Anticipatory governance for responsible innovation in synthetic biology

2. Emerging governance approaches in synthetic biology

Anticipatory governance of synthetic biology involves crafting policies that are proactive, inclusive, and adaptable in the face of rapid technological change. The OECD Framework provides five key elements – Values, Strategic Intelligence, Stakeholder Engagement, Agile Regulation, and International Co-operation – that can guide policymakers in designing forward-looking, resilient governance.

While many policies relevant to synthetic biology already exist across research, innovation, industrial, environmental and security domains, they are rarely designed or implemented as a coherent system explicitly aligned with responsible innovation objectives (Hynek, 2025[20]). A central challenge for governments is therefore not the absence of instruments, but their integration: ensuring the strategies, regulatory approaches, financing mechanisms and engagement processes work together in a way that is value-based, evidence-informed, adaptive over time and coordinated across sectors and borders.

This paper takes a comparative approach structured around the OECD Framework and focuses on five categories of policy instruments that play a central role in the governance of synthetic biology: 1) National strategies and roadmaps, 2) Financial and investment instruments; 3) Regulatory instruments; 4) Multistakeholder platforms and public consultation mechanisms; and 5) Advisory and expert bodies. These instruments constitute the primary means through which governments seek to implement responsible innovation in practice. At the same time, they serve as the main vehicles through which the principles of anticipatory governance are operationalised in national contexts. They are particularly relevant to synthetic biology because of its platform character, cross-sectoral applications and convergence with digital technologies. Governing synthetic biology requires tools that can articulate long-term direction, mobilise and steer investment, manage biosafety and biosecurity risks, incorporate societal values, and support learning under uncertainty. No single instrument can fulfil these functions alone. Their effectiveness depends on how they are combined, sequenced and aligned with broader governance objectives, including safety, security, sustainability and public trust.

This section brings these elements together with the empirical material drawn from the analysis of five key policy instruments. By examining how countries operationalise each element through these instruments, the section illustrates the diverse, yet converging approaches governments are taking to implement anticipatory governance in practice. It also highlights the extent to which these instruments collectively contribute to institutionalising responsible innovation in the field of synthetic biology.

2.1 Guiding values: embedding values and ethics in synthetic biology governance

Putting “guiding values” into practice means ensuring that the development of synthetic biology aligns with foundational societal principles – such as human rights, sustainability, safety – at multiple stages of the innovation and policy cycle. Policymakers should explicitly consider whether national biotechnology agendas advance the public good and how those value commitments are embedded in institutional processes. In practical terms, this entails articulating ethical frameworks within national strategies, applying principles such as precaution and sustainability in regulatory and investment decisions, including funding lines that specifically consider ethical, legal and social aspects of synthetic biology, and establishing mechanisms – such as ethics councils, public dialogues, and value-based funding criteria – to translate normative commitments into action. The objective is to steer innovation towards societal benefit while maintaining public trust by integrating ethical and social considerations from the outset.

2.1.1 How to operationalise values

Evidence from national policy initiatives shows that in the field of synthetic biology countries are using a range of mechanisms to embed ethics and societal values into the innovation cycle so that these can feed into processes of agenda setting, structuring research and development (R&D), early commercialisation and regulation (figure 2.1). The OECD Framework distinguishes different steps in this integration process, including values deliberation and values integration throughout the innovation process.

Figure 2.1. Key mechanisms to operationalise values in the innovation cycle

Source: OECD authors based on analysis of synthetic biology initiatives and (OECD, 2024[7]).

Embedding values in national strategies

The emerging good practice across these examples is to link technological development to broad societal outcomes (e.g. health, environmental sustainability, equity) and to be explicit that progress in synthetic biology is not a goal in itself but a means to serve public interests. South Korea’s 2022 Synthetic Biology Strategy goes as far as to reference bioethical norms in its policy framework, requiring that researchers and officials consider cultural values and moral implications alongside scientific development.

Many countries’ bioeconomy and synthetic biology strategies explicitly ground their vision in societal values and public goods. For example, Austria’s 2019 Bioeconomy Strategy ties biotechnology to sustainability and social responsibility, framing the bioeconomy as a means to achieve climate and environmental goals while upholding fairness and ethics. Germany’s 2020 National Bioeconomy Strategy is similarly rooted in the principle that “the bioeconomy must be designed to be ecologically compatible, economically viable and socially acceptable,” emphasising contributions to the UN Sustainable Development Goals and respect for planetary boundaries. German policymakers stress that progress in the bioeconomy should occur in tandem with societal dialogue and ethical reflection, ensuring that technologies like synthetic biology are continually evaluated against social welfare criteria. France’s 2011 National Strategy for Synthetic Biology likewise declared that innovation should address major societal challenges (health, environment, quality of life) and called for transparency and public reassurance in the face of “legitimate concerns” about “the artificialisation of the living” (translated). In doing so, France acknowledged cultural and ethical sensitivities around synthetic biology, insisting that democratic values and public trust must guide the field’s advance.

Depth and operationalisation of value commitments vary across strategies. In some cases, values such as transparency, inclusiveness, or sustainability are referenced in high-level terms but are not yet accompanied by concrete implementation tools such as oversight bodies, ethical guidelines, or mechanisms for value-based assessment. Other strategies emphasise economic resilience, security, or competitiveness as primary objectives, with societal goals acknowledged but not elaborated. For instance, Canada’s 2021 Biomanufacturing and Life Sciences Strategy articulates guiding principles focused on scientific excellence, capability-building, and national health preparedness – reflecting pragmatic goals in response to the COVID-19 pandemic context. While such framing is consistent with the strategy’s objectives, it illustrates how value commitments may be shaped by immediate policy imperatives. Nevertheless, even in economically focused initiatives, there is growing recognition that societal trust and public acceptance are critical to the long-term success of emerging biotechnologies. As many strategies move from design to implementation, there may be further opportunities to integrate anticipatory and value-based dimensions more systematically.

Early public dialogue: Identifying societal values and concerns

Public dialogue serves two purposes in the governance of emerging technologies: first, to identify the values and concerns that matter most to different communities; and second, to ensure that these values and concerns are meaningfully reflected in the design and direction of innovation. The lesson is that early and continuous societal reflection (beyond one-off consultations) helps clarify which public values must be addressed for technological development to earn societal legitimacy. Several governments encourage public engagement at the earliest stages of synthetic biology R&D to ensure societal values are considered in technology design. For example, the Netherlands has a long history of dialogue on emerging biotechnologies. The Rathenau Institute facilitated a “Meeting of Young Minds” as early as 2011, bringing together youth political representatives and iGEM synthetic biology students to debate the societal implications of synthetic biology. This and subsequent forums (involving NGOs and political leaders) have surfaced public hopes and fears, reflecting a commitment to pluralistic values in shaping technology (Bhatt et al., 2022[21]).

