Global Patterns in Access and Benefit-Sharing: A Comprehensive Review of National Policies

Abstract Introduction The goal of Access and Benefit-Sharing (ABS) in global health governance is to ensure that countries that provide genetic resources, including pathogens, receive equitable access to the benefits derived from their use. The increasing availability of genetic resource digitalization has brought this issue to the forefront of discussions on global health security and health equity. While originally conceptualized in supranational agreements, implementation of these treaties requires national-level legislation in each country. This work represents the first comprehensive effort to map ABS policies in all 193 United Nations member states. Methods We conducted a standardized review of the legislation for 193 United Nations Member States across 3 global legal databases (ABS Clearing House, WIPOLEX, and FAOLEX), national legal databases, and a systematic Google search. Legally-enforceable policies were identified, and data was extracted across the following 8 aspects of ABS legislation: Scope of Legislation, Digital Sequence Information, Access to Resources, Prior Informed Consent, Contractual Terms, Benefit-Sharing, Compliance, and Legal Sanctions. Results We found that 104 countries have legally-enforceable policies on ABS, with 92 countries having ABS policies relevant to microorganisms. Of these, 74 countries have chosen to restrict access to their domestic pathogens, and 53 have chosen to link access to pathogenic resources with an obligation to share benefits. Altogether 60 countries have a codified position on Digital Sequence Information (DSI) with regard to ABS: 20 have included it, 34 have excluded it, and 6 have ambiguous wording. WHO regional coverage of ABS or DSI policy ranged from 28% (3/11) of countries in the Eastern Mediterranean Region, to 62% (33/54) of countries in the European Region. Conclusion These findings highlight the heterogeneity found in the global policy landscape as it pertains to ABS, and provide data to inform future agreements and research efforts related to ABS. Key Questions Recent pandemics and technological advances have put Access and Benefit-Sharing (ABS) in the center stage of global health diplomacy. Yet, efforts to harmonize these policies have stagnated in multilateral negotiations. There is a distinct scarcity of evidence on the differing interpretations of ABS around the world, and further research is urgently needed to inform ongoing negotiations. This study provides the first detailed global mapping exercise of the ABS policy landscape. We found that while over half of the world’s countries have legally-enforceable policies relevant to ABS, only about a fourth have defined a position on Digital Sequence Information. There was also significant geographic variation in policy coverage within WHO regions. This study provides data to inform future research endeavors, highlighting global trends in national policy and identifying governance gaps. This open-source policy database could inform future evidence-based policy-making on ABS at the national level and enhance understanding of the current legal environment for ongoing negotiations on a Pathogen Access and Benefit-Sharing mechanism.