Digital Sequence Information on Genetic Resources

Overview

After several years of informal discussions and formal negotiations, the 15th Conference of the Parties to the Convention on Biological Diversity (CBD) in December 2022 decided to establish, as part of the Kunming-Montreal Global Biodiversity Framework (KMGBF), a multilateral mechanism for benefit-sharing from the use of digital sequence information on genetic resources (DSI), including a global fund.

COP 15 further agreed to a time-bound process to develop the multilateral mechanism, for finalization at COP 16.

In February 2024, benefit-sharing on the use of DSI through a multilateral system has also been adopted as part of the Agreement under the United Nations Convention on the Law of the Sea (UNCLOS) on the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction (BBNJ).

Further, multilateral benefit-sharing arrangements are under discussion in the World Health Organization (WHO) in the context of the negotiations of the Pandemic Accord and reform of the International Health Regulations (IHR), as well as in the Food and Agricultural Organization (FAO) in the context of the revision of the International Treaty for Plant Genetic Resources for Food and Agriculture (ITPGRFA) and the work of the Commission on Genetic Resources for Food and Agriculture (CGRFA).

To understand the current debates on the topic of DSI, we first need to look at the principles of life on earth. As many will know from their biology classes, every human body, every animal, every plant and every living being carries an internal construction plan in form of a genetic code called deoxyribonucleic acid, short DNA inside them. The information stored in the sequence of nucleotides as building blocks of the DNA is translated into proteins which are the main drivers of the body’s metabolism, the main building block of the body organs, the nervous system and more. The information stored in the DNA has a big impact on what we look like, our development growth, reproduction, and functions, just like it does for every other living being.

While the CBD negotiations on DSI or the BBNJ Agreement do not (yet) provide for a definition of the term DSI, the WHO in its draft version of the Pandemic Treaty defines a subset of DSI, the Genomic Sequence Data, as “the order of nucleotides found in a molecule of DNA or RNA”. In general, it is assumed that DSI refers to data and information derived from molecules that are characterised by a sequential structure of a specific set of building blocks. This specific sequence embodies information that triggers defined activities of this molecule in driving and regulating cellular functions. Examples are DNA, RNA, and proteins (with their distinct sequence of nucleotides or amino acids, respectively).

Based on Houssen et al. (2020), Digital Sequence Information on Genetic Resources: Concept, Scope and Current Use, CBD/DSI/AHTEG/2020/1/3

After the human genome project was initiated in 1984, it took scientists 20 years to publish the entire sequence of the human genetic code, going through a time-consuming and costly process. Science has progressed rapidly since then and it is now a lot easier to unravel the genetic information contained in living organisms. The progress of biological science is strongly linked to the invention and accessibility of the internet, the so called “big data”, and advances in computer science in general. These parallel developments enabled a much faster and quicker sequencing, storing, and sharing of biological data.

Nowadays, biological researchers from all around the world can quickly and easily access genetic codes via journal repositories and private and public databases, where sequenced information of DNA and proteins is stored. This means that it is in many cases no longer necessary to collect a physical specimen and to travel to different countries and regions where the biological resource originates to undertake research at the genetic level.

The information stored in databases can be used for many different purposes in biological sciences, e.g., for diagnosing diseases and pests, identifying microorganisms, adapting crops for climate change, food quality control or protecting endangered species and many more. One prominent example of the scientific benefits of DSI is the sharing of a “digital copy” of the Coronavirus SARS-CoV-2. It enabled researchers from all over the world to start developing vaccines, even before the biological material had reached their shores.

Digital Sequence Information on Genetic Resources

In fact, the sequencing of genetic information became such a common practice in all fields of biological sciences that it led to an enormous amount of information being generated and stored every day. One of the main databases for DSI is administered by the European Bioinformatics Institute (EMBL-EBI) with an influx of data that is growing faster than the ability to store and process it. The EMBL-EBI not only stores its data, but also synchronises the data in daily routines with two other databanks: the DNA Data Bank in Japan and the GenBank hosted by the National Center for Biotechnology Information in the US. Together they form the International Nucleotide Sequence Database Collaboration sharing an open and free access policy. The databanks also offer the possibility to add more (descriptive) information to an individual dataset of a gene sequence, the so-called labelling or metadata. Meanwhile, it is mandatory to name the country from which the genetic resource originated which DSI is uploaded to the databank. 

