Op-Ed: A great genetic plundering can be legitimized at COP16
Without strong safeguards, the multilateral mechanism for digital sequence information could deepen the divide between developing and developed countries
Expanded version of the Article published by Down to Earth
Op-Ed by Nithin Ramakrishnan
Senior Researcher at Third World Network (TWN)
The 16th Conference of Parties (COP16) to the Convention on Biological Diversity (CBD), taking place in Cali, Colombia from October 21 to November 1, 2024, is on the verge of operationalizing 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 hand over 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 in this regard.
This situation reflects the deep-rooted legacy of colonial plunder that took place upon the arrival of Colombus in the Americas in 1490s, with Charter that gave him the right to “discover and conquer” lands and peoples. Over 500 years later, Vandana Shiva called the corporate monopolization of genetic resources through intellectual property rights as “the second coming of Columbus.” Both in 1490s, and 1990s, “control over resources” were taken over by the colonizers or monopolisers, who justified such takeover as necessary for “improvement” of resources.
The proposed MLM risk enabling a “third coming of Columbus” by legitimizing the “unaccountable sharing and use” of DSI through databases controlled by developed countries, justifying the very same “unaccountable practices” as important for maintaining a globally integrated DSI dataset for researchers across countries. Another great gene plunder will be legitimized, if COP16 fails to take right decisions.
Digital Biopiracy: Exploitation of Genetic Resources Using Digital Technology
Biopiracy refers to the practice of researchers or organizations extracting genetic resources contrary to the norms and standards sets in the CBD i.e. accessing and carrying out research and development (R&D) activities and monopolising the R&D outcome mainly through intellectual property (IP) without the prior informed consent (PIC) and not sharing the benefit emerging from R&D. Digital biopiracy refers the use of digital technologies and infrastructures like sequence databases to bypass PIC and benefit-sharing requirements to utilizing genetic resources and the monopolise R&D outcomes through IP.
One Scholar sums up the situation in Harvard International Law Journal in 2022 – “vast amounts of what is being called digital sequence information DSI are being used and patented, without permission from the countries that own the genetic resources from which the sequences are derived.”
Generally speaking, 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 such information for research and product development bypassing access to physical materials. Further, it is well known that researchers use DSI to create products like vaccines, therapeutics and diagnostics without the need to access physical genetic materials. For example, vaccines for Ebola and Covid19, and antiviral drugs for arenavirus infections were developed using sequences uploaded into databases. Further, wide availability of DSI also bears the danger of non-peaceful use such as in 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. Further, current practices of databases not only compromise benefit-sharing but also decontextualize and diminish national sovereignty over genetic resources. Further, it takes away the control from real owners of genetic materials and information, while failing to guarantee access to scientists. Interesting they are also not guaranteeing open access to all users. Some of them even retain 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 U.S., and EU. These databases often do not respect the rights and obligations under CBD or Nagoya Protocol, nor are they accountable to the parties of CBD. They neither verify whether the DSI deposited is from a genetic material that was 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, often, they 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 abilities to secure benefits, and to maintain national security. At the same time, developed countries and/or their database managers could also control how much access is provided to researchers from other countries in future. An example illustrating the above point is the complaint against a pathogen DSI database, recommended by WHO and funded by Germany and other developed countries, for its discriminatory approach toward scientists and users.
COP16: The Battle for Access and Benefit Sharing continues
The CBD and its Nagoya Protocol mandate the fair and equitable sharing of benefits arising from the utilisation of genetic resources, including through 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 research utilizing DSI is distinct from utilization of genetic resources covered under CBD.
At COP15 in Montreal, held 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 now backtracking, claiming they only agreed to voluntary benefit-sharing.
The current draft decision under the consideration MLM, proposes to operationalize a “Global Fund” to which users of DSI from the so-called “public databases” are “encouraged” to contribute. Although developing countries seek to make MLM effective and obligatory to users of DSI, the developed countries disagree on all efforts in this regard.
The draft decision is mainly developed out of the European Position – which argues when States make DSI from their genetic resources available in a public database, no additional benefit sharing obligations arise on the users of such DSI from databases. The users may voluntarily contribute to the MLM.
The draft decision proposes Parties to introduce national policies or legal changes to encourage users from their jurisdiction to share monetary contributions to the global fund. However, it is neither obligatory for Parties to do so, nor the policy changes are expected to obligate 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 duplication of 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 would lead to a situation where companies based in developed countries could utilize the DSI from all countries through any of the databases, which are often placed in such database in violation of the national ABS laws, and get away with it by paying donations to MLM. The proposed MLM, if adopted the way E.U. and their allies want, it would make then entire Nagoya Protocol and the foundational principles of CBD redundant.
“Global DSI Dataset” or “Great Gene Plunder”?
Two flawed narratives are being used to support the proposed model of MLM. First, 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 existing so-called public databases are controlled by various private parties and governments. Their unilateral decisions can affect access to the data. Interestingly, during the negotiations that adopted CBD, developed countries tried to argue that genetic resources are the “common heritage of mankind”, which was rejected and now the same argument is made by characterizing DSI datasets as ‘global common resources” originating from a single universal ancestor. At the same time, they do not want any rules or accountability in the use of DSI and oppose creating accountable databases through international organizations.
Further the second narrative is the classic ingenious attempt to remove the real value from biological resources as well as traditional knowledge. Though scientists routinely compare and analyze data, but not all data significantly impact research outcomes. There are several patent applications which discloses natural sequences and their country of origins – i.e. there are products based on identified genetic materials as well in the market.
Thus, individual sequences and their provider countries and communities still hold value beyond the large-scale data analysis by AI or processes like codon optimization. The second narrative is oblivious to this value and seeks to remove control not only over genetic resources but also over benefit sharing through the MLM.
Take the example of EVD treatment drug “Inmazeb”, produced by Regeneron, approved by U.S. FDA in October 2020. This product used Ebola Virus strain from Guinea, a country in West Africa. Regeneron is the recipient from the U.S. government of US$45.9 million for the anti-Ebola antibody therapeutics development program, and up to US$756.4 million contract for national stockpiling. Fair and equitable benefit sharing obligations if followed, all populations suffering from Ebola should have received affordable access to products at the earliest and a share of profits of Regeneron should have gone to specifically Guinea.
However, the current draft decision on MLM does not help both forms of benefit sharing. It does not include practical steps to secure the real global benefits, such as medicines produced out of genetic resources. At the same time, it requires developing countries to make contributions to the global community - a share of the monetary gains they make through ABS.
If the argument is developing countries should be contributing to global biodiversity conservation, from the benefits it receives, such an argument over looks the common but differentiated responsibilities (CBDR) of developed and developing countries in protecting biodiversity. The fact that the proposed MLM can remove the control of genetic resources from developing countries to the developed countries shows how unduly costs and burden will be shifted to the developing countries.
In short, both principles of national sovereignty over natural resources and CBDR are undermined by the proposed model of MLM. Without accountability and transparency measures, it will remain as an instrument legitimizing inequitable extraction of genetic resources from developing countries.