Periodic Reporting for period 1 - SynBioGov (A framework for the fair and responsible governance of synthetic biology)
Reporting period: 2021-09-01 to 2023-08-31
Positioned in the context of international environmental law and governance, the SynBioGov project aims at developing an integrative conceptual framework for the fair and responsible governance of synthetic biology. Synthetic biology refers to an emerging interdisciplinary area of science and technology that involves the application of engineering principles to biology. Far from being a homogeneous field, it encompasses a wide range of enabling methodologies such as DNA sequencing, and tools associated with novel biotechnologies such as gene editing, all aiming at the (re-)design and fabrication of biological components and systems that do not already exist in the natural world.
Synthetic biology has progressed by leaps and bounds in recent years, accompanied by great promises and grave risks. At the same time, law and governance lag behind. While legal orders at the national and regional level are struggling, lab experimentation and field trials take place in a legal vacuum. Developments related to synthetic biology pose challenges for the legal frameworks regulating both access to genetic resources (the raw material for biotechnological innovation) and fair and equitable sharing of the benefits arising from their use, and biosafety (the safety of biotechnological applications for the environment and human/animal health). Global deliberations on these two aspects, covering the environmental and socio-economic impacts of synthetic biology, are held under the auspices of UN multilateral environmental agreements, including the Convention on Biological Diversity (CBD). An additional challenge relates to the diverse communities of actors that have arisen around synthetic biology. Previous waves of biotechnological innovation were confined in companies and research institutes. On top of these traditional actors, a do-it-yourself (DIY) community engages in synbio research, claiming to democratize science and problem-solving.
Aiming at empirically-rich and policy-relevant socio-legal analysis, the SynBioGov project covers both the macro-level (global institutions and multilateral environmental agreements) and the micro-level (actors involved in lab research), also addressing the institutional structures for risk management and practices for responsible research and innovation that connect them. It includes:
• an assessment of the current state of international environmental law, including an analysis of regulatory gaps and normative challenges regarding both biosafety and equity and justice-related objectives, with focus on the CBD and the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA);
• a review of social sciences literature on risk and innovation, including gendered approaches; and
• development of an exploratory typology of actors involved in synthetic biology research, including their claims and motivations.
The resulting framework builds on the principles of fairness and safety to promote global justice outcomes, further aiming to improve accountability of decision makers and actors involved in research, and enhance the legitimacy both of decision making and of the innovation process. Using a Third World Approaches to International Law (TWAIL) analytical lens, it approaches biotechnology governance through a decolonized approach to international law scholarship and science and technology studies (STS).
Synthetic biology has progressed by leaps and bounds in recent years, accompanied by great promises and grave risks. At the same time, law and governance lag behind. While legal orders at the national and regional level are struggling, lab experimentation and field trials take place in a legal vacuum. Developments related to synthetic biology pose challenges for the legal frameworks regulating both access to genetic resources (the raw material for biotechnological innovation) and fair and equitable sharing of the benefits arising from their use, and biosafety (the safety of biotechnological applications for the environment and human/animal health). Global deliberations on these two aspects, covering the environmental and socio-economic impacts of synthetic biology, are held under the auspices of UN multilateral environmental agreements, including the Convention on Biological Diversity (CBD). An additional challenge relates to the diverse communities of actors that have arisen around synthetic biology. Previous waves of biotechnological innovation were confined in companies and research institutes. On top of these traditional actors, a do-it-yourself (DIY) community engages in synbio research, claiming to democratize science and problem-solving.
Aiming at empirically-rich and policy-relevant socio-legal analysis, the SynBioGov project covers both the macro-level (global institutions and multilateral environmental agreements) and the micro-level (actors involved in lab research), also addressing the institutional structures for risk management and practices for responsible research and innovation that connect them. It includes:
• an assessment of the current state of international environmental law, including an analysis of regulatory gaps and normative challenges regarding both biosafety and equity and justice-related objectives, with focus on the CBD and the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA);
• a review of social sciences literature on risk and innovation, including gendered approaches; and
• development of an exploratory typology of actors involved in synthetic biology research, including their claims and motivations.
The resulting framework builds on the principles of fairness and safety to promote global justice outcomes, further aiming to improve accountability of decision makers and actors involved in research, and enhance the legitimacy both of decision making and of the innovation process. Using a Third World Approaches to International Law (TWAIL) analytical lens, it approaches biotechnology governance through a decolonized approach to international law scholarship and science and technology studies (STS).
The project’s objectives are achieved via a mix of tools and methods, including:
• training, including on qualitative research methods in the host institution;
• legal doctrinal methods, including analysis and interpretation of multilateral environmental agreements, decisions of their governing bodies, and other UN documents; and
• qualitative research methods, including observer participation at UN meetings, interviews, and content analysis.