The large amount of open data mentioned above is mainly used by researchers for non-commercial activities but private companies also use the data from open-source databases to optimize sequences used for product development. This can be done by searching and comparing thousands of related sequences and, ultimately, identifying those responsible for the desired traits of a product in development. Companies from predominantly developed countries are using information accessed via opensource databanks for innovative products and seek intellectual property protection for their sometimes highly profitable inventions, including vaccines, beauty, and nutraceutical products. Biodiversity-rich countries “owning” the genetic resource from which the digital sequence information was initially taken from, do not yet profit in terms of benefit-sharing agreements which could contribute to the sustainable use and conservation of biodiversity as foreseen under the Nagoya Protocol. Therefore, many Parties to the CBD criticize the use of DSI based on the absence of benefit-sharing obligations and the equitable sharing of benefits arising from the utilization of DSI.

Indisputably, the sharing and availability of biological data has many advantages from a research perspective. Therefore, researchers generally welcome open-access databanks. They argue that DSI has become so important and indispensable for modern sciences and biotechnological innovations that its use should not be regulated. Many fear that breakthrough innovations potentially resulting in societal benefits could be negatively affected. Some also argue that open access to DSI constitutes sufficient benefit-sharing, even though developing countries rich in biodiversity often lack the capacity to use DSI and therefore cannot benefit from it in the same way. Many developing, and biodiversity-rich countries acknowledge the potential benefits of open access to DSI but argue that these benefits do not justify the exclusion of benefit-sharing obligations. The African Group – a term used to describe the representatives of African countries defending their joint interests - uses patent protected innovations as an example to illustrate their position. Patent protected inventions may benefit society but patent owners are in control of who could use the invention and for which purposes. They are under no obligation to share benefits with the providing country while they are financially rewarded when others use their invention.

With the decision 15/9 of the CBD, member states and also stakeholders agreed to a set of policy decisions related to benefit-sharing on the use of DSI:

  • benefits from the use of DSI should be shared fairly and equitably;
  • monetary and non-monetary benefits arising from the use of DSI should, in particular, be used to support conservation and sustainable use of biological diversity and, inter alia, benefit indigenous peoples and local communities; and
  • as part of the Kunming-Montreal Global Biodiversity Framework, a multilateral mechanism for benefit-sharing from the use of DSI, including a global fund, shall be established.

The bilateral ABS mechanism foreseen in the Nagoya Protocol applies when researchers physically collect a genetic resource and sequence its genetic information for R&D. The providing country regulates the utilization of DSI in the ABS-contract which includes an agreement with the user on fair and equitable sharing of the benefits. The problem lies in passing these contractual obligations to the next user. Typically, DSI is uploaded into international databases for access by other users, but the databanks do not allow the uploading of related ABS contracts. But even if they did, complete genomes or other big data sets would make it literally impossible to comply with potentially dozens or hundreds of contracts.  

With decision 15/9 of the CBD, a multilateral system for DSI benefit-sharing will be established which will operate in parallel to national bilateral ABS-systems. The future triggers for multilateral benefit-sharing will very likely be decoupled from access to DSI in databanks but instead relate to certain elements of its use and commercialization. 

With a series of technical webinars and informal policy dialogues the ABS Initiative and its partners are supporting the formal negotiation process. These events and several information tools enabled a more substantial understanding of DSI and fostered a constructive dialogue between CBD parties and stakeholders on solutions for DSI related to benefit-sharing.  

More information on ABS here.

