ABS Fact Sheet and Answers to Frequently Asked Questions
Authored by members of the GGBN policies task force: Katharine Barker, GGBN Secretariat & National Museum of Natural History, Smithsonian Institution; Carol Butler, National Museum of Natural History, Smithsonian Institution; Manuela da Silva, FIOCRUZ; Gabi Droege, GGBN Technical Secretariat, Botanic Garden and Botanical Museum Berlin; Christopher Lyal, Natural History Museum London; David Schindel, Consortium for the Barcode of Life; Ole Seberg, Natural History Museum of Denmark; Breda Zimkus, Museum of Comparative Zoology, Harvard University
Contents
Awareness of the Convention on Biological Diversity (CBD)
This overview is intended to build awareness of the Convention on Biological Diversity and associated collections stewardship considerations.
The United Nations Convention on Biological Diversity (CBD) is an international treaty that came into force on 29 December 1993. The CBD makes clear the fundamental concept of “biodiversity” falling under the “sovereign rights” of each country as agreed at the UN in 1962. Thus, each nation is responsible for managing its own biodiversity. It introduced the concept of fair and equitable sharing of benefits arising from the use of genetic resources; the key rationale if this was to emphasize the intrinsic value stream associated with exploitation of biodiversity and hence the need for biodiversity conservation to remain a sustainable resource. Users of biological resources are now responsible for complying with regulations on biodiversity use at the national and/or regional levels (see section V below). These regulations differ between countries and may be constantly changing. These frequent changes and their implications for ownership rights have created an exceptional level of uncertainty for biological research and development, as well as the role and responsibilities of natural history collections.
The CBD has three main objectives:
- The conservation of biological diversity
- The sustainable use of components of biological diversity
- The fair and equitable sharing of benefits arising from the utilization of genetic resources (this objective is also called ABS)
The conservation and sustainable use objectives of the CBD are based on having sound information and science. In addition to sharing information on genetic resources available for research using an access and benefit sharing framework, GGBN Member institutions work within many science programs spread across the world either directly or indirectly by supplying information on protected areas and ecosystems and possible threats to them.
However, implementing an ABS regime on biodiversity has turned out to be exceedingly difficult due to the many people representing widely different objectives. Uncertainties range from an unclear definition of what “access” means in context of the Nagoya Protocol (see below) to what constitutes sharing of “benefits arising from the utilization of genetic resources.” This has hampered harmonisation tremendously, which, at least temporarily, has made collection and movement of genetic resources more difficult and uncertain.
In addition, there is added complexity to the ABS obligation which stems from an extension of benefit sharing to encompass utilization of traditional knowledge, innovations and practices relevant for the sustainable use and conservation of biological diversity (often referred to as TK). The TK discourse is sometimes intermixed with the genetic resources discussions, but we will keep them separate as they are affecting different processes within countries and internationally (with many of the TK discussions now occurring in the World Intellectual Property Organization [WIPO]). However, GGBN Member institutions should pay attention to TK in the context of ABS and utilization of Genetic Resources. Note that the Nagoya Protocol covers Traditional Knowledge associated with Genetic Resources (aTK) rather than TK on its own.
More information on ratification, contracting Party obligations, implementation tools and mechanisms can be found at the following CBD websites: https://absch.cbd.int/ (ABS Clearing House) and https://www.cbd.int/abs/
The Nagoya Protocol and Access and Benefit Sharing
The Nagoya Protocol on access to genetic resources and fair and equitable sharing of benefits arising from their utilization entered into force on 12 October, 2014. It is an international agreement adopted under the Convention on Biological Diversity (CBD). The Nagoya Protocol provides a guideline for the effective implementation of the third objective of the CBD.
GGBN is following discussions on the Nagoya Protocol carefully to make sure that GGBN and its Members can fulfil any obligations which might arise from those discussions. Not all countries have ratified the Nagoya Protocol, but researchers from countries that have done so will need to be compliant with national regulations.
Many countries have developed or are in the process of developing appropriate laws and regulations to manage their sovereign rights over their genetic resources. GGBN expects that researchers working on behalf of GGBN Member institutions follow national laws wherever they work. The regulations of provider countries may carry obligations that apply after samples have left the country, such as restrictions on use, third party transfer, and tracking of any shared benefits. These obligations place demands on a GGBN Members’ internal documentation of compliance, data, and research procedures.
