1Along with the funding of conservation efforts, access and benefit-sharing, or ABS, has become one of the major sticking points in negotiations over the CBD which, at the risk of over-simplifying, have pitted industrialised nations rich in technology against developing nations rich in biodiversity. Above and beyond the tensions caused by globalisation and unequal exchanges, this antagonism also says a lot about the way our societies are being transformed by digital and biotechnological innovation, reshaping both our relationship to the environment and the distribution of the value derived from its exploitation. These tensions are embodied in the debate over DSI – Digital Sequence Information – which we propose to analyse in this chapter.

2The implementation of the Nagoya Protocol has not lived up to expectations. Ten years on, there is no avoiding the fact that the monetary benefits generated by the ABS mechanism have been negligible and hampered by lengthy negotiations, while the accompanying administrative formalities have been decried as obstacles to research and innovation. In light of these criticisms, emanating from both provider countries and the users of genetic resources, why does the Nagoya Protocol not appear to have been seriously challenged?

3The Access and Benefit-Sharing Clearing House (ABSCH) continues to register new ratifications from countries party to the Protocol. The total now stands at 131, all signed up to both the theoretical principles and the concrete obligations of ABS (as of September 2021, 68 countries were still non-parties to the Protocol). Many States have thus committed to passing binding national legislation, accompanied by costly implementation processes, based upon the ABS model set out in the Protocol. Some of them do not appear to have given much thought as to the viability of such a model. At the international level, the preparatory working documents for the Post-2020 Global Biodiversity Framework to be negotiated at COP15 propose counting the number of countries who have actually received monetary or non-monetary benefits in return for granting access to genetic resources and associated traditional knowledge, as well as the total value of these monetary benefits established with the goal of “meeting people’s needs through sustainable use and benefit-sharing.”1 This ambitious proposal seems misguided, when the examples of ABS recorded by the ABSCH are so few in number and so poorly-documented, whereas the frustrations of the research community are being voiced loud and clear (Divakaran et al., 2018; Deplazes-Zemp et al., 2018; Rourke, 2018).

4The results achieved by the Nagoya Protocol thus far have been so disappointing that we might have expected a thorough overhaul. Instead, the plan appears to be to carry on regardless, engaging is some sort of race between advances in scientific practice and modifications to the scope of the CBD, which is clearly struggling to keep pace.

Carry on regardless

5In spite of all the evidence to the contrary, the “green gold” myth dangled by the CBD is alive and well among many of those designated as “providers.” And yet, for many “users,” the idea of bioprospecting for biological resources lost its sheen well before the signing of the CBD in 1992. This model, based on accessing physical resources held by a given country or community, no longer reflected the realities of the pharmaceutical industry, which was already busy developing high-throughput screening techniques to seek out new active ingredients from among the thousands of molecules supplied by the chemical industry.

6The scope of the biological resources eligible for ABS, which was initially limited to those containing functional units of heredity (i.e. genetic resources as defined in the CBD), has gradually been expanded since it became obvious that the most substantial financial rewards would come not from the utilisation of genetic materials, but instead from molecules used to create new drugs. The Nagoya Protocol was thus expanded to encompass derivatives, which it defines as follows: “Derivative: a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity (Art. 2c).”

7The ABS model championed by the Protocol therefore applies to natural molecules, resulting from the metabolism of organisms living or dead, including crude extracts. Enzymes, essential oils, resins etc. are thus classified as derivatives.

8Negotiations are now in progress for further expanding the scope of application of the ABS mechanism under the aegis of the CBD. The plan is to encompass DSI (Digital Sequence Information), a field in which the dedicated working group has yet to reach agreement on the preferred terminology to be used.

DSI (Digital Sequence Information)

What is it?

9All of the new branches of science denoted by the suffix -omics (genomics, proteomics, transcriptomics, metabolomics and so on and so forth) generate billions of units of digital data. DSI is the fruit of DNA sequencing technologies which have become progressively cheaper and faster.

