The Regulatory Challenge of Biotechnology: Human Genetics, Food and Patents (Biotechnology Regulation series)

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 (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 synthesises 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. 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. Regulating Biotechnology : Lessons From Environmental Policy / Neil Gunningham -- Rethinking Regulatory Governance For The Age Of Biotechnology / Colin Scott -- Red Lights And Rogues : Regulating Human Genetics / Roger Brownsword -- An Abstract Approach To The Regulation Of Human Genetics : Law, Morality And Social Policy / Justine Burley -- Constructing Risks : Gmos, Biosafety And Environmental Decision-making / Paul Street -- Legal Framework And Political Strategy In Dealing With The Risks Of New Technology : The Two Faces Of The Precautionary Principle / Wolfgang Van Den Daele -- Regulating Gm Food : Three Levels, Three Issues / Bernd Van Der Meulen. Restrictions On The Cultivation Of Genetically Modified Organisms : Issues Of Ec Law / Sara Poli -- A Tale Of Two Commons : Plant Genetic Resources And Agricultural Trade Reform / Mary E. Footer -- Should We Regulate Biotechnology Through The Patent System? : The Case Of Terminator Technology / Graham Dutfield -- Patents, Patients, And Consent : Exploring The Interface Between Regulation And Innovation Regimes / Graham Laurie -- Reshaping Bio-patents : Measures To Restore Trust In The Patent System / Geertui Van Overwalle. Edited By Han Somsen. Includes Bibliographical References And Index. COPYRIGHT......Page 4 Contents......Page 5 Contributors......Page 7 Foreword......Page 12 Acknowledgements......Page 21 Abbreviations......Page 22 PART I General perspectives on biotechnology regulation......Page 25 1. Regulating biotechnology: lessons from environmental policy......Page 27 2. Rethinking regulatory governance for the age of biotechnology......Page 43 PART II Regulating human genetics......Page 61 5. Constructing risks: GMOs, biosafety and environmental decision-making......Page 119 6. Legal framework and political strategy in dealing with the risks of new technology: the two faces of the precautionary principle......Page 142 7. Regulating GM food: three levels, three issues......Page 163 8. Restrictions on the cultivation of genetically modified organisms: issues of EC law......Page 180 9. A tale of two commons: plant genetic resources and agricultural trade reform......Page 198 PART IV Regulating biotechnology through the patent system......Page 225 10. Should we regulate biotechnology through the patent system? The case of terminator technology......Page 227 11. Patents, patients and consent: exploring the interface between regulation and innovation regimes......Page 238 12. Reshaping bio-patents: measures to restore trust in the patent system......Page 262 Index......Page 281 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.