Advancing Global Biodiversity Goals: The Cartagena and Nagoya Protocols

The Convention on Biological Diversity (CBD), adopted at the 1992 Rio Earth Summit, set out three core objectives: conserving biodiversity, ensuring its sustainable use, and guaranteeing the fair sharing of benefits from genetic resources. But broad objectives alone don’t create enforceable international rules. That is where the two landmark protocols under the CBD come in – the Cartagena Protocol on Biosafety and the Nagoya Protocol on Access and Benefit Sharing (ABS). Together, they operationalize the CBD’s goals in two very different but equally critical domains: the safe movement of genetically modified organisms across borders, and the equitable distribution of gains from the use of nature’s genetic wealth.

The Cartagena Protocol on Biosafety 🔗

The Cartagena Protocol on Biosafety is a supplementary agreement to the CBD that specifically addresses the risks posed by living modified organisms (LMOs) – organisms whose genetic material has been altered through modern biotechnology, such as genetically modified crops or microorganisms used for bioremediation. It was adopted on 29 January 2000 in Montreal, Canada, and entered into force on 11 September 2003 after the required 50 instruments of ratification were deposited.

The Protocol grew out of a recognition that while modern biotechnology holds enormous promise – in food security, medicine, and agriculture – it also carries risks that are difficult to predict or fully quantify. The Biosafety Protocol seeks to protect biological diversity from the potential risks posed by LMOs resulting from modern biotechnology and makes clear that countries may apply caution even where complete scientific certainty is absent – this is known as the precautionary principle.

Core mechanism: Advance Informed Agreement (AIA) 🔗

The Protocol’s most significant procedural tool is the Advance Informed Agreement (AIA) procedure. This applies to LMOs that are intended to be deliberately released into the environment – for instance, genetically modified seeds meant for planting in open fields. Under the AIA procedure, an exporting country must provide a notification to the importing country before the first shipment of such LMOs, and the importing country must acknowledge receipt within 90 days and communicate its decision within 270 days. This mechanism ensures that every importing nation has the information and time needed to conduct its own risk assessment and make an informed decision before accepting the LMO.

A separate – and somewhat simpler – procedure applies to LMOs intended for direct use as food, feed, or for processing (commonly referred to as LMOs-FFP). For these, countries that approve and market such LMOs must make their decisions and associated risk assessments publicly available through the Biosafety Clearing-House (BCH), an internet-based information exchange platform established under the Protocol to help countries share scientific, technical, environmental, and legal information.

Documentation, labelling, and liability 🔗

The Cartagena Protocol provides minimum documentation requirements for the international movement of LMOs, requiring that shipments be properly identified and labelled so that importing countries always know what they are receiving. Countries retain the right to impose additional documentation requirements under their domestic laws, provided these are consistent with the Protocol’s objectives.

In 2010, a Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress was adopted to complement the Cartagena Protocol. This supplementary protocol establishes rules on liability and redress in cases where damage to biodiversity results from transboundary movements of LMOs.

Significance for developing nations 🔗

One of the Protocol’s most important features is its explicit recognition of the right of developing countries to ban LMO imports if they determine that adequate scientific evidence of safety is lacking. This directly addresses the imbalance between biotech-producing nations – primarily wealthy, industrialized countries – and biodiversity-rich developing nations that may bear the ecological consequences of LMO releases. As of 2023, 173 states and the European Union are Parties to the Cartagena Protocol, making it one of the most widely ratified environmental treaties in the world.

The Nagoya Protocol on Access and Benefit Sharing 🔗

While the Cartagena Protocol tackles biosafety, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization addresses a fundamentally different problem: who benefits when genetic resources – derived from plants, animals, or microbes – are accessed for commercial or research purposes? The Nagoya Protocol was adopted at the tenth meeting of the CBD Conference of Parties in Nagoya, Japan in October 2010 and entered into force on 12 October 2014. It has since been ratified by 142 countries.

The Protocol operationalizes the third objective of the CBD – fair and equitable benefit sharing – by creating a legally binding international framework. The Nagoya Protocol affirms the sovereign rights of countries over their natural resources, empowering each nation to govern access to genetic resources within its territory and to impose benefit-sharing requirements on those who utilize them.

Three pillars: access, benefit sharing, and compliance 🔗

The ABS framework under the Nagoya Protocol rests on three interconnected pillars. The first is Access – countries may require prior authorization before a researcher or company can collect or use genetic resources from their territory. The second is Benefit Sharing – when those resources generate commercial value, a portion of that value must be shared with the provider country and the local communities that have historically conserved those resources. The third is Compliance – user countries must put in place measures to monitor and ensure that their researchers and companies adhere to the access terms set by provider countries.

The Protocol also extends protection to traditional knowledge associated with genetic resources. Where indigenous or local communities hold knowledge about the properties or uses of biological materials – such as the medicinal uses of a plant – that knowledge itself is subject to ABS requirements. This means companies seeking to exploit such knowledge must obtain prior informed consent (PIC) from those communities and negotiate mutually agreed terms (MAT) for any benefit sharing.

India and the fight against biopiracy 🔗

India’s experience with the Nagoya Protocol is deeply personal. As one of the world’s 17 mega-diverse countries – holding 7-8% of the world’s recorded species on just 2.4% of its land area – India has been a repeated victim of biopiracy. Well-known cases include the patenting of neem-based fungicides in Europe and the patenting of turmeric’s wound-healing properties in the United States, both of which appropriated centuries-old traditional knowledge without permission or compensation. India successfully challenged both patents – the European Patent Office revoked the neem patent in 2005, and the US Patent and Trademark Office revoked the turmeric patent in 1997 – but the legal battles were lengthy and costly.