Integrating ethical and societal research alongside scientific innovation

Some countries embed societal values directly into research and innovation processes by funding dedicated research on the Ethical, Legal and Social Implications (ELSI/A) of synthetic biology alongside technical R&D. This approach ensures that questions such as ethics, equity of access, public perception and regulatory challenges are examined in parallel with scientific advances, allowing policymakers and researchers to identify societal concerns and governance needs early in the innovation cycle.

A good practice is Canada’s GE3LS programme (Genomics and its Ethical, Environmental, Economic, Legal and Social aspects). Through Genome Canada and its provincial partners, large genomics projects are required to include a GE3LS component that examines the broader societal implications of the science. According to Genome Canada, this approach continues to embed a GE3LS research component and genomics-in-society strategy in all our challenge-driven initiatives, supporting interdisciplinary research that bridges genomic science with social science and policy analysis. Germany has adopted a complementary model through a federal programme supporting research on the ethical, legal and social aspects of life sciences. Funding from the Federal Ministry of Research, Technology and Space (BMFTR) supports interdisciplinary research aimed at generating evidence on the societal implications of modern life sciences, including genetic engineering.

In other cases, values are embedded directly in binding regulatory frameworks. Norway’s Genetic Technology Act, adopted in 1993, requires that ethical justifiability, societal benefit and sustainability be assessed as explicit criteria before approving genetically modified organisms. This legal provision formally integrates societal values into regulatory decision-making, ensuring that biotechnology developments are evaluated not only for health and environmental safety but also for their broader societal contribution.

Codes of conduct and scientific guidelines

Codes of conduct and professional guidelines represent another mechanism through which values can be embedded in day-to-day scientific practice. These instruments translate broad principles such as responsibility, transparency and “do-no-harm” into expectations for researchers and institutions, complementing formal regulatory frameworks in rapidly evolving scientific fields.

For example, the American Society for Microbiology updated its Code of Ethics in 2021 to emphasise values such as inclusion, diversity, equity, access and accountability (IDEAA) in microbial sciences. The code explicitly discourages misuse of biological research and highlights the responsibility of scientists to consider the societal consequences of their work. At the international level, the Tianjin Biosecurity Guidelines for Scientists, developed in 2021 by a coalition of global experts, outline ten guiding principles aimed at preventing the misuse of bioscience. Endorsed by the InterAcademy Partnership and presented to the Biological Weapons Convention, the guidelines provide a common ethical reference point that research institutions worldwide can adopt to strengthen responsible research practices.

Mission-oriented funding criteria

Public and philanthropic funding programmes can also embed societal values by linking financial support to public-interest outcomes. Mission-oriented funding models increasingly incorporate criteria related to sustainability, health outcomes, biosecurity or broader societal benefits, encouraging innovators to align technological developments with public policy goals.

One example is the United Kingdom’s SynBioVen (SBV) initiative, launched in 2022 to support early-stage synthetic biology companies pursuing socially beneficial applications. Initially capitalised with GBP 20 million from a private philanthropist and developed in partnership with the innovation centre SynbiCITE, the initiative selects start-ups partly based on their potential to contribute to environmental sustainability, health innovation or bio-based manufacturing. The programme also involves scientific experts in assessing both the technical feasibility and societal relevance of proposals, and reinvests returns into future ventures, creating a self-sustaining model for supporting public-interest innovation.

A related approach can be found in the United States through the BioMADE bioindustrial manufacturing institute. Established in 2021, BioMADE integrates responsible innovation principles into its funding criteria, requiring member organisations to engage in education on bioethics and biosecurity. Projects are evaluated not only on their technological merit but also on their contribution to safety and broader societal objectives.

2.2 Strategic intelligence: foresight to anticipate synthetic biology developments

The “Strategic Intelligence” element in the OECD Framework refers to the capacity of governments to anticipate technological developments and their societal implications. It encompasses tools such as horizon scanning, foresight, technology assessment and data analytics that help policymakers detect emerging signals, identify risks and opportunities, and adapt policies in light of new evidence. Rather than predicting the future, these approaches support preparedness by helping governments explore plausible technological trajectories and adjust strategies, regulations and investments accordingly (OECD, 2020[22]; Robinson, Winickoff and Kreiling, 2023[23]).

OECD analysis points to two persistent gaps in strategic intelligence. First, most countries lack standards of quality and coordination for foresight and technology assessment. The Strategic Intelligence Tools for Emerging Technology Governance paper calls for the development of “international standards of robustness” and mapping of national capacities. Second, there is limited international collaboration on forward-looking technology appraisal despite global technology convergence (Robinson and Doherty, 2025[24]). The Technology Assessment for Emerging Technology study suggests that coordination across strategic intelligence communities could enable “technology as a public good” – pooling foresight outputs and methods into a shared international knowledge base (Robinson, Winickoff and Kreiling, 2023[23]).

In a rapidly evolving field such as synthetic biology, strategic intelligence is increasingly recognised as a core governance capability. Continuous monitoring and learning loops – combining foresight, evidence gathering and evaluation – allow governments to identify emerging risks and opportunities early and adjust policy responses before challenges escalate (see figure 2.2). These mechanisms are particularly important in contexts of technological convergence, including the growing interaction between synthetic biology and artificial intelligence (Patrick, 2024[25]).

Figure 2.2. Key mechanisms to expand strategic intelligence within governments

Source: OECD authors based on analysis of synthetic biology initiatives and (OECD, 2024[7]).

2.2.1 Building strategic intelligence capabilities for synthetic biology governance

Good practice emerging in several countries is to treat synthetic biology policies as “living documents” that will be revisited and revised as new intelligence comes in. For instance, Australia built into its roadmap process an intent to issue periodic progress reviews (as it did after 3 years). Sweden’s Bioeconomy Inquiry proposal recommends issuing rolling 4-year action plans with biennial evaluations; in essence, every couple of years the government would assess what has changed (scientifically, economically, socially) and update actions accordingly. This creates an iterative governance cycle: foresight → plan → implement → learn → adjust enabling policies to evolve alongside technological developments. Where such mechanisms are lacking, policies risk becoming quickly outdated in a fast-moving field like synthetic biology.

2.2.1.1 Strategic roadmaps for anticipating synthetic biology development

Most synthetic biology or bioeconomy strategies studied have a strong forward-looking element. These strategies set long-term visions and often specific targets for 5, 10, or even 20 years into the future, indicating that governments recognise the importance of planning for technology’s evolution. For example, Japan’s Bioeconomy Strategy declares the ambition to become “the world’s most advanced bioeconomy society by 2030,” and backs that up with quantitative goals for key sectors by that date. Australia’s Synthetic Biology Roadmap similarly looked ahead two decades, presenting multiple growth scenarios for synthetic biology applications and milestones to reach by 2040. Notably, Australia released a Progress Report in 2021 revisiting those scenarios and updating projections based on intervening developments. This exemplifies a learning approach – using initial foresight as a baseline and then refreshing it periodically. France’s strategy called for “permanent monitoring and foresight” to guide the field’s development, implying that a standing capability should track scientific advances and societal trends (such as public acceptance) to inform policy adjustments. Spain’s proposed Bioeconomy Observatory is also a good practice – an inter-ministerial unit charged with continuously scanning progress on strategy implementation and new scientific/market trends, which would regularly feed reports into policy review.

