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The Regulatory Challenge of Biotechnology

Human Genetics, Food and Patents Edited by Han Somsen, Vice Dean, Tilburg Institute for Law, Technology and Society (TILT), Tilburg University and Centre for Environmental Law, University of Amsterdam, The Netherlands
This book will make a significant contribution to the debate surrounding the effective regulation of biotechnology.

The contributing authors assess how regulatory regimes can accommodate the many different and often conflicting issues to which biotechnology is giving rise to (including a very tainted public image). The book’s ultimate aim is to explore ways of designing a regulatory regime that takes heed of these different demands whilst, at the same time, answering to the imperatives of effectiveness and efficiency.
Extent: 296 pp
Hardback Price: $146.00 Web: $131.40
Publication Date: 2007
ISBN: 978 1 84542 489 3
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  • Economics and Finance
  • Environmental Economics
  • Environment
  • Biotechnology
  • Environmental Economics
  • Environmental Law
  • Law - Academic
  • Biotechnology and Pharmaceutical Law
  • Environmental Law
  • Intellectual Property Law
  • Regulation and Governance
Biotechnology has prompted a revolution in science and society in the truest sense of the word. For what superficially appears to be a revolution in biotechnology, in effect touches upon the fundamentals of life and the way in which humans relate to it. This book will make a significant contribution to the debate surrounding the effective regulation of biotechnology.

The contributing authors assess how regulatory regimes can accommodate the many different and often conflicting issues to which biotechnology is giving rise to (including a very tainted public image). The book’s ultimate aim is to explore ways of designing a regulatory regime that takes heed of these different demands whilst, at the same time, answering to the imperatives of effectiveness and efficiency.

The book synthesizes three fields of legal analysis; the first focuses on the risk-dominated regulation of GM food and bio-agriculture; the second involves human genetics as a field dominated by considerations of ethics. Finally, patent law has been chosen as an area captured by notions of property.

With its holistic approach, The Regulatory Challenge of Biotechnology will be of great interest to academics, policymakers and regulators as well as biotechnology and law students.
‘. . . a compilation of 12 invaluable contributions on this issue by internationally known experts in their respective fields. . . a valuable resource for academic professionals, policy makers and legislators, advocacy groups and scholars in legal and development studies. It is a storehouse of learning and practical knowledge for anyone interested in environmental policy, biosafety issues, biotechnology processes and associated regulatory constraints.’
– Marcelin Tonye Mahop, Review of European Community and International Environmental Law

‘For bioethicists, legal scholars and regulators struggling with what controls to place on biotechnology, this is required reading.’
– John Avellanet, Journal of Commercial Biotechnology
Contributors: R. Brownsword, J. Burley, G. Dutfield, M.E. Footer, N. Gunningham, G. Laurie, S. Poli, C. Scott, P. Street, W. van den Daele, B. van der Meulen, G. Van Overwalle
Contents:

Foreword

PART I: GENERAL PERSPECTIVES ON BIOTECHNOLOGY REGULATION
1. Regulating Biotechnology: Lessons from Environmental Policy
Neil Gunningham

2. Rethinking Regulatory Governance for the Age of Biotechnology
Colin Scott

PART II: REGULATING HUMAN GENETICS
3. Red Lights and Rogues: Regulating Human Genetics
Roger Brownsword

4. An Abstract Approach to the Regulation of Human Genetics: Law, Morality and Social Policy
Justine Burley

PART III: GMOs AND AGRICULTURAL BIOTECHNOLOGY: REGULATING RISK
5. Constructing Risks: GMOs, Biosafety and Environmental Decision-Making
Paul Street

6. Legal Framework and Political Strategy in Dealing with the Risks of New Technology: The Two Faces of the Precautionary Principle
Wolfgang van den Daele

7. Regulating GM Food. Three Levels, Three Issues
Bernd van der Meulen

8. Restrictions on the Cultivation of Genetically Modified Organisms: Issues of EC Law
Sara Poli

9. A Tale of Two Commons: Plant Genetic Resources and Agricultural Trade Reform
Mary E. Footer

PART IV: REGULATING BIOTECHNOLOGY THROUGH THE PATENT SYSTEM
10. Should we Regulate Biotechnology through the Patent System? The
Case of Terminator Technology
Graham Dutfield

11. Patents, Patients and Consent: Exploring the Interface between
Regulation and Innovation Regimes
Graeme Laurie

12. Reshaping Bio-patents: Measures to Restore Trust in the Patent
System
Geertrui Van Overwalle

Index