The rapid advancement of biotechnological research has fundamentally transformed how the world interacts with biological diversity, shifting the focus from physical specimens to the digital realm. Genetic sequences and information derived from plants, animals, microorganisms, and other biological resources are increasingly utilized in bio-based research and innovation across a multitude of sectors, including pharmaceuticals, agriculture, cosmetics, and environmental management. Much of this critical data is stored in open-access databases, complementing traditional research involving physical samples and enabling scientists in both the public and private sectors to innovate at an unprecedented pace. To understand the gravity of this shift, one must consider the process: a scientist sequences a plant, a microorganism, or a pathogenic virus—or perhaps even creates a synthetic sequence. When this resulting genetic sequence is uploaded to a public database, it allows researchers across the globe to access that data digitally, bypassing the need for physical transport of biological material across borders.
Recognizing that existing national regulations governing the use of physical genetic resources could not easily be applied to this digital landscape, the Convention on Biological Diversity (CBD) has initiated the creation of a new global system. This mechanism is designed to facilitate the sharing of benefits arising from the use of Digital Sequence Information (DSI). As governments prepare to operationalize this mechanism at the upcoming COP17, the International Chamber of Commerce (ICC) is spearheading a call for a framework that provides the legal certainty, clarity, and proportionality required to encourage broad participation from the global business community. The ICC argues that without a predictable and streamlined system, the very innovation that the CBD seeks to fund could be stifled by administrative complexity and legal risk.
The Evolution of Genetic Resource Governance: A Chronology
The journey toward a global mechanism for DSI benefit-sharing is rooted in decades of international environmental law. To understand the current friction and the ICC’s recent advocacy, a review of the historical timeline is essential.
In 1992, the Convention on Biological Diversity was adopted at the Earth Summit in Rio de Janeiro. Its three primary objectives were the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. However, at that time, "utilization" almost exclusively referred to physical samples.
The 2010 Nagoya Protocol further refined these goals by creating a legal framework for Access and Benefit-Sharing (ABS). The protocol required users of genetic resources to obtain Prior Informed Consent (PIC) from the provider country and agree on Mutually Agreed Terms (MAT). While effective for physical materials, the rise of high-throughput sequencing technology soon created a loophole: researchers could access genetic information online without ever touching a physical specimen, potentially bypassing the Nagoya Protocol’s obligations.
By 2022, at COP15 in Montreal, the Kunming-Montreal Global Biodiversity Framework (GBF) was adopted. A landmark decision was made to establish a multilateral mechanism for benefit-sharing from the use of DSI, including a global fund. This was a departure from the bilateral approach of the Nagoya Protocol, signaling a shift toward a more centralized, globalized system.
At COP16 in Cali, Colombia, in late 2024, the "Cali Fund" was formally established. While this was a significant step, many of the technical details regarding who pays, how much they pay, and how the money is distributed were left for further negotiation. As the international community looks toward COP17, the focus has shifted to the "operationalization" phase—the stage where the ICC is now demanding clear guardrails to protect the integrity of the global research ecosystem.
Supporting Data: The Economic and Scientific Scale of DSI
The scale of the data in question is staggering. The International Nucleotide Sequence Database Collaboration (INSDC), which includes repositories like GenBank, holds billions of sequences. As of recent estimates, the volume of genomic data is doubling every few months, far outstripping the growth of Moore’s Law in traditional computing.
From an economic perspective, the sectors reliant on DSI represent a significant portion of the global GDP. The pharmaceutical industry, which utilized DSI extensively to develop mRNA vaccines during the COVID-19 pandemic, is a trillion-dollar sector. Similarly, the global seeds and biotechnology market is valued at over $100 billion. The ICC points out that because DSI is integrated into the foundational research of these industries, any poorly designed levy or "tax" on data usage could have cascading effects on consumer prices and the speed of scientific breakthroughs.
Current proposals for the Cali Fund suggest that large companies in sectors reliant on DSI should contribute approximately 1% of their profits or 0.1% of their revenue to the fund. However, the definition of which sectors are "reliant" remains a point of contention. Data from the World Intellectual Property Organization (WIPO) indicates that patent filings involving genetic sequences have increased by over 300% in the last two decades, highlighting the commercial stakes involved in the COP17 negotiations.
