The Nagoya Protocol 2010
Chapter Twenty-Nine
Syllabus topic 1, "Bio-diversity"
Pages 88 to 91 of 818
In one line
The Nagoya Protocol turns article 15 of the Convention from a principle into a working system, and its innovation is that it asks the user country, not only the provider, to do something.
In exam wording: the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization was adopted at Nagoya on 29 October 2010 as a protocol to the Convention on Biological Diversity; article 5 requires benefits arising from utilization to be shared with the providing Party on mutually agreed terms; article 6 governs access to genetic resources on prior informed consent; article 7 governs access to traditional knowledge associated with genetic resources held by indigenous and local communities; and articles 12 to 18 create the compliance machinery, including the Access and Benefit-sharing Clearing-House and the checkpoints that make a user country responsible for monitoring the utilization of another country's resources.
Why article 15 was not enough
Article 15 of the Convention gave the provider country the right to require consent and to be paid. It gave the provider nothing to use once the material had left. A provider country's law binds people inside it; the value is realised in a laboratory somewhere else.
So a provider could refuse access and receive nothing, or grant access and be unable to check what was done with the material. That is the problem the Protocol was written to solve, and every one of its distinctive features follows from it.
The core articles
Article 1, objective. 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 and by appropriate funding, thereby contributing to the conservation of biological diversity and the sustainable use of its components.
Article 2, use of terms. It defines utilization of genetic resources to mean conducting research and development on the genetic or biochemical composition of genetic resources, including through the application of biotechnology; and derivative to mean a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity. The Indian definition of derivative in section 2(fa), inserted in 2023, follows it.
Article 3, scope. Genetic resources within the scope of article 15 of the Convention, benefits arising from their utilization, and traditional knowledge associated with genetic resources.
Article 4, relationship with other agreements. The Protocol does not affect rights and obligations under other agreements, except where doing so would cause serious damage or threat to biological diversity, and it is to be implemented mutually supportively with other instruments, including the International Treaty on Plant Genetic Resources for Food and Agriculture.
The Nagoya Protocol 2010
Article 5, benefit sharing. Benefits arising from utilization, and from subsequent applications and commercialisation, shall be shared in a fair and equitable way with the Party providing the resources, on mutually agreed terms. Paragraph 2 requires measures so that benefits arising from utilization of resources held by indigenous and local communities are shared with them; paragraph 5 does the same for traditional knowledge.
Article 6, access to genetic resources. In the exercise of sovereign rights, access is subject to prior informed consent of the providing Party unless it determines otherwise. Paragraph 3 lists what a Party requiring consent must do: legal certainty, clarity and transparency; fair and non-arbitrary rules; information on how to apply; a written decision from a competent national authority, issued in a cost-effective manner and within a reasonable period; a permit or its equivalent as evidence of the decision and of the establishment of mutually agreed terms, notified to the Clearing-House; criteria and processes for consent of indigenous and local communities where they have the established right to grant access; and clear rules for mutually agreed terms.
Article 7, traditional knowledge. Each Party shall take measures with the aim of ensuring that traditional knowledge associated with genetic resources held by indigenous and local communities is accessed with their prior and informed consent or approval and involvement, and that mutually agreed terms are established.
What a checkpoint is
A checkpoint, under article 17, is a body designated by a Party through which utilization of genetic resources passes and which collects or receives relevant information about prior informed consent, the source of the resource, and the establishment of mutually agreed terms. Patent offices and research funding bodies are the obvious candidates.
The importance is that the checkpoint sits in the user country. The provider country cannot inspect a foreign laboratory, but the user country can require its own patent office to ask where the material came from. That is how the Protocol reaches conduct the Convention could not.
The internationally recognized certificate of compliance, under article 17(2) to (4), is the permit issued by the provider and published on the Clearing-House. Producing it is evidence that the material was lawfully obtained.
Articles 8 to 12
Article 8, special considerations. Simplified access for non-commercial research; due regard to present or imminent emergencies threatening human, animal or plant health; and regard to the importance of genetic resources for food and agriculture.
