which had ultimately lead to the establishment of the European Medicines Agency. Further on, in the fifth chapter, the author evaluates the EU regulatory regime for pharmaceuticals, the centralised authorisation procedure and the mutual recognition procedure, focusing in particular on member states’ credible commitment to the regime, and its relative success.

                The third part of the book is dedicated to the EU regulatory regime for foodstuffs and is structured in line with the second part on the pharmaceutical regulation. Hence, in chapter six the author analyses the development of European foodstuffs regulation from 1950s onwards, starting with the evaluation of the mutual recognition principle and the so-called ‘simplified procedure’ within the Single Market programme, where the Commission was assisted and/or controlled by several committees. In this chapter the author has stressed the weaknesses of the 1990s EU regulatory regime for foodstuffs in light of the BSE (mad cow) scandal, the  ‘Europeanization’ of disease and the attempt to implement intergovernmental cooperation to regain consumer confidence, which necessitated the establishment of the European Food Safety Authority. Chapter seven is an analysis of the efficiency criteria and legitimacy of the regulatory regime for foodstuffs. However, the delegation of powers to national regulatory agencies, and the success of the EU’s agenda in the food sector, was weaker than in pharmaceutical sector.