The rapid evolution of biotechnology has fundamentally altered the landscape of biological research, shifting the focus from physical specimens found in forests and oceans to the vast digital repositories of genetic data known as Digital Sequence Information (DSI). As the global community approaches the 17th Conference of the Parties (COP17) to the Convention on Biological Diversity (CBD), the International Chamber of Commerce (ICC) has issued a comprehensive call for a multilateral benefit-sharing mechanism that balances the need for conservation with the practicalities of modern innovation. The transition from physical access to digital utilization represents one of the most significant shifts in international environmental law since the inception of the CBD in 1992, necessitating a regulatory framework that provides the legal certainty, clarity, and proportionality required to sustain global scientific progress.
Genetic sequences and information derived from plants, animals, microorganisms, and other biological resources have become the bedrock of bio-based research across multiple sectors, including pharmaceuticals, agriculture, cosmetics, and environmental remediation. Much of this information is currently stored in open-access databases, which serve as a global commons for public and private sector scientists alike. The utility of these databases cannot be overstated; they allow a researcher in one corner of the globe to analyze the genetic blueprint of a pathogenic virus or a drought-resistant plant sequenced in another, without the need for the physical transport of biological material. However, this ease of access has raised complex questions regarding how the benefits derived from such data should be shared with the countries of origin, leading to the proposed creation of a new global system under the CBD.
The Evolution of Genetic Resource Governance: A Chronology
The journey toward a digital benefit-sharing mechanism began with the 1992 Convention on Biological Diversity, which established the principle that states have sovereign rights over their biological resources. This was further codified in the 2010 Nagoya Protocol on Access and Benefit-Sharing (ABS), which created a legal framework for the fair and equitable sharing of benefits arising from the utilization of physical genetic resources.
However, as sequencing technologies became faster and more affordable, the "digitalization" of biology outpaced the existing legal frameworks. By the mid-2010s, it became clear that the bilateral "point-of-access" model used for physical samples was ill-suited for digital data, which can be shared instantly and utilized by thousands of researchers simultaneously.
The turning point occurred at COP15 in Montreal in December 2022, where parties agreed to establish a multilateral mechanism for benefit-sharing from the use of DSI, including a global fund. This decision recognized that the existing national regulations on physical resources could not easily be applied to digital information without stifling innovation. Since then, the focus has shifted toward operationalizing this mechanism, with COP16 serving as a critical negotiation junction and COP17 targeted as the milestone for a fully functional, predictable global system.
The Economic and Scientific Stakes of DSI
The importance of DSI to the global economy is reflected in the scale of the industries that rely on it. The global biotechnology market was valued at approximately $1.55 trillion in 2023 and is projected to grow significantly by 2030. Within this sector, the use of genetic data is ubiquitous. For instance, in the pharmaceutical industry, nearly all modern drug discovery processes involve the screening of digital genetic libraries to identify potential therapeutic targets or to understand the mechanisms of disease.
In the agricultural sector, DSI is instrumental in developing crops that are resilient to climate change, pests, and diseases. By accessing digital sequences of wild relatives of food crops, scientists can identify genes responsible for heat tolerance or water efficiency. Similarly, the cosmetic and specialty chemical industries utilize DSI to develop sustainable bio-based ingredients, reducing the need for synthetic chemicals derived from fossil fuels.
The ICC emphasizes that for these sectors to continue contributing to global sustainable development goals, the benefit-sharing mechanism must not become a barrier to data access. The vast majority of DSI is currently housed in the International Nucleotide Sequence Database Collaboration (INSDC), which maintains a policy of free and unrestricted access. Any mechanism that introduces significant friction into this system could inadvertently slow down scientific responses to global crises, such as pandemics or food insecurity.
Business Priorities: A Call for Legal Certainty and Proportionality
As governments move to finalize the operational details of the DSI mechanism, the ICC, representing millions of businesses worldwide, has outlined specific criteria necessary for the system’s success. The business community’s primary concern is that a poorly designed mechanism could lead to a fragmented landscape of overlapping national regulations, creating "double-dipping" scenarios where companies are forced to pay multiple times for the same resource.