10Breakthroughs in genomics and bioinformatics, methods of statistical analysis and cross-comparison with other data make it possible to extract results from DSI which can be used in various disciplines and at various levels. Among other things, they can cast new light on the mechanisms of molecular interaction and the evolutionary history of living organisms. Research into the living world has now entered the age of in silico biodiversity. Much of this work is done on computers, connected to data processing centres and making use of what we might describe as dematerialised genetic resources. The information and knowledge contained in DNA sequences can thus be extracted, transformed and exchanged independently of the physical genetic material to which they relate. For researchers in the life sciences, accessing DSI is more like accessing a service than using a material asset, although the latter status is still assigned to genetic resources in the text of the Protocol.

11The rise of DSI has been made possible by the development of calculation capacities and new methods for processing big data, as well as free or open access to the principal genetic sequence databases. The International Nucleotide Sequence Data Base (INSCD) is acknowledged in the CBD as a key partner for the recognition and protection of biodiversity. It encompasses the three main databases maintained at national or regional level: GenBank in the USA, DNA Data Bank in Japan and EMBL-EBI for the European Union. The data they contain are freely available to anybody with a computer and an internet connection. There are even entire genome sequences free to download in open access mode (CETAF, 2017).

12These genetic sequence databases are, naturally enough, supplied by researchers. They are invited – or obliged – by the major scientific journals to register their sequences so that their articles can be reviewed and published. Nature and Science both insist upon the registration of sequence data as a compulsory precondition for publication (Rourke, 2018), like the botany journals which require registration of a reference specimen with a herbarium, as per the requirements set out in the International Code of Botanical Nomenclature. Making data available to others is thus common practice in the scientific community, and may also be backed up by national research policies. In France, the Digital Republic Law of 26 October 2016 requires all data gathered, produced or published with public money to be made available to citizens. This enthusiasm for open data stands in stark contrast to the restrictions placed upon access to in situ or ex situ genetic resources by texts such as the Nagoya Protocol. Scientists thus find themselves caught between contradictory injunctions.

13New practices have revolutionised research involving genetic resources. DSI are now being touted as a new form of “green gold”, with online consultations of genome databases viewed in much the same way as prospecting for natural substances in situ was envisaged in the 1980s and 1990s, the sort of activity that the CBD was intended to regulate. The results thus far have been broadly similar, too: illusory visions of wealth and accusations of biopiracy. The Convention on Biological Diversity thus finds itself confronted with a phenomenon which, for some, is a textbook example of open science advancing thanks to the pooling of biological materials, data and knowledge; while for others it is simply a new form of biopiracy (Aubertin, 2018).

Historical note

14We can trace the origins of the DSI debate back to the 2015 meeting of the Ad Hoc Technical Expert Group of the Cartagena Protocol on Biosafety – another CBD protocol which came into force in 2003 – a group responsible for examining the potential negative and positive effects of synthetic biology (Keiper & Atanassova, 2020). They flagged up the utilisation of ‘digital genetic information’ derived from genetic resources and not accompanied by fair and equitable benefit-sharing. States party to the Nagoya Protocol were encouraged to look into this matter.2

15At COP13 in Cancun in 2016, the key topics of discussion for the two CBD protocols thus overlapped: the risks of synthetic biology, covered by the Cartagena Protocol, and the implementation of an access and benefit-sharing (ABS) mechanism for information on genetic resources in the form of data sequences, falling within the scope of the Nagoya Protocol.

16The utilisation of digital sequence information has now expanded far beyond the realm of academic research on biodiversity. Rapid advances in genome editing techniques (including the famous CRISPR-Cas9 protein) are opening up vast new horizons for the manipulation of the living world, with potentially serious implications for biodiversity and equally colossal possibilities for businesses in the food, pharmaceutical and cosmetics industries. There are concerns that this technology is currently escaping democratic control; 150 NGOs have demanded a moratorium on “gene drive” organisms. Meanwhile the industrial sector (for example, seed-producing firms editing the genomes of cultivated plant varieties using information derived from “desirable” gene sequences), unfettered by ABS mechanisms, is making full and free use of DSI available in open access format. Furthermore, these new techniques primarily benefit researchers and industrialists in developed nations, equipped with the technological and human resources required to exploit them (bioinformatics, molecular biology).