Given the focus on the principles of fairness and safety, the legal assessment focuses on two streams of international policy-making under the CBD and the ITPGRFA: access to genetic resources and fair and equitable benefit-sharing (ABS), in order the analyze and assess the fairness of biotechnological developments and related governance efforts; and biosafety, in order to analyze the safety of biotechnological developments for the environment and human/animal health. These developments are placed in the context of general international law and relevant international instruments under the World Health Organization and the UN Convention on the Law of the Sea, among others. The legal assessment is then enriched by discourses revealed by the social sciences literature review, including on the North/South divide, orders and systems of knowledge, and the feminist ethics of care.
The typology of actors is based on a review of the online landscape of synthetic biology research, and organization and conduct of a series of semi-structured interviews with researchers in the field.
Research results are disseminated and exploited through:
• a series of scientific conference presentations, including at the 2022 Biannual Conference of the International Law Association, the 2022 Conference on Earth System Governance, the 2023 Conference of the European Society of International Law, and the 2023 STS Italia annual conference;
• two side-events organized in the context of the ITPGRFA Governing Body sessions;
• scientific publications, including in collaboration with other scholars; and
• lectures, seminars, and outreach activities, including in collaboration with other EU-funded projects.
• training, including on qualitative research methods in the host institution;
• legal doctrinal methods, including analysis and interpretation of multilateral environmental agreements, decisions of their governing bodies, and other UN documents; and
• qualitative research methods, including observer participation at UN meetings, interviews, and content analysis.
Given the focus on the principles of fairness and safety, the legal assessment focuses on two streams of international policy-making under the CBD and the ITPGRFA: access to genetic resources and fair and equitable benefit-sharing (ABS), in order the analyze and assess the fairness of biotechnological developments and related governance efforts; and biosafety, in order to analyze the safety of biotechnological developments for the environment and human/animal health. These developments are placed in the context of general international law and relevant international instruments under the World Health Organization and the UN Convention on the Law of the Sea, among others. The legal assessment is then enriched by discourses revealed by the social sciences literature review, including on the North/South divide, orders and systems of knowledge, and the feminist ethics of care.
The typology of actors is based on a review of the online landscape of synthetic biology research, and organization and conduct of a series of semi-structured interviews with researchers in the field.
Research results are disseminated and exploited through:
• a series of scientific conference presentations, including at the 2022 Biannual Conference of the International Law Association, the 2022 Conference on Earth System Governance, the 2023 Conference of the European Society of International Law, and the 2023 STS Italia annual conference;
• two side-events organized in the context of the ITPGRFA Governing Body sessions;
• scientific publications, including in collaboration with other scholars; and
• lectures, seminars, and outreach activities, including in collaboration with other EU-funded projects.
The project produced a series of key insights to enrich the state of the art, including:
• There is a high degree of terminological confusion regarding the term “synthetic biology,” revealed by the analysis of legal documents and confirmed in interviews with researchers in the field.
• The institutional landscape is polycentric and global governance fragmented; the CBD however is the primary instrument of relevance, due to its broad scope, span of its agenda, history in biotechnology governance, and almost universal application.
• In view of synthetic biology applications in various sectors and of the increasing complexity of the institutional landscape, cooperation and coordination among the various international agreements and bodies is crucial for effective governance.
• A diversity of actors and disciplines are involved in the field of synthetic biology, including academia, industry and private sector, venture capital, and DIY synthetic biologists, from the disciplines of molecular biology, biotechnology, bioinformatics, chemistry, pharmacy, and engineering, among others, with applications ranging from agricultural, pharmaceutical and medical, to several industrial uses.
• The International Genetically Engineered Machine (iGEM) student competition holds a central part in the field’s development, but more traditional actors, such as industry and academia, participate in the CBD expert discussions.
• Research activity remains largely concentrated in the Global North.
• It is vital to bridge the two objectives of fairness and safety in biotechnological innovation towards a broad understanding of risk to include environmental, socio-economic, and cultural dimensions, and reflection of this understanding into societally-appropriate scientific and technological pathways.
• There is a high degree of terminological confusion regarding the term “synthetic biology,” revealed by the analysis of legal documents and confirmed in interviews with researchers in the field.
• The institutional landscape is polycentric and global governance fragmented; the CBD however is the primary instrument of relevance, due to its broad scope, span of its agenda, history in biotechnology governance, and almost universal application.
• In view of synthetic biology applications in various sectors and of the increasing complexity of the institutional landscape, cooperation and coordination among the various international agreements and bodies is crucial for effective governance.
• A diversity of actors and disciplines are involved in the field of synthetic biology, including academia, industry and private sector, venture capital, and DIY synthetic biologists, from the disciplines of molecular biology, biotechnology, bioinformatics, chemistry, pharmacy, and engineering, among others, with applications ranging from agricultural, pharmaceutical and medical, to several industrial uses.
• The International Genetically Engineered Machine (iGEM) student competition holds a central part in the field’s development, but more traditional actors, such as industry and academia, participate in the CBD expert discussions.
• Research activity remains largely concentrated in the Global North.
• It is vital to bridge the two objectives of fairness and safety in biotechnological innovation towards a broad understanding of risk to include environmental, socio-economic, and cultural dimensions, and reflection of this understanding into societally-appropriate scientific and technological pathways.