The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity (CBD) entered into force on 12 October 2014, with 54 ratifications at the time.
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity (CBD) entered into force on 12 October 2014, with 54 ratifications at the time. In accordance with the provisions of its Article 26(6), the first meeting of the Conference of the Parties serving as the Meeting of the Parties (COP/MOP 1) to the Nagoya Protocol was held from 13-17 October 2014, during the second week of the twelfth meeting of the Conference of the Parties (COP 12) to the CBD.
An Introduction to ABS and the Nagoya Protocol
The evolution of modern bio-sciences has led to the rapid growth of scientific research on genes and naturally occurring bio-chemicals for use in different sectors including agriculture, medicine, cosmetics and energy. In the field of medicine alone, terrestrial plants and microorganisms have been important natural sources used in the development of new medicines. The commercial value of genetic resources is not clear; companies relying on genetic resources for their research and development, however, include pharmaceutical and food companies earning more than US$50 billion annually, with combined industry and government expenditures in research and development in the pharmaceutical sector totaling US$68 billion in 2010.
Bioprospecting – the search for plants and animals from which commercially valuable compounds can be obtained – is often a transnational activity: it involves situations where genetic resources are found in one State but are used in another. International law aims to address the trans-jurisdictional aspects of regulating in one country access to genetic resources by users (often private entities) based in other countries, and to reward States holding genetic resources for their contribution to the development of products that are eventually commercialized by actors in other countries. In addition, international law is needed to ensure fairness in transnational ABS transactions in order to reduce asymmetries among developed and developing States, and to guide the development of domestic legislation on ABS.
The CBD was the first instrument to introduce the concept of ABS in international environmental law. It subjected access to genetic resources to the prior informed consent (PIC) of the State providing the resource, and included among its objectives the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. Most of the world’s biodiversity is found in developing countries; whereas developed countries usually host research institutes and companies that make commercial use of this biodiversity. In light of the asymmetries between States providing and using genetic resources, as well as of the growing expectations concerning the commercial value of biodiversity, ABS was conceived as a tool for sustainable development.
However, few CBD Parties translated the CBD provisions on ABS into national legislation, largely due to the complexity of the subject matter and limited international guidance. The CBD provides a set of basic principles on ABS, but gives little guidance on how to address non-ideal ABS situations. Industrialized Parties in particular were very hesitant to adopt measures supporting effective benefit-sharing by their researchers and companies towards provider countries.
The need for more detailed guidance on ABS led to the development of the non-binding Bonn Guidelines in April 2002. The Guidelines aim to guide governments in establishing legislative, administrative or policy measures on ABS. Reflecting the CBD provisions, they acknowledge that specific benefit-sharing arrangements may vary depending on the specific conditions of each individual case, and should thus be determined on a case-by-case basis through mutually agreed terms (MAT). They nevertheless provide some guidance with regard to the types, timing and distribution of benefits, and mechanisms for benefit-sharing, in order to assist Parties and stakeholders in the development of MAT. Notably, they provide a list of monetary and non-monetary benefits, which is reproduced almost verbatim in the Annex to the Nagoya Protocol. Still, only a limited number of CBD Parties developed domestic ABS legislation after adoption of the Bonn Guidelines. Four months after their adoption, heads of State and government attending the World Summit on Sustainable Development (WSSD) in August 2002 agreed to launch negotiations on an international regime on fair and equitable benefit-sharing. The WSSD mandate triggered the negotiations that eventually led to the adoption of the Nagoya Protocol.
Adopted on 29 October 2010 in Nagoya, Japan, the objective of the Nagoya Protocol is the fair and equitable sharing of the benefits arising from the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding, thereby contributing to the conservation of biodiversity and the sustainable use of its components. It applies to genetic resources covered by the CBD and to traditional knowledge associated with such genetic resources, also covering genetic resources held by indigenous and local communities. In this regard, it spells out, for the first time in legally binding provisions, the benefit-sharing obligation arising from the use of traditional knowledge for research and development purposes. The Protocol expands upon the text of the CBD by detailing obligations on access, benefit-sharing and compliance; and provides for the establishment of national focal points and competent national authorities, an ABS Clearing-house, and implementation support through capacity building, technology transfer and financial provisions.
