Blood Safety & Availability

The Thalassaemia International Federation (TIF) advocates for national policies that secure sufficient, safe blood and blood components through regular, voluntary and unpaid donation. This requires sustained investment in coordinated blood services, effective oversight and transfusion practices that respond to the needs of people with thalassaemia and other haemoglobin disorders.

Global inequalities in blood availability and safety

Progress in blood donation has improved access for many patients, but major inequalities persist. WHO’s latest global assessment reports approximately 120.4 million donations worldwide. High-income countries collect 36% of these donations while accounting for only 15% of the world’s population.

Source: WHO, June 2026. The assessment covers 168 countries and 97% of the world’s population, using mainly 2023 data, with older figures for some countries. 

These disparities reflect gaps in the systems needed to maintain a reliable blood supply. Inadequate financing, weak infrastructure, logistical barriers and insufficient donor recruitment limit collection and distribution. WHO reports that more than one in seven countries has neither dedicated government budget allocations nor cost-recovery mechanisms for blood services. Without sustained national programmes, recruitment, testing, service quality and supply planning are difficult to maintain.

Safety and monitoring capacity also vary substantially. Ten reporting countries cannot screen every donation for all four infections recommended by WHO: HIV, hepatitis B, hepatitis C and syphilis. Only 88 of the 168 reporting countries have a haemovigilance system for monitoring adverse events associated with blood donation and transfusion.

These findings reinforce the need to plan specifically for people who require repeated transfusions. National programmes must account for their ongoing requirements alongside emergency demand, including access to compatible blood and the specialist services needed to use it safely.

Voluntary donation and sustained national programmes

Regular, voluntary and unpaid blood donors are the foundation of a dependable blood supply. A sustained donor programme requires accessible donation services, appropriate donor assessment, and consistent efforts to recruit and retain donors. WHO reports that 80 countries obtain more than 90% of their blood supply from voluntary unpaid donors, while 59 still obtain more than half from family or replacement donors and paid donors. 

Donation programmes must operate within a nationally coordinated blood system with reliable funding, trained staff, quality assurance and effective regulation. World Health Assembly Resolution WHA63.12 remains a foundational policy instrument for sustainable blood and plasma programmes, voluntary unpaid donation and progress towards national self-sufficiency. 

Safety throughout the transfusion process

Blood safety depends on every stage of care, from donor assessment and infection screening to processing, storage, transport and transfusion. The World Health Organization (WHO) emphasises this comprehensive approach through World Health Assembly Resolution WHA63.12, which calls for quality assurance and effective regulatory oversight throughout the transfusion chain. WHO also stresses the importance of reliable reporting of adverse reactions and incidents, with haemovigilance enabling services to investigate risks, identify preventable errors and improve practice.

For thalassaemia, safe care also requires attention to the effects of repeated transfusion. TIF’s 2025 clinical guidelines emphasise extended red cell antigen typing, appropriate matching, including Rh and Kell antigens, and careful review of a patient’s antibody history. These measures help reduce alloimmunisation, the development of antibodies against transfused red cells that can complicate future treatment. Patients should receive clear information about their transfusion care and participate in decisions. 

The European Union policy framework

The most significant recent EU development is Regulation (EU) 2024/1938 on substances of human origin, known as the SoHO Regulation. Adopted in 2024, it establishes a broader framework for the quality and safety of blood, tissues, cells and other human substances used in healthcare. It strengthens protection for donors and recipients and supports more consistent oversight across Member States. 

Most provisions apply from 7 August 2027, with certain provisions applying a year later. The Regulation will replace the existing EU Blood Directive and Tissues and Cells Directive. During the transition, the current blood legislation remains relevant. 

For blood services and patients who rely on regular transfusions, its principal provisions concern:

• Stronger oversight, with clearer responsibilities for national authorities and common procedures for assessing and authorising SoHO preparations.
• Improved vigilance and rapid alerts when serious safety or quality incidents could affect donors or recipients.
• Supply resilience, including national emergency plans and measures to respond to critical shortages.
• More consistent standards and cooperation to facilitate exchange between Member States.
• Voluntary and unpaid donation, with any donor compensation or reimbursement governed by national rules and the prohibition of financial incentives. 

Until the new framework applies, Directive 2002/98/EC and its three core implementing directives remain the essential references: 2004/33/EC on technical requirements, 2005/61/EC on traceability and notification of serious adverse reactions and events, and 2005/62/EC on quality systems. Together, they underpin the current EU standards for blood and blood components. 

The Council of Europe’s EDQM Blood Guide is another essential technical reference. Its 22nd edition, published in May 2025, updates standards for blood components, revises haemovigilance guidance and adds a chapter on blood supply contingency and emergency planning. 

WHO policy and guidance

WHO’s Action framework to advance universal access to safe, effective and quality-assured blood products 2026–2030, published in June 2026, provides the current strategic direction for strengthening national blood systems. It prioritises governance and regulation, availability and affordability, appropriate clinical use, surveillance and haemovigilance, and preparedness for emerging threats. Sustained political commitment and adequate resources are central to implementation.

The framework is complemented by WHO’s 2025 guidance on implementing patient blood management. Patient blood management supports better outcomes through appropriate anaemia management, prevention and control of blood loss, and careful transfusion decisions. For people with transfusion-dependent thalassaemia, these principles must be applied alongside disease-specific guidance and dependable access to clinically indicated transfusions.

WHO resolutions and technical guidance inform national policy and practice. Their role differs from binding EU legislation, which establishes legal requirements within its jurisdiction.

TIF priorities for equitable access

TIF’s advocacy places the needs of people who depend on transfusion at the centre of blood policy. The priorities are sustained national blood programmes, voluntary unpaid donation, consistent safety and quality standards, and effective implementation of the SoHO Regulation. Patients’ continuing transfusion needs must inform supply planning and preparedness for shortages. 

Progress should be assessed through patients’ access to timely, appropriate treatment, supported by reliable information on availability, service quality and transfusion outcomes. A dependable blood supply gives people with thalassaemia the continuity of care on which their health and daily lives depend.

Key policies and resources;

• EU legislation: SoHO Regulation and implementation and current blood directives.
• European technical guidance: ECDC infection guidance and EDQM Blood Guide.
• WHO policy: Action framework 2026–2030 and Resolution WHA63.12.
• WHO clinical guidance: Patient blood management, 2025.
• Evidence and clinical care: WHO global blood safety report and TIF clinical guidelines, 2025.