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, also known as the Nagoya Protocol on Access and Benefit Sharing (ABS), is a 2010 supplementary agreement to the 1992

Convention on Biological Diversity The Convention on Biological Diversity (CBD), known informally as the Biodiversity Convention, is a multilateral treaty. The Convention has three main goals: the conservation of biological diversity (or biodiversity); the sustainable use of its ...

(CBD). Its aim is the implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of

genetic resources Genetic resources are genetic material of actual or potential value, where genetic material means any material of plant, animal, microbial genetics, microbial or other origin containing functional units of heredity. Genetic resources is one of the ...

, thereby contributing to the conservation and sustainable use of

biodiversity Biodiversity is the variability of life, life on Earth. It can be measured on various levels. There is for example genetic variability, species diversity, ecosystem diversity and Phylogenetics, phylogenetic diversity. Diversity is not distribut ...

. It sets out obligations for its contracting parties to take measures in relation to access to genetic resources, benefit-sharing and compliance. The protocol was adopted on 29 October 2010 in

Nagoya is the largest city in the Chūbu region of Japan. It is the list of cities in Japan, fourth-most populous city in Japan, with a population of 2.3million in 2020, and the principal city of the Chūkyō metropolitan area, which is the List of ...

, Japan, and entered into force on 12 October 2014. , it has been ratified by 137 parties, which includes 141

UN member states The United Nations comprise sovereign states and the world's largest intergovernmental organization. All members have equal representation in the UN General Assembly. The Charter of the United Nations defines the rules for admission of ...

and the

European Union The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The u ...

. From a concrete perspective, it gives each country sovereignty rights over its biological resources, making

biopiracy Biopiracy (also known as scientific colonialism ) is the unauthorized appropriation of knowledge and genetic resources of farming and indigenous communities by individuals or institutions seeking exclusive monopoly control through patents or in ...

illegal. Concerns have been expressed that the added

bureaucracy Bureaucracy ( ) is a system of organization where laws or regulatory authority are implemented by civil servants or non-elected officials (most of the time). Historically, a bureaucracy was a government administration managed by departments ...

and

legislation Legislation is the process or result of enrolling, enacting, or promulgating laws by a legislature, parliament, or analogous governing body. Before an item of legislation becomes law it may be known as a bill, and may be broadly referred ...

could be damaging to the monitoring and collection of biodiversity, to conservation, to the international response to infectious diseases, and to research.

Aims and scope

The Nagoya Protocol applies to genetic resources that are covered by the CBD, and to the benefits arising from their utilization. The protocol also covers traditional knowledge associated with genetic resources that are covered by the CBD and the benefits arising from its utilization. Its aim is the implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising out of the utilization of genetic resources, thereby contributing to the conservation and sustainable use of

Adoption and ratification

The protocol was adopted on 29 October 2010 in

, Japan, at the tenth meeting of the Conference of the Parties, held from 18 to 29 October 2010 and entered into force on 12 October 2014. The parties to the treaty decided in 2016 to consider the inclusion of digital sequence information (DSI) in the Nagoya framework. The Access and Benefit-Sharing (ABS) method, if applied to DSI, would have greatly disrupted the operations of the

International Nucleotide Sequence Database Collaboration The International Nucleotide Sequence Database Collaboration (INSDC) consists of a joint effort to collect and disseminate databases containing DNA and RNA sequences. It involves the following computerized databases: NIG's DNA Data Bank of Japan ( ...

, in which all data is free and unrestricted. The multilateral framework for DSI, established in COP 15 (2022), decouples access from benefit-sharing. , it has been ratified by 137 parties, which includes 136

and the

Obligations

The Nagoya Protocol sets out obligations for its contracting parties to take measures in relation to access to genetic resources, benefit-sharing and compliance.