17We can easily understand why countries lacking these capacities would take issue with a practice which to their eyes is inconsistent and unfair: access to digitised resources is free and easy. Most digitised genetic sequences are accessible via public databases which do not require submissions to specify the origin of the resources from which sequences are derived, nor to identify all contributors or users, nor to sign up to general terms conditions. DSI are thus beyond the reach of access and benefit-sharing mechanisms, and accusations of biopiracy have returned with renewed intensity.3

18This debate harks back to some of the issues which inspired the creation of the CBD: how can intellectual property rights be used to stave off the risk of DSI being appropriated improperly? How can it be ensured that the benefits derived from the utilisation of DSI are shared fairly? Does open access to DSI databases constitute a circumvention of the Nagoya Protocol?

19At COP14 in Egypt, negotiations led to an agreement that DSI could not be effectively managed within the framework of the Nagoya Protocol, charging the CBD with proposing an appropriate sharing system.

Spirited discussions

20Since 2016, the issue of DSI has been firmly on the CBD agenda. A programme of work has been established, under the aegis of both the CBD4 and the Nagoya Protocol.5 A study was commissioned (Laird & Wynberg, 2018), and a technical expert group formed. The latter, after much deliberation, produced a “recommendation” (a set of reflections intended to inform a future decision on how best to manage DSI under the Nagoya Protocol at COP14) that was entirely in brackets, reflecting the lack of a clear consensus among the Parties.6

21Two calls for submissions were launched by the CBD Secretariat in 2016 and 2018. National governments, NGOs, research centres and businesses were all invited to submit their views on the matter. The resulting position papers were published on the CBD website: https://www.CBD.int/DSI-gr/2019-2020/submissions/. They provide an insight into the dynamics of the debate (Nothias, 2020).

22It should come as no surprise that we find, broadly speaking, two opposing camps in this debate. Countries in the Global North and various learned societies are determined to fight the inclusion of DSI within the remit of the CBD. Still reeling from the difficult experience of implementing the Nagoya Protocol, they argue that the free flow of information is essential to scientific and industrial innovation.7 Countries from the South, on the other hand, argue that DSI very clearly originates from genetic material, and as such there should be controls="true" on database access and a system for the fair and equitable sharing of the benefits derived from its use, in accordance with the Nagoya Protocol. Frustrated by the lack of financial returns generated by the Protocol, they protest that its scope of application is too narrow. Their view is that it should be expanded to encompass all tangible and intangible forms of life, with no time limit to ensure retroactive applicability. The debate now hinges upon the definition of DSI, and how to apply an ABS mechanism.

Agreeing on the terminology

23At time of writing, the dedicated working group has yet to agree upon a definition of DSI. And yet, from a legal perspective, it is absolutely essential to define the terminology in order to determine whether or not an ABS mechanism may be applied.

24To bring it within the scope of application of the CBD, DSI would have to be regarded as a “genetic resource” (Article 2 of the CBD) or, at least, as a form of “utilisation of genetic resources,” tantamount to “research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology.” Or else, following the example of “associated traditional knowledge,” DSI might be regarded as information associated with a genetic resource.

25Brazil decided not to wait for an international consensus, adding genetic information to its definition of genetic heritage in a law passed in 2015. The Brazilian government has demanded ABS procedures for digital sequences derived from its own biodiversity registered in foreign genetic databases. Ethiopia also defines genetic resources as “all material derived from a biological resource containing genetic information with actual or potential value for humanity, including derivatives and DSI.” India holds that the value of genetic material “resides in the genetic information that it contains, whether it be tangible, intangible or potential.” Argentina, meanwhile, interprets the term DSI as “digital information concerning the sequences of genetic resources,” treating information as a component of genetic resources, and thus considering DSI to be included in genetic material.

