2. Legalization and De-legalization

Back in 2000, the world was witnessing ‘a move to law’ in international relations, according to the introduction to the special issue of International Organization, which laid the foundation for the concept of ‘legalization’.Footnote ¹⁰ Some 20 years later, the Interest Group on Social Sciences and International Law of the European Society on International Law (ESIL) issued a call for papers on the ‘de-legalization’ of international law,Footnote ¹¹ drawing attention to the opposite trend. In this section we review relevant literature from political science, international relations, and international law, and apply it to the CBD context. We use this terminology while acknowledging that scholars use different terms to explore the function of international collaboration and the resulting normative activity or lack thereof.Footnote ¹²

Kenneth Abbott and co-authors conceptualized ‘legalization’ along three dimensions: (i) obligation, meaning that states and other actors are legally bound by international rules or commitments; (ii) precision, referring to the unambiguous content of the rules; and (iii) delegation, referring to the authority of third parties to implement, interpret, and apply the rules.Footnote ¹³ ‘Each of these dimensions is a matter of degree and gradation, not a rigid dichotomy’, they noted; the concept of legalization thus ‘encompasses a multidimensional continuum’Footnote ¹⁴ from hard to soft law, with forms of legalization involving different combinations of attributes.Footnote ¹⁵ Their analysis has some limitations: it understands law narrowly, as a ‘collection of formalized and institutionalized features’,Footnote ¹⁶ and does not take into consideration the underlying processes and effects of legitimacy, including the relation between legitimacy and obligation and the ‘continuum of legality from informal to more formal norms’.Footnote ¹⁷ However, it is still a useful starting point for this discussion.

Legalization is reflected in the emergence of increasingly dense webs of international treaties over the course of the second half of the 20^th century, including a proliferation of legally binding multilateral environmental agreements, and in the rise of international courts and tribunals in areas that range from trade and investment to international humanitarian law.Footnote ¹⁸ Beyond a historical trend towards binding treaty law and an international judiciary, one particularly salient conceptualization refers to the specificity with which international rules describe state rights and obligations.Footnote ¹⁹ Typically, the legalization of global politics is associated with higher degrees of effectiveness in the implementation of international rules, relative to soft law solutions that are usually limited in binding effect, accuracy, and enforceability. While deeply legalized international arrangements are costly to negotiate and may be prone to defection,Footnote ²⁰ ‘binding rules involve more credible commitments and are often accompanied by more stringent procedures for verification, review and response’.Footnote ²¹

While the concept of legalization captures important elements of the development of the post-1945 international order, mounting evidence suggests that it is not a unidirectional phenomenon. Already in the 2000 special issue, it was noted that the trend is ‘hardly uniform’.Footnote ²² Abbott and Snidal integrated soft law in the legalization continuum, optimistically arguing that ‘international actors often deliberately choose softer forms of legalization as superior institutional arrangements’.Footnote ²³ Although soft law is ‘by no means a brand-new phenomenon’Footnote ²⁴ and has clear doctrinal characteristics regarding its legal effects and lack of justiciability,Footnote ²⁵ legal scholars continue to debate its nature and relation to binding international law, drawing attention to questions of effectiveness, legitimacy, and persuasiveness, and ultimately the distinction between law and non-law.Footnote ²⁶

As novel forms of governance arrangements are on the rise, expansion of international treaty law has been slowing down in recent years and may be approaching its limits.Footnote ²⁷ While global challenges deepen, ‘multilateralism is in retreat’.Footnote ²⁸ Some authors note a tendency towards ‘dejudicialization of international politics’, that is, ‘the complete removal from judicial cognizance of a policy issue that had previously been subject to judicialization’.Footnote ²⁹ The deadlock of dispute settlement under the World Trade Organization, once considered an archetype of international judicialization, highlights the possibility of retrenchment in the face of pushback from powerful nation states.Footnote ³⁰ Resistance against international tribunals is accompanied by increasing disrespect for their judgments and lack of implementation of even binding commitments in all areas but international trade and finance,Footnote ³¹ raising difficult questions about the reach and impact of international law. This retreat is further illustrated by the increasing employment of soft law and a steep decline in the precision of legal provisions in both treaties and soft law instruments. Addressed here under the concept of de-legalization, these trends can possibly be explained through structural changes in the international system, including economic or geopolitical ones, as a result of unilateralism, rising nationalism, or resistance to the unequal allocation of resources.Footnote ³²