Article 9. Encouragement to direct benefits towards conservation and sustainable use.
Article 10. Consideration of a global multilateral benefit-sharing mechanism for transboundary situations or where prior informed consent cannot be granted.
Article 11. Cooperation where the same resources or the same traditional knowledge are found in more than one Party.
The Nagoya Protocol 2010
Article 12. Obligations relating to traditional knowledge: to take into account customary laws and community protocols, to inform potential users, and to support the development of community protocols and model contractual clauses.
The Indian connection
India ratified the Protocol, and the Biological Diversity (Amendment) Act 2023 was passed in part to align the Indian Act with it. Three changes track the Protocol directly.
The definition of derivative in section 2(fa) follows article 2 of the Protocol.
The definition of codified traditional knowledge in section 2(ea), and its exclusion from the benefit claimer definition in section 2(aa) for Indians, are India's own choices about how far article 7 reaches.
Section 6 is the Indian equivalent of a checkpoint. Since 1 April 2024 a foreign or foreign-controlled applicant needs the Authority's prior approval before an intellectual property right is granted, while an Indian applicant must register with the Authority before grant under section 6(1A) and obtain its approval at the time of commercialisation under section 6(1B).
Worked example
An Indian company and a Swiss company jointly develop a product from a plant collected in Kerala. Which instrument reaches which party?
The Indian company. Section 7 of the Biological Diversity Act 2002 requires prior intimation to the State Biodiversity Board before accessing the resource for commercial utilisation, subject to the 2023 proviso. Section 6(1A) requires it to register with the National Biodiversity Authority before any intellectual property right is granted, and section 6(1B) requires the Authority's approval when it commercialises the invention. Section 21 fixes benefit sharing.
The Swiss company. Section 3 requires the previous approval of the National Biodiversity Authority, but enforcement inside Switzerland depends on Swiss law.
The Protocol's answer. If Switzerland is a Party, article 15 requires it to take measures to provide that genetic resources utilised within its jurisdiction have been accessed in accordance with prior informed consent and that mutually agreed terms have been established. Article 17 requires it to designate checkpoints. Article 18 requires it to encourage the inclusion of dispute resolution provisions in mutually agreed terms and to provide an opportunity to seek recourse in its own legal system.
The practical consequence. The Indian permit, notified to the Clearing-House and becoming an internationally recognized certificate of compliance under article 17, is the document the Swiss checkpoint will ask for. Without it the joint application is exposed in Switzerland, not only in India.
Quick revision
- Adopted at Nagoya on 29 October 2010; a protocol to the Convention under article 28.
- Article 5 benefit sharing; article 6 access on prior informed consent; article 7 traditional knowledge.
- Article 2 defines utilization and derivative; India copied the derivative definition in 2023.
- Articles 15 to 18: compliance, checkpoints, the internationally recognized certificate, and access to justice.
- The innovation is that the user country has obligations.
- Article 8(a) requires simplified access for non-commercial research.
The Nagoya Protocol 2010
Test yourself
1. What problem does the Protocol solve that the Convention did not? The provider country's law cannot reach conduct in the user country. The Protocol places obligations on the user Party, requiring it to ensure that resources utilised within its jurisdiction were lawfully accessed, to designate checkpoints, and to provide access to justice.
2. What is an internationally recognized certificate of compliance? The permit or its equivalent issued by the providing Party as evidence of its prior informed consent decision and of the establishment of mutually agreed terms, once it has been notified to the Access and Benefit-sharing Clearing-House under article 17.
3. Which Indian definition was taken from the Protocol in 2023? Section 2(fa) of the Biological Diversity Act 2002, defining derivative as a naturally occurring biochemical compound or metabolism of biological resources even if it does not contain functional units of heredity, which follows the definition of derivative in article 2 of the Protocol.
The rest of this subject
These notes are cut from the University's printed syllabus. Open the syllabus itself, or the past papers, for the same subject.