Regulation of the Pharmaceutical Industry

by J. Abraham, H. Lawton Smith, Kenneth A. Loparo

Overview

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.

Product Details

ISBN-13:	9780333790441
Publisher:	Palgrave Macmillan UK
Publication date:	06/10/2003
Series:	Studies in Regulation
Edition description:	2003
Pages:	278
Product dimensions:	5.51(w) x 8.50(h) x 0.03(d)

About the Author

OONAGH CORRIGAN Post-Doctoral Research Fellow, Department of Sociology, Goldsmiths College, University of London, UK ARTHUR DAEMMRICH Policy Analyst and Post-Doctoral Research Fellow, Chemical Heritage Foundation CLAIRE FOSTER Secretary for Science, Medicine, Technology and Environmental Issues, Church of England's Board for Social Responsibility MORVEN HADDEN Senior Assistant in the EC and Competition Law Group of Simmons and Simmon Law Firm, London, UK ELINA HEMMINKI Research Professor, National Research and Development Centre for Welfare and Health (STAKES), Helsinki, Finland HELEN KELLY Senior Assistant, Matheson, Ormsby and Prentice Law Firm GRAHAM LEWIS Research Fellow, University of York, UK NORMA MORRIS Research Fellow, University College London, UK EEVA OLLILA Senior Research Fellow, National Research and Development Centre for Welfare and Health, Helsinki, Finland TOINE PETERS Professor in the History of Pharmacy, Groningen University, The Netherlands TIM REED Research Fellow, University of Sussex, UK JESSIKA VAN KAMMEN Project Leader, STT Netherlands Study Centre on Technology Trends

Table of Contents

List of Tables and Figures Notes on the Contributors Acknowledgements Introduction; J.Abraham Regulatory Laws and Political Culture in the United States and Germany; A.Daemmrich Europeanization of Medicines Regulation; J.Abraham & G.Lewis Globalization of Medicines Control; J.Abraham & T.Reed Sales Licensing Documentation and Trade Secrecy: The Case of Norplant Contraceptives; E.Ollila & E.Hemminki Biological Medicines in the Age of Biotech: Public Policy Issues; N.Morris New Molecules, Markets and Changing Drug Regulatory Practices; T.Peters Users' Involvement in Regulating Contraceptive Innovation: The Design of Anti-Fertility Vaccines; J.van Kammen Regulations for Ethical Purposes: Medical Research on Humans; C.Foster The Limitations of Current Ethical Regulations; O.Corrigan Mergers and Joint Ventures in the Pharmaceutical Industry; H.Kelly & M.Hadden