Context:
Recently, Lok Sabha passed the Biological Diversity (Amendment) Bill 2021 to amend the Biological Diversity Act, 2002.
| PYQ:
Q. How is the Government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies? (2019) |
About Biological Diversity Act, 2002:
- It was enacted to conserve the country’s biological diversity and promote the sustainable use of its biological resources.
- Regulatory Structure: It sets up a three-tier structure for regulation:
- National Biodiversity Authority(NBA) at the national level.
- State Biodiversity Boards(SBB) at the state level.
- Biodiversity Management Committees at the local body level.
- Benefit Sharing: The Act provides for sharing of benefits with conservers of biodiversity and holders and creators of associated knowledge.
- Benefits may be shared in various forms such as monetary compensation, sharing of intellectual property rights, or technology transfer.
- Adherence to UN Convention: It was framed to give effect to the United Nations Convention on Biological Diversity (CBD), 1992.
- Inclusion of Intellectual Property Rights (IPRs): The Act includes in its ambit the transfer of research results and application for IPRs relating to Indian biological resources.
Key Provisions of the Biological Diversity (Amendment) Bill, 2021:
| Provision |
The Biological Diversity Act, 2002 |
Biological Diversity Amendment Bill 2021 |
- Approval/Intimation requirement for accessing biological resources or associated knowledge
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Prior intimation required to SBB (for certain domestic entities)
- Entities: Indian citizens, and companies registered in India except those which require NBA approval.
- Activities: Obtaining biological resources occurring in India for commercial utilization.
- Exemptions: Use by local people and communities including growers and cultivators of biodiversity, and vaids and hakims practicing indigenous medicine.
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Prior intimation to SBB
- Activities: Access to associated knowledge for commercial utilization will also require prior intimation
- Exemptions: Adds exemptions for:
- codified traditional knowledge,
- cultivated medicinal plants and their products,
- AYUSH practitioners; limits the exception to vaids and hakims, and AYUSH practitioners to use for sustenance and livelihood.
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| Offenses & Penalties |
- Under the Act, failing to obtain approval or provide prior intimation for various activities are considered offenses punishable with imprisonment of up to five years, a fine, or both.
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- The Bill decriminalizes the offenses and makes offenses punishable with a penalty between one lakh rupees and Rs 50 lakh.
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- It allows domestic companies to use biodiversity without the permission from biodiversity boards.
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- As per the amendments, only foreign controlled companies will require permission. This indicates companies with shares controlled by foreign companies would also be exempted.
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- Codified Traditional Knowledge (CTK)
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- Users of codified traditional knowledge and AYUSH practitioners will be exempted from sharing benefits with local communities.
- The World Intellectual Property Organization defines CTK as “traditional knowledge, which is in some systematic and structured form, in which the knowledge is ordered, organized, classified and categorized in some manner.
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- Sharing of Traditional Knowledge
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- As per the Bill, any person cannot share or transfer any research results on biological resources or associated traditional knowledge from India to an individual, whether for monetary gain or otherwise, without prior written approval from the National Biodiversity Authority.
- However, codified traditional knowledge can only be shared within India and does not require approval.
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- Monitoring of Biological Resources from Foreign Countries
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- A new Section 36(A) has been added emphasizing on the monitoring of the Biological Resources obtained from foreign countries for use in India as per the provisions of the Nagoya Protocol on access and benefit sharing.
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- Approval for Intellectual Property Rights (IPR)
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- The Bill specifies distinct approval processes based on the origin of the entity. Foreign entities will require approval from the National Biodiversity Authority ( NBA ) whereas domestic entities will be required to register with NBA.
- However, domestic entities will need approval from the NBA at the time of commercialisation of IPR.
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- The Act recognizes the rights of local communities to access biological resources and share the benefits arising from their use.
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- The Bill removes research and bio-survey activities from the purview of benefit sharing requirements.
- Benefit sharing will be based on terms agreed between the user and the local management committee represented by the National Authority.
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Concerns
- Ambiguity: The term Codified Traditional Knowledge has not been defined. A broad interpretation might exempt all local traditional knowledge from benefit sharing requirements.
