The Nagoya Protocol on Access and Benefit Sharing

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http://bioscience.oxfordjournals.org June 2015 / Vol. 65 No. 6 • BioScience 543

BioScience 65: 543–550. © 2015 Watanabe. All rights reserved. doi:10.1093/biosci/biv056

The Nagoya Protocol on Access and Benefit Sharing

MYRNA E. WATANABE

International treaty poses challenges for biological collections

When researchers take genetic resources—organisms, tissue,

DNA—from another country, what obligation are they under to share potential benefits, if any, of their find with the country of origin? How about natural history museums that accept new specimens for their col-lections? According to the Nagoya Protocol (NP), collectors of genetic resources should share the benefits with the countries where the materials originate, which often are in poorer regions of the Southern Hemisphere. Although 59 parties have ratified this agreement, few of those affected by it in the museum, botanical garden, and collection communities in the United States have even heard of it.

The agreement—whose offi-cial name is the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity—has been in the making since 1998. It clarifies the access and benefit-sharing (ABS) portions of the Convention on Biological Diversity (CBD). The CBD, which came into force on 29 December 1993, is an international treaty to sup-port “the conservation and sustainable use of biological diversity.” It allows for benefit sharing between those who take genetic resources from the envi-ronment and the countries that harbor those genetic resources. One of the concerns leading to the CBD was that

Gregory Watkins-Colwell, of Yale’s Peabody Museum of Natural History, holds a preserved sample of,an Arfak Mountains frog (Hylarana arfaki), from Papua

New Guinea. The specimen was collected by R. Storez in 1969, predating the Convention on Biological Diversity. Photograph: Sally Pallatto, Graphics

Department, Yale Peabody Museum of Natural History.

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foreign commercial interests (mostly in the Northern Hemisphere), such as pharmaceutical companies, could take natural product sources and tradi-tional knowledge from less developed countries without compensating them. The NP, which came into force on 12 October 2014, addresses these and related concerns.

Sitting in the middle of this Southern–Northern agreement are natural history museums, botanical gardens, microbiological collections, universities, and research institutes that often send researchers to biodi-versity-rich countries to make collec-tions for research—not for commercial purposes. Some of them had no idea that this extra level of documentation and agreement was in the works.

“I first became aware of it at the SPNHC [pronounced “spinach,” for The Society for the Preservation of Natural History Collections] meet-ing in 2014 in Cardiff [Wales],” said Gregory Watkins-Colwell, collection manager of herpetology and ichthyol-ogy at the Yale Peabody Museum of Natural History.

Andrew Bentley, president of SPNHC and ichthyology collection manager at the University of Kansas Biodiversity Institute, in Lawrence, noted, “The whole collections commu-nity is a little surprised by the impact of this.” He continued that there is “a lot of confusion in the community about how we’re going to change our practices and what we’re going to have to put in place.”

Botanical gardens are similarly unaware of the NP. Kate Davis and col-leagues (see the “Additional resources” box) carried out a survey to determine whether botanical gardens were famil-iar with the CBD, ABS, and the NP. Many respondents in the United States reported that they had “never heard of ” the NP, although botanical gardens in the global North (more developed countries, minus the United States) and global South (less developed coun-tries) were more familiar with it. Davis, a consultant on ABS from Ottawa, Canada, who serves as an adviser to Botanic Gardens Conservation

International, pointed out that, unlike the European Union, which has rati-fied the NP, neither the United States nor Canada signed it. “There’s no sup-port or guidance from government [in the United States] from a user coun-try perspective, unlike in EU member states,” she stated.

In fact, because the United States has not ratified the CBD, it cannot now sign the NP. According to Margo Bagley of the University of Virginia School of Law, in Charlottesville, Senate ratification “appears unlikely in the near term.” But, noted SPNHC’s Bentley, “Even though the US has not

ratified the CBD and signed onto the Nagoya Protocol, it’s pretty much a given that the US supports the prin-ciples contained in it.”

Who is covered?The NP covers procedures for access-ing genetic resources, benefit sharing between those accessing the resources and the country that “provides” the resources, and guaranteeing that the use of resources is legal. It also covers the acquisition and use of traditional knowledge associated with genetic resources obtained from indigenous and local communities.

