Risk Regulation in the Single Market - The Governance of Pharmaceuticals and Foodstuffs in the European Union

Why do the regulatory institutions of the EU look different across similar policy areas? Why do they work with different degrees of success? This book provides a theoretically driven comparison of two important areas of EU risk regulation. Whereas the functional demands for supranational risk regulation are similar in pharmaceutical and foodstuff regulation, the efficiency of the two respective regulatory regimes has differed widely during the last 15 years. The EU regulatory regime for pharmaceuticals has managed to establish a single market for highly innovative pharmaceuticals – including 'red biotechnology'. In contrast, the single market for foodstuffs was shattered by the BSE crisis, and 'green biotechnology' – that is, GMOs and Gen-Food – is still highly contested. As this book demonstrates, these differences in the efficiency and legitimacy of EU risk regulation can be traced back to the different institutional designs of the respective regimes, which in turn result from different developmental paths.

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