In 2020, when the Covid-19 pandemic was at its peak and vaccine manufacturers rushed to find a vaccine, a research director at the US vaccine company Inovio Pharmaceuticals Inc said that it took them only "three hours" to design a vaccine, once they were able to download the DNA [Deoxyribonucleic acid] sequence — the molecule that has genetic information about an organism — of the virus from an online database that China provided.
This was a repeat of the earlier instance when the Ebola vaccine was developed by online access to the sequence of the West African Ebola strain. However, in both cases products from developing countries were accessed and used globally to research and develop appropriate vaccines. Despite this, initiatives to distribute vaccines to developing countries came in much later. As of April 2022, only 11% of the population in low-income countries is vaccinated against Covid-19, compared with 73% of those in high-income countries.
This inequity became a talking point in World Health Organization (WHO) and World Trade Organization (WTO) negotiations. However, at the recent negotiations at the Convention on Biological Diversity (CBD) in Nairobi, developing countries sought to correct this by securing the rights of provider countries and communities' access to genetic resources and sharing of the benefits of digital sequence information (DSI), which is genetic data stored on computers.
"The WHO does not have a legally binding mechanism to share vaccines, diagnostics and therapeutics that are developed using genetic information and resources shared freely globally," said Nithin Ramakrishanan, who was a member of the non-profit Third World Network, and part of the delegation at the CBD negotiations. "The WTO failed to adopt a meaningful Intellectual Property waiver for the very same products allowing for developed countries to monopolize these products."
DSI is key to scientific advancement and technological innovation and has great potential to enhance fields such as medicine, food security, green energy production and biodiversity conservation. For instance, through the use of DSI, scientists in England have re-generated a local plant species that was on the verge of extinction, in new suitable sites. A 2019 study by Sylvain Aubry, an academic from Switzerland, has called the DSI another face of "Big Data" that can challenge the way we think about the world.
Though the negotiating session of the CBD held in Nairobi in June 2022 did address the issue of creating an infrastructure for this kind of data that will ensure access to genetic resources and benefits for local communities, participating countries failed to find common ground. The issue went to different groups, and is ultimately being deferred to the final 15th Conference of Parties to be held in Montreal, Canada in December 2022.
What is Digital Sequence Information (DSI)?
The premise of Digital Sequence Information is to simplify the genetics of a plant/ specimen in a lab so that the researchers no longer need the original plant itself.
For instance, Poliovirus, which in 2002 became the first virus to be wholly synthesized — that is, produced from scratch in the lab — is about 7,500 nucleotides long. The nucleotide is the basic building block of DNA. Ten years later, in 2012, a 14,500-nucleotide influenza virus was synthesized. In 2016, an American scientific team announced the synthesis of adenovirus, with a genome of 34,000 nucleotides.
DSI is stored in private and public, or "open access", databases that are free for corporations to use and profit from. The easy availability of this kind of advanced genetic data will lead to potential misuse, experts attending the CBD conference noted.
"DSI was not envisaged when the Nagoya Protocol on access and benefit sharing (with the local countries and communities) was negotiated among countries," said Lim Li Ching, an NGO representative from the Third World Network with expertise on sustainable agriculture, biotechnology and biosafety. "Misappropriation of genetic resources through use of DSI will undermine this and render the Nagoya Protocol meaningless."
The CBD's Nagoya protocol, in force since 2014, is an international agreement on sharing of benefits from access to biological resources, of which India is a signatory. The protocol mandates that parties using a biological resource should get the prior informed consent of the provider country and community, and have mutually agreed terms, along with introducing a compliance mechanism.
Historical misuse, called biopiracy, has happened when developed nations have exploited traditional resources for commercial gain without sharing any of the revenue or benefits. This leads to exploitation of the cultures these bioresources are drawn from. Examples include attempts by foreign firms to obtain patents on products long in use in India, such as neem, Basmati rice, turmeric and Darjeeling tea.
Access and benefit sharing with provider communities and countries
The debate over who will get access to DSI has been one of the long-standing points of contention in biodiversity negotiation. DSI has formally been on the table of the CBD for nearly six years, since late 2016.
"The issue now at hand is one of deciding how to apply the 30-year-old access and benefit-sharing obligations of the Convention on Biological Diversity (CBD) to the age of information," said Ching.
