Here, Dominic Muyldermans and Markus Wyss explore the opportunities and challenges on the journey towards effective access and benefit sharing across the globe
The objectives of the Convention on Biological Diversity (CBD) of 1992 are the conservation and sustainable use of biodiversity, as well as the fair and equitable sharing of benefits arising out of the utilization of genetic resources. The CBD recognizes that countries have sovereign rights over their genetic resources and already included the principles of Access and Benefit Sharing (ABS). These ABS principles have been further operationalized in the Nagoya Protocol, which entered into force in 2014.
Pursuant to the recognition of sovereign rights over their genetic resources, countries started to enact national ABS laws requiring prospective users to conclude an ABS agreement with the provider country. Since these national ABS laws often differ in scope and provisions, business and academic users have to deal with a myriad of legal obligations when undertaking research, development and/or commercialization involving genetic resources.
Over the years, this has resulted in a complex legal ABS framework with high transaction costs and legal uncertainty. This, in turn, negatively impacts value creation and the development of technologies or products that are needed to address societal challenges like environmental sustainability, food security and human health.
Above and beyond this existing legal framework and due to the growing importance of data in research and development, the topic of “Digital Sequence Information on genetic resources” (DSI) came to the forefront in the international negotiations.(1) DSI was first included in a CBD decision in 2016 and since then was the subject of a multi-layered process including reports, expert groups and intersessional discussions that culminated in a seminal decision at the 15th Conference of the Parties (COP15) in Montreal in December 2022.
What has been decided
After lengthy negotiations, COP15 adopted a decision “to establish, as part of the Kunming-Montreal Global Biodiversity Framework, a multilateral mechanism for benefit-sharing from the use of digital sequence information on genetic resources, including a global fund”, recognizing that the current bilateral approach to ABS cannot be reasonably applied to DSI. At the same time “a fair, transparent, inclusive, participatory and time-bound process [was set up] to further develop and operationalize the mechanism, to be finalized at the sixteenth meeting of the COP”.
The decision also provides a list of issues for further consideration, including (i) the potential to voluntarily extend the multilateral mechanism to genetic resources or biological diversity in general and (ii) the interface between existing national, bilateral ABS systems and the new multilateral benefit-sharing mechanism.
The new multilateral mechanism could pave the way for a future ABS framework which safeguards the value creation from the use of DSI and, eventually, also genetic resources. It is, however, largely unclear how this mechanism shall work in practice, i.e. who will implement and govern it, who will contribute and how much, and how contributions will be allocated. We have a skeleton, but the muscles and nerves are still missing.
How to make it work
The COP15 decision specifically acknowledges that the generation of, access to, and use of DSI support innovation and contribute to achieving the objectives of the CBD and the Global Biodiversity Framework. Furthermore, it is stated that tracking and tracing of all DSI is not practical. In that context, it is important to refer to the huge amounts of DSI that are being accessed, shared and used in the international academic and commercial research community via open-access databases, i.a. the databases of the International Nucleotide Sequence Database Collaboration. This means that the principle of open access to and secured use of DSI is specifically recognized and, thus, needs to be safeguarded in the new multilateral system to be developed.
Additional key criteria for the new multilateral system include, i.a., the need to:
- Be efficient, feasible and practical,
- Generate more benefits, including monetary and non-monetary, than costs,
- Be effective,
- Provide certainty and legal clarity for providers and users, and
- Not hinder research and innovation.
All these criteria are of paramount importance to ensure a balanced system.
Let’s make it a success!
In operationalizing the system, we encourage policymakers to have due regard to the following guiding principles:
- A holistic approach
- Any mechanism that is being developed needs to consider biodiversity as a whole. From a scientific perspective, a distinction between genetic resources and DSI is artificial and does not respect the realities of current scientific research. Thus, while the new multilateral mechanism is destined in the first place to cover all publicly available DSI, countries should also be given the possibility to include the genetic resources in its scope.
- Emphasis on value creation and value sharing
- Rather than solely focusing on monetary benefit sharing, the mechanism should focus on reinforcing value creation and sharing. This means further reinforcing the inclusive and open access to DSI, and capacity building to bridge the gap between developed and developing countries.
- Sense of urgency
- The timeline of two years for operationalizing the mechanism should be carefully guarded, to avoid a next wave of frustration and the further proliferation of national ABS laws covering DSI.
- Simplicity
- To reach all the above, the new mechanism must be as simple as reasonably possible, to secure legal certainty and broad understanding and endorsement. Every single piece of additional complexity risks to make negotiations more cumbersome and time consuming, and to dilute the impact that this new mechanism can and should have.
We call upon policymakers to duly involve all relevant stakeholders in the design and implementation of a sustainable benefit-sharing system that supports the conservation and use of biodiversity in the best interest of society. Next to national authorities, academic users, indigenous people and local communities, and database providers, the business community will need to play an active and supportive role in its design and implementation.
Footnotes
- “DSI” is used as a placeholder, and no final decision has yet been taken on its exact scope and definition. Instead, “Genetic Resource Sequence Data” or “Nucleotide Sequence Data” have been proposed as more precise terms.