Negotiations spanned six years. Major controversial issues included: the scope of the instrument; derivatives of genetic resources and the concept of utilization; the relationship with other international instruments; measures to support compliance, including with domestic ABS requirements; measures to monitor the utilization of genetic resources; traditional knowledge-related issues; and considerations regarding health emergencies and food security. CBD COP 10 adopted the Nagoya Protocol as part of a “package” including the Strategic Plan for Biodiversity 2011-2020 and its Aichi Targets, and a decision on implementation of the CBD Strategy for Resource Mobilization. It also established the Intergovernmental Committee for the Nagoya Protocol (ICNP) to undertake the preparations necessary for COP/MOP 1, which held three meetings from 2011-2013.
COP/MOP 1: Main Steps towards Implementation
COP/MOP 1 participants celebrated the entry into force of the Protocol and at the same time the early achievement of Aichi Target 16. The meeting considered the status of the ratification and implementation of the Protocol, and adopted a series of decisions, including on: the ABS Clearing-house and information-sharing; monitoring and reporting; compliance; model contractual clauses and other voluntary instruments; capacity building; awareness-raising; the need for, and modalities of, a global multilateral benefit-sharing mechanism; and organizational, financial and budgetary matters. 
The meeting’s major achievement was the establishment of a compliance committee and agreement on procedures and mechanisms to promote compliance and address cases of non-compliance. The final outcome includes a number of innovative provisions on the participation of, and feedback from, representatives of indigenous and local communities.
Article 30 of the Nagoya Protocol mandates COP/MOP 1 to establish multilateral procedures and mechanisms for monitoring compliance and addressing instances of non-compliance with the Protocol. In accordance with this mandate and in line with its work plan, the ICNP addressed the issue of compliance at all its three meetings, making steady progress on a draft text. Issues of controversy concerned mainly the participation of representatives of indigenous and local communities in the compliance committee and in the submission process, as well the possibility for the committee to impose sanctions for non-compliance.
A contact group on compliance started work informally during the first week of COP 12, before the COP/MOP’s official opening. Discussions were held in a remarkable spirit of cooperation, and the agreement finally reached can be considered a major achievement of the process. Negotiators managed to respond creatively to the challenges related to the role of indigenous and local communities in the structure promoted by the Protocol with regard to access to their traditional knowledge and genetic resources held by them, and to fair and equitable benefit-sharing.
In line with experience gained under other multilateral environmental agreements, including the CBD Cartagena Protocol on Biosafety, a Compliance Committee was established, tasked with promoting compliance with the Protocol provisions and addressing cases of non-compliance. The compliance procedures and mechanisms shall be non-adversarial, cooperative, simple, expeditious, advisory, facilitative, flexible and cost-effective. Their operation shall be guided by the principles of fairness, due process, rule of law, non-discrimination, transparency, accountability, predictability, and will pay particular attention to the needs of developing country Parties, especially least developing countries (LDCs) and small island developing States (SIDS) among them, and Parties with economies in transition.