Beyond a few scattered cases, empirical evidence for de-legalization and theoretical engagement with its drivers remain limited. We address both gaps by focusing on de-legalization trends at the intersection between global environmental and technology governance: rule development on novel biotechnologies under the CBD. This article thus addresses central questions of international regulation in a technological field with profound significance for research, development, and innovation across multiple social and economic sectors, including agriculture and health, and major implications for global equity and sustainable development. Historically, the CBD has been at the forefront of international biotechnology regulation, contributing to the institutionalization of international norms on precaution and on the fair and equitable sharing of benefits arising out of the (biotechnological) utilization of genetic resources of plant, microbial, and other origin.

In the CBD context, de-legalization occurs at the level of rule development. International institutions require constant adaptation to changes in their institutional environment lest they gradually drift into irrelevance as the conditions for which they were initially created increasingly cease to hold. This is particularly the case for institutions dealing with fast-moving technological changes.Footnote ³³ Appropriate rule development thus ensures that an institution remains relevant and can continue to assert its principles and objectives even in the face of changing circumstances. De-legalization threatens such institutional adaptation: while some rules continue to be produced, their soft law nature and increasingly vague normative content limit their potential for implementation at the national level, as well as the potential for inducing behavioural changes in line with institutional objectives. As we discuss below, the de-legalization of rule development for biotechnology under the CBD is driven primarily by shifts in coalition politics, underpinned by the shifting global political economy of biotechnology. We thus highlight the role of international interest constellations in shaping the trajectory of international law, in the direction of either legalization or de-legalization, further drawing attention to underlying socio-economic considerations. Focusing on three CBD agenda items at different points of the biotechnological value chain – DSI, risk assessment and risk management, and synthetic biology – we show why and how the de-legalization trend leads to widening gaps in the international legal framework for novel biotechnologies. We argue that, because of the central role of the CBD in global biodiversity governance, this trend has important implications for environmental multilateralism more broadly.

In the following section we start by exploring policy developments on DSI, a term referring to data derived from genetic resources. A crucial tool in biotechnological innovation, as well as the conservation of genetic resources, the governance of DSI is a highly controversial topic in all ABS-related processes, including the CBD.

3. Digital Sequence Information on Genetic Resources

Scientific and technological advances in genomics and bioinformatics have transformed the process of sourcing raw material for use in bio-based research and development. Improvements in computing power and the development of tools that can generate and analyze large quantities of genotypic, phenotypic, and environmental data, along with reductions in the cost of sequencing,Footnote ³⁴ have led to a dramatic acceleration of the innovation process, and to the generation and potential exchange of a ‘tsunami of genomic information’,Footnote ³⁵ termed DSI in the CBD context. Synthetic biology and other approaches have made possible the use of the information content of genetic resources in the industrial, pharmaceutical, and agriculture sectors, with no need for access to physical samples. In the pharmaceutical sector, for example, the ability to use DSI has resulted in the emergence of new approaches to vaccine development that do not require live influenza viruses.Footnote ³⁶ In agricultural research, large-scale sequencing techniques allow the searching of genebank accessions for material containing desired genetic elements for use in plant breeding programmes, with the value lying in the amount of data analyzed, rather than in a single sample.Footnote ³⁷

Such developments not only facilitate biotechnological innovation but also have a crucial role in biodiversity conservation and sustainable use,Footnote ³⁸ including through identifying species and monitoring ecosystems. However, they have created challenges for the ABS architecture of the CBD and other ABS-related processes. With physical genetic resources no longer required, there is a risk of bypassing benefit-sharing obligations for access to genetic resources provided for by national laws, and thus undermine the third CBD objective on fair and equitable benefit-sharing.