Many strategies were also developed through evidence-gathering exercises leveraging expert advisory groups or foresight studies. The United Kingdom’s National Vision for Engineering Biology explicitly drew on a decade of prior foresight work – including a 2010 national public dialogue on synthetic biology and a 2022 Call for Evidence that collected input from academia, industry, and civil society on emerging issues. Sweden’s recent Bioeconomy Inquiry (which resulted in recommendations for the development of a potential future strategy in 2023) similarly undertook extensive data collection, surveying other countries’ policies and analysing domestic R&D and market trends, to ensure the strategy was grounded in a comprehensive understanding of the innovation landscape.

An emerging good practice is the integration of strategic intelligence into a whole-of-government anticipatory governance approach. Korea’s 2025 Synthetic Biology Promotion Act – which builds upon national strategies to promote synthetic biology development – illustrates this model by positioning synthetic biology as a national strategic technology and establishing a coordinated planning and oversight architecture early in the field’s development. The Act mandates a five-year Basic Plan and annual implementation plans, supported by technology roadmapping, horizon scanning and technology assessments to inform investment priorities and identify emerging risks. A national Deliberation Committee and working bodies coordinate policy across ministries and research institutions, linking foresight directly to decision-making. The Act also includes procedures for expert and public input and provides mechanisms to recommend regulatory adjustments as evidence and technologies evolve. In this way, strategic intelligence functions are embedded across agenda-setting, coordination, engagement and regulatory review, reinforcing coherence and adaptability in the governance system.

2.2.1.2 Horizon scanning and technology assessment

Beyond national strategies, a growing ecosystem of strategic intelligence initiatives contributes to anticipatory governance of synthetic biology. Horizon scanning and technology assessment exercises are increasingly conducted by international organisations, research institutions and advisory committees. Examples include the Convention on Biological Diversity’s horizon-scanning process on synthetic biology, foresight studies conducted by the European Parliament’s Science and Technology Options Assessment (STOA) panel, and the U.S. National Institutes of Health’s NExTRAC committee examining emerging biotechnology issues. These initiatives combine scientific analysis with stakeholder input to inform policy discussions and regulatory development.

Strategic intelligence tools are also being embedded in the regulatory process for emerging biotechnologies, including those underpinning synthetic biology applications. A recent example in the European Union occurred during consideration of new rules for “new genomic techniques” (NGTs) in agriculture. Before the European Commission drafted a proposal, the Council of the European Union called for evidence gathering. In response, the French Parliamentary Office for Scientific and Technological Assessment (OPECST) in 2023 produced a scientific note with recommendations for the European Union’s new gene editing regulation, effectively providing a foresight-informed legislative input. Simultaneously, the European Food Safety Authority (EFSA) has begun publishing horizon scans of scientific literature on NGTs every six months to continuously update risk assessment knowledge for regulators. This means that as European Union discussions on gene-edited crops proceed, they are buoyed by a stream of up-to-date intelligence on potential environmental and food safety impacts. Collectively, these practices mark efforts towards more adaptive, data-informed regulatory development approach.

2.2.1.3 Ad hoc expert groups

Ad hoc expert groups have been established at the national and international level, drawing primarily on experts from the academy, but increasingly other stakeholders like industry where relevant. Studies such as the U.S. National Academies report Safeguarding the Bioeconomy and analyses by Australia’s Synthetic Biology Expert Working Group examine technological trends and societal implications to inform policy debates. In Germany, bodies such as the German Ethics Council and the National Academy of Sciences Leopoldina provide independent assessments and policy advice on developments in the life sciences.

Strategic intelligence is also increasingly pooled at the international level. Parties to the Convention on Biological Diversity established an Ad Hoc Technical Expert Group to conduct global horizon scanning on synthetic biology developments (UN Convention on Biological Diversity, 2025[26]). Within the OECD, initiatives such as the Global Forum on Technology’s expert group on synthetic biology have brought together specialists from multiple countries to analyse emerging opportunities and risks and produce shared evidence for policy development. In the same vein, the OECD Working Party on Biotechnology, Nanotechnology and Converging Technologies (BNCT), together with the United Kingdom Department for Science, Innovation and Technology, convened in 2025 a workshop with a broad variety of stakeholders from government, academia, industry, trade unions and civil society from OECD member and accession countries to gather information for the development of the draft Recommendation on Responsible Innovation in Emerging Biotechnologies.

2.2.1.4 Institutionalising foresight advisory bodies

Several countries have institutionalised these functions through permanent foresight and advisory institutions. Those advisory groups and expert consultation refer to the use of different tools for evidence gathering to help relevant expert stakeholders – notably government decision-makers and policy makers – anticipate developments in a technology and implement more effective governance measures. They are a set of tools for advancing policy learning that aim to improve the design and implementation of policies or that seek to fine-tune STI governance arrangements. Possible examples include policy evaluations, benchmarking studies, system reviews, technology assessments and foresight exercises (OECD, 2025[27]).

The Rathenau Institute in the Netherlands advises parliament on technological developments, while the United Kingdom’s Engineering Biology Responsible Innovation Advisory Panel brings together experts from academia, industry, and civil society to horizon-scan emerging risks and opportunities in synthetic biology and to counsel the government on responsible innovation measures. Similarly, the Israel Innovation Authority conducts technology reviews and horizon-scanning exercises to inform national investment strategies, including in research, infrastructure, and companies.

2.2.1.5 Technology observatories

Technology observatories represent another emerging tool for gathering and disseminating intelligence on emerging biotechnologies (OECD, 2024[7]). By aggregating scientific evidence, policy analysis and stakeholder perspectives, they can support more informed agenda-setting and decision-making around rapidly evolving technologies. For example, the Global Observatory for Genome Editing facilitates international dialogue and foresight on genome editing technologies, while the German Bundestag’s Office of Technology Assessment (TAB) provides parliament with scientific analysis of technological developments.

2.3 Stakeholder engagement: Co-creating governance with diverse actors

“Stakeholder engagement” is the OECD Framework element that ensures governance is a collective effort rather than a top-down mandate. Synthetic biology involves distributed knowledge, diverse innovation actors, and potentially wide societal impacts. As a result, governance processes benefit from incorporating perspectives from scientists, engineers, entrepreneurs, industry actors, civil society organisations, communities directly affected by applications, and the broader public. Engagement helps surface practical insights, identify societal concerns early, and strengthen the legitimacy and effectiveness of policy decisions.

Early engagement can improve both the quality and acceptance of governance. Researchers and companies may identify technical or regulatory barriers that policymakers would otherwise overlook, while broader societal dialogue can reveal ethical concerns, risk perceptions or distributional questions that influence public acceptance. In emerging fields such as synthetic biology, where uncertainties remain high and applications may have far-reaching societal implications, engagement can help anticipate governance challenges before they become sources of controversy or policy delay.

