Enhanced regulation of synthetic biology

Abstract

The accelerating pace of scientific research and uncertainties about the risks and benefits of emerging technologies create complex challenges for regulation. These include whether a new technology requires a new regulatory approach, managing the time lag between science and law, and facilitating beneficial innovation. This multidisciplinary thesis explores the interplay between regulation and emerging technologies by analysing the challenges posed by synthetic biology, a burgeoning new field. Synthetic biology promises benefits such as greener energy and improved medical treatments, but also poses great risks including damage to the environment, bioterrorism, and harm arising from 'do-it-yourself biology'. Vast amounts of public and private funding are being invested in synthetic biology research. This thesis lays the groundwork for bespoke regulation of synthetic biology. The debate surrounding synthetic biology has tended to focus on scientific, sociological and political questions. Legal discussion has tended to consider the individual regulatory issues in isolation. A broader approach is taken here, exploring the extent to which the regulatory challenges posed by synthetic biology are distinctive. This question is addressed using legal analysis buttressed by a critical examination of the science of synthetic biology and its potential impacts. The major regulatory challenges lie in very different fields. They encompass various issues of risk as well as issues of intellectual property. This thesis analyses whether synthetic biology can be regulated within existing regulatory structures or whether new mechanisms are needed. A starting premise is that the role of regulation in relation to emerging technology includes both facilitating beneficial innovation and minimising potential harms, as argued by Roger Brownsword, Morag Goodwin and Han Somsen. The investigation focuses on the United States, the most prominent jurisdiction in synthetic biology research and policy debate. The recommendations of the Presidential Commission for the Study of Bioethical Issues are critically analysed. This thesis considers strategies for managing risks to the environment in light of legal approaches to scientific uncertainty and the differences between synthetic biology and earlier biotechnologies. The emerging community of do-it-yourself biologists is investigated to elucidate the challenges posed. Regulatory approaches to synthetic biology's security risks are analysed with reference to new scientific capabilities, the existing regulatory environment and self-regulation. The potential for intellectual property to impede innovation in synthetic biology is considered in light of recent case law and analysis of the examination of a sample of synthetic biology patent applications. This research also investigates the ability of a unique synthetic biology 'commons' to promote innovation. This thesis argues that synthetic biology poses particular regulatory challenges. These arise from the distinctiveness of its science - including the use of engineering principles and the development of new tools - its novel communities of scientists and amateur scientists, and the uncertainty surrounding its risks. This research identifies the key regulatory changes needed and considers the creation of a new institution for enhanced regulation of synthetic biology, to manage risk and promote desirable innovation.