gut feeling Who gets ownership of useful genetic data? Digital sequence information alters how researchers look at the worlds genetic resources. Peter Andrey Smith, Undark Mar 6, 2025 10:38 am | 9 Credit: NurPhoto via Getty Credit: NurPhoto via Getty Story textSizeSmallStandardLargeWidth *StandardWideLinksStandardOrange* Subscribers only Learn moreCow D lived on a dairy farm in New Zealand. The animal looked like the typical black-and-white cow farmers raise for milk, except for one thing: Researchers had outfitted Cow D with an artificial fistulaa hole offering them a way to reach the microbes inhabiting the animals bathtub-size stomach. But its what happened next that offers a porthole into the global debate over the use of genetic data.In the spring of 2009, Samantha Noel, then a doctoral researcher at Massey University in Palmerston North, New Zealand, reached into Cow Ds rumen and plucked out a strain of Lachnospiraceae bacterium, later dubbed ND2006. Another team of geneticists sequenced the microbes complete set of genes, or genome, and uploaded the information, which was then shared with GenBank, a public database run by the US National Institutes of Health. If genes are the book of life, then this process was like adding a digital copy to an online library. In policy circles, these lines of code go by another name: digital sequence information, or DSI.Eventually, a section of the sequence found inside Cow D caught the attention of scientists on the other side of the world. The sequence contained a promising new genetic tool for modifying DNA, a CRISPR. Editas Medicine, a Massachusetts-based company focused on commercializing gene-editing technology for medical applications, used these data to build its platform and now holds the license on a portfolio of patentsall without ever interacting with the cow or its microbes directly. The company subsequently developed an experimental therapy, which involved injecting a modified CRISPR-associated molecule into patients eyeballs to treat a common form of inherited blindness. Editas billed the breakthrough as the first such treatment administered to people anywhere in the world. The results, published in the New England Journal of Medicine, contain little mention of any sequence data and even less about its origins.These origins also arent mentioned in conjunction with other products, including a commercially synthesized enzyme identified as Lb ND2006, 5 milligrams of which sells for $8,695. When Undark first contacted Noel, now an associate professor in the Department of Animal and Veterinary Sciences at Aarhus University in Denmark, she wrote back to say she had no idea: No one has ever contacted me about CRISPR before.CRISPR provides one example of how biotechnology comes about through efforts to understand biodiversity. The research also illustrates how computation has become fundamental to biology: Algorithms and search tools allow scientists to comb through digital databases, and that data is what powers artificial intelligence programs, like AlphaFold2, the Nobel-prize winning model that predicts protein structures. Its being used everywhere, said Margo Bagley, a former chemical engineer who is now an Asa Griggs Candler professor of law at Emory University School of Law. People just go to the databases.But these data still come from organisms, and these organisms come from somewhere. Add politics and policies to the equation, and questions around the use of DSI become a volatile mix. The question is not: Who owns life? The Biodiversity Convention, a UN treaty, resolved that, landing on the agreement that countries own genetic resources that are found within their borders. Rather, the question over DSI concerns the fine line between use and misuse: How should humanity share the worlds genetic data, keeping resources accessible while also ensuring a fair share from any profit? Some refer to the search for new and useful products in nature as bioprospecting. Others see a more parasitic framework and contend that profiting off biodiversity without paying back royalties is a form of theft, like stealing precious resources without paying the locals a dime. Theres even a pejorative term for it: biopiracy.Regardless of these varying perspectives, one thing is clear: The existing legal framework was not designed for the digital age. And although international negotiators wrangled over DSI for many years, they reached a consensus that left its use in a gray zone. When you have a lack of legal certainty, then folks tend to try to avoid it, Bagley said. That's not necessarily good for society as a whole because there's still so much biodiversity that has not been analyzed that could hold the key to cures for diseases, et cetera. So we want to find a way to justly and fairly have access to that in a way that has low transaction costsa way that everyone benefits from.And so, despite the routine use of DSI, the parties involved in the international negotiations have yet to figure out a fair and equitable exchange. Technical details aside, another factor complicates