CBD debates on DSI were initiated in 2015, during technical discussions on synthetic biology. Participating experts identified potential adverse effects of synthetic biology for the third CBD objective, and a ‘shift in the understanding of what constitutes a genetic resource’.Footnote ³⁹ In the years that followed, the need to ensure benefit-sharing from the use of DSI became a central topic in the CBD negotiations, involving questions which are primarily political, as well as legal and technical. Legal and technical discussions revolved around the term ‘genetic resource’ – and whether it could be interpreted to include non-material elements such as information, while remaining within the scope of the Convention and the Nagoya ABS Protocol – and implementation-related concerns regarding identification of users and tracking of DSI use. The political challenge relates to the deep-rooted conflict between developed and developing countries on who benefits from biotechnological innovation and the need and intention to fulfil benefit-sharing requirements.Footnote ⁴⁰

The question of benefit-sharing from the use of DSI received major political attention on the road to the Kunming-Montreal Global Biodiversity Framework. Considerable technical work and several rounds of consultations addressed legal and implementation challenges. Positions at COP15 remained polarized, however, with some developed countries maintaining the view that DSI falls outside the scope of the CBD and the definition of genetic resource.Footnote ⁴¹ The final agreement to establish a global multilateral mechanism for benefit-sharing from DSI use, including a global fund,Footnote ⁴² came as a surprise.Footnote ⁴³ Part of a package of six key decisions proposed by the meeting’s Presidency, with success in reaching agreement, reflected a key compromise between the negotiating blocs of industrialized and developing countries, which involved items beyond DSI, such as specific targets of the Kunming-Montreal Global Biodiversity Framework.

The DSI decision had major political significance: it marked a move by the international community towards accepting the need for benefit-sharing from DSI use, and thus ‘a phase shift in the approach to governance of genetic resources’.Footnote ⁴⁴ Indeed, the political compromise behind the decision arguably opened the way for adoption of the legally binding Agreement under the UN Convention on the Law of the Sea on the Conservation and Sustainable Use of Marine Biological Diversity of Areas Beyond National Jurisdiction (BBNJ Agreement),Footnote ⁴⁵ which establishes an ABS mechanism with regard to the utilization of marine genetic resources as well as DSI.Footnote ⁴⁶ It is also expected to influence the process under the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA),Footnote ⁴⁷ which negotiates the revision of its own multilateral system for ABS regarding plant genetic resources for food and agriculture, with benefit-sharing from DSI use remaining a deeply controversial issue.

At the same time, the COP15 decision on DSI reveals a lack of legal precision, as well as gaps and inconsistencies, which call into question the successful operationalization of the multilateral mechanism. In addition to recognizing in its preamble the divergent views on whether DSI falls within the scope of the CBD, virtually all operational details of the multilateral mechanism remained unresolved. This includes the questions of how the multilateral mechanism would interact with the Nagoya ABS Protocol, which establishes a system based on bilateral transactions between providers and users of genetic resources, or how it would interact with national ABS measures, as well as the rights of Indigenous peoples over their traditional knowledge and genetic resources. Most importantly, the decision glosses over questions of patents and other intellectual property rights. The interface between ABS and intellectual property has been extraordinarily controversial in both the CBD and intellectual property forums, including the World Trade Organization and the World Intellectual Property Organization (WIPO).Footnote ⁴⁸ The WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge,Footnote ⁴⁹ concluded in May 2024 after almost 25 years of negotiations, is the first international instrument to address this interface. Albeit remarkable as an achievement for establishing a mandatory disclosure requirement of the origin or source of genetic resources and traditional knowledge in patent applications,Footnote ⁵⁰ the WIPO Treaty takes a narrow approach to this requirement and is silent on patents based on DSI, although most patents concerning genetic resources are based on DSI.Footnote ⁵¹

The operational modalities of the CBD global multilateral benefit-sharing mechanism were adopted at COP16 in 2024.Footnote ⁵² A surprisingly horizontal approach to benefit-sharing from DSI is put forward: DSI users in sectors that directly or indirectly benefit from its use in their commercial activities should contribute to the newly established ‘Cali Fund’, depending on their size.Footnote ⁵³ These sectors involve pharmaceuticals, cosmetics, and animal and plant breeding, among others.Footnote ⁵⁴ At the same time, the potential effectiveness of this admittedly broad approach is jeopardized by multiple layers of imprecision and legal uncertainty. While implementation in any case rests with national governments and requires national legislation or policies, the decision uses weak legal language that does not correspond to any clear obligation: parties and non-parties are invited to take administrative, policy or legislative measures, consistent with national legislation, to incentivize users in their jurisdiction to contribute to the Fund.Footnote ⁵⁵ The assimilation of parties and non-parties further accentuates the absence of any legal obligation to implement. In addition, the basis of benefit-sharing contributions is highly uncertain: both the rates for benefit-sharing contributions by users, as well as the list of sectors that benefit from DSI use, are merely indicative.Footnote ⁵⁶ This imprecise and open-ended legal wording aims to allow a high degree of flexibility for national implementation in an effort to reach intergovernmental consensus on a divisive policy matter. It is questionable, however, whether this lack of precision can promote effectiveness in implementation, and this is implicitly acknowledged in the decision, with a process for review of effectiveness to begin at COP18.Footnote ⁵⁷ Overall, the wording of the decision reveals parties’ reluctance to assume any legal obligations with regard to benefit-sharing from DSI use, which stands in contrast with the Nagoya Protocol negotiations 15 years ago.

