The Nagoya Protocol on Access and Benefit-Sharing (ABS) is a legally binding international treaty under the Convention on Biological Diversity (CBD). It governs access to genetic resources and associated traditional knowledge while ensuring fair and equitable sharing of benefits.
- Ensures fair compensation to biodiversity-rich countries and Indigenous communities.
- Strengthens Indigenous rights and prevents biopiracy.
- Promotes biodiversity conservation and sustainable development.
- Regulates genetic material use in industries such as pharmaceuticals, agriculture, and biotechnology.
- Adopted in 2010, entered into force in 2014; ratified by 138 countries as of 2025.
Core Principles of the Nagoya Protocol
- Access to Genetic Resources: Countries have sovereign rights; Prior Informed Consent (PIC) is mandatory before accessing genetic material.
- Benefit-Sharing (ABS): Benefits must be shared via royalties, funding, technology transfer, or joint research.
- Protection of Traditional Knowledge (TK): Indigenous communities must give consent for use of their knowledge.
Illustrative Cases
- Neem Patent Case (India): Western firms patented neem pesticides without compensating Indian communities; India revoked the patent.
- Hoodia Cactus Case (Southern Africa): San communities gained benefit-sharing from weight-loss drug patents.
ABS Mechanism
- Prior Informed Consent (PIC): Permission from provider country/community.
- Mutually Agreed Terms (MAT): Contracts detailing benefit-sharing.
- Benefit-Sharing Agreements (BSA): Define monetary, non-monetary, and social benefits.
Examples of benefits:
- Monetary: Royalties, equity shares, licensing fees.
- Non-Monetary: Technology transfer, training, research collaboration.
- Social: Infrastructure like schools, healthcare, water facilities.
Key Developments (2024–2025)
COP-16 (Colombia, 2024) – Digital Sequence Information (DSI)
- DSI = genetic data in digital form, widely used in genomics, synthetic biology, and AI-driven drug discovery.
- Before 2024, no ABS rules covered DSI; companies freely used it without compensating biodiversity-rich nations.
- Breakthrough: Global DSI Benefit-Sharing Fund established.
- Companies using DSI must contribute financially to conservation in origin countries.
- Prevents digital biopiracy and ensures Indigenous communities share benefits.
- Example: Firms using Amazonian plant data for cancer drugs must now contribute to the ABS fund.
India’s 2024 Amendment to the Biological Diversity Act
- Reduced barriers for Indian startups/researchers to use biodiversity.
- Stricter enforcement for foreign firms, with higher profit-sharing and heavy fines.
- Indigenous rights strengthened: Royalty-sharing with local communities made mandatory.
- Example: $50 million ABS deal for Himalayan medicinal plants ensured tribal communities receive direct profits.
EU’s 2025 Regulations on ABS
- Mandatory disclosure of genetic resource origin in patents.
- Strong penalties: Up to €10 million for violations.
- Pharma and biotech firms must file annual ABS compliance reports.
- Example: French firm fined €8 million for failing to disclose Amazonian fungi source.
Synthetic Biology, CRISPR, and ABS
- Gene-editing technologies (CRISPR) often use wild genetic sequences.
- Raises key questions: Who owns AI-discovered modifications? How to regulate synthetic products?
- Brazil (2025): Introduced royalties on Amazonian genetic material.
- Indonesia (2025): Mandatory ABS agreements for foreign firms.
- Proposal for COP-17 (2026): AI & ABS Governance Framework to regulate AI-created genetic sequences.
Challenges in Implementing the Protocol
National Enforcement Gaps
- Weak laws and governance in biodiversity-rich countries.
- Example: Peru, despite strong biodiversity, faces widespread unregulated genetic resource exports.
Digital Sequence Information (DSI) Compliance Issues
- DSI is easily transferable across borders, making monitoring difficult.
- Example: Arctic Microbiome Dispute (2024): Firms patented Arctic microbes without ABS agreements; later forced to share revenues.
Indigenous Rights Violations
- Many communities lack legal literacy or representation.
- Example: Madagascar Vanilla Case: Firms patented vanilla genes without farmer consent; protests led to renegotiated ABS deals.
Future Trends in ABS and Genetic Governance
Rise of AI in Genetic Research
- AI reconstructs genomes and discovers new drugs, often bypassing ABS.
- Example: Silicon Valley firm used AI to recreate Amazonian medicinal plants synthetically; Indigenous groups demanded recognition.
- Expected COP-17 Reforms:
- AI-discovered gene sequences to be covered under ABS rules.
- Mandatory disclosure of AI dataset origins.
- Global standards for AI-driven bioprospecting.
Indigenous-Led Conservation Funds
- Amazon Indigenous Biodiversity Fund (2024): $500 million to support ABS enforcement.
- Similar funds emerging in the Himalayas and Africa.
- Example: Kenya (2025): Maasai people negotiated ABS deals giving them 15% profits from drugs developed from local plants.
Global ABS Compliance Fund (Proposed 2026) – Aims to ensure biotech, AI, and synthetic biology firms contribute to biodiversity protection globally.
Conclusion
The Nagoya Protocol remains central to balancing innovation with equity in genetic resource use. The 2024–25 updates mark a turning point with:
- Inclusion of digital genetic data (DSI) in benefit-sharing.
- Stronger national laws in India, EU, Brazil, and Indonesia.
- Anticipated governance for AI-driven bioprospecting at COP-17.
Future ABS frameworks must combine technology-driven compliance, Indigenous empowerment, and international cooperation. The Protocol’s success will depend on fair governance, effective enforcement, and global solidarity in protecting biodiversity while enabling ethical scientific progress.