In 2019, Regeneron Pharmaceuticals developed an Ebola vaccine known as Inmazeb using a genetic sequence of the virus collected from a 28-year-old Ebola survivor in Kissidougou, Guinea. The epidemic that spawned the virus had killed over 11,000 people across West Africa five years earlier. In 2020, New York-based Regeneron received a U.S. government contract worth over $345 million to produce a national vaccine stockpile and then went on to accrue additional patents in India, Nigeria and South Africa, and applications in over a hundred other countries.
For its part, Guinea did not receive any benefits from Inmazeb. Although it was the source of information critical to the vaccine’s creation, the West African country received no shares of Regeneron’s profits or support in developing a vaccine of its own. And today, Ebola vaccines remain largely inaccessible to the world’s most vulnerable populations.
Despite the existence of two Ebola vaccines — Regeneron’s Inmazeb and Miami-based Ridgeback’s Ebanga — there is still no global emergency stockpile, and treatment is not adequately available where outbreaks regularly occur. Between 2020 and 2022, less than 35% of people infected with Ebola during five outbreaks in Guinea and the nine countries that make up the Democratic Republic of the Congo–countries where Regeneron has conducted randomized trials — received treatment by either vaccine. Since patents to both vaccines are held by U.S. companies, nearly all the available doses are controlled by the U.S. and accessed primarily through ad hoc donations, reported Médecins Sans Frontières in March.
Regeneron hasn’t done anything illegal, because Guinea has no laws ensuring that benefits garnered from its genetic resources are shared. But human rights groups have accused the company of exploiting a legal loophole regarding the use of digitally sequenced genetic information, or DSI, to skirt providing Guinea with a share of Inmazeb’s profits or other non-monetary benefits, like support in developing vaccines of its own.
Under the Nagoya Protocol to the Convention on Biological Diversity on Access and Benefit Sharing — an international treaty for the equitable use and sharing of genetic resources — countries regulate access to the genetic information of plants, animals and microorganisms like viruses, and must support compliance with national access and benefit-sharing requirements and contracts. It is ultimately up to countries to write legislation that governs how to share any benefits from the use of genetic resources obtained from within their borders.
However, the scope of this requirement does not apply if the information is accessed as DSI, rather than as a laboratory sample in cold storage. DSI is a digital record of a resource’s genetic fingerprint, encompassing proteins, amino acids and nucleotides — essentially everything someone would need to make or modify their own copy of the resource.
Regeneron didn’t take the Ebola sequence it used directly from Guinea; it downloaded its DSI from an open-access bank of genetic information in Bethesda, Maryland, which had in turn copied the data from the Bernhard Nocht Institute in Germany. The original Guinean sample had been collected by an MSF team in Kissidougou.
There is still no global emergency stockpile.
Thanks to the rise of digital sequencing in commercial biotech, the most intimate building blocks of life are becoming as commodified as fossil fuels, cobalt and teakwood. Technological leaps in supercomputing and machine learning have enabled the sudden evolution of DSI analysis and sequencing technologies, and, as Inmzeb’s story makes clear, international laws governing it have not kept pace.
Left to the free market and minimal governmental oversight, genetic resources related to everything from viruses that cause zoonotic diseases to microbes that survive on methylamine in volcanic glaciers and the patents on mosquitoes and chimpanzees, are vulnerable to the kind of exploitation and abuse that has plagued the pharmaceutical industry.
This month, the world’s delegates will gather in Cali, Columbia for the the United Nations Biodiversity Conference of the Parties to the U.N. Convention on Biological Diversity. COP16 will feature a particular focus on how to manage and regulate the access, use and control of genetic resources, including DSI in environmental conservation. At Cali, delegates have the opportunity to take a strong stance to ensure accountability around the use of DSI, not just physical genetic resources, and set new standards for sharing the benefits from the use of DSI, which is currently excluded from international law.
