Synthetic biology’s multiple dimensions of benefits and risks: implications for governance and policies

König, Harald; Frank, Daniel; Heil, Reinhard; Coenen, Christopher

doi:10.1007/978-3-658-10988-2_14

Cited by 10 publications

(4 citation statements)

References 53 publications

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“…91 Shifting from cultivated to synthetic medical products could, inter alia, concentrate power in the hands of Western pharmaceutical companies by transferring production from developing countries, 92 and threaten the livelihoods of small-scale farmers, 93 while IP frameworks may prevent developing countries from accessing the benefits produced. 94 The implications of synbio for the relationship between man and nature, or the distinction between man and machine, 95 prompt ethical concerns. Finally, the inherently industrial and commercial ends of synbio 96 raise questions about the kind of world that we want to create, how widely shared visions of the future are, and the purposes of this research.…”

Section: Synthetic Biology: Promises and Risksmentioning

confidence: 99%

Synthesize this: integrating innovation governance and EU regulation of synthetic biology

Hamlyn

2022

Journal of Law and Society

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Responsible innovation (RI) is an innovation governance framework developed by science and technology studies (STS) that seeks to transform innovation processes. While legal academia has derived valuable insights from STS for regulating technology, it has largely overlooked the implications of developments in research on RI for the law. This article aims to address this gap using European Union governance of synthetic biology (synbio) as a case study. It highlights how the existing regulatory framework struggles to accommodate the diverse issues that synbio raises, and explores hybrid approaches using soft mechanisms to enhance the effectiveness of hard law in governing technology.Considering the 'governance continuum' as a whole, the article argues, first, that while such hybrid approaches offer the potential for implementing RI, they are currently limited, and, second, that for RI to transform innovation processes, hard law must also adapt. The article suggests finally that RI itself offers guidance for addressing those two needs.

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Section: Synthetic Biology: Promises and Risksmentioning

confidence: 99%

Synthesize this: integrating innovation governance and EU regulation of synthetic biology

Hamlyn

2022

Journal of Law and Society

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“…Numerous environmental risks of SynBio products have been identified or hypothesized and discussed in the SynBio risk literature, including increased virulence and target host range (König et al, 2016), impacts to biodiversity by outcompeting native organisms or through propagation of homogeneity in the gene pool (Breckling and Schmidt, 2015), aid to detrimental organisms by serving as a host for pathogens (Epstein and Vermeire, 2016), production of toxic compounds or metabolites (König et al, 2013), and destruction of habitat, biogeochemical cycles, essential nutrient sources, or food webs (Tucker and Zilinskas, 2006). These risks ultimately stem from risk factors that may either apply to all organisms released to the environment, such as an organism's response to environmental stressors, or may be unique to SynBio products, such as an organism's response to off-target gene edits or failure of an intrinsic biocontainment mechanism.…”

Section: Synbio Environmental Risk Factorsmentioning

confidence: 99%

A quantitative risk assessment method for synthetic biology products in the environment

Rycroft¹,

Hamilton²,

Haas³

et al. 2021

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The need to prevent possible adverse environmental health impacts resulting from synthetic biology (SynBio) products is widely acknowledged in both the SynBio risk literature and the global regulatory community. However, discussions of potential risks of SynBio products have been largely speculative, and the attempts to characterize the risks of SynBio products have been non-uniform and entirely qualitative. As the discipline continues to accelerate, a standardized risk assessment framework will become critical for ensuring that the environmental risks of these products are characterized in a consistent, reliable, and objective manner that incorporates all SynBio-unique risk factors. Current established risk assessment frameworks fall short of the features required of this standard framework. To address this, we propose the Quantitative Risk Assessment Method for Synthetic Biology Products (QRASynBio) – an incremental build on established risk assessment methodologies that supplements traditional paradigms with the SynBio risk factors that are currently absent and necessitates quantitative analysis for more transparent and objective risk characterizations. The proposed framework facilitates defensible quantification of the environmental risks of SynBio products in both foreseeable and hypothetical use scenarios. Additionally, we show how the proposed method can promote increased experimental investigation into the likelihood of hazard and exposure parameters and highlight the parameters where uncertainty should be reduced, leading to more targeted risk research and more precise characterizations of risk.

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“…En los últimos diez años aproximadamente, y sobre todo en los Estados Unidos y Europa, se ha publicado una cantidad casi inabarcable de informes de distintas instituciones y de bibliografía ética y sociológica sobre la biología sintética y sus perspectivas de aplicación (cfr. König et al 2016) -que tanto en cantidad como en contenido es muy similar a lo que se publicó hace unos años sobre biotecnología (cfr. por ejemplo Bud 1994, sobre todo pp.…”

Section: El Discurso De La Biología Sintética Y La Innovación Responsunclassified

El discurso sobre la biología sintética y la innovación responsable: observaciones desde una perspectiva histórica

Coenen

2016

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RESUMEN. El discurso sobre la biología sinté-tica, altamente visionario y marcado por el enfoque de 'investigación e innovación responsable' (RRI) puede interpretarse como un terreno para confrontar perspectivas sobre el futuro de nuestras sociedades en su conjunto. En un momento en el que, con el final de la confrontación de sistemas entre capitalismo y socialismo, los debates sociales amplios sobre cuestiones políticas y socioeconómicas fundamentales se han vuelto infrecuentes, los discursos sobre las ciencias naturales y la tecnología parecen poder ayudar a tematizar estas cuestiones de manera indirecta. Esta función del discurso sobre la biología sinté-tica puede clarificarse mediante una contextualización histórica del mismo, en la que se analizan aproximaciones anteriores sobre la relevancia social de la biología y sus aplicaciones tecnológicas.Palabras clave: Investigación e innovación responsable (RRI); biología sintética; progreso; transhumanismo; bio-utopismo; SYNENERGENE. ABSTRACT. Dominated as it is by visionary images of the future and influenced by the 'Responsible Research and Innovation' (RRI) approach, the discourse about synthetic biology (SynBio) and the prospects for its application may be interpreted as an arena for argument about the future of our societies generally. At a time when the widespread end of the systemic conflict between capitalism and socialism has made it rare for the whole of society to engage in debates on fundamental political and socioeconomic issues, discourses on science and technology can apparently be used to address questions of this kind indirectly. It is possible to clarify this function of SynBio discourse by setting it in its historical context, in which respect the focus is placed on older discourses about the societal significance of biology and its technological applications.

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Synthetic biology’s multiple dimensions of benefits and risks: implications for governance and policies

Cited by 10 publications

References 53 publications

Synthesize this: integrating innovation governance and EU regulation of synthetic biology

Synthesize this: integrating innovation governance and EU regulation of synthetic biology

A quantitative risk assessment method for synthetic biology products in the environment

El discurso sobre la biología sintética y la innovación responsable: observaciones desde una perspectiva histórica

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