The government introduced the Biological Diversity (Amendment) Bill, 2021, in the Lok Sabha to facilitate fast-tracking research, encourage the Indian system of medicine, and decriminalise specific provisions for local communities, ‘Vaids,’ ‘Hakims,’ and registered AYUSH practitioners who have been practising indigenous medicines for “sustenance and livelihood“.

The Bill exempts Ayush practitioners from the Biological Diversity Act, 2002, allowing the Indian traditional medicine sector more accessible access to biological resources and traditional knowledge. On the other hand, legal experts have expressed worries that loosening industry regulations could harm the environment and go against the notion of sharing commercial profits with indigenous populations.

The Biological Diversity Amendment Bill 2021 is a Bill that seeks to protect biological diversity

The Biological Diversity Act of 2002 was enacted to promote biological diversity protection and a fair and equitable distribution of monetary advantages derived from the commercial utilisation of biological resources and traditional knowledge. Now, the Biological Diversity (Amendment) Bill, 2021, seeks to reduce pressure on wild medicinal plants by encouraging medicinal plant cultivation; exempts Ayush practitioners from notifying biodiversity boards for accessing biological resources or knowledge; facilitates fast-tracking of research, simplifies the patent application process, and decriminalises certain offences; and attract more foreign investments in biological research.

What is the purpose of amending the Biodiversity Act of 2002?

Concerns from the Ayush medicine, seed, industrial, and research sectors were expressed in the Bill. The government was urged to simplify, streamline, and decrease the compliance burden to create a suitable joint research and investments environment. They also wanted to simplify the patent application process, expand access, and share benefits with local communities. Most of the time, this is a percentage of the sale price.

Ayush firms have been requesting that the benefit-sharing provisions be relaxed. The Divya Pharmacy in Uttarakhand is a case in point, which Swami Ramdev and Acharya Balkrishna created. In 2016, the Uttarakhand Biodiversity Board (UBB) issued a notice to Divya Pharmacy, stating that the company had violated the Biodiversity Act by using biological resources from the state for its ayurvedic formulations without informing the board and that the company would be required to pay an access and benefit-sharing fee. In December 2016, the company filed a writ petition in the Uttarakhand high court, contesting the biodiversity board’s powers to decide benefit-sharing by Indian enterprises, in response to the board’s notification. In a 2018 ruling, the court maintained the biodiversity board’s authority.

The Biological Diversity Amendment Bill 2021 was proposed without a public consultation period, as required under the pre-legislative consultative policy. “The measure has only recently been introduced. According to a senior official of the ministry of environment, forest, and climate change, the environment ministry will also publish the law for public discussion, with a month to respond“.

What amendments does the Biological Diversity Amendment Bill 2021 intend to make?

The law focuses on who has access to biological resources and information and monitoring that access. Ayush practitioners have been spared from the Act’s scope, which is significant because the Ayush business relies heavily on India’s biological resources. In the Bill, the role of state biodiversity boards has been strengthened and clarified. According to Kanchi Kohli, a legal scholar at the Centre for Policy Research, significant modifications are proposed in the crimes section. Violations of the law relating to access to biological resources and benefit-sharing with communities, which are currently recognised as criminal offences and are not subject to bail, are proposed to be reclassified as civil offences.

This Bill would have provided a crucial chance to align domestic law with the 2010 Nayogya Protocol on ABS’s free prior informed consent requirements“. However, the proposed revisions continue to marginalise biodiversity management committees. Thus this was a missed opportunity (BMCs). Their authority has not been expanded, and the proposed modifications empower state biodiversity boards to represent BMCs in determining benefit-sharing arrangements, Kohli explained.

National and state biodiversity boards are mandated by the Biodiversity Act of 2002 to consult biodiversity management committees (formed by every local body) before making any decisions on the use of biological resources.

What are Bill’s other drawbacks?

One of the most significant changes in the new Bill is that registered Ayush practitioners who have been practising indigenous medicine can now use any biological resource and its associated knowledge for commercial purposes without notifying the state biodiversity board first. The modification appears to have been made solely for the advantage of the Ayush industry. The Bill’s primary goal is to enable biodiversity trading rather than conservation, biodiversity protection, or local community knowledge. According to environmental lawyer Ritwick Dutta, the modifications are “totally antithetical to the goal and objective of the Biological Diversity Act, 2002.”

Dutta further pointed out that the phrase “bio-utilization” is not included in the law. “Bio-utilization is a key component of the Act. “Leaving out bio use would leave out a slew of commercially motivated operations including characterisation, incentivisation, and bioassay,” noted Dutta.

The Bill also exempts cultivated medical plants from the Act’s reach, although it determines which species are produced and that are wild. Under the Act’s access and benefit-sharing provisions, this clause could allow huge corporations to avoid the need for prior approval or to share the benefit with local communities. Many people are concerned that if the Bill is passed, it will allow businesses to avoid ABS (Access Benefit Sharing) compliance. When comparing the amendment Bill to the existing BD Act, it is found that certain elements were decriminalised, allowing enterprises who commercially utilise bio-resources and breach ABS standards to get away with a fine.

These offences are cognisable and non-bailable under Section 58 of the present BD Act. Section 58 of the amendment Bill is repealed, depriving states of their ability to penalise criminals. The State Biodiversity Board’s maximum penalty for violating corporations is a fine of Rs 1-5 lakh. If the fine is not paid or the breach continues, an additional penalty of up to ‘1 crore may be applied. However, the adjudicating official chosen by the Central government will decide on such a penalty.

What is the difference between access and benefit-sharing?

Benefits obtained from the use of biological resources must be shared fairly and equitably among indigenous and local populations, according to the Convention on Biological Diversity and the Nagoya Protocol on Access and Benefit Sharing, both of which India is a signatory. When an Indian or foreign corporation or individual wants to access biological resources like therapeutic plants or knowledge about them, they must first get permission from the national biodiversity board. The board can apply a benefit-sharing fee or royalty and requirements requiring the corporation to share the monetary advantage from the commercial use of these resources with local people working to preserve biodiversity in the area.

Conclusion: The amended Bill aims to decrease the impact on wild medicinal plants by supporting medicinal plant cultivation and promoting the Indian medical system. It also seeks to speed up research, the patent application procedure, and the transfer of research results “while utilising the biological resources available in India without jeopardising the United Nations Convention on Biological Diversity and its Nagoya Protocol’s objectives“. The measure also aims to decriminalise specific laws in order to encourage more foreign investment in the biological resource chain, including research, patenting, and commercialisation, “without jeopardising national security“. If the new Bill passes, all AYUSH enterprises would claim that they have access to grown medicinal plants and refuse to pay the ABS fee. No agency has the authority to confirm whether the raw materials utilised by businesses come from the forest or developed lands.

Disclaimer: The present article intends to provide general guidance on the subject, and you can also consult us in your specific case.

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    Abhishek is an intellectual property Attorney. He specializes in the registration and maintenance of patents, designs, trademarks, and copyrights. He regularly assists companies in relation to crucial technology issues. He also helps organizations or individuals to develop patent portfolio management strategies for exciting new inventions and processes. Abhishek has past work experience with reputed firms like SaiKrishna and Associates Advocates, L.S. Davar and Co., Masilamani Law Partners, and Ripple IP Services (NCR).