The rapid and reliable sharing of pathogen digital sequence information (DSI) is essential for genomic surveillance and the development of health products. Such sharing occurs largely through specialized databases governed by their own policies. However, in the absence of agreed international rules, an increasing number of states have sought to assert sovereign control over DSI via domestic Access and Benefit-Sharing (ABS) legislation. As pathogen DSI governance gains prominence, the rules governing its use are poised for change. The recently agreed WHO Pandemic Agreement and multilateral mechanism under the UN Convention on Biological Diversity aim to balance open access to DSI with fair and equitable benefit-sharing. The advancement and reduced costs of sequencing technologies, coupled with limitations of existing international legal framework, prompt a reevaluation of principles best suited for the regulation of pathogen DSI and benefit-sharing. In this article, I first conceptualize sovereignty and commons-oriented approaches to DSI regulation. I map out and compare international ABS frameworks applicable to pathogens. I describe policies of the leading pathogen DSI databases, INSDC and GISAID. Drawing on a review of 14 domestic ABS laws, I identify common patterns and divergent approaches to regulating pathogen DSI. I argue that the concept of sovereignty is ill-adapted to govern large-scale transboundary data flows and that a joint stewardship model is needed. I propose commons-oriented design elements for a future multilateral ABS system: providing standardized downstream benefit-sharing obligations, metadata disclosure and notification requirements, proportionate traceability, preserving interoperability of databases, and clear scope, conflict, and enforceability rules to reduce fragmentation across legal regimes.
Adam Strobeyko (Mon,) studied this question.
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