This work is licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International.
Dominic Muyldermans and Markus Wyss welcome the official establishment of “a multilateral mechanism for benefit-sharing from the use of digital sequence information on genetic resources, including a global fund” [FN1]. Economics explains how the mechanism and the fund, as stipulated in Decision 15/9, undermine the objectives of the CBD and NP, once “genetic resources” are accurately interpreted for the purposes of R&D [FN2].
Since introduction of “digital sequence information on genetic resources” (DSI) in COP13, no official definition has emerged. The 2018 Ad Hoc Technical Expert Group on DSI reached consensus that DSI was “not the appropriate term” [FN3]. In COP14 and COP15, the question of scope was left unresolved. Are genetic resources still genetic resources once dematerialized? If DSI is officially undefined and out of the scope, why explore a mechanism and a fund? And if DSI is within scope, why select only the digital medium of a dematerialized genetic resource?
The “D” in DSI has meaning prima facie. Print a downloaded sequence and the printout is not digital. Record the sequence on film and the celluloid is not digital. Verbalize the sequence and the utterance, not digital. In contrast, the alternative term “natural information” remains natural information whether the sequence is printed, filmed or voiced [FN4].
To prevent legal avoidance of ABS through printing, etc., COP16 will have to include all media in any future definition of DSI. Isn’t it just simpler to ditch DSI and adopt “natural information”?
The answer is resoundingly YES. Users, therefore, dare not ask the question [FN5]. Why? A rigorous literature associated with “natural information” justifies “economic rents” through “bounded openness”, whereby patent-holders pay rent-rich royalties [FN6]. The royalty income for Providers is akin to the limited-in-time monopoly profits from intellectual property, so solemnly defended by Users. Happily, what is fair and equitable is also efficient [FN6].
Recognition that dematerialized genetic resources are within the scope of the CBD and NP makes redundant any “multilateral mechanism for benefit-sharing from the use of digital sequence information on genetic resources, including a global fund”. Article 10 of the NP envisions consideration of a Global Multilateral Mechanism on Benefit Sharing (GMBSM). Redundancy defies simplicity and epitomizes inefficiency.
Should Decision 15/9 succeed in displacing the question of scope, Providers may agree to a rent-free “mechanism” and its extension to the GMBM. The scheme has the contours of bait-and-switch: (1) Bait Providers with the lure of a “global fund”; (2) Keep unresolved the question of scope; (3) Let royalty percentages be negotiated for out-of-scope DSI; (4) Switch the mechanism for the GMBSM and, nudge, nudge, preserve those percentages.
Muyldermans and Wyss deploy a hortatory metaphor: “We have a skeleton, but the muscles and nerves are still missing”. This is of public concern. Providers and stakeholders at COP16 would be well advised to arrive with shovels in hand. Inter.
FN[1] UNSCBD, Decision 15/9, Dec. 2022, https://www.cbd.int/doc/decisions/cop-15/cop-15-dec-09-en.pdf
FN[2] Joseph Henry Vogel, “Economics Affords Powerful Abstraction”, Submission of views on…15/9” Mar. 2023. Item #7 (Observers): https://www.cbd.int/notifications/2023-003
FN[3] UNSCBD, “Report of The AHTEG on DSI, Feb. 2018, p. 5. https://www.cbd.int/doc/c/4493/56b5/4ec917358b3cb37c7f7061f5/dsi-ahteg-2018-01-04-en.pdf
FN[4] Peruvian Society for Environmental Law (Sociedad Peruana de Derecho Ambiental), “Lawful Avoidance of ABS: Jurisdiction Shopping and Selection of non-Genetic-Material Media”, May 2017. https://www.cbd.int/emerging/.
FN[5] Joseph Henry Vogel, “Re-boot: the crash of DSI-the-neologism and where to go on ABS”, Submission of views..DSI”, SCBD/NPU/TS/CGA/AC/89861, Sep. 2021, https://www.cbd.int/api/v2013/documents/1064A1BB-40EE-9AAD-9D61-7BAC37F6596F/attachments/213834/Prof.%20Vogel%2028%20September.pdf
FN[6] Joseph Henry Vogel, Manuel Ruiz Muller, Klaus Angerer, Dino Delgado-Guitiérrez, Alfredo Gálvez Ballón, “Bounded openness: A robust modality of access to genetic resources and the sharing of benefits”, PLANTS PEOLE PLANET, Vol 4 Issue 1 (2022) https://doi.org/10.1002/ppp3.10239
FN[7] Sociedad Peruana de Derecho Ambiental, Fairness, Equity and Efficiency for the Convention on Biological Diversity and the Nagoya Protocol: Analysis of a Rodent, a Snail, a Sponge and a Virus. Report. 2021. Eschborn, Germany: The ABS Capacity Development Initiative. https://www.abs-biotrade.info/fileadmin/Downloads/Resources/Fairness-Equity-Efficiency-for-the-CBD-and-the-NP/Study-Fairness-Equity-Efficiency-for-the-CBD-and-the-NP-2021.pdf