What does the 2022 UN Biodiversity Summit outcome on digital sequence information mean for the ocean and ocean research? (Part 2)
Following on from a previous blog post on the UN Biodiversity Conference of the Parties (COP15, held on 7-19 December 2022 - Montreal, Canada), this post reflects on the decision to establish a multilateral mechanism for benefit-sharing from digital sequence information (DSI), including a global fund, and its implications of for the ocean, ocean-dependent human rights and ocean research. In doing so, this post draws on the contributions from One Ocean Hub research to this process, as well as the work that remains outstanding, under the Convention on Biological Diversity (CBD), the World Health Organisation and the newly concluded international Agreement on marine biodiversity of areas beyond national jurisdiction (BBNJ).
Background
Central to discussions at COP15 was international alarm around ‘the continued loss of biodiversity and the threat that this poses to nature and human well-being.’ The resulting Kunming-Montreal Global Biodiversity Framework (GBF) includes, as one of its action-oriented 23 targets, Target 13, which calls for benefits arising from the use of genetic resources and DSI to be increased significantly by 2030. The GBF was the central part of a package deal that includes Decision 15/9 on DSI, which sets out a broad range of measures relating to DSI, including the establishment of a multilateral fund to share benefits arising from the use of DSI.
While there is not as yet an agreed upon definition of DSI, it is generally presumed to refer to the ‘information’ in a genetic resource such as, for example, nucleic acid sequence reads, amino acid sequences and cellular metabolites. DSI is mostly generated, ‘from basic research on plants, animals, fungi, bacteria and viruses in which DNA sequences from collection materials are placed in the public domain for taxonomic, phylogenetic or evolutionary studies.’ DSI is key to scientific advancement and innovation in energy, health, agriculture and biodiversity conservation, as well being valuable for many commercial applications.
The 1992 CBD – its third objective being the fair and equitable sharing of the benefits arising out of the utilization of genetic resources - and its associated 2010 Nagoya Protocol were originally premised upon the sharing of benefits following access to physical genetic resources. Such access and benefit-sharing (ABS) arrangements would in general be bilateral, accompanied by prior informed consent from the country of origin of the genetic resources and/or holder of these resources and associated traditional knowledge, and on mutually agreed terms. While multilateral benefit-sharing mechanisms are foreseen in the Nagoya Protocol (Article 10) in respect of genetic resources occurring in transboundary areas or where prior informed consent cannot be obtained, no such mechanisms have been created to date.
As is typical in policy processes, however, scientific, and technological innovations have moved faster than the processes themselves (see, for example, Wynberg and Laird, 2018). Developments in synthetic biology and sequencing technology over the past thirty years have led to the so-called dematerialisation of genetic resources whereby it is often the information contained in that resource – rather than the physical sample, which is of value. Indeed, a large array of both public and private databases host DSI, and this is often freely available with ‘open exchange of DNA sequences and related data (the) standard practice in non-commercial scientific research in which public international data repositories facilitate the rapid sharing of digital sequence information.’
The wide availability of DSI in databases has created something of a loophole in the access and benefit-sharing regimen established by the CBD and Nagoya Protocol. Put simply, the ABS system was constructed when genetic resources were largely in the form of physical samples. Where the information contained in a genetic resource is freely available via a DSI database such as the International Nucleotide Sequence Database Collaboration, benefit-sharing obligations which could affix to the use of a physical genetic resource are more complex to implement. In essence, the, ‘technological reality (is) that genetic resources can be accessed as digital sequence information in databases independently of access to the underlying biological material and result in commercial applications (i.e. independently of access or benefit sharing within the ABS framework of the CBD).’
