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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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Intellectual property issues and synthetic biology

Business models for synthetic biology need to address intellectual property. There is an apparent tension between the desire for “openness” and freedom of access to new parts and the need for intellectual property (IP) protection to allow companies to protect their investments and form the basis for developing their business. Patenting has for decades been a difficult area for life science business. Some envisage that synthetic biology will require a broader range of instruments: trademarks and industrial designs, copyrights, materials transfer agreements and database protection. However, a clear message from the IP community is that, although synthetic biology may present its own challenges, the global IP system is likely to be able to cope and is not under any serious threat. There are identifiable roles for government policies, especially in improvements to access and technology transfer.

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