Bioinformatics and access to subcellular information are becoming increasingly important tools in efforts to conserve and restore wildlife. At COP16, delegates hope to figure out how to share the benefits derived from the use of DSI. Members of the delegation from developing countries including Cuba, India, Jordan and African nations, as well as civil society groups representing Indigenous and women’s rights and sustainable development are demanding new rules and standards to govern conservation genomics. They want to strengthen oversight, support accountability and equity and avoid exploitative models of corporate abuse that harm countries and communities from which genetic sequences are sourced.
“The status quo isn’t working for developing countries or provider communities, because no benefits are being shared — or, definitely not equitably,” said Lim Li Ching, co-chair of the International Panel of Experts on Sustainable Food Systems and senior researcher at Third World Network, a research and advocacy nonprofit focusing on the Global South. “We think that it’s important to have something that is accountable to parties, and with robust governance mechanisms that can ensure benefit-sharing.”
Without equitable commitment from developed countries and multinational corporations that have historically exploited the natural resources of developing nations, she told Truthdig, the burden of responsibility is placed on the latter “because they bear the burden of implementing biodiversity action [and] reporting.”
One of the biggest regulatory challenges is getting bioindustry companies to pay for the use of original genetic resources from flora and fauna, explained Hartmut Meyer, project leader for the ABS Capacity Development Initiative and BioInnovation Africa at the German Development Cooperation.
At COP16, delegates hope to figure out how to share the benefits derived from the use of DSI.
“Morphine, aspirin — that’s all now synthetic. Nobody needs the willow tree for aspirin any longer,” Meyer told Truthdig. As a result, it is currently unclear where accountability lies when genetic sequences are synthesized through recombinant techniques that muddy their origin. This leaves the door open for scientists to synthesize, patent and mass produce copies or modification of species with cultural value, like a sacred peyote plant that has been harvested in Huiricuta or Navajo Nation, for example, for pharmaceutical development of synthetic mescaline without reimbursing communities of origin.
Another top concern for developing countries and human rights watchdogs is the predatory capture of public domain information by private corporations. To avoid this, they are calling for the obligatory sharing of monetary and non-monetary benefits from the use of DSI from genetic resources, as well as the creation of a conservation genetics database where genetic sequences could be published under a creative commons license but with obligations for benefit-sharing. The goal is to allow low-income countries to generate income from genetic resources extracted from their territories while gaining access to commercial products created with the information.
The monetary benefits of DSI can add up multiple times along a genomics value chain, and so developing countries view conservation and genomics technologies as industries to drive economic development, said Nithin Ramakrishnan, a senior researcher at TWN. Non-monetary benefit sharing like lab development and professional mentorship, which are poorly integrated into current legal frameworks around genetic resources, can also help origin countries grow their own research and development capacity, liberating them from dependency on corporate charity and the conditions imposed by foreign aid programs.
For this to happen, though, companies need to be forced to pay and share resources and technical capacity with developing countries. As it stands, CBD policy is weak. Developed countries are pushing for regulations that favor corporate interests over moral obligations, while critics warn that lax regulation sets a dangerous precedent for other sectors using DSI.
Genetic information housed in biobanks like the U.K.’s CryoArks can save threatened species, help scientists understand the genetic structures and biochemical processes that allow plants and animals to thrive in their environments, and even bring extinct animals back to life. In 2016, for instance, scientists successfully reintroduced the scimitar-horned oryx into the plateaus of Chad 23 years after the animal had been declared extinct in the wild. Using DSI, scientists in sub-Saharan Africa have cultivated strains of cassava that are more resilient to pests and climate change and preserved thousands of varieties of apples and hundreds of varieties of rice that are at risk of extinction. In late 2010, the chemotherapy drug eribulin, derived from Japanese sea sponges, was harnessed for treating breast cancer.
Analyzing just a handful of genetic sequences so they can be of use, however, can take a decade. This means that the power and money lie not in an individual sequence, but in control over bodies of information.
“The value is in the collection of data,” explained Marcel Jaspars, chair of chemistry at the University of Aberdeen and former scientific project leader of the international marine drug consortium PharmaSea. “There is no value in a single sequence, unless you do a ton of work, or you’ve got the database.”