While a few countries have domestic legislation regulating access and benefit-sharing associated with DSI, conserved sequences, which ‘are similar or identical sequences in DNA, RNA and proteins or polysaccharides occurring across species, or within different molecules produced by the same organism’ are also extremely common, adding additional complexity to notions of sovereignty and countries of origin which underpin the CBD/Nagoya Protocol. More generally, the application of the CBD and Nagoya Protocol access and benefit-sharing regime to DSI has raised practical concerns regarding, ‘(w)idespread non-compliance (exacerbating mistrust and hindering the incorporation of ABS to research workflows globally) or avoidance (as researchers will be incentivised to avoid using digital sequence information from countries with onerous requirements).’ Some in the scientific community have expressed concern, for example, as to the potential impact on open science, and innovation, should DSI be regulated in the same way as physical genetic resources in terms of access and benefit-sharing. By extension, there has been widespread debate about whether DSI falls within the scope of the CBD/Nagoya Protocol. At the same time, it has been argued by low and middle-income countries that technological and funding constraints hinder their capacity to innovate from DSI and unregulated open access to DSI would exacerbate global inequalities in scientific research and innovation. There is also concern that companies and others can derive genetic information and recreate key genes from DSI, in the process undermining the control of Indigenous and local communities of their physical genetic resources and associated traditional knowledge.
The 2022 CBD decision on digital sequence information
In a 2019 research paper authored by Hub Researchers Elisa Morgera, Stephanie Switzer, Miranda Geelhoed, with inputs from Sarah Laird and Rachel Wynberg, which was discussed at a CBD webinar on Policy Options for DSI in 2020, it was argued that:
- DSI is within the scope of the CBD and the Nagoya Protocol
- The very nature of DSI means that in practical terms it cannot be adequately addressed through a bilateral, transactional approach to ABS;
- A transactional approach/ logic of exchange in the context of negotiating mutually agreed terms has been detrimental to the identification of opportunities for increased cooperation for the realisation of all the objectives of the CBD and their global benefits for human well-being as well as the realisation of the Sustainable Development Goals
- A global fund for biodiversity under the CBD that decouples access from benefit sharing is suitable for multilateral monetary benefit-sharing from DSI;
- A multilateral platform for dialogue, learning, oversight, and priority setting is needed to ensure that the system would respond to the needs of expected beneficiaries and allow the international community to understand and respond to the different communities involved, including by addressing the needs of scientific researchers.
It is heartening to see that many of these recommendations are now included in Decision 15/9 of the CBD COP and the recognition that while the benefits from the use of DSI should be shared fairly and equitably, the distribution of DSI and distinctive practices regarding its use require a distinctive solution for benefit-sharing.
While encouraging the depositing of more DSI – including appropriate information on geographical origin and relevant metadata in public databases – the Decision 15/9 establishes, as part of the GBF, a multilateral mechanism for benefit-sharing from the use of DSI, including a global fund. While the mechanics of the mechanism are still to be worked out, a central element of the Decision is the establishment of a ‘fair, transparent, inclusive, participatory and time-bound process to develop and operationalise the mechanism.’ This is significant as it emphasises the importance of a representative and iterative approach to fairness and equity, as well as the need to explore further the viability of benefit-sharing arrangements from DSI.
Although the CBD Decision does not establish the details of a benefit-sharing mechanism, it calls for such a mechanism to be developed and finalized by the next COP. To that end, it sets out criteria for developing any solution for fair and equitable benefit-sharing on DSI on genetic resources (para 9):
(a) Efficiency, feasibility and practicality;
(b) The capacity to generate more benefits, including both monetary and non-monetary, than costs;
(c) Effectiveness;
(d) Certainty and legal clarity for providers and users of DSI;
(e) The avoidance of hindering research and innovation;
(f) Consistency with open access to data;
(g) Compatibility with international legal obligations;
(h) Mutual supportiveness with other ABS instruments;
(i) Account the rights of Indigenous peoples and local communities, including with respect to the traditional knowledge associated with genetic resources that they hold.
An Annex to the Decision sets out a range of issues for further consideration, including governance of the scheme, triggering points for benefit-sharing and the interface between ABS national systems and any multilateral mechanism. Accordingly, while the above criteria are praiseworthy, the hard work will now be in creating a fair, transparent, inclusive, participatory, and time-bound process for applying them.
The need for a fair and inclusive process to implement the decision
Any such process must explicitly involve the participation of and respect for the human rights of Indigenous peoples and local communities, and the traditional knowledge associated with genetic resources that they hold. Ensuring accountability as well as diverse and equitable participation in decision-making procedures will be critical to the success of such a process, alongside the need for continuous dialogue and learning across disciplines and sectors. Such a process also needs to focus on desirable outcomes rather than technical obstacles to progress, and be capable of overcoming the false dichotomy between monetary and non-monetary benefits and focusing instead on the commercial benefits that arise from the use of DSI – information that to date has been near impossible to ascertain. Increasing the transparency of how DSI is used in biotechnology products and processes, and associated profits, is a vital part of this information gathering.
