Regulation of the Pharmaceutical Industry

by Abraham, John; Lawton-Smith, Helen

• ISBN13: 9780333790441
• ISBN10: 0333790448
• Format: Hardcover
• Copyright: 2003-08-23
• Publisher: Palgrave Macmillan

Summary

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.

Author Biography

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.

Table of Contents

List of Tables and Figures	vi
Notes on the Contributors	vii
Acknowledgements	x
Introduction	1	(10)
John Abraham
Regulatory Laws and Political Culture in the United States and Germany	11	(31)
Arthur Daemmrich
Europeanization of Medicines Regulation	42	(40)
John Abraham
Graham Lewis
Globalization of Medicines Control	82	(26)
John Abraham
Tim Reed
Sales Licensing Documentation and Trade Secrecy: the Case of NorplantR Contraceptives	108	(17)
Eeva Ollila
Elina Hemminki
Biological Medicines in the Age of Biotech: Public Policy Issues	125	(21)
Norma Morris
New Molecules, Markets and Changing Drug Regulatory Practices	146	(14)
Toine Pieters
Users' Involvement in Regulating Contraceptive Innovation: the Design of Anti-Fertility Vaccines	160	(21)
Jessika van Kammen
Regulation for Ethical Purposes: Medical Research on Humans	181	(14)
Claire Foster
The Limitations of Current Ethical Regulations	195	(17)
Oonagh Corrigan
Mergers and Joint Ventures in the Pharmaceutical Industry	212	(22)
Helen Kelly
Morven Hadden
Bibliography	234	(34)
Index	268