The extremely messy, profoundly confusing fight over who should profit from animal DNA --[Reported by Umva mag]

Stuck to rocks, shells, and piers in oceans around the world is a strange little creature called a sea squirt. It resembles a squishy potato and has two valves poking out, which it uses to suck in and expel seawater.

Sea squirts are special for a few reasons. They tend to shoot water out of their valves when you squeeze them. And like oysters and clams, they filter ocean water, helping keep it clean. They also produce chemical compounds to defend themselves that are known to damage cancer cells. Scientists have used those compounds to develop drugs for patients with certain kinds of cancer. 

Sea squirts are among an endless list of animals, plants, and microbes that stand to improve human lives. 

Researchers estimate that an astonishing 70 percent of antibiotics and cancer treatments in use today are rooted in natural organisms, from plants to snakes to sea sponges. The first medication to treat HIV came from a Caribbean sea sponge. The cosmetic drug Botox is derived from a bacterium. The enzyme used to stonewash jeans was originally derived from wild microbes in salt lakes in Kenya. 

Collectively, these natural derivatives — and the profits they generate — are considered the benefits of a planet with healthy biodiversity. And maintaining these benefits is a key justification for protecting nature: It can literally save our lives. But a key question that has long been a source of division among global conservation leaders is who, exactly, should reap those biodiversity benefits.

There’s a long history of what some advocates and researchers call biopiracy. It typically refers to when companies take organisms from poor nations and Indigenous communities, such as medicinal plants, and use them to develop commercial products, failing to share the benefits back with them. Those benefits include things like money but also access to those products and research results.

Until recently, the solution to exploitative innovation was, at least in theory, relatively straightforward. Under a United Nations treaty called the Convention on Biological Diversity (CBD), countries can require that foreign researchers sign benefit-sharing agreements before granting them permission to retrieve wild organisms. Essentially, under those agreements, you can’t walk out of a country with medicinal plants without first agreeing on how you’ll compensate that country and its people.

But there’s an enormous loophole to this approach that keeps getting bigger. 

Major advances in biotechnologies have made it easier to sequence and analyze DNA. Now, researchers and companies no longer rely only on physical samples to make stuff derived from biodiversity. They increasingly make products — drugs, vaccines, better crops, and so on — using DNA and RNA sequences, or other genetic data.

This digital biodiversity data, referred to by the arcane term digital sequence information, or DSI, is found abundantly in scientific databases that are free for anyone to use. And it’s not regulated by the CBD treaty. That means industries can create vaccines and other commercial products using DSI without sharing the benefits from those products — the benefits of biodiversity — with whatever country or local community the sequence information originates from. It’s kind of like what platforms like Napster did to the music industry: Instead of having to buy CDs from stores and funneling money to musicians, once music was digitized, you could eventually stream unlimited music online for free.

If you find DSI confusing, that’s because it is. 

Experts who have been debating for years about how to regulate DSI don’t even agree on how to define the term. Does it cover just DNA and RNA sequences? Would it also include 3D images of proteins and epigenetic data (i.e., changes to how genes are expressed)? They also don’t agree on how benefit sharing should work. Some countries, especially those with smaller economies, want genetic information tracked from its place of origin all the way to the final products. Others say that’s essentially impossible.

This debate will come to a head this October in the Colombian city of Cali. Countries that are party to CBD — which notably does not include the US, in part because conservative lawmakers tend to dislike global treaties — will convene for their biannual meeting to discuss global conservation issues. One of their main goals this year, at what will be known as COP16 — but not that COP — is to hammer out a plan to bring more accountability to the use of DSI around the world. 

On one hand, such a plan seems impossible to put in place. Companies hold a tremendous amount of power and typically want fewer regulations, not more. But it could also be a massive opportunity. If developed nations and industries shared some of the money and knowledge that is derived from digital biodiversity data, it could be used to conserve nature in the places where it is most vital — and most at risk.

Who benefits from nature?

The debate and tensions around DSI are rooted in inequality. Put simply, rich nations have loads of scientific resources, whereas many poorer nations have loads of less-explored biodiversity. And up until now, the relationship between the two groups has been lopsided. 

Decades ago, a US pharmaceutical company developed anticancer drugs with the help of a plant from Madagascar called the rosy periwinkle; the company didn’t share its profits with the people of Madagascar. You can find similar stories with the antifungal spray Neemax, derived from a tree in India, and muscle relaxants made with compounds from curare, a group of poisonous plants from the Amazon.  

“Scientists from the global north have frequently extracted data and samples from the Global South without the permission of the people there, without collaborating meaningfully — if at all — with local scientists, and without providing any benefit to the countries where they conduct their work,” a team of researchers wrote earlier this year. 