Andrew Bentley, president of the Society for the Preservation of Natural History Collections, sees the collections community as being supportive of the

Nagoya Protocol but confused about its requirements. Photograph: Biodiversity Institute, University of Kansas.


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According to Dirk Neumann, ich-thyology collections manager of the Bavarian Natural History Collections, in Munich, Germany, and his col-leagues from collections across Europe (see the “Additional resources” box), “Because the NP governs genetic resources (GR) in general, it applies to any organismal research or col-lection storing organismal life.” Not only does it cover biological collec-tions, but it also covers “research disciplines indirectly linked to biosci-ences, such as earth or climate sci-ence (GR in drill cores, water, or soil samples) and archaeological sciences (archaeobotany, archaeozoology, and archaeology),” and, Neumann added in an e-mail, “if these samples are approached for sequencing, e.g., for ancient DNA.”

Article 5 of the NP refers to the sharing of “benefits arising from the utilization of genetic resources as well as subsequent applications and com-mercialization.” Therefore, one goal of the NP requires an economic agree-ment between a provider country that allows potential exploitation of its genetic resources for commercial use and someone bioprospecting for a cor-porate entity, with the provider’s goal of financing protection of biodiver-sity. This makes some in the museum community think that they are being caught up in a large net meant for commercial interests. Luiz Rocha, associate curator of ichthyology at the California Academy of Sciences, in San Francisco, stated that the NP is “all about the profit. The big bioprospect-ing companies get permits and will make money out of it.”

To some in the museum, botanical garden, and other collections commu-nities, it seems as though the CBD and NP inadvertently put them in the mid-dle of a place where they do not quite belong. Said David Skelly, director of the Yale Peabody Museum, “We’re not using what we find to patent any-thing. It’s not a source of economic exploitation.” According to Andrew Wyatt, vice president of horticulture and living collections at the Missouri Botanical Garden, in St. Louis, “We do

not commercialize any material col-lected and our agreements clearly state that… any use commercial or other-wise not agreed upon would require us to ask for specific permission to move forward.” This includes material obtained from other collections under a material acquisitions agreement and materials in their collection shared

with other collections via a material transfer agreement (MTA), Wyatt explained. He said, “Our… agreements cover our uses of material, and most are happy to sign.”

What are the requirements?“If a country ratifies the NP, it is absolutely obliged to implement it,”

California Academy of Sciences ichthyologist Luiz Rocha, who conducts field research all over the world, prepares to dive in Hawaii to explore deep reefs

for as yet unknown species of marine life. Photograph: California Academy of Sciences.


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according to Davis. “However,” she continued, “there is room for slightly different interpretations of the pro-tocol and certainly different legisla-tive/administrative/policy measures.” According to the NP, the country must carry out certain responsibili-ties related to it, including entering information about its agreements in the ABS Clearing-House, such as a certificate of compliance, which is “evidence that an agreement has been made… [but] not the precise terms of the agreement,” said Davis. “Each party must establish at least one check-point,” an event that triggers a need to prove that the genetic resources were acquired legally from the country of origin, said Davis.

As Neumann and his colleagues explained, noncommercial users of genetic resources, such as museums and other collections, along with com-mercial users, usually negotiate a prior informed consent (PIC) agreement and mutually agreed terms (MAT) before starting fieldwork in a coun-try that restricts access. Work cannot start without agreements that state what work will be done “with the final disposition and use of the specimens” and “how any benefits of the work are to be shared.” Neumann said that these benefits “could also be nonmonetary, such as teaching, education,” and so on. These agreements must be negoti-ated with the national government. “The MAT and PIC do not include collecting permits, and vice versa,” said Neumann. For work in indig-enous areas, there may be a need for additional agreements with the local community. The agreements will spell out exactly what collecting will be allowed, what work will be allowed to be carried out on any specimens, and where the specimens will reside at the end of the project. They will often spell out who the in-country cooperating institution is (Brazil, e.g., requires an in-country cooperator) and the terms for publication of research results.