""Prior Informed Consent (PIC)"" Prior informed consent (PIC) is a permission given by the Competent National Authority of a country to an individual researcher or institution seeking to obtain access to genetic resources and/or TK, complying with an appropriate legal and institutional framework (CBD Secretariat Information Kit). It covers what is collected and how, the expected uses of the collected material, and any emergent conditions that may require re-negotiation of the existing PIC. Consequently, in seeking PIC you must provide a full explanation of these elements.
Mutually Agreed Terms (MAT)
Mutually agreed terms (MAT) is an agreement between provider country/provider of genetic resources (and traditional knowledge) and the users, on the conditions of access and utilization of the resources, and on the benefits to be shared between both parties (CBD Secretariat Information Kit). This might address issues such as restrictions of use, third party transfer, reporting requirements, data sharing and/or other benefit sharing. Change of use etc. may require re-negotiation.
Benefit-sharing
Benefits can be both economic and non-economic, including academic, such as joint research and training. Benefits range from direct payments to knowledge attained. The Nagoya Protocol has an annex with a list of possible monetary and non-monetary benefits, which might be listed in a MAT (see below). Having materials in GGBN Member collections provides long-term security that there will be access to the materials under the conditions originally agreed or new agreed conditions with the provider country.
Traditional Knowledge
Traditional Knowledge can be found in a wide variety of contexts. It is knowledge resulting from intellectual activity in a traditional framework that is specific or general in its relationship to the genetic resources. It includes know-how, practices, skills, and innovations. As knowledge is shared locally, finding the right people to have PIC and MAT discussions with is not always clear. Multiple claims on the same knowledge across different communities further complicate this approach. Note that the Nagoya Protocol explicitly covers Traditional Knowledge Associated with Genetic Resources.
Monetary and Non-monetary Benefits
Monetary and Non-monetary benefits, as outlined by the Annex of the Nagoya Protocol
Monetary benefits may include, but not be limited to:
(a) Access fees/fee per sample collected or otherwise acquired;
(b) Up-front payments;
(c) Milestone payments;
(d) Payment of royalties;
(e) License fees in case of commercialization;
(f) Special fees to be paid to trust funds supporting conservation and sustainable use of biodiversity;
(g) Salaries and preferential terms where mutually agreed;
(h) Research funding;
(i) Joint ventures;
(j) Joint ownership of relevant intellectual property rights.
Non-monetary benefits may include, but not be limited to:
(a) Sharing of research and development results;
(b) Collaboration, cooperation and contribution in scientific research and development programs, particularly biotechnological research activities, in the Party providing genetic resources;
(c) Participation in product development;
(d) Collaboration, cooperation and contribution in education and training;
(e) Admittance to ex situ facilities of genetic resources and databases;
(f) Transfer to the provider of the genetic resources of knowledge and technology under fair and most favourable terms, including on concessional and preferential terms where agreed, in particular, knowledge and technology that make use of genetic resources, including biotechnology, or that are relevant to the conservation and sustainable utilization of biological diversity;
(g) Strengthening capacities for technology transfer;
(h) Institutional capacity-building;
(i) Human and material resources to strengthen the capacities for the administration and enforcement of access regulations;
(j) Training related to genetic resources with the full participation of countries providing genetic resources, and where possible, in such countries;
(k) Access to scientific information relevant to conservation and sustainable use of biological diversity, including biological inventories and taxonomic studies;
(l) Contributions to the local economy;
(m) Research directed towards priority needs, such as health and food security, taking into account domestic uses of genetic resources in the Party providing genetic resources;
(n) Institutional and professional relationships that can arise from an access and benefit- sharing agreement and subsequent collaborative activities;
(o) Food and livelihood security benefits;
(p) Social recognition;
(q) Joint ownership of relevant intellectual property rights.