The ABS Initiative produced a short, animated video clip explaining the issue of digital sequence information on genetic resources (DSI) and illustrating its importance for the CBD’s three objectives. It explains the concept of DSI and describes how DSI is being generated, used and stored.

Further Information

DSI Retreat - The Hague

Informal Retreat on Digital Sequence Information (DSI)

On behalf of the South African Department of Forestry, Fisheries and the Environment (DFFE) and the Norwegian Government the Informal Retreat on Digital Sequence Information (DSI) was organized by the ABS Capacity Development Initiative (ABS Initiative) and hosted by the Government of the Neth-erlands. The Retreat was held at NH Atlantic Den Haag in The Hague, Netherlands, from 10th to 11th November 2022.

Global DSI Dialogues

After a series of webinars (two Global and regional webinars based on time zones of Asia/Pacific, Africa/Europe and the Americas) we finished with a reflection webinar, where areas of convergence and divergence were identified and points of further consideration were presented and discussed.

Find below the recordings of the webinar in French and Spanish: 

 

The 1st Global DSI Dialogue organized by the ABS Initiative offered a forum for open exchange reflecting about scientific, technical and policy issues. Participants were informed about the general patterns in production, storage and use of DSI by three international experts. Furthermore, the Secretariat of the CBD and five other international organisations presented on the current state of discussions on DSI in the respective fora. The main outcomes of the dialogue were: – Five options for sharing benefits arising from the (commercial) use of DSI; – A list of points for consideration with regards to analysing and evaluating benefit-sharing options for the utilisation of DSI;

Here are the reports of the 1st and 2nd Global DSI Dialogue (2019 and 2021): 

Policy Webinar on Digital Sequence Information (DSI)

In collaboration with the ABS Initiative, the Secretariat of the Convention on Biological Diversity offered a global webinar series and online discussion forum to share information related to DSI.

This series is informal and not part of the formal process.  It is organized by the co-chairs of the post-2020 Global Biodiversity Framework with the support of the Secretariat to facilitate broader understanding and exchange of ideas among parties and stakeholders. 

This webinar series aims to foster a common understanding of DSI and its importance and linkages to:

This webinar series is open to everyone interested in understanding how DSI is being addressed under the CBD, in preparation for the third meeting of the Open-ended Working Group on the Post-2020 Global Biodiversity Framework.

 

Webinar 1: Understanding DSI - This webinar focused on the exchange of technical information regarding DSI. It did not serve as a platform for negotiations, or understanding different views or questions related to the scope of DSI or regulatory options.

Click on the link below for the French version of the webinar.

    

Webinar 2: DSI under  the CBD - Process and recent outcomes related to digital sequence information on genetic resources under the CBD.

 

Webinar 3: Policy Options for ABS and DSI - This webinar presented different policy options for access and benefit-sharing and digital sequence information on genetic resources emerging from various studies and dialogues, being proposed by different actors and stakeholders.

 

Webinar4: Reflection on the co-chairs panel - At CBD COP 14, Parties committed to working towards resolving their divergence of views regarding benefit- sharing from the use of DSI on genetic resources. To broaden and deepen the science- and policy-based process around this topic, the ABS Capacity Development Initiative has organized a reflection webinar on 24 March 2021 to discuss potential criteria for assessing DSI policy options, among other topics.

Click on the links below for the French and Spanish version of the webinar

Synthesis report of the webinar: 

Technical Webinars on DSI

This series of webinars focuses on technical aspects of digital sequence information (DSI) and aims to support the science-policy process agreed at CBD CoP 14.

 

Webinar 1: The Role of IPLCs and associated traditional knowledge in the DSI debate - The objective of this technical DSI webinar was to make everyone aware of how key DSI issues are relevant for and affect indigenous peoples and local communities (IPLCs) and traditional knowledge. The current science- and policy-based process on DSI under the CBD did not yet specifically address this important topic.

