Digital Sequence Information (DSI)

Background

‘Digital Sequence Information’ (DSI) is currently a contentious issue under the CBD and other international agreements (the International Treaty for Plant Genetic Resources for Food and Agriculture [ITPGRFA], the developing instrument for Biodiversity Beyond National Jurisdiction, and WHO). Access and utilisation of physical genetic resources – plants, animals and microorganisms – are covered by the Nagoya Protocol (or, in specific circumstances the ITPGRFA or WHO).  However, it is now possible to download DNA sequences from public databases and reconstruct the DNA, then use it as one might a gene extracted directly from an organism. In the view of many provider countries, this provides a loophole for commercial exploitation, since there is no need for a user to seek any type of permit or agree terms for benefit sharing. They have termed such exploitation ‘digital biopiracy’.

As a response some countries, such as Brazil, have included DSI in their domestic Access legislation clauses even the DSI if held outside their borders. Others are restricting sequencing or the publication of those sequence data.

Currently many countries, including UK, understand that ‘DSI’ downloaded from public databases is not covered by the Nagoya Protocol. However, some countries believe that it should be or even is covered by the Protocol. For this reason they are making a strong case to include it in the CBD; the other instruments mentioned are awaiting a decision under the CBD. If it is eventually decided that DSI comes under the CBD and Nagoya Protocol, it could lead to benefit-sharing requirements and increased complexity of access to resources such as GenBank, as well as monitoring by national authorities.

Current discussions are taking place under the planning for a Post-2020 global biodiversity framework, which is seeking a mechanism for benefit sharing which would not necessarily involve inclusion under the Nagoya Protocol. Some decisions are expected at COP 15 in December 2022, although probably not a fully workable modality.

What is DSI?

While the term ‘Digital Sequence Information’ is used in CBD discussions, it is undefined and interpreted differently by different stakeholders, with its scope ranging from nucleotide sequence data to protein composition to the chemistry of cell metabolites, and at the extreme all information including contextual information about the genetic resource. Several attempts have been made to clarify the scope, and many submissions made to the CBD by stakeholders, including the NHM, RBG Kew and RBG Edinburgh (links given below). The most recent attempt to provide clarity to negotiators is by the 2020 CBD AHTEG (see here)

The concept is still not agreed by negotiators. 

Key documents include:

CBD

The CBD web page on DSI provides links to many of the documents, and also to a series of webinars on the subject.

AHTEGs

  • Report of the 2018 CBD Ad Hoc Technical Expert Group on DSI (AHTEG) (see here)
  • A study in Concept and Scope commissioned by the CBD in 2019 is on the CBD web site here.
  • A Combined study on digital sequence information in public and private databases and traceability commissioned by the CBD in 2019 which is available here.
  • Report of the 2020 CBD AHTEG (see here). 

Post-2020 Global Biodiversity Framework process

The report of the 2020 AHTEG has been considered by the CBD group discussing the Post-2020 Global Biodiversity Framework, which is due to report to COP 15 in Montreal In December 2022. This has been developed through an Open Ended Working group (OWEG) which itself set up an Informal Advisory Committee (IAC). The work of the IAC finished in November 2022, and the fifth meeting of the OEWG will take place in Montreal just prior to COP 15. A recommended draft Decision for COP will be decided at that meeting.

OEWG 3.

  • Digital sequence information on genetic resources - CBD/WG2020/3/4 
  • Digital sequence information on genetic resources - Addendum - CBD/WG2020/3/4/ADD1
  • Update of digital sequence information on genetic resources in relevant international processes and policy debates CBD/WG2020/3/INF/1 
  • Views and new information on policy approaches, options or modalities for digital sequence information on genetic resources CBD/WG2020/3/INF/7
  • Co-leads' report on the work of the Informal Co-Chairs' Advisory Group on digital sequence information on genetic resources CBD/WG2020/3/INF/8 
  • Information from the Commission on Genetic Resources for Food and Agriculture related to digital sequence information on genetic resources CBD/WG2020/3/INF/9 

OEWG 4.

