Anticipatory governance for responsible innovation in synthetic biology

3. Policy actions for responsible innovation in synthetic biology

This section draws on insights from the previous mapping of empirical examples against the OECD Framework’s five elements. The analysis highlighted emerging governance mechanisms, areas where alignment remains partial, and opportunities to strengthen coherence across policy instruments.

Moving beyond the identification of trends and good practices, this section focuses on how anticipatory governance can be put into practice – by operationalising values in policy, integrating foresight, stakeholder engagement, agility and international co-operation into the design and implementation of policy tools. The findings provide key points to consider on how governments can develop more adaptive, evidence-informed and values-driven governance systems for synthetic biology.

3.1 Integrating elements of anticipatory governance in policy frameworks

Responsible innovation in synthetic biology requires coherent coordination across policy instruments. Many science, technology, and innovation policies remain compartmentalised within national innovation agendas, limiting integration across ministries or with global frameworks (OECD, 2025[2]). In emerging cross-sectoral fields such as synthetic biology, this fragmentation can create contradictory incentives, dilute accountability, and deter private investment (OECD, 2025[31]).

Achieving coherence in synthetic biology governance requires more than horizontal coordination. It implies that policy frameworks internalise the principles of anticipatory governance, embedding its five elements – guiding values, strategic intelligence, stakeholder engagement, agile regulation, and international co-operation – into the design and functioning of individual policy instruments. These elements are interdependent: effective anticipatory governance emerges when values, intelligence, engagement, regulation and international cooperation reinforce each other across the policy cycle. Their integration ensures that instruments reinforce one another and align towards common goals. For instance, financing mechanisms informed by foresight and stakeholder dialogue are better positioned to address systemic bottlenecks, while agile regulation, supported by strategic intelligence and international collaboration, fosters flexible yet predictable governance environments.

A key example of this integrative approach is the 4TU project on Ethical and Regulatory Issues Raised by Synthetic Biology. This initiative combines normative reflections on biosafety (guiding values), foresight and technology assessment (strategic intelligence), co-creation with scientific communities (stakeholder engagement), adaptive regulatory analysis (agile regulation), and transnational collaboration (international co-operation). Similarly, the United Kingdom Engineering Biology Responsible Innovation Advisory Panel institutionalises a continuous feedback loop between government, industry, and academia, ensuring that evidence leads to timely policy adaptations.

3.1.1 Guiding values

The review of national approaches in Section 2.1 indicates that countries seeking to embed societal values in synthetic biology governance rely on a combination of policy instruments rather than a single mechanism. These include the articulation of value commitments in national strategies, the institutionalisation of ethical and societal reflection through advisory bodies or ELSI/A research programmes, structured public dialogue mechanisms, and the use of funding and investment criteria to orient innovation towards public-interest outcomes. Across the examples reviewed, these instruments operate primarily as enabling governance tools: they shape expectations, guide behaviour and support learning, rather than substituting for binding regulatory safeguards.

Taken together, these approaches reflect growing recognition that responsible innovation in synthetic biology depends on embedding societal values early and continuously in the innovation process. Doing so helps ensure that technological developments remain aligned with public priorities, supports long-term policy effectiveness, and mitigates the risk of public concern or loss of trust once applications reach the market. Past experiences in areas such as agrifood biotechnology and environmental applications illustrate that limited engagement with societal values can undermine acceptance and delay or constrain otherwise beneficial innovation (Robinson and Nadal, 2025[4]) . By contrast, governance arrangements that integrate ethical reflection, societal dialogue and public-interest orientation from the outset can strengthen the social robustness of innovation ecosystems.

Drawing on these observed practices, policymakers aiming to operationalise guiding values in the governance of synthetic biology may consider the following actions:

• Identify and articulate the societal values that should guide synthetic biology policy and embed them throughout the innovation cycle. This may involve clarifying both foundational values and values specific to the governance of emerging biotechnologies, ensuring that these principles inform research priorities, funding criteria, regulatory oversight and public engagement mechanisms.

• Translate value commitments into implementable instruments. Beyond referencing ethics, sustainability or safety in high-level strategies, governments can embed these values in concrete mechanisms such as ethics councils, advisory panels or assessment criteria that inform funding decisions, strategy reviews or regulatory updates.