GGBN’s role
Open access to biodiversity research data and corresponding specimens in repositories is vital for basic, non-commercial biological science and essential to support the objectives of the CBD. GGBN Member institutions commit themselves to acquiring, using and managing genetic resources in compliance with international conventions and national laws and regulations. Accordingly, GGBN has developed Material Transfer Agreements, Code of Conduct, and Best Practice guidance documents for Members’ use. It is recommended that GGBN Members provide information on the provenance of samples when providing or transferring material (this may be required under national law, as in all EU Member States). Downstream monitoring and tracking of utilised genetic resources is a recognized challenge that must be met. In response to this challenge, GGBN has developed a permit vocabulary as part of the GGBN Data Standard that helps to standardize the tracking of permit information associated with genetic resource records across GGBN Member institutions and beyond. By 2020 it is mandatory that all GGBN Member institutions providing data to the GGBN Data Portal link associated information on permits and compliance agreements to specimens collected on or after 12 October 2014.
Next Steps
GGBN task forces are currently working to identify ways to trace information on usage of genetic resources within and beyond the network, such as
- exploring the need or usefulness of an IPEN (International Plant Exchange Network)-like Code of Conduct, see https://www.bgci.org/files/ABS/IPEN/conduct.pdf.
- exploring ways to ensure that unique permit identifiers and ABS documents are associated with both original and descendent samples (e.g. individuals taken from a multi-specimen lot, tissues taken from specimens, DNA extracted from tissues).
- exploring how to create durable links between the identifier and the permits and other ABS documents.
- exploring the use of physical tags that can be placed on specimens with the identifier of the permit and ABS agreements (e.g. test string or QR code) and mutually agreed terms (e.g., “no 3rd party transfer”, or “do not sequence”).
- proposing the GGBN data standard as the global standard for implementing the Nagoya Protocol across all portals and to ensure that all relevant portals are cross-linking permit information. Targeted portals include BOLD, INSDC, and GBIF.
Resources to assist compliance with the Nagoya Protocol
Note that some of these documents will soon be superseded by newer versions; please be aware of the effective dates associated with each document/resource.
Access and Benefit Sharing Clearing House: https://absch.cbd.int/
Nagoya Protocol on Access and Benefit Sharing: https://www.cbd.int/abs/doc/protocol/nagoya-protocol-en.pdf
ABS Information kit: https://www.cbd.int/abs/information-kit-en/
GGBN Tools to Manage ABS and Nagoya
Global Genome Biodiversity Network Guidance: Best Practice for Access and Benefit Sharing: https://library.ggbn.org/share/s/546zVMjjQTKnv44IqXvkGQ
Global Genome Biodiversity Network Guidance: Code of Conduct https://library.ggbn.org/share/s/UM5JietQR9aevtYDymHbjw
Global Genome Biodiversity Network Guidance: Standard Material Transfer Agreements https://library.ggbn.org/share/s/AeJP2ZiDR3ShS9a7qZwmyA
Global Genome Biodiversity Network permit vocabulary: http://terms.tdwg.org/wiki/GGBN_Permit_Vocabulary
- Example with Permit entries (scroll down): http://data.ggbn.org/ggbn_portal/search/record?unitID=NHMO-BI-84005/1-B&collectioncode=BI&institutioncode=NHMO
- Example for linking permit and other rights information to specimen records using an Enterprise-level data management system, see frequently asked questions, number eight, below (please note that this is a work in progress, developed by the National Museum of Natural History, Smithsonian Institution).