The Committee consists of 15 regional representatives nominated by Parties. Parties may choose to nominate representatives of indigenous and local communities (ILCs). In addition, two ILC representatives, at least one from a developing country, nominated directly by ILCs, shall serve as observers and shall be entitled to participate in the deliberations of the committee, but not in decision-making. Committee members as well as ILC representatives shall have recognized competence, including technical, legal or scientific expertise. The first set of Committee members was elected on 17 October, with only nomination of few alternate members pending, to be submitted to the Secretariat at a later stage: Ayman Tharwat Abdel Aziz (Egypt), Naritiana Rakotoniaina Ranaivoson (Madagascar), Christine Echookit Akello (Uganda) and alternate Betty Kauna Schroeder (Namibia) from the African Group; Luther Rangreji (India), Clark Peteru (Samoa) and Achmad Gusman Catur Siswandi (Indonesia) from the Asia-Pacific; Kaspar Sollberger (Switzerland), Alejandro Lago Candeira (Spain), Helge Elisabeth Zeitler (EU) and alternate Gaute Voigt-Hanssen (Norway) from the Western European and Others Group; Norma Munguía Aldaraca (Mexico), Andrés Valladolid (Peru) and Indarjit Ramdass (Guyana) from Latin America and the Caribbean; Elena Makeyeva (Belarus), Elvana Ramaj (Albania), Elzbieta Martyniuk (Poland) and alternate Dilovarsho Dustov (Tajikistan) from Central and Eastern Europe; and Preston Hardison (Tulalip Tribes), Jennifer Corpuz (Tebtebba) and alternate Onel Masardule (Forest Peoples Programme) as observers from ILCs.
The Committee shall meet at least once in each intersessional period and may hold additional meetings. It shall develop its own rules of procedure, including those on confidentiality and conflict of interest, and submit them to the COP/MOP for consideration and approval. Every effort should be made to reach agreement on all matters of substance by consensus; if nevertheless no agreement can be reached, any decision shall, as a last resort, be taken by a three-quarters majority of the members present and voting or by eight members, whichever is greater. The meetings shall be open, unless the Committee decides otherwise. When the Committee is dealing with individual cases of Parties whose compliance is under consideration, the meetings shall be closed to the public, unless the Party concerned agrees otherwise. Its reports and recommendations shall be submitted to the COP/MOP for consideration and appropriate action.
In an interesting provision aimed at promoting synergies, it is provided that, in performing its functions, the Committee may consult with the compliance committees of other agreements, to share experience on compliance issues and options for their resolution.
With regarding to triggering the procedure, any Party with respect to itself, any Party with respect to another Party, and the COP/MOP may send submissions to the Committee. The Committee may also examine a situation where a Party fails to submit its national report, or where information submitted indicates that the Party concerned is faced with difficulties complying with its obligations under the Protocol. Such information may be received through a national report, from the ABS Clearing-house or from the Secretariat. The Secretariat is also to screen the information submitted by ILCs, review the information received from ILCs against the information received by the Party concerned, and transmit issues to the Committee that have not been resolved.
In examining the cases brought to its attention, the Committee may seek, receive and consider information from relevant sources, including from affected ILCs; seek advice from independent experts, including, in particular where ILCs are directly affected, from an ILC expert; and undertake, upon invitation of the Party concerned, information-gathering in the territory of that Party.
In considering measures to promote compliance and address cases of non-compliance, the committee shall take into account: the concerned Party’s capacity, special needs of developing country Parties and Parties with economies in transition; and such factors as the cause, type, degree and frequency of non-compliance. A range of potential measures is at the disposal of the committee: it may offer advice or facilitate assistance to the Party concerned; request or assist the Party to develop a compliance action plan; and invite the Party to submit progress reports on its efforts to comply with its obligations. In addition, the COP/MOP, upon the recommendations of the Committee, may facilitate access to financial and technical assistance, technology transfer, training and other capacity-building measures; issue a written caution, statement of concern or a declaration of non-compliance; and decide on any other measure in accordance with Article 26(4) of the Protocol on promoting effective implementation and the applicable rules of international law, bearing in mind the need for serious measures in cases of grave or repeated non-compliance.
Despite extensive discussions on the possible establishment of an ombudsman to assist developing countries and ILCs in identifying instances of non-compliance, held during the Protocol negotiations as well as under the ICNP, the final decision does not include a provision on an ombudsman. Instead, the Committee will consider, at a meeting to be held before COP/MOP 2, the need for and modalities of a flexible mechanism to provide advice and assistance to developing country Parties and ILCs.
