Anticipatory governance for responsible innovation in synthetic biology

1. Synthetic biology and the need for anticipatory governance

Synthetic biology – often described as the engineering of biology – is a multidisciplinary field at the frontier of biotechnology, combining engineering, biology, computer science and chemistry to design or modify biological systems for useful purposes. It applies engineering design such as standardisation, orthogonality, and abstraction (OECD, 2014[1]), and increasingly draws on advanced computational tools, including automation and artificial intelligence, to accelerate the development of novel organisms and production pathways (OECD, 2025[2]; OECD, 2025[3]). As a foundational platform – integrating interdisciplinary techniques and therefore enabling the development of multiple products and applications – synthetic biology underpins developments in health, agriculture, industry and environmental sustainability, and is increasingly recognised by many OECD countries as a strategic domain within national technology and bioeconomy agendas. OECD analysis identified several high-impact areas with transformative potential, including personalised therapies, food and soil resilience, bio-based materials and circular production systems, AI-enabled biological design, and decentralised manufacturing (Robinson and Nadal, 2025[4]). Beyond economic opportunity, synthetic biology is increasingly linked to geopolitical competitiveness and national security considerations.

Alongside its transformative potential, synthetic biology raises uncertainties and governance challenges. The ability to design novel organisms, scale automated biological production and analyse large genomic datasets may generate new biosafety and biosecurity risks. For example, the release of engineered organisms into ecosystems may have unintended ecological effects; expanding access to DNA synthesis and automated lab tools could increase the risk of misuse; and uneven regulatory capacity across countries may create “weak links” in global biosecurity (Robinson and Nadal, 2025[4]). Many impacts of synthetic biology are also difficult to anticipate. They may unfold across multiple temporal and geographic scales, accumulate gradually, and generate complex externalities. As a result, governance challenges extend beyond isolated catastrophic scenarios to include more systemic risks that may be less visible but equally consequential (OECD-Hoover Institution, 2025[5]). At the same time, rapid technological convergence – particularly with artificial intelligence – accelerates the pace of discovery and innovation (OECD, 2025[3]). These characteristics challenge governance systems that rely primarily on reactive or static regulatory approaches (OECD, 2025[6]).

In response to such dynamics across emerging technologies, the OECD has increasingly emphasised the importance of responsible innovation and anticipatory governance, ensuring that science and technology are guided by values, responsive to societal needs, and accountable to the public. The OECD Framework for Anticipatory Governance of Emerging Technologies (OECD, 2024[7]) (hereafter the OECD Framework) provides a structured approach to shaping innovation upstream rather than responding only after risks materialise. Developed through cross-government collaboration and endorsed at ministerial level, it identifies five core elements of forward-looking governance. These include embedding guiding values throughout the innovation process; strengthening strategic intelligence through foresight and technology assessment; fostering early and continuous stakeholder engagement; enabling agile regulatory approaches capable of adapting to technological change; and strengthening international co-operation to support shared learning and coordinated governance. Essentially, the OECD Framework underscores that responsible technology development will require innovations in governance approaches as much as in technologies themselves.

Previous OECD initiatives illustrate the application of these principles in practice. The OECD Recommendation on Responsible Innovation in Neurotechnology marked an early effort to guide a field with significant ethical, legal and societal implications (OECD, 2019[8]). Experiences with fast-moving technologies like artificial intelligence have further underscored the need for anticipatory approaches. The unexpected acceleration of generative AI, for example, demonstrated how quickly transformative technologies can outpace policy frameworks and societal preparedness (Sarliève et al., 2025[9]; Lorenz, Perset and Berryhill, 2023[10]). These developments highlight the importance of anticipatory, flexible and internationally coordinated governance approaches. The early uptake of the OECD Framework in European Commission research policy illustrates the growing relevance of these approaches (European Commission, 2024[11]).

Synthetic biology represents a salient example of a technological field where an anticipatory approach to governance is relevant. A growing number of OECD countries have identified synthetic biology as a strategic area within their national technology or bioeconomy agendas. The European Union’s Strategic Technologies for Europe Platform (2025), the United Kingdom’s Science and Technology Framework (2025) the United States’s NSTC Critical and Emerging Technologies List (updated in 2024), are but examples of rising strategic interest in this technological field. As a foundational and cross-disciplinary technology, it sits at the intersection of scientific innovation, industrial transformation and public policy. Synthetic biology cuts across traditional regulatory boundaries, raises biosafety and biosecurity concerns, and its trajectory raises also questions around ethical responsibility, societal legitimacy and equitable access. OECD-convened expert groups have therefore identified synthetic biology as a priority area for operationalising anticipatory governance approaches.