There are also other human rights considerations to be taken into account, as noted in the Global Biodiversity Framework. Fair and equitable benefit-sharing from DSI has implications for the realisation of everyone’s human right to a healthy environment, as well as their human right to food and health, with particular attention to women’s human rights and children’s human rights. In addition, as argued in other Hub contributions, international human rights law provides clear approaches and benchmarks for transparent and participatory processes that should be taken into account in the implementation of the CBD decision.
An inclusive process can also support a more rounded and integrated approach to the development of such a mechanism taking into account the critiques to the effectiveness of ABS in general (Laird et al. 2020). Concerns have ranged from the complexity of ABS as a transactional mechanism (Hampton, 2023), to the lack of monetary benefit-sharing from ABS, which has failed to generate the expected benefits for conservation (Laird et al. 2020, Wynberg, 2023).
More generally, the, ‘question remains as to whether ABS is the best and only way to benefit provider countries, science, and conservation from the use of DSI’ (Laird et al. 2020). A key component of the critique towards ABS is that it has done little to level the playing field but has in effect become a compliance mechanism to maintain inequitable provider-user relations. A multilateral mechanism for DSI may run the same risk of institutionalising token benefits in the absence of accountability measures without a genuine intention for global collaboration. Any such mechanism must therefore not allow well-resourced users of DSI to dictate the terms of benefit-sharing. Furthermore, the transactional focus of ABS may detract from solidarity, and undermine flows of global benefits. Clearly, the focus of the mechanism should be on the actual realisation of equity and fairness in benefit-sharing, rather than on tokenistic ‘compliance.’ An exciting development could see the global multilateral mechanism and fund used as an opportunity to leverage wider benefits for biodiversity, not only from the sectors benefiting from the use of DSI, but also from industries such as agriculture and forestry that continue to rely on biodiversity, but with little support for its conservation. Similarly, calls for a ‘biodiversity tax’ by extractive industries such as mining, oil, and gas, could yield benefits for biodiversity conservation – and for the local custodians of biodiversity – that far outweigh those secured from the use of DSI. This wider contextual picture is one we should not lose sight of in the quest to secure equitable benefit-sharing.
Whether the multilateral mechanism will be able to take on board the above concerns will depend upon its design and structure. Central to this will be how benefits are shared. Clearly, a multilateral, fully decoupled system for the sharing of benefits according to agreed criteria offers the most opportunities to achieve equity and fairness, by moving beyond the problematic issues associated with the bilateral, transactional ABS mechanism in the DSI sphere. A specific mandate should also be included to review periodically the extent to which equitable outcomes are achieved under any global fund, as well as to collect and reflect on any lessons learnt with a view to iteratively adapting to them.
What happens next at the CBD?
In terms of next steps, an ad hoc open-ended working group on benefit-sharing from the use of DSI will recommend how to develop the multilateral mechanism, to the next COP to be held in Turkiye in 2024. Governments, Indigenous peoples, local communities and relevant organisations will be invited to submit views on the issues set out in the annex to the decision on issues for further consideration, such as governance of the fund and the interface of any multilateral mechanism with national schemes.
To inform this process, the CBD Secretariat is further mandated to:
- Compile lessons learned from other international funding mechanisms;
- Commission a study to analyse and model the extent to which a multilateral mechanism for benefit-sharing from the use of DSI, and any other options meet the criteria set out in Article 9, as well as the extent to which the monetary and non-monetary benefits arising from any such mechanism is used to support conservation and sustainable use of biological diversity and, inter alia, benefit Indigenous peoples and local communities; and
- Commission a study on the options for revenue-generating measures at different points along the value chain, the feasibility of their implementation and their costs relative to their potential revenue.