Engagement processes often involve different categories of actors whose roles and interests vary. As illustrated in figure 2.3, discussions of gene drive governance distinguish between communities, stakeholders and publics (Committee on Gene Drive Research in Non-Human Organisms: Recommendations for Responsible Conduct et al., 2016[28]) and (OECD, 2024[7]).

Although individuals may belong to multiple categories, distinguishing between them helps policymakers select appropriate engagement tools and avoid treating engagement as a single homogeneous activity. Moreover, in synthetic biology, public perception can determine whether the technology is successfully deployed or rejected. Hence inclusive governance builds trust. A pluralistic society’s values and interests may conflict, but by integrating diverse viewpoints through dialogue, policymakers can navigate trade-offs and guide biotechnology innovation in a direction that is broadly acceptable (Delaney, 2019[29]).

Figure 2.3. Diversity of engagement in gene drives field: Communities, publics, and stakeholders

Source: Committee on Gene Drive Research in Non-Human Organisms: Recommendations for Responsible Conduct et al. (2016[28]).

Countries that have deeply engaged citizens early (through dialogues, citizen science initiatives, collaborative platforms, and other participatory tools) are finding greater legitimacy and public trust. For example, in Netherlands, the Rathenau Institute has been serving as a set of for a to debate the societal implications of synthetic biology, identifying the heterogenous public perspectives in shaping technological trajectories (Bhatt et al., 2022[21]). The United Kingdom Department for Science, Innovation and Technology (DSIT) conducted a survey on public attitudes towards synthetic biology in 2024 to assess public perceptions of engineering biology across key application domains, capturing a broad understanding of social expectations, concerns and perceived benefits associated with emerging engineering biology innovations.

2.3.1 Mechanisms for anticipatory stakeholder engagement

The OECD Framework highlights three complementary mechanisms through which engagement can support anticipatory governance: capacity building, consultation and communication, and co-creation. These mechanisms respond to different policy objectives and often operate in combination (see figure 2.4).

Figure 2.4. Key mechanisms for upstreaming stakeholder engagement

Source: OECD authors based on analysis of synthetic biology initiatives and (OECD, 2024[7]).

2.3.1.1 Capacity-building and the need for long-term societal engagement

Stakeholder engagement for capacity building often takes the form of educational initiatives, dialogue platforms, or programmes aimed at improving societal understanding of emerging technologies. In synthetic biology, such initiatives can help cultivate a culture of responsibility among researchers while enabling broader societal participation in governance discussions. The global iGEM competition is a prominent example of non-governmental stakeholder engagement that nonetheless influences policy thinking. With participants from more than 50 countries and over 86,000 individuals in its alumni community, iGEM not only trains students in synthetic biology but also embeds reflection on safety, ethics and societal impact into project design. Initiatives such as the 2024 OECD-iGEM Responsibility in Synthetic Biology Conference create structured dialogue between emerging innovators and policymakers, helping bridge gaps between scientific communities and governance institutions. Governments can leverage such forums to engage early with the next generation of practitioners and integrate their perspectives into policy discussions.

Public programmes can also combine scientific debate with societal learning. For example, Germany’s ELSA Discourse funding instrument supports projects in which scientists engage with members of the public on ethical and societal dimensions of biotechnology. Such initiatives strengthen both scientific literacy and citizens’ capacity to participate in informed decision-making. Moreover, public art and science museums constitute an important means for capacity building. For example, the exhibition “Gene Cultures” at the new MIT Museum in Boston invited the public to participate in the debate concerning fundamental questions in the field of emerging biotechnologies by exploring significant advancements in genetic technologies and engaging with artworks that prompt reflection on the future unfolding before us.

2.3.1.2 Communication and consultation mechanisms

Consultation and communication mechanisms provide structured channels through which governments can gather input from expert communities, industry actors and civil society. These mechanisms are particularly important in emerging fields such as synthetic biology, where policy decisions must often be taken under conditions of uncertainty and rapidly evolving technological trajectories.

Institutionalised advisory mechanisms support continuous policy learning. For example, the United Kingdom’s Engineering Biology Responsible Innovation Advisory Panel provides ongoing guidance to government on responsible innovation challenges in engineering biology. Similarly, the United Kingdom Government Office for Science convenes expert roundtables to rapidly discuss emerging issues such as mirror-life research. In Israel, the National Bioconvergence Program is supported by a Scientific Advisory Board composed of experts from academia, industry, investment and government. The Board provides multidisciplinary guidance and serves as a mechanism to align perspectives from research, industry and public interests in programme design and implementation.

Regulatory agencies are also formalising stakeholder engagement practices. For example, the European Food Safety Authority (EFSA) released a Stakeholder Consultation Toolkit in 2025 to guide how it collects input on scientific risk assessments and policy proposals. By standardising consultation processes and transparency practices, such toolkits aim to improve the quality of engagement and strengthen public confidence that stakeholder input is meaningfully considered.

Public consultations provide an additional mechanism for gathering broad input. The European Commission’s consultation on the planned European Union Biotech Act (2025) invited feedback from innovators, industry actors, researchers, civil society organisations and citizens on regulatory barriers and policy priorities for biotechnology development. Beyond collecting ideas, such consultations can help policymakers gauge the level of consensus or controversy around specific issues. High participation can reveal areas where stakeholder expectations converge or diverge, allowing governments to anticipate potential implementation challenges and strengthen policy legitimacy before new frameworks are adopted.

2.3.1.3 Co-creation and collaborative governance

In some cases, engagement goes beyond consultation to involve stakeholders directly in shaping strategies, standards or innovation ecosystems. Consultative processes are now common in the development of national bioeconomy and synthetic biology strategies. For example, Australia’s Synthetic Biology Roadmap involved over 140 participants from around 60 organisations across government, academia and industry. Austria’s Bioeconomy Strategy combined expert working groups with public consultations, while Spain’s Bioeconomy Action Plan involved workshops with actors ranging from farmers’ associations to biotechnology firms.

Many countries are also institutionalising engagement during the implementation phase of policies. Germany’s Bioeconomy Council, for example, provides ongoing advice on the implementation of the national bioeconomy strategy and integrates perspectives from academia, industry and civil society. Similarly, the United Kingdom plans to establish an Engineering Biology Advisory Panel to guide the implementation of its National Vision for Engineering Biology and maintain dialogue with innovation ecosystem actors.

In the strongest cases, strategies explicitly emphasise upstream engagement. A good practice comes again from France’s synthetic biology research strategy, prioritising “upstream dialogue with all concerned actors.” It recommended setting up sustained forums for public discussion and even suggested embedding social scientists or representatives of societal groups within research program committees to constantly integrate social considerations.

Collaborative governance can also occur through public-private coordination platforms. In Japan, public-private councils for biotechnology domains bring together industry stakeholders and government representatives to jointly develop technology roadmaps and identify policy barriers to innovation. Similarly, the Engineering Biology Research Consortium (EBRC) in the United States provides a platform for collaboration among academic institutions, industry actors and government agencies.