  • Co-leads’ report on the work of the Informal Co-Chairs’ Advisory Group on Digital Sequence Information on genetic resources since the third meeting of the Open-ended Working Group on the Post-2020 Global Biodiversity Framework  CBD/WG2020/4/INF/4 
  • Digital sequence information on genetic resources - CBD/WG2020/4/3
  • Recommendation adopted by the working group on the post-2020 global biodiversity framework 4/2. Digital sequence information on genetic resources.CBD/WG2020/REC/4/2  

OEWG 5

  • Co-leads’ report on the work of the informal co-chairs’ advisory group on digital sequence information on genetic resources since the fourth meeting of the open-ended working group on the post-2020 global biodiversity framework.  Note by the co-leads of the Informal Co-Chairs’ Advisory Group on digital sequence information on genetic resources. CBD/WG2020/5/INF/1
  • Digital sequence information on genetic resources. Note by the Executive Secretary.CBD/WG2020/5/3

What countries regulate DSI, and how?
An increasing number of countries include DSI in some concept in their domestic legislation. This may impact how taxonomists use the data. The CBD commissioned a report on Domestic legislation, which can be found here.

Engagement by NHM, Kew and Edinburgh

This area is being considered by ABS experts in NHM, RBG Kew, CETAF and GGBN, who are keeping a watching brief on developments, sending represnetatives to relevant meetings and workshops, and advising where appropriate. NHM made submissions to Defra and the CBD on the subject in 2017 and 2019 explaing  our understanding of the terminology, the significance of ‘DSI’ to conservation and sustainable use, and how benefit-sharing operates in the context of DSI. Organisations to which NHM, RBG Kew and RBG Edinburgh belong (e.g. CETAF, SPNHC, GGBN), have also made submissions to the CBD (links to submissions in next section).

Further information

The CBD has placed on its website information and documents about the discussion and negotiations, including relevant COP decisions. This can be found here

2017 submissions (including from NHM, Kew and Edinburgh, and CETAF) are here
2019 submissions (including from NHM, RBGK and RBGE, and CETAF) are here

The German Federal Ministry of Education and Research (BMBF) has funded an interdisciplinary project (WiLDSI) led by the Leibniz Institute DSMZ and the Leibniz Institute IPK Gatersleben to investigate possible solutions for how to handle DSI within the CBD framework. This has produced a very helpful report, and has a very strong science and collection-based engagement. Further information can be found here.

Defra in the UK commissioned a report which was published in January 2021 “Digital Sequence Information: An Evidence Review” which can be found linked from this page as “BE0167 Final Report

The ABS Capacity Development Initiative as been very active, and much useful information is on its page here

The DSI Scientific Network is a group of scientists from many countries to engage with policy. They have delivered an Open Letter stating their position on behalf of research globally.

Several presentations from Chris Lyal (NHM) may be of interest:

The use of DSI for taxonomy and other related non-commercial research on biodiversity – this can be found here

On legal issues and definitional issues, and can be found here.

On the results of the 2020 AHTEG, which can be found here.

Presentations delivered in Webinars on DSI in late 2020 – 2022 are available on the ABS Capacity Development Initiative

Other discussions

Relevant discussions are also be taking place in other fora:

  1. The International Treaty on Plant Genetic Resources for Food and Agriculture is considering the issue. A relevant background document can be accessed here
  2. The Commission on Genetic Resources for Food and Agriculture is also considering the issue and their website is here. A report “Digital Sequence Information” on Genetic Resources for Food and Agriculture and its Relevance for Food Security is available here. An earlier fact-finding study is available here. A more recent (2021) report “Digital Sequence Information” on Genetic Resources for Food and Agriculture: Innovation Opportunities, Challenges and Implications” can be found here
  3. The United Nations Convention on the Law of the Sea is developing an International Instrument on Biodiversity Beyond National Jurisdiction. This will include an element on ABS relating to Marine Genetic Resources. See here
  4. The WHO has been discussing Genetic Sequence Data in the context of influenza virus.  Information can be found here. It includes a link to a report "Optimal characteristics of an influenza genetic sequence data sharing system under the pip framework"

Relevant Publications
Many relevant reports and papers are available, of which this is only a small subset:

ABS Capacity Development Initiative, 2019, Digital Sequence Information on Genetic Resources (DSI) - An Introductory Guide for African Policymakers and Stakeholders.