In the next section, we continue by examining policy developments on LMOs, the outcome of biotechnological innovation that is often commercialized and released into the environment, which have been on the CBD agenda since its inception.

4. Risk Assessment of Living Modified Organisms

LMOs have been used in an increasing variety of contexts since the early 1990s. Agriculture has seen a rapid rise in the cultivation of living modified (LM) crops over the past three decades, particularly in South and North America, and LM fish are produced in commercial aquaculture.Footnote ⁵⁸ LMOs are also used in industrial applications, such as for the production of specific enzymes. Some environmental remediation techniques, including for oil spills, revolve around releases of LM bacteria. Emerging applications include the use of LM crops to produce pharmaceuticals, in what is known as ‘biopharming’.Footnote ⁵⁹ In the past few years, mass releases of insects genetically engineered for sterility have taken place in Brazil and the United States (US) for the suppression of natural insect populations that cause harmful environmental and health-related impacts, including as vectors for infectious diseases.Footnote ⁶⁰

Alongside their potential and actual benefits, the risks that LMOs may pose to biodiversity have been a major area of concern under the CBD since its earliest days. Under Article 8(g) CBD, parties must establish and maintain appropriate regulatory frameworks for associated risks, while Article 19.3 commits parties to consider the modalities of a potential biosafety protocol, culminating in the conclusion of the Cartagena Protocol on Biosafety in 2000. The Protocol aims for safety in the transfer, handling, and use of LMOs with potentially adverse impacts on biodiversity.Footnote ⁶¹ It establishes a mechanism for regulating bilateral trade in agricultural LMOs, while also providing rules and guidelines on risk assessment of LMOs.Footnote ⁶² Risk assessment is central to its operation, especially with regard to controls on transboundary movements.Footnote ⁶³ The development of international guidance thus contributes to the diffusion of minimum standards and best practices. In the years since adoption, the COP serving as the Meeting of the Parties to the Protocol (MOP) has explored the need for further developing the risk assessment component through a series of decisions as well as intersessional work under ad hoc technical expert groups. In 2018, MOP9 established a structured process for identifying new priority issues for risk assessment.Footnote ⁶⁴

The discussion following MOP9 focused on two key areas: engineered gene drives and LM fish. Both areas pose biosafety risks that go beyond the scope of existing risk assessment methodologies. Engineered gene drives are genetic modifications that bias inheritance rates and thus allow, in principle, for the large-scale biological control of species with short reproduction cycles.Footnote ⁶⁵ Gene drives are presently under development as possible instruments for disease vector control as well as to combat invasive alien species.Footnote ⁶⁶ LM fish is an area of growing commercial interest, including in the context of marine sustainability, as industry claims that aquaculture keeps overfishing partially in check.Footnote ⁶⁷ Biosafety risks relate to their mobility, the potential for invasiveness and hybridization with wild populations, and crossing of national borders.Footnote ⁶⁸

The development of risk assessment guidance for these two areas of biotechnological applications links to the regulation of transboundary movements of LMOs under the Biosafety Protocol. In principle, such transboundary movements are subject to the advance informed agreement (in other contexts known as prior informed consent) of the importing party.Footnote ⁶⁹ Parties have the right to require a risk assessment prior to the authorization of any such transboundary movement.Footnote ⁷⁰ The existence of appropriate risk assessment methodologies is thus a precondition for decision-making regarding the environmental release of LMOs such as LM fish, or gene drive systems that are plausibly prone to transboundary migration.Footnote ⁷¹

In 2022, MOP10 decided to proceed with the development of voluntary risk assessment guidance for gene drive systems with the focus on gene drive mosquitoes, but not for LM fish.Footnote ⁷² MOP11, in 2024, ‘welcomed’ the voluntary guidance materials developed through an Ad Hoc Technical Expert GroupFootnote ⁷³ and did not identify further areas in need of specific guidance for risk assessment.Footnote ⁷⁴ While the MOP left in place the process for the identification of new issues established by MOP9, further rule development on risk assessment under the Cartagena Biosafety Protocol has ceased for the time being.

