The 16th Conference of Parties (COP16) to the Convention on Biological Diversity (CBD), set to take place in Cali, Colombia, from October 21 to November 1, 2024, is on the verge of operationalising a multilateral mechanism (MLM) for sharing benefits arising from the use of digital sequence information (DSI) of genetic materials.
However, this mechanism, in its current form, would effectively transfer control of genetic resources from developing countries to developed countries through digital means. Text proposals by developing countries to avoid this danger are all inside the brackets in the draft decision that will be considered by the COP16.
This situation reflects the deep-rooted legacy of colonial plunder that began with Columbus’s arrival in the Americas in the 1490s. The proposed MLM legitimises the “unaccountable sharing and use” of DSI through databases controlled by developed countries, justifying it as essential for maintaining a globally integrated DSI dataset for researchers across nations. Another great gene plunder will be legitimised if COP16 fails to make the right decisions.
Biopiracy refers to the practice of researchers or organisations extracting genetic resources contrary to the norms and standards set in the CBD. These groups monopolise the outcomes of research and development (R&D) primarily through intellectual property (IP) and do not share the benefits emerging from R&D.
Digital biopiracy refers to the use of digital technologies and infrastructures, such as sequence databases, to bypass prior informed consent (PIC) and benefit-sharing requirements while utilising genetic resources, thereby monopolising R&D outcomes through IP.
DSI consists of genetic sequence data obtained by sequencing the DNA or RNA of plants, animals, microbes, etc. With advancements in synthetic biology, once this information has been extracted from genetic materials and made available to secondary users, they can use it for research and product development, bypassing access to the physical materials.
It is well known that researchers use DSI to create products such as vaccines, therapeutics and diagnostics without needing to access physical genetic materials. For example, vaccines for Ebola and COVID-19 and antiviral drugs for arenavirus infections, were developed using sequences uploaded into databases. Moreover, the wide availability of DSI also poses the risk of non-peaceful uses, such as bioterrorism.
Currently, the ownership and control of major DSI databases are concentrated in a few developed countries, which retain the power to set terms for access and usage. For instance, these databases have resisted including a mandatory field for the country of origin in metadata for decades, effectively controlling access to such information and frustrating countries’ ability to seek benefit-sharing.
Furthermore, current database practices not only compromise benefit-sharing but also decontextualise and diminish national sovereignty over genetic resources. This removes control from the rightful owners of genetic materials and information while failing to guarantee access to scientists. Interestingly, these databases also do not guarantee open access to all users, with some even retaining the right to unilaterally suspend access to users.
Oddly, sequences with high commercial value and significant biosecurity risks are stored and shared anonymously through online databases hosted and financed primarily by developed countries like Japan, the United States and the European Union. These databases often do not respect the rights and obligations under the CBD or the Nagoya Protocol, nor are they accountable to the parties of the CBD.
They neither verify whether the DSI deposited comes from genetic material accessed in compliance with PIC and benefit-sharing norms nor check whether the submitters have the requisite permissions from the relevant authorities to make the DSI publicly available. Similarly, they often do not impose any conditions on benefit-sharing while facilitating access to DSI.
This means developing countries and their communities lose control over how their genetic resources are used, compromising their ability to secure benefits and maintain national security. Meanwhile, developed countries and/or their database managers could also control how much access is provided to researchers from other countries in the future.
One example of this is the complaint against a pathogen DSI database, recommended by the World Health Organization and funded by Germany and other developed countries, for its discriminatory approach towards scientists and users.
The CBD and its Nagoya Protocol mandate the fair and equitable sharing of benefits arising from the utilisation of genetic resources, including through the application of biotechnology. The instruments do not treat utilisation through digital means distinctly from other forms of utilisation. Nevertheless, many developed countries and their industries avoid benefit-sharing obligations, arguing that research utilising DSI is distinct from the utilisation of genetic resources covered under the CBD.
At COP15 in Montreal in December 2022, developed countries finally agreed to explore mechanisms for sharing benefits from the use of DSI. This agreement led to the proposed MLM, now under discussion at COP16. Yet, these countries are backtracking, claiming they only agreed to voluntary benefit-sharing.
The current draft decision on the MLM proposes to operationalise a “global fund” to which users of DSI from so-called “public databases” are “encouraged” to contribute. Although developing countries seek to make the MLM effective and obligatory for users of DSI, the developed countries disagree with these efforts.
The draft decision is mainly based on the European position, which argues that when states make DSI from their genetic resources available in a public database, no additional benefit-sharing obligations arise for the users of such DSI. The users may voluntarily contribute to the MLM.
The draft decision proposes that parties introduce national policies or legal changes to encourage users within their jurisdiction to share monetary contributions to the global fund. However, it is neither obligatory for parties to do so, nor are these policy changes expected to compel users to share benefits.
At the same time, the draft restricts parties from imposing national measures for sharing benefits arising from DSI in “public databases,” stipulating that such measures should be compatible with the MLM and avoid duplicating payments. Notably, there is no clear definition of what constitutes a “public database” or clarity whether these databases will be accountable to CBD parties, despite their central role in the proposed solution.
This could lead to a situation where companies based in developed countries could utilise DSI from all countries via any database and avoid obligations by paying donations to the MLM. If adopted as the EU and its allies propose, the MLM would render the entire Nagoya Protocol and the foundational principles of the CBD redundant.
Two flawed narratives are being used to support the proposed MLM model. First, that the existing public DSI databases are “open to all” and represent “global common resources,” available to everyone. Second, the argument that the value of DSI lies not in individual sequences but in researchers’ ability to analyse large datasets — the so-called global DSI dataset — making it unnecessary to share benefits directly with provider countries or communities.
As shown above, the first narrative is far from true. The so-called public databases are controlled by various private parties and governments. Their unilateral decisions can affect access to the data. During the negotiations that adopted the CBD, developed countries tried to argue that genetic resources are the “common heritage of mankind,” which was rejected.
Now, the same argument is being made by characterising DSI datasets as “global common resources” originating from a single universal ancestor. At the same time, they oppose creating accountable databases through international organisations and do not want any rules or accountability regarding the use of DSI.
The second narrative is an attempt to remove the real value from biological resources and traditional knowledge. Numerous patent applications disclose natural sequences and their countries of origin, indicating that there are products based on identified genetic materials already on the market.
The second narrative ignores this value and seeks to remove control over both genetic resources and benefit-sharing through the MLM.
Take the example of the EVD treatment drug Inmazeb, produced by Regeneron, which was approved by the US federal agency Food and Drug Administration in October 2020. This product used an Ebola virus strain from Guinea, a country in West Africa. Under fair and equitable benefit-sharing obligations, all populations suffering from Ebola should have received affordable access to the products at the earliest opportunity and a share of Regeneron’s profits should have gone specifically to Guinea.
However, the current draft decision on the MLM does not facilitate either form of benefit-sharing. It does not include practical steps to secure global benefits, such as medicines produced from genetic resources. At the same time, it requires developing countries to contribute a share of the monetary gains they make through access and benefit sharing to the global community for protection of biodiversity in furtherance of the Kunming-Montreal Global Biodiversity Framework goals and targets.
This overlooks the common but differentiated responsibilities (CBDR) of developed and developing countries in protecting biodiversity.
In short, both principles of national sovereignty over natural resources and CBDR are undermined by the proposed MLM model. Without accountability and transparency measures, it will remain an instrument legitimising the inequitable extraction of genetic resources from developing countries.
Nithin Ramakrishnan is Senior Researcher at Third World Network
Views expressed are the author’s own and don’t necessarily reflect those of Down To Earth