Engagement can also include the integration of traditional knowledge perspectives. For example, negotiations within the World Intellectual Property Organization (WIPO) on an international legal instrument relating to genetic resources and traditional knowledge have aimed to improve transparency in patent systems and ensure that traditional knowledge associated with genetic resources is appropriately recognised.

Box 2.1. Collaborative platforms in synthetic biology governance: creating “convergence spaces” for responsible innovation

Collaborative platforms are structured arrangements that bring together multiple actors in the innovation system – research organisations, firms (including start-ups), funders, regulators and, in some cases, civil society – to accelerate problem-solving while strengthening responsible innovation practices. OECD analysis of collaborative platforms across emerging technology fields (including synthetic biology) highlights that platforms are most effective when they operate as “convergence spaces”: places where disciplines, actors and technologies can interact, share infrastructure, and co-develop standards, practices and pathways to scale.

In synthetic biology, collaborative platforms can support governance objectives in several ways. They reduce barriers to experimentation and scale-up by providing shared facilities and services (such as design–build–test–learn capabilities, pilot-scale production and validation tools), helping research groups and smaller firms access advanced infrastructure. Platforms can also embed responsible practices upstream by integrating biosafety, biosecurity, ethics and transparency requirements into operational protocols, training and access conditions. Finally, because platforms convene diverse actors on a continuous basis, they facilitate co-creation and collective learning, helping identify governance gaps, diffuse good practices and inform policy updates over time.

Illustrative examples observed in national approaches include:

• Biofoundries and shared infrastructure networks established in several countries (including Canada, France, Italy, Japan, the United Kingdom and the United States) to support the responsible development and testing of engineered organisms.

• Ecosystem-building forums and networking platforms, such as Germany’s SynBio Reactor or the EBRC Community BioFutures initiative in the United States, which connect researchers, start-ups, investors and public actors to align priorities and identify bottlenecks.

• Programme-level collaboration mechanisms, such as applied R&D consortia under Israel’s National Bioconvergence Program, which support knowledge transfer between academia and industry and facilitate commercialisation pathways.

OECD analysis emphasises that governance arrangements shape platform outcomes. Participation rules, access conditions, incentive structures and accountability mechanisms influence whether platforms primarily accelerate innovation or also reinforce responsible innovation objectives. When intentionally designed, collaborative platforms can therefore function as policy instruments that strengthen coordination across actors while promoting responsible innovation in synthetic biology.

Source: Analysis of synthetic biology initiatives and Winickoff, D. et al. (2021[30]) and (OECD, 2025[31]).

2.3.2 From one-off to continuous engagement

A challenge ahead is ensuring stakeholder engagement is ongoing. It’s notable that all countries studied acknowledge stakeholder engagement in their strategies to some degree (even if just to highlight the need for public support). However, the depth and continuity of engagement can range widely. Good practices are emerging that emphasise early, frequent, and iterative engagement. Early-stage engagement can help shape research agendas and governance approaches before technologies reach deployment. For example, public perception studies conducted during the development of Australia’s Synthetic Biology Roadmap helped identify areas where communication and trust-building were needed. In addition, institutionalised forums such as advisory councils or standing dialogue platforms can ensure continuous interaction between policymakers and stakeholders. These mechanisms support two-way information flows, enabling governments to monitor emerging developments while informing stakeholders about regulatory expectations and policy priorities. In some areas, governance approaches increasingly involve elements of co-regulation or co-production, where stakeholders participate directly in developing standards or best practices. For example, the U.S. National Institute of Standards and Technology (NIST) facilitates collaborative initiatives to develop measurement standards for synthetic biology, involving researchers, industry actors and government laboratories. These practices illustrate a broader shift from episodic consultation toward more systematic and participatory governance of emerging biotechnologies, where engagement supports both policy learning and the responsible development of innovation ecosystems.

2.4 Agile regulation: Towards adaptive and fit-for-purpose regulatory approaches

The “Agile Regulation” element of the OECD Framework examines the capacity of governance systems to respond to and shape emerging technologies in real time, rather than only react once products are deployed. In fast-moving fields such as synthetic biology, traditional regulatory approaches can be slow, fragmented and overly prescriptive, creating a “pacing problem” between technological development and policy development (OECD, 2025[6]). Agile regulation seeks to narrow this gap by making governance more adaptive, iterative and learning-orientated. This includes ensuring that regulatory approaches can evolve alongside innovation, that adjustments are informed by evidence, and that oversight remains consistent with public policy objectives such as safety, security, and other societal standards.

Agile governance is defined as a whole-of-government approach that adapts tools, processes, and institutional arrangements so that governance can both enable responsible innovation and manage emerging risks. Rather than “regulate and forget,” it promotes “adapt and learn”: building feedback loops, shortening response times, and integrating review and adjustment throughout the policy cycle (OECD, 2021[32]). This implies that regulators do not act in isolation or solely at the end of the innovation process, but engage innovators, users, civil society and other authorities early and continuously to anticipate issues, generate evidence and co-develop regulatory responses where appropriate (OECD, 2025[6]).

Importantly, agile regulatory governance does not imply weakened or lighter regulation. Rather, it recognises that different levels and forms of regulatory intervention are required depending on the nature, severity and uncertainty of risks. In areas where synthetic biology applications raise significant concerns for health, safety, security or the environment – particularly in relation to biosafety, biosecurity or dual-use risks – clear and enforceable regulatory requirements remain essential and form a core pillar of responsible innovation governance. Agile approaches complement such safeguards by ensuring that regulatory systems remain effective over time: enabling timely updates to rules, improving regulatory coherence across sectors, and avoiding gaps or inconsistencies as technologies evolve (OECD, 2025[33]; OECD, 2025[6])

The policy challenge for governments is to guide the development of technology in a manner that protects public interests, while avoiding regulatory approaches that unnecessarily delay beneficial applications or push innovation into less transparent or less well-governed settings. In the context of innovation governance, agile regulatory governance means (i) creating mechanisms that allow experimentation in a controlled and accountable way; (ii) reducing unnecessary uncertainty or delay where existing rules are unclear or duplicative; (iii) ensuring that standards, guidance and oversight practices can be updated as knowledge evolves; and (iv) coordinating across sectors and jurisdictions, because technologies like synthetic biology cuts across health, agriculture, environment, biosecurity, data protection and trade (OECD, 2014[1]; OECD, 2021[32]; OECD, 2025[33]).

Agile mechanisms are the concrete tools and processes used to operationalise agile governance (see figure 2.5). OECD work groups these mechanisms into four broad categories: (1) strategic intelligence; (2) regulatory experimentation; (3) outcomes-based approaches; and (4) non-binding approaches (OECD, 2025[6]). These mechanisms help align the technology development cycle (from early research to deployment) with the policy cycle (from agenda setting to evaluation). They create structured points of contact between innovators and public authorities, generate evidence on real-world feasibility and risk, and support iterative adjustment of governance arrangements rather than one-off rulemaking.