26Industrialised nations, meanwhile, maintain that DSI is a form of immaterial, intangible data not covered by either the CBD or the Nagoya Protocol. They insist on the distinction between data, which are the fruit of research, and information associated with genetic resources. Australia, for example, defines DSI as “non-physical entities of an electronic nature,” and thus not containing any genetic material. France has proposed a definition which translates as “digital sequence data from genetic resources.”

27On a more general level, industrialised nations have pointed out that gene banks hold a wide variety of materials. They have pushed for a more precise definition of DSI, classifying sequence information into multiple groups (DNA and RNA, proteins and epigenetic modifications, metabolites and other macromolecules etc.) which need to be handled differently. They argue that the majority of sequences found in gene banks are human sequences, or sequences from organisms collected in developing nations where they are freely available in open access mode, and thus not subject to the Protocol.

Resolving technical issues

28The arguments deployed have not been limited to haggling over the definition of DSI. Existing criticisms of the constraints imposed by the Nagoya Protocol have resurfaced: administrative chicanery, the complexity of handling large quantities of data, the notion of benefit-sharing etc. These arguments have focused particularly on the long delays and bureaucratic obstacles involved in obtaining permits to access and gather data, as well as the risk of legal uncertainty. In an age of high-speed access to genome data, the time required to obtain access and usage permits is viewed as a waste.

29The technical difficulties inherent to DSI, already encountered in relation to marine micro-organisms, have also been highlighted (WiLDSI, 2020). Cross-disciplinary research would also require multiple authorisations. Evolutionary biology (for computational phylogenetics), research into active ingredients (screening immense quantities of DNA sequences) and research on infectious diseases (studying new pathogens) all require access to thousands, or even millions of sequences. How would it be possible to assess the provenance and value of each individual sequence?

30Sequences themselves cannot be patent-protected. A large number of identical or highly similar sequences are to be found in many organisms, on account of the common origins shared even by organisms which seem very different. Within a given species, a sequence may vary from one individual to the next, and natural mutations may contribute to this variation within a relatively short timeframe. Potential commercial developments would in any case be derived from a combination of sequences, so how would the usage value of a single sequence be calculated?

31Industrialised nations argue that open access to DSI is conducive to scientific progress and the attainment of the global biodiversity targets set by the CBD. DSI is a vital tool for taxonomical studies, allowing researchers to identify, describe and compare species in order to better understand genetic variation in populations, the role of genes in the development of organisms and the factors determining resilience to climate change, all useful knowledge for the purposes of biodiversity conservation and management (CETAF, 2017; Laird & Wynberg, 2018). The availability of DSI in open access mode, for both users and providers, is thus consistent with the first two CBD objectives – conservation and sustainable utilisation – and also corresponds to Aichi Target No. 19: “By 2020, knowledge, the science base and technologies relating to biodiversity, its values, functioning, status and trends, and the consequences of its loss, are improved, widely shared and transferred, and applied.” Restricting access to DSI would thus be counter-productive with regard to the stated aims of the CBD.

32The free availability of digital sequence information is the result of international scientific policy, with the financial backing of those countries who created the gene banks and ensure their continued availability. The position papers submitted by these industrialised nations maintain that open access is justified by the need to democratise science by making it available to all, and that this is itself a form of benefit-sharing. This argument has been largely rejected in the Global South, by countries who would prefer to retain control over their genetic heritage and obtain more monetary compensation.

Options up for debate

33The Convention on Biological Diversity was signed during a phase of rapid globalisation, dominated by market dynamics but also increasingly aware of the urgent need to address global environmental issues through international cooperation. At a time when globalisation is being called into question and national egos are coming to the fore, it is hard to envisage a renegotiation of the CBD without undermining the existing text, let alone the Nagoya Protocol, which is still not fully operational.

