Abstract:

Background: The decision to develop a multilateral mechanism, including a global fund, for sharing the benefits derived from the use of digital sequence information on genetic resources (DSI) was adopted during Phrase II of the 15th meeting of the Conference of Parties to the Convention on Biological Diversity (COP15) at the end of 2022. It was further resolved that the modalities of the mechanism would be finalized at COP16. On November 2, 2024, COP16 adopted a subsequent decision on these modalities, including the establishment of the Cali Fund. This mechanism is considered a potential solution to globally concerning issue of digital bio-piracy. According to its rules and requirements, Parties, non-Parties and other stakeholders are expected to take action to facilitate the implementation of the mechanism at both global and national levels. Its operation is anticipated to have significant implications for DSI governance at these levels.

Results: The multilateral mechanism applies to DSI that is publicly available in accordance with national legislation and that is not covered by mutually agreed terms (MATs) for access to genetic resources and by other international instruments on access and benefit-sharing. It grants Parties, non-Parties, public databases operators, and users corresponding rights and obligations in aspects such as monetary benefit-sharing, Cali Fund governance, non-monetary benefit-sharing, data governance, and operation management. The launch of Cali Fund signifies that the multilateral mechanism has entered the global implementing stage. Although the multilateral mechanism is not legally binding, its execution is expected to facilitate the transition of open access to DSI derived from genetic resources within national jurisdictions from scientific practice to customary international law. It is also anticipated to promote the advancement of international and domestic legislation related to DSI. As a major producer and user of DSI in scientific research, China has begun to establish a foundational DSI management system. However, DSI generated from domestic genetic resources is currently stored primarily in large international public databases. China’s commercialization of DSI lags behind that of major developed countries, and gaps remain in its DSI management framework, particularly in areas such as property right.

Recommendations: DSI is considered a fundamental, crucial and strategic production factor for the development of the bioeconomy and for maintaining global competitiveness. There is an urgent need to improve the DSI governance system and to develop a cross-sectoral coordination mechanism based on unified leadership and clear division of responsibilities by integrating DSI into national big data governance. To enhance the legal framework for DSI management, national competent authorities should conduct legislative studies on issues such as property rights attribution, data generation, collection and storage, classification, research and development, data infrastructure construction, cross-border transmission, and data security. Furthermore, a national biodiversity digitalization project should be launched to create a unified plan generation, storage, application and benefit-sharing of DSI. This project should aim to digitalize and informatize key ecosystems, species, genes, and traditional knowledge, while establishing a set of standards for data collection, storage and benefit-sharing. Finally, the potential spillover effects of the multilateral mechanism on other ongoing or future international negotiations should be thoroughly examined.

Key words: digital sequence information on genetic resources, multilateral mechanism, Cali Fund, benefit-sharing, Convention on Biological Diversity