- Removal of Prior Informed Consent: There is no provision for a mechanism for obtaining prior informed consent of the local and indigenous communities. This is in contrast with the framework under Nagoya Protocol.
- For Example: In Divya Pharmacy vs Union of India (2018), the Uttarakhand High Court had observed that under the Nagoya Protocol, the concept of fair and equitable benefit sharing is focused on the benefits for local and indigenous communities.
About Nagoya Protocol:
- It requires a signatory country to ensure that prior informed consent or approval and involvement of indigenous and local communities is obtained for access to genetic resources and traditional knowledge.
- India signed the Nagoya Protocol in 2011.
About Benefit Sharing?
- It refers to requiring applicants to share monetary and non-monetary benefits with benefit claimants and local people.
- Benefit claimants are conservers of biodiversity, or creators or holders of associated traditional knowledge.
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- Removal of Direct Role of Local Communities: The Bill removes the direct role of local communities in determining benefit sharing provisions.
- No Differentiation in Offenses: The Bill has not made any differentiation based on the type of offence.
- For Example: The punishment is the same for failing to take approval for either research or commercial utilization.
- Empowerment Executive: The Bill changes the adjudicating authority from a Judge to a government official. The penalty decisions will be based on an inquiry instead of a judgment after arguments in an open court.
Significance of Biological Diversity (Amendment) Bill, 2021 :
- Boost Foreign Investments: It seeks to bring more foreign investments in the chain of biological resources, including research, patent and commercial utilization and promotes ‘ease of doing business’.
- Promotion of Indian System of Medicine: It intends to encourage the Indian system of medicine, facilitate fast-tracking of research, the patent application process and cultivation of wild medicinal plants.
- Congruency in Legislation: Definition of a foreign company in the bill has been aligned with the definition already given in the Companies Act, 2013 to ensure that companies come under the Regulatory Framework of NBA for commercial utilization and obtaining patent and other companies by SBB.
Way Forward:
- Protected Areas and Conservation Reserves: Establish and expand protected areas and conservation reserves to safeguard critical habitats and ecosystems.
- Community Involvement and Indigenous Knowledge: Engage local communities, including indigenous peoples, in conservation efforts.
- Sustainable Agriculture and Fisheries: Promote sustainable agricultural practices that prioritize biodiversity conservation, such as organic farming, agroforestry, and supporting biodiversity-friendly fishing practices.
- Research and Monitoring: Invest in scientific research and monitoring programs to understand biodiversity patterns, threats, and the effectiveness of conservation measures.
- International Cooperation: Engage in international agreements and initiatives, such as the Convention on Biological Diversity and the Nagoya Protocol, to enhance biodiversity conservation on a global scale.
- Corporate Responsibility: Encourage businesses to adopt sustainable practices and consider biodiversity conservation in their operations and supply chains.
About Biodiversity:
- Biodiversity refers to the number and variety of organisms found within a specified geographic region.
- It relates to the variability among living organisms on the earth, including the variability within and between the species and that within and between the ecosystems.
- Biodiversity can be discussed at three levels:
- Genetic Diversity: Genetic biodiversity refers to the variation of genes within species
- Species Diversity: It relates to the number of species in a defined area. The diversity of species can be measured through its richness, abundance and types.
- Ecosystem Diversity: Ecosystem diversity refers to the variety of different ecosystems found within a specific geographical area or across the entire planet.
Constitutional Provisions relating to Biodiversity:
- Article 48A: Protection and improvement of environment and safeguarding of forests and wildlife. The State shall endeavor to protect and improve the environment and to safeguard the forests and wildlife of the country
- Article 51-A (g): It shall be the duty of every citizen of India to protect and improve the natural environment including forests, lakes, rivers and wildlife and to have compassion for living creatures.
United Nations Convention on Biological Diversity:
- The United Nations Convention on Biological Diversity, informally known as the Biodiversity Convention is a multilateral treaty opened for signature at the Earth Summit in Rio De Janeiro in 1992.
- It comes under the United Nations Environment Programme (UNEP).
- India is also a party to the Convention.
- The convention is legally binding on its signatories.
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News Source: The Hindu
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July 26, 2023