The ICC Mandate: Business Requirements for a Functional Mechanism
The International Chamber of Commerce, representing millions of businesses worldwide, has outlined a specific set of criteria for the DSI mechanism. The ICC emphasizes that for the system to be successful, it must be attractive for businesses to join voluntarily or comply with easily.
Business calls for a mechanism that:
- Ensures legal certainty by providing a single, clear set of rules that apply globally, rather than a patchwork of conflicting national regulations.
- Avoids "reach-through" claims, where benefit-sharing obligations follow a product through every stage of development, creating an infinite chain of liability.
- Maintains the open-access nature of databases, as any "paywalls" or restrictive access controls would slow down urgent research into climate change and public health.
- Implements a "multilateral" approach that decouples the act of accessing data from the act of sharing benefits, thereby reducing the administrative burden on individual researchers.
ICC is therefore urging COP17 to prioritise:
- The establishment of a clear "trigger" for benefit-sharing that is easy to identify and measure, such as the commercialization of a final product.
- The creation of an exhaustive list of sectors covered by the mechanism to prevent unexpected "regulatory creep" into industries that use genetic data incidentally.
- The development of a simple, centralized reporting system that minimizes the paperwork for Small and Medium Enterprises (SMEs), which may lack the legal resources of multinational corporations.
ICC also calls attention to the importance for business of:
- Ensuring that funds collected are distributed transparently and effectively to support biodiversity conservation and the indigenous communities who act as stewards of biological resources.
- Recognizing non-monetary benefit sharing, such as capacity building, technology transfer, and joint research projects, which are often as valuable as direct financial contributions.
Stakeholder Reactions and Divergent Perspectives
The push for a DSI mechanism is not without its critics and competing interests. While the ICC represents the "user" side of the equation, "provider" countries—often biodiversity-rich nations in the Global South—have expressed concerns that a voluntary or overly simplified system will fail to generate the necessary funds for conservation.
Representatives from the Group of 77 and China have frequently argued for a more mandatory approach, suggesting that if the mechanism is too "business-friendly," it will not address the historical inequities of "biopiracy," where genetic resources from developing nations were used to create high-profit products without any return to the source country.
Conversely, the academic and scientific community has voiced fears that any mechanism that places a price on data access could hinder "blue-sky" research. Organizations like the DSI Scientific Network argue that the free flow of information is a global public good. They point to the rapid sharing of the SARS-CoV-2 genome as a prime example of why DSI must remain unencumbered by complex benefit-sharing triggers at the point of access.
Analysis of Implications: The Road to COP17
The success of COP17 will hinge on the ability of negotiators to balance these three competing pillars: the need for conservation funding (the Global South), the need for open science (the academic community), and the need for legal certainty and economic viability (the ICC and the business sector).
One of the most significant risks of an ill-conceived mechanism is "double-dipping" or duplicate obligations. If a company is already paying for access to physical samples under the Nagoya Protocol and is then asked to pay again for the digital representation of those same samples under the new DSI mechanism, it creates a financial and administrative deterrent. The ICC has been vocal about the need to harmonize these two systems to ensure they are mutually supportive rather than redundant.
Furthermore, the expansion of the mechanism to cover more countries and a broader range of data—including potentially "omitted" data types like proteomics or metabolomics—would make participation more attractive to business, provided it ensures legal certainty. A broader base of contributors could allow for a lower percentage-based contribution, making the fund more sustainable in the long term.
As the global community moves toward the final stages of operationalizing the Cali Fund, the role of the private sector cannot be understated. Business is not just a source of funding; it is the primary engine of the innovation that makes genetic data valuable in the first place. By calling for proportionality and clarity, the ICC is attempting to ensure that the pursuit of equity does not inadvertently dismantle the very tools—open data and scientific collaboration—that are essential for solving the world’s most pressing environmental and health challenges.
The outcome of COP17 will determine whether the DSI mechanism becomes a global success story of multilateral cooperation or a cautionary tale of regulatory overreach. For the ICC, the path forward is clear: a system that is simple, fair, and legally sound is the only way to ensure that both nature and business can thrive in the digital age.
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