Access obligations

Domestic-level access measures aim to: * Create legal certainty, clarity, and transparency * Provide fair and non-arbitrary rules and procedures * Establish clear rules and procedures for prior informed consent and mutually agreed on terms * Provide for issuance of a permit or equivalent when access is granted * Create conditions to promote and encourage research contributing to biodiversity conservation and sustainable use * Pay due regard to cases of present or imminent emergencies that threaten human, animal, or plant health * Consider the importance of genetic resources for food and agriculture for food security

Benefit-sharing obligations

Domestic-level benefit-sharing measures aim to provide for the fair and equitable sharing of benefits arising from the utilization of genetic resources with the contracting party providing genetic resources. Utilization includes research and development on the genetic or biochemical composition of genetic resources, as well as subsequent applications and commercialization. Sharing is subject to mutually agreed terms. Benefits may be monetary or non-monetary such as royalties and the sharing of research results.

Compliance obligations

Specific obligations to support compliance with the domestic legislation or regulatory requirements of the contracting party providing genetic resources, and contractual obligations reflected in mutually agreed terms, are a significant innovation of the Nagoya Protocol. Contracting parties are to: * Take measures providing that genetic resources utilized within their jurisdiction have been accessed in accordance with prior informed consent, and that mutually agreed terms have been established, as required by another contracting party * Cooperate in cases of an alleged violation of another contracting party's requirements * Encourage contractual provisions on dispute resolution in mutually agreed terms * Ensure an opportunity is available to seek recourse under their legal systems when disputes arise from mutually agreed terms (MAT) * Take measures regarding access to justice * Monitor the use of genetic resources after they leave a country by designating effective checkpoints at every stage of the value chain: research, development, innovation, pre-commercialization, or commercialization

Implementation

The Nagoya Protocol's success will require effective implementation at the domestic level. A range of tools and mechanisms provided by the Nagoya Protocol will assist contracting parties including: * Establishing national focal points (NFPs) and competent national authorities (CNAs) to serve as contact points for information, grant access, or compliance * An Access and Benefit-sharing Clearing-House to share information, such as domestic regulatory ABS requirements or information on NFPs and CNAs * Capacity-building to support key aspects of implementation. Based on a country's self-assessment of national needs and priorities, capacity-building may help to: * Develop domestic ABS legislation to implement the Nagoya Protocol * Negotiate mutually-agreed terms * Develop in-country research capability and institutions * Raise awareness * Transfer technology * Target financial support for capacity-building and development initiatives through the GEF

European Union

The European Union has ratified a European Nagoya Protocol regulation to implement the Protocol. * Scientists must file a unsolicited Due Diligence Declaration to national authorities when a biological resource is used in connection to a funded research project. The declaration promises to obey the Nogoya-related laws. * Suppliers of biological resources such as DSMZ can certify that a resource is "Nagoya compliant" and provide information that can be used to fill the Due Diligence Declaration. * Collection of a biological resource (e.g. live cells) need prior informed consent (PIC) and mutually agreed terms (MAT) documentation from National Focal Point and/or Competent National Authorities in the place of collection. Moving it to a different country requires a material transfer agreement (MTA) stating the purpose and restrictions of the transfer. If a researcher aims to deposit in a cultural collection, it should be communicated in the MTA that secondary distribution according to the MTA of the collection is allowed. A compliant culture collection such as DSMZ will check for all of these documentation.

Relationship to other international agreements

A growing number of Preferential Trade Agreements (PTAs) include provisions related to access to genetic resources or to the sharing of the benefits that arise out of their utilization. Indeed, some recent trade agreements, originating notably from Latin American countries, provide specific measures designed to facilitate the implementation of the ABS provisions contained in the Nagoya Protocol, including measures related to technical assistance, transparency and dispute settlement.

Criticism

However, there are concerns that the added bureaucracy and legislation will, overall, be damaging to the monitoring and collection of biodiversity, to conservation, to the international response to infectious diseases, and to research. Many scientists have voiced concern over the protocol, fearing the increased

red tape Red tape is a concept employed to denounce excessive or redundant regulation and adherence to formal rules for creating unnecessary constraints on action and decision-making. The occurrence of red tape is usually associated with governments but a ...

