Background

Researchers in the life sciences and biotech companies worldwide have freely downloaded genomic sequences from public databases such as GenBank to develop new drugs and crop varieties. In the past, research required the direct collection of physical biological specimens; however, with the dramatic advancement of sequencing technologies, biological genetic resources themselves have transitioned into the form of Digital Sequence Information (DSI). Researchers have arrived at a research environment where they can easily obtain genetic information of rare tropical rainforest plants or deep-sea microorganisms with just a few clicks.

However, this data openness reignited a long-standing conflict between resource-rich countries and multinational corporations. The Nagoya Protocol, which entered into force in 2014, stipulated the fair sharing of benefits arising from genetic resources with the country of origin; however, Digital Sequence Information (DSI), lacking physical substance, fell into a regulatory blind spot. Countries with rich biodiversity, such as Amazonian and African developing nations, have consistently pointed out that advanced pharmaceutical and biotech companies from developed countries are obtaining their genetic resources in data form free of charge, reaping astronomical commercial profits while not sharing the costs of resource conservation. This is why there was an urgent need for realistic funding measures to prevent commercial free-riding on public genomic data and to protect the ecosystem.

Key Findings

Global leaders attending the 17th Conference of the Parties to the UN Convention on Biological Diversity (COP17) strongly criticized companies that commercially utilize public genetic information for largely ignoring their obligation to contribute funds to nature conservation. Although the voluntary contribution fund, the Cali Fund, was launched in accordance with the profit-sharing mechanism agreed upon at the previous general meeting, it has been pointed out that its actual fundraising performance falls far short of initial expectations.

According to the General Assembly report, standards have been established recommending that large enterprises with assets exceeding $50 million or annual sales of at least $20 million voluntarily contribute an amount equivalent to 0.1% of their sales or 1% of their net profit from companies that have generated profits by utilizing public genomic data. Hundreds of top global companies in the pharmaceutical, agricultural biotechnology, and cosmetics sectors were classified as potential contributors; however, it was confirmed that less than 5% of these companies actually made contributions to the fund.

While the existing Nagoya Protocol framework relied on complex bilateral agreements between individual countries, resulting in substantial administrative costs, the multilateral fund approach aimed for transparent global collection. However, the limitations of its voluntary payment mechanism, which lacks enforceability, were clearly exposed. Representative Parties from South America and Africa condemned the reality that large pharmaceutical companies fully benefit from open databases while failing to fulfill their obligations for biodiversity conservation, denouncing it as an unfair act exploiting the public good nature.

Meaning and Prospects

This dispute clearly highlights the point where the free flow of data and the definition of global resources, core values of Open Science, directly conflict. The academic community raises concerns that excessive cost barriers or new administrative regulations regarding access to genomic data could significantly slow down basic life sciences research and the development of vaccines for emerging infectious diseases. Researchers argue that open-access databases play a role akin to oxygen in the research ecosystem.

The industry is also not hiding its perplexed stance. This is because, for cutting-edge technologies that cross-train tens of millions of public data points, such as synthetic biology or AI-based protein design, it is realistically difficult to trace back the origin of specific genetic sequences that contributed to the final product development and calculate their contribution. Since there are no clear criteria for quantifying how much commercial value a certain sequence has generated, companies calculate that even voluntary donations can act as legal risks.

Ultimately, the international community is expected to continue its heated debate over whether to introduce legally binding measures beyond voluntary contributions. While producing countries strongly demand the introduction of legally binding obligation-sharing provisions, developed countries and industry are advocating for a cautious approach on the grounds that it would weaken industrial competitiveness. If a compromise that maintains the unrestricted sharing of public data while stably supporting ecosystem conservation activities in developing countries is not derived, there is a risk that the entire global bio-research cooperation system will be divided.