34In order for a new agreement to be reached, a sharing mechanism needs to be imagined which does not undermine the ease of access expected by “user” nations, while also ensuring remuneration for the “provider” countries of the natural resource from which genetic sequences are extracted.

35Inspiration might be sought in the multilateral sharing mechanism introduced by the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA, see Chap. 1), which replaces prior consent with easier access and which, in return, requires users to pay into a benefit-sharing fund destined primarily for farmers in developing nations who conserve and use plant genetic resources in a sustainable manner. This would represent a paradigm shift from the bilateral arrangements promoted in the Nagoya Protocol towards a binding multilateral system. Some of the scenarios envisaged at the 1^st Global Dialogue on DSI (Pretoria, November 2019) involve the creation of a multilateral benefit-sharing fund for DSI, an option also explored in a recent report which claims to offer a “scientific perspective.” (WiLDSI, 2020).

36Identifying contributors, users and the provenance of genetic sequences does not appear to be an insurmountable task, as long as computing tools are developed so as to ensure the traceability of resources. It would be possible to connect digital sequences to the physical origins of the material from which they were derived by improving the data passport system, including the information already connected with sequences in databases, linking DSI publications to the genetic resources held in ex situ collections and indicating the country of origin of genetic resources in all patent applications. The Chinese and Brazilian patent offices already require patent applications to specify the origin of the genetic resources which provided the raw material for the discovery, while the French Law on Biodiversity of 2016 requires patent applicants to register information on their original resources with the National Institute for Intellectual Property (INPI).

37The Nagoya Protocol contains tools (PIC and MAT) which could be used to take DSI into consideration when accessing biological resources: will the resource be sequenced or not? Will the sequence be registered with an open access database? How will any benefits be shared? etc. Specific training and special authorisations enabling providers to access these databases could form part of benefit-sharing arrangements. Research partnerships benefiting researchers from the Global South could also be agreed at the forthcoming COP meeting, as part of the “resource mobilisation” component of the Post-2020 Global Biodiversity Framework (Laird et al., 2020).

38How might these two systems of benefit-sharing coexist? Genetic resources could remain subject to the Nagoya Protocol, while DSI could be subject to an open access system which ensures that they remain findable, accessible, interoperable and reusable (FAIR). Handling DSI differently – with a more flexible approach stripped of the “formalism” associated with the system for genetic resources, which would remain subject to the Nagoya Protocol – could have the effect of making genetic resources even less desirable for the purposes of research and bioprospecting.

The horse-trading continues

39The ongoing negotiations over DSI represent a continuation of pre-existing geopolitical conflicts which, above and beyond the tensions between competing worldviews, reflect the difficulties inherent to reconciling environmental policy and economic development within the restrictive framework of multilateral agreements. Since the first UN Conference on the Environment, held in Stockholm in 1972, commitments to protecting biodiversity proposed by countries from the Global North have run up against the demands of the Global South, keen to see more support for sustainable development and more benefit-sharing. These demands for compensation inspired the third stated objective of the CBD, set out in Rio in 1992 : “fair and equitable sharing of the benefits arising out of the utilisation of genetic resources.” At the 2010 Nagoya Conference, the eponymous Protocol was then signed by the parties in return for the acceptance by the Global South of the strategic plan for 2011-2020, also known as the Aichi Targets. In the near future, the possibility of expanding the Protocol to encompass DSI looks likely to be used as a bargaining chip to encourage countries from the Global South to sign up to the post-2020 strategy backed by Europe at COP15. COP15 is supposed to adopt a new global strategy for biodiversity, since the strategic plan for 2011-2020 has now expired, albeit without fulfilling any of the 20 Aichi Targets (6 of the targets were judged to have been “partially” attained, see SCBD, 2020). Without some sort of benefit-sharing mechanism for DSI, it will be very difficult to reach a consensus on a Post-2020 Global Biodiversity Framework.8

40Demands focusing on digital sequence information held in gene banks are primarily concerned with the potential loss of economic opportunities, a far cry from the initial definition of the biopiracy which the Nagoya Protocol was intended to combat. The Nagoya Protocol is at risk of being perceived as an instrument of economic warfare, rather than a tool for the protection of biodiversity and traditional populations.

