The Emerging Regime Complex for Pathogen Genetic Sequence Data (GSD) Sharing Platform Infrastructure

The COVID-19 pandemic has demonstrated the crucial role of rapid and reliable international pathogen genetic sequence data (GSD) sharing in global genomic surveillance and development of medical countermeasures (WHO, 2022a; IHR Review Committee, 2023). Such sharing occurs on specialized digital platforms, such as GenBank and GISAID, subject to platform policies and the scientific principle of open science. However, the rules governing pathogen GSD sharing are soon likely to change, as the topic has attracted increased attention from policymakers and has been included as part of the ongoing international regulatory processes. The amendment of the International Health Regulations (IHR), negotiation of a new pandemic instrument, publication of the WHO guiding principles for pathogen genome data sharing, as well as the recent decision to include GSD as part of Kunming-Montreal Global Diversity Framework and the proposal to establish European Health Data Space (EHDS) may all contribute to the establishment of a regime complex for pathogen GSD sharing, affect the pathogen GSD sharing platforms and, thus, have impact on the way we prepare for and respond to future pandemics. Research questions: What are the policies and principles which currently govern pathogen GSD sharing through GenBank and GISAID? Based on the outcomes of the ongoing international regulatory processes, what are the new rules of the emerging international regime complex for pathogen GSD sharing? How will the new international rules affect the pathogen GSD sharing digital platforms? How has the infrastructural aspect of GSD sharing platforms featured in platform policies and in the international regulatory processes? Method: The collection of data will be done by 1) desk research of platform policies currently governing pathogen GSD sharing; 2) participation in webcasted meetings and 3) gathering of policy documents and reports from international organizations (IOs), governments and non-state actors concerning international regulatory processes for GSD; 4) 25-30 semi-structured interviews with: informants from pathogen GSD sharing platforms, database managers, staff at public and academic laboratories and experts from IOs; and 6) analysis of the collected data through the lens of academic literature on regime complexity and infrastructural approaches to platform regulation.Novelty: This project constitutes the first academic study which maps the emerging regime complex for pathogen GSD sharing while treating platforms in this space as infrastructures. It proposes to track the ongoing progress in international regulatory and legislative reform processes and negotiations, where new data is expected to be generated in real-time. Furthermore, the project envisages a novel conceptual contribution to the literature on regime complexity and infrastructural approaches to platform regulation by applying insights from scholarship to a new and emergent field of regulation. Finally, this research project seeks to address the empirical question of how ongoing regulatory processes in international law affect the GSD sharing platforms and, thus, study the impact of new international legal rules on digital platforms in the context of pathogen GSD sharing. Expected outcomes and impact: Two academic articles in leading international law journals, the first article mapping out the emerging international regime complex for pathogen GSD sharing and the second article building upon the empirical data to outline the impact of new international rules on pathogen GSD sharing platforms understood as infrastructures of global pandemic preparedness and response (PPR). The research aims to contribute to the scholarship on regime complexity and infrastructural approaches to platform regulation with insights generated by application of concepts from the literature to an emerging international regime for pathogen GSD sharing. It also aims to be of use to practitioners in the field who are interested in navigating the emerging international regime complex.