Figure 2.5. Key mechanisms for implementing agile regulation

Source: OECD authors based on analysis of synthetic biology initiatives and the OECD (2024), Framework for Anticipatory Governance of Emerging Technologies, https://doi.org/10.1787/0248ead5-en.

2.4.1 Recognition of the need for regulatory flexibility

Policymakers and innovators are increasingly trialling a variety of agile mechanisms to achieve synthetic biology governance objectives more effectively and promote responsible innovation. This growing emphasis on regulatory experimentation and adaptive oversight is not only limited to synthetic biology, but reflects a broader shift in technology governance across sectors facing innovation-related challenges (OECD, 2025[6]). In several countries, governments are establishing dedicated institutional capacities to support more flexible and iterative approaches to regulation. In the United Kingdom Department for Science, Innovation and Technology, for example, the Regulatory Innovation Office (RIO) has been framed as a cross-cutting mechanism to help regulators address such barriers created by emerging technologies by improving co-ordination, supporting experimentation, and identifying where rules may need to be adapted or clarified in support. Similar initiatives can be observed elsewhere, where governments are investing in regulatory sandboxes, testbeds, and cross-agency coordination platforms across domains such as artificial intelligence, digital health, fintech, and advanced manufacturing, etc.

For synthetic biology governance specifically, these mechanisms include national regulatory experimentation, such as the United Kingdom Engineering Biology Sandbox Fund, which supports sandbox initiatives to generate evidence for pro-innovation regulatory reform, as well as international testbeds such as the European Union BIOMAT project (“Open Innovation Test Bed for Nano-Enabled Bio-Based PUR Foams and Composites”). In line with OECD guidance, multi-stakeholder initiatives such as the 4TU project on Ethical and Regulatory Issues Raised by Synthetic Biology identify ethical issues jointly with relevant stakeholders and assess whether existing ethical and regulatory frameworks are equipped to address emerging challenges.

Most countries reviewed acknowledge the importance of agile or adaptive regulation for synthetic biology in their national strategies, though the specificity of proposed actions varies. Some national strategies signal awareness that current regulatory regimes may be either too stringent, too outdated or too fragmented for emerging biotechnologies, even if proposed reforms are deferred. For example, France’s synthetic biology strategy noted that future economic development of the field is “closely linked to its future regulatory and normative framework,” and cautioned that overly strict rules could hamper progress while overly lax rules could undermine public trust. It therefore called for French authorities to contribute to a supportive but responsible framework at European and international level. Similarly, Costa Rica’s strategy refers to establishing a favourable policy environment for bio-innovation, implying the need to adjust existing regulation to enable development, but without specifying concrete changes.

Other strategies outline specific measures for regulatory reform. The United Kingdom’s National Vision committed to establishing the Engineering Biology Regulators’ Network (EBRN) – a cross-agency platform for regulators in areas such as medicines, food, agriculture and environment to share information on emerging developments and coordinate responses. This network meets regularly and identifies which regulators have a stake in engineering biology governance, supporting the work of HMG’s Regulatory Innovation Office. Such a network is intended to reduce gaps, overlaps and inconsistent requirements across regulatory domains, and to ensure that learning in one area (e.g. gene therapies) informs oversight in another (e.g. environmental release of engineered microbes). Japan’s Bioeconomy Strategy similarly identifies specific legal barriers for revision. For instance, Japan’s Act on Living Modified Organisms – originally designed for earlier-generation GMOs – is described as not fully adapted to modern genome editing techniques. The strategy therefore calls for streamlining approval processes, including possible exemptions for low-risk organisms and simplified documentation. It likewise highlights emerging areas such as consumer genetic testing and genome data privacy, and calls for updated guidance to pre-empt governance gaps.

Common themes across these national approaches include reviewing existing regulations to identify outdated provisions, removing duplicative or inconsistent requirements across agencies, and updating definitions and scopes – for example, ensuring that regulations define synthetic biology products in ways that capture new techniques appropriately. Austria’s Bioeconomy Strategy states that many laws will need to be adapted – acknowledging that a systemic regulatory update is required as part of bioeconomy implementation. Canada’s Biomanufacturing and Life Sciences Strategy made “Agile Regulation” one of its five pillars for growing the life sciences sector, committing to “ensure world-class regulation that keeps pace with innovation” and to explore novel regulatory techniques that could make Canada an attractive location for biotechnology investment.

2.4.2 Mechanisms for agile synthetic biology governance

While there is broad consensus on the importance of agile regulation, implementation remains at an early stage in most jurisdictions. Only a limited number of countries have launched mechanisms such as regulatory sandboxes or formal adaptive licensing pathways specifically for synthetic biology. Many others reference agility but continue to rely on established processes such as periodic regulatory review or improved interagency coordination.

Some practices are emerging that aim to make agility more systematic. One is the use of review or sunset clauses in strategies and legislation (for example, Sweden’s Bioeconomy Inquiry proposed biennial evaluations, or commitments in the United Kingdom to revisit GMO-related rules in light of scientific advances). Such clauses create formal triggers to reassess regulatory settings rather than allowing them to become fixed. Another practice is comprehensive regulatory mapping. Some countries (e.g. South Korea in internal analyses, and the European Union through impact assessments) are mapping all relevant regulatory requirements touching synthetic biology – from biosafety to pharmaceuticals, chemicals and data governance – to identify overlaps, conflicts and gaps. Mapping exercises of this kind are a first step towards prioritising areas where regulatory adaptation is most urgent (OECD, 2025[6]; Sarliève et al., 2025[9]).

Examples of innovative agile regulatory mechanisms being tested are exhibited below.

2.4.2.1 Regulatory sandboxes

A sandbox is a controlled environment in which companies can test innovations under regulatory supervision and, where appropriate, under time-limited regulatory flexibilities (OECD, 2025[34]). The objective is to generate evidence on safety, performance and governance needs to inform future rulemaking. Sandboxes are especially useful in fields where regulatory uncertainty or fragmentation is a problem. Synthetic biology often converges with other emerging tech (AI in biotechnology, automation in labs, etc.), and companies can be deterred by unclear regulations (OECD, 2025[2]). Sandboxes offer a provisional safe harbour and a chance to clarify rules. The United Kingdom launched an Engineering Biology Sandbox Fund to resource regulators to partner with firms on sandbox trials for novel bio-based products, specifically seeking to improve regulation of cell cultivated products and engineered bacteriophage. The second round of this fund supported a cross-sector regulatory sandbox to address regulatory gaps for engineered bacteriophage (phage) products across One Health and working in collaboration with relevant regulators and expert support. Likewise, Israel’s Disruptive Innovation in Bio-Convergence Programme offers firms access to a dedicated regulatory sandbox with direct engagement from regulators and the Ministry of Health, to develop and test bio-convergence technologies (like combining 3D-printed tissues with AI diagnostics) that don’t squarely fit existing regimes. In addition to regulatory guidance, the programme provides financial co-funding (20-50% of project budget) for participating projects. This model aims to address simultaneously two common barriers identified by innovators: regulatory uncertainty and access to capital. This is consistent with the use of regulatory experimentation as an evidence-generation tool rather than simply a relaxation of rules (OECD, 2025[6]).

