Addressing the Nagoya Protocol and Access Benefit sharing

The Convention on Biological Diversity and its Nagoya Protocol are reshaping how biotechnology companies can access and commercialize biological resources including strains, metagenomes, and digital sequence information (DSI).

Historically, countries in the Global South supplied valuable biological resources while receiving only limited economic benefits. This led to the recognition that biodiversity and genetic resources should be used based on fair compensation rather than exploitation. Under the framework of the Convention on Biological Diversity, international discussions have since focused on protecting biodiversity while ensuring fair access to biological resources, genetic materials, and traditional knowledge. Today, these discussions increasingly include DSI, computational biology, and AI-driven biotechnology applications.

In the jungle of confusing obligations regarding Access and Benefit-sharing (ABS), these proven, proprietary resources are becoming increasingly important from both strategic and regulatory perspectives.

Why Digital Sequence Information (DSI) Is Becoming Increasingly Important

Over many years, scientists have created large public DNA databases by sequencing microorganisms and environmental samples from highly diverse ecosystems, including hydrothermal vents, Antarctic environments, marine ecosystems, and terrestrial habitats worldwide. In biotechnology, many well-known industrial tools originate from such unique environments. 

When DNA is isolated and sequenced, the primary value often no longer resides in the physical sample itself but rather in the resulting digital sequence data. Therefore, DSI has become a major focus of international ABS discussions. At the Convention on Biological Diversity meeting in February 2025, the “Cali Fund” was launched to support the sharing of benefits arising from the use of DSI derived from genetic resources.

How the Nagoya Protocol Affects Computational Biology

It is relatively straightforward to understand that the direct use of genetic sequences originating from a Nagoya-compliant source may trigger ABS obligations and potentially royalty payments. However, additional regulatory questions arise when software tools, machine learning systems, and AI models are trained on such data. This creates unresolved regulatory questions for the biotechnology industry: Should AI-trained models based on DSI trigger ABS obligations? How should royalties be calculated? Do synthetic sequences fall within the scope of ABS frameworks?

Complexity and Uncertainty in Global ABS Regulation

One of the major challenges associated with ABS compliance is the fragmented nature of global implementation. Individual countries may establish their own ABS legislation, and some countries even allow regional or local governance structures. For example, India has approximately 270,000 local Biodiversity Management Committees that may need to be consulted when negotiating access to biological diversity.¹ This illustrates the operational complexity of properly implementing and complying with ABS regulations, which may be subject to further changes.

The resulting legal uncertainty may ultimately encourage some companies to avoid sourcing biological materials from jurisdictions perceived as legally complex or commercially unpredictable.

Recommendation for Industry

• Companies developing new products based on biological materials, including enzymes and microorganisms, should establish an ABS strategy at an early stage to minimize regulatory risk, protracted contractual negotiations, and potential royalty-exposure.
   
• Through MetXtra™ and the BRAIN BioArchive, customers gain access to curated, ABS-free metagenomic and microbial resources designed to support compliant innovation in industrial biotechnology while reducing regulatory uncertainty and potential royalty exposure.
   
• By combining scientific expertise with regulatory-conscious resource development, BRAIN Biotech supports customers in advancing scalable and commercially viable industrial biotechnology programs based on robust biological assets.