The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization is a supplementary international agreement to the 1992 Convention on Biological Diversity (CBD). Adopted in 2010, the Protocol establishes a transparent legal framework for implementing one of the CBD’s three objectives: ensuring the equitable sharing of benefits derived from the utilization of genetic resources. This framework governs access to biological materials and ensures that resulting financial and non-financial gains are shared fairly with the resource providers.
The Core Mechanism of Access and Benefit-Sharing
The functional core of the Nagoya Protocol is the establishment of a clear, bilateral process for accessing and utilizing genetic resources, built on two interdependent requirements: Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT).
Prior Informed Consent (PIC) is the formal permission granted by the country providing the genetic resources, establishing the legal basis for the transaction. The provider country, through its designated national authority, must clearly outline the rules and procedures for access, ensuring they are transparent.
The second requirement, Mutually Agreed Terms (MAT), is a contract negotiated between the resource provider and the user. This contract specifies the conditions for the utilization of the genetic resources and the eventual sharing of benefits. Benefits can be categorized as either monetary or non-monetary, providing flexibility for different types of utilization.
Monetary benefits often include:
- Upfront payments
- Milestone payments made at different stages of development
- Access fees
- Payment of royalties from the commercialization of a resulting product
Non-monetary benefits can involve:
- Sharing of research results
- Technology transfer
- Participation in research activities
- Specialized training
- Contributing to trust funds that support conservation efforts
The MAT translates the goal of fair sharing into a binding contractual obligation that must be respected by the user.
What Materials and Knowledge are Covered
The Protocol’s scope is defined by the specific materials and associated information that fall under its regulatory framework. The primary focus is on genetic resources, which are broadly defined as any material of plant, animal, microbial, or other origin containing functional units of heredity that hold actual or potential value.
The agreement also extends its coverage to include Associated Traditional Knowledge (ATK) that is relevant to the genetic resources. ATK refers to the knowledge, know-how, and practices of indigenous and local communities that have been developed over generations concerning the properties, uses, and habitats of the genetic resources.
For genetic resources and ATK held by indigenous and local communities, the Protocol mandates that access must be granted in accordance with their customary laws and procedures. The Protocol does not apply to human genetic resources or genetic resources governed by other specialized international instruments, such as those used for food and agriculture purposes.
National Implementation and Compliance Measures
To ensure the Protocol’s requirements are met, signatory countries are obligated to translate the international agreement into enforceable domestic law. This involves establishing national legislative, administrative, or policy measures, which create the specific legal framework for Access and Benefit-Sharing (ABS) within their jurisdiction.
A significant innovation of the Nagoya Protocol is the requirement for countries to establish checkpoints to monitor the utilization of genetic resources after they have been accessed. These checkpoints are designated institutions placed at different stages of the research and development value chain, such as research funding agencies, patent offices, or regulatory authorities.
The Protocol also established the Access and Benefit-Sharing Clearing-House (ABS-CH), an online platform that acts as a central hub for sharing information related to the national implementation of the agreement. The ABS-CH enhances legal certainty and transparency by making national access requirements, contact details for regulatory authorities, and internationally recognized certificates of compliance (IRCCs) publicly available.
The Protocol’s Role in Global Biodiversity
The Nagoya Protocol is designed to support the conservation and sustainable use of global biodiversity. By creating a pathway for fair and equitable benefit-sharing, the Protocol generates incentives for countries and communities to conserve their genetic resources.
The Protocol reinforces the principle that countries have sovereign rights over their natural resources, established by the CBD in 1992. This legal recognition makes biopiracy, the unauthorized appropriation of genetic material, illegal for all signatory parties.
By promoting appropriate access and the transfer of relevant technologies, the Protocol aims to foster research and innovation while ensuring that resource providers share in the economic gains.