• Institutionalise early and continuous societal dialogue. Rather than relying on ad hoc consultations, countries can establish standing or recurring dialogue mechanisms whose outputs are formally linked to policy processes (e.g. strategy revisions, priority-setting or programme design).

• Integrate ethical and societal analysis into research and funding programmes. Requiring interdisciplinary approaches – such as the inclusion of ELSI/A or GE3LS components in publicly funded synthetic biology projects – can ensure that ethical, legal and social considerations inform scientific trajectories in real time, rather than retrospectively.

• Use funding and investment criteria to orient innovation toward public-interest outcomes. Mission-oriented or challenge-oriented funding models can encourage innovators to align business models and research agendas with societal goals such as environmental sustainability, health resilience or biosecurity, while still supporting commercial viability.

• Strengthen transparency and feedback loops to build trust. Governments can reinforce legitimacy by clearly communicating the anticipated benefits, risks and uncertainties of synthetic biology applications, and by making transparent how societal input has informed policy choices, funding priorities or governance adjustments.

3.1.2 Strategic intelligence

The comparative analysis in Section 2.2 indicates that strategic intelligence is a foundational enabling capacity for anticipatory governance of synthetic biology. Across countries, governments are investing in a range of foresight, horizon scanning and technology assessment tools to better understand emerging scientific trajectories, market developments and societal implications. The most effective approaches are characterised not by one-off studies, but by the institutionalisation of strategic intelligence functions that are linked to national strategies, funding priorities, regulatory review and coordination across ministries. Where such linkages are weak, intelligence risks remaining descriptive rather than shaping policy choices.

Strategic intelligence enables governments to move from reactive risk management toward proactive and proportionate governance. In a field such as synthetic biology policy decisions must often be taken under conditions of uncertainty. Foresight and technology assessment aim to prepare governments for a range of plausible futures, support learning over time, and reduce uncertainty for innovators and regulators alike. By embedding intelligence into policy cycles, governments can better align innovation support, safeguards and societal expectations.

To implement the strategic intelligence element, policymakers should invest in forward-looking capacities and integrate them into policy cycles. Policymakers can consider the following:

• Institutionalise horizon scanning and foresight as standing functions. Rather than commissioning ad hoc studies, governments can establish permanent or recurring units (e.g. observatories, foresight panels or inter-ministerial intelligence hubs) tasked with monitoring scientific advances, market trends and societal concerns related to synthetic biology.

• Link strategic intelligence explicitly to decision points in the policy cycle. Foresight outputs are most effective when they inform concrete processes such as the development or revision of national strategies, the design of funding programmes, or the review of regulatory frameworks. Formal requirements can help ensure uptake.

• Integrate anticipatory research into funding and research programmes. Supporting research on future trajectories, ethical and societal implications, and emerging risks (e.g. through ELSI/ELSA or GE3LS-type components) helps ensure that knowledge about impacts keeps pace with technical innovation and feeds back into governance.

• Adopt whole-of-government approaches to intelligence and learning. Examples such as coordinated planning architectures or cross-ministerial deliberation committees illustrate how strategic intelligence can support coherence across innovation, industrial, environmental and security policies, reducing fragmentation in fast-moving fields.

• Treat strategies and roadmaps as living instruments. Countries that embed review, evaluation and updating mechanisms into strategies, through progress reports or scheduled reassessments, are better positioned to adapt governance arrangements as evidence and conditions evolve.

3.1.3 Stakeholder engagement

The review of national approaches in Section 2.3 indicates that stakeholder engagement in synthetic biology governance is increasingly institutionalised through a wide array of mechanisms. These include advisory councils, public-private partnerships, co-creation platforms, consultation processes linked to strategies and legislation, and participatory initiatives such as biofoundries, community programmes and educational fora. Across countries, engagement is most effective when it is continuous, linked to decision-making processes, and tailored to different categories of actors, such as expert communities, directly affected groups and the broader public, rather than treated as a one-off consultation exercise.

