EU Policies & Directives

Blood Safety & Donation

Regular blood transfusions have been a central aspect of the treatment of thalassaemia since the 1960s. As blood transfusion is a lifelong treatment for thalassaemia, the Thalassaemia International Federation (TIF) advocates for the promotion and development of policies by national health authorities for ensuring the safety and adequacy of blood and blood components through voluntary and unpaid regular blood donation practices, intended for patients with transfusion dependent thalassaemia and other haemoglobin disorders.

Blood Availability

Great variability exists regarding availability of blood and blood donation practices among countries, influenced by socioeconomical factors. In high-income countries, blood collection tends to be a well-established practice and a large percentage of the general population are volunteer blood donors. The majority of blood products are administered to older people (>60 years old). On the contrary, in low-income countries, blood donation is disproportionally low and large percentages of blood donors are replacement or paid donors. The majority of blood products is administered to paediatric patients. Some key figures are given below.

  • 5 million blood donations collected globally. High-income countries collect 40% of all blood donations, representing only 16% of the world’s population
  • In high-income countries, 75% of all transfusions are administered to patients over 60 years of age, and in general, transfusion is most commonly used for supportive care in cardiovascular surgery, transplant surgery, massive trauma, and therapy for solid and haematological malignancies. In low-income countries, up to 54 % are administered to patients below 5 years of age, and blood is more often used to manage pregnancy-related complications and severe childhood anaemia
  • The median blood donation rate is 31.5 donations per 1000 people in high-income countries, 15.9 donations in upper-middle-income countries, 6.8 donations in lower-middle-income countries and 5.0 donations in low-income countries

The World Health Organization (WHO) recommends that all activities related to blood collection, testing, processing, storage and distribution be coordinated at the national level through effective organization and integrated blood supply networks. The national blood system should be governed by national blood policy and legislative framework to promote uniform implementation of standards and consistency in the quality and safety of blood and blood products. Specific legislation covering the safety and quality of blood transfusion are only implemented in 64% of countries worldwide (including 79% of high-income countries, 63% of middle-income countries and 39% of low-income countries).

Blood Safety

Blood safety also varies significantly among high- and low-income countries. Transfusion-Transmitted Infections (TTIs) have higher prevalence in low-income countries, as shown in the table below. This is a reflection of higher prevalence of these infections in the general population, less effective blood testing and donor selection testing methods as well as the lower percentage of voluntary blood donation.

Prevalence of transfusion-transmissible infections in blood donations (Median, Interquartile range (IQR)), by income groups. Source: WHO (https://www.who.int/news-room/fact-sheets/detail/blood-safety-and-availability)

HIV HBV HCV Syphilis
High-income countries 0.001% 0.01% 0.06% 0.01%
(0% – 0.01%) (0.003% – 0.13%) (0.002% – 0.05%) (0.002% –0.11%)
Upper middle-income countries 0.10% 0.29% 0.18% 0.34%
(0.03% – 0.23%) (0.15% – 0.62%) (0.06% – 0.35%) (0.11% –1.08%)
Lower middle-income countries 0.19% 1.96% 0.38% 0.69%
(0.03% – 0.77%) (0.76% – 5.54%) (0.03% –0.80%) (0.16% – 1.25%)
Low-income countries 0.70% 2.81% 1.00% 0.92%
(0.33% – 1.66%) (2.00% – 4.50%) (0.50% – 2.23%) (0.60% – 1.81%)

According to WHO recommendations, all blood donations should be compulsory screened for HIV, hepatitis B, hepatitis C and syphilis prior to use. Additional screening for other infectious agents (e.g. Malaria, West Nile Virus, hepatitis E, etc) may be included depending on local epidemiology data.

WHO strategy for blood safety and availability addresses the following five key areas:

  • the establishment of well-organized, nationally-coordinated blood transfusion services to ensure the timely availability of safe blood and blood products for all patients requiring transfusion.
  • the collection of blood from voluntary unpaid blood donors from low-risk populations.
  • quality-assured testing for transfusion-transmissible infections, blood grouping and compatibility testing.
  • the safe and appropriate use of blood and a reduction in unnecessary transfusions.
  • quality systems covering the entire transfusion process, from donor recruitment to the follow-up of the recipients of transfusion.

 

Blood Donation

There are three types of blood donors:

  • voluntary unpaid,
  • family/replacement
  • paid

Voluntary non-remunerated blood donation (VNRBD) is considered as the safest and most sustainable source of blood globally and its global achievement has been recognised as the important national policy direction for ensuring a safe, secure and sufficient supply of blood and blood products, including labile blood components and plasma-derived medicinal products. VNRBD is supported by numerous official organizations, including

  • World Health Assembly (WHA) resolutions 63.12, 58.13 and 28.72
  • World Health Organization, Melbourne Declaration (June 2009)
  • European Union, EU Blood Directive 2002/98/EC

Despite advances, a significant percentage of countries still relies on remunerated blood donation. 62 countries have achieved 100% VNRBD and in total 79 countries collect more than 90% of their blood supply from voluntary unpaid blood donations (38 high-income countries, 33 middle-income countries and 8 low-income countries). However, 16 countries still report collecting paid donations and in a total of 56 countries, more than 50% of the blood supply is still dependent on family/replacement and paid blood donors (9 high-income countries, 37 middle-income countries and 10 low-income countries).

