The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their Utilization was adopted in 2010, as a supplementary agreement to the Convention on Biological Diversity (CBD).
It entered into force on 12 October 2014. The objective of the Nagoya Protocol is the fair and equitable sharing of benefits arising from the utilisation of genetic resources and associated traditional knowledge. It is aimed at providing a transparent legal framework for Access and Benefit-Sharing, supporting compliance by both providers and users of genetic resources.
Protocol to the CBD
The Nagoya Protocol aims to provide a transparent legal framework for the effective implementation of one of the three objectives of the CBD: the fair and equitable sharing of benefits arising from the utilisation of genetic resources. It is intended to create greater legal certainty and transparency for both providers and users of genetic resources by:
- establishing more predictable conditions for access to genetic resources;
- helping to ensure benefit-sharing when genetic resources leave the contracting Party providing them, to be utilised by another contracting Party.
The Nagoya Protocol applies to genetic resources that are covered by the CBD, and to the benefits arising from their utilisation. It also covers traditional knowledge (TK) of genetic resources dealt with by the CBD and the benefits arising from the utilisation of such knowledge. The Nagoya Protocol takes the utilisation of genetic resources to mean to conduct research and development on the genetic and/or biochemical composition of genetic resources, through the application of biotechnology as well as by other means. Parties who are not conducting research and development are not considered to be users in the sense intended by the Nagoya Protocol. The provisions of the Nagoya Protocol are only binding on use of genetic resources obtained from other countries that have become a party to the Nagoya Protocol.
The Nagoya Protocol rests on three main pillars: measures relating to access, measures relating to benefit-sharing, and measures relating to compliance.
Domestic-level access measures are intended to:
- create legal certainty, clarity and transparency;
- provide fair, systematic rules and procedures;
- establish clear rules and procedures for prior informed consent (PIC) and mutually agreed terms (MAT);
- provide for issuance of a permit or equivalent when PIC is granted;
- create conditions to promote and encourage research contributing to biodiversity, conservation and sustainable use;
- pay due regard to present or imminent emergencies that threaten human, animal or plant health;
- consider the importance of genetic resources for food and agriculture in the interests of food security.
Domestic-level benefit-sharing measures are intended to ensure the fair and equitable sharing of benefits arising from the utilisation of genetic resources with the contracting Party providing genetic resources. Utilisation includes research and development on the genetic or biochemical composition of genetic resources, as well as subsequent applications and commercialisation. Sharing is subject to mutually agreed terms. Benefits may be monetary or non-monetary such as sharing of royalties and the sharing of research results.
Specific obligations to support compliance by domestic legislation or regulations drafted by the Party providing genetic resources, and contractual obligations reflected in mutually agreed terms, are a significant innovative aspect of the Nagoya Protocol. Contracting Parties are urged to:
- take measures to ensure that genetic resources utilised within their jurisdiction have been accessed in accordance with prior informed consent, and that
mutually agreed terms have been established, as required by another
- cooperate in cases of alleged violation of another contracting Party’s requirements;
- encourage that contractual provisions on dispute resolution are included in mutually agreed terms;
- ensure an opportunity is available to seek recourse under their legal systems when disputes arise from mutually agreed terms;
- take measures to ensure access to justice;
- take measures to monitor the utilization of genetic resources after they leave the jurisdiction of a provider country.
Relation with the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA)
Article 4 of the Nagoya Protocol determines the relationships with other international agreements and instruments. It states among other things that “The provisions of this Protocol shall not affect the rights and obligations of any Party deriving from any existing international agreement […] This paragraph is not intended to create a hierarchy between this Protocol and other international instruments.”, and “[…] Where a specialized international ABS-instrument applies, […], this protocol does not apply for the Party or Parties to the specialized instrument […]”. In other words, where the ITPGRFA applies, this Protocol does not. This will also hold if any other specific ABS instruments are developed in future.