“There is no value in a single sequence.”
Currently, the world’s database network is a patchwork of public and privately-owned gene banks connected over the cloud. These include big pharma databases like Regeneron’s, public-private medical biobanks like Finland’s FinnGen, and the U.K.’s nonprofit Biobank. Zoologists from around the world contribute to the Catalogue of Life, which collects data on all living beings on the planet, from wasps and jellyfish to ginkgo trees and stony corals. There are also pharmacology databases like the Danish Medicinal Plant Biobank, animal biobanks like the Frozen Ark, and even consumer DNA collections like AncestryDNA.
Among the world’s largest genetics databases is the International Nucleotide Sequence Database Collaboration, an open-access collaboration between GenBank in the U.S., the European Nucleotide Archive and the DNA Data Bank of Japan. The INSDC dominates because of its size; in 2020, it totalled more than 9 petabytes of sequence data, storage equivalent to 1.9 billion MP3 songs. At the start of 2024, GenBank housed over 3.7 billion nucleotide sequences for over half a million species, and its collection of data doubles approximately every 18 months.
The expense of maintaining large-scale genebanks has left control over data infrastructure and data policy in the court of developed countries. Operating the INSDC, for instance, is estimated to cost $50-60 million annually.
To share the wealth — and costs of storing — so much data, developing countries have proposed a clearinghouse under the administration of the CBD from which DSI could be licensed to other databases. From this central hub, the CBD could ensure that there is accountability for compliance with global and national legislation around access to and benefit-sharing of DSI. Lim, of TWN, explained that if delegates approve a DSI clearinghouse, it would be funded through state contributions to the CBD.
The implementation of national laws around ethical sourcing and use is up to individual countries to develop, but proponents are arguing for global standards in the event that a clearinghouse is developed.
These would include tracking resource origins with geolocation metadata to identify not only a country of origin but also whether a genetic resource was obtained from a sovereign Indigenous territory. And they’re calling for certificates or digital permits to prove that genetic data was ethically sourced and that benefit sharing agreements were fulfilled. These labeling standards are still new, however. The INSDC only introduced minimum standards for citing a sequence’s location, date and time of collection this spring.
“It’s actually not about centralizing [the data],” Ramakrishnan explained. “It’s about having a clear discipline about where scientists upload sequences at the first instance. Right now, it’s complete anarchy, you do whatever you want.”
Today, the Nagoya and Cartagena Protocol on Biosafety govern the use and trade of genetic materials and living modified organisms. But the scope of each protocol’s protections is limited, and questions over key issues — like determining ownership of a genetic resource discovered outside its country of origin — have yet to be settled. To further complicate matters, powerful nations like Canada and the U.S. have not signed onto these international agreements, and neither protocol specifically relates to DSI. They are instead limited to physical genetic resources and the products of synthetic sequencing.
The existing loosely regulated and privately managed system may not be perfect, but delegates from countries including Norway, Japan and the U.S. aren’t sold on the idea of a new DSI clearinghouse that carries more restrictions than most open-source databases already in use.
The DSI Scientific Network, a global network with 90 members from 27 countries who use DSI in academic research, has argued that developing a new system would be too expensive and challenging to regulate. Members like Amber Scholz, head of the Science Policy Department at the Leibniz Institute, have also criticized the proposal for introducing policing measures into databases or the DSI multilateral mechanism, instead of keeping compliance with national access and benefit-sharing instruments established by the Nagoya protocol.
“Right now, it’s complete anarchy.”
While otherwise vocally opposed to introducing a new database, the DSI Scientific Network ultimately stated its support for a clearinghouse mechanism. Still, it worries that tighter regulations could undermine the goal of improving accountability. While not aligned with developing countries’ vision for a CBD clearinghouse, the DSI Scientific Network has argued for the creation of a single depository for DSI and the harmonization of regulations across different U.N. fora, like the World Health Organization and Food and Agriculture Organization.