41It should thus come as no surprise that tensions over DSI have become apparent in the UN’s negotiating structures: at the FAO committee in charge of genetic resources for food and agriculture, and particularly with regard to the ITPGRFA and the revision of its multilateral ABS system; at the Intergovernmental Conference on Marine Biodiversity of Areas Beyond National Jurisdiction (BBNJ), where the issue of sharing the benefits derived from the exploitation of marine genetic resources is the first item on the agenda; at the working group for Article 8(j) of the CBD relative to indigenous peoples and local communities; at the World Health Organisation in discussions of access to human pathogens (PIP framework for influenza pandemics), as well as related debates over animal health at the OIE and plant health at the FAO, of particular relevance in an era of epidemics and pandemics; and of course at the World Intellectual Property Organisation. All of these instances, the arenas in which North-South confrontations play out, appear to be waiting on a decision from the CBD in order to continue their work.

42We might well question the strategic importance afforded to the issue of DSI, described in some quarters as a deal-breaker for international negotiations, but which would appear to be of secondary importance compared to the climate emergency and the need to act rapidly to stem the collapse of biodiversity.

43But we could also argue that the negotiations over the CBD are also tackling issues of vital importance: value grabbing, the appropriation and manipulation of the living world, and the governance of digitised biodiversity. Issues of governance are also at the heart of negotiations over the Cartagena Protocol, including demands for a moratorium on synthetic biology and new techniques of gene editing, another source of tensions within the CBD.

44The collateral effects of the Nagoya Protocol, such as the development of more open and balanced research partnerships, may well prove to be more significant than its stated intentions in terms of biodiversity conservation.

References

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46CETAF, 2017 – Submission on the potential implications of the use of Digital Sequence Information. ABS Core Group, 8 septembre 2017, multigr., 10 p.

47Deplazes-Zemp A. et al., 2018 – The Nagoya Protocol could backfire on the Global South. Nature Ecology & Evolution, published on line:14 May 2018.

48Divakaran P. et al., 2018 – When the cure kills - CBD limits biodiversity research. Science, 360 (6396): 1405-1406.

49Keiper F., Atanassova A., 2020 – Regulation of Synthetic Biology: Developments Under the Convention on Biological Diversity and Its Protocols. Front Bioeng. Biotechnol., 8: 310. Published 2020 Apr 9. doi:10.3389/fbioe.2020.00310

50Laird S., Wynberg R-P., 2018 – Fact-finding and scoping study on DSI on genetic resources in the context of the Convention on Biological Diversity and the Nagoya Protocol. CBD/AHTEG/DSI/2018/1/3

51Laird S. et al., 2020 – Rethink the expansion of access and benefit sharing. Science, 367 (6483): 1200-1202.

52Nothias Y., 2020 – L’état des négociations sur la réglementation des Digital Sequence Information à la veille de la COP-15 de la Convention sur la diversité biologique. Mémoire de master Biologie, Écologie, Évolution, MNHN, 36 p.

53Rourke M., 2018 – Access and benefit-sharing in practice: non-commercial research scientists face legal obstacles to accessing genetic resources. JSPG, 13 (1), October 2018.

54SCBD - Secretariat of the Convention on Biological Diversity, 2020 – Global Biodiversity Outlook 5. Montreal. www.cbd.int/GBO5.

55WiLDSI, 2020 –Finding compromise on ABS & DSI in the CBD: Requirements & policy ideas from a scientific perspective. https://www.dsmz.de/fileadmin/user_upload/Collection_allg/Final_WiLDSI_White_Paper_Oct7_2020.pdf