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Regulation of Synthetic Biology

BioBricks, Biopunks and Bioentrepreneurs Alison McLennan, Assistant Professor, School of Law and Justice, Faculty of Business, Government and Law, University of Canberra, Australia
This book explores the interplay between regulation and emerging technologies in the context of synthetic biology, a developing field that promises great benefits, and has already yielded fuels and medicines made with designer micro-organisms. For all its promise, however, it also poses various risks. Investigating the distinctiveness of synthetic biology and the regulatory issues that arise, Alison McLennan questions whether synthetic biology can be regulated within existing structures or whether new mechanisms are needed.
Extent: c 424 pp
Hardback Price: $155.00 Web: $139.50
Publication Date: 2018
ISBN: 978 1 78536 943 8
Availability: In Stock
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  • Law - Academic
  • Biotechnology and Pharmaceutical Law
  • Regulation and Governance
This book explores the interplay between regulation and emerging technologies in the context of synthetic biology, a developing field that promises great benefits, and has already yielded fuels and medicines made with designer micro-organisms. For all its promise, however, it also poses various risks. Investigating the distinctiveness of synthetic biology and the regulatory issues that arise, Alison McLennan questions whether synthetic biology can be regulated within existing structures or whether new mechanisms are needed.

Adopting an interdisciplinary approach, McLennan draws on diverse areas of law, the science of synthetic biology and the history and sociology of science. She concludes that synthetic biology presents novel regulatory challenges relating to environmental risk, biosafety, biosecurity and intellectual property. These challenges arise from the uniqueness of the science, the nature of its communities of scientists (including citizen scientists or ‘biobunks’) and the uncertainty surrounding possible hazards. Some scientists see intellectual property protection as a way to push innovation forward (bioentrepreneurs), while others openly share synthetic biology tools such as BioBricks. By understanding the range of regulatory challenges, the book make a case for enhanced regulation that protects us from synthetic biology’s risks, whilst capturing its potential to improve our world.

Regulation of Synthetic Biology will be essential reading for academics and students in the social sciences and law, as well as for scientists working in synthetic biology, and policymakers in innovation, science and the regulation of these fields.
‘This book provides a comprehensive, clear and up-to-date overview of the legal and regulatory issues raised by the field of synthetic biology, covering topics such as biosafety, biosecurity and intellectual property. It also develops an original critical analysis of the report on the ethics of synthetic biology by the Presidential Commission for the Study of Bioethical Issues, and puts forward novel arguments for the formation of a new Synthetic Biology Agency.’
– Jane Calvert, University of Edinburgh, UK

‘In Regulation of Synthetic Biology, Alison McLennan provides a thoroughly-researched, incisive, and engaging account of a vitally-important field at the bleeding-edge of biology. From synthetic biology's origins at the intersection of life sciences and engineering, to the safety and security alarm bells it has set off among citizens and governments, to creative institutional attempts at self-government, McLennan weaves together complexities of science, ethics, law, and regulation into a fascinating story of runaway innovation and society's attempts to govern it.’
– Andrew W. Torrance, University of Kansas and MIT Sloan School of Management, US

Contents: Part I: The new world of synthetic biology: Possibilities, challenges and debates 1. Introduction 2. Making biology easy to engineer: The science of synthetic biology, the emergence of the field and its major applications 3. Science meets politics, activists and governance: Evaluating key positions in synthetic biology debates 4. New Directions? The United States Presidential Commission’s investigation of synthetic biology’s risks, benefits and oversight Part II: Regulating for the Risks 5. Environmental Risk: Uncertainty, precaution, prudent vigilance and adaptation 6. Synthetic Biology, Biosafety and ‘Biopunks’ 7. Biosecurity: Potential for deliberate misuse of synthetic biology Part III Regulating for the Benefits 8. How will patents affect synthetic biology? 9. Building with BioBricks: a commons for sharing synthetic biology research 10. Conclusion and Future Directions Bibliography Index