In an interview with “Science” before COP15, Scholz raised concerns that licensing that links access to DSI with obligatory benefit-sharing agreements could splinter the current system of sequencing data. Data that is not linked to benefit-sharing agreements would be left out of some genebanks, she explained.
The DSI Scientific Network has further argued that a licensing system could create a “marketplace” in which some DSI is more economically attractive than others, because each country would set its own rules. Whereas companies are currently skirting benefit-sharing obligations governed by the Nagoya protocol by turning to DSI, licensing might push them to shop around for DSI that is not attached to national benefit-sharing obligations, again depriving countries or communities of origin of any benefits.
Putting licensing and regulation in the hands of origin countries may help assert national sovereignty over DSI and curb corporate abuse, but critics warn it could also limit availability to researchers trying to act quickly in global crises like epidemics. For instance, respondents to a 2023 study on pathogen access claimed that Mpox samples held at a European biobank were inaccessible because a national authority “never responded to a request for permit.”
The Nagoya Protocol has proven particularly controversial in how it links benefit-sharing and state sovereignty. While it protects the rights of Indigenous communities to assert sovereignty over DSI, the protocol also enables states to draw territorial borders and restrict access around genetic resources, turning DNA and rNA into commodities like fossil fuels and critical metals. The dangers of this nationalization and commodification became apparent during the 2005 to 2007 avian influenza outbreak, when Indonesia claimed sovereignty over the lethal strain of the influenza virus and restricted access to H5N1 samples.
The rationale, published by four Indonesian scientists and officials, including then Health Minister Siti Fadilah Supari, in the June 2008 issue of “Annals Academy of Medicine Singapore,” was that Indonesian H5N1 samples had been analyzed without notification or permission from Indonesia. As the WHO tried to wrest back global access to virus samples, Supari criticized the commercial vaccine development model for allowing private companies to benefit from virus information freely shared by developing countries through the WHO, while origin countries were unlikely to receive vaccines and other resulting benefits of pathogen research.
The future of the financialization of digital sequencing information and genetic resources is still being written. At COP15 held in Montréal in 2022, delegates called for the creation of a fund for sharing profits derived from the use of DSI. The intention is to inject funding from the DSI fund into global efforts to halt and reverse biodiversity loss. However, countries and corporate lobbies, including the Japan Bioindustry Association, the International Federation of Pharmaceutical Manufacturers and Associations and the Consultative Group on International Agricultural Research, are still divided over how funds from the use of DSI will be shared and who will be obligated to contribute to the fund.
Headed by Senegal, African countries have argued for obligatory state contribution to the DSI fund and a 1% levy on all global retail sales of “products using biodiversity,” such as cosmetics and pharmaceuticals that were produced through the use of genetic sequences.
“We haven’t had the means to control access [to genetic resources],” said Moumouni Ouedraogo, CBD delegate from Burkina Faso’s Ministry of the Environment. Emphasizing that negotiations have often been derailed by developed countries, he told Truthdig that “Because of this, whether or not it’s a private sector enterprise, we want all users to be implicated in the benefit-sharing mechanism.”
Nations including Japan and Norway, however, don’t want to be obligated to pay into the DSI fund and are instead calling for it to depend on the private sector and corporate philanthropy from foundations like the Bezos Earth Fund.
This would leave the world’s largest biotech companies footing the bill for the DSI fund and effectively controlling global genetic resources. Global chemical and pharmaceutical giants like BASF, the Japan Bioindustry Association, Monsanto, Nova and Syngenta are among the world’s largest users of DSI, and have been closely following the CBD’s biodiversity negotiations under the umbrella of the ICC International Chamber of Commerce. Fearing the implications of outsized influence over genetic resources, India argued this year during a CBD working group on benefit-sharing meeting in Montréal that contributors to the fund should have “no role to play in the governance or distribution of funds irrespective of the size of the contribution.”
At the same meeting, the Japan Bioindustry Association expressed opposition to a levy proposed by African countries, arguing that the expense would deter companies from DSI-related commercial development. Cuts into profits could prove to be significant: The global market for products derived from genetic resources is estimated to be worth between $500 and $800 billion USD, up to roughly six times that of the EV battery market. Countries are also divided over how to distribute money from the benefit-sharing mechanism. Some, like Switzerland, have supported project-based funding to ensure that DSI funds “have a positive impact on biodiversity.”