A related discussion emerged on the basis of a recommendation by the Protocol’s Compliance Committee concerning the case of genome-edited plants. Today, genome editing is increasingly used as a plant breeding technique, which uses genetic pathways for obtaining outcomes, such as induced mutagenesis, which are at the core of conventional (non-genetic) techniques. As these so-called new genomic techniques do not involve the insertion of foreign DNA, there are ongoing debates in the European Union (EU) and elsewhere on the extent to which the resulting organisms fall under LMO regulation.Footnote ⁷⁵ The issue only appeared on the MOP’s agenda in 2024, as the Compliance Committee recommended considering the implications of diverging interpretations of the definition of LMO and the varying legislative approaches among parties resulting from developments including genome editing.Footnote ⁷⁶

The question of whether organisms produced via novel biotechnological techniques of considerable commercial relevance fall within the scope of the Cartagena Biosafety Protocol, and are thus subject to its risk assessment provisions, is of major legal significance. However, stark divergences among parties, mainly between EU Member States and large exporters of LM crops, resulted only in a limited information-gathering exercise. In a further illustration of current limitations on rule development, the MOP encouraged parties to submit information regarding relevant national legislation, regulations and guidelines on new developments in modern biotechnology that are not published in the Protocol’s Biosafety Clearing House.Footnote ⁷⁷

In principle, elaboration of additional guidance on risk assessment would ensure synchronization between the Biosafety Protocol and rapid developments in the life sciences that lead to novel types of LMO that have novel risk profiles and are prone to transboundary migration. It is thus remarkable that the only additional such guidance developed so far is limited to gene drive systems for one specific species, mosquitoes, in a manner that may risk duplication with work undertaken in the context of the World Health Organization (WHO)Footnote ⁷⁸ and does not capture the full range of applications that are currently being explored, notably rodents.Footnote ⁷⁹ In addition, while the Ad Hoc Technical Expert Group on Risk Assessment did not see a need for the development of guidance on LM fish, various studies do point to novel biosafety issues with LM fish, as well as other LMOs in the aquatic environment.Footnote ⁸⁰

Adjustments to the risk assessment regime of the Cartagena Biosafety Protocol have thus been minimal, while the development of LMOs with novel risk profiles is proceeding apace. The limited output that does exist, on gene drive systems in mosquitoes, is normatively weak by design, as implied by its title ‘additional voluntary guidance materials’ and the fact that the MOP did not ‘adopt’ it but ‘welcomed’ it.Footnote ⁸¹ For the purposes of Article 15 of the Biosafety Protocol, it amounts to a ‘recognized risk assessment technique’ to be taken into account by governments in their decision-making process. An alternative legal route to address the numerous biosafety issues associated with the emergence of new types of LMO would be to amend or add to the mandatory criteria contained in the Protocol’s Annex III. Yet, the MOP has chosen to create non-binding guidance with the focus on a subset of novel biotechnological applications.

Such limitations in agenda-setting, which have an impact on the capacity of the CBD to provide a governance framework for novel biotechnologies, are coupled with limitations in policy development in the field of synthetic biology, explored in the next section.

5. Horizon-Scanning, Monitoring and Assessment of Synthetic Biology

Synthetic biology is an umbrella term used for a wide range of potentially disruptive biotechnological innovations. Areas typically associated with synthetic biology include computer-designed cells synthesized from inorganic components, genetic sequences that incorporate nucleotides which do not exist in nature, directed evolution, metabolic pathway engineering and protein design.Footnote ⁸² There is no scientific consensus on which technologies should fall within the term, resulting in the lack of an agreed definition.Footnote ⁸³ Current CBD work is guided by an operational definition developed in 2016, according to which synthetic biology is ‘a further development and new dimension of modern biotechnology that combines science, technology and engineering to facilitate and accelerate the understanding, design, redesign, manufacture and/or modification of genetic materials, living organisms and biological systems’.Footnote ⁸⁴ This encompassing definition, in practice, covers any contemporary biotechnological development, ranging from commercialized applications, such as genome-edited plants, to speculative methods for large-scale in situ genetic engineering.

