Balmer A., Martin P., 2008, Synthetic Biology: Social and Ethical Challenges, Institute for Science and Society, University of Nottingham. Available here (PDF)
This report summarizes the fundamental social and ethical issues brought on by the emergence of synthetic biology. Drawing from a survey of media reports and academic publications over the last five years, the report aims to provide definitions of synthetic biology and summarize the central areas of scientific research, describe recent developments in both the technology itself and the public debate surrounding its implications for policy, and reflect on lessons learned from earlier debates over genetic engineering to garner recommendations for future policymakers.
IRGC 2008, Concept note: Synthetic Biology: Risk and Opportunities of an emerging field, International Risk Governance Council, Geneva. Available here (PDF)
This concept note outlines some of the important risk governance issues associated with synthetic biology, attempting to provide a stimulus for discussion rather than concrete recommendations. It first discusses the issue of synthetic biology’s definition, highlighting the distinctions between synthetic biology and genetic engineering, and the relationship of synthetic biology to systems biology. Next, the concept note examines the major areas of research in synthetic biology, and their environmental, health, and industrial applications. The report also explores the risks of such applications, specifically in the areas of biosafety, biosecurity and intellectual property, and also addresses prominent ethical issues, such as whether synthetic biology blurs the distinction between “natural” and “unnatural.” Finally, the report examines the present regulatory arena, exploring proposals for self-governance and the objections raised to these initiatives.
Parliamentary Office of Science and Technology (POST), POSTNOTE – Synthetic Biology, January 2008, N° 298. Available here (PDF)
This publication outlines recent developments, the possible applications and risks of synthetic biology and examines policy options for the development and governance of the research.
Schmidt M., 2008, Diffusion of synthetic biology: a challenge to biosafety, Syst Synth Biol, June 2008. Available here (PDF)
This article looks at how synthetic biology presents society with both risks and opportunities. On one hand, by making biological systems easier to engineer, synthetic biology can finally unleash the full potential of biotechnology and spark a wave of medical, environmental and industrial innovation. On the other hand, however, the domestication of biology can lead to safety challenges, as new self-replicating life forms threaten their surrounding ecosystems, or illicit substances are produced synthetically and for much less money. Ultimately, policy makers need to be aware of these hypothetical scenarios in order to devise programs which can best mitigate their potential risks.
van Est R., de Vriend H., Walhout B., 2007, The world of synthetic biology, Rathenau Institute, The Hague Netherlands. Available here (PDF)
In the summer 2007, a group of 17 top international researchers hailed synthetic biology as a “new technology revolution” which could provide solutions to major problems. Their report says synthetic biologists do not just want to create new biological systems, they also want to improve them. Clean biofuels and cheap malaria drugs are just some of the visions synthetic biologists cherish. But social and ethical questions are also present: What will the impact be on health and the environment? What about potential negative uses such as biological warfare? And what will be the commercial implications? Can one patent life itself?
Garfinkel M., Endy D., Epstein GL., Friedman RM., 2007, Synthetic Genomics – Options for Governance. Available here (PDF)
Garfinkel, Epstein and Friedman offer a survey of the current state of synthetic biology technology and policy initiatives, an overview of the possible benefits and risks of synthetic biology research, and a comprehensive system of policy proposals. The authors characterize synthetic biology as possessing an inherent “dual-use” risk, challenging policymakers to design ways to impede malicious uses while not blocking more productive and beneficial avenues of research. While biosecurity issues such as biowarfare or bioterrorism are not discussed, a significant amount of attention was paid to the biosafety concern of chimeric organisms. The authors note that while containment systems would be necessary to prevent an accidental release in the environment, they could very well be cost prohibitive, creating an undue impediment to beneficial research.
Henkel, J. and Maurer, SM., 2007, The Economics of Synthetic Biology, Molecular Systems Biology 3 (117):1-4. Available here (PDF)
Henkel and Maurer attempt to predict the characteristics of the synthetic biology market if the agenda to standardize synthetic biological parts is widely successful. Their basic conclusion is “[t]he average cost of using a part will decline steeply the more it is used.” This trend creates what are known as “Network Effects,” (e.g. the more users a product has, the more attractive it becomes,” and helps to explain the “winner-take-all” dynamics of the industry). Henkel and Maurer also argue that this trend will generate strong incentives to create entire libraries of parts, as opposed to specializing in a few specific parts.
Selgelid M., 2007, The tale of two studies: Ethics, Bioterrorism, and the Censorship of Science, Hastings Center Report 37, no. 3:35-43. Available here (PDF)
Widespread publication of synthetic biology research presents policymakers with a unique “dual-use” biosecurity dilemma: while scientific progress depends on the publication of research findings, knowledge of certain synthetic biology procedures (such as the ability to synthesize vaccine-resilient strands of smallpox) can be used by terrorists or rogue states to produce weapons of mass destruction. Although unchecked governmental control of research publication would be worrisome, Selgelid argues that the threat of biological terrorism justifies censorship at least in some instances. He proposes the creation of a panel comprised of representatives from the scientific and security communities to regulate the publication of articles with potentially sensitive information.
Tucker JB. and Zilinskas, RA., 2006, The Promise and Perils of Synthetic Biology, The new Atlantis, Spring 2006, p.25-45. Available here (PDF)
Tucker and Zilinskas offer a survey of current synthetic biology technology, the potential risks of synthetic biology research, and a series of policy prescriptions for mitigating those risks. The authors point to three risks of synthetic biology research. First, there is the possibility that synthetic organisms might be accidentally released into the open environment. Second, a microbe designed for use in the natural environment could have harmful side effects once it is released into the open environment. Lastly, there is the risk of a rogue state or terrorist organization deliberately releasing a harmful pathogen into the environment.
Bhutkar A., 2005, Synthetic Biology: Navigating the Challenges Ahead, J. BIOLAW & BUS., Vol. 8, No. 2, p.19-29. Available here (PDF)
In this article, Arjun Bhutkar analyzes the current status of synthetic biology technological development, and then outlines various issues in patentability, ethics, and regulatory risk management that confront synthetic biology practitioners and policymakers. Bhutkar argues that the current ad-hoc intellectual property framework for synthetic biology products should be replaced by a system that clearly shows that human intervention in biological systems should be patentable. This would include a two-part test which requires applicants to show that, (1) “the organism under review would have little chance of developing naturally,” and (2) “that natural selection would actually work against the organism but for the intervention of human interest and technology.” Bhutkar also observes that advances in synthetic biology will test the distinction between non-living engineered machines, and living biological organisms.