Synthetic Biology and Biosafety Governance in the European Union and the United States (original) (raw)
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This paper deals with the emerging synthetic biology, its challenges and risks, and tries to design a model for the governance and regulation of the field. The model is called of "prudent vigilance" (inspired by the report about synthetic biology, drafted by the U.S. Presidential Commission on Bioethics, 2010), and it entails (a) an ongoing and periodically revised process of assessment and management of all the risks and concerns, and (b) the adoption of policies -taken through "hard law" and "soft law" sourcesthat are based on the principle of proportionality (among benefits and risks), on a reasonable balancing between different interests and rights at stake, and are oriented by a constitutional frame, which is represented by the protection of fundamental human rights emerging in the field of synthetic biology (right to life, right to health, dignity, freedom of scientific research, right to environment). After the theoretical explanation of the model, its operability is "checked", by considering its application with reference to only one specific risk brought up by synthetic biologybiosecurity risk, i.e. the risk of bioterrorism.
Advances in Synthetic Biology and Biosafety Governance
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Tremendous advances in the field of synthetic biology have been witnessed in multiple areas including life sciences, industrial development, and environmental bio-remediation. However, due to the limitations of human understanding in the code of life, any possible intended or unintended uses of synthetic biology, and other unknown reasons, the development and application of this technology has raised concerns over biosafety, biosecurity, and even cyberbiosecurity that they may expose public health and the environment to unknown hazards. Over the past decades, some countries in Europe, America, and Asia have enacted laws and regulations to control the application of synthetic biology techniques in basic and applied research and this has resulted in some benefits. The outbreak of the COVID-19 caused by novel coronavirus SARS-CoV-2 and various speculations about the origin of this virus have attracted more attention on bio-risk concerns of synthetic biology because of its potential pow...
The art of trans-boundary governance: the case of synthetic biology
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SYNTHETIC BIOLOGY AS A NEW THREAT TO BIOSECURITY. IS THERE A ROAD TO SUITABLE GOVERNANCE?
Synthetic biology, which is a new emerging technology aiming at re-writing existing biological systems and designing completely new parts and devices, brings several potential benefits, but at the same time it constitutes a new threat to biosecurity: for such "double Janus face", it can be considered as a "dual use research". Indeed, the risk that its theoretical discoveries and applications are handled by bioterrorists and used for malevolent purposes is not a mere hypothesis. Therefore, it is necessary to look for possible solutions for the governance of this type of risk. In order to try to achieve such purpose, the analysis focuses, first of all, on the overview of the existing regulations against bioterrorism. Then, these regulations are evaluated in the light of the constitutional frame of fundamental rights at stake (in the belief that any policy/regulation should take into account and be based on the respect of fundamental rights). Thirdly, the applicability of the existing regulatory framework to synthetic biology is checked. Fourthly, the different positions that have been proposed so far for addressing biosecurity risks in the area of synthetic biology are shown and put into comparison. Finally, the proposal of a model of governance, called of "prudent vigilance", is described.
Synthetic Biology: Opportunities and Governance
Synthetic biology is already producing results that may have far-reaching implications in such sectors as biomedicine and agriculture. However, with research and development advancing quickly, new techniques accessible and affordable to many, and the potential for harm as well as for good, synthetic biology is raising a number of issues in the fields of ethics and responsible research. In 2014, IAP published its ‘Statement on Realising Global Potential in Synthetic Biology: Scientific Opportunities and Good Governance’, calling for capacity building in the field of synthetic biology so that its benefits can be exploited, responsible research, and encouraging its member academies and others to communicate with scientists, social scientists, ethicists, regulators and users (including the public) and to debate the ethical implications of synthetic biology.
NATO Science for Peace and Security Series C: Environmental Security, 2021
Synthetic biology promises to make biology easier to engineer (Endy 2005), enabling more people in less formal research settings to participate in modern biology. Leveraging advances in DNA sequencing and synthesis technologies, genetic assembly methods based on standard biological parts (e.g. BioBricks), and increasingly precise gene-editing tools (e.g. CRISPR), synthetic biology is helping increase the reliability of and accessibility to genetic engineering. Although potentially enabling tremendous opportunities for the advancement of the global bioeconomy, opening new avenues for the creation of health, wealth and environmental sustainability, the possibility of a more ‘democratic’ (widely accessible) bioengineering capability could equally yield new opportunities for accidental, unintended or deliberate misuse. Consequently, synthetic biology represents a quintessential ‘dual-use’ biotechnology – a technology with the capacity to enable significant benefits and risks (NRC 2004).
Taking Self-Governance Seriously: Synthetic Biology’s Last, Best Chance to Improve Security
SSRN Electronic Journal, 2000
Synthetic biologists have vigorously debated the need for community-wide biosecurity standards for the past decade. Despite this, the US government's official response has been limited to weak and entirely voluntary Guidelines. This article describes attempts by journal editors, academic scientists, and commercial firms to organize private alternatives at the grassroots level. Private commercial standards, in particular, are significantly stronger than federal Guidelines and currently operate across more than eighty percent of the synthetic DNA industry. The paper generalizes from these examples by asking when strong private standards are both feasible and likely to produce outcomes that are comparably democratic to conventional agency regulation. It closes by describing interventions that government can use to promote and manage grassroots standards initiatives.
Governing synthetic biology for global health through responsible research and innovation
Synthetic biology (SynBio) is a global endeavour with research and development programs in many countries, and due (in part) to its multi-use characteristics it has potential to improve global health in the area of vaccine development, diagnostics, drug synthesis, and the detection and remediation of environmental toxins. However, SynBio will also concurrently require global governance. Here we present what we have learnt from the articles in this Special Issue, and the workshop we hosted in The Hague in February of 2012 on SynBio, global health, and global governance that generated many of the papers appearing here. Importantly we take the notion of ‘responsible research and innovation’ as a guiding perspective. In doing so our understanding of governance is one that shifts its focus from preventing risks and other potential negative implications, and instead is concerned with institutions and practices involved in the inclusive steering of science and technology towards socially desirable outcomes. We first provide a brief overview of the notion of global health, and SynBio’s relation to global health issues. The core of the paper explores some of the dynamics involved in fostering SynBio’s global health pursuits; paying particular attention to of intellectual property, incentives, and commercialization regimes. We then examines how DIYbio, Interactive Learning and Action, and road-mapping activities can be seen as positive and productive forms of governance that can lead to more inclusive SynBio global health research programs