2.4.2.2 Testbeds and pilot environments

Beyond sandboxes, governments and international consortia are promoting testbeds that allow technologies to be demonstrated at semi-real scale with regulatory supervision. In the European Union, the Horizon 2020 project BIOMAT created an Open Innovation Test Bed for bio-based materials, bringing together 26 partners in 8 countries. It provides SMEs with access to high-end pilot production facilities and offers regulatory guidance and standardisation support during the testing of their new biomaterials. Such cross-border testbeds can reduce administrative burden on smaller firms by centralising expertise and working with regulators to provide early advice on compliance pathways. OECD work notes that testbeds, if done collaboratively, can accelerate learning on what regulatory frameworks work best for new technology (OECD, 2025[6]). Related initiatives include discussions between European Union and African partners on joint “innovation pathways” for gene drive mosquito technologies aimed at malaria control. These discussions focus on coordinated field trials under jointly developed guidelines, which function as transnational regulatory pilots.

2.4.2.3 Standards, guidelines, and soft law

In areas where regulatory certainty is still evolving, many stakeholders turn to technical standards, voluntary guidelines or codes of conduct. These instruments can typically be developed and updated more quickly than legislation, and can support convergence across jurisdictions (OECD, 2024[7]). For example, standardised frameworks in biosafety can significantly facilitate more efficient and consistent risk assessment processes for novel organisms (Pei, Garfinkel and Schmidt, 2022[35]). Voluntary screening guidelines for DNA synthesis providers are another frequently cited example, such as the United States’ Synthetic Biology Standards Consortium working on measurement standards. The United Kingdom Department for Science, Innovation and Technology (DSIT) similarly issued guidance in 2023 setting out expectations for customer and sequence screening to manage biosecurity risks, and explicitly framed this guidance as iterative: industry feedback and technical advances (e.g. improved screening software) are expected to inform future updates. DSIT’s approach allows norms to be established quickly and refined over time, creating an intermediate layer between no rule and formal regulation. Finally, non-government actors play a significance in the creation of standards. The International Gene Synthesis Consortium (IGSC), a private association of major DNA synthesis companies, has also developed its own code of conduct and screening standard, providing de facto global coverage in an area where national legislation alone may be hard to enforce. Public authorities can later endorse or reference such private standards.

It is worth noting an outstanding gap: biosafety standards for synthetic biology are still uneven, a challenge compounded by the interdisciplinary character of this field. Researchers have pointed out that many synthetic biology labs still lack standardised protocols for novel organisms or practices, partly because traditional biosafety guidelines were written with older genetic engineering in mind (Pei, Garfinkel and Schmidt, 2022[35]). This lack of standardisation can slow down regulatory approvals with each project being assessed ad hoc, and leave uncertainty about risk management expectations. A case-specific approach will require identifying the appropriate regulatory instruments for each discipline and addressing any gaps, overlaps or conflicts adequately.

Addressing this gap requires updating safety assessment methods and guidance in line with current science (e.g. ecological impact assessment for gene-drive organisms; biosecurity assessment of automated DNA synthesis). International co-operation is important here since harmonised technical standards can support mutual recognition of assessments and reduce regulatory uncertainty for firms, while helping regulators converge on what constitutes proportionate oversight. OECD analysis highlights that collaborative platforms in synthetic biology can play a role in iterating such standards and surfacing areas where regulatory clarification is most needed (Winickoff et al., 2021[30]).

Finally, while agile and adaptive approaches can help governance systems keep pace with technological change, they are not a substitute for precaution where risks are uncertain, potentially irreversible, or societally unacceptable. The precautionary principle remains a foundational component of biotechnology governance in many jurisdictions and international frameworks, particularly in relation to environmental release, biosecurity and biosafety (Keiper and Atanassova, 2025[36]). In the context of synthetic biology, it has been articulated as a forward-looking responsibility to anticipate potential harm and, where scientific uncertainty persists, to adopt preventive or restrictive measures until safety can be reasonably demonstrated. In some cases, this may involve delaying, limiting, or prohibiting specific applications while allowing research to continue under controlled conditions. Evidence from ethical governance literature emphasises that precautionary approaches are intended to prevent serious or irreversible harm where causal pathways are not yet fully established, and to guide decision-makers in situations of deep uncertainty (Bohua et al., 2023[37]). At the same time, the OECD Framework recognises that responsible innovation typically relies on a mix of governance tools, including legally binding regulation, outcome-based requirements, and adaptive policy mechanisms. These instruments can be combined in risk-proportional approaches that maintain strong safeguards while enabling learning, monitoring, and adjustment over time. In effect, anticipatory governance complements precaution by strengthening early risk identification, evidence generation, and policy responsiveness so that decisions can be better informed and periodically reassessed as knowledge evolves.

2.5 International co-operation: Coordinating global governance of synthetic biology

Synthetic biology is inherently a global enterprise. Research teams collaborate across borders, DNA sequences circulate via the internet, biological products are traded internationally, and any major biotechnology risks and benefits will not be confined to one country. Therefore, “International Co-operation” is an element of the OECD Framework that underscores the need for countries to work together in governing synthetic biology to support foresight, risk management and market formation (see figure 2.6). It does so by (i) creating inclusive fora to exchange evidence and align expectations; (ii) promoting compatible standards, guidance and principles; and (iii) supporting capacity building so that no jurisdiction becomes a weak link (OECD, 2024[7]).

This need for co-operation is unfolding in a context of growing strategic competition and technological sovereignty (OECD, 2025[2]). As a result, trusted and values-based fora such as the OECD are becoming increasingly important as spaces where governments can share evidence, build consensus, and avoid fragmentation in the governance of synthetic biology (Robinson and Nadal, 2025[4]).

Figure 2.6. Key mechanisms to foster international co-operation

Source: OECD authors based on analysis of synthetic biology initiatives and (OECD, 2024[7]).

Most national strategies reviewed treat international co-operation as a central component of responsible innovation in synthetic biology. Across countries, the rationale varies. In some cases, co-operation is closely linked to sustainability and knowledge-sharing agendas: Austria’s Bioeconomy Strategy emphasises international research partnerships, while Germany situates biotechnology within broader global sustainability efforts and international dialogue on ethical and societal issues. In other cases, international engagement is framed more explicitly through the lens of technological leadership and strategic positioning. The United Kingdom’s National Vision for Engineering Biology, for example, presents partnerships with countries such as the United States, Singapore and Canada as important both for responsible innovation and for maintaining competitiveness. For emerging bioeconomies, international co-operation may also serve as a route to knowledge exchange, market access and institutional legitimacy, as illustrated by Costa Rica’s emphasis on collaboration with organisations such as UNEP and the OECD.

