SynBioGov · A framework for the fair and responsible governance of synthetic biology

A framework for the fair and responsible governance of synthetic biology

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).

Data: CORDIS, © European Union