Systematic Analysis of factors required for achieving 100% voluntary non-remunerated blood donation: A qualitative interview-based study of international experiences using the PESTELE framework

Systematic Analysis of factors required for achieving 100% voluntary non-remunerated blood donation: A qualitative interview-based study of international experiences using the PESTELE framework | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Systematic Analysis of factors required for achieving 100% voluntary non-remunerated blood donation: A qualitative interview-based study of international experiences using the PESTELE framework Tomohiko Sato, W Martin Smid, Noriko Namba, Veera Sekaran Nadarajan, and 8 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7698728/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 5 You are reading this latest preprint version Abstract This international study provides the first systematic analysis of factors required for achieving 100% voluntary non-remunerated blood donation (VNRD). Semi-structured interviews with 15 experts from 12 countries using the PESTELE framework examined P olitical, E conomic, S ocial, T echnological, E nvironmental, L egal, and E thical factors influencing VNRD implementation. Countries were classified as achieving (≥90%) or underachieving (<90%) VNRD based on reported rates. Analysis identified 41 distinct elements across seven PESTELE domains, with only 16 shared between groups. Achieving countries exhibited focused strategies with fewer unique elements, whereas underachieving countries showed fragmentation with greater element variation, revealing an inverse relationship between factor complexity and implementation success. Modeling suggested a three-tiered hierarchical structure positioning political and legal factors as foundational enablers, economic factors as resource providers, and social, technological, environmental, and ethical factors as implementation mechanisms. Three developmental pathways were identified: crisis-driven transformation, economic development integration, and systematic international framework adoption. Findings indicate that successful VNRD implementation depends on sustained political commitment, integrated financing, and context-specific cultural adaptation through focused and sequential rather than simultaneous interventions across the PESTELE domains. These insights may help to advance globalization of VNRD through adoption of evidence-based strategies and international development assistance more targeted to hierarchical stages of development. Social science/Development studies Business and commerce/Information systems and information technology voluntary non-remunerated blood donation (VNRD) PESTELE framework qualitative research blood safety health policy Figures Figure 1 Figure 2 Figure 3 Introduction Voluntary non-remunerated blood donation (VNRD) represents a cornerstone of safe and sustainable blood supply systems worldwide. The World Health Organization (WHO) set the ambitious goal of achieving 100% VNRD globally with an initial target of 2025 1,2 . This objective reflects the fundamental principles of blood safety, ethics in donation, and equitable access to blood products as outlined in WHO recommendations and other international blood standards. However, VNRD has not been achieved globally, highlighting the persistent challenges in its implementation. Despite the clear benefits of VNRD systems, significant disparities persist in global implementation 3,4 . While some countries have successfully transitioned to > 99% voluntary donation, others—particularly low- and middle-income countries (LMICs)—continue to face substantial barriers to reaching this goal 5,6 . There is a sharp contrast between high-achieving countries taken here as those achieving > 90% VNRD, and underperforming countries where remunerated or family replacement donations continue to dominate the blood collection practices 7,8 . The transition towards 100% VNRD is a complex, multifaceted process that extends far beyond simple policy implementation 9,10 . Previous research targeting underachieving countries, mainly LMICs, has identified numerous barriers, including inadequate healthcare infrastructure, limited public awareness, cultural and religious considerations, economic constraints, and insufficient regulatory frameworks 11,12 . However, systematic analyses of these factors across diverse national contexts has been lacking, limiting the development of evidence-based strategies for achieving global VNRD implementation. To advance an understanding of the relevant factors promoting and impeding a successful transition towards 100% VNRD this study applied the PESTELE framework—a comprehensive analytical tool that examines P olitical, E conomic, S ocial, T echnological, E nvironmental, L egal, and E thical dimensions of organizational and policy challenges 13 . Through its Working Party for Global Blood Safety (WP GBS), the International Society of Blood Transfusion (ISBT), a global scientific society that brings together blood banking and transfusion medicine professionals from over 100 countries to promote blood transfusion safety worldwide 14 , initiated this international interview survey. The aim of the survey is to identify and categorize key factors influencing progress toward 100% VNRD, drawing on expert perspectives from a selected set of countries spanning a wide range of societal contexts. Results Participant Characteristics and Country Classification Fifteen key informants from 12 countries participated in the international interview survey. Their affiliations, types of blood service organization, and responses describing the status of blood donation in their countries are summarized in Table 1. For purposes of analysis, the countries were classified arbitrarily into two groups based on their reported VNRD achievement rates (Table 2): Achieving Countries (VNRD rate ≥90%, n=7): Ethiopia (100%), Finland (100%), Japan (100%), Malaysia (100%), Oman (96%), Thailand (90-100%), and Türkiye (90%); and Underachieving Countries (VNRD rate <90%, n=5): Brazil (65%), Indonesia (66-92%), Georgia (36%), Ghana (25%), and Saudi Arabia (40%). Overview of PESTELE Analysis Qualitative analysis identified 41 elements across the seven PESTELE factors: Political (5 elements), Economic (5 elements), Social (10 elements), Technological (8 elements), Environmental (5 elements), Legal (4 elements), and Ethical (4 elements). Sixteen were common to both country groups, while 25 were unique (Table 3). Political Factor Five political elements were identified (Table 4). "Policy making by the government" was the sole common element across both country groups, highlighting its universal importance. Achieving countries highlighted decisive governmental action. In Japan: " The cabinet government [decided] to establish a system to secure blood for transfusion from voluntary, non-remunerated blood donations. " Türkiye reported: " To supply the national need of blood and blood component from the VNRD, we developed a National Blood Policy and Strategy, and a National Blood Program on VNRD and blood safety. " The other four elements, constructing blood services, regulation making by the government, program development for blood safety & VNRD, resolving political instability, were unique to underachieving countries. Economic Factor Five economic elements were identified with no overlap (Table 4). Achieving countries emphasized national economic growth and special budgets to promote VNRD. Underachieving countries cited economic activity of private services, resolving economic instability, and governmental investment. Social Factor The social factor yielded the highest number of elements (10) (Table 4). Common ones included awareness about the importance of VNRD, public education, community engagement, reward systems, and desire to improve blood safety. Japan illustrated successful mobilization: “ The post-Olympics period… social desire to improve safety of blood products… supported by mass media coverage. ” Thailand described cultural change: “ Changing perceptions with a shift in societal attitudes towards altruism and the value of voluntary contributions. ” Achieving countries uniquely emphasized resolving misunderstanding on blood donation risk. Underachieving countries stressed resolving conflicts with religious precepts, external cooperation, resolving social instability, and dealing with threats from infectious diseases. Technological Factor Eight technological elements were identified (Table 4). Both groups recognized testing for blood safety, and social media utilization as essential. Achieving countries focused on blood collection systems and data management. Underachieving countries highlighted interaction between blood centers, research activities, logistics management, and blood banking capacity. Environmental Factor Five environmental elements were reported (Table 4). Common elements included construction of blood services, and community generation. Achieving countries emphasized human resource development, whereas underachieving countries noted investment into infrastructure resilience, and dealing with public health threats. Legal Factor Four legal elements were identified (Table 4), with substantial overlap: regulating remunerated donation, regulating the obligation of blood services, and legal reward systems. Achieving countries demonstrated comprehensive legal frameworks. Türkiye noted: “ VNRD requirement is defined in the Blood and Blood Products Law and commercial blood collection is forbidden with national legal legislation. ” Religious involvement appeared only in underachieving countries. Ethical Factor Four ethical elements were noted (Table 4). Common ones were nonmaleficence and fidelity. Beneficence and justice were reported only in underachieving countries. As for beneficence, Ghana noted: “Ethical aspects of blood donation and appealing to the societal and cultural norms of the society to appeal to the altruistic donation,” highlighting altruism is distinct intrinsic motivator for VNRD. Hierarchical Structure of PESTELE Factors for 100% VNRD Achievement Based on the themes identified for each PESTELE domain and the descriptions of national experiences, a three-tiered hierarchy of the factors and related themes was suggested by the analysis (Figure 2): Political and legal factors formed the foundation level, economic factors the resource level, and social, technological, environmental, and ethical factors the implementation level. This model illustrated how achieving countries advanced toward 100% VNRD. Using this model, the processes toward VNRD in achieving and underachieving countries can be described as follows. Case Descriptions of Achieving Countries 1. Japan: Crisis-Catalyzed Pioneer (1974-1990) Japan’s achievement was driven by public health crises. “ The incident in which Mr. Edwin Reischauer [SIC: who contracted fatal serum hepatitis from a blood transfusion during emergency surgery after he was stabbed by a mentally ill Japanese youth] 15,16 … was a great shock… leading the cabinet government to establish a system to secure blood for transfusion from voluntary, non-remunerated donations ” shows how crises spurred reform. Centralization under the Japanese Red Cross Blood Services ensured control, while universal health insurance provided financial sustainability. Social mobilization involved students, religious groups, and mass media. The HIV-tainted blood scandal of 1982 reinforced the importance of VNRD and legal accountability (Supplemental Figure 1). 2. Finland: Nordic Welfare Integration (1980s) Finland’s success reflected integration into a comprehensive welfare state. Strong political commitment and universal healthcare financing supported sustainability, while cultural homogeneity and high social trust facilitated acceptance. Early EU alignment provided regulatory and technological support, ensuring long-term stability (Supplemental Figure 2). 