Synthetic biology falls fully within the definition of biotechnology under Article 2 CBD as ‘any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use’. The CBD thus has a clear mandate to engage with its implications for its three objectives. In addition, there are several other CBD provisions relevant to LMOs produced via synthetic biology, such as those on putting in place domestic regulatory frameworks to address risks associated with LMOs, enhancing participation in biotechnological research, and promoting technology transfer and technical and scientific cooperation.Footnote ⁸⁵ Synthetic biology applications also generally fall within the scope of the Cartagena Biosafety Protocol, and are highly relevant for ABS, as noted in the section on DSI. There is thus ample legal basis for the CBD to engage with synthetic biology. Past practice also indicates that the CBD has typically responded to novel biotechnological developments in a robust manner. This includes not only the Cartagena Biosafety Protocol and its Supplementary Protocol on Liability and Redress, but also COP decisions, such as that on genetic use restriction technologies intended to engineer agricultural crops for sterility to enforce intellectual property rights.Footnote ⁸⁶

The COP first addressed synthetic biology in 2012, when it noted ‘the need to consider the potential positive and negative impacts of components, organisms and products resulting from synthetic biology techniques’.Footnote ⁸⁷ In 2014, the COP urged parties to adopt a precautionary approach towards synthetic biology and established an Ad Hoc Technical Expert Group for further assessment during the intersessional period.Footnote ⁸⁸ By 2018, the COP had agreed on a need for broad and regular horizon-scanning, monitoring and assessment of the most recent technological developments in the field.Footnote ⁸⁹ COP15 established an operational process for broad and regular horizon-scanning, monitoring and assessment, to be supported for one intersessional period by a multidisciplinary Ad Hoc Technical Expert Group (mAHTEG) seeking to ensure a wide range of expertise, yet under terms of reference largely similar to those of its previous incarnation.Footnote ⁹⁰ The work of this mAHTEG resulted, inter alia, in the identification of five priority items for further consideration by parties, including gene drive systems for rapid and large-scale in situ genetic engineering, self-spreading vaccines for use in wildlife, and the convergence between synthetic biology and artificial intelligence.

COP16 subsequently gutted the process for horizon-scanning, monitoring and assessment, and merely ‘noted’ the intersessional work of the mAHTEG.Footnote ⁹¹ Work on this agenda item during the following intersessional period will revolve primarily around the development of a thematic action plan on capacity-building in synthetic biology. Whereas the COP had previously sought a balanced approach towards the potential negative and positive impacts of synthetic biology vis-à-vis the objectives of the Convention, the COP16 decision gives priority to potential positive impacts and related capacity-building. The lack of any reference to the priority items identified by the mAHTEG further highlights how COP16 has de-prioritized the consideration of biosafety risks and equity challenges associated with synthetic biology.

Several factors have been complicating CBD deliberations on synthetic biology. Firstly, a major debate until COP15 revolved around the question of whether synthetic biology formally constitutes a ‘new and emerging issue’, which would make it a permanent fixture on the CBD agenda. Because of political disagreements, COP15 crafted a compromise by deciding not to decide on the matter.Footnote ⁹² Beneath what appears to be an arcane procedural question lies fundamental disagreement on whether the CBD should address synthetic biology in the first place. A second complicating factor relates to whether synthetic biology should be addressed under the CBD or the Cartagena Biosafety Protocol. Addressing the item under the Protocol would imply a narrow focus on risks of LMOs produced via synthetic biology, while addressing it under the CBD allows a broader perspective on the technological field beyond organisms, including applications and techniques such as artificial intelligence and generative biology, as well as consideration of potential benefit-sharing considerations, alongside risks. As a further indication of the complexity and politicization of the process, some parties at COP16 curiously argued in favour of both moving synthetic biology to the Cartagena Biosafety Protocol and prioritizing its potential benefits.

Having provided empirical evidence of de-legalization in the context of three critical agenda items linked to biotechnology governance under the CBD and its Protocols, in the following section we explore possible explanations and drivers of this de-legalization trend in the broader institutional and socio-economic context.

6. Exploring Drivers of the De-legalization of Novel Biotechnology Governance under the CBD

The CBD has historically been more than a classic nature protection instrument. It has addressed diverse politically contentious technological questions over the years, with the rapid pace of innovation raising new regulatory challenges.Footnote ⁹³ However, at a time when the use of biotechnologies is expanding and accelerating,Footnote ⁹⁴ CBD policy outcomes at the last two COP meetings appear to shift towards lower stringency in substance and weaker institutionalization in process, indicating that CBD parties distance themselves from biotechnology governance.

