India, being one of the seventeen megadiverse countries of the world, hosts approximately 7-8% of the recorded species of the planet. Recognizing the critical need to conserve this rich biological heritage while ensuring equitable sharing of benefits arising from its utilization, the Indian Parliament enacted the Biological Diversity Act in 2002.
1. Genesis and Objectives
The Biological Diversity Act, 2002 (Act No. 18 of 2003) was enacted to fulfill India's obligations under the United Nations Convention on Biological Diversity (CBD), ratified by India in 1994. The Act came into force on February 5, 2003, establishing a comprehensive legal framework for the conservation of biological diversity, sustainable use of its components, and fair and equitable sharing of benefits arising from the utilization of biological resources and associated traditional knowledge.
The primary objectives of the Act are threefold: to conserve biological diversity, to ensure sustainable utilization of biological resources, and to facilitate equitable sharing of benefits arising from the use of biological resources and knowledge. The legislation recognizes that biological resources have enormous economic potential and that local communities possess invaluable traditional knowledge about these resources.
2. Salient Features of the Act
2.1 Three-Tier Institutional Structure
The Act establishes a robust three-tier regulatory mechanism to oversee all matters relating to biological diversity:
National Biodiversity Authority (NBA): Established at the national level and headquartered in Chennai, the NBA is the apex regulatory body that regulates access to biological resources and associated traditional knowledge by foreign individuals, institutions, or companies. It advises the Central Government on matters relating to conservation, sustainable use, and equitable sharing of benefits.
State Biodiversity Boards (SBBs): Constituted by State Governments to regulate access to biological resources and associated knowledge by Indian nationals for commercial purposes. Each state has the authority to establish its own Board to address regional biodiversity concerns.
Biodiversity Management Committees (BMCs): Created at local body levels (Gram Panchayats, Municipalities, and Corporations) to promote conservation, sustainable use, and documentation of biological diversity. BMCs are responsible for preparing People's Biodiversity Registers (PBRs) documenting local biological resources and associated traditional knowledge.
2.2 Regulation of Access to Biological Resources
The Act imposes stringent regulations on accessing India's biological resources. Any person or organization, whether foreign or Indian, seeking to obtain biological resources or associated knowledge for commercial utilization, research, or bio-survey must obtain prior approval from the appropriate authority. Foreign nationals, non-resident Indians, and foreign-controlled companies require approval from the NBA, while Indian citizens and organizations need permission from the State Biodiversity Boards for commercial purposes.
The Act prohibits transfer of Indian biological resources and associated knowledge to foreign nationals without specific approval. It also restricts the application for intellectual property rights in India or abroad based on research or information on biological resources obtained from India without prior approval from the NBA.
2.3 Protection of Traditional Knowledge
A significant feature of the Act is its recognition and protection of traditional knowledge held by indigenous and local communities. The Act mandates that benefits arising from the commercial utilization of such knowledge must be shared equitably with the knowledge holders. It empowers BMCs to document traditional knowledge through People's Biodiversity Registers, which serve as important repositories of community-held wisdom regarding local biological resources.
2.4 Intellectual Property Rights Provisions
The Act contains specific provisions regarding intellectual property rights related to biological resources. Section 6 prohibits any person from applying for any intellectual property right in or outside India for any invention based on research or information on biological resources obtained from India without obtaining prior approval from the NBA. This provision aims to prevent biopiracy and ensure that India and its local communities receive due recognition and benefits from their biological resources.
2.5 Penalties and Offences
To ensure compliance, the Act prescribes stringent penalties for contraventions. These include imprisonment for terms up to five years and fines up to ten lakh rupees, depending on the nature of the offense. Violations such as unauthorized access to biological resources, non-compliance with benefit-sharing agreements, or unauthorized transfer of resources to foreign entities attract substantial penalties.
3. Access and Benefit Sharing (ABS)
3.1 Conceptual Framework
Access and Benefit Sharing (ABS) constitutes the cornerstone of the Biological Diversity Act. The ABS mechanism is designed to ensure that when biological resources or associated traditional knowledge are accessed for commercial or research purposes, the benefits arising from such utilization are shared fairly and equitably with the providers of these resources, including local and indigenous communities.