At the international level, the European Union illustrates how international co-operation can also operate through regulatory integration. Initiatives such as the proposed European Union Biotech Act aim not only to strengthen the internal market for biotechnology, but also to position the European Union as a global standard-setter. This reflects broader OECD findings on international regulatory co-operation, which suggest that coherent domestic or regional frameworks can strengthen a jurisdiction’s ability to promote interoperable governance approaches internationally (OECD, 2021[38]).

2.5.1 Shared evidence, horizon scanning, and capacity building

A first major function of international co-operation is the creation of shared evidence and collective strategic intelligence. Governments increasingly recognise that horizon scanning, foresight and technology assessment cannot be conducted effectively in isolation. Several international mechanisms now aim to create shared situational awareness of emerging developments in synthetic biology and related biotechnologies.

Examples include the OECD Global Forum on Technology’s synthetic biology focus group, which brought together experts from countries at different stages of capability to identify technical developments, policy risks and governance gaps (Robinson and Nadal, 2025[4]). The Convention on Biological Diversity has also established a global horizon-scanning mechanism for synthetic biology, supported by a multidisciplinary expert group, to identify emerging trends, assess potential risks and benefits, and flag needs for regulation or capacity building. At the same time, OECD consensus documents on the harmonisation of regulatory oversight in biotechnology provide practical technical information to support national risk assessment and regulatory review (OECD, 2026[39]).

International co-operation also takes the form of collaborative platforms and partnerships for research and capacity building. Examples include European Union Horizon programmes, bilateral funding initiatives such as US-UK collaboration on bioengineering, and the International Biosecurity and Biosafety Initiative for Science (IBBIS), which develops tools such as DNA synthesis screening software and training resources that can be used across countries. Such initiatives help pool expertise, reduce duplication and address the reality that weak governance capacity in one jurisdiction can create broader international vulnerabilities.

This is why many national strategies link international co-operation to capacity building. Shared risk-assessment methods, technical training, joint infrastructures and support for regulatory development are all framed as ways to reduce “weak links” in global governance. OECD and other international initiatives increasingly emphasise that co-operation should not consist only in the diffusion of rules, but also in investment in the ability of countries to govern, manufacture and benefit locally from emerging biotechnologies (Winickoff et al., 2021[30]; OECD, 2024[7]).

However, this model of knowledge sharing is under growing pressure. Countries have increasing incentives to restrict access to data, industrial know-how and critical technologies for reasons of competitiveness, bargaining power or national security (OECD, 2025[2]; Robinson and Nadal, 2025[4]). This creates a tension at the heart of synthetic biology governance: governments seek collective foresight and early warning, while simultaneously tightening controls over data, supply chains and platform technologies.

2.5.2 Regulatory interoperability, international standards and principles

1. A second major function of international co-operation is to reduce regulatory fragmentation. Many countries recognise that divergent rules can slow innovation, raise compliance costs and create gaps in safety oversight. International regulatory co-operation in synthetic biology therefore often focuses not on full harmonisation, but on building interoperability by aligning definitions, data requirements, standards and risk assessment methods.

Several examples illustrate this trend. Japan’s synthetic biology strategy highlights participation in international standard-setting on issues such as biosecurity and data sharing. The Tianjin Biosecurity Guidelines provide an emerging reference point for responsible scientific conduct, while the NATO Principles of Responsible Use for biosciences show how even security-focused organisations are adopting high-level ethical and safety principles in biotechnology governance. Joint testbeds, such as European Union-led open innovation test beds for bio-based materials, also contribute to interoperability by generating regulatory evidence that can be used across jurisdictions and by linking innovation support with standards and risk assessment (OECD, 2021[38]).

The OECD has long played a role in this area through soft-law instruments and technical guidance. Since its early work on recombinant DNA governance in the 1980s, the Organisation has adopted several legal instruments relevant to biotechnology and continues to publish science-based consensus documents supporting harmonised regulatory oversight. Examples include the Recommendation of the Council on Assessing the Sustainability of Bio-Based Products [OECD/LEGAL/395], the Recommendation of the Council on Human Biobanks and Genetic Research Databases [OECD/LEGAL/0375], the Recommendation of the Council on Quality Assurance in Molecular Genetic Testing [OECD/LEGAL/0350], the Recommendation of the Council on the Licensing of Genetic Inventions [OECD/LEGAL/0342] or the Best Practice Guidelines for Biological Resource Centres (BRCs) (OECD, n.d.[40]; OECD, n.d.[41]; OECD, n.d.[42]; OECD, n.d.[43]; OECD, 2007[44]). More recently, OECD work under the Global Forum on Technology and the BNCT has helped structure international dialogue on responsible innovation in synthetic biology. The draft Recommendation on Responsible Innovation in Emerging Biotechnologies is expected to further strengthen this role by providing a shared reference point for policymakers, innovators and civil society.

Synthetic biology governance has also seen important developments through international initiatives aimed at strengthening coordination and promoting interoperable standards (Keiper and Atanassova, 2025[36]). For example, the Engineering Biology Research Consortium (EBRC) is supporting the development of International Best Practices for Robust Synthetic Nucleic Acid Screening, an initiative designed to advance globally consistent approaches to DNA screening. In parallel, the EBRC Working Group on Policy and International Engagement has launched two global initiatives: the Global Forum for Engineering Biology, which facilitates international dialogue on the strategic direction of engineering biology research; and the Global Center for Biofoundry Applications, which seeks to define globally recognised standards for biofoundries, thereby supporting scalable operations and enhancing their international interoperability and impact.

2.5.3 Cross-cutting challenges

Despite these developments, important challenges remain. Experts repeatedly warned that if governance of synthetic biology develops mainly within a small group of advanced economies, global inequities may deepen (Robinson and Nadal, 2025[4]). Countries with weaker infrastructures risk being treated primarily as testing or deployment sites for high-impact applications without an equal role in shaping acceptable risk, governance conditions or benefit-sharing arrangements.

Uneven capacity also creates collective exposure. Weak biosafety and biosecurity practices in one part of the world can undermine global security, while limited production and regulatory capacity can prolong supply chain fragilities during crises. For this reason, experts increasingly call for co-operation models that invest in local capability – including regulatory training, shared facilities, access to standards and joint funding instruments – rather than only exporting rules or guidance (Robinson and Nadal, 2025[4]).

Strengthening international co-operation mechanisms is consequently a condition for more robust and inclusive governance of synthetic biology. As seen in the good practice examples above, international co-operation supports capacity building and resource sharing between and across jurisdictions. This includes technical training (sharing methodologies for risk assessment, lab safety, etc.), legal assistance, and creating international databases or platforms. Examples such as the WHO’s work on gene editing trial registries and governance discussions on gene-drive mosquitoes show how international institutions can help ensure that countries with different levels of capacity are all able to contribute to, and prepare for, emerging biotechnology developments.