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Regulation of Synthetic Biology

Biobricks, Biopunks and Bioentrepreneurs Alison McLennan, Assistant Professor, School of Law & Justice, Faculty of Business, Government & 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, but 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 regulatory structures or whether new mechanisms are needed.
Extent: c 392 pp
Hardback Price: $155.00 Web: $139.50
Publication Date: April 2018
ISBN: 978 1 78536 943 8
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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, but 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 regulatory structures or whether new mechanisms are needed.

Adopting an interdisciplinary approach, McLennan draws on diverse areas of law as well as the science of synthetic biology and history and sociology of science. She concludes that synthetic biology presents regulatory challenges relating to environmental risk, biosafety, biosecurity and intellectual property. These challenges arise from the uniqueness of the science, its novel communities, and the uncertainty surrounding possible hazards. By understanding these challenges, this book aims to lay the groundwork 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, The University of Edinburgh, UK
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? 10. Conclusion and Future Directions Bibliography Index