3. Thailand: Cultural Integration Model (1990s-2000s) Thailand’s transition built on cultural integration, with Royal patronage and Buddhist values promoting altruism. Economic growth and healthcare expansion enabled systematic awareness programs and engagement through local and religious leaders. Progress was gradual, emphasizing cultural transformation over crisis-driven change (Supplemental Figure 3). 4. Oman: Rapid Modernization (2000s-2010s) Oman achieved rapid progress through petroleum wealth and strategic planning. “ The Sultan’s vision… incorporating blood self-sufficiency into national development planning ” drove top-down reform, while oil revenue funded infrastructure. Modernization included replacing imported blood products and integrating Islamic values with medical practice, reaching 96% VNRD (Supplemental Figure 4). 5. Ethiopia: Governmental Transition (2012-2014) Ethiopia’s recent achievement followed restructuring: “ Ethiopian Blood and Tissue Bank Service (EBTBS) autonomy established in 2014 ” after transferring services from the Red Cross in 2012. Despite limited resources, donor clubs and religious partnerships drove success. “ 352,962 units collected with 99.9% voluntary donation rate ” demonstrated that political commitment and community mobilization could overcome economic barriers (Supplemental Figure 5). 6. Türkiye: EU Harmonization Framework (2005-2016) Türkiye aligned with EU standards, with accession talks driving legal harmonization. The National Blood Policy and Strategy provided national frameworks. Within the scope of the “ National Safe Blood Supply Program ” launched in 2005 by the Turkish Red Crescent (TRC), campaigns such as “ Target 25 ” as a youth program at the universities, community education, training of staff on communication skills, and the establishment of effective coordination between Ministry of Health (MoH), Ministry of National Education (MoE) and TRC supported donor recruitment. EU funding for capacity building (2014–2016) accelerated transformation, achieving 90% VNRD (Supplemental Figure 6). 7. Malaysia: Multi-Sector Coordination (2010s-2020s) Malaysia advanced through multi-sector and multi-ethnic engagement. A National Blood Policy with state-level adaptation balanced regional differences. Community-specific programs engaged Islamic, Chinese, and Indian populations, while partnerships with schools and universities broadened participation. This model showed how coordinated, inclusive strategies could achieve VNRD in diverse societies (Supplemental Figure 7). Case Descriptions of Underachieving Countries 1. Brazil: Constitutional Foundation with Implementation Gaps (1980-) Brazil demonstrates the challenge of translating legal frameworks into practice. "Paid donation was forbidden by law in 1980" established early prohibition, yet " the country is still struggling to have 100% VNRD " four decades later. The strategic choice to " transfer the task to family/replacement donors, instead of starting as VNRD " created long-term dependency patterns. Decentralized "governmental, non-governmental, and private multiple blood services" without national coordination reflects both system resilience and organizational fragmentation. Despite clear legal definitions, the persistent 30-35% family/replacement rate indicates constitutional mandates require sustained cultural transformation (Supplemental Figure 8). 2. Saudi Arabia: Hospital-Based Fragmentation Saudi Arabia's decentralized model shows both potential and limitations. " Around 300 hospitals collecting blood independently " creates dramatic variation where " voluntary blood donation reaches up to 90% in some hospitals while in others between 20-50%. " Strong governmental support through MOH and 20+ years of legal prohibition exist alongside " movements from religious groups " and " positive attitude of young Saudis. " However, " only 5% female donors " and " erratic " guideline compliance limit progress. International accreditation standards contrast with coordination challenges, while " political/economic factors hindered the move to complete 100% VNRD " (Supplemental Figure 9). 3. Georgia: EU-Driven Reform with Grassroots Innovation Georgia combines EU alignment with NGO advocacy. The " Association Agreement in 2014 " and " new Law on Quality and Safety of Blood adopted December 2022 " mandate centralization to " no more than three blood establishments by July 2025. " NGO " Volunteer Blood Donors " demonstrates innovation with " over 20,000 followers " despite lack of legal recognition. However, fundamental challenges persist: " high-ranking individuals seek medical treatment abroad " indicates low healthcare confidence, while " difficult economic situation led to decentralization and commercialization " creating income dependency on blood donation (Supplemental Figure 10). 4. Ghana: Systematic Government Transformation with Implementation Challenges Ghana exemplifies comprehensive government-led reform through " National Blood Service Act, 2020 (ACT 1042) " establishing the National Blood Service as a corporate body. The systematic approach emphasizes " continuous education and sensitization " through " donor groups (schools, religious bodies, corporate organizations) " with development partner support. Technological innovation includes " integration of digital information systems " and " drone services for emergencies. " Despite strong legislative foundations and infrastructure investment, " ineffective coordination ," " weak enforcement ," and persistent " misconceptions about blood donation " limit cultural acceptance and progress (Supplemental Figure 11). 5. Indonesia: Political Innovation Despite Institutional Challenges Indonesia demonstrates political creativity through unprecedented civic integration. " The governor made a regulation that if someone wanted to make or renew the driver license, that person has to give blood first " represents groundbreaking linkage to essential services, extended to " all government employees give blood ." High-level recognition through " Satya Lencana Bakti Sosial award given by President when donor gives blood 100 times " establishes donation as a pathway to national honor. Social mobilization through " establishment of Blood Donor Associations " and religious integration via " opinion of religious experts about blood donation made into decree " removes cultural barriers. However, " blood services run by 2 organizations: MoH and Indonesian Red Cross " creates coordination challenges, while cultural diversity across 17,000 islands creates implementation variations. Despite innovative approaches, "policies & guidelines for blood donation still need to be improved" alongside inadequate government pricing and infrastructure limitations in remote areas (Supplemental Figure 12). Discussion This study, which utilized the established PESTELE framework, provides the first systematic international analysis of factors required for achieving 100% VNRD. The identification of 41 elements across seven factors, with only 16 shared by both achieving and underachieving countries, underscores the multifaceted nature of VNRD implementation and the need for context-specific strategies 17,18 . Political and Legal Frameworks as Foundation The most striking finding is the fundamental role of government-led political and legal factors in enabling a successful transition to VNRD. The hierarchical structure of the factors modeled in the analysis reveals that political and legal factors serve as fundamental enablers for progress in other PESTELE domains (Fig. 3 ). Without strong governmental commitment and supportive legal frameworks, economic investments, social mobilization, technological improvements, and environmental enhancements a foundation for sustained impact is lacking 19 . Achieving countries consistently demonstrated decisive governmental action, exemplified by Japan's cabinet-level decision after the Reischauer incident and Türkiye's comprehensive National Blood Policy and Strategy (Supplementary Figs. 1, 6). Finland's integration into Nordic welfare structures and Ethiopia's " government ownership transition in 2012 " show how sustained political commitment creates systematic transformation (Supplementary Figs. 2, 5). Conversely, underachieving countries faced obstacles from political instability and fragmented governance (Table 4, Supplementary Figs. 8–12). A critical gap in achievement of VNRD is seen to emerge from inconsistent or ineffective implementation of national policies. While underachieving countries often possess strong legal frameworks—Brazil's " paid donation forbidden by law in 1980 " and Ghana's " National Blood Service Act, 2020 "—they struggle with sustained political commitments to implementation beyond initial stages (Supplementary Figs. 8, 11). Brazil's four-decade struggle despite early constitutional prohibition and Ghana's " ineffective coordination and weak enforcement of standards " illustrate how policy-implementation disconnects undermine progress. This finding has important implications for international development strategies, suggesting that technical assistance should prioritize political and legal framework development as prerequisite conditions, with sustained implementation support extending well beyond initial policy adoption. The Complexity-Success Relationship: Focus versus Fragmentation A notable finding is the inverse relationship between VNRD achievement and factor complexity (Table 3 ). Achieving countries demonstrated focused approaches with fewer unique elements per PESTELE factor, while underachieving countries exhibited greater element variability. This counterintuitive finding—that greater complexity correlates with reduced success—likely reflects the difference between systematic, coordinated implementation strategies versus fragmented, reactive approaches to multiple challenges. Rather than representing a true paradox, this pattern demonstrates that successful VNRD programs benefit from strategic prioritization and sequential implementation of interventions. This pattern reflects the distinction between countries achieving early systemic integration versus those implementing fragmented, reactive approaches. Finland's welfare state integration and Thailand's cultural alignment with Buddhist values demonstrate focused strategies with sustained results (Supplementary Fig. 2, 3). Conversely, Saudi Arabia's " around 300 hospitals collecting blood independently " with dramatic variation between facilities, and Indonesia's coordination challenges with " blood services run by 2 organizations: MoH and Indonesian Red Cross ," illustrate how fragmentation undermines progress despite strong individual components (Supplementary Fig. 9, 12). Pathway Patterns and Temporal Dynamics Three pathway patterns emerged—crisis-driven transformation, economic development integration, and systematic international framework adoption—providing models for countries at different development stages (Fig. 3 ). Early achievers (Japan, Finland) were driven by crisis response or welfare state integration, establishing strong institutional foundations (Supplementary Figs. 1, 2). Middle-period achievers (Thailand, Oman) leveraged economic development and cultural integration (Supplementary Figs. 3, 4). Recent achievers (Ethiopia, Türkiye, Malaysia) benefited from international frameworks and evidence-based approaches informed by global best practices (Supplementary Figs. 5–7). Political factors consistently emerged as foundational across all pathways, with government decisions preceding other changes in every case. Legal frameworks provided essential binding requirements overriding economic interests, while economic resources flowed from political priorities (Fig. 2 , Table 4). This sequential pattern suggests successful VNRD transformation requires careful attention to timing and coordination, rather than simultaneous intervention in all areas. Resource Allocation and Economic Sustainability Achieving countries establish systematic financing mechanisms integrating VNRD into broader healthcare systems. Japan's " universal health insurance covering blood product costs ," Malaysia's " multi-sector funding coordination ," and Türkiye's " special budget allocated for VNRD recruitment activities " demonstrate targeted investment with sustainable resource flows (Table 4, Supplementary Figs. 1, 4, 5). Underachieving countries face persistent resource constraints limiting systematic expansion. Ghana reports "inadequate government funding and high production costs," while Indonesia notes "blood rates set by government too small for development of blood products." Saudi Arabia's acknowledgment that "political/economic factors hindered complete VNRD transition" illustrates how resource allocation challenges can undermine otherwise strong foundations (Supplementary Figs. 9, 11,12). This suggests sustainable VNRD achievement requires economic integration into healthcare financing systems rather than fragmented, project-based funding. Social Mobilization Complexity Social factors emerged as the most complex domain, with 10 distinct elements identified across country groups (Table 3 , 4). Common elements—awareness about VNRD importance, public education, community engagement, reward systems, and desire to improve blood safety—represent universal requirements for donor recruitment and retention. However, challenges in underachieving countries extend beyond basic awareness campaigns 20 . The need to resolve conflicts with religious precepts, address social instability, and manage infectious disease threat reflects broader socioeconomic contexts. Achieving countries demonstrate deep cultural integration—Ethiopia's " 175 + donor clubs and religious engagement ," Thailand's " Buddhist values supporting altruistic donation ," and Japan's " social movements from students, religious groups, supported by mass media "—creating sustained social momentum (Table 4, Supplementary Fig. 1, 3, 5). Technology and System Integration Technological factors consistently supported but rarely drove transformation across country groups. Achieving countries leverage technology for system optimization—Türkiye's "social media campaigns and digital outreach" and Ethiopia's comprehensive data systems support systematic donor management and recruitment. However, technology implementation follows rather than precedes political commitment and social acceptance. Innovation Potential and Global Strategy Underachieving countries reveal both significant challenges and innovative solutions offering potential for global model development. Indonesia's civic service integration through driver license requirements, Georgia's NGO-led advocacy, and Ghana's comprehensive legislative approach demonstrate greater creativity than some achieving countries’ approaches. The current study itself, through qualitative analysis of expert knowledge from both country groups, demonstrated the value of knowledge transfer, fostering mutual learning opportunities. These innovations suggest valuable bidirectional knowledge exchange opportunities. Achieving countries can share implementation strategies and sustainability mechanisms, while underachieving countries contribute innovative approaches to civic engagement and social mobilization. International frameworks should facilitate sustained political commitment, adequate resource allocation, and cultural adaptation across diverse contexts. Implications for Policy and Practice Our findings have several important implications for policy development and programmatic interventions. For international organizations and development partners, the PESTELE framework provides a structured approach for assessing national VNRD readiness and designing targeted support programs 13 . The hierarchical importance of political and legal factors suggests that international organizations should prioritize support for political and legal framework development as fundamental enablers for progress in other areas (Fig. 2 ). The pathway patterns indicate that countries at different development stages require different approaches. Early-stage countries may benefit from crisis-catalyzed transformation or economic development integration, while countries with existing healthcare infrastructure may find systematic international framework adoption more appropriate (Fig. 3 ). The inverse complexity-success relationship (Table 3 ) suggests that focused, sequential interventions may prove more effective than comprehensive simultaneous approaches across all domains. For national governments in underachieving countries, the 15 common elements identified across both country groups provide a roadmap of universal requirements for VNRD systems (Tables 3 , 4). However, our findings emphasize that successful implementation requires addressing country-specific challenges while maintaining focus on core interventions rather than attempting to address all barriers simultaneously. The innovation demonstrated by underachieving countries suggests that creative adaptation can overcome traditional obstacles, but requires institutional support for sustainable implementation. Limitations and Future Research The qualitative nature limits ability to quantify relative importance of different PESTELE factors. Snowball sampling may have introduced selection bias toward countries with established blood service networks. Interviews conducted in 2023 may not reflect current situations given dynamic health system reforms and policy changes. Future research should examine transition pathways between different VNRD achievement levels through longitudinal analyses. Quantitative measures assessing relative impact of different interventions would complement these qualitative insights from this study. Comparative analysis of countries with similar contexts but different outcomes could provide deeper insights into critical factors for success. Conclusions Achieving 100% VNRD requires coordinated action across multiple domains, with political and legal frameworks functioning as fundamental enablers. The PESTELE framework effectively mapped both universal requirements and country-specific challenges, offering a solid evidence base for global policy and program design. The hierarchical structure provides clear guidance for sequencing international development assistance. The complexity paradox suggests strategic focus may prove more important than comprehensive intervention across all barriers. The three pathway patterns offer flexible models that countries can adapt based on development stage and institutional capacity: global 100% VNRD achievement is attainable through systematic application of proven strategies adapted to local contexts, with sustainability depending on embedding principles within national healthcare and legal frameworks over time. Methods Study Design This study employed a qualitative research design utilizing semi-structured interviews to explore factors required for achieving 100% VNRD worldwide. The research was conducted under the auspices of the ISBT Working Party for Global Blood Safety through its subgroup on Replacement versus Voluntary Donation. An overview of the study design and analytical framework is provided in Figure 1. Participants and Data Collection Participants were recruited using a snowball sampling strategy 21 , based on recommendations from members of the ISBT Working Party for Global Blood Safety. This approach leveraged an existing network of international blood transfusion experts to identify knowledgeable representatives from diverse geographical regions and with varying levels of VNRD achievement. Characteristics of the participants and a descriptive status of blood donations in their countries is provided in Table 1. Fifteen key informants from 12 countries participated between June and December 2023. Participants were selected for their expertise in blood transfusion services and their ability to provide informed perspectives on national blood donation systems (Table 1). Semi-structured, paper-based interviews were focused on two main areas: (1) the types of blood donation currently practiced in each country and their respective rates, and (2) expert opinions on important factors required for achieving 100% VNRD. The semi-structured format allowed for systematic data collection while maintaining flexibility to explore country-specific contexts. Country Classification and Analysis with the PESTELE Framework Twelve countries were classified arbitrarily into two groups based on their reported VNRD achievement rates (Table 1, 2): Achieving Countries (VNRD rate ≥90%, n=7): Ethiopia (100%), Finland (100%), Japan (100%), Malaysia (100%), Oman (96%), Thailand (90-100%), and Türkiye (94%); and Underachieving Countries (VNRD rate <90%, n=5): Brazil (65%), Indonesia (66-92%), Georgia (36%), Ghana (25%), and Saudi Arabia (40%). Reported ranges in the rates of VNRD reflected geographic variations within an individual country. PESTELE analysis is an expanded version of the traditional PEST framework, originally developed for strategic business planning and later adapted for policy analysis and public health research 13,22–24 . The framework systematically examines Political, Economic, Social, Technological, Environmental, Legal, and Ethical factors that influence complex systems or policy implementations. Qualitative responses regarding factors required for achieving 100% VNRD were analyzed using the PESTELE framework. Interview transcripts were systematically coded according to the seven external factors. The coding process included initial coding and iterative classification through code abstraction, identifying key elements within each PESTELE domain. Theme analysis was then applied to each of these elements (Table 1). Hierarchical analysis The seven dimensions of the PESTELE framework were further organized into three hierarchical levels: Foundation Level (Top tier), Resource Level (Middle tier), and Implementation Level (Bottom tier), based on country-specific descriptions of the progress toward achieving 100% VNRD as illustrated in Figure 2. This hierarchical approach enabled visualization of the sequential processes and interdependencies involved in advancing toward full attainment of VNRD. Identification of distinct developmental pathways Analysis of commonalities among the hierarchical factors that led to effective development towards 100% VNRD in the achieving countries was performed to identify distinct developmental pathways. The analysis yielded three successful developmental pathways: crisis-driven transformation, economic development integration, and systematic international framework adoption. Characteristics of the three observed patterns are summarized in Figure 3. Ethics This study was based on paper-based interviews regarding national blood donation systems, related regulations, historical context, and donor population statistics. The leadership of the Working Party for Global Blood Safety determined that the scope and intended use of the interview template were fully consistent with established ethical practices of the ISBT, and the organizing committee reviewed and approved the study protocol. The study involved interviews with blood transfusion professionals sharing organizational expertise and did not constitute human subjects research requiring institutional ethical approval. Consistently, the Jikei University School of Medicine Research Promotion Center, which oversees research ethics review and research support, determined that ethical review is not required for this study, as no individual medical information or personally identifiable data were collected and the study does not fall under the scope of research to which the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects are applicable. Informed consent was obtained from all participants, who explicitly agreed to share their professional knowledge. The study adhered to international research ethics standards, including the principles of the Declaration of Helsinki, with particular attention to confidentiality and the appropriate use of expert knowledge. Declarations Acknowledgement The authors acknowledge the contributions of all participants from the ISBT Global Blood Safety Working Party. The authors thank the following key informants who generously shared their expertise and time for this study: Johanna Nystedt (Finland); Kazuo Muroi (Japan); Zainab Al-Arimi (Oman); Chanakarn Vipusmith, Pawinee Kupatawintu (Thailand); Yasmin Ayob (Malaysia); Habtamu Taye (Ethiopia); Ketevan Shermadini, Melano Durmishidze (Georgia); Justina Ansah (Ghana). Data Availability Statement The PESTELE framework analysis results and country-level summary data supporting the conclusions of this article are included within the article and its supplementary information files. Raw interview transcripts are not publicly available but are available from the corresponding author upon reasonable request with appropriate justification. Conflict of Interest TS has received joint research funding from the Japanese Red Cross Society outside the submitted work; has received honoraria for lectures from Werfen, Chugai Pharmaceutical, Zeria Pharmaceutical, Sysmex outside the submitted work. NN and NHT are employees of the Japanese Red Cross Society. WMS is employed by Sanquin Consulting Services. No other potential conflicts of interest relevant to this article were reported. Funding This work was partly supported by the Japan Society for the Promotion of Science (JSPS) KAKENHI Grant Number 24K13470. Author contributions TS, WMS, NN, HV, JE, and NHT conceived and designed the study. TS and NHT conducted interviews. TS analyzed data and wrote the manuscript. VSN, NSIH, TT, NEÖ, SW, and SH participated in data collection. WMS, HV, SW, JE, and NHT provided critical insights, and reviewed the manuscript. All authors contributed to critical reading and discussion on the original article and approved the final manuscript. 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Global Status Report on Blood Safety and Availability 2021. 1–184 https://www.who.int/publications/i/item/9789240051683 (2022). Roberts, N., James, S., Delaney, M. & Fitzmaurice, C. The global need and availability of blood products: a modelling study. Lancet Haematol. 6 , e606–e615 (2019). Williamson, L. M. & Devine, D. V. Challenges in the management of the blood supply. Lancet 381 , 1866–1875 (2013). Lownik, E., Riley, E., Konstenius, T., Riley, W. & McCullough, J. Knowledge, attitudes and practices surveys of blood donation in developing countries. Vox Sang. 103 , 64–74 (2012). S.Lewis-Beck, M., Bryman, A. & Liao, T. F. Snowball Sampling. SAGE Encycl. Soc. Sci. Res. Methods 1044–1044 (2004) doi:10.4135/9781412950589. Hong, J., Kafa, N. & Jaegler, A. Exploring barriers and motivations in the adoption of food waste mobile applications. Int. Trans. Oper. Res. 0 , 1–25 (2024). Vardopoulos, I. et al. An Integrated SWOT-PESTLE-AHP Model Assessing Sustainability in Adaptive Reuse Projects. Appl. Sci. 11 , 7134 (2021). Dalirazar, S. & Sabzi, Z. Strategic analysis of barriers and solutions to development of sustainable buildings using PESTLE technique. Int. J. Constr. Manag. 23 , 167–181 (2023). Tables Tables 1 to 4 are available in the supplementary files section Additional Declarations No competing interests reported. Supplementary Files SupplFigs112PESTELE.pdf Tables14PESTELE.pdf Cite Share Download PDF Status: Under Review Version 1 posted Reviewers invited by journal 17 Feb, 2026 Editor assigned by journal 27 Jan, 2026 Editor invited by journal 01 Oct, 2025 Submission checks completed at journal 30 Sep, 2025 First submitted to journal 30 Sep, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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shown.\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-7698728/v1/11cf8a0bd1cc534b74c6da48.png"},{"id":99579938,"identity":"d1cdf38b-fe85-4581-9b67-87589ae9477b","added_by":"auto","created_at":"2026-01-06 06:03:46","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":184372,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eHierarchical framework of PESTELE factors for 100% VNRD achievement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA three-tier hierarchy of each PESTELE factor with respective themes included is shown.\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-7698728/v1/1bdfad20d7954d48966da44c.png"},{"id":99579930,"identity":"9dbc9efe-19d8-452e-8111-52266eb5872d","added_by":"auto","created_at":"2026-01-06 06:03:46","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":171697,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThree success patterns for VNRD achievement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThree success patterns identified from the study are shown.\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-7698728/v1/de47a8c3f05b099cd3dc88a0.png"},{"id":99804369,"identity":"0e69247c-6096-472e-9f64-25b922066b74","added_by":"auto","created_at":"2026-01-08 14:13:15","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1655009,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7698728/v1/e02c749b-7c9f-479e-9163-c57953dc3139.pdf"},{"id":99579926,"identity":"be53835e-2c7d-4d2e-b756-3b671e758c6c","added_by":"auto","created_at":"2026-01-06 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framework","fulltext":[{"header":"Introduction","content":"\u003cp\u003eVoluntary non-remunerated blood donation (VNRD) represents a cornerstone of safe and sustainable blood supply systems worldwide. The World Health Organization (WHO) set the ambitious goal of achieving 100% VNRD globally with an initial target of 2025\u003csup\u003e1,2\u003c/sup\u003e. This objective reflects the fundamental principles of blood safety, ethics in donation, and equitable access to blood products as outlined in WHO recommendations and other international blood standards. However, VNRD has not been achieved globally, highlighting the persistent challenges in its implementation.\u003c/p\u003e \u003cp\u003eDespite the clear benefits of VNRD systems, significant disparities persist in global implementation\u003csup\u003e3,4\u003c/sup\u003e. While some countries have successfully transitioned to \u0026gt;\u0026thinsp;99% voluntary donation, others\u0026mdash;particularly low- and middle-income countries (LMICs)\u0026mdash;continue to face substantial barriers to reaching this goal\u003csup\u003e5,6\u003c/sup\u003e. There is a sharp contrast between high-achieving countries taken here as those achieving\u0026thinsp;\u0026gt;\u0026thinsp;90% VNRD, and underperforming countries where remunerated or family replacement donations continue to dominate the blood collection practices\u003csup\u003e7,8\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe transition towards 100% VNRD is a complex, multifaceted process that extends far beyond simple policy implementation\u003csup\u003e9,10\u003c/sup\u003e. Previous research targeting underachieving countries, mainly LMICs, has identified numerous barriers, including inadequate healthcare infrastructure, limited public awareness, cultural and religious considerations, economic constraints, and insufficient regulatory frameworks\u003csup\u003e11,12\u003c/sup\u003e. However, systematic analyses of these factors across diverse national contexts has been lacking, limiting the development of evidence-based strategies for achieving global VNRD implementation.\u003c/p\u003e \u003cp\u003eTo advance an understanding of the relevant factors promoting and impeding a successful transition towards 100% VNRD this study applied the PESTELE framework\u0026mdash;a comprehensive analytical tool that examines \u003cb\u003eP\u003c/b\u003eolitical, \u003cb\u003eE\u003c/b\u003economic, \u003cb\u003eS\u003c/b\u003eocial, \u003cb\u003eT\u003c/b\u003eechnological, \u003cb\u003eE\u003c/b\u003environmental, \u003cb\u003eL\u003c/b\u003eegal, and \u003cb\u003eE\u003c/b\u003ethical dimensions of organizational and policy challenges\u003csup\u003e13\u003c/sup\u003e. Through its Working Party for Global Blood Safety (WP GBS), the International Society of Blood Transfusion (ISBT), a global scientific society that brings together blood banking and transfusion medicine professionals from over 100 countries to promote blood transfusion safety worldwide\u003csup\u003e14\u003c/sup\u003e, initiated this international interview survey. The aim of the survey is to identify and categorize key factors influencing progress toward 100% VNRD, drawing on expert perspectives from a selected set of countries spanning a wide range of societal contexts.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003eParticipant Characteristics and Country Classification\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFifteen key informants from 12 countries participated in the international interview survey. Their affiliations, types of blood service organization, and responses describing the status of blood donation in their countries are summarized in Table 1. For purposes of analysis, the countries were classified arbitrarily into two groups based on their reported VNRD achievement rates (Table 2): Achieving Countries (VNRD rate \u0026ge;90%, n=7): Ethiopia (100%), Finland (100%), Japan (100%), Malaysia (100%), Oman (96%), Thailand (90-100%), and T\u0026uuml;rkiye (90%); and Underachieving Countries (VNRD rate \u0026lt;90%, n=5): Brazil (65%), Indonesia (66-92%), Georgia (36%), Ghana (25%), and Saudi Arabia (40%).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOverview of PESTELE Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eQualitative analysis identified 41 elements across the seven PESTELE factors:\u0026nbsp;Political (5 elements), Economic (5 elements), Social (10 elements), Technological (8 elements), Environmental (5 elements), Legal (4 elements), and Ethical (4 elements). Sixteen were common to both country groups, while 25 were unique (Table 3).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePolitical Factor\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFive political elements were identified (Table 4). \u0026quot;Policy making by the government\u0026quot; was the sole common element across both country groups, highlighting its universal importance. Achieving countries highlighted decisive governmental action. In Japan: \u0026quot;\u003cem\u003eThe cabinet government [decided] to establish a system to secure blood for transfusion from voluntary, non-remunerated blood donations.\u003c/em\u003e\u0026quot; T\u0026uuml;rkiye reported: \u0026quot;\u003cem\u003eTo supply the national need of blood and blood component from the VNRD, we developed a National Blood Policy and Strategy, and a National Blood Program on VNRD and blood safety.\u003c/em\u003e\u0026quot; The other four elements, constructing blood services, regulation making by the government, program development for blood safety \u0026amp; VNRD, resolving political instability, were unique to underachieving countries.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEconomic Factor\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFive economic elements were identified with no overlap (Table 4).\u0026nbsp;Achieving countries emphasized national economic growth and special budgets to promote VNRD. Underachieving countries cited economic activity of private services, resolving economic instability, and governmental investment.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSocial Factor\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe social factor yielded the highest number of elements (10) (Table 4). Common ones included awareness about the importance of VNRD, public education, community engagement, reward systems, and desire to improve blood safety. Japan illustrated successful mobilization: \u0026ldquo;\u003cem\u003eThe post-Olympics period\u0026hellip; social desire to improve safety of blood products\u0026hellip; supported by mass media coverage.\u003c/em\u003e\u0026rdquo; Thailand described cultural change: \u0026ldquo;\u003cem\u003eChanging perceptions with a shift in societal attitudes towards altruism and the value of voluntary contributions.\u003c/em\u003e\u0026rdquo; Achieving countries uniquely emphasized resolving misunderstanding on blood donation risk. Underachieving countries stressed resolving conflicts with religious precepts, external cooperation, resolving social instability, and dealing with threats from infectious diseases.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTechnological Factor\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEight technological elements were identified (Table 4). Both groups recognized testing for blood safety, and social media utilization as essential. Achieving countries focused on blood collection systems and data management. Underachieving countries highlighted interaction between blood centers, research activities, logistics management, and blood banking capacity.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEnvironmental Factor\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFive environmental elements were reported (Table 4). Common elements included construction of blood services, and community generation. Achieving countries emphasized human resource development, whereas underachieving countries noted investment into infrastructure resilience, and dealing with public health threats.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLegal Factor\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFour legal elements were identified (Table 4), with substantial overlap: regulating remunerated donation, regulating the obligation of blood services, and legal reward systems. Achieving countries demonstrated comprehensive legal frameworks. T\u0026uuml;rkiye noted: \u0026ldquo;\u003cem\u003eVNRD requirement is defined in the Blood and Blood Products Law and commercial blood collection is forbidden with national legal legislation.\u003c/em\u003e\u0026rdquo; Religious involvement appeared only in underachieving countries.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Factor\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFour ethical elements were noted (Table 4). Common ones were nonmaleficence and fidelity. Beneficence and justice were reported only in underachieving countries. As for beneficence, Ghana noted: \u0026ldquo;Ethical aspects of blood donation and appealing to the societal and cultural norms of the society to appeal to the altruistic donation,\u0026rdquo; highlighting altruism is distinct intrinsic motivator for VNRD.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHierarchical Structure of PESTELE Factors for 100% VNRD Achievement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eBased on the themes identified for each PESTELE domain and the descriptions of national experiences, a three-tiered hierarchy of the factors and related themes was suggested by the analysis (Figure 2): Political and legal factors formed the foundation level, economic factors the resource level, and social, technological, environmental, and ethical factors the implementation level. This model illustrated how achieving countries advanced toward 100% VNRD. Using this model, the processes toward VNRD in achieving and underachieving countries can be described as follows.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCase Descriptions of Achieving Countries\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.\u0026nbsp; \u0026nbsp;Japan: Crisis-Catalyzed Pioneer (1974-1990)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eJapan\u0026rsquo;s achievement was driven by public health crises. \u0026ldquo;\u003cem\u003eThe incident in which Mr. Edwin Reischauer [SIC: who contracted fatal serum hepatitis from a blood transfusion during emergency surgery after he was stabbed by a mentally ill Japanese youth]\u003c/em\u003e\u003csup\u003e15,16\u003c/sup\u003e\u003cem\u003e\u0026hellip; was a great shock\u0026hellip; leading the cabinet government to establish a system to secure blood for transfusion from voluntary, non-remunerated donations\u003c/em\u003e\u0026rdquo; shows how crises spurred reform. Centralization under the Japanese Red Cross Blood Services ensured control, while universal health insurance provided financial sustainability. Social mobilization involved students, religious groups, and mass media. The HIV-tainted blood scandal of 1982 reinforced the importance of VNRD and legal accountability (Supplemental Figure 1).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.\u0026nbsp; \u0026nbsp;Finland: Nordic Welfare Integration (1980s)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFinland\u0026rsquo;s success reflected integration into a comprehensive welfare state. Strong political commitment and universal healthcare financing supported sustainability, while cultural homogeneity and high social trust facilitated acceptance. Early EU alignment provided regulatory and technological support, ensuring long-term stability (Supplemental Figure 2).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.\u0026nbsp; \u0026nbsp;Thailand: Cultural Integration Model (1990s-2000s)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThailand\u0026rsquo;s transition built on cultural integration, with Royal patronage and Buddhist values promoting altruism. Economic growth and healthcare expansion enabled systematic awareness programs and engagement through local and religious leaders. Progress was gradual, emphasizing cultural transformation over crisis-driven change (Supplemental Figure 3).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e4.\u0026nbsp; \u0026nbsp;Oman: Rapid Modernization (2000s-2010s)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOman achieved rapid progress through petroleum wealth and strategic planning. \u0026ldquo;\u003cem\u003eThe Sultan\u0026rsquo;s vision\u0026hellip; incorporating blood self-sufficiency into national development planning\u003c/em\u003e\u0026rdquo; drove top-down reform, while oil revenue funded infrastructure. Modernization included replacing imported blood products and integrating Islamic values with medical practice, reaching 96% VNRD (Supplemental Figure 4).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e5.\u0026nbsp; \u0026nbsp;Ethiopia: Governmental Transition (2012-2014)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthiopia\u0026rsquo;s recent achievement followed restructuring: \u0026ldquo;\u003cem\u003eEthiopian Blood and Tissue Bank Service (EBTBS) autonomy established in 2014\u003c/em\u003e\u0026rdquo; after transferring services from the Red Cross in 2012. Despite limited resources, donor clubs and religious partnerships drove success. \u0026ldquo;\u003cem\u003e352,962 units collected with 99.9% voluntary donation rate\u003c/em\u003e\u0026rdquo; demonstrated that political commitment and community mobilization could overcome economic barriers (Supplemental Figure 5).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e6.\u0026nbsp; \u0026nbsp;T\u0026uuml;rkiye: EU Harmonization Framework (2005-2016)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eT\u0026uuml;rkiye aligned with EU standards, with accession talks driving legal harmonization. The National Blood Policy and Strategy provided national frameworks. Within the scope of the \u0026ldquo;\u003cem\u003eNational Safe Blood Supply Program\u003c/em\u003e\u0026rdquo; launched in 2005 by the Turkish Red Crescent (TRC), campaigns such as \u0026ldquo;\u003cem\u003eTarget 25\u003c/em\u003e\u0026rdquo; as a youth program at the universities, community education, training of staff on communication skills, and the establishment of effective coordination between Ministry of Health (MoH), Ministry of National Education (MoE) and TRC supported donor recruitment. EU funding for capacity building (2014\u0026ndash;2016) accelerated transformation, achieving 90% VNRD (Supplemental Figure 6).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e7.\u0026nbsp; \u0026nbsp;Malaysia: Multi-Sector Coordination (2010s-2020s)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMalaysia advanced through multi-sector and multi-ethnic engagement. A National Blood Policy with state-level adaptation balanced regional differences. Community-specific programs engaged Islamic, Chinese, and Indian populations, while partnerships with schools and universities broadened participation. This model showed how coordinated, inclusive strategies could achieve VNRD in diverse societies (Supplemental Figure 7).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCase Descriptions of Underachieving Countries\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.\u0026nbsp; \u0026nbsp;Brazil: Constitutional Foundation with Implementation Gaps\u003c/strong\u003e \u003cstrong\u003e(1980-)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBrazil demonstrates the challenge of translating legal frameworks into practice. \u0026quot;Paid donation was forbidden by law in 1980\u0026quot; established early prohibition, yet \u0026quot;\u003cem\u003ethe country is still struggling to have 100% VNRD\u003c/em\u003e\u0026quot; four decades later. The strategic choice to \u0026quot;\u003cem\u003etransfer the task to family/replacement donors, instead of starting as VNRD\u003c/em\u003e\u0026quot; created long-term dependency patterns. Decentralized \u0026quot;governmental, non-governmental, and private multiple blood services\u0026quot; without national coordination reflects both system resilience and organizational fragmentation. Despite clear legal definitions, the persistent 30-35% family/replacement rate indicates constitutional mandates require sustained cultural transformation (Supplemental Figure 8).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.\u0026nbsp; \u0026nbsp;Saudi Arabia: Hospital-Based Fragmentation\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Saudi Arabia\u0026apos;s decentralized model shows both potential and limitations. \u0026quot;\u003cem\u003eAround 300 hospitals collecting blood independently\u003c/em\u003e\u0026quot; creates dramatic variation where \u0026quot;\u003cem\u003evoluntary blood donation reaches up to 90% in some hospitals while in others between 20-50%.\u003c/em\u003e\u0026quot; Strong governmental support through MOH and 20+ years of legal prohibition exist alongside \u0026quot;\u003cem\u003emovements from religious groups\u003c/em\u003e\u0026quot; and \u0026quot;\u003cem\u003epositive attitude of young Saudis.\u003c/em\u003e\u0026quot; However, \u0026quot;\u003cem\u003eonly 5% female donors\u003c/em\u003e\u0026quot; and \u0026quot;\u003cem\u003eerratic\u003c/em\u003e\u0026quot; guideline compliance limit progress. International accreditation standards contrast with coordination challenges, while \u0026quot;\u003cem\u003epolitical/economic factors hindered the move to complete 100% VNRD\u003c/em\u003e\u0026quot; (Supplemental Figure 9).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.\u0026nbsp; \u0026nbsp;Georgia: EU-Driven Reform with Grassroots Innovation\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGeorgia combines EU alignment with NGO advocacy. The \u0026quot;\u003cem\u003eAssociation Agreement in 2014\u003c/em\u003e\u0026quot; and \u0026quot;\u003cem\u003enew Law on Quality and Safety of Blood adopted December 2022\u003c/em\u003e\u0026quot; mandate centralization to \u0026quot;\u003cem\u003eno more than three blood establishments by July 2025.\u003c/em\u003e\u0026quot; NGO \u0026quot;\u003cem\u003eVolunteer Blood Donors\u003c/em\u003e\u0026quot; demonstrates innovation with \u0026quot;\u003cem\u003eover 20,000 followers\u003c/em\u003e\u0026quot; despite lack of legal recognition. However, fundamental challenges persist: \u0026quot;\u003cem\u003ehigh-ranking individuals seek medical treatment abroad\u003c/em\u003e\u0026quot; indicates low healthcare confidence, while \u0026quot;\u003cem\u003edifficult economic situation led to decentralization and commercialization\u003c/em\u003e\u0026quot; creating income dependency on blood donation (Supplemental Figure 10).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e4.\u0026nbsp; \u0026nbsp;Ghana: Systematic Government Transformation with Implementation Challenges\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGhana exemplifies comprehensive government-led reform through \u0026quot;\u003cem\u003eNational Blood Service Act, 2020 (ACT 1042)\u003c/em\u003e\u0026quot; establishing the National Blood Service as a corporate body. The systematic approach emphasizes \u0026quot;\u003cem\u003econtinuous education and sensitization\u003c/em\u003e\u0026quot; through \u0026quot;\u003cem\u003edonor groups (schools, religious bodies, corporate organizations)\u003c/em\u003e\u0026quot; with development partner support. Technological innovation includes \u0026quot;\u003cem\u003eintegration of digital information systems\u003c/em\u003e\u0026quot; and \u0026quot;\u003cem\u003edrone services for emergencies.\u003c/em\u003e\u0026quot; Despite strong legislative foundations and infrastructure investment, \u0026quot;\u003cem\u003eineffective coordination\u003c/em\u003e,\u0026quot; \u0026quot;\u003cem\u003eweak enforcement\u003c/em\u003e,\u0026quot; and persistent \u0026quot;\u003cem\u003emisconceptions about blood donation\u003c/em\u003e\u0026quot; limit cultural acceptance and progress (Supplemental Figure 11).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e5.\u0026nbsp; \u0026nbsp;Indonesia: Political Innovation Despite Institutional Challenges\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIndonesia demonstrates political creativity through unprecedented civic integration. \u0026quot;\u003cem\u003eThe governor made a regulation that if someone wanted to make or renew the driver license, that person has to give blood first\u003c/em\u003e\u0026quot; represents groundbreaking linkage to essential services, extended to \u0026quot;\u003cem\u003eall government employees give blood\u003c/em\u003e.\u0026quot; High-level recognition through \u0026quot;\u003cem\u003eSatya Lencana Bakti Sosial award given by President when donor gives blood 100 times\u003c/em\u003e\u0026quot; establishes donation as a pathway to national honor. Social mobilization through \u0026quot;\u003cem\u003eestablishment of Blood Donor Associations\u003c/em\u003e\u0026quot; and religious integration via \u0026quot;\u003cem\u003eopinion of religious experts about blood donation made into decree\u003c/em\u003e\u0026quot; removes cultural barriers. However, \u0026quot;\u003cem\u003eblood services run by 2 organizations: MoH and Indonesian Red Cross\u003c/em\u003e\u0026quot; creates coordination challenges, while cultural diversity across 17,000 islands creates implementation variations. Despite innovative approaches, \u0026quot;policies \u0026amp; guidelines for blood donation still need to be improved\u0026quot; alongside inadequate government pricing and infrastructure limitations in remote areas (Supplemental Figure 12).\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study, which utilized the established PESTELE framework, provides the first systematic international analysis of factors required for achieving 100% VNRD. The identification of 41 elements across seven factors, with only 16 shared by both achieving and underachieving countries, underscores the multifaceted nature of VNRD implementation and the need for context-specific strategies\u003csup\u003e17,18\u003c/sup\u003e.\u003c/p\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003ePolitical and Legal Frameworks as Foundation\u003c/h2\u003e \u003cp\u003eThe most striking finding is the fundamental role of government-led political and legal factors in enabling a successful transition to VNRD. The hierarchical structure of the factors modeled in the analysis reveals that political and legal factors serve as fundamental enablers for progress in other PESTELE domains (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Without strong governmental commitment and supportive legal frameworks, economic investments, social mobilization, technological improvements, and environmental enhancements a foundation for sustained impact is lacking\u003csup\u003e19\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eAchieving countries consistently demonstrated decisive governmental action, exemplified by Japan's cabinet-level decision after the Reischauer incident and T\u0026uuml;rkiye's comprehensive National Blood Policy and Strategy (Supplementary Figs.\u0026nbsp;1, 6). Finland's integration into Nordic welfare structures and Ethiopia's \"\u003cem\u003egovernment ownership transition in 2012\u003c/em\u003e\" show how sustained political commitment creates systematic transformation (Supplementary Figs.\u0026nbsp;2, 5). Conversely, underachieving countries faced obstacles from political instability and fragmented governance (Table\u0026nbsp;4, Supplementary Figs.\u0026nbsp;8\u0026ndash;12).\u003c/p\u003e \u003cp\u003eA critical gap in achievement of VNRD is seen to emerge from inconsistent or ineffective implementation of national policies. While underachieving countries often possess strong legal frameworks\u0026mdash;Brazil's \"\u003cem\u003epaid donation forbidden by law in 1980\u003c/em\u003e\" and Ghana's \"\u003cem\u003eNational Blood Service Act, 2020\u003c/em\u003e\"\u0026mdash;they struggle with sustained political commitments to implementation beyond initial stages (Supplementary Figs.\u0026nbsp;8, 11). Brazil's four-decade struggle despite early constitutional prohibition and Ghana's \"\u003cem\u003eineffective coordination and weak enforcement of standards\u003c/em\u003e\" illustrate how policy-implementation disconnects undermine progress. This finding has important implications for international development strategies, suggesting that technical assistance should prioritize political and legal framework development as prerequisite conditions, with sustained implementation support extending well beyond initial policy adoption.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eThe Complexity-Success Relationship: Focus versus Fragmentation\u003c/h2\u003e \u003cp\u003eA notable finding is the inverse relationship between VNRD achievement and factor complexity (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Achieving countries demonstrated focused approaches with fewer unique elements per PESTELE factor, while underachieving countries exhibited greater element variability. This counterintuitive finding\u0026mdash;that greater complexity correlates with reduced success\u0026mdash;likely reflects the difference between systematic, coordinated implementation strategies versus fragmented, reactive approaches to multiple challenges. Rather than representing a true paradox, this pattern demonstrates that successful VNRD programs benefit from strategic prioritization and sequential implementation of interventions.\u003c/p\u003e \u003cp\u003eThis pattern reflects the distinction between countries achieving early systemic integration versus those implementing fragmented, reactive approaches. Finland's welfare state integration and Thailand's cultural alignment with Buddhist values demonstrate focused strategies with sustained results (Supplementary Fig.\u0026nbsp;2, 3). Conversely, Saudi Arabia's \"\u003cem\u003earound 300 hospitals collecting blood independently\u003c/em\u003e\" with dramatic variation between facilities, and Indonesia's coordination challenges with \"\u003cem\u003eblood services run by 2 organizations: MoH and Indonesian Red Cross\u003c/em\u003e,\" illustrate how fragmentation undermines progress despite strong individual components (Supplementary Fig.\u0026nbsp;9, 12).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003ePathway Patterns and Temporal Dynamics\u003c/h2\u003e \u003cp\u003eThree pathway patterns emerged\u0026mdash;crisis-driven transformation, economic development integration, and systematic international framework adoption\u0026mdash;providing models for countries at different development stages (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Early achievers (Japan, Finland) were driven by crisis response or welfare state integration, establishing strong institutional foundations (Supplementary Figs.\u0026nbsp;1, 2). Middle-period achievers (Thailand, Oman) leveraged economic development and cultural integration (Supplementary Figs.\u0026nbsp;3, 4). Recent achievers (Ethiopia, T\u0026uuml;rkiye, Malaysia) benefited from international frameworks and evidence-based approaches informed by global best practices (Supplementary Figs.\u0026nbsp;5\u0026ndash;7).\u003c/p\u003e \u003cp\u003ePolitical factors consistently emerged as foundational across all pathways, with government decisions preceding other changes in every case. Legal frameworks provided essential binding requirements overriding economic interests, while economic resources flowed from political priorities (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e2\u003c/span\u003e, Table\u0026nbsp;4). This sequential pattern suggests successful VNRD transformation requires careful attention to timing and coordination, rather than simultaneous intervention in all areas.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eResource Allocation and Economic Sustainability\u003c/h2\u003e \u003cp\u003eAchieving countries establish systematic financing mechanisms integrating VNRD into broader healthcare systems. Japan's \"\u003cem\u003euniversal health insurance covering blood product costs\u003c/em\u003e,\" Malaysia's \"\u003cem\u003emulti-sector funding coordination\u003c/em\u003e,\" and T\u0026uuml;rkiye's \"\u003cem\u003especial budget allocated for VNRD recruitment activities\u003c/em\u003e\" demonstrate targeted investment with sustainable resource flows (Table\u0026nbsp;4, Supplementary Figs.\u0026nbsp;1, 4, 5).\u003c/p\u003e \u003cp\u003eUnderachieving countries face persistent resource constraints limiting systematic expansion. Ghana reports \"inadequate government funding and high production costs,\" while Indonesia notes \"blood rates set by government too small for development of blood products.\" Saudi Arabia's acknowledgment that \"political/economic factors hindered complete VNRD transition\" illustrates how resource allocation challenges can undermine otherwise strong foundations (Supplementary Figs.\u0026nbsp;9, 11,12).\u003c/p\u003e \u003cp\u003eThis suggests sustainable VNRD achievement requires economic integration into healthcare financing systems rather than fragmented, project-based funding.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eSocial Mobilization Complexity\u003c/h2\u003e \u003cp\u003eSocial factors emerged as the most complex domain, with 10 distinct elements identified across country groups (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e, 4). Common elements\u0026mdash;awareness about VNRD importance, public education, community engagement, reward systems, and desire to improve blood safety\u0026mdash;represent universal requirements for donor recruitment and retention.\u003c/p\u003e \u003cp\u003eHowever, challenges in underachieving countries extend beyond basic awareness campaigns\u003csup\u003e20\u003c/sup\u003e. The need to resolve conflicts with religious precepts, address social instability, and manage infectious disease threat reflects broader socioeconomic contexts. Achieving countries demonstrate deep cultural integration\u0026mdash;Ethiopia's \"\u003cem\u003e175\u0026thinsp;+\u0026thinsp;donor clubs and religious engagement\u003c/em\u003e,\" Thailand's \"\u003cem\u003eBuddhist values supporting altruistic donation\u003c/em\u003e,\" and Japan's \"\u003cem\u003esocial movements from students, religious groups, supported by mass media\u003c/em\u003e\"\u0026mdash;creating sustained social momentum (Table\u0026nbsp;4, Supplementary Fig.\u0026nbsp;1, 3, 5).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eTechnology and System Integration\u003c/h2\u003e \u003cp\u003eTechnological factors consistently supported but rarely drove transformation across country groups. Achieving countries leverage technology for system optimization\u0026mdash;T\u0026uuml;rkiye's \"social media campaigns and digital outreach\" and Ethiopia's comprehensive data systems support systematic donor management and recruitment. However, technology implementation follows rather than precedes political commitment and social acceptance.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eInnovation Potential and Global Strategy\u003c/h2\u003e \u003cp\u003eUnderachieving countries reveal both significant challenges and innovative solutions offering potential for global model development. Indonesia's civic service integration through driver license requirements, Georgia's NGO-led advocacy, and Ghana's comprehensive legislative approach demonstrate greater creativity than some achieving countries\u0026rsquo; approaches.\u003c/p\u003e \u003cp\u003eThe current study itself, through qualitative analysis of expert knowledge from both country groups, demonstrated the value of knowledge transfer, fostering mutual learning opportunities. These innovations suggest valuable bidirectional knowledge exchange opportunities. Achieving countries can share implementation strategies and sustainability mechanisms, while underachieving countries contribute innovative approaches to civic engagement and social mobilization. International frameworks should facilitate sustained political commitment, adequate resource allocation, and cultural adaptation across diverse contexts.\u003c/p\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003eImplications for Policy and Practice\u003c/h2\u003e \u003cp\u003eOur findings have several important implications for policy development and programmatic interventions. For international organizations and development partners, the PESTELE framework provides a structured approach for assessing national VNRD readiness and designing targeted support programs\u003csup\u003e13\u003c/sup\u003e. The hierarchical importance of political and legal factors suggests that international organizations should prioritize support for political and legal framework development as fundamental enablers for progress in other areas (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe pathway patterns indicate that countries at different development stages require different approaches. Early-stage countries may benefit from crisis-catalyzed transformation or economic development integration, while countries with existing healthcare infrastructure may find systematic international framework adoption more appropriate (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e3\u003c/span\u003e). The inverse complexity-success relationship (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e) suggests that focused, sequential interventions may prove more effective than comprehensive simultaneous approaches across all domains.\u003c/p\u003e \u003cp\u003eFor national governments in underachieving countries, the 15 common elements identified across both country groups provide a roadmap of universal requirements for VNRD systems (Tables\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e, 4). However, our findings emphasize that successful implementation requires addressing country-specific challenges while maintaining focus on core interventions rather than attempting to address all barriers simultaneously. The innovation demonstrated by underachieving countries suggests that creative adaptation can overcome traditional obstacles, but requires institutional support for sustainable implementation.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec24\" class=\"Section2\"\u003e \u003ch2\u003eLimitations and Future Research\u003c/h2\u003e \u003cp\u003eThe qualitative nature limits ability to quantify relative importance of different PESTELE factors. Snowball sampling may have introduced selection bias toward countries with established blood service networks. Interviews conducted in 2023 may not reflect current situations given dynamic health system reforms and policy changes.\u003c/p\u003e \u003cp\u003eFuture research should examine transition pathways between different VNRD achievement levels through longitudinal analyses. Quantitative measures assessing relative impact of different interventions would complement these qualitative insights from this study. Comparative analysis of countries with similar contexts but different outcomes could provide deeper insights into critical factors for success.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusions","content":"\u003cp\u003eAchieving 100% VNRD requires coordinated action across multiple domains, with political and legal frameworks functioning as fundamental enablers. The PESTELE framework effectively mapped both universal requirements and country-specific challenges, offering a solid evidence base for global policy and program design.\u003c/p\u003e\n\u003cp\u003eThe hierarchical structure provides clear guidance for sequencing international development assistance. The complexity paradox suggests strategic focus may prove more important than comprehensive intervention across all barriers. The three pathway patterns offer flexible models that countries can adapt based on development stage and institutional capacity: global 100% VNRD achievement is attainable through systematic application of proven strategies adapted to local contexts, with sustainability depending on embedding principles within national healthcare and legal frameworks over time.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy Design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study employed a qualitative research design utilizing semi-structured interviews to explore factors required for achieving 100% VNRD worldwide. The research was conducted under the auspices of the ISBT Working Party for Global Blood Safety through its subgroup on Replacement versus Voluntary Donation. An overview of the study design and analytical framework is provided in Figure 1.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipants and Data Collection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants were recruited using a snowball sampling strategy\u003csup\u003e21\u003c/sup\u003e, based on recommendations from members of the ISBT Working Party for Global Blood Safety. This approach leveraged an existing network of international blood transfusion experts to identify knowledgeable representatives from diverse geographical regions and with varying levels of VNRD achievement. Characteristics of the participants and a descriptive status of blood donations in their countries is provided in Table 1.\u003c/p\u003e\n\u003cp\u003eFifteen key informants from 12 countries participated between June and December 2023. Participants were selected for their expertise in blood transfusion services and their ability to provide informed perspectives on national blood donation systems (Table 1).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSemi-structured, paper-based interviews were focused on two main areas: (1) the types of blood donation currently practiced in each country and their respective rates, and (2) expert opinions on important factors required for achieving 100% VNRD. The semi-structured format allowed for systematic data collection while maintaining flexibility to explore country-specific contexts.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCountry Classification and Analysis with the PESTELE Framework\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTwelve countries were classified arbitrarily into two groups based on their reported VNRD achievement rates (Table 1, 2): Achieving Countries (VNRD rate \u0026ge;90%, n=7): Ethiopia (100%), Finland (100%), Japan (100%), Malaysia (100%), Oman (96%), Thailand (90-100%), and T\u0026uuml;rkiye (94%); and Underachieving Countries (VNRD rate \u0026lt;90%, n=5): Brazil (65%), Indonesia (66-92%), Georgia (36%), Ghana (25%), and Saudi Arabia (40%). Reported ranges in the rates of VNRD reflected geographic variations within an individual country.\u003c/p\u003e\n\u003cp\u003ePESTELE analysis is an expanded version of the traditional PEST framework, originally developed for strategic business planning and later adapted for policy analysis and public health research\u003csup\u003e13,22\u0026ndash;24\u003c/sup\u003e. The framework systematically examines Political, Economic, Social, Technological, Environmental, Legal, and Ethical factors that influence complex systems or policy implementations. Qualitative responses regarding factors required for achieving 100% VNRD were analyzed using the PESTELE framework. Interview transcripts were systematically coded according to the seven external factors. The coding process included initial coding and iterative classification through code abstraction, identifying key elements within each PESTELE domain. Theme analysis was then applied to each of these elements (Table 1).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHierarchical analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe seven dimensions of the PESTELE framework were further organized into three hierarchical levels: Foundation Level (Top tier), Resource Level (Middle tier), and Implementation Level (Bottom tier), based on country-specific descriptions of the progress toward achieving 100% VNRD as illustrated in Figure 2. This hierarchical approach enabled visualization of the sequential processes and interdependencies involved in advancing toward full attainment of VNRD.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIdentification of distinct developmental pathways\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAnalysis of commonalities among the hierarchical factors that led to effective development towards 100% VNRD in the achieving countries was performed to identify distinct developmental pathways. The analysis yielded three successful developmental pathways: crisis-driven transformation, economic development integration, and systematic international framework adoption. Characteristics of the three observed patterns are summarized in Figure 3. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was based on paper-based interviews regarding national blood donation systems, related regulations, historical context, and donor population statistics. The leadership of the Working Party for Global Blood Safety determined that the scope and intended use of the interview template were fully consistent with established ethical practices of the ISBT, and the organizing committee reviewed and approved the study protocol. The study involved interviews with blood transfusion professionals sharing organizational expertise and did not constitute human subjects research requiring institutional ethical approval. Consistently, the Jikei University School of Medicine Research Promotion Center, which oversees research ethics review and research support, determined that ethical review is not required for this study, as no individual medical information or personally identifiable data were collected and the study does not fall under the scope of research to which the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects are applicable. Informed consent was obtained from all participants, who explicitly agreed to share their professional knowledge. The study adhered to international research ethics standards, including the principles of the Declaration of Helsinki, with particular attention to confidentiality and the appropriate use of expert knowledge.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors acknowledge the contributions of all participants from the ISBT Global Blood Safety Working Party. The authors thank the following key informants who generously shared their expertise and time for this study: Johanna Nystedt (Finland); Kazuo Muroi (Japan); Zainab Al-Arimi (Oman); Chanakarn Vipusmith, Pawinee Kupatawintu (Thailand); Yasmin Ayob (Malaysia); Habtamu Taye (Ethiopia); Ketevan Shermadini, Melano Durmishidze (Georgia); Justina Ansah (Ghana).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability Statement\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe PESTELE framework analysis results and country-level summary data supporting the conclusions of this article are included within the article and its supplementary information files. Raw interview transcripts are not publicly available but are available from the corresponding author upon reasonable request with appropriate justification.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of Interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTS has received joint research funding from the Japanese Red Cross Society outside the submitted work; has received honoraria for lectures from Werfen, Chugai Pharmaceutical, Zeria Pharmaceutical, Sysmex outside the submitted work. NN and NHT are employees of the Japanese Red Cross Society. WMS is employed by Sanquin Consulting Services. No other potential conflicts of interest relevant to this article were reported.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work was partly supported by the Japan Society for the Promotion of Science (JSPS) KAKENHI Grant Number 24K13470.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTS, WMS, NN, HV, JE, and NHT conceived and designed the study. TS and NHT conducted interviews. TS analyzed data and wrote the manuscript. VSN, NSIH, TT, NEÖ, SW, and SH participated in data collection. WMS, HV, SW, JE, and NHT provided critical insights, and reviewed the manuscript. All authors contributed to critical reading and discussion on the original article and approved the final manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eWHO and International Federation of Red Cross and Red Crescent Societies. 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Blood donors\u0026rsquo; perceptions, motivators and deterrents in Sub-Saharan Africa \u0026ndash; a scoping review of evidence. \u003cem\u003eBr. J. Haematol.\u003c/em\u003e \u003cstrong\u003e177\u003c/strong\u003e, 864\u0026ndash;877 (2017).\u003c/li\u003e\n\u003cli\u003eMohammed, S. \u0026amp; Essel, H. B. Motivational factors for blood donation, potential barriers, and knowledge about blood donation in first-time and repeat blood donors. \u003cem\u003eBMC Hematol.\u003c/em\u003e \u003cstrong\u003e18\u003c/strong\u003e, 1\u0026ndash;9 (2018).\u003c/li\u003e\n\u003cli\u003eBuciuniene, I., Stonien\u0026euml;, L., Blazeviciene, A., Kazlauskaite, R. \u0026amp; Skudiene, V. Blood donors\u0026rsquo; motivation and attitude to non-remunerated blood donation in Lithuania. \u003cem\u003eBMC Public Health\u003c/em\u003e \u003cstrong\u003e6\u003c/strong\u003e, 1\u0026ndash;8 (2006).\u003c/li\u003e\n\u003cli\u003eGasparovic Babic, S., Krsek, A. \u0026amp; Baticic, L. Voluntary Blood Donation in Modern Healthcare: Trends, Challenges, and Opportunities. \u003cem\u003eEpidemiologia\u003c/em\u003e \u003cstrong\u003e5\u003c/strong\u003e, 770\u0026ndash;784 (2024).\u003c/li\u003e\n\u003cli\u003eMammen, J. J., Asirvatham, E. S., Sarman, C. J., Ranjan, V. \u0026amp; Charles, B. A review of legal, regulatory, and policy aspects of blood transfusion services in India: Issues, challenges, and opportunities. \u003cem\u003eAsian J. Transfus. Sci.\u003c/em\u003e \u003cstrong\u003e15\u003c/strong\u003e, 204\u0026ndash;211 (2021).\u003c/li\u003e\n\u003cli\u003eNureye, D. \u0026amp; Tekalign, E. Opportunities and Challenges of Blood Donation and Blood Therapy in Ethiopia. \u003cem\u003eInt. J. Med. Res. Heal. Sci.\u003c/em\u003e \u003cstrong\u003e8\u003c/strong\u003e, 122\u0026ndash;127 (2019).\u003c/li\u003e\n\u003cli\u003eRastogi, N. \u0026amp; Trivedi, M. K. PESTLE technique\u0026ndash;a tool to identify external risks in construction projects. \u003cem\u003eInt. Res. J. Eng. Technol.\u003c/em\u003e \u003cstrong\u003e3\u003c/strong\u003e, 384\u0026ndash;388 (2016).\u003c/li\u003e\n\u003cli\u003eWhat is ISBT | The International Society of Blood Transfusion (ISBT). https://www.isbtweb.org/about.html.\u003c/li\u003e\n\u003cli\u003eRobertson, J. Hemato-nationalism: The Past, Present, and Future of \u0026ldquo;Japanese Blood\u0026rdquo;. \u003cem\u003eMed. Anthropol.\u003c/em\u003e \u003cstrong\u003e31\u003c/strong\u003e, 93\u0026ndash;112 (2012).\u003c/li\u003e\n\u003cli\u003eOkazaki, H., Goto, N., Momose, S. Y., Hino, S. \u0026amp; Tadokoro, K. The Japanese Hemovigilance System. \u003cem\u003eHemovigilance An Eff. Tool Improv. Transfus. Saf.\u003c/em\u003e 159\u0026ndash;167 (2012) doi:10.1002/9781118338179.CH13.\u003c/li\u003e\n\u003cli\u003eWHO. Global Status Report on Blood Safety and Availability 2021. 1\u0026ndash;184 https://www.who.int/publications/i/item/9789240051683 (2022).\u003c/li\u003e\n\u003cli\u003eRoberts, N., James, S., Delaney, M. \u0026amp; Fitzmaurice, C. The global need and availability of blood products: a modelling study. \u003cem\u003eLancet Haematol.\u003c/em\u003e \u003cstrong\u003e6\u003c/strong\u003e, e606\u0026ndash;e615 (2019).\u003c/li\u003e\n\u003cli\u003eWilliamson, L. M. \u0026amp; Devine, D. V. Challenges in the management of the blood supply. \u003cem\u003eLancet\u003c/em\u003e \u003cstrong\u003e381\u003c/strong\u003e, 1866\u0026ndash;1875 (2013).\u003c/li\u003e\n\u003cli\u003eLownik, E., Riley, E., Konstenius, T., Riley, W. \u0026amp; McCullough, J. Knowledge, attitudes and practices surveys of blood donation in developing countries. \u003cem\u003eVox Sang.\u003c/em\u003e \u003cstrong\u003e103\u003c/strong\u003e, 64\u0026ndash;74 (2012).\u003c/li\u003e\n\u003cli\u003eS.Lewis-Beck, M., Bryman, A. \u0026amp; Liao, T. F. Snowball Sampling. \u003cem\u003eSAGE Encycl. Soc. Sci. Res. Methods\u003c/em\u003e 1044\u0026ndash;1044 (2004) doi:10.4135/9781412950589.\u003c/li\u003e\n\u003cli\u003eHong, J., Kafa, N. \u0026amp; Jaegler, A. Exploring barriers and motivations in the adoption of food waste mobile applications. \u003cem\u003eInt. Trans. Oper. Res.\u003c/em\u003e \u003cstrong\u003e0\u003c/strong\u003e, 1\u0026ndash;25 (2024).\u003c/li\u003e\n\u003cli\u003eVardopoulos, I. \u003cem\u003eet al.\u003c/em\u003e An Integrated SWOT-PESTLE-AHP Model Assessing Sustainability in Adaptive Reuse Projects. \u003cem\u003eAppl. Sci.\u003c/em\u003e \u003cstrong\u003e11\u003c/strong\u003e, 7134 (2021).\u003c/li\u003e\n\u003cli\u003eDalirazar, S. \u0026amp; Sabzi, Z. Strategic analysis of barriers and solutions to development of sustainable buildings using PESTLE technique. \u003cem\u003eInt. J. Constr. Manag.\u003c/em\u003e \u003cstrong\u003e23\u003c/strong\u003e, 167\u0026ndash;181 (2023).\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 4 are available in the supplementary files section\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"voluntary non-remunerated blood donation (VNRD), PESTELE framework, qualitative research, blood safety, health policy","lastPublishedDoi":"10.21203/rs.3.rs-7698728/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7698728/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eThis international study provides the first systematic analysis of factors required for achieving 100% voluntary non-remunerated blood donation (VNRD). Semi-structured interviews with 15 experts from 12 countries using the PESTELE framework examined \u003cstrong\u003eP\u003c/strong\u003eolitical, \u003cstrong\u003eE\u003c/strong\u003economic, \u003cstrong\u003eS\u003c/strong\u003eocial, \u003cstrong\u003eT\u003c/strong\u003eechnological, \u003cstrong\u003eE\u003c/strong\u003environmental, \u003cstrong\u003eL\u003c/strong\u003eegal, and \u003cstrong\u003eE\u003c/strong\u003ethical factors influencing VNRD implementation. Countries were classified as achieving (≥90%) or underachieving (\u0026lt;90%) VNRD based on reported rates. Analysis identified 41 distinct elements across seven PESTELE domains, with only 16 shared between groups. Achieving countries exhibited focused strategies with fewer unique elements, whereas underachieving countries showed fragmentation with greater element variation, revealing an inverse relationship between factor complexity and implementation success. Modeling suggested a three-tiered hierarchical structure positioning political and legal factors as foundational enablers, economic factors as resource providers, and social, technological, environmental, and ethical factors as implementation mechanisms. Three developmental pathways were identified: crisis-driven transformation, economic development integration, and systematic international framework adoption. Findings indicate that successful VNRD implementation depends on sustained political commitment, integrated financing, and context-specific cultural adaptation through focused and sequential rather than simultaneous interventions across the PESTELE domains. These insights may help to advance globalization of VNRD through adoption of evidence-based strategies and international development assistance more targeted to hierarchical stages of development.\u003c/p\u003e","manuscriptTitle":"Systematic Analysis of factors required for achieving 100% voluntary non-remunerated blood donation: A qualitative interview-based study of international experiences using the PESTELE framework","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-01-06 06:03:39","doi":"10.21203/rs.3.rs-7698728/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewersInvited","content":"","date":"2026-02-17T18:08:03+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-01-27T11:01:08+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-10-01T16:03:26+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-09-30T04:27:20+00:00","index":"","fulltext":""},{"type":"submitted","content":"Scientific Reports","date":"2025-09-30T04:23:41+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"ccd90603-22e9-40d6-a2d2-1d231857c1a0","owner":[],"postedDate":"January 6th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[{"id":59629532,"name":"Social science/Development studies"},{"id":59629533,"name":"Business and commerce/Information systems and information technology"}],"tags":[],"updatedAt":"2026-02-17T18:23:12+00:00","versionOfRecord":[],"versionCreatedAt":"2026-01-06 06:03:39","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7698728","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7698728","identity":"rs-7698728","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}