CBD, the Nagoya Protocol and the Biological Diversity Act

1. The Convention on Biological Diversity, 1992

Opened for signature at the Rio Earth Summit in 1992 and in force from 1993, the CBD has three objectives (Article 1): conservation of biological diversity, sustainable use of its components, and the fair and equitable sharing of benefits arising from the utilisation of genetic resources. India is a party; the United States is not.

• Article 3: states have the sovereign right to exploit their own resources under their environmental policies, and the responsibility not to damage the environment of others.
• Article 8(j): respect, preserve and maintain the knowledge, innovations and practices of indigenous and local communities, promote their wider application with the approval of the holders, and encourage equitable sharing of benefits.
• Article 15: the authority to determine access rests with national governments; access is subject to the prior informed consent (PIC) of the providing country and on mutually agreed terms (MAT); benefits of research and commercial use are to be shared fairly.
• Article 16: access to and transfer of technology, with a clause that parties shall cooperate to ensure that patents and other IP “are supportive of and do not run counter to” the Convention’s objectives.
• Article 19: participation in and sharing of benefits of biotechnology.

The CBD ended the “common heritage” view of genetic resources. Its tension with TRIPS is that TRIPS requires patents on inventions derived from genetic resources without asking how the resources were obtained, while the CBD makes access conditional on consent and benefit sharing. The disclosure-of-origin debate in the WTO and WIPO comes from this gap.

2. The Nagoya Protocol, 2010

The Bonn Guidelines (2002) on ABS were voluntary. The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization was adopted in 2010 and entered into force in October 2014. India has ratified it. Its main features:

• Access obligations on providing countries: legal certainty, clear rules for PIC, a competent national authority, and permits.
• Benefit sharing of benefits from utilisation (research and development on the genetic or biochemical composition of genetic resources), including subsequent applications and commercialisation, monetary and non-monetary.
• Traditional knowledge associated with genetic resources requires the PIC or approval and involvement of the indigenous and local communities holding it.
• Compliance by user countries: measures to ensure that genetic resources used in their jurisdiction were accessed under PIC and MAT (Articles 15–16); checkpoints to monitor use (Article 17), such as research funding bodies or patent offices; and the internationally recognised certificate of compliance issued through the ABS Clearing-House. The EU implemented these through Regulation (EU) No 511/2014.

The Kunming-Montreal Global Biodiversity Framework (2022) committed parties to a multilateral mechanism for benefit sharing from digital sequence information; a fund for this was created by a decision at COP16 in Cali, Colombia in 2024.

3. The Biological Diversity Act, 2002

India implemented the CBD through the Biological Diversity Act, 2002 and the Biological Diversity Rules, 2004. The structure has three tiers:

1. the National Biodiversity Authority (NBA) at Chennai, which handles access by foreign persons, transfer of research results, and IP approvals;
2. State Biodiversity Boards (SBBs), which regulate commercial use by Indian entities; and
3. Biodiversity Management Committees (BMCs) at local-body level, which prepare People’s Biodiversity Registers and must be consulted on use of resources from their area.

Core rules (as amended):

• A foreign person or foreign-controlled entity needs the NBA’s prior approval to obtain any biological resource occurring in India or associated knowledge for research, commercial use, bio-survey or bio-utilisation.
• The results of research using Indian biological resources cannot be transferred to a foreign person for money without NBA approval.
• IP rights: no person may obtain any IP right, in or outside India, for an invention based on research or information on a biological resource obtained from India without NBA approval. After the 2023 amendment the approval is needed before grant of the right, not before filing the application. Approval for PBRs under the PPV&FR Act is not required in the same way, since that Act has its own benefit-sharing scheme.
• Indian entities give prior intimation to the SBB before commercial use.
• Benefit sharing is determined on mutually agreed terms and can take the form of royalties, joint IP ownership, technology transfer, location of production units in the area, or payment to the National Biodiversity Fund or to benefit claimers.
• Exemptions cover local people and communities, including growers and cultivators of biodiversity, and vaids and hakims practising indigenous medicine, and normally traded commodities notified by the Central Government.

4. The 2023 amendment

The Biological Diversity (Amendment) Act, 2023 changed the Act significantly:

• decriminalised most offences, replacing imprisonment with monetary penalties imposed by adjudicating officers;
• exempted codified traditional knowledge and registered AYUSH practitioners from certain intimation and benefit-sharing requirements, and allowed exemptions for cultivated medicinal plants;
• defined a “foreign-controlled company” and treated it like a foreign person;
• moved the IP approval to before grant.

Supporters say the amendment encourages research, the AYUSH sector and investment. Critics say that exempting codified TK (most Ayurvedic knowledge is codified in classical texts) and the AYUSH industry removes benefit sharing from the largest users, and that decriminalisation weakens deterrence against biopiracy.

5. Benefit sharing: the overall picture

Benefit sharing appears in three Indian statutes: the Biological Diversity Act (for biological resources and associated knowledge), the PPV&FR Act (section 26, for genetic material used in a registered variety, paid into the National Gene Fund; see the note on rights under the Act), and indirectly the Patents Act (source disclosure under section 10(4)). The ITPGRFA has its own system for Annex I crops. The common problem is identifying the beneficiary: which community, which village, which state?

How this is examined

An essay on “access and benefit sharing under the CBD and Indian law” or a short note on the Nagoya Protocol or on benefit sharing. State the CBD principles with articles, Nagoya’s compliance machinery, the BDA’s three tiers and IP approval rule, the 2023 changes and the Divya Pharmacy case.