Stakeholder engagement enables responsible innovation by bringing diverse forms of knowledge into governance processes. In synthetic biology, technical expertise is widely distributed across academia, industry and civil society, while societal perceptions can strongly shape the acceptance and deployment of new applications. Engagement can therefore improve policy design by surfacing operational insights, ethical concerns and emerging risks early. It can also strengthen the long-term viability of innovation by building shared understanding, reducing uncertainty and fostering trust between governments, innovators and society. Countries that have embedded engagement in strategy development, advisory structures and research programmes are better positioned to anticipate challenges and co-develop workable governance solutions.

Policymakers looking to strengthen stakeholder engagement in synthetic biology governance can take several steps:

• Systematically map the relevant engagement landscape. Effective engagement begins with identifying the range of actors involved or affected, including scientific communities, start-ups and industry, regulators, civil society organisations, local communities, and emerging networks. Several countries have done this implicitly through strategy consultations and advisory structures that bring together diverse perspectives.

• Use differentiated engagement formats aligned with policy needs. Evidence from national strategies and initiatives shows that different tools serve different purposes: expert advisory panels for technical guidance, public consultations for broad input, participatory workshops for co-creation, and networking platforms or community initiatives for ecosystem-building. Combining these formats can help ensure that engagement supports both policy design and implementation.

• Institutionalise co-creation in selected governance processes. In areas such as standards development, codes of conduct or research agendas, involving practitioners who will implement governance measures can improve feasibility and uptake. Examples from standards consortia, public-private roadmapping exercises and collaborative platforms illustrate how shared ownership can strengthen compliance and innovation outcomes.

• Embed engagement mechanisms in formal policy cycles. Countries that integrate stakeholder input into the development and periodic review of national strategies, funding programmes or regulatory frameworks – through advisory councils, standing forums or recurring consultations – create feedback loops that help governance evolve alongside the technology.

• Strengthen transparency and feedback mechanisms. Publishing consultation outcomes, “what we heard” summaries or advisory panel recommendations helps demonstrate how stakeholder input informs policy decisions. This can improve trust and sustain participation over time.

• Actively address participation asymmetries. Evidence suggests that engagement processes can be dominated by well-resourced actors unless deliberately designed to be inclusive (Paunov and Planes-Satorra, 2023[45]). Governments can broaden participation by using digital tools, supporting the involvement of underrepresented groups, and ensuring that small firms, regional actors and civil society organisations have meaningful opportunities to contribute.

3.1.4 Agile regulation

The review in Section 2.4 indicates that countries are increasingly exploring regulatory approaches that combine strong safeguards with mechanisms for learning and adaptation. In synthetic biology, this includes practices such as regulatory sandboxes, testbeds, cross-agency coordination platforms, iterative guidance, and periodic review of regulatory frameworks. These approaches are typically introduced not to replace existing regulatory regimes, but to complement them by generating evidence, reducing uncertainty and improving coherence across sectors. Where agile mechanisms are embedded in broader governance systems through coordination networks, review clauses or pilot initiatives, they help ensure that regulation evolves alongside scientific and technological change.

Agile regulatory approaches can support responsible innovation by helping regulators respond to emerging technologies in a timely and proportionate manner. In a fast-moving and cross-sectoral field such as synthetic biology, regulatory uncertainty can slow beneficial innovation, while outdated or fragmented rules may create safety gaps or inconsistent oversight. Adaptive regulatory practices, when anchored in robust safety and security frameworks, can enable governments to test new oversight models, learn from implementation, and refine regulatory approaches over time. This can improve both the effectiveness of safeguards and the predictability of governance for innovators.

To operationalise agile regulation, in addition to ensuring compliance with existing regional, sub-regional, national and international regulation, policymakers should embrace a “design, experiment, learn, and adjust” mentality in regulatory policy:

• Design regulatory frameworks that can evolve with technology. Where appropriate, outcome-based or principles-based provisions, combined with periodic review mechanisms, can help ensure that rules remain relevant as techniques and applications develop. Several countries are already signalling the need to update legacy biotechnology frameworks or adapt definitions and scopes to reflect new methods.

• Use complementary governance instruments where appropriate. Non-binding tools such as standards, guidelines, codes of conduct and “by-design” approaches can provide flexible governance mechanisms while evidence and regulatory frameworks evolve.

