[Analysis] Proposal on digital sharing of genetic information could circumvent benefit-sharing rights

A text related to sharing of digital information of genetic resources, fed into the biodiversity negotiations towards the end of the recently-concluded Convention on Biodiversity (CBD) talks, has experts and observers worried. They fear that it could lead to genetic-resource rich developing countries losing on their access and benefits rights that they could gain if a product, for example, a vaccine, is developed using such digital information.

In the biodiversity talks, digital sequence information (DSI) is used as a placeholder term for digital information of genetic resources such as organisms, or parts thereof, in which genes are present. Examples of this would be a plant or a virus strain. The negotiations will determine if the benefit rights, that are applicable on the sharing of physical samples, will also apply and to what extent, on the sharing of DSI.

In the last two days of the talks under the CBD, that concluded in Geneva, Switzerland, on March 29, 2022, a text that put nine conditions for the benefit sharing to be applicable on the DSI was introduced. This text was developed in a side meeting, different from the standard protocol, where few countries were present with some developed countries having a clear influence. Observers privy to the negotiations said that these conditions are of very wide scope and can be subjected to a variety of arbitrary interpretations undermining the access and benefit sharing rights of genetic resource rich countries.

The text that has been finalised in these talks will feed into the 15th Conference of Parties to the CBD (CBD COP15), where the final decisions on these subjects will be negotiated. The CBD COP15 is expected to be held at Kunming, China, at the end of August 2022.

Why is the DSI and its benefit sharing discussion important

Unlike physical samples, for instance, a microorganism, a biological specimen or a plant, sharing of their digital information, so far, is not governed by the global accords that protect the rights of the host country from where the sample has originated. Digital sharing could also help accessors circumvent the need to go through the sovereign laws and agreements of the host country to access the information.

For example, if a country wants to access a physical sample of a plant species from India, it will have to go through the Indian laws to do so. In turn, under the global Convention on Biodiversity and its Nagoya Protocol, the country which is taking the physical sample will have to not only negotiate with India as per the country’s law but will also be obligated to share the access and benefits with India, if for example a drug or a therapeutic product is developed from the research on the plant species.

Digitising this information and its sharing has enabled the scientific world to save a lot of time and effort. It has also led to scientists working together and finding speedy solutions for global problems such as COVID-19 pandemic. But there are examples where the digital sharing of such information led to the access and benefit rights of the host country being ignored.

A 2019 study by the Third World Network found out that open sharing of DSI can be used by big commercial actors to develop products and technologies and then monopolise such benefits without sharing it fairly and equitably with the states and peoples who provided access to such genetic resources. The study is not associated with the CBD talks.

For instance, a drug ‘REGN-EB3’ received its first approval on October 14, 2020 in the USA for the treatment of infection caused by Zaire ebolavirus in adult and paediatric patients. The drug was developed by New York based Regeneron Pharmaceuticals using the DSI of a 2014 West African Ebola strain. The strain, named C15, had been isolated in the clinical sample of a 28-year-old Guinean woman by researchers from the Pasteur Institute in Lyon, France, in cooperation with the Nocht Institute in Hamburg, Germany. The Nocht Institute sequenced the C15 virus and posted the result in Genbank, a public ‘no strings attached’ database sponsored by the U.S. government. The Regeneron company downloaded the C15 Ebola virus sequence from Genbank, synthesised portions of the virus and used them to create the drug. Now, just because Regeneron accessed DSI from Genbank rather than obtaining a virus sample from Nocht, no benefit sharing clause became applicable on them. The host country, in this case Guinea, did not benefit from this.

The ongoing negotiations on DSI and whether the rules of access and benefit sharing apply to them are crucial to ensure that such instances do not happen. This is especially important to protect the rights of all the bio-resource rich developing countries from getting exploited at the hands of powerful commercial actors and interested developed countries with resources, experts said.

The nine conditions

The circulated text, in its paragraph five, puts nine conditions to be followed in the process of developing a possible solution to make benefit sharing applicable on DSI. The text notes that a solution for fair and equitable benefit-sharing on digital sequence information on genetic resources should be efficient, feasible and practical; generate more benefits that costs; be effective; provide certainty and legal clarity for providers and users of DSI on genetic resources; not hinder research and innovation; be consistent with open access to data; be compatible with international legal obligations; be mutually supportive of other access and benefit sharing instruments and finally, take into account the rights of indigenous people and local communities, including with respect to the traditional knowledge associated with genetic resources that they hold.

Delegates from some of the countries and experts, however, have reservations about the interpretation of these paragraphs when it comes to access and benefit sharing.

The first condition, that a solution should be “efficient”, “feasible” and “practical” are mutually reinforcing, making a very high threshold that a solution to benefit sharing is unlikely to meet quite often. The scope is certainly larger than being merely practical or efficient, Nithin Ramakrishnan, representative for non-governmental organisations attending the CBD meetings and an expert on the subject, said.

