By Iqra Sharjeel

The Nagoya Protocol is an international agreement that aims to ensure the fair and equitable sharing of benefitsarising from the utilization of genetic resources. It is part of the Convention on Biological Diversity (CBD) and was adopted on October 29, 2010, in Nagoya, Japan.
Purpose:
To create a legal framework for the Access and Benefit-Sharing (ABS) of genetic resources, especially for the use in research, biotechnology, agriculture, and pharmaceuticals, ensuring that countries and communities providing these resources are compensated fairly.
Key Elements:
- Access to Genetic Resources:
- Countries have sovereign rights over their natural resources.
- Access is subject to Prior Informed Consent (PIC) from the provider country.
- Users must negotiate Mutually Agreed Terms (MAT) for how the resources will be used.
- Fair and Equitable Benefit-Sharing:
- Benefits can be monetary (royalties, license fees) or non-monetary (research collaboration, technology transfer).
- Indigenous communities also have rights over traditional knowledge associated with genetic resources.
- Compliance Measures:
- Countries must ensure users within their jurisdiction comply with the protocol.
- Creation of national checkpoints to monitor access and benefit-sharing agreements.
Timeline:
- Adopted: October 2010
- Entered into Force: October 12, 2014
Importance:
- Protects biodiversity and encourages conservation.
- Empowers indigenous peoples and local communities.
- Encourages responsible scientific research.
- Helps in combatting biopiracy (unauthorized use of genetic resources or traditional knowledge).
Case Study: India and the Nagoya Protocol

India, a country rich in biodiversity and traditional knowledge, has been a party to the Nagoya Protocol since October 9, 2012. As one of the world’s most biologically diverse nations, India has long recognized the importance of protecting its genetic resources and ensuring fair benefit-sharing. To uphold the principles of the Nagoya Protocol, India enforces these rights through its national legislation, the Biological Diversity Act of 2002, which provides a legal framework for access to and benefit-sharing (ABS) of biological materials and traditional knowledge.
One particularly well-known example that illustrates how the protocol operates in practice is the case of the neem tree, scientifically known as Azadirachta indica. The neem tree, native to India, has been used for generations in traditional Indian systems of medicine, especially Ayurveda, for its antimicrobial and insecticidal properties. In the 1990s, this valuable plant became the center of international controversy when a European company, along with associated researchers, sought to patent a neem-based pesticide in the United States and Europe, claiming it was a novel invention.
The controversy arose because this so-called innovation was already well known and used traditionally in India for the same purpose. The attempt to patent neem products without recognizing Indian traditional knowledge was labeled as biopiracy — the unethical or unlawful appropriation of indigenous knowledge and biological resources without permission or compensation. This action sparked a significant response from Indian authorities and legal experts.
India promptly challenged the patent through legal avenues, particularly at the European Patent Office (EPO). In order to support its case, India leveraged the Traditional Knowledge Digital Library (TKDL), a government-managed database that documents ancient medicinal practices recorded in Sanskrit, Urdu, Tamil, and other languages. The evidence from TKDL demonstrated that the use of neem for pesticidal purposes had been established long before the foreign patent application. Ultimately, the European Patent Office agreed and revoked the patent, affirming India’s claim that this knowledge was not new or inventive.
This legal victory exemplified the principles behind the Nagoya Protocol. According to the protocol, any party wishing to access genetic resources from a country like India must obtain prior informed consent (PIC) and establish mutually agreed terms (MAT), including fair and equitable sharing of benefits. While the neem patent dispute occurred before the protocol officially entered into force in 2014, it played a key role in illustrating why such a framework is necessary for protecting the interests of countries rich in biodiversity and traditional wisdom.
Today, India uses tools like the Traditional Knowledge Digital Library and the establishment of local Biodiversity Management Committees (BMCs) to regulate access to its biological resources and monitor compliance. These mechanisms help prevent the unauthorized use of native species and indigenous practices, promote ethical research, and ensure that benefits are shared with the rightful knowledge holders, including local and indigenous communities.
The outcome of the neem case not only protected India’s cultural heritage and biological assets but also set a powerful global precedent. It demonstrated that countries can stand up to exploitation and enforce their rights under international law. It also encouraged multinational corporations and researchers to engage in more transparent and equitable collaborations, aligning with the values of the Nagoya Protocol.
Ultimately, India’s proactive stance and legal tools have made it a global leader in biodiversity conservation and benefit-sharing compliance. The neem case serves as a compelling example of how a country can defend its natural resources and traditional knowledge through both national legislation and international cooperation, ensuring that these assets are used sustainably and respectfully for the benefit of all.







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