How it worksIchthyologist Henry “Hank” Bart Jr., director of the Tulane University

Biodiversity Research Institute, in Belle Chasse, Louisiana, is carrying out research in Kenya, collecting fish from rivers and streams. “In many cases, the species are unknown spe-cies,” Bart noted. “We have to get permits for all the work we’re doing in Kenya. The way we’re approach-ing that is entering into the agree-ments with the Kenyans that basically agree… with the Nagoya Protocol.” Tissue samples taken in the field are shared equally with the National Museums of Kenya, following the

wishes of the museum administra-tors. “We collaborate in the published results,” continued Bart, “so that we give the Kenyans authorship of the work.” In accordance with the wishes of the Kenyans, all specimens were deposited into the National Museums of Kenya. The Kenyans made sub-samples of the material and gave them to Bart on a permanent loan. “When I want or need stuff for study, they will either loan it to me on a temporary or permanent basis,” he said.

Andrew Wyatt, of the Missouri Botanical Garden, reaches for a mistletoe cactus (Rhipsalis baccifera). He was on an expedition to conduct plant conservation of

threatened flora of Mauritius. Photograph: Jennifer Smock.


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The Kenyans further agreed that type specimens will be distributed to other museums. But specimens owned by the National Museums of Kenya, no matter where they are, will be credited in Tulane’s database as provided by the Kenyan museums “so the Kenyans will always be credited as providing that sample,” said Bart.

Scott Schaefer, associate dean of sci-ence for collections at the American Museum of Natural History (AMNH), in New York City, explained that Brazil has “instituted specific procedures and practices” that have been carried out over the last 10 to 15 years. Therefore, an MTA is required to export “tis-sue samples and preserved biologi-cal specimens from Brazil.” The MTA “specifies the conditions by which the materials will be exchanged and studied, in recognition of CBD and Brazilian law on genetic heritage management.”

Wyatt explained the Missouri Botanical Garden’s procedure: “When we work in a foreign country, the premise of CBD and NP is that you ask permission [because] the material is owned by the people of that country. All of our agreements clearly state how we are going to use the material at the Missouri Botanical Garden, and if we share the material with a third party, we will determine to the best of our ability that the third party will also use the material as agreed.”

Were some institutions prepared?Despite the general lack of knowledge about the NP, some organizations around the world were prepared for its complex requirements. For exam-ple, entries into the ABS Clearing-House, which was launched in concert with the NP’s coming into force, include legislation, identification of the national authority for permitting, PICs and MATs, codes of conduct and best practices, and much additional relevant information. These must be in metadata form—use of a controlled vocabulary to make it easier to retrieve information from the database—some of which is generated as the database user enters its information.

Said Bentley, “The Darwin Core is the uniform data standard for sharing data online” used by natural history museums. “I get the impression that the Europeans and the Australians and a couple of other countries are way ahead due to necessity, as legislation in those countries is more advanced.”

In Europe, Neumann and his col-leagues began to push to form a work-ing group, beginning around 2011. “The main thought behind it was,

‘Wouldn’t it be good to have a solu-tion ready by the end of 2015 instead of [to] start thinking [then]?’” recalled Neumann. “If yes, why not try to develop a common standard that brings providers into the boat and is suited to promote rather than to hin-der biodiversity research?”

E. Margaret Cawsey, metadata cura-tor at the Australian National Wildlife Collection of the National Research Collections Australia, Commonwealth

E. Margaret Cawsey holds a specimen of a galah (Eolophus roseicapilla) in the bird vault of the Commonwealth Scientific and Industrial Research Organisation

(CSIRO) National Facilities and Collections in Canberra, Australia. Photograph: Robert Palmer, Collection Manager, Australian National Wildlife

Collection, CSIRO, National Research Collections of Australia.


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Scientific and Industrial Research Organisation, National Facilities and Collections, in Canberra, is in the mid-dle of adding metadata for their tissue samples “to deal with the requirements of the Nagoya Protocol,” she wrote in an e-mail. She continued, “The impli-cations of the protocol extend not only to ensuring that our collecting/export/import/ethics permits are in order, but to storing the information in our collection database metadata so that we can assure ourselves and our colleagues that our specimens and samples have been collected legally, in compliance with the protocol.” They will be using “the new genomic extension to the Darwin Core meta-data standard…, the Global Genome Biodiversity Network data standard,” Cawsey explained.