Further, the conditions note that for a solution to be fair and equitable, benefit sharing should generate more benefits than costs. Ramakrishnan said that the para does not specify benefits to whom and costs to whom. “This can jeopardise the entire governance and regulatory mechanism on access and benefit sharing for digital sequence information on genetic resources.” The conditions also note that solutions should not hinder research and innovation. “Here again, ‘should not hinder’ can mean including a lot of ideas and conditions including strong implementation of Intellectual property laws,” added Ramakrishnan.

This could also block national laws regulating the online platforms sharing digital sequence information freely and without guaranteeing benefits back. The EU and US Security interests promote online platforms sharing rapid access to information bypassing all national scrutiny of information shared from other countries, he added.

On similar lines, the South American country of Bolivia registered a strong opposition against  some of the conditions, specifically the one that says the solution should be consistent with open access to data. “We don’t want to see an open data as a free access to data,” Bolivia said at the talks, demanding that this para should either be deleted or put in brackets.

Ramakrishnan added, the obligation to share back the benefits developed is always attached to the data shared or accessed openly. The current situation with ‘Open access’ databases is that it is free for all. Big corporations are able to access DSI freely with no benefit sharing obligations. While the databases which are publicly accessible may remain to allow access for scientific research, this does not mean free access for commercialization of such benefits. Standard terms and conditions are needed to put in place benefit sharing obligations, he added.

Along with Bolivia, other countries such as Jordan, also made noted their concerns and disagreements with some of the conditions.

The meeting reached an impasse after which the co-chair announced a solution where all countries agreed to add a line in the meeting reports for the conditions suggested in the documents, which read, “This recommendation is intended to facilitate the further process on DSI issues and does not prejudge that definition and the views on the parameters and the principles governing a final solution.” This line ensures that countries are not compelled to adopt the solutions developed based on the conditions and discussions will continue.

Ramakrishnan, however, warns that while the line in the meeting reports will protect negotiation interests of parties in CBD discussions the conditions mentioned in the main negotiating document could still serve as a persuasive tool. The delegates coming to discuss some of the issues related to DSI sharing, let’s say in the World Health Organisation or Food And Agriculture Organization (FAO), could cite para 5 and say that CBD parties are looking at solutions based on these conditions. Cross-referring the conditions from the CBD document without disclosing the line of caution from the meeting reports is a real risk that looms.

Read more: Bioresource access and benefit-sharing: How far have we come in India?

The sudden mid-night emergence of nine conditions

How the nine conditions made their way into the main negotiation text at the meetings is also a story that throws light over the power games played at these talks.

In a standard process there are three groups in a negotiation meeting. One is a contact group, which is open to all countries, civil society organisations, indigenous people in local communities, businesses, academy institutions, etc. They can give their inputs on the subject that is being discussed at this contact group. And then the matter goes to plenary where it’s basically only open to the parties to CBD.

A new text is usually first proposed at the contact group in the form of a non-paper and after the discussions it moves to the plenary in the form of the Conference Room Paper (CRP). After the plenary is done discussing the CRP it takes the form of the ‘L document’ [meaning last or final document] which usually is sent to COP for final negotiations.

What happened with the DSI issue, narrate observers that Mongabay-India spoke to, is that during the contact group, on March 27, the third last day of the negotiations, co-leads of the contact group came up with a process called “friends of co-leads”. Developed by Europe, this process, of late, has become common in the negotiations. However, it is not as inclusive as a standard contact group because it does not involve non-state actors. In this new process the discussion on a non-paper is limited to state actors. One delegate from ‘developed’ and one from ‘developing’ countries become co-leads who steer these meetings. Often the co-lead, who comes from a strong developed country, has more influence, an observer said, adding that because developing countries are present in these meetings, the process might look participatory but more often than not, it is not participatory.

Although it has become an acceptable practice, “friends of the co-leads” is a process that circumvents deeper, richer and more inclusive discussion of a standard contact group.

The DSI discussion went down a similar path with 20 countries identifying themselves as “friends of co-leads” participating in the process. India was not part of this cohort and joined the contact group meeting after the “friends of co-leads” discussions were over. In the contact group meeting, the non-paper created in the previous meeting was presented and it was announced that this would be converted into a Conference Room Paper (CRP). A CRP is usually what a contact group prepares after thorough discussions on the subject. But this process, under “friends of the co-leads” with a non-paper directly converted into a CRP, bypassed the opportunity of a deeper scrutiny of the text, noted an observer.

Read more: Solving multiple challenges while considering biodiversity and human rights

Bhasker Tripathi is a journalist who has been covering climate, biodiversity, energy and their intersection with society for over a decade. 

Banner image: Malabar gliding frog (Rhacophorus malabaricus) endemic to Malabar region. Photo by Gyaltsen.wangdi/Wikimedia Commons.