The ABS framework is grounded in the principle of sovereignty of states over their natural resources and recognizes the rights of communities over their traditional knowledge. It seeks to create a balanced approach that promotes innovation and research while ensuring that those who have conserved and nurtured biological diversity receive appropriate compensation and recognition.
3.2 Mechanisms for Access
Access to biological resources and associated knowledge is granted through a structured process involving applications to the appropriate authority (NBA for foreign entities, SBBs for Indian entities). The applicant must submit detailed information about the intended use, the biological resources sought, and the terms and conditions under which benefit sharing will occur.
The authorities evaluate applications based on several criteria including conservation concerns, sustainable use considerations, the nature of access sought, and the adequacy of proposed benefit-sharing arrangements. Prior Informed Consent (PIC) from relevant stakeholders, particularly local communities possessing traditional knowledge, is a mandatory requirement before granting access.
3.3 Forms of Benefit Sharing
Benefits arising from the utilization of biological resources and traditional knowledge can be both monetary and non-monetary. The Act provides flexibility in determining appropriate benefit-sharing arrangements based on the specific circumstances of each case.
Monetary Benefits include:
- Direct payment of a percentage of gross revenue or net profit
- Upfront payments or milestone payments during research and development
- License fees for commercialization of products
- Royalty payments on the sale of products derived from biological resources
- Technology transfer fees and joint venture arrangements
Non-Monetary Benefits include:
- Sharing of research and development results with the provider communities
- Technology transfer and capacity building initiatives
- Participation in product development and scientific research
- Institutional capacity development for conservation and sustainable use
- Education and training opportunities for local communities
- Access to scientific information and databases
- Joint intellectual property rights ownership
- Support for conservation initiatives and livelihood programs
3.4 Benefit Sharing Agreements
The NBA or SBBs, as applicable, enter into benefit-sharing agreements with applicants after consultation with relevant stakeholders, including BMCs representing local communities. These agreements specify the terms and conditions for access to biological resources and the mechanism for sharing benefits. The agreements are legally binding and their violation attracts penalties under the Act.
Benefit-sharing agreements typically address the quantum and mode of benefit sharing, timelines for payment, conditions for intellectual property rights, conservation measures to be undertaken, and mechanisms for monitoring and compliance. The National Biodiversity Fund and State Biodiversity Funds have been established to collect benefit-sharing amounts, which are then utilized for conservation and development activities benefiting local communities.
3.5 Challenges in ABS Implementation
Despite the robust legal framework, implementation of ABS provisions faces several challenges. These include difficulties in valuing biological resources and traditional knowledge, determining appropriate benefit-sharing ratios, ensuring effective participation of local communities in decision-making, and monitoring compliance with benefit-sharing agreements. The documentation of traditional knowledge through People's Biodiversity Registers, while crucial, remains incomplete in many regions.
Furthermore, the interface between the Biological Diversity Act and other intellectual property laws, particularly the Patent Act, requires careful navigation to prevent biopiracy while encouraging legitimate research and innovation. The Act's extraterritorial provisions, which seek to regulate even overseas intellectual property applications based on Indian biological resources, present enforcement challenges.
4. Achievements and Way Forward
The Biological Diversity Act has achieved significant milestones since its enactment. The establishment of the National Biodiversity Authority and State Biodiversity Boards has created institutional capacity for biodiversity governance. Over two lakh Biodiversity Management Committees have been constituted across the country, representing grassroots-level engagement in biodiversity conservation. The preparation of People's Biodiversity Registers has begun documenting invaluable traditional knowledge in many states.
The Act has successfully prevented several instances of biopiracy and unauthorized access to Indian biological resources. It has also facilitated legitimate research and commercial utilization of biological resources through its access and benefit-sharing mechanisms, channeling benefits to conservation efforts and local communities.
Moving forward, strengthening implementation mechanisms, enhancing awareness among stakeholders, completing the documentation of traditional knowledge, streamlining procedures for access, and building capacity at all institutional levels remain critical priorities. The Act must evolve to address emerging challenges such as digital sequence information, synthetic biology, and the intersection of biodiversity conservation with climate change mitigation efforts.