everything: Underlying the contemporary debate is the contested history of colonial powers extracting materials, often in an exploitative manner. Where some see an altruistic search for scientific knowledge, others see a pattern of unbridled greed.Early antibioticsIn 1948, the Rev. William W. Conley set off on a mission in Indonesia, collecting specimens for the US drug company Eli Lilly and Co. Conley and his colleagues eventually mailed back a vial of soil, which contained the bacteria used to develop the antibiotic vancomycin. According to one account, the company donated $1,000 to the Christian and Missionary Alliance. (The drug generates just under $400 million annually.)Similarly, erythromycin, an antibiotic commonly smeared into the eyes of newborns in the US, comes with a contested backstory: The Philippines maintains that the drug came from samples collected in the country under false premises. Over the last century, other alleged examples of commercialization without consent emerged, too. W.R. Grace, a US chemical company, tried to patent biopesticides from neem trees traditionally used in India and Nepal; a dietary product sold by the British company Phytopharm and the multinational firm Unilever came from the hoodia plant, which had a history of use among the tribesmen of the Kalahari; captopril, a drug marketed by E.R Squibb & Sons (now known as Bristol Myers Squibb), came from the venom of a Brazilian viper.Until 1992, bioprospecting went largely unregulated. That year, the Biodiversity Convention convened in Rio de Janeiro, laying the groundwork for whats become known as the Nagoya Protocol for access and benefit-sharing. The protocol covers all plant, microbial, and animal material (excluding genetic material from humans). Its roughly analogous to a mining permit: Researchers obtain permission from the providers and agree to share the profit should they extract something of value. Notably, the US is the only United Nations member state not to have ratified the agreement.In 2002, as discussions for the protocol were still underway, negotiators created a set of non-binding benefit-sharing guidelines and tried to assist countries in setting up agreements. Nobody implemented them, said Bart Van Vooren, a Brussels attorney who specializes in life sciences. Then there was a push to negotiate the Nagoya Protocol, he added. Negotiators rarely said so bluntly, in his view, but the onerous agreements undermined the entire premise of benefit sharing. Because the compliance cost is so high, very few get permits, he said. Its very hard.More recently, advances in gene sequencing created a digital loophole. Instead of sending an emissary to scoop up soil in another country, researchers could just trawl through genetic information freely posted online, find what they wanted, and synthesize the genetic material in the labwithout needing a passport or a permit. Some believed that DSI fell under the Nagoya Protocol and that the definition of genetic resources included physical samples and digital representations. Others felt digital copies were intangible and therefore excluded. When negotiations resumed in 2016, discussions got off to a rocky start. One group of researchers wrote a letter claiming that if DSI were put into existing protocols, it would hamstring scientists. According to sources who attended the meetings, both sides would trade barbed insults; one representative reportedly compared the illicit sharing of genetic information to child sexual abuse images.In mid-2024, as the talks inched closer to an agreement, negotiators met in Montral. At the meeting, according to Michael Halewood at CGIAR, a global partnership researching food security, everybody involved in this process got educated and got a better understanding of what DSI is and how its used. With a clearer definition in place, negotiators floated the idea of a mandatory fund: Countries would make companies using DSI pay up. But the proposal did not go over well with everyone. After the meeting, the International Federation of Pharmaceutical Manufacturers and Associations issued a statement saying its members had serious concerns about the lack of clarity, which, the association said, would be detrimental to innovation.Then, in October of 2024, at a summit in Cal, Colombia, delegates agreed to establish a voluntary fund. Businesses that profit from biodiversity, such as pharmaceutical and biotechnology companies, the agreement said, should contribute 1 percent of their profits (or 0.1 percent of their revenue) to the newly established Cal fund, which could raise an estimated $1 billion annually for conservation. Public institutions are exempt and contribute as-yet-undefined non-monetary benefits should they develop products using DSI.Where some saw an imperfect compromise, other attendees apparently left the talks in disgust. In published reports, for instance, Sajeewa Chamikara, an environmental activist in Sri Lanka, referred to the agreement as digital colonialism and legalized robbery.Biopiracy?Are these concerns about DSI mostly