New Access and Benefit Sharing Regulations: A Comprehensive Review for 2025

In August 2020, the Indian Ministry of Environment, Forest and Climate Change released the draft Access and Benefit Sharing (ABS) Rules 2020, proposing new guidelines for the access and sharing of biological resources and associated knowledge. These new regulations aim to replace the previously implemented ABS guidelines of 2014 and align with the objectives of the Nagoya Protocol to the Convention on Biological Diversity. As a law firm, it is essential to understand the key changes proposed in the draft ABS regulations, and their potential implications for your clients.

Background: The Nagoya Protocol and ABS Regulations

The Nagoya Protocol, adopted in 2010, aims to ensure fair and equitable sharing of benefits arising from the utilization of genetic resources, traditional knowledge, and associated innovations. India, being a party to the Nagoya Protocol, implemented its rules and guidelines in 2014, bringing in a legal framework for access to genetic resources and associated knowledge. However, with the emergence of new challenges and advancements in the biotechnology industry, the need for revised regulations has become apparent.

Key Changes in the Draft ABS Rules 2020

1. Expanded Definition of Genetic Resources

The draft ABS regulations 2020 propose an expanded definition of genetic resources, which now includes all plant, microbial, and animal genetic material, as well as products derived from such material. Additionally, biological resources covered by the Biodiversity Act of 2002 and any traditional knowledge associated with such resources, will also be considered as genetic resources.

2. Mandatory ABS Clearing House

The ABS Clearing House will serve as a centralised information hub to facilitate the exchange of information and monitor compliance with the ABS regulations. The draft rules make it mandatory for every access and transfer agreement to be registered on the ABS Clearing House.

The draft rules propose a new legal instrument, called the ABSA, which will formalize the relationship between the provider and user of genetic resources. Any person or organisation seeking to access genetic resources will now be required to enter into an ABSA with the provider in accordance with the guidelines prescribed by the National Biodiversity Authority (NBA).

4. Provisions for Remote Access and Research Collaboration

With the advancement of technology and the growing trend of remote research collaborations, the draft rules propose a provision for remote access and research collaboration. However, the terms of such collaboration must be notified to the ABS Clearing House and the NBA.

The draft ABS rules introduce a mandatory benefit-sharing mechanism, requiring both the user and provider of genetic resources to share benefits arising out of their utilisation with the NBA. The benefits may include monetary and non-monetary contributions, such as technology transfer, capacity building, and conservation of biological resources.

6. Protection of Traditional Knowledge

The draft rules also propose to safeguard the traditional knowledge of indigenous communities by requiring their prior informed consent for access and usage of such knowledge. Additionally, any commercial use of traditional knowledge must also result in an equitable share of benefits for the concerned community.

7. Compliance and Enforcement Measures

The draft ABS regulations 2020 also lay down strict compliance and enforcement measures to ensure adherence to the regulations. Violation of these rules may result in cancellation or suspension of ABS clearance, fines, or imprisonment.

Implications

The proposed changes in the new ABS regulations are aimed at strengthening the legal framework for access and benefit sharing of biological resources and associated traditional knowledge. These regulations provide a more comprehensive definition of genetic resources and bring in mandatory benefit-sharing and compliance mechanisms. Additionally, with the mandatory registration of ABS agreements on the ABS Clearing House, the process of monitoring and enforcing these regulations will become more effective and transparent.

Conclusion

As the Indian government seeks to finalise and implement these draft ABS rules, it is imperative for stakeholders and biotechnology companies to familiarise themselves with the proposed changes and assess their impact on their business operations. As a law firm, it is essential to keep abreast of these developments and provide your clients with the necessary legal guidance to ensure compliance with the new regulations.

New Access and Benefit Sharing Regulations: A Comprehensive Review for 2025