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Alison McLennan

This book explores the interplay between law and emerging technologies in the synthetic biology context. Synthetic biology is a rapidly developing field which promises transformative benefits, but also poses significant risks. This chapter introduces the key issues to be explored in this book: the debate over the risks and benefits of synthetic biology, the extent to which synthetic biology and its social context are distinctive from those of earlier technologies, the regulatory issues that arise, and whether synthetic biology can be regulated within existing regulatory structures or whether new mechanisms are needed. Chapter 1 explains the goals of regulation of emerging technologies and criteria for assessing the regulatory environment. These are regulatory legitimacy, effectiveness, connection, prudence and cosmopolitanism. The chapter introduces these criteria in the synthetic biology context. It introduces the regulatory challenges posed by synthetic biology in intellectual property, biosecurity, biosafety and environmental law.

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Alison McLennan

Discussion of the regulation of synthetic biology must be grounded in an understanding of the science. Chapter 2 explains the science of synthetic biology, and explores the development of the field, the key approaches and tools, the leading scientists, the location and funding of research. It also discusses the key applications of synthetic biology in biofuels, medicine, agriculture and environmental remediation.

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Alison McLennan

Chapter 3 evaluates key policy positions in the debate over regulation of synthetic biology. These are represented by leading scientists, J Craig Venter and Drew Endy, sociologists, Joy Y Zhang, Claire Marris and Nikolas Rose, and the civil society organisation, ETC Group. Venter has promoted the benefits of synthetic biology and encouraged government investment and lighter regulation. This approach has limitations in terms of public and government involvement and consideration of risks and ethical concerns. Endy has sought to develop the new field of engineering of biology and create a research community underpinned by positive communal norms. While these have positive influence, this self-regulatory strategy alone is insufficient as a regulatory approach to synthetic biology. The ETC Group emphasises the risks of synthetic biology and has argued that in the absence of adequate oversight, there should be a moratorium. This is not appropriate as a regulatory strategy for synthetic biology.

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Alison McLennan

Chapter 4 considers the role and recommendations of the Presidential Commission for the Study of Bioethical Issues’ inquiry into synthetic biology. The Presidential Commission published its findings in its report 'New Directions: The Ethics of Synthetic Biology and Emerging Technologies'. Chapter 4 critiques the recommendations, which are based on the principles of ‘public beneficence’, ‘democratic deliberation’, ‘intellectual freedom and responsibility’, ‘responsible stewardship’ and ‘justice and fairness’. The Presidential Commission was successful in creating a deliberative public forum for debate of the issues surrounding synthetic biology. However, it could have gone further in its recommendations, which emphasised the similarity between synthetic biology and earlier biotechnologies. It could have given greater consideration to the distinctiveness of the technology and the intellectual property and biosecurity issues.

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Alison McLennan

Chapter 5 considers the potential for applications of synthetic biology to be released into the environment and cause environmental harm. There is uncertainty about the harm that could be caused and disagreement about the degree of risk. The chapter explores strategies for managing these risks to the environment in light of legal and policy approaches to regulating where there is scientific uncertainty. It critiques the Presidential Commission’s approach to issues of risk and uncertainty, which is based on the principle of ‘responsible stewardship’ and the concept of ‘prudent vigilance’. It argues that in relation to environmental risk, the Presidential Commission should have adopted the precautionary principle in favour of prudent vigilance. The policy tool of ‘planned adaptation’ is useful for synthetic biology regulation as it will assist in managing uncertainty and maintaining regulatory connection.

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Alison McLennan

Chapter 6 examines the potential biosafety issues arising from synthetic biology. The chapter analyses the existing biosafety oversight mechanisms and guidelines which apply to academic biological research and biotechnology companies. Interest in experimenting with synthetic biology, and biotechnology generally, has also spread outside research institutions and biotechnology companies. There is an area of risk in relation to the new breed of ‘do-it-yourself’ biologists, which overlaps with and mirrors aspects of the synthetic biology community. Chapter 6 investigates this emerging community of do-it-yourself biologists, their culture and motivations, to elucidate the regulatory challenges posed. The main regulatory challenge is one of biosafety regulation, and risks are currently identifiable. The chapter proposes that it is not appropriate to ignore these, and self-regulation in the field should be supplemented with other strategies. There should also be ongoing engagement with do-it-yourselfers and monitoring of capability in this field.

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Alison McLennan

Chapter 7 considers the debate that has been occurring over biosecurity regulation of synthetic biology. Synthetic biology raises biosecurity concerns for several reasons including: the dual-use nature of some synthetic biology research; rapidly improving capacity to build synthetic DNA; the emphasis on de-skilling; and the emergence of do-it-yourself biology. Chapter 7 explores oversight efforts including: the existing legislation; voluntary guidelines for oversight of gene synthesis; self-regulation by the synthetic biology community; and voluntary standards developed by gene synthesis companies. The chapter argues that there is a need to adopt an enforceable regulatory approach. This is for reasons of regulatory legitimacy, effectiveness and connection. Due to the potential severity of a bioterrorism event, a more cautious approach is needed. This approach should be based on the rule of law, and should encompass adaptation to the changing stage of scientific development and changes in the general biosecurity environment.

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Alison McLennan

Chapter 8 investigates the interaction between patent law and synthetic biology, in the context of longstanding debate over patenting and the life sciences. It evaluates the likelihood of patents having an unintended negative impact on synthetic biology innovation. It also explores the application of case law on patentable subject matter, including the Myriad cases. This case law is unlikely to preclude patenting of various tools and processes within synthetic biology. Chapter 8 further argues that promoting synthetic biology innovation requires regulation to be directed to encouraging sharing and open access within synthetic biology research, and promoting patent quality. The chapter explores the patent examining practices of the United States Patent and Trademark Office in relation to several families of patent applications filed by scientists of the J Craig Venter Institute. The case study shows that patent law principles and examining practices have worked well in relation to these applications.

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Alison McLennan

Chapter 9 investigates the ability of a unique synthetic biology ‘commons’, built by the BioBricks Foundation and its collaborators, to promote innovation in the field. This is a response by some synthetic biologists to the perceived potential problems of the patent system. This commons involves sharing of research information and data, as well as shared norms and goals. It is partially underpinned by contractual arrangements known as the BioBrick Public Agreement. Chapter 9 considers why this commons approach has been adopted in synthetic biology, how it is governed and how successful this project is likely to be in achieving its goals. Chapter 9 argues that this standard biological parts commons is likely to facilitate access to basic research tools in synthetic biology. The chapter also analyses the patent access tools of compulsory licensing, patent pools and the experimental use defence.