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 is a 2010 supplementary agreement to the 1992 Convention on Biological Diversity. 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 biodiversity. 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. The protocol was adopted on 29 October 2010 in Nagoya, Japan, and entered into force on 12 October 2014. It has been ratified by 126 parties, which includes 125 UN member states and the European Union. Another supplementary protocol to the CBD is the Cartagena Protocol on Biosafety.
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
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 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 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
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 and competent national authorities to serve as contact points for information, grant access, or cooperate on issues of 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
A growing number of Preferential Trade Agreements 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
Many scientists have voiced concern over the protocol, fearing the increased red tape will hamper disease prevention and conservation efforts, and that the threat of possible imprisonment of scientists will have a chilling effect on research. Non-commercial biodiversity researchers and institutions such as natural history museums fear maintaining biological reference collections and exchanging material between institutions will become difficult.
