Risk Regulation in the Single Market: The Governance of Pharmaceuticals and Foodstuffs in the European Union (Palgrave Studies in European Union Politics)

This book seeks to compare two important regulatory regimes in the EU, those relating to pharmaceuticals and foodstuffs, in terms of a theoretical framework derived from rational institutionalism. Contents......Page 8 List of Figures and Tables......Page 10 Preface......Page 11 List of Abbreviations......Page 14 1 Introduction: The Need for a Systematic Analysis of Supranational Risk Regulation......Page 16 Part I: An Institutionalist Approach to Supranational Risk Regulation......Page 30 2 Functional Pressure and Path-Dependencies: The Emergence and Development of Supranational Regulatory Regimes......Page 32 3 Efficiency and Legitimacy: The Evaluation of Supranational Regulatory Regimes......Page 48 Part II: The Authorisation of Pharmaceuticals in the EU......Page 74 4 From National Crises to a Strong Supranational Regime: The Development of Pharmaceutical Authorisation in Europe......Page 76 5 A Strong Regulatory Network: The Evaluation of the European Regulatory Regime for Pharmaceuticals......Page 101 Part III: The Regulation of Foodstuffs in the EU......Page 134 6 From an Early Single Market to a Crisis of Consumer Confidence: The Development of Foodstuff Regulation in Europe......Page 136 7 A Weak Supranational Agency: The Evaluation of the European Regulatory Regime for Foodstuffs......Page 166 Part IV: Conclusion......Page 196 8 A Comparison of Pharmaceutical and Foodstuff Regulation in Europe......Page 198 Notes......Page 210 Bibliography......Page 223 C......Page 236 G......Page 237 N......Page 238 S......Page 239 W......Page 240 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 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 1red biotechnology2. In contrast, the single market for foodstuffs was shattered by the BSE crisis, and 1green biotechnology2 - 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 The need for a systematic analysis of 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 From national crises to a strong supranational regime : the development of pharmaceutical authorisation in europe A strong regulatory regulatory network : The evaluation of the European regulatory regime for pharmaceuticals 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 A comparison of pharmaceutical and foodstuff regulation in Europe. Zbrani prispevki ponujajo bralcu analize primerov evropske zunanje politike na raznih, pogosto tudi zapostavljenih področjih in regijah v svetu. Poskušajo oceniti moč in vpliv Evropske unije v tujini v zadnjih letih, obenem pa analizirati dva v procesu evropske politične integracije jasno opredeljiva nasprotna trenda: politično zbliževanje držav članic in stalnost globokih razlik med nacionalnimi interesi. Pojavnost Evropske unije v svetovnem merilu in značilnosti ter omejitve evropske mednarodne vloge so prikazane v luči mednarodnega sistema, političnih velesil, reševanja političnih sporov in regionalnih politik EU Offices in Brussels representing the interests of regional actors in the EU have carved out a niche position within Europe's expanding multi-level political system. They are now the most visible indicators of the growing role played by EU regions. How can we understand their contribution to EU governance? What do they deliver to Europe's regions? What will be the future of security cooperation in Europe after the Bush Administration? This work explores security challenges confronting Europe, from relations with the United States and Russia to the use of military force and the struggle against terrorism. It shows that European states will increasingly act alone, independent of America This book demonstrates how the Thalidomide catastrophe of the 1960s and the BSE crisis of the 1990s led to regulatory regimes for pharmaceuticals and foodstuffs in Europe. However, the developmental paths of these regimes differ – and so does the efficiency and legitimacy of regulatory policy-making.