Over the past decade, botanist Pete Lowry has noticed a worrying trend in his field. An expert on the Sciodaphyllum (formerly Schefflera) genus of neotropical plants, he used to have a relatively easy time doing fieldwork abroad, he says. Now, however, he and his colleagues at the Missouri Botanical Garden face a mountain of logistical hurdles to gain permission to work in the various countries they want to visit, let alone bring samples back home with them.
For example, although one of Lowry’s study species, S. patulum, extends from southeastern Ecuador through Peru and into Bolivia, he says he often has to limit the scope of his research to a single country to avoid engaging in the time-consuming and costly process of obtaining permits in each. It’s frustrating, he says, because “with the exception of islands and locally endemic species, species don’t know border limits. [They] occur wherever they occur.”
The cause of this red tape can be traced back, perhaps surprisingly, to a 1993 international treaty known as the Convention on Biological Diversity (CBD). Responding to alarm over staggering declines in biodiversity in the 1980s because of human activities, the CBD enshrined for the first time in international law the idea that the conservation of biodiversity is “a common concern of humankind.”
Aware of the effects of colonialism—which has robbed biodiverse territories of their resources, and indigenous peoples of their traditional knowledge—the framers of the convention went further by calling for the fair and equitable sharing of benefits arising from genetic resources, which they defined as biological material such as seeds or specimens that contains genes and/or metabolic material derived from genes. After decades of intense negotiations among diplomats, this latter goal was codified in 2010 in the Nagoya Protocol, a multilateral treaty with 128 parties that set obligations for countries to regulate access to their genetic resources and to ensure the consent of, and sharing of benefits with, indigenous communities whose traditional knowledge often identified the potential of those resources.
Researchers who spoke to The Scientist agree that, since it came into effect in 2014, the Nagoya Protocol has achieved some of its intended effects—in particular, fostering collaborations between foreign and local scientists. But they also say that the protocol has had damaging, unintended consequences, including a wave of protectionism by governments worried about potential exploitation by foreign interests; a complicated patchwork of regulations that differ by country; and a decrease in research in some of the most biodiverse areas of the world—effects that Lowry says run counter to the CBD’s foundational goal to conserve biodiversity.
Now, as the Nagoya Protocol’s signatories discuss the expansion of the agreement to include protections for digital sequence information—a much-debated term that has been used to describe DNA, RNA, and other data on an organism’s gene transcription and metabolites—researchers worry that further restrictions could smother their research. (See “Pathogens and Digital Sequence Information: Preventing the Next Pandemic” below.)
The current situation is already a lose-lose for researchers, countries, medicine, and conservation, says Duquesne University assistant law professor Aman Gebru, whose research focuses on patent law as it relates to genetic resources. “Scientists lose because they’re not able to innovate,” he says. “Communities lose because maybe the scientists could add something to their knowledge or maybe they could get some royalty fees . . . and of course the public loses because we’re not getting life-saving treatments” discovered through international collaboration.
A patchwork of permits
Luiz Rocha, a curator and chair of ichthyology at the California Academy of Sciences who researches coral reefs throughout the tropics, is unhappily familiar with the burden of applying for permits. To study the population genetics of the fishes Coris gaimard and C. cuvieri, which can be found from South Africa to Hawaii, Rocha and his colleagues spent more than two years obtaining research permits from 17 different countries. His main frustration, he says, is that experience with one country’s system rarely translates to expertise with another. “I never know which branch of the government to approach—if it’s the ministry of fisheries, if it’s the ministry of environment, if it’s the ministry of science—every country is different.”
This problem has arisen because although the Nagoya Protocol cemented the sovereign rights of individual countries to govern their genetic resources, it largely left the implementation to each country, resulting in a lack of standardization in permit application processes, and even in the definition of “genetic resource,” among its signatories . What’s more, there’s no official database listing each country’s restrictions or timeframes for obtaining particular permits, so scientists have for the most part been navigating the process blindly. Indeed, some researchers have instead compiled their own unofficial versions—a blog on the subject by Chris Grinter, an entomologist at the California Academy of Sciences, for example, has become a popular resource for researchers thinking about conducting research abroad.
It’s not just research permits that scientists have to worry about, either. After a research project is complete, many countries, including Rocha’s home country of Brazil, require scientists to apply for an export permit that details each of the specimens being taken, including when, where, and by whom they were collected. “It’s like a nightmare,” says Rocha, who sometimes collects upward of 500 specimens—such as fin clips and gill filaments—on a single trip. “It’s more work to just make the spreadsheet to get the permit than it is to work with the data.” And that’s not to mention the fees associated with successful applications: Rocha says a single research permit from Tanzania cost him and his three collaborators $1,250, which came out of his limited grant money.
