Emerging Policy Issues in Synthetic Biology

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04 June 2014
9789264208421 (PDF) ;9789264208414(print)

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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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  • Foreword

    Synthetic biology is an emerging technology that shows promise for investigating some of the burning issues in biological research. It also has the potential to address some of the grand challenges facing society, such as climate change and energy security. Some argue that it has the potential to create a new manufacturing paradigm and has obvious roles in a future bioeconomy. With the creation of engineering standards, it is hoped that synthetic biology will enable mass manufacturing based on several decades of biotechnology research and development.

  • Abbreviations and acronyms
  • Executive summary
  • Synthetic biology: A new and promising technology

    Opinions on what synthetic biology actually is range from a natural extension of genetic modification and recombinant DNA technology to a new manufacturing paradigm. Synthetic biology attempts to bring engineering standardisation to biotechnology to enable many decades of biotechnology research to pay off in the form of mass-market applications. It has been championed and popularised through the international Genetically Engineered Machine (iGEM) competition, and now several governments are investing in developing national synthetic biology capabilities. However, it remains to some a controversial technology. Public policy issues range across R and D investment and commercialisation, education and training, biosafety and biosecurity, intellectual property issues, and public perception.

  • The applications and potential benefits of synthetic biology

    Synthetic biology can be regarded as a platform technology that cuts across several key market sectors, such as energy, chemicals, medicine, environment and agriculture. Its formative years have been spent in developing the basic tools for applications in biofuels and other bio-based products, where the earliest products have been seen. It holds out very high expectations and potential for applications to human and animal health, with the potential for greatest benefits in the developing and poor nations. With a growing global population and threats to water and soil quality, agricultural applications are envisaged that could have far-reaching consequences for productivity and efficiency, but in many parts of the world such agricultural applications are controversial.

  • Research infrastructure challenges for synthetic biology

    While many of the fundamental laboratory techniques of biology and biotechnology are also applicable to synthetic biology, the major departure from the biological sciences tradition is in the development of technologies for the synthesis of large DNA sequences (of the gene and operon scale and above). Currently the cost of DNA synthesis lags a considerable way behind the spectacular advances in lowering the cost of DNA sequencing, although progress is being steadily made. In line with the aspirations to bring engineering standardisation to synthetic biology, there is a pressing need for new software developments, especially in design and manufacture. Chassis organisms, usually microorganisms engineered to be "minimal" life forms, are being developed as hosts for synthetic biology applications to reduce the noise and interference that is typical in biology. The bottleneck in synthetic biology is now shifting from DNA synthesis to dealing with the massive amounts of genetic and digital data being produced. If there is any role for co-ordinated international research infrastructure, it is to deal with this issue.

  • 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.

  • 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.

  • 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.

  • 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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