• Use controlled experimentation to generate regulatory learning. Pilot initiatives such as regulatory sandboxes or testbeds can provide structured environments for regulators and innovators to jointly explore how existing rules apply to novel applications. Evidence generated through these mechanisms can inform future rulemaking and reduce uncertainty for both regulators and industry.

• Embed review and learning mechanisms into regulatory systems. Practices such as sunset clauses, scheduled reassessments, or regular regulatory mapping exercises can help identify outdated provisions, overlaps across agencies, and areas where guidance needs updating. Countries that treat regulation as an iterative process are better positioned to maintain coherence over time.

• Strengthen regulatory capacity and cross-agency coordination. Synthetic biology spans multiple domains and mechanisms such as regulators’ networks, inter-ministerial coordination platforms or shared technical advisory structures can help avoid fragmentation and support consistent approaches to emerging issues.

• Engage stakeholders in the development and refinement of regulatory approaches. Involving industry, researchers and public-interest actors in the design of pilot initiatives, guidance documents or standards can improve feasibility, encourage compliance and surface practical implementation challenges early.

• Promote learning across jurisdictions. Monitoring regulatory experiments and reforms in other countries, and sharing experiences through international platforms, can help identify emerging best practices and support gradual convergence in areas such as safety assessment methods, standards and oversight approaches.

3.1.5 International co-operation

Section 2.5 highlights that synthetic biology is inherently transnational: knowledge, materials, products and risks move across borders, and governance choices in one jurisdiction can have spillover effects elsewhere. Countries are increasingly embedding international engagement into their national strategies through research partnerships, multilateral foresight platforms, standards-setting initiatives and capacity-building efforts. Emerging practice suggests that international co-operation plays several distinct roles: supporting shared strategic intelligence, promoting interoperability of regulatory approaches, strengthening global biosafety and biosecurity, and helping build governance capacity in lower-resourced contexts. At the same time, geopolitical competition, data sensitivity and security concerns are creating tensions around openness and knowledge sharing.

International co-operation can help reduce blind spots by pooling evidence, aligning expectations and supporting consistent safety practices. It also plays a role in sustaining public trust and market development by reducing fragmentation and ensuring that governance standards evolve in a broadly coherent direction. In a context of uneven technical and regulatory capacity, collaborative approaches can help prevent the emergence of “weak links” in biosafety or biosecurity systems, while supporting more inclusive participation in innovation benefits.

International co-operation strengthens all dimensions of anticipatory governance. Policymakers can:

• Embed international co-operation into national governance strategies. Assign clear institutional responsibility for international engagement across ministries and agencies, recognising that synthetic biology spans multiple policy domains including health, agriculture, environment, security and trade. Treating co-operation as a strategic function can improve coherence and continuity.

• Invest in shared strategic intelligence. Participating in multilateral horizon scanning, foresight and technology assessment initiatives can strengthen domestic anticipatory capacity and provide early visibility on global trends, risks and opportunities. Shared intelligence platforms can help align national policy responses and reduce duplication of effort.

• Work towards interoperable governance approaches. Full regulatory harmonisation may not be feasible, but gradual alignment on definitions, data requirements, safety assessment methods and technical standards can reduce fragmentation. Interoperability can support trade, facilitate collaborative research and strengthen safety by enabling mutual learning across jurisdictions.

• Use trusted fora to address sensitive governance questions. In areas such as biosecurity, dual-use research or environmental release of engineered organisms, value-based international platforms can provide space to align principles and expectations early. These settings can support dialogue even where geopolitical competition limits deeper integration.

• Strengthen international collaboration in science and innovation. Joint research programmes, shared infrastructures and collaborative technology assessment initiatives can support common evidence bases and foster shared approaches to governance.

• Plan jointly for transboundary impacts. Some applications, such as gene drive organisms, distributed biomanufacturing for health products, or large-scale environmental interventions, may have cross-border implications. Developing advance notification mechanisms, data-sharing practices and joint risk-response protocols with partners can strengthen preparedness and policy coherence.

• Support international capacity building. Uneven governance capacity can create vulnerabilities and inequities. Collaborative efforts that share risk-assessment methodologies, regulatory training, technical expertise and infrastructure can help ensure that all countries can participate meaningfully in governing and benefiting from synthetic biology.