As discussed in our 2019 study, the creation of a multilateral platform for dialogue, learning, oversight, and priority-setting in the DSI benefit-sharing sphere seems an essential complement to a multilateral mechanism for benefit-sharing and a multilateral fund. The imperative behind our proposal was that beneficiaries’ agency is an essential, often overlooked, element of fairness and equity in benefit-sharing. The platform would need to make specific efforts to ensure the integration of local and indigenous knowledge in decision-making procedures, as well as scientists from different geographies and capacities, database managers, and experts from different sectors. Such a platform would ensure transparency, accountability and genuine partnership-building. It would place specific emphasis on iterative learning on fairness and equity (across different disciplines necessary to tackle the DSI issues from different perspectives and a variety of beneficiaries) and take an inclusive and representative approach to co-developing guiding principles for both the accrual of funds as well as fund disbursement.
Such a multilateral platform could also provide an opportunity to learn on an ongoing basis how benefit-sharing approaches to DSI can work or not for scientists, in the Global South and Global North, as well as the implications for biodiversity conservation and sustainable use. On that basis, the platform could proactively identify opportunities to facilitate and broker, and possibly also oversee and identify gaps or issues in, an otherwise ad hoc flow of information-sharing, scientific cooperation, and capacity-building activities. A more institutionalised approach could ensure responsiveness to the needs of those benefiting from information-sharing, provide oversight of the distribution of benefits across different regions, and contribute to a more systematic encouragement of virtuous circles through capacity building.
Scientists often work in global consortia of complementary expertise to achieve their outcomes but at times have been hesitant to publicly share DSI for fear of losing out on potential benefits. This is especially true of researchers from low and middle-income countries who may not be able to mine sequence data to the same extent as their high-income counterparts or who lack the resources to advance a novel innovation to commercialisation. If these existing inequalities are made explicit, a multilateral platform and benefit-sharing mechanism could offer opportunities for these inequalities to be addressed while advancing international scientific cooperation in science and innovation. Importantly, given innovations are often skewed towards the needs of high-income countries as the funders, a responsive approach will ensure that benefit-sharing is targeted towards enhancing the research and innovation capabilities of low and middle-income countries to address their own needs, as well as contribute more collaboratively to global challenges in health, food security, energy, and biodiversity conservation.
A multilateral platform could also support the understanding of different communities of practices involved in the use of DSI, thereby more effectively responding to the needs of researchers and the conservation community through co-development of solutions. It could also lead to the identification of users that could become benefit-sharing leaders in their sector (as developers and implementers of best practices in fair and equitable benefit-sharing), including in the context of the implementation of other relevant international instruments such as the recently agreed-upon BBNJ instrument and future pandemic instrument under the WHO (discussed below).
What happens next in other areas of international law?
Of course, the issue of DSI is not unique to the CBD and Nagoya Protocol. How to deal with benefit-sharing in respect of the genetic sequence data of pathogens has been central to current discussions on a proposed Pandemic Instrument being negotiated within the World Health Organisation. These negotiations are due to conclude by 2024 and notably, the most recent zero draft text (February 2023) of the Instrument sets out a mechanism for pathogen access and benefit-sharing (PABS). Genetic sequence data falls explicitly within this proposed mechanism, but the intricacies of how the PABS system might work, and how benefit-sharing might relate to the use of such data, remains to be determined. Arguably, the principles advanced in paragraph 9 of Decision 15/9 should guide the development of other multilateral mechanisms, including the PABS system, with a view to ensuring coherence in international processes. Moreover, under the ‘issues for further consideration’ set out under the Annex of CBD Decision 15/9 is the adaptability of any mechanism with other resource mobilisation instruments or funds. While the issues raised by pathogen sharing and the sharing of benefits such as medical countermeasures – vaccines, antivirals etc. – arguably require a bespoke solution (and indeed, the zero draft of the Pandemic Instrument sets out that PABS would need to be considered a specialised international instrument compared to the Nagoya Protocol), it may be that governance of any fund arising from the PABS system could follow similar modalities with the global fund envisaged under CBD Decision 15/9.