ABS Capacity Development Initiative, 2020, Report - First Global Dialogue on Digital Sequence Information on Genetic Resources 6–8 November 2019, Pretoria, South Africa. Available here

Bagley, M.A., 2015, Digital DNA: The Nagoya Protocol, Intellectual Property Treaties, And Synthetic Biology. University of Virginia School of Law. Online here.

Bagley, M.A., 2017, Towering Wave or Tempest in a Teapot? Synthetic Biology, Access & Benefit Sharing, and Economic Development, in Susy Frankel and Daniel Gervais eds.THE INTERNET AND INTELLECTUAL PROPERTY: THE NEXUS WITH HUMAN AND ECONOMIC DEVELOPMENT (Victoria University Press, forthcoming 2017). Text available here.

Bagley, M.A., A.K. Rai (2013). The Nagoya Protocol and synthetic biology research: a look at the potential impacts, Wilson Center, Washington, DC. Available here.

Buschbom, J., Zimkus, B., Bentley, A., Kageyama, M., Lyal, C.H.C., Neumann, D., Waagmeester, A., Hardisty, A., 2021.  Participative Decision Making and the Sharing of Benefits: Laws, ethics, and data protection for building extended global communities September 2021 Biodiversity Information Science and Standards 5. DOI: 10.3897/biss.5.75168   

CETAF (2018)  Digital Sequence Information (DSI) of Genetic Resources. Executive Statement. Online here

Dedeurwaerdere T, P. Melindi-Ghidi, A. Broggiato (2016). “Global scientific research commons under the Nagoya Protocol: topwards a collaborative economy model for the sharing of basic research assets”, Environmental Science & Policy 55:1, 1-10. Available here

Dedeurwaerdere T., A. Broggiato, S. Louafi, E. Welch, F. Batur (2012). “Governing Global Scientific Research Commons under the Nagoya Protocol” in Morgera E., M. Buck, E. Tsioumani (eds)  The Nagoya Protocol in Perspective: Implications for International Law, Martinus Nijhoff. Available here.

Garrity G.M., L.M. Thompson, D.W. Ussery, N. Paskin, D. Baker, P. Desmeth, D.E. Schindel and P.S. Ong (2009) Studies on Monitoring and Tracking Genetic resources. UNEP/CBD/WG-ABS/7/INF/2. (2013).

Hammond, E. (2016). Digital genebankers plan to ignore UN request on the impact of genomics and synthetic biology on access and benefit sharing, Third World Network, A preliminary Report, 4 April. Available here

Hammond, E., 2016. TWN briefing “Digital DNA” and Biopiracy: Protecting Benefit-Sharing as Synthetic Biology Changes Access to Genetic Resources. Available here.

Karger, E., du Plessis and Meyer, Hartmut (2019) Digital Sequence Information on Genetic Resources (DSI) - An Introductory Guide for African Policymakers and Stakeholders.  ABS Capacity Development Initiative. Available here.

Lawson, C. & Rourke, M., 2016, Open Access DNA, RNA and Amino Acid Sequences: The Consequences and Solutions for the International Regulation of Access and Benefit Sharing. Available for download here.   Abstract:  This article addresses how open access to DNA, RNA and amino acid sequences might be reconciled with the benefit sharing obligations under the United Nations’ Convention on Biological Diversity and its Nagoya Protocol, the Food and Agriculture Organisation of the United Nations’ International Treaty on Plant Genetic Resources for Food and Agriculture and the World Health Organisation’s Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits. Tracing the evolution of open access databases the article posits models for reconciling open access and benefit sharing, the article concludes, however, that none of the proposed solutions – monitoring and tracing, the contract model, and the copyright and database right model – provides a perfect solution. Each model does, however, suggest that open access to these sequences might be at least partially reconciled with benefit sharing.