 

Visuals taken from WHO, World Blood Donor Day 2021 & World Blood Donor Day 2019

 

Use of Blood

Blood products are crucial components of life-saving treatments, therefore they must be used prudently. Unnecessary blood transfusions not only expose patients to avoidable risks but also constitute false allocation of valuable resources. WHO recommends the development of systems, such as hospital transfusion committees and haemovigilance, to monitor and improve the safety of transfusion processes. Effective haemovigilance systems must have the capacity to trace the route of all blood donations from the donors to the recipients (vein to vein) and all transfusion adverse events must be reported and investigated. Hospital transfusion committees are responsible for developing local protocols and coordinating the optimal use of blood and transfusion practices. In high-income countries haemovigilance systems and hospital transfusion committees are present in higher percentages compared to low-income countries.

 

Blood Safety & Donation Legislation in the European Union

The formulation of a European-wide strategy to ensure the safety to the blood transfusion chain and promoting self –sufficiency where blood was concerned was the main topic of a high – level EU meeting held in 1994 in Ireland. Prior to this the EU has little involvement in blood safety regulations.

Therefore, formulation of high standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components across the EU is the primary objective of Directive 2002/98/EC of the European Parliament and Council. Its implementation is supported by Commission Directives 2004/33/EC, 2005/61/EC, and 2005/62/EC.

In place since 2002, Directive 2002/98/EC makes detailed references to specific technical requirements for blood donation practices, blood establishments, haemovigilance, and data protection.

 

Important aspects of the legislation:

  • Blood establishments, defined in Directive 2002/98/EC as any body responsible for any aspect of collection and testing of human blood or blood components as well as their processing, storage and distribution, must be designated, authorized, accredited or licensed by the national competent authority. Furthermore, the legislation requires that inspection must be conducted on a regular basis and not more than two years apart. This is supported by Directive 2005/62/EC.
  • As of January 2009, 764 blood establishments have been authorized under Directive 2002/98/EC.
  • Haemovigilance, consisting of the components of traceability and the monitoring of serious adverse events is fundamental to the quality and safety standards that Directive 2002/98/EC sets. Indeed data needed for full traceability from donor to recipient and vice versa shall be kept for at least 30 years. In the case of adverse events and/or reactions resulting from the safety of blood and blood components, national competent authorities should be notified immediately. Blood and blood components imported from third countries and intended for distribution in the EU, should meet equivalent EU standards and specifications relating to traceability and serious adverse reactions. The implementation of a robust haemovigilance system is supported by Directive 2005/61/EC.
  • Blood donations, Directive 2002/98/EC recommends, should be as far as possible be provided by voluntary and non- remunerated (unpaid) donors. Donors are required to provide personal information (e.g. identification, state of health, medical history etc) and signature and must be informed about the characteristics of their blood and blood products. If test results reveal any form of pathology they must be contacted. All data however, including genetic information must be rendered anonymous so that the donor is unidentifiable. This is supported by Directive 2004/33/EC.

 

Read the Directives:

Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments

Commission Directive 2014/110/EU of 17 December 2014 amending Directive 2004/33/EC as regards temporary deferral criteria for donors of allogeneic blood donations

Commission Directive 2009/135/EC of 3 November 2009 allowing temporary derogations to certain eligibility criteria for whole blood and blood components donors laid down in Annex III to Directive 2004/33/EC in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic

Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events

Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments

Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC

 

Useful links

WHO, Strategic Framework for Blood Safety and Availability 2016-2025

WHO, Key Facts on Blood Safety and Availability (2020)

WHO, Global Status Report on Blood Safety and Availability (2016)

WHO, Global Consultation on Haemovigilance (2012)

WHO, Expert Consensus Statement on achieving self-sufficiency in safe blood and blood products, based on voluntary non-remunerated blood donation (VNRBD) (2012)

WHO, Melbourne Declaration of June 2009

EU Commission Report on Voluntary and Unpaid Donation of Blood and Blood Components (2011)

European Blood Alliance on Position Paper On Voluntary Non-Remunerated Donations

European Blood Alliance, Voluntary Non-Remunerated Donors – Summary

International Federation of Red Cross and Red Crescent, Global action towards 100 per cent voluntary, non-remunerated blood donation

 

WHO Resolutions on Blood Safety & Donation

WHA63.12 – Availability, Safety and Quality of Blood Products

WHA28.72 – Utilization and Supply of Human Blood and Blood Products

EB79.R1 – Blood and blood products

WHA63.18 – Viral hepatitis


 

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