Business calls for a mechanism that:
- Provides a "Safe Harbor" through Multilateralism: The mechanism should offer a clear, centralized path for compliance that exempts users from navigating a patchwork of inconsistent national DSI laws.
- Ensures Practicality and Simplicity: Benefit-sharing obligations should be easy to calculate and trigger, avoiding complex "tracking and tracing" requirements that are technically unfeasible for digital data.
- Maintains Open Science: The system must not restrict the flow of data into public databases, as the openness of these repositories is the primary driver of bio-innovation.
ICC is therefore urging COP17 to prioritise:
- A Clear Trigger for Benefit-Sharing: The ICC advocates for benefit-sharing to be linked to the commercialization of products derived from DSI, rather than the act of accessing the data itself. This ensures that academic and pre-competitive research remains unburdened.
- Proportionate Financial Contributions: The expectations for monetary contributions to the global fund should be realistic and calibrated to the actual value added by DSI in the final product, ensuring that the burden does not fall disproportionately on Small and Medium-Sized Enterprises (SMEs).
- Legal Exclusivity: Once a company has fulfilled its obligations under the multilateral mechanism, it should be granted legal certainty that it has met all requirements regarding DSI, protecting it from future claims by individual jurisdictions.
ICC also calls attention to the importance for business of:
- Governance and Transparency: The global fund established under the mechanism must be managed with high standards of transparency, with clear rules on how the funds are disbursed to support biodiversity conservation and sustainable use in developing nations.
- Avoiding Duplication: There must be a clear distinction between the DSI mechanism and existing obligations for physical genetic resources under the Nagoya Protocol to prevent administrative overlap.
- Capacity Building: The ICC supports initiatives that help developing countries build their own domestic capacities for sequencing and bio-innovation, creating a more equitable global bio-economy.
Analysis of Implications: Balancing Innovation and Equity
The challenge facing negotiators at COP17 is a classic "tragedy of the commons" in reverse. While the open sharing of DSI provides immense collective benefits, the lack of a structured benefit-sharing system has led to perceptions of "biopiracy" among biodiversity-rich nations in the Global South. These nations argue that their biological heritage is being digitized and commercialized by companies in the Global North without any return on investment for the conservation of those very resources.
The ICC’s stance reflects a pragmatic realization: business is willing to pay into a global fund if, and only if, that payment guarantees a stable and predictable operating environment. If the mechanism is perceived as a "tax on research" or if it involves burdensome reporting requirements, companies may shift their R&D away from natural products toward synthetic biology or other non-regulated fields. This would ultimately result in less money for biodiversity conservation, defeating the primary purpose of the CBD.
Furthermore, the scope of the mechanism remains a point of contention. Expanding the mechanism to cover more countries and a broader range of data and materials—such as proteomic or metabolomic data—would make participation more attractive to business by providing a "one-stop-shop" for compliance. However, this expansion is only viable if it ensures absolute legal certainty and avoids the creation of duplicate obligations.
Looking Toward COP17: The Path Forward
The success of COP17 will depend on the ability of parties to move beyond ideological differences and focus on the technical realities of the biotech industry. The ICC’s intervention highlights that the private sector is not inherently opposed to benefit-sharing; rather, it is opposed to ambiguity.
In the coming months, the international community will need to define the exact percentage of revenue or profit that will be contributed to the DSI fund and determine how "users" of DSI are identified. There is also the significant task of ensuring that the mechanism is "future-proof," capable of adapting to advancements in artificial intelligence and machine learning, which are increasingly used to analyze genetic sequences at scale.
As the world faces an accelerating biodiversity crisis, the DSI mechanism represents a unique opportunity to create a sustainable funding stream for conservation. By listening to the calls for legal certainty and proportionality from the business community, COP17 negotiators can build a system that fosters innovation while ensuring that the benefits of the digital biological revolution are shared fairly with the stewards of the planet’s natural wealth. The goal remains a balanced ecosystem where science thrives, businesses invest with confidence, and nature is preserved for future generations.
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