The immediate effect of this complicated and often expensive web of restrictions has been a reduction in international research in some countries. Rocha, for example, says that he works with collaborators from Brazil who used to send him DNA samples to be sequenced, as the process is much quicker through his lab. But after Brazil implemented stricter regulations following the Nagoya Protocol a few years ago, rather than gain approval to send their samples, his Brazilian colleagues would now rather wait upward of two years to sequence their samples themselves at their own institutions.
There are hints that these effects might be widespread. Since 2014, there have been more than 2,000 internationally recognized permits formally documented under Nagoya procedures, according to The Access and Benefit-Sharing Clearing-House, which scientists say pales in comparison to the volume of international transfers of genetic resources they’d expect to see. “That’s evidently extremely unsatisfactory for scientists,” says Andreas Graner, the managing director of the Leibniz Institute of Plant Genetics and Crop Plant Research in Germany, whose gene bank sends upward of 30,000 samples domestically and internationally each year. Most of those samples are exchanged under a multilateral agreement enacted prior to the Nagoya Protocol and thus are largely exempt from the new rules so long as they are used for research, breeding, or training of agronomists in food and agriculture—and not for pharmaceutical or chemical purposes. Adding new specimens to gene banks, however, would fall under the auspices of the Nagoya Protocol.
David Ainsworth, a spokesperson for the Secretariat of the CBD, says in a statement to The Scientist that there have been positives to the new rules, although he acknowledges that their implementation has been complex and time-consuming. Before the Nagoya Protocol, many national laws didn’t provide clear and transparent procedures for access to genetic resources at all, he says. “This lack of clarity and legal certainty left many users of genetic resources such as researchers in situations where they were striving to follow [Access and Benefit Sharing] regulations with fear of being accused of misappropriation.”
Part of scientists’ frustration with the regulations ushered in by the Nagoya Protocol comes from the fact that the rules can hurt the very people, institutions, and countries they should be trying to encourage. For example, Rocha notes that large companies interested in commercializing discoveries in other countries often have an entire legal team to handle the permitting process, whereas basic researchers navigate it themselves with far less funding. “Oftentimes I feel like scientists are the only ones that are affected in a meaningful way by these permitting processes,” he says. In particular, young researchers lose out because they haven’t yet forged international collaborations and might not have the clout of a well-known research institute to guide them through the process, says Lowry.
Delays and cancellations to research projects carry important real-world consequences for the organisms scientists work on, too, says Gustav Paulay, a curator at the Florida Museum of Natural History who studies marine invertebrates. “My agenda is driven by the fact that the biosphere is undergoing a massive alteration because of us, and this is basically the last generation where we can document for the future what species and ecosystems were like in a quasi-natural state,” he says. Indeed, the international community as a whole failed this year to meet even a single one of its 20 biodiversity targets that the CBD set a decade ago. A 2019 report by the United Nations starkly states that, at the current rate of species loss, approximately a million plant and animal species are “now threatened with extinction, many within decades.”
If the trend of mounting red tape continues for scientists, Paulay fears that, in his field, most biodiverse coral areas, particularly in countries protective of their genetic resources, will lose most of their fauna before they are even documented. Researchers have a particularly difficult time gaining access to protected areas such as national parks—often hotspots for biodiversity—and must apply for additional permits, adds Lowry.
Compounding this problem is the fact that countries with the most biodiverse ecosystems, hoping to preserve their vast genetic resources, are often the ones with the thorniest regulations. For example, Indonesia and the Philippines, two of the most diverse hubs of corals on the planet, are also two of the most restrictive countries in which to obtain genetics resources, explains Rocha. Asked if he’d ever done research in Indonesia, Rocha laughed at the idea of successfully obtaining a permit to study coral reefs there. “There’s a whole laundry list of things I’ve wanted to do there,” he says.
Paulay, meanwhile, has collaborators in India—also considered to be one of the most biodiverse countries on the planet, he says—who are no longer allowed to ship him specimens, even on loan. Grinter, in his blog listing countries’ permitting requirements, has a blunt message for researchers hoping to obtain genetic resources from India: “Forget it.”
Cassandra Quave, an ethnobotanist at Emory University who studies plant-based medicine of Mediterranean indigenous cultures, says that the permitting landscape has, in part, shaped where she focuses her research: “I often get asked why I don’t work in South America, and it’s because getting permits [there] is impossible.” She says she watched in horror as the Amazon rainforest went up in flames the past two years and felt powerless to work with affected communities due to the impracticality of establishing a research project there.
