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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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National policies for the development and application of synthetic biology

The lack of policy development reflects two things: synthetic biology is still very young, and it may still be too indistinct from genetic modification and recombinant DNA technology to warrant specific policy developments and interventions. Countries are taking different approaches to public funding of synthetic biology R and D. Educational initiatives are key to the future of the field, as the need for an interdisciplinary approach in higher education is a challenge to science education, owing to the need for sufficient depth and breadth in both the biological sciences and engineering. Public engagement to date has been limited and this requires serious consideration. A noticeable development is the spread of interest in competitions to countries outside of the United States. Some consider that the most pressing near-term need is to develop technology roadmaps for synthetic biology. There is even a feeling that a global roadmap might be enabling and a key element of policy. It is clear that a technology roadmap can also serve as a policy roadmap, with the inclusion of strategies for public engagement and educational priorities.

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