"The DSI issue cannot and should not be resolved without keeping access and benefit sharing obligations in mind," said V.B. Mathur, India's official delegate to the fourth meeting of the CBD negotiation held in Nairobi and chairman of the National Biodiversity Authority — a statutory body of the environment ministry — in a response to a question from IndiaSpend. This correspondent also reached out to the environment ministry on July 7 for their response on the DSI debate.
"Looking at DSI in the context of access and benefit sharing has been a challenge," said David Cooper, Deputy Executive Secretary at the UN Convention on Biological Diversity. "This issue is also relevant in FAO [Food and Agricultural Organization] and WHO when it comes to access to vaccines etc. It's challenging to address this conundrum — how to maintain access and benefits of genetic sequences without hindering science."
"No one is asking for open access to the biological resources," Ching said. "All we (developing countries and civil society organizations from such countries) are asking for is fair and equitable access to resources. We have seen unfairness in access of Covid vaccines which are all based on DSI."
"Developed countries say giving open access to databases is a non-monetary benefit. Developing countries, especially the Africa group of nations, are demanding 1% tax on every biological resource used."
The last two-and-a-half years have seen pandemic delays and frequent but fitful online discussions about DSI. While an interminable series of webinars were held with the best intentions, the discussions have swirled around as much as they have clarified and moved forward, observers told us.
An indecisive initial round of in-person talks was conducted in early 2022 in Geneva. After this session, the contact group made an informal co-chair advisory group that met five times to address issues ranging from definition and scope of DSI to tracking and tracing and the roles and interests of stakeholders. The group was co-chaired by South Africa and Norway, and it prepared a report with policy options to consider.
The policy options included either no benefit sharing from DSI, or benefits in the form of monetary payment, technical and scientific assistance. A source who was part of the discussion told us on condition of anonymity that policy options on access and benefit sharing are broken down to choose either/or when in fact all the criteria should apply, as for instance requiring consent and a standard license to access and share benefits.
The same delegates to the CBD met in Nairobi in late June, where the discussion moved from contact group (includes all countries and civil society) to friends of co-chair group (a smaller group led by one developed and one developing country delegate, that can also give some representation to non-state actors), to friends of co-lead (a much smaller group that is only restricted to some country delegates), with no resolution.
The matter is now being referred to an informal advisory committee that will make recommendations, based on which, countries that are set to meet later this year in Montreal at the 15th Conference of Parties to the UN CBD, are likely to make a final decision.
What is at stake?
The story of Ebola is illustrative of the immensity of the problem, and of the issues involved. The virus was first identified in 1976, through simultaneous outbreaks in South Sudan and the Democratic Republic of Congo. In the latter, the disease was first located in a village on the banks of the Ebola River.
Since then, Ebola outbreaks have occurred intermittently in sub-Saharan Africa, with the WHO recording 41 outbreaks between 1976 and 2021, resulting in over 15,000 deaths. The Congo has seen fresh outbreaks in 2017, 2018 and 2019, leading the WHO to declare it a world health emergency.
In 2020, the United States Food and Drug Administration approved Immazeb, a triple antibody cocktail developed by Regeneron Pharmaceuticals, as the first ever Ebola virus treatment. The US government had paid the company over $190 million to develop and begin production of the drug, which has since earned huge revenues for the company.
Meanwhile, as recently as late March this year, Congo declared yet another Ebola outbreak — its 14th — which officially ended on July 4. And yet Regeneron's drug, based on the DNA sequence obtained by isolating the strain from a 28-year-old Guinean woman, and accessed from a public database, run by a European Research Institute, is only made available in the Congo in limited quantities for experimental purposes. The West African country received no benefits.
The tangible value of benefit sharing is that it can help those most responsible for biodiversity conservation, who also happen to be some of the most vulnerable, such as local indigenous communities, wrote Margo Bagley, academic from Emory University, in a 2022 paper published by the Harvard International Law Journal.
The paper elaborated that fair and equitable benefit-sharing from DSI is also about upholding commitments to those that create and sustain the diversity that benefits us all, and about adapting agreements that set out collective human, environmental, and social goals to a changing reality.
This story was produced as part of a Biodiversity Media Initiative travel grant to the 2022 UN Convention on Biological Diversity’s 4th Meeting of the Open-ended Working Group on the Post-2020 Global Biodiversity Framework. It was originally published by IndiaSpend on 11 July 2022 and has been lightly edited for length and clarity. The Biodiversity Media Initiative is supported by Arcadia — a charitable fund of Peter Baldwin and Lisbet Rausing.
Banner image: A pipette in a lab / Credit: Louis Reed via Unsplash.