Regulation Of The Pharmaceutical Industry

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How are pharmaceutical technologies developed and controlled in our societies? To what extent should the availability of these technologies be determined by scientific experts, a democratic state, the interests of final users, or ethical principles? This unique collection brings together the work of social scientists, ethicists, lawyers, and policy analysts on regulation, ethics and innovation in the pharmaceutical industry. Regulatory systems and their implications for public health in North America, Europe, and developing countries are discussed, including case studies of norplant, interferon, and anti-fertility vaccines.

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Product Details

  • ISBN-13: 9780333790441
  • Publisher: Palgrave Macmillan
  • Publication date: 8/23/2003
  • Series: Studies in Regulation Series
  • Edition description: REV
  • Pages: 288
  • Product dimensions: 5.50 (w) x 8.50 (h) x 0.81 (d)

Meet the Author

John Abraham is Professor of Sociology and Co-Director, Centre for Research in Health and Medicine (CRHaM), Sussex University.

Helen Lawton Smith is Founder and Research Director, Oxfordshire Economic Observatory, School of Geography and the Environment, Oxford University.

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Table of Contents

List of Tables and Figures
Notes on the Contributors
Introduction 1
1 Regulatory Laws and Political Culture in the United States and Germany 11
2 Europeanization of Medicines Regulation 42
3 Globalization of Medicines Control 82
4 Sales Licensing Documentation and Trade Secrecy: The Case Of Norplant[superscript R] Contraceptives 108
5 Biological Medicines in the Age of Biotech: Public Policy Issues 125
6 New Molecules, Markets and Changing Drug Regulatory Practices 146
7 Users' Involvement in Regulating Contraceptive Innovation: The Design of Anti-Fertility Vaccines 160
8 Regulations for Ethical Purposes: Medical Research on Humans 181
9 The Limitations of Current Ethical Regulations 195
10 Mergers and Joint Ventures in the Pharmaceutical Industry 212
Bibliography 234
Index 268
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