These episodes directly shaped India’s domestic legislative response. The Biological Diversity Act, 2002 (BD Act) was enacted to prevent the misappropriation of genetic resources and the traditional knowledge of local communities in India, and it has since served as a model for biodiversity legislation in many developing countries. India signed the Nagoya Protocol in 2011 and ratified it in 2012. To implement ABS, India’s BD Act establishes a three-tier institutional structure: the National Biodiversity Authority (NBA) at the national level, State Biodiversity Boards (SBBs) at the state level, and Biodiversity Management Committees (BMCs) at the local level.

India also maintains the Traditional Knowledge Digital Library (TKDL), a database that documents traditional medicinal knowledge from ancient Indian texts – including Ayurveda, Unani, and Siddha – in formats accessible to international patent examiners. This proactive measure reduces the risk of biopiracy by making prior art readily searchable, thereby helping patent offices reject applications based on already existing traditional knowledge.

Challenges in implementation 🔗

Despite a robust legal framework, implementation of ABS under the Nagoya Protocol remains difficult across the globe. As researchers have noted, “access continues while benefits remain illusory” – meaning that while genetic resources continue to be commercially exploited, the communities that custodianship those resources rarely see tangible benefits. Practical challenges include tracking how genetic resources are used once they leave provider countries, establishing effective consent mechanisms with local communities, and dealing with the growing use of Digital Sequence Information (DSI) – where companies extract genetic sequence data from public databases without ever physically accessing the biological material, potentially bypassing ABS obligations entirely.

In India specifically, recent amendments to the Biological Diversity Act drew criticism from environmentalists and legal scholars, who warned that streamlining approval processes and decriminalizing violations could dilute ABS obligations and open the door to increased commercial exploitation of India’s ecosystems.

How the two protocols reinforce each other and the CBD 🔗

The Cartagena and Nagoya Protocols operate in different domains but share the same foundational logic: that the use of biological resources and the power of biotechnology must be governed in a way that is ecologically responsible, scientifically grounded, and economically just. The Cartagena Protocol ensures that when genetic material is modified and transferred across borders, it is done safely, with full information and national consent. The Nagoya Protocol ensures that when genetic material is accessed for research or commerce, the communities and countries from which it originates receive a fair share of any resulting benefits.

Together, they address one of the central tensions in biodiversity governance: how to promote scientific and economic innovation while preventing the exploitation of nature and of the communities that have lived with and protected it for generations. Countries like India – biodiversity-rich but historically vulnerable to biopiracy – have a direct stake in ensuring both protocols are effectively implemented and enforced at both the international and domestic levels.

Key takeaways for law students 🔗

For students of IP and international law, these two protocols illustrate how international treaties are layered and specialized. The CBD sets the broad mandate; the protocols provide the operational detail. The Cartagena Protocol applies the precautionary principle to LMO transfers, while the Nagoya Protocol applies the concept of sovereign rights over natural resources to create binding access and benefit-sharing obligations. Both require domestic implementing legislation – in India’s case, the Biological Diversity Act, 2002 and associated rules – which then become the first point of engagement for lawyers, businesses, and researchers dealing with biodiversity-related intellectual property.

Understanding these frameworks is also important in the context of TRIPS and the broader IP system. The tension between patent protection for biotech innovations and the rights of source communities over their genetic resources and traditional knowledge sits at the heart of ongoing international negotiations – from WIPO’s Intergovernmental Committee (IGC) to the CBD’s own discussions on Digital Sequence Information. Both protocols are not static agreements; they are living frameworks that continue to evolve as biotechnology advances.

What do you think? Should countries like India prioritize stricter enforcement of existing ABS rules, even if it slows down scientific research and investment in biotechnology? And as Digital Sequence Information increasingly allows commercial value to be extracted from genetic data without physical access to biological material, do you think the current framework of the Nagoya Protocol is still adequate to prevent biopiracy?

References

1. https://www.cbd.int/biosafety
2. https://www.cbd.int/article/cartagena-protocol-20th-anniversary
3. https://en.wikipedia.org/wiki/Cartagena_Protocol_on_Biosafety
4. https://www.isaaa.org/resources/publications/pocketk/8/default.asp
5. https://www.nepad.org/content/background-cartagena-protocol-biosafety
6. https://eur-lex.europa.eu/EN/legal-content/summary/convention-on-biological-diversity-cartagena-protocol-on-biosafety.html
7. https://www.globalpolicywatch.com/2024/10/the-nagoya-protocol-at-its-10th-anniversary-lessons-learned-and-new-challenges-from-access-and-benefit-sharing/
8. https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2023.1124120/full
9. https://www.pib.gov.in/newsite/printrelease.aspx?relid=88149
10. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3048709
11. https://www.legalbites.in/environment-law/the-biological-diversity-act-2002-overview-of-access-and-benefit-sharing-provisions-1128830
12. https://india.mongabay.com/2020/04/india-bioresource-access-and-benefit-sharing-how-far-have-we-come/
13. https://www.science.org/content/article/amendments-indian-biodiversity-laws-could-open-doors-exploitation