ABS Clearing-House and Information-Sharing
The ABS Clearing-House, established according to Article 14 of the Protocol, is a key mechanism for its effective and transparent implementation. It is essentially a database compiling information provided by Parties in accordance with the provisions of Article 14. During the pilot phase of its operation, Parties and the Secretariat addressed mainly technical issues, and a valuable collaboration was established in that regard with the Secretariat of the International Treaty on Plant Genetic Resources for Food and Agriculture. The COP/MOP established an informal advisory committee to assist the Secretariat with the implementation of the ABS Clearing-House, tasked with providing technical guidance. In addition, it was decided that Parties (and non-Parties on an optional basis) should designate a national focal point, one or more competent national authorities, one publishing authority nominated by the national focal point and, if needed, one or more national authorized users designated by the publishing authority. This provision aims to ensure the validity and accuracy of information posted to the ABS Clearing-House.
Furthermore, the COP/MOP agreed to the guidelines and format for submission of the interim national report on the implementation of the Protocol; and adopted a strategic framework for capacity building and development, and an awareness-raising strategy for the Protocol. It also invited further work, including commissioning a study on the global multilateral benefit-sharing mechanism under Article 10 of the Protocol. On institutional issues, it decided to designate the Subsidiary Body on Implementation (SBI), established by CBD COP 12, to also serve the Nagoya Protocol; and to hold its future ordinary meetings concurrent with the meetings of the COP and Cartagena Protocol COP/MOP within a two-week period.
Notwithstanding the possible practical challenges, the decision to hold the meetings of the Convention and its Protocols concurrently represents an opportunity to revisit the Convention processes in order to ensure synergistic operations in view of the three CBD objectives: conservation and sustainable use of biodiversity, and fair and equitable benefit-sharing. The next round of meetings, to be held in December 2016 in Los Cabos, Mexico, will provide the first indications in that regard. In the meantime, the contribution of biodiversity, including ABS, to sustainable development will be assessed also in the context of the discussions on the post-2015 development agenda and the Sustainable Development Goals (SDGs). IISD Reporting Services will be following these developments, aiming to synthesize them and bring them in a concise manner to our readers’ attention.
 Adopted by CBD Decision X/1 on 29 October 2010, the Nagoya Protocol required 50 ratifications for entry into force. For an updated list of Parties, see: http://www.cbd.int/abs/nagoya-protocol/signatories/.
 See Elisa Morgera, Elsa Tsioumani and Matthias Buck, 2014. Unraveling the Nagoya Protocol: A Commentary on the Nagoya Protocol on Access and Benefit-sharing to the Convention on Biological Diversity. Leiden/Boston: Martinus Nijhoff Publishers/Brill.
 Aichi Target 16 states: By 2015, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization is in force and operational, consistent with national legislation.
 The IISD Reporting Services’ daily and summary reports of the meeting are available at: http://enb.iisd.org/biodiv/cop12/. The meeting’s official webpage, including background documents, is available at: http://www.cbd.int/npmop1/. The official report of the meeting was not available at the time of writing. The draft decisions, in the form of in-session documents, are available at: http://www.cbd.int/npmop1/insession.
 See Elisa Morgera, Elsa Tsioumani, Soledad Aguilar and Hugh Wilkins “Implementation Challenges and Compliance in MEA Negotiations” in Pamela Chasek and Lynn Wagner (eds), 2012. The Roads from Rio: Lessons learned from Twenty Years of Multilateral Environmental Negotiations. New York: RFF Press.
 See CBD Secretariat Press Release, 11 December 2014 ‘Major sustainable development outcomes of biodiversity meeting to be transmitted to 69th session of UN General Assembly for consideration in post-2015 Development Agenda,’ available at: http://www.cbd.int/doc/press/2014/pr-2014-12-11-cop12-sdgoutcomes-en.pdf.