1.1 From research guidelines to anticipatory governance: The evolution of biotechnology governance

The governance of synthetic biology has evolved out of earlier regimes for biotechnology, genomics, and the life sciences. In the 1970s and 1980s, genetic engineering was largely managed through scientist-led guidelines and existing regulatory frameworks developed for biotechnology (Barkstrom, 1986[12]). A landmark example is the 1975 Asilomar Conference, where researchers agreed on voluntary safety measures for DNA experiments – an early case of proactive self-regulation in biotechnology (Grace, 2015[13]), but one also that has been subsequently criticised from the perspective of public and stakeholder engagement. By the 1980s, governments began adapting general biotechnology oversight to new genetic techniques (e.g. the United States’ 1986 Coordinated Framework for Biotechnology, and the European Union’s regulations on genetically modified organisms in the 1990s) (White House, 2015[14]; Damien and Guy, 2010[15]). These approaches primarily focused on biosafety, containment and risk assessment of tangible products such as GM crops or biologics, often addressing issues after innovations were underway.

In parallel, the genomics era of the 1990s saw a more formal institutionalisation of reflection on broader societal impacts of life-science research. This was exemplified by the Human Genome Project and subsequently in concomitant research typically addressed under the labels Ethical, Legal, and Social Implications (ELSI) or Aspects (ELSA) programs (Collins, 2001[16]; Chadwick and Zwart, 2013[17]). While societal considerations had long featured in scientific and public discourse, these programmes marked an important step in embedding them more systematically within the governance ecosystem surrounding life-science innovation. Taken together, these developments reflect an early expansion of governance beyond laboratory risk mitigation alone to include ethical and societal dimensions of life-science innovations, primarily through soft governance mechanisms and concomitant research.

The governance of synthetic biology initially followed a similar path, extending existing biotechnology regulations to synthetic biology applications. Throughout the 2000s, as synthetic biology emerged as a distinct field, regulators mostly treated it under pre-existing laws (e.g. regulations for genetically modified organisms, laboratory biosafety standards, biosecurity controls on pathogens) (OECD, 2014[1]). Early policy discussions often presumed that no entirely new regulatory regime was needed, barring clear evidence of novel risks. Nonetheless, the mid-2000s saw growing awareness of the field’s unprecedented capabilities (such as possible futures for constructing novel genomes, engineering organisms with no natural precedent) and its diffuse community (including not just academic and industry labs but also DIY biology hobbyists). This spurred calls for more forward-looking oversight (Office parlementaire d'évaluation des choix scientifiques et technologiques, 2012[18]). For instance, in 2010 the U.S. Presidential Commission for Bioethical Issues recommended a stance of “prudent vigilance” for synthetic biology – a middle way between moratorium and unfettered pursuit of innovation (Presidential Commission for the Study of Bioethical Issues, 2010[19]). The Commission argued that while a ban was unjustified, ongoing monitoring of risks and benefits and periodic re-evaluation of policies would be essential as the science advanced. It also articulated core ethical principles (public beneficence, stewardship, intellectual freedom and responsibility, justice, etc.) to guide the field’s development. Governance was no longer only about controlling risks, but also about ensuring innovation proceeds in line with societal values.

By the late 2010s and into the 2020s, discourse around the governance of synthetic biology is increasingly characterised by efforts to be anticipatory (forward-looking and preventative), based on multi-stakeholder engagement, and values-driven, aligning with the broader responsible innovation paradigm. This evolution is reflected in a growing international interest in forward-looking, agile, ethically grounded governance frameworks in science and technology policy. Anticipatory and responsible innovation principles are starting to materialise in concrete policy instruments. Notably, Korea’s Synthetic Biology Promotion Act – which aims to establish a foundation for research and development (R&D) in synthetic biology and to promote innovation in science and technology using synthetic biology – stands out as the first legislative initiative globally to reflect the OECD Framework into its statutory structure, referencing its principles.

This evolution sets the stage for analysing how countries are beginning to translate anticipatory governance principles into policy practice. Many recent strategies and initiatives explicitly aspire to these principles, although the extent to which they are operationalised varies across jurisdictions.

1.2 Applying the OECD Framework to synthetic biology governance

Against this backdrop, this paper examines how anticipatory governance and responsible innovation principles are beginning to shape national approaches to synthetic biology. Drawing on a comparative review of national strategies, legislative initiatives and governance mechanisms across OECD and partner countries, it identifies how governments are translating responsible innovation principles into concrete policy instruments and institutional arrangements. Given the absence of an internationally agreed definition of synthetic biology and its overlap with broader biotechnology domains, the analysis adopts a pragmatic scoping approach to capture relevant governance practices across related fields (see Annex A).

Using the OECD Framework as an analytical lens, the paper maps emerging practices across five governance dimensions: Values, Strategic Intelligence, Stakeholder Engagement, Agile Regulation, and International Co-operation. The following section highlights how these elements are beginning to materialise in policy, illustrating emerging patterns as well as remaining governance gaps.