Synthetic biology – often described as the engineering of biology – is rapidly expanding the range of possibilities in medicine, agriculture, industrial production and environmental sustainability. Scientists and bio-engineers are gaining power to design biological systems to produce materials, develop new therapies, or restore ecosystems. At the same time, these capabilities raise complex governance questions. Synthetic biology transcends traditional regulatory boundaries, accelerates scientific discovery through its convergence with artificial intelligence and automation, and introduces new concerns related to biosafety and biosecurity. As a result, governments are confronted with a dual challenge: how to unleash the transformative potential of synthetic biology, while ensuring that innovation develops in ways that are safe, socially beneficial and aligned with public values. Synthetic biology challenges governance frameworks built around discrete sectors, products or risks. The role of policy therefore shifts from managing isolated risks to shaping the trajectory of the innovation ecosystem.
This paper examines how OECD countries are responding to this challenge. Using the OECD Framework for Anticipatory Governance of Emerging Technologies (the “OECD Framework”), the analysis maps national governance approaches to synthetic biology and identifies emerging policy practices that support responsible innovation. It aims to offer guidance and best-practice examples to support OECD countries in strengthening responsible innovation for synthetic biology.
Across the countries reviewed, five governance trends consistent with the OECD Framework are emerging.
First, governments are making values more explicit as they seek to steer innovation. Many national strategies emphasise sustainability, safety, equity and public benefit as core principles for biotechnology development. These values are being translated into practice through mechanisms such as ethics advisory bodies, research programmes on the ethical and societal implications of biotechnology, codes of conduct for scientists, and funding criteria that encourage innovation aligned with public-interest outcomes.
Second, countries are strengthening strategic intelligence to anticipate technological developments. Foresight exercises, horizon scanning initiatives and technology assessment programmes are becoming important tools for helping policymakers understand emerging scientific trajectories and potential societal implications. When integrated into policy cycles, these tools can support more proactive governance and reduce uncertainty for both regulators and innovators.
Third, stakeholder engagement is becoming more institutionalised. Governments are increasingly involving researchers, industry, civil society organisations and the public in shaping biotechnology policy. Engagement mechanisms range from public consultations and advisory panels to collaborative platforms that connect scientific, industrial and policy communities. These approaches recognise that governance of emerging technologies benefits from diverse knowledge and perspectives.
Fourth, policymakers are experimenting with more agile regulatory approaches. Given the pace of innovation in synthetic biology, some countries are exploring mechanisms such as regulatory sandboxes, pilot initiatives and iterative guidance processes to test governance approaches and generate evidence for future regulation. These mechanisms are typically designed to complement – rather than replace – existing regulatory frameworks.
Fifth, countries are cooperating internationally to coordinate approaches. Because biological knowledge, materials and risks move across borders, national policies increasingly emphasise collaboration through research partnerships, standards development, and multilateral dialogue. International co-operation can support shared strategic intelligence, reduce regulatory fragmentation and strengthen global biosafety and biosecurity systems.
While these developments point toward a more anticipatory model of governance, implementation remains uneven. In many countries, responsible innovation principles are articulated in strategies but not yet fully embedded in policy instruments. Strategic intelligence capacities remain fragmented, stakeholder engagement is often episodic, and regulatory systems continue to struggle with technologies that cross sectoral regulations, creating gaps and overlaps in regulator mandates.
Drawing on the analysis of policy initiatives across OECD countries, the paper identifies a set of policy considerations for strengthening anticipatory governance of synthetic biology. These include:
advancing research and development that aligns with societal values and needs;
institutionalising foresight and technology assessment to inform policy decisions;
developing structured and continuous stakeholder engagement mechanisms;
enabling adaptive regulatory approaches while maintaining robust biosafety and biosecurity safeguards;
strengthening international co-operation to address transboundary risks and align governance approaches.
Taken together, these actions can help governments move toward governance systems that are more forward-looking, evidence-informed and responsive to societal expectations in order to enable responsible innovation in the field.
Synthetic biology is still an evolving field, but its trajectory is likely to shape the future bioeconomy. Ensuring that governance evolves alongside technological capabilities will be critical to maintaining public trust, fostering responsible innovation, and enabling societies to realise the benefits of this emerging technological domain.