A possible explanation of the observed trend is that large steps in international environmental governance are often preceded by smaller ones.Footnote ⁹⁵ The Nagoya ABS Protocol, for instance, was the result of more than a decade of soft law rule-making on the basis of Article 15 CBD,Footnote ⁹⁶ including in the form of the non-binding 2002 Bonn Guidelines on ABS.Footnote ⁹⁷ There is thus merit in considering the steps the CBD has taken in the past decade on DSI, risk assessment, and synthetic biology as necessary preconditions for reaching more robust legal outcomes further down the road. Rather than pointing to incremental regime formation, however, we argue that the post-2010 period is indicative of a de-legalization trend through a progressive softening of the law and governance framework, vague normative content, and limitations in agenda-setting that stand in contrast to the pace of technological development. We explore this argument below with regard to the ABS and the biosafety side of biotechnology governance, in turn.

Part of the broader ABS agenda, the 2022 and 2024 decisions on DSI are a compromise between developed and developing countries, and part of overall ‘package deals’. The COP15 package explicitly included the Kunming-Montreal Global Biodiversity Framework and decisions on resource mobilization and monitoring.Footnote ⁹⁸ This is a familiar trend in CBD decision-making. As most developed countries are reluctant to accept benefit-sharing obligations, which would arguably limit their industries’ innovation potential, past breakthroughs on ABS have also required ‘package deals’: the Nagoya ABS Protocol was itself part of a package, which also included the Strategic Plan for Biodiversity 2010–2020 and a decision on implementation of the resource mobilization strategy.Footnote ⁹⁹ Yet, COP10 resulted in a legally binding instrument – the Nagoya ABS Protocol – while COP15 resulted in merely a barebones decision on DSI, which established a process forward but lacked both in legal obligation and in legal precision, as detailed above. While ambitious in reach, the modalities of the global multilateral benefit-sharing mechanism adopted at COP16 follow the same direction of intentionally limited obligation and precision, which will have an impact on implementation and effectiveness.

On the ABS front, there is at least consensus among parties to continue with a process going forward on DSI. By contrast, on the biosafety front, influential member states are making sustained efforts to curtail the CBD’s biosafety agenda in unprecedented ways. The proceedings of the meetings of both the COP and the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) provide evidence in that respect.Footnote ¹⁰⁰ Notably, the Kunming-Montreal Global Biodiversity Framework does not contain a single reference to precaution, and its ‘target’ on biosafety is not a real target but merely repeats Convention language.Footnote ¹⁰¹ Reference to synthetic biology was dropped during the negotiations, following consistent opposition by a number of parties, despite its dominance in contemporary life sciences. No biosafety-related decision was considered prominent enough to make it into a ‘package deal’.

One way of examining the drivers of the observed trend is to start by reversing the question and ask why the CBD engaged with it in the first place. For one, the global politics of biotechnology have become considerably messier since the 1990s. Back then, biotechnological research, development and innovation were marginal or non-existent in most developing countries, leading them to oppose at the international level a technological field likely to entail substantial commercial advantages for large exporters of agricultural commodities but risks for importers and more diverse agricultural economies. At the time, the European Union pushed for precautionary international regulation to reflect its own stringent regulatory framework, developed as a result of broad societal concerns, as well as to address its lack of competitiveness vis-à-vis the US, Canada, and a handful of others.Footnote ¹⁰²

Over the years, the landscape of both the regulation and political economy of biotechnology has changed. In a significant change of course, with conflicts deepening among its Member States, the EU is currently considering deregulating at least some genome-edited crops,Footnote ¹⁰³ thus excluding them from the requirements of its regulatory framework on genetically modified organisms.Footnote ¹⁰⁴ Monsanto, once the epitome of the aggressive and potentially unsafe exploitation of novel biotechnological methods within the lenient regulatory environment of the US, was bought by German Bayer AG in 2018. Brazil today is a major powerhouse in biotechnology, in agriculture and beyond, and appears to prefer the CBD to pull back from biotechnology regulation.Footnote ¹⁰⁵ China and India have become major players in agricultural and pharmaceutical biotechnology. The African Union has been addressing novel biotechnologies, including genome editing, with a focus on their development and agricultural productivity potential.Footnote ¹⁰⁶ Some African countries, as well as Australia and New Zealand, are considering gene drives as potential options for addressing vector diseases or biological invasions. Only a handful of civil society organizations currently push for precautionary biotechnology regulation by the CBD. Instead, the emphasis has shifted towards the sharing of the benefits of technological innovation, including biotechnology, and away from the regulation of risks. The COP16 decision on synthetic biology, focusing mainly on the development of a capacity-building plan, is a testament to that.