Other Codes of Conduct, Best Practices, and learning tools
Access and Benefit Sharing Information Forum (note that this is a work in progress, developed by Natural History Museum London, Royal Botanic Gardens Kew and Royal Botanic Gardens Edinburgh): http://nagoyaprotocol.myspecies.info/
Botanic Garden principles: https://www.bgci.org/resources/article/0007/
Botanic Gardens Conservation International Learning tool: http://www.bgci.org/policy/abs_learning/
CETAF Code of Conduct and Best Practices (May 2014): http://cetaf.org/sites/default/files/final_cetaf_abs_coc.pdf
FIOCRUZ: https://portal.fiocruz.br/en/content/access-genetic-resources-and-associated-traditional-knowledge
MOSAICC (now being superseded by TRUST, see below): http://bccm.belspo.be/projects/trust
MIRRI (in development): http://www.mirri.org/fileadmin/mirri/media/Dokumente/generalDocs/MIRRI_ABS_Manual_web.pdf (May 2016)
Mediterranean Science Commission: http://www.ciesm.org/forums/index.php?post/2013/03/14/CIESM-Charter-on-ABS
PATGEN: https://www.prp.unicamp.br/patgen/
International Federation of Pharmaceutical Manufacturers and Associations: http://www.ifpma.org/resource-centre/ifpma-code-of-practice/
International Plant Exchange Network (2003): https://www.bgci.org/files/ABS/IPEN/conduct.pdf
Implementing Access and Benefit-Sharing (ABS) and Ensuring Academic Non-Commercial Research for the Conservation and Sustainable Use of Biodiversity: http://www.icsu.org/latin-america-caribbean/what-we-do/priority-areas/biodiversity/access-benefit-sharing/ICSUROLACABSsummary_Eng.pdf
Access and Benefit-Sharing In Latin America and the Caribbean. A Science-Policy Dialogue for Academic Research: http://www.icsu.org/latin-america-caribbean/what-we-do/priority-areas/biodiversity/access-benefit-sharing/ICSUROLACABSINLAC_English.pdf?bcsi_scan_2687365ababd2c82=0&bcsi_scan_filename=ICSUROLACABSINLAC_English.pdf
Report of the ABS BONN Workshop on Access and Benefit Sharing: Benefit Sharing from Academic Research: https://tinyurl.com/Bonn-workshop
World Federation of Culture Collections: Transparent Users-Friendly System of Transfer (full extended version): http://bccm.belspo.be/documents/files/projects/trust/trust-march-2016.pdf
World Federation of Culture Collections: Transparent Users-Friendly System of Transfer (abbreviated version): http://bccm.belspo.be/documents/files/projects/trust/trust-handbook-march-2016.pdf
And many others – coming soon, see https://www.cbd.int/abs/instruments/
Other Material Transfer Agreements
CETAF Standard MTA for provision of material with no change in ownership (May 2014): http://cetaf.org/sites/default/files/final_cetaf_mta_1-_provision_no_change_in_ownership.pdf
CETAF Standard MTA for provision of material with change in ownership (May 2014): http://cetaf.org/sites/default/files/final_cetaf_mta_2-_provision_change_in_ownership_0.pdf
CETAF Standard MTA for receipt of material with change in ownership (May 2014): http://cetaf.org/sites/default/files/final_cetaf_mta_3-_receipt_change_in_ownership.pdf
Swiss Academy of Sciences Agreement on ABS for Non-Commercial Research (2010): http://www.naturalsciences.ch/organisations/biodiversity/abs/toolbox
Answers to Frequently Asked Questions (FAQ) on ABS
1. What is the ABS clearing house?
The Access and Benefit-Sharing Clearing-House (ABSCH) is a platform for exchanging information on ABS (incl. Country specific information for Parties) and a key tool for facilitating the implementation of the Nagoya Protocol. https://absch.cbd.int/
2. My country hasn’t signed or ratified the Nagoya Protocol yet. Does it affect my field work and associated research?
It is recommended that the user follow the legislation or regulatory measures of the provider country. This is usually done by negotiating prior informed consent (PIC) and mutually agreed terms (MAT), when required. Understanding these concepts will greatly assist in making sure you have all of the appropriate paperwork and permissions to do the research you intend to do.
The impact on a user from a non-party country may come if there is a research partner working in a country that is a party to the Nagoya Protocol, as the research partner may have to implement requirements of his or her domestic legislation.
3. What steps do I have to take if I want to collect samples?
Obtain PIC (if required) and establish MAT if required by national law of the country where you are collecting (e.g. PIC might be granted by the national or state government or by local communities, MAT might be negotiated with the relevant government contact or with communities or scientific partners). The providing country's Competent National Authority (CNA) will issue a permit or its equivalent to the user, or may issue evidence that the user obtained PIC as required (e.g. from local communities). (Note: other non-ABS permits may still be necessary!). Any collection permits etc. might need to be secured as usual.
National ABS Focal points for both parties and non-parties to the Nagoya Protocol can be contacted for help with obtaining collecting permits. Focal points for each country can be found on the ABS Clearing-House at https://absch.cbd.int/search/nationalRecords?schema=focalPoint. Note that not all countries have a focal point in place!
It must be noted that this applies to collecting samples in any country, not just parties to the Nagoya Protocol.
