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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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Changing investment patterns in synthetic biology

Over the last decade or so, there has been a marked increase in public and private investment in synthetic biology. Several countries have been particularly prompt to invest, and the effects are easier to see in the United States. The pattern of investment shows that the technology is also appealing to several key developing nations, and clearly China has strong ambitions. Several countries have also recognised a need to develop international funding mechanisms for student exchange and for reducing wasteful research overlap and duplication. Several key foundational companies have gone through favourable initial public offerings, most of them in the biofuels and bio-based chemicals sectors. However, such companies struggle with the complexities of scale-up to commercial production, especially in transport fuels. There has been a recent shift from biofuels to bio-based chemicals, which have lower production volumes. There may be a case for countries to offer specialised support to small and medium-sized enterprises, such as provision of access to demonstrator plants, testing and certification facilities.

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