Pathogen sharing is also referenced in the ongoing negotiations to reform the WHO’s International Health Regulations (IHR) (2005). The purpose of the IHR (2005), as presently constructed, is to, ‘prevent, protect against, control and provide a public health response to the international spread of disease’ (Article 2). While information-sharing obligations exist under the IHR (2005) (Article 6 and Article 7), these do not extend to sharing pathogens, or genetic sequence data. The sharing of pathogens and related genetic sequence data has, however, been raised in the ongoing negotiations on amending the IHR. This issue has, perhaps not unexpectedly, been subject to significant debate with a proposed draft amendment to Article 6 IHR directing that no such sharing shall be considered unless and until, ‘an effective and transparent access and benefit sharing mechanism with standard material transfer agreements governing access to and use of biological material including genetic sequence data or information relating to such materials as well as fair and equitable sharing of benefits arising from their utilisation is agreed to by WHO Member States, is operational and effective in delivering fair and equitable benefit sharing.’ Clearly, the logics of any pathogen sharing scheme, together with the relationship between an amended IHR and a new Pandemic Instrument are still to be worked out, and how any such scheme will interact with the proposed multilateral mechanism for benefit-sharing from the use of DSI remains to be determined. However, coherence is vital in this already fragmented area and as argued above, the principles set down in CBD Decision 15/9 should guide the development of other multilateral mechanisms, including in respect of pathogen sharing.
The recently concluded Agreement on marine biodiversity of areas beyond national jurisdiction (BBNJ) also includes provisions on DSI, starting with a preambular acknowledgment that the generation of, access to, and utilization of digital sequence information on marine genetic resources of ABNJ, together with the fair and equitable sharing of benefits arising from its utilization, contribute to research and innovation and to the general objective of the Agreement. The Agreement then includes among its objectives benefit-sharing from the use of DSI collected or generated before entry into force, unless a Party makes an exception, as well as capacity-building with respect to DSI. Similarly to the CBD, the Agreement provides for monetary benefits from the utilization of DSI, including commercialization, through a financial mechanism, with modalities to be determined by the BBNJ Conference of the Parties, ‘recognizing that such modalities should be mutually supportive of and adaptable to other ABS instruments.’ Thus, the BBNJ Agreement opens the door for mutual learning across international regimes. To that end, the agreement also provides that the BBNJ Access And Benefit-Sharing Committee may consult and facilitate exchanges of information with relevant legal instruments and frameworks and relevant global, regional, sub-regional and sectoral bodies on activities under its mandate including benefit-sharing, the use of DSI on marine genetic resources, best practices, tools and methodologies, data governance and lessons learned. As noted above, under the Annex of CBD Decision 15/9 in respect of ‘issues for further consideration’ is the adaptability of any mechanism with other resource mobilisation instruments or funds. This provides scope for greater coherence between the CBD approach to DSI with that applicable to BBNJ. The BBNJ Agreement further calls upon parties to ensure coherence across regimes, by requiring parties to ‘endeavour to promote, as appropriate, the objectives of this Agreement when participating in decision-making under other relevant legal instruments and frameworks’ (art. 6).
Finally, DSI is also under consideration in the International Treaty on Plant Genetic Resources for Food and Agriculture. Although there has been little progress to date on the issue, the Treaty’s experiences of administering and implementing a benefit-sharing fund will be an important part of the process of exploring similar mechanisms as part of Decision 15/9 of the CBD COP.
Outlook
It remains to be seen how these multiple international developments on DSI will be operationalised and may learn from one another. Ultimately, how they will address fairness and equity between Global North and South countries, as well as among different knowledge holders and beneficiaries, also matters from a human rights perspective. As captured under the human right to science, there is a need to balance competing rights and interests, avoid discrimination, and respond to the needs of the vulnerable, while preventing negative environmental and socio-economic consequences of scientific research. These also provide pre-conditions for international cooperation on ABS to effectively contribute to the conservation of biodiversity for the benefit of all human rights dependent on it and everyone’s human right to a healthy environment.
Ongoing research by the authors
Hub researchers at Strathclyde University (Switzer and Morgera) have been commissioned by the CBD Secretariat to lessons learned from other international funding mechanisms, and are continuing research on learning across ABS regimes, including by sharing findings with WHO negotiators (see here and here). Switzer has also received, along with Mark Eccleston-Turner of King’s College, Royal Society of Edinburgh funding to look further at issues pertaining to pathogen sharing under the proposed Pandemic Treaty. Wynberg is involved in ongoing research initiatives to rethink ABS, and to analyse and explore experiences of implementing ABS, and its contribution to equity, conservation, and biodiversity science.