These changes also reflect a shift in societal discourse: the attention of environmental movements has largely shifted away from LMOs and towards climate change. The industry has long been advocating the supposed benefits of biotechnology for climate adaptation, further arguing that more than 30 years of experience with agricultural biotechnologies have relieved many of the fears regarding environmental risks. Yet, questions of biosafety have become more significant with recent biotechnological developments, while questions of corporate power, market consolidation, and ownership of intellectual property rights remain central for the fair and effective global governance of biodiversity and biotechnology alike. In the current context of extreme patent expansion and market concentration in the agro-chemical sector,Footnote ¹⁰⁷ industrialized agriculture is among the main drivers of biodiversity loss, while the ABS approach alone fails to deliver tangible benefit-sharing streams to promote biodiversity conservation and address global inequities.Footnote ¹⁰⁸ The case of gene drives exemplifies the combination of socio-economic and environmental risk. A controversial novel biotechnology with significant biosafety risks, gene drives are promoted to have a potentially transformative impact on sustainable development challenges relevant to the developing world. However, the first systematic account of its organizational structure has shown that global gene drive research has limited organizational and geographical diversity and is firmly dominated by elite US-based organizations,Footnote ¹⁰⁹ posing the question of who reaps the benefits and who bears the risks.

The course of the CBD also needs to be considered in the context of regime complexity, as multiple and partially overlapping international institutions address related issues. The ABS landscape has become increasingly complex. ABS has become the ‘go-to’ solution for international negotiators, having provided space for discussions on equity and justice in bio-based innovation.Footnote ¹¹⁰ DSI on genetic resources is thus under consideration in several forums addressing access to genetic resources for research and development purposes beyond the CBD and its Nagoya ABS Protocol, including the ITPGRFA, the WHO Pandemic Influenza Preparedness Framework,Footnote ¹¹¹ and the WHO Pandemic Agreement.Footnote ¹¹² The BBNJ agreement contains legally binding and far-reaching ABS rules addressing both marine genetic resources and associated DSI.

Various organizations have also been addressing biosafety issues as part of their mandate. The WHO has developed technical guidance on risk assessment of genetically modified mosquitoes;Footnote ¹¹³ and the Food and Agriculture Organization of the United Nations (FAO), which has been addressing LM fish in its technical work, was invited by the UN General Assembly to provide guidance on the potential risk and effects of genetically engineered fish species on wild fish stocks and biodiversity.Footnote ¹¹⁴ The International Union for the Conservation of Nature (IUCN) has also been addressing conservation aspects of synthetic biology for several years.Footnote ¹¹⁵

This regime complexity raises risks of fragmentation while underscoring needs for coordination and cooperation.Footnote ¹¹⁶ The CBD Working Group on benefit-sharing from DSI use acknowledged such needs,Footnote ¹¹⁷ with an inter-forum body or process on DSI being proposed as a way to facilitate coordination and ensure mutual supportiveness.Footnote ¹¹⁸ At COP16, parties opted for a clause on mutual supportiveness, including an invitation for collaboration with the multilateral mechanism, ‘to avoid the stacking of obligations and, where appropriate, to streamline processes’.Footnote ¹¹⁹ COP decisions frequently refer to the need to pursue ‘coordinated and non-duplicative’ approaches,Footnote ¹²⁰ with the expectation that parallel policy processes would transition from initial inconsistencies and tensions between the relevant international institutions to a distinct division of labour, whereby respective institutional jurisdictions are clearly demarcated.Footnote ¹²¹ At the same time, the failure of the CBD in making substantive progress on DSI, risk assessment, and synthetic biology may jeopardize its central role in the wider governance architecture for bio-based innovation.Footnote ¹²² One implication of de-legalization may thus be a trend towards decentralization, as the CBD increasingly abdicates its coordinating and orchestrating institutional function in these issue areas.Footnote ¹²³