Global environmental leaders recognized this problem decades ago. When they established the Convention on Biological Diversity in 1992, still the world’s most important biodiversity agreement, they made benefit-sharing one of three main goals of the treaty, along with conserving biodiversity and using it sustainably. Under the agreement, benefits derived from plants and animals should, at a minimum, be shared with the countries and local communities where that biodiversity is found — and especially with the groups who have safeguarded it, such as Indigenous communities.

Nearly two decades later, CBD made the requirements around benefit-sharing more concrete and enforceable through an agreement called the Nagoya Protocol, named after the Japanese city where it was adopted. The agreement essentially affirms that countries have the legal right to regulate access to physical plants, animals, and other elements of biodiversity within their borders. All countries are also supposed to make sure that any bits of biodiversity they — or their companies — use that come from other nations are collected with the consent of that country. 

The Protocol has, at best, a mixed record. Middle-income nations, like Brazil, or those with a lot of donor support, have established systems that work. In many poorer nations, however, access is still poorly regulated or unregulated. In general, very little money has flowed into countries via the Nagoya Protocol, said Marcel Jaspars, a professor at the University of Aberdeen and a leading expert on DSI in the Global North.

DSI only adds to these benefit-sharing woes. When environmental leaders crafted the CBD and the Nagoya Protocol, digital biodiversity data wasn’t as easily accessible or as useful as it is today; these agreements don’t even mention DSI. It’s widely understood that CBD and the Protocol only pertain to physical materials — microbes, plants, compounds from a sea squirt — not genetic sequences. That leaves the use of DSI, now a massive source of scientific innovation, largely unregulated. 

What DSI is and how it works

DSI is one of the most confusing concepts in the environmental world, which is already racked with confusing terminology and technical jargon. Here’s the gist: After researchers collect plants, animals, and other organisms, they commonly sequence their DNA, or part of it, and upload that information to a database. The largest global collection of DNA and RNA sequences — which is the subject of much of these discussions — is (take a breath) the International Nucleotide Sequence Database Collaboration. It houses billions of genetic sequences and is free for anyone to use. Downloading the data and using it to develop commercial products does not trigger the legal obligations under CBD that harnessing a biological sample would. You’re basically harvesting information from a computer instead of from the environment.

Scientists use DSI for a mind-bending array of projects. Consider the Moderna Covid-19 vaccine. The company used nearly 300 genetic sequences, according to the patent, many of which were drawn from open-access databases, to produce the shot (which the company was able to design in just two days).

Researchers also use DSI to figure out how unique a particular genetic sequence might be, or what it might do — as in, what physical trait it might be linked to. This is incredibly valuable for the biotech and agriculture industries. A seed company, for example, might have a crop that appears more drought tolerant in their private collection. They can sequence the plant’s DNA and cross-reference its genetic information with online databases. Those databases often list information about the role of different sequences. Ultimately, this can help the company identify which particular sections of the plant genome might be associated with an ability to survive droughts, a valuable trait. Artificial intelligence, including projects like Google’s AlphaFold, makes these sorts of predictions even easier.

Conservation scientists also benefit from DSI in a big way. They increasingly rely on an approach called environmental DNA (eDNA) to catalog what species live in a particular area, such as a stream or the forest floor. Researchers will gather samples of water or soil and filter out bits of DNA that were shed by animals or microbes into the environment. Then they’ll look for a direct match with those sequences in open-access databases, revealing what those animals are. If the species are rare or otherwise considered important, this information could, say, help justify protecting habitat. 

This is to say: DSI is useful! There’s a good reason it’s open to everyone. It both enables and speeds up research, some of which is literally life-saving. At the same time, it maintains inequities and furthers exploitation when the people who prosper from it are largely in wealthy economies (a problem that’s especially pronounced and worrying when it comes to developing vaccines.)

“DSI makes it possible to get all kinds of commercial advantages,” said Michael Halewood, an expert in genetic resource policy at CGIAR, a global agriculture organization. “That creates a big gap that needs to be closed. We all agree on the inequities of the situation. What’s a sensible way to close that gap without undermining science?”

What a plan to regulate DSI might look like

Even as COP16 looms, the debate around DSI is still a mess. There’s a lack of trust between country negotiators, leading to an enormous amount of uncertainty about how this digital data might be regulated on a global scale. 

Consensus has, however, grown around the idea that companies, entire sections of the economy, or perhaps even consumers should pay into a fund that supports conservation and development, especially in the Global South. From there, two big questions rise to the top: Who, exactly, pays to use DSI, and who ultimately receives those payments?

A handful of low- and middle-income countries want what negotiators refer to as a “track and trace” system. That would entail tracing genetic sequences, i.e., DSI, from open-access databases to specific products, such as medicines or drought-tolerant crops, that generate value. So if a company in Europe makes a drug using DNA from a sea squirt found in, say, Panama, it would have to share benefits from that drug — money and also access to the drug itself, perhaps — back with the Panamanian people.