hypothetical? Some say yes; others say no. Textbook cases of physical biopiracy exist, but a clear case of digital biopiracy is harder to come by. As Halewood put it, Its not like you can just go and say, Oh, I found this golden gene sequence from the single genome that was put up online and become a biopirate, Halewood said. Its never that simple.Even the case of Cow D in New Zealand is not clear cut, and that was exactly the point. Experts that spoke to Undark had a range of perspectives, but many agreed it underscored the complexity and the importance of getting any such policy right.To some observers, CRISPR seemed like a perfect example, since these tools allow researchers to tinker with genetic sequences found all over the world. But the development of new CRISPR tools usually involves the comparison of many sequences and gene-cutting enzymes and synthetic modifications to the sequence. The resulting patents came about from many sources. Rather than stealing from one countrys well, the process drew from a collective pool.In 2024, the DSI Scientific Network, an informal group of scientists that formed to advise the CBD negotiations, wrote a case study on another example: the first vaccines against COVID-19. These shots came about because of the digital availability of copies of SARS-CoV-2 and related viruses that cause respiratory illnesses. Within days of researchers publishing the sequence data online, scientists from the pharmaceutical company Moderna made synthetic copies in the lab. The company eventually patented their resulting vaccines, although the patents drew from many sources, involving 176 genetic strains from a large range of countries. As the case study points out, No single sequence was vital to its work. As such, the authors suggest the use of DSI is a non-issue and further underscored the idea that use involved far more steps and material than a single copy of sequence. The study concludes there would be no obligations associated with the use of any one sequence from any one countryand likely negligible benefits.For her part, Bagley has argued that the use of digital sequence as a workaround is not hypothetical. After the 2014 Ebola outbreak, Regeneron, a New York pharmaceutical company, developed a vaccine; researchers used a strain that had originally been isolated from a surviving patient in Guinea, the West African country, and was provided by the Bernhard Nocht Institute for Tropical Medicine. The institute would have required a licensing agreement for the use of a physical copy of the Ebola virus but had uploaded its sequence to a public databaseessentially with no strings attached. Regeneron had no legal obligations to pay back the patient or the country of origin. (Moreover, Guinea had no relevant national laws of its own.) The company made hundreds of millions of dollars; Guinea got nothing.But the Ebola and COVID-19 examples involve pathogens, which some consider exempt from Nagoya, and such viruses fall under a separate regulatory regime. Similarly, the use of any one sequence can be complicated by multiple agreements made under the auspices of the UN, such as the High Seas Treaty, which pertains to biodiversity beyond national jurisdiction, or the so-called Plant Treaty, which outlines the use of seeds from food crops. Legal observers describe these as lasagna layers of legislation, which pose problems for compliance. It's not that companies don't want to pay, Van Vooren, the Brussels attorney, said. But if you have a pathogen regime, you have a multilateral DSI regime, if you have a national Nagoya Protocol regime, if you have a high seas regime, if you have a plant treaty regime, you've just made a total mess because its one product can trigger five of them.Other fine-grained questions about the implementation of the new Cal fund remain. In an email, Amber Hartman Scholz, a microbiologist and head of the science policy department at the Leibniz Institute DSMZ and a volunteer member of the DSI Scientific Network, listed several: When will the first payments start? Who will take leadership? Governance and/or monitoring of the mechanism is mostly undecided. What counts as a non-monetary benefit? And how will we keep track of these?The consensus-building resulted in a resolution, but the agreement lacked clarity in the one respect that mattered most: Creating legal certainty about the use of DSI.Meanwhile, in Iceland... A Basecamp Research team member in Iceland. In 2019, Oliver Vince and his team collected samples on the ice, sequencing the DNA of previously undescribed microorganisms on portable devices. The trip laid the groundwork for Vince to co-found Basecamp. Credit: Basecamp Research A Basecamp Research team member in Iceland. In 2019, Oliver Vince and his team collected samples on the ice, sequencing the DNA of previously undescribed microorganisms on portable devices. The trip laid the groundwork for Vince to co-found Basecamp. Credit: Basecamp Research There may be another way. In 2019, Oliver Vince, a biomedical engineer in the UK, went to Iceland. His team pulled