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Emerging Policy Issues in Synthetic Biology

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Synthetic biology is at such an early stage of development that there is no uniform agreement as yet about what it actually is. To some, it represents a natural extension of genetic engineering, and therefore is “business as usual”. For others, it is a way to bring mass manufacturing out from the decades of biotechnology research. Currently the discipline is limited by the ability to synthesise DNA cost-effectively but this is a technical barrier that it is anticipated will be overcome. Synthetic biology raises a number of policy issues around R&D funding, company investment, PPP arrangements and innovative financing, infrastructure requirements, education and training, intellectual property (IP), regulation, and public engagement. In preparation for the continuing development and greater use of synthetic biology, some countries have started to prepare synthetic biology technical roadmaps and a global roadmap for the medium term would be an extremely useful policy tool. Technical roadmaps could both identify likely future policy requirements, and be a useful vehicle in public engagement.

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Governance, regulation and risk management in synthetic biology

To date the regulation of synthetic biology is effectively the regulation of genetically modified organisms (GMOs). The thinking on whether this is adequate is polarised. The over-riding opinion of the synthetic biology community itself is that regulation is currently sufficient: it is felt that GMO regulation is already onerous and that further regulation may stifle research. Nevertheless, vigilance is required to ensure that any additional biosafety and biosecurity issues are discovered as early as possible and dealt with both rationally and rigorously. The main difference with GMO regulation may be the ability to order tailor-made DNA sequences. While the vast majority of these will be created for valid reasons by responsible individuals and institutions, the risk of mal-intentioned use calls for an inspection process and oversight. Governance and regulation must also take account of public opinion regarding synthetic biology, and the need for early and sustained public engagement is increasingly recognised. Potential international regulatory and governance conflicts could damage legitimate international trade. Therefore, even in parts of the world where there is little controversy, there would still be international trade issues.

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