Blood, Sweat and Tears: Enhancing Access to Quality-Assured and Safe Blood and Blood Products in Low- and Middle-Income Countries

Abstract

Access to safe and effective blood and blood products remains a crucial public health challenge in low- and middle-income countries (LMICs), regardless of the essential role in treatment of several diseases, such as, major trauma, haemophilia and obstetric complications. This dissertation explores the diverse global and regional facets in the selection, registration, and regulation of blood products, highlighting the systemic gaps that limit access and emerging opportunities for data-driven approaches to strengthen access and safety. The first part of the research investigates the global selection of essential medicines on 105 NEMLs and their registration in 61 LMICs. Our findings showed a low uptake of essential blood products, especially, blood and blood components, and frequent registration of non-essential blood products like Albumin. LMICs from Africa, in particular, showed significant under-registration of WHO recommended blood and blood products. These insights suggest an urgent need for policy reforms that are guided by national health priorities and supported by evidence-based inclusion criteria, regulatory system strengthening and international collaboration to improve availability and accessibility. The second section turns the focus to Africa and evaluates the regulatory landscape for blood and blood products using the WHO Global Benchmarking Tool (GBT)+ Blood. Data from 12 countries show better performance in regulating plasma-derived medicines compared to the regulation of blood components and plasma for fractionation, which remains weak. Similarly, haemovigilance systems across 10 countries show major gaps in the implementation of governance, legal frameworks, and human resource. It is evident from our findings that nascent blood regulatory frameworks exist in many countries and advocate for urgent, targeted support to build resilient regulatory systems capable of overseeing the entire blood value chain, from collection to patient use. Finally, this thesis explores how data-driven haemovigilance, using global tools such as the WHO’s VigiBase, can support safety monitoring of blood products. By analysing over 111,000 reports from across the world, the study highlights the potential for improved global surveillance if systems are better harmonised. The work also showcases the impact of the BloodTrain initiative, which has strengthened blood regulation in African countries through tailored capacity building, system development, and stakeholder engagement. The thesis concludes by calling for increased investment in local production of plasma-derived medicines, regional regulatory centres of excellence and sustained global support to ensure equitable access to blood products in LMICs.