gear to a base camp at the northern edge of Vatnajkull, Europes largest ice cap mass. The researchers collected samples and sequenced the DNA of previously undescribed microorganisms on portable devices, off the grid.The trip laid the groundwork for Basecamp Research, which Vince co-founded in London and which has raised more than $85 million to date. The company aims to build the worlds largest genetic database. After all, if their researchers could collect data from a remote camp on ice to later upload to a vast database, then people could do the same from anywhere. Users can send genetic sequences to Basecamp, which uses AI models to crunch large sets of biological data; companies and other non-commercial users can leverage this data to design drugs, therapies, and more. If the companies make money, the country of origin of the original sequences receives royalties.According to Vince, the approach solves the practical and pragmatic issues around DSI by offering legal certainty. The other approach of using public databases, he said, mirrors the murkiness around the access to human cell lines. So in human genetics originally, it was a Wild West, right? he said. There were these big open public databases and everyone was just sort of, freely pulled from it, particularly commercial users. Then, obviously, loads of rules came in and now it's absolutely impossible to share data without permission, without consent, without paying back, with all those sorts of protocols around it, which makes sense. The DSI agreement in Cal, he said, showed the same was becoming true with biodiversity data.He also saw a lack of incentive for people to participate by uploading dataand more data was a requirement for the whole system to work well. What you find when you actually go out there and you talk to people all over the world is there are people who are both interested and capable of learning these techniques, he said, who want to study the biodiversity, who are motivated to do so, but for whom there isn't a purpose to do it. There isnt someone willing to support that.To that end, Basecamp Research has partners in 25 countries, including nonprofits and academic centers like the Scripps Institution of Oceanography in California. In exchange for sending data, the providers got data that could, among other potential applications, be used for biodiversity monitoring. Nobody objected to paying back, he said, now that there was a tight agreement in terms of traceability and legal clarity.Among the companys headline partnerships is the David Liu lab. Liu, director of the Merkin Institute for Transformative Technologies in Healthcare at the Broad Institute of MIT and Harvard, co-founded Editas Medicine. The basis for one of Editas products, according to the published scientific literature, had first been identified in a public database, including the microbe found inside Cow D. (Liu did not respond to a request for comment.)The path to Editas discovery from Cow D wasn't just a simple, single step. Rather, it involved many incremental achievements, underscoring the difficulty of assigning value to a snippet of a genetic sequence, an organism, or a single researchers hand plunged into a steaming hot rumen. Moreover, as one DSI Scientific Network volunteer member, Andrew Hufton, described it, patents cover the use of DSI for a specific application. Unlike the physical world, where mining exhausts the resource, data mining in computational biology does not prevent someone else from coming along and using those same genetic sequences. When it came to the use of the CRISPR found in Cow Ds microbes, Hufton said, Editas patents did not prevent someone else from finding commercial applications in the same or very similar genetic sequences, which almost certainly exist elsewhere. When you patent scissors, he added, you arent stopping everyone else from using sharp edges.Seen this way, the cow-to-CRISPR pipeline appeared to be a perfect example of DSI. While Western scientists saw the collaborative use of data as a largely unremarkable altruistic search for scientific knowledge, others saw the potential for exploitation.The need for reparations, paying back for the wrongdoing of the past, had been made explicit during the recent international negotiations. The agreements made under the Biodiversity Convention aimed for true collaboration and attempted to build toward a common goal: The common good. But, so far, in Halewoods view, the implementation missed the mark. It just hasn't been allowed to work, he said. So we keep repackaging it, we keep running at it. Again, DSI created a wonderful opportunity to create something broad and flat that cut across the sectoral divides.The latest round of negotiations seemed poised to simplify DSI. And yet we seem to have maybe not quite got over the line again, Halewood added. Maybe companies will come forward and make payments, but we'll know in a couple of years.This article was originally published on Undark. Read the original article.Peter Andrey Smith, UndarkPeter Andrey Smith, Undark 9 Comments