Many academic researchers and developed countries call this a nonstarter. The chain of development for drugs and other products is long and tangled and relies on hundreds if not thousands of individual sequences. Even if it’s clear that an end product is based on a specific bit of genetic code, the research process to find that sequence — which could involve scientists across dozens of institutions, all using their own bits of DNA — relies on sifting through unimaginable amounts of genetic material. That makes it hard to determine who, exactly, should receive the benefits. Plus, many of the sequences in global databases don’t come with location information; geotagging wasn’t required until somewhat recently. That makes it even harder to direct benefits to a specific country. 

Scientists also fear that a complex tracking system would slow the pace of innovation, and be incredibly expensive to operate. “By making track and trace a necessity, the system will cost more than it generates, almost certainly,” Jaspars said.

Many of the groups who oppose a track and trace approach, including many developed economies and academic scientists, prefer what they describe as a “sector” approach. This would require companies in sectors of the economy that are highly dependent on DSI — such as agriculture and pharmaceuticals — to put a small percentage of their profits or sales (or other measure of value) into a DSI fund. That money would likely be dished out to countries or specific projects for the benefit of conservation and human development.

Proponents of this approach argue that it would allow money from DSI to flow quickly; it wouldn’t be contingent on companies profiting from specific DSI-based products. It’s also simpler because it doesn’t involve tracking sequences. 

While this sector approach has a lot of support from scientists and rich countries, it’s still not clear how to determine which industry sectors, or parts of sectors, would need to pay up.

The corporate world, meanwhile, has serious concerns about requiring payments from broad sectors of the economy, according to Daphne Yong-D’Hervé, who leads global policy at the International Chamber of Commerce. Different companies use vastly different quantities of DSI, she said. And generally speaking, trying to regulate DSI as separate from physical materials is problematic, Yong-D’Hervé said. Organisms and their genetic sequences are often used collectively during R&D. 

Ultimately, she said, what corporations want is a simple, unified system to use DSI and physical materials that gives them a license to operate worldwide. Without paying too much, of course.

“Businesses support the principle of benefit sharing, but this has to be implemented in a way which is aligned with scientific and business realities, is simple, and does not discourage investments in research and innovation,” Yong-D’Hervé told Vox.

Then there are some wealthy countries, such as Japan and Switzerland, that seem to be in favor of the status quo. They prefer a deal that encourages companies that actively use digital biodiversity data to contribute to a DSI fund, but without the legal obligation to do so. 

But advocates for lower-income countries say this, too, would be a nonstarter — a continuation of exploitation. 

“We are asking for accountability,” said Nithin Ramakrishnan, a senior researcher at Third World Network (TWN), a group that advocates for human rights and benefit sharing. To TWN, Ramakrishnan says, the priority is getting an agreement that makes sharing benefits from DSI mandatory.  

Will this ultimately help biodiversity?

None of these proposals are perfect, and they represent only a handful of the issues pertaining to DSI that countries disagree on.

There are questions about sharing benefits other than money and access to drugs, such as lab equipment. Some researchers and advocates are also concerned about who will manage the DSI fund and about the databases that store genetic data. The big databases are largely hosted by organizations in developed nations, so poorer countries have little control over how they operate, Ramakrishnan said. 

Making everything more complicated is the reality that there are other international treaties — including those pertaining to crops and the high seas — that are also trying to figure out how to manage access to DSI. Regulating genetic data on a global scale will likely only work if all of these treaties are aligned and define DSI in the same way. 

And even if countries come to an agreement, it’s not clear they’ll be able to enforce it at the national level. (This is a problem for other international agreements. The 2015 Paris Accord, for example, lacks teeth because it doesn’t have a strong enforcement mechanism). Can environmental officials get entire corporate sectors to pay up? In some countries, these payments might also require governmental approval. 

Also not helping: The US, the world’s premier scientific power, is not a party to CBD, so it wouldn’t be bound by any framework that officials finalize in Cali. (However, some of the big US pharmaceutical companies have told Jaspars they are “open to sharing benefits.”)

So yes, crafting an effective plan will not be easy. Then again, the payoff of such a system could be huge — it could be lifesaving. 

Researchers estimate that the gap in funding for biodiversity conservation globally is somewhere around $700 billion a year; that’s a key reason why biodiversity is in peril. And critically, any payments for using DSI could help close that gap, especially if they’re generated from entire sectors. 

Far more support is needed for things like restoring coral reefs, managing parks, and preventing wildfires, much of which Indigenous groups and local communities have already been doing. These efforts help ensure that biodiversity, and all the secrets it still holds, is left intact. 

“There’s a whole incredible world still to discover,” said Sarah Laird, co-director of People and Plants International, a nonprofit environmental organization. “We know a lot, but there are things we can’t even imagine out there. There are amazing opportunities.”

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