Lyal, C.H.C. (2020) [2019] Chapter 19: Current situation on Digital Sequence Information (DSI), pp119-124 IN Kamau, EC (ed)  "Implementation of the Nagoya Protocol: Fulfilling new obligations among emerging issues." BfN-Skripten 564 pp x + 142.

Lyal, C.H.C., 2022. Digital Sequence Information on Genetic Resources and the Convention on Biological Diversity. Pp 589-619 in E. Chege Kamau (ed.), Global Transformations in the Use of Biodiversity for Research and Development, Ius Gentium: Comparative Perspectives on Law and Justice 95,  https://doi.org/10.1007/978-3-030-88711-7_21

Manzanella, D. 2016, The Global Information System And Genomic Information: Transparency Of Rights And Obligations. Background paper commissioned by the International Treaty on Plant Genetic Resources for Food and Agriculture (click on title to open).

Morgera, E. et al. (2020), Study of the European Commission on ‘Possible Ways to Address Digital Sequence Information’ – Legal and Policy Aspects.

Muller, M.R., 2015, Genetic Resources as Natural Information: Implications for the Convention on Biological Diversity and Nagoya Protocol. Routledge.  170pp. Available here.

Oldham, P. (2020) Digital Sequence Information -Technical Aspects.

Reichman, J.H., Paul F. Uhlir, P.F. & Dedeurwaerdere, T., 2016, Governing Digitally Integrated Genetic Resources, Data and Literature: Global Intellectual Property Strategies for a Redesigned Microbial Research Commons. (Cambridge U. Press)   Information on how to obtain the book here. [NB There is an option to read a pre-publication version; whever I have tried to access it my browser has frozen]

Scholtz et al., (2020) “Finding Compromise  on  ABS  &  DSI  in  the  CBD:  Requirements  &  Policy  Ideas  from  a  Scientific Perspective”. doi: 10.13140/RG.2.2.35180.80001. available here

Scholz A.H., Freitag J., Lyal C.H.C, Sara R., Cepeda M.L, Cancio I., Sett S., Hufton A.L., Abebaw Y., Bansal K., Benbouza H., Boga H.I., Brisse S., Bruford M.W., Clissold H., Cochrane G., Coddington J.A., Deletoille A.-C., García-Cardona F., Hamer M., Hurtado-Ortiz R., Miano D.W., Nicholson D., Oliveira G., Bravo C.O., Rohden F., Seberg O., Segelbacher G., Shouche Y., Sierra A., Karsch-Mizrachi I., da Silva J., Hautea D.M., da Silva M., Suzuki M., Tesfaye K., Tiambo C.K., Tolley K.A., Varshney R., Zambrano M.M. & Overmann J., 2022. Multilateral benefit-sharing from digital sequence information will support both science and biodiversity conservation. Nature Communications 13:1086  https://doi.org/10.1038/s41467-022-28594-0

Servick, K., 2016, Rise of digital DNA raises biopiracy fears. Science DOI: 10.1126/science.aal0395  Online here

Smyth, S.J., Macall, D.M., Phillips, P.W.B. and de Beer, J. (2018) Governance of Digital Sequence Information and Impacts for Access and Benefit Sharing. A report prepared by: Centre for the Study of Science and Innovation Policy Johnson Shoyama Graduate School of Public Policy University of Saskatchewan. 24pp. Available here

Scratchpads developed and conceived by (alphabetical): Ed Baker, Katherine Bouton Alice Heaton Dimitris Koureas, Laurence Livermore, Dave Roberts, Simon Rycroft, Ben Scott, Vince Smith