will hamper disease prevention and conservation efforts. Developing countries have refused to issue permits for basic biodiversity research unrelated to bioprospecting, even prosecuting the scientist in some cases. Scientists worry that threats of possible imprisonment of scientists will have a chilling effect on research. Non-commercial biodiversity researchers and institutions such as

natural history museum A natural history museum or museum of natural history is a scientific institution with natural history scientific collection, collections that include current and historical records of animals, plants, Fungus, fungi, ecosystems, geology, paleo ...

s fear maintaining biological reference collections and exchanging material between institutions will become difficult. Museums have reservations about loaning out to developing countries for fear that the return "transfer" will not be approved. The bilateral transfer framework of the Nagoya Protocol also has low throughput. In comparison, the

International Treaty on Plant Genetic Resources for Food and Agriculture The International Treaty on Plant Genetic Resources for Food and Agriculture (also known as ITPGRFA, International Seed Treaty or Plant Treaty) is a comprehensive international agreement in harmony with the Convention on Biological Diversity, ...

has a multilateral access/transfer framework via the Standard Material Transfer Agreement, allowing 8500 transfers every week. This is different from Article 10 of the Nagoya Protocol, which asks for a multilateral benefit-sharing framework, which has been continuously "revisited" without an actual implementation. Lack of implementation at the national level was frequently attributed as a major factor behind the failure of Nagoya Protocol.

References

External links

* (CBD website) * {{Pollution 2010 in Japan Anti-biopiracy treaties Biopiracy Biodiversity History of Nagoya Traditional knowledge Treaties concluded in 2010 Treaties entered into force in 2014 Treaties of Afghanistan Treaties of Albania Treaties of Antigua and Barbuda Treaties of Argentina Treaties of Belarus Treaties of Belgium Treaties of Benin Treaties of Bhutan Treaties of Bolivia Treaties of Botswana Treaties of Bulgaria Treaties of Burkina Faso Treaties of Myanmar Treaties of Burundi Treaties of Cambodia Treaties of Cameroon Treaties of the Central African Republic Treaties of the People's Republic of China Treaties of the Comoros Treaties of the Democratic Republic of the Congo Treaties of the Republic of the Congo Treaties of Croatia Treaties of Cuba Treaties of the Czech Republic Treaties of Denmark Treaties of Djibouti Treaties of the Dominican Republic Treaties of Egypt Treaties of Equatorial Guinea Treaties of Eritrea Treaties of Ethiopia Treaties of Fiji Treaties of Finland Treaties of France Treaties of Gabon Treaties of the Gambia Treaties of Germany Treaties of Guatemala Treaties of Guinea Treaties of Guinea-Bissau Treaties of Guyana Treaties of Honduras Treaties of Hungary Treaties of India Treaties of Indonesia Treaties of Ireland Treaties of Ivory Coast Treaties of Jordan Treaties of Kazakhstan Treaties of Kenya Treaties of Kyrgyzstan Treaties of Laos Treaties of Lesotho Treaties of Liberia Treaties of Luxembourg Treaties of Madagascar Treaties of Malawi Treaties of Malaysia Treaties of Mali Treaties of the Marshall Islands Treaties of Mexico Treaties of Moldova Treaties of Mongolia Treaties of Malta Treaties of Mauritania Treaties of Mauritius Treaties of the Federated States of Micronesia Treaties of Mozambique Treaties of Namibia Treaties of the Netherlands Treaties of Niger Treaties of Norway Treaties of Pakistan Treaties of Palau Treaties of Panama Treaties of Peru Treaties of the Philippines Treaties of Rwanda Treaties of Saint Kitts and Nevis Treaties of Samoa Treaties of Senegal Treaties of Serbia Treaties of Seychelles Treaties of Sierra Leone Treaties of Slovakia Treaties of South Africa Treaties of Spain Treaties of Sudan Treaties of Sweden Treaties of Eswatini Treaties of Switzerland Treaties of Syria Treaties of Tajikistan Treaties of Tanzania Treaties of Togo Treaties of Tuvalu Treaties of the United Arab Emirates Treaties of the United Kingdom Treaties of Uruguay Treaties of Venezuela Treaties of Vietnam Treaties of Zambia Treaties entered into by the European Union Environmental treaties United Nations treaties Genetics Convention on Biological Diversity