Others, like Brazil, have argued funding should be allocated directly to countries and used at their discretion. Developing countries like Malawi support this proposal and have argued that disbursements should be made based on the “level of development of a country, fairness and equity.”
The decision could determine whether DSI and physical genetic resources collected for conservation purposes may be turned into a revenue stream for the industries that have contributed the most to biodiversity loss and environmental degradation while committing human rights violations against environmental defenders. Direct allocation from the DSI fund can give agency to developing nations and Indigenous communities to determine their own development priorities. But this can also backfire if money from genetic sequencing is given to countries that use it to prop up sectors like fossil fuel and rare earth extraction, rather than putting it back into conservation.
Little has changed since Regeneron’s exploitation of the West African Ebola outbreak. In August, the WHO declared an Mpox outbreak across East Africa to be a global health emergency as cases spread out of eastern DRC to neighboring Burundi, Kenya, Rwanda and Uganda. Despite a more virulent and deadlier strain of Mpox currently circulating in eastern DRC, vaccine delivery has been delayed. Meanwhile, developed countries including the U.S. and Canada have been accused of hoarding vaccines.
With much fanfare in June 2022, the WHO created a vaccine-sharing mechanism to stop an earlier wave of the Mpox outbreak in Europe and North America. But this initiative was not introduced to African countries where diseases are endemic and compounding humanitarian crises have devastated medical infrastructure. African countries currently produce less than 2% of vaccines used on the continent. Meanwhile, Danish company Bavarian Nordic flaunts the capacity to provide 10 million doses of the JYNNEOS Mpox vaccine to the Africa Centre for Disease Control by the end of 2025.
Over 720 people have died of Mpox in the DRC alone since the start of 2023. And while the DRC is on track to receive around 200,000 doses, the Africa CDC has said the cost of $100 per dose for this life-saving vaccine and the $4 billion cost of fighting Mpox is prohibitive.
In anticipation of COP16, 65 civil society groups released a letter to the CBD in August. International food sovereignty groups, human rights groups, as well as intellectual property rights and public health equity groups joined in calling out neocolonial practices in DSI access and benefit-sharing as inconsistent with the CBD, the Nagoya Protocol and the UNESCO Recommendation on Open Science.
Whatever is decided in Cali, the regulations being proposed for benefit-sharing from the use of DSI are not legally binding —unlike the Cartagena and Nagoya Protocols, and international treaties on plant genetic resources or marine biodiversity. Calling out this failure, signatories to the letter have criticized the CBD for perpetuating “inequitable and inaccessible practices.”
“It was a mistake in the beginning to not go for a treaty,” said Meyer, of the GIZ. The CBD expected public pressure from groups like Greenpeace to make companies pay, “but I don’t see public pressure here. Even at the Nagoya negotiations [in the early 2000s], civil society organizations faded out and were not interested.”
“It was a mistake in the beginning to not go for a treaty.”
Why? Meyer couldn’t point to a single reason for the lack of public engagement and advocacy during the early years of developing genomics regulation. What is certain is that the political economies of the bioinformatics structures that underpin more commonly known social issues around genetically modified foods and wild release of patented mosquitos, for example, have largely remained opaque to the general public.
Exploitative models already in play at the WHO have long empowered corporate abuse of open access data and thriving biotech industries in developed countries to the detriment of poorer nations and vulnerable communities on the frontlines of biodiversity loss. Developing countries and human rights watchdogs are now looking at policy developments at the CBD with concern, as they don’t want to see weak regulation on conservation genomics enable further corporate exploitation in other sectors that use DSI ostensibly gathered for the purposes of preserving the planet’s biodiversity.
This month in Cali, world leaders have the opportunity to take a strong stance on global equity and corporate accountability in access and benefit-sharing of digital sequencing information, but will it be enough?
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