Click on the link below for the French recording of the webinar: 

Webinar report:

Presentations of the webinar:

    

Webinar 2: Assessing capacity development needs for the use of DSI - The general importance of developing additional technical, human and institutional capacity, especially in developing countries, to generate and use digital sequence information is widely acknowledged in the discussions around DSI. But what would this mean in practice? Who will provide it, who will receive it, who will pay for it? How does this relate to wider capacity development and technology transfer measures under the CBD and its Protocols? And what role can capacity development play in sharing the benefits arising from the use of DSI? All these questoins are addressed in the webinar recorded above. 

Click on the link below for the French recording of the webinar:

Webinar report:

Presentations of the webinar:

 

 

Webinar 3: Contribution of DSI in the  development of commercial applications - One of the key topics in the international discussions around DSI is sharing the benefits of commercial utilization and products based on DSI. To increase common understanding the webinar looked at ways in which DSI is accessed and used for commercial purposes, discussed the intellectual property aspects of commercial DSI use, and examined potential benefit sharing options for specific examples of products using DSI.

Click on the link below for the French version of the webinar.

Webinar report 

Presentations:

   

Webinar 4: The interplay between Open Science, open access to data, database terms and conditions, and potential options for tracking and tracing

The first formal discussions on DSI in the context of the Post2020 Global Biodiversity Framework took place at OEWG 3.1 and will be continued by the Co-chairs’ Informal Advisory Group on DSI (DSI IAG) before the face-to-face negotiations planned for Geneva in January 2022. At this stage one of the main divergences appears to be between those who value open access to DSI above all else, and those who believe that ensuring benefit sharing from the use of DSI would require terms and conditions (T&Cs) and/or tracking and tracing of DSI use (e.g. through metadata tags identifying the provider country and/or IPLCs holding aTK). To resolve this divergence, this webinar serves as a factual and open exchange of views on the feasibility, practicalities, costs, benefits and legal implications of following either of these approaches, including whether and where a possible middle ground could be found.

Click on the link below for the French recording of the webinar: 

Webinar report: 

  

Webinar 5: Traceability of digital sequence information on genetic resources (DSI)

Background: The first formal discussions on DSI in the context of the Post2020 Global Biodiversity Framework took place at OEWG 3.1 and will be continued by the Co-chairs’ Informal Advisory Group on DSI (DSI IAG) before the face-to-face negotiations planned for Geneva in January 2022. One main topic raised in the discussions dealt with the traceability of DSI. In the context of the bilateral ABS model of the Nagoya Protocol, traceability was regarded by some participants as essential to ensure sharing the benefits arising from the use of DSI with providers. But it was also mentioned that approaches to track and trace the use of DSI would pose significant administrative tasks for databanks and researchers without substantial benefit sharing in many cases. Participants also noted that multilateral approach for DSI benefit sharing would reduce the need for traceability.

Webinar report:

   

Webinar 6: The report of the informal Co-Chairs’ Advisory Group on DSI (DSI IAG)

Established at the 3rd session of the Open-Ended Working Group on the Post-2020 Global Biodiversity Framework, the DSI IAG held four working meetings, aimed at assisting the OEWG Co-Chairs in conducting informal consultations on DSI.

The report contains:

- a proposed multi-criteria analysis framework for evaluating DSI policy options
- a co-leads’ summary of the discussions on potential convergences and apparent divergences
- proposals for potential further work before CoP 15

In this webinar the report of the DSI IAG is presented, followed by a panel discussion with opportunities for questions and comments from the audience.

Click on the links below for the French and Spanish recording of the webinar: 

Webinar report: 

Webinar 7: A performance matrix for assessing policy options for DSI benefit-sharing

In the webinar possibilities for exploring opportunities and challenges, as well as benefits and limitations of using the multi-criteria performance matrix presented to the Open-Ended Working Group 3, were presented and discussed.

The focus of the event was on the matrix methodology – not the actual assessment of policy options. A panel of four international experts exchanged experiences and discussed insights from filling the matrix and sharing the results amongst each other

Click on the links below for the English, French and Spanish recording of the webinar: 

Webinar report: