Transforming hemophilia registries into tools for health equity in low- and middle-income countries: From counting patients to changing care

To the Editor, We read with great interest the Short Communication by Shrivastava et al. on strengthening hemophilia registries globally.[1] Their article is timely: The World Bleeding Disorders Registry (WBDR) now exceeds 10,000 patients,[2] the 2025 World Health Organization Essential Medicines List (EML) has added emicizumab and recombinant clotting factors,[3] and real-world emicizumab data demonstrate unprecedented bleed control.[4] Taken together, these developments demand a shift from registries that record toward registries that change care, particularly in low- and middle-income countries (LMICs). Yet in many LMICs, fewer than one-third of people with hemophilia are identified in national datasets, with registry coverage as low as 10%–20% of expected cases in some settings,[2] underscoring the magnitude of the equity gap. While Shrivastava et al.[1] highlight global gaps, comparative insights remain underexplored. The European Hemophilia Safety Surveillance System has demonstrated real-time signal detection for adverse events across >30,000 patients,[5] whereas the US ATHN registry emphasizes payer integration and longitudinal outcome tracking. In contrast, many LMIC registries remain limited to enumeration, with minimal links to pharmacovigilance or policy. Examples from India and Brazil show that even in constrained settings, national registries can progressively evolve – from static counts to web-based platforms that inform public procurement and comprehensive care – when they are embedded in national programs and linked to reimbursement decisions.[3,5] Bridging these models with WBDR’s inclusive design through shared governance (e.g., joint steering groups involving WBDR, national programs, and patient organizations) and technical integration (e.g., interoperable minimum datasets, common outcome measures, and shared analytic dashboards) could catalyze innovation in resource-constrained settings. We propose a ten-point operational strategy to make registries actionable Adopt a harmonized core dataset aligned with WBDR fields (diagnosis, genotype, inhibitors, therapy, and outcomes), with LMIC programs prioritizing variables that directly inform tendering, subsidy design, and Universal Health Coverage (UHC) benefit packages Embed patient-reported outcomes (PROs) and digital diaries – real-world data from a nationwide digital diary program in the Netherlands show mean treated annualized bleeding rates of 1.5 and >60% bleed-free at 24 weeks on emicizumab.[4] LMIC registries can start with simple mobile or SMS-based diaries, scaling later to app-based platforms as digital infrastructure matures Enforce data quality at entry using logic checks and periodic audits.[1,2] This can be implemented pragmatically in LMICs through quarterly data quality cycles, simple error dashboards, and peer benchmarking across hemophilia treatment centers Automate secure EHR interfaces (HL7-FHIR) while ensuring privacy-preserving record linkage (PPRL) for ethical data sharing.[6] HL7-FHIR provides a common “language” for exchanging clinical data across disparate hospital systems, while PPRL uses cryptographic techniques to link records without exposing names or identifiers – crucial where stigma, conflict, or weak data-protection laws heighten privacy risks Expand beyond FVIII/IX to include nonfactor prophylaxis, gene therapy, and emerging CRISPR-based editing trials, with registry modules that capture treatment modality, line of therapy, adherence patterns, and switching between factor and nonfactor prophylaxis Integrate pharmacovigilance to capture thrombotic events, inhibitor kinetics, and supply-chain alerts in real time.[2,5] Registry-triggered safety signals (for example, unusual inhibitor clusters or product batch-linked events) can be automatically routed to national regulatory authorities and hospital pharmacy networks Prepare for gene therapy by tracking vector immunity, transaminase flares, and durability of factor expression.[7] Long-term follow-up fields (e.g., scheduled ≥10-year laboratory, imaging, and PRO assessments) should be hard-wired into the registry, allowing regulators and payers to monitor durability and late toxicities in routine care Target the undiagnosed majority through newborn screening, cascade family testing, and syndromic prompts in primary care. Syndromic prompts can be embedded into primary care electronic records or paper checklists (e.g., “recurrent joint swelling,” “postcircumcision bleeding,” and “postpartum hemorrhage with normal platelets”), automatically flagging high-risk children and women for basic coagulation testing or referral Link registry outputs to reimbursement and procurement, ensuring rational allocation and reducing wastage. In LMICs, even simple annual reports – bleeds, factor consumption, and school/work days lost by region – can be used to negotiate tenders, adjust distribution, and justify stepwise expansion of prophylaxis Ensure transparent governance with open dashboards, public charters, and patient co-leadership – addressing both equity and ethics. Patient organizations can co-chair governance committees, nominate “community data stewards,” and co-design public-facing dashboards, ensuring that registry priorities reflect lived experience rather than solely biomedical or commercial imperatives. Registries are not neutral data tools; they are policy instruments. By tying outcomes to UHC and Sustainable Development Goals, registry outputs can directly influence funding, tendering, and inclusion of new therapies in national formularies. Ethical stewardship – consent, data sovereignty, and privacy – must be foregrounded in LMICs, where trust deficits can erode participation. Operationalizing these principles requires context-specific consent models (including re-consent when introducing new data uses), clear rules on cross-border data flows, and periodic public reporting on who accesses registry data and for what purposes. Innovation pipeline The future trajectory of hemophilia management is clear Factor prophylaxis (baseline standard) Nonfactor therapies such as emicizumab (EML-listed)[3] Gene therapies like valoctocogene roxaparvovec with durable bleed reduction[7] CRISPR-based editing is now entering clinical testing, requiring novel registry modules for genomic safety surveillance.[8] To remain relevant, hemophilia registries must explicitly incorporate this therapeutic evolution: Pretreatment modules (baseline genotype, inhibitor history, comorbidities, and vector immunity), structured follow-up fields for gene therapy (e.g., factor levels, liver enzymes, integration-site monitoring, and late-onset adverse events), and CRISPR-specific safety elements (on-and off-target effects, durability of edits, and inter-generational considerations).[8] These features will allow LMIC programs to participate in, rather than merely observe, global innovation pipelines. Registries must evolve in parallel, ensuring that Iraq and comparable health systems are not merely late adopters but early integrators of innovation pipelines. Conclusion We commend IJH for spotlighting this systems-level agenda. By advancing from static enumeration toward registries as engines of equity, LMIC programs can reduce bleed rates, improve school and work participation, and close urban–rural disparities. When registry modernization is aligned with broader health-system investments – laboratory networks, human resources, and digital health platforms – it strengthens system resilience and sustainability rather than creating isolated “data islands.” We call upon policymakers, patient groups, clinicians, and global partners to prioritize registry modernization as a core component of national UHC strategies for bleeding disorders, ensuring that every dataset generated is translated into safer, more equitable care. The time has come to make hemophilia registries not only repositories of data but also instruments of health justice. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.