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 access to genetic resources, including pathogens, receive equitable access to the benefits derived from their use. The increasing digitalisation of health data has brought this issue to the forefront of discussions on global health security and health equity. While originally conceptualised in supranational agreements, implementation of these treaties requires national-level legislation in each country. This descriptive analysis represents to our knowledge the first open-access comprehensive effort to map ABS policies in all 193 United Nations member states.

Methods: We conducted a standardised review of the legislation for 193 United Nations Member States across three global legal databases (ABS Clearing House, WIPOLEX and FAOLEX), national legal databases and a systematic Google search. Legally enforceable policies were identified, and data were extracted across the following eight aspects of ABS legislation: Scope of Legislation, Digital Sequence Information (DSI), 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 22 countries have a codified position on DSI with regard to ABS in legally enforceable policy: 16 have explicitly included it, 2 have explicitly excluded it and 4 have ambiguous wording. WHO regional coverage of ABS policy on genetic resources ranged from 28% (3/11) of countries in the Eastern Mediterranean Region to 57% (21/35) in the Region of the Americas. Likewise, regional coverage of legally enforceable ABS policy related to DSI ranged from 0% in the Eastern Mediterranean and European Regions to 36% (4/11) of countries in the Southeast Asian 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.

Keywords: Communicable Disease Control; Epidemics; Legal Epidemiology.

Figure 1. Methodology protocol utilised in the analysis and mapping of policies for emerging infectious diseases topic on access and benefit-sharing. Numbering illustrates the sequential approach to project completion.

Figure 2. Heat map of percentage of countries within World Health Organization regions with legally-enforceable policy applicable to each subtopic. Shading represents the percentage of countries with applicable legislation, with darker shading indicating a higher percentage of countries with identifiable legislation pertaining to that subtopic category. Black numbering represents percentages less than 40.0%, while white numbering demonstrates percentages over 40.0%. Percentages were calculated as the number of countries within a WHO region with applicable policies for a subtopic divided by the total number of countries in the WHO region and rounded to the nearest tenth.

Figure 3. Graphical and mapped representation of countries with (A) legally-enforceable policy pertaining to genetic resource access, (B) sanctions included in legally-enforceable ABS policy, and (C) legally-enforceable policy that covers Digital Sequence Information (DSI). Bar graphs are arranged by WHO regions, with bars illustrating the percentage of countries within the region with identifiable policy for each of the subtopics. The corresponding maps, located to the right of each bar graph, demonstrate country-level status.