The Missouri Botanical Garden’s Wyatt claimed, “I believe we’re the only botanic garden in the world to have such a sophisticated permit tracking system as part of our data set. It enables us to track individual acces-sions back to specific agreements.” This puts them in a good position to abide by the NP requirements.

The World Federation for Culture Collections (WFCC) was forced to digi-tize early because of the nature of the organisms within the collection. Its liv-ing microorganism collections date back more than 100 years, explained WFCC President Philippe Desmeth, in Brussels, Belgium. These microorganisms “needed more labeling and informa-tion because they can’t be seen with-out a microscope, [so] there was more description,” Desmeth stated. “The con-cept of a minimum data set goes back with projects coming 30, 40 years ago.” This minimum data set for scientific purposes, he said, hews closely to the information needed for administrative purposes by the collection. The WFCC’s many years of data collection have led to a program called “Gaining TRUST, Building TRUST,” with the acronym standing for transparent user-friendly system of transfer, which includes a com-plex database system that will interface with the ABS Clearing-House, a code of conduct, an integrated conveyance

The fungus Uncinula necator, which causes grape powdery mildew, is an economically important species that is maintained in microbial culture collections.

Photograph: Belgian Co-ordinated Collections of Micro-organisms, Mycothèque de l’Université Catholique de Louvain, Cony Decock, Philippe Desmeth.

Microbial culture collections hold specimens that are important to biomedical research. For example, the filamentous fungus Cunninghamella elegans is used for

metabolic studies. Photograph: Belgian Co-ordinated Collections of Micro-organisms, Mycothèque de l’Université Catholique de Louvain, Cony Decock, Philippe Desmeth.

system for the transfer of genetic resources, a “microbial commons” to allow for freely accessible material, the implementation of this microbial com-mons in Asia, and a “bundle of rights” of ownership. “We need to be user friendly,” Desmeth noted.

Nothing is simpleProblems and questions abound. “The Nagoya Protocol is almost out of date from the get go,” maintained Davis, pointing out, “It doesn’t clearly cover utilization of genetic information, and, increasingly, information is what we get and what we transfer.”


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Although some people are certain that the NP permitting requirements began for specimens obtained on or after 12 October 2014, even that is unclear. Davis says that for purposes of having a permit in an institution’s files, specimens may be considered to be pre-CBD, post-CBD, pre-Nagoya, and post-Nagoya. Cawsey explained this: “Although there were no explicit details on how to comply with the CBD, some may insist that we need to comply back to 1992”—just before the CBD came into force, depending on the legislation of a particular country or in cases in which there are stringent rules from countries that wish to bor-row specimens or from institutions or publishers, among others.

Whether or not a country is a signa-tory, it will have to comply with legisla-tion from provider countries, scientific journals (that may require proof that a specimen was obtained legally), and other institutions. Neumann said some US collection managers think that the Lacey Act, which regulates interstate commerce in illegally taken fish, wild-life, and plants, may force institutions to “be obliged to implement ABS mea-sures on a voluntary basis, even if the US does not ratify the NP. If US researchers want to collect in a country that restricts access, it might help dur-ing negotiations that home institutions have established clear and transparent internal ABS policies, as researchers often are not entitled to sign such agreements for their institutions.”

Rocha is concerned that the deposi-tion of sequences of entire genomes in public databases, such as GenBank, will make bioprospecting a computer activ-ity. “Companies don’t need to go into the field anymore. They can make all their discoveries online,” he warned. This would compromise research institu-tions’ noncommercial PICs and MATs. This would be a particular problem if genomes of the same species obtained from specimens from different coun-tries were taken for commercial pur-poses, as could occur with species that have wide distributions. “Even if those companies are required by law to share the profits with the country of origin,

how can you prove the species belongs to them?” Rocha asked.

Bentley added, “The unintended effects of the community practice of sharing data through portals as well as ancillary data like images, field notes, etc… may expose additional data (such as traditional knowledge or associated species) to third-party com-munities for profit.”