Finding a balance
By and large, there’s comprehension in the scientific community about why regulations have evolved the way they have. “You have this long history of colonialist perspectives that puts countries on guard,” explains Quave. “If you think about all the things we enjoy today, whether it’s tea or coffee or chocolate—these things were taken from other countries.”
Most researchers also see the value in the CBD and the motivation behind the rules it inspired. University of Pretoria medicinal plant expert Namrita Lall, who works with indigenous communities to systematically test the validity of their treatments, says that as unwieldy as the regulations may be, they don’t negate a fundamental principle of the Nagoya Protocol: if access to a genetic resource involves indigenous knowledge, researchers should make good faith efforts to engage with the community and share the benefits of the research.
Oftentimes I feel like scientists are the only ones that are affected in a meaningful way by these permitting processes.—Luiz Rocha, California Academy of Sciences
If national governments meaningfully engage local and indigenous communities in the process of benefit sharing, it can help boost these communities both economically and through capacity building, agrees Mongezi Mabena, a software engineer whose father, a South African traditional healer, has worked with Lall. Many South Africans are still deeply distrustful of pharmaceutical giants such as Pfizer, which in 2002 marketed weight-loss supplements that used the Hoodia cactus, a plant used by the San people for generations to ward off hunger, without permission from them. Such incidents have made traditional healers skeptical of the scientific community, Mabena explains, and agreements that promote benefit sharing, such as the Nagoya Protocol, have begun to restore faith in the scientific community. At the same time, he says, he worries that scientists will be dissuaded from exploring South Africa’s genetic resources.
Instead, researchers who spoke to The Scientist hope that processes to access genetic resources might be standardized—for example, by implementing similar forms and requirements regardless of country, says Rocha. He and Lowry also proposed the creation of a separate set of procedures for applied or for-profit research, which they say carries a much higher risk of exploitation than does the basic research that they and their colleagues do. They say that such a separation could reduce the regulatory burden on basic-science researchers by expediting their permits and reducing their fees while still ensuring that all research, especially if it’s for-profit or applied, is properly scrutinized. There are no official plans to make these changes, Ainsworth says in the statement.
In the meantime, Lowry recommends that researchers do their part to embrace the fundamental goal of the CBD when conducting their research. “It was there to encourage people to do things, but to do them in a particular way—one that is morally and ethically appropriate, and one that takes into consideration the legitimate sovereign rights of each country in which biodiversity occurs,” he says. “A lot of this has been lost in the mix.”
Pathogens and Digital Sequence Information: Preventing the Next Pandemic
The US, the European Union, and Japan have consistently argued that the Nagoya Protocol, a supplementary agreement to the 1993 Convention on Biological Diversity (CBD), applies only to tangible biological materials. But other countries, such as India, Brazil, Ethiopia, and Malaysia, assert that the agreement also applies to information derived from genetic resources, including digital sequence information (DSI), which can include various types of data on an organism’s genetic and molecular makeup.
While World Health Organization (WHO) member states are required to notify the agency of all “public health information” on anything that may constitute a health emergency of international concern, the WHO’s rules make no mention of physical specimens of a pathogen or of DSI derived from pathogens. Partly as a result of the ambiguity, some countries have tightly regulated the export of these resources via what are known as Access and Benefit Sharing agreements, which stem from the CBD framework. This trend worries some scientists, particularly in the context of a pandemic, when speed and international collaboration are paramount.
Invoking the CBD treaty, for example, Indonesia refused in 2007 to share specimens or DSI of the lethal H5N1 influenza virus with the WHO, arguing that the samples would be used to develop vaccines that Indonesians could not afford. This episode was part of the motivation for the WHO to create, in 2011, the Pandemic Influenza Preparedness Framework, which aims to promote international collaboration and access to vaccines. But scientists and legal experts have argued that these rules instead enshrined countries’ sovereignty over their pathogens, imposed no direct penalties for refusing to share information with the WHO, and, perhaps most importantly given the COVID-19 pandemic, apply only to influenza viruses.
China, which is not a signatory of the Nagoya Protocol, publicly shared the genetic sequence of SARS-CoV-2 less than two weeks after the WHO announced the virus’s existence. But had China followed Nagoya Protocol requirements, “it could have embarked on discussions with each country, one by one, about how to share the sequence of this pathogen,” thereby delaying scientists’ access to the critical data, writes Thomas Cueni, the director general of the International Federation of Pharmaceutical Manufacturers and Associations, in a February 2020 STAT opinion article, in which he proposes exempting pathogens from Nagoya Protocol procedures.