Reviewing New Access And Benefit Sharing Regulations, 2025

These Guidelines have now been revised and notified on 30th April, 2025 to be called the Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Benefit Sharing) Regulations, 2025 (ABS Regulations, 2025). What is interesting to note is that the ABS Regulations were sought to be revised prior to 2025 as well. This time, however, the new regulations were brought out after the parent legislation, the BD Act underwent a major amendment and its associated rules, Biological Diversity Rules, 2004 (BD Rules) revised in 2024. Thus, for the first time, all three laws are attempting to be in consonance with each other. Moreover, unlike many other countries, Indian ABS law has been successful in receiving monetary benefits. For instance, the National Biodiversity Authority (NBA) has received Rs.221.14 crore from its inception till April 2024 as benefit sharing as evidenced from the Annual Report of 2023-2024. Various State Biodiversity Boards (SBBs) have also received benefit sharing amounts.

A bit of clarity for the users and a complete smokescreen for the providers

At the outset, it must be said that the ABS Regulations, 2025 attempts to clarify ABS processes for the resource users to some degree. Foremost, it clarifies that India intends to regulate digital sequence information which is one of the issues that is being internationally discussed. It has not defined digital sequence information as the term is used as a place holder term in the international debates.

Secondly, users are aware that certain categories of resources and knowledge attract different slabs of benefit sharing amount. For instance, those biological resources that are of high conservation value or high economic value fetch higher benefit sharing for research and for commercial utilisation. Another instance is that of traditional knowledge. Innovations based on traditional knowledge fetch more benefit sharing if innovator is applying for intellectual property rights. It is 25% more than the generally prescribed due percentage. But on inventions using bio-resources that protects humanity from epidemics, pollution, food shortage or biodiversity loss, a low range of benefit sharing has been recommended to incentivise such projects.

Thirdly, under the ABS Regulations, 2014 the benefit sharing obligation for commercial utilisation was applicable to all applicant persons whereas the ABS Regulations, 2024 completely exempts those persons and entities whose annual turnover is till 5 crores from sharing the prescribed benefits from commercial utilisation.

Fourthly, the new regulations clarify the difference between the terms 'prior approval' and 'prior intimation'. The process of prior approval which is required from the NBA was elaborated in the BD Rules, 2024 whereas the process of prior intimation which is required from the SBBs is now elaborated in the new regulation. As per the Regulation, the SBBs are supposed to give their approval for the Section 7 application or reject the application within 15 days. In case the Board or the Council does not respond within 15 days, it is deemed that approval is granted for a period of one year. This feature of deemed approval is not granted for the applications before the NBA which requires “prior approval”. Additionally, mode of benefit sharing to SBB is prescribed which aligns with the power of the SBBs to receive benefit sharing for commercial utilisation.

For the providers, the new Regulations like the amended BD Act and the revised BD Rules do not offer much. Instead, it takes away a few of their entitlements. For instance, under the ABS Regulation, 2014, 95% of the benefits had to be channelled to the benefit claimers. The ABS Regulation, 2025 reduced the sharing ratio to 85-90 % of the benefits. And as per the new Regulations even when the resources are sourced from individuals, groups, organisations, only 85-90% of benefits will go to them directly. This is ultra vires the BD Act which in Section 21(3) mandates the benefit sharing money to be paid directly to the identified providers and does not talk about any division of the benefit sharing money.

Additionally, there is a clause in the ABS Regulation 2025 which states that in case the benefit claimer is not known, the NBA and the SBB will retain the full benefit sharing amount. It is pertinent to recall here that the 2023 Amendment Act to the BD Act was criticised for lack of public participation and transparency in the whole amendment process. The current ABS Regulations 2025 was notified without even a draft being put out for public comments. The NBA on short notice has merely invited comments to revise the ABS Regulations.

Then there is the question of obtaining prior informed consent (PIC) and mutually agreed terms from stewards of bio-resources. While the new BD Rules gave hope by mandating PIC from benefit claimers, the new regulations instead of elaborating the process of obtaining PIC, are completely silent on the same. As per the Nagoya Protocol, in additional to PIC, mutually agreed terms are also required for creating an ABS agreement. But BD Act, BD Rules and these regulations are silent about this.

A lot of elaboration on monetary benefit sharing and barely anything on non-monetary benefits

The new regulations like the old Regulations emphasize monetary benefits over non-monetary benefits. The Regulations describes in detail, various kinds of monetary benefits, quantum that need to be shared, the formula for sharing it and so on. For instance, the prescribed kinds of monetary benefit sharing include (a) proceeds of auction, sale amount or purchase price; (b) gross ex-factory sale price of the product; (c) monetary consideration; (d) license fee; (e) assignment fee; and (f) royalty. The Regulation also stipulates when these kinds of monetary benefits kick in. For example, for commercialisation, a share of gross the ex-factory sale price of the commercialised product is the monetary benefit that is generally targeted. Further elaborating the monetary benefit sharing option, it is important to note that the ABS Regulations 2025 defines upfront payment for the first time (Regulation 2) and prescribes upfront payment for many regulated activities including research, commercial utilisation (under Section 3 and Section 7, BDA). Such kind of elaboration on non-monetary benefit sharing is completely missing from the new Regulations. It only has a form that lists down options for non-monetary benefits.

Other Drawbacks

Coming to other misses, with this new regulation, there was an opportunity within the BDA as well as these regulations to provide some definitions hitherto before, undefined. This was not done. Thus, there is no understanding of the scope of terms like 'digital sequence information', 'traditional knowledge' or 'academic research'. Further, the exemption carved out for cultivated medicinal plants (of a threatened status) within BDA and reiterated in these regulations could lead to a channel for wildlife laundering under the guise of legal trade in cultivated products and may incentivize excessive harvesting of wild-origin parental stock for artificial breeding. Furthermore, a sectoral approach towards benefit sharing is mentioned but there is no understanding on what this approach could look like and leaves the matter open for interpretation.

While an effort is being made to bring more coherence to the ABS mechanism in the country, the new regulations could do with bringing clarity to the aspects mentioned above. It is important that the ABS agreements are well rounded and is advantageous to sustainability of the bio-resources, its users and as well its stewards. India, as a country with two decades of experience on ABS, could have become an international role model by addressing all the issues related to ABS in law and practice. This has not happened yet.

Alphonsa is a PhD candidate at the University of Newcastle, Australia and Adv. Shyama Kuriakose is an independent legal consultant, based out of Kochi, Kerala. Views are personal.