There are concerns that laws may be too stringent or the costs of permits too high, discouraging researchers from working on a particular species. Yale’s Skelly pointed out that if there are difficulties with accessibility or with permitting and timing of grant-funded studies, researchers will go to countries with less stringent rules or a more efficient permitting process.

Yale’s David Skelly stands in the Great Hall of the museum next to several ancient members of the collection. Photograph: Patrick Lynch, Yale Office of

Public Affairs and Communications.

Additional resources.

Bagley MA, Rai AK. 2013. The Nagoya Protocol and Synthetic Biology Research: A Look at the Potential Impacts. Synthetic Biology Project/Synbio 6. Woodrow Wilson International Center for Scholars. (8 April 2015; www.synbioproject.org/site/assets/files/1291/nagoya_final-1.pdf)

Blomquist RF. 2002. Ratification resisted: Understanding America’s response to the Convention on Biological Diversity, 1989–2002. Golden Gate University Law Review 32: 493–586. (8 April 2015; http://digitalcommons.law.ggu.edu/ggulrev/vol32/iss4/5)

Convention on Biological Diversity. The Nagoya Protocol on Access and Benefit-Sharing. (8 April 2015; www.cbd.int/abs)

Davis K, Smit MF, Kidd M, Sharrock S, Allenstein P. 2015. An access and benefit-sharing awareness survey for botanic gardens: Are they prepared for the Nagoya Protocol? South African Journal of Botany 98: 148–156. (8 April 2015; http://dx.doi.org/10.1016/j.sajb.2015.01.015)

Neumann D, Lyal CHC, Bodegård J, Löhne C, Casino A, Nivart A, Williams C, Giere P. 2014. Access and benefit sharing—Global implications for biodiversity research, collections and collection management arising from the Nagoya Protocol. SPNHC Connection 28: 40–42. (www.spnhc.org/media/assets/ABS-GlobalImplications_SPNHC-Sep2014Vol28.pdf)


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AMNH’s Schaefer warned that if pro-vider nations “tighten their regula-tions of the permitting process, make it more difficult, and [cause] delays, then it will have an unintended nega-tive consequence in the pursuit of aca-demic science.”

In museums that have collections of millions of biological samples, “Is it any tissue” that’s covered by the NP, “or does it have to be collected with intent?” posed Skelly.

What does one do when a sal-vaged specimen with no permits is brought to the collection? “We receive a strain, and it’s an interesting one,” said WFCC’s Desmeth. “Should we say we cannot keep it or destroy it?” There needs to be a way to put “a strain that was in the gray zone into the white zone again.”

The positiveNevertheless, some researchers are quite enthusiastic about the effects of partnering with researchers in other countries. “We are working with six developing countries to enable them to use barcoding data in investigat-ing and prosecuting wildlife crime. They’re contributing valuable data to the public reference library of DNA barcodes that will now include endan-gered species and their closely related species,” said David Schindel, execu-tive secretary of the Consortium for the Barcode of Life at the Smithsonian National Museum of Natural History.

Bart is advising the Kenyans on how to protect their specimens. Furthermore, the US Agency for International

Development’s Partnerships for Enhanced Engagement in Research program funds his Kenyan collabora-tors. “I’m donating jars to my col-laborators, and I’m advising them of curatorial practices to make sure things will be safe in Kenya. We all have the responsibility to make sure the people who will be custodians of the specimens have the right training, right conditions,” noted Bart.

Missouri Botanical Garden’s Wyatt is optimistic: “Any large international

initiative like this is a complex one. Any time you can get 194 countries together talking about conserving bio-diversity is a good thing.”

Wrote SPNHC’s Bentley, “The col-lections community definitely sup-ports what [the Nagoya Protocol] aims to achieve.”

Myrna E. Watanabe ([email protected]) is a science and grant writer in Patterson, New

York.

Antoinette Aluoch, a Barcode of Wildlife Project trainee from the Kenya Wildlife Service, works on samples at the Biosciences eastern and central Africa–

International Livestock Research Institute in Nairobi. The project is under the Consortium for the Barcode of Life and trains scientists to work

on samples in country, avoiding export of biological samples. Photograph: Rodah Syombua, Barcode of Wildlife Project journalist.


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The Nagoya Protocol on Access and Benefit Sharing