EU Policies & Directives

Blood safety & donation

Visual taken from WHO, World Blood Donor Day 2017

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.

Click below to see what TIF does with regards to blood donation and safety.

The World Health Organization (WHO) supports that providing safe and adequate blood should be an integral part of every country’s national health care policy and infrastructure. Indeed the WHO recommends that all activities related to blood collection, testing, processing, storage and distribution be coordinated at the national level through effective organization and a national blood policy.

Specific legislation covering the safety and quality of blood transfusion are only implemented in 62% of countries worldwide (of which 81% are high-income countries, 60% are middle-income countries and 44% are low-income countries). Thus there is marked difference in the level of access to safe blood between low- and high-income countries, especially considering that up to 65% of blood transfusions are given to children under five years of age in low-income countries.

Blood Donation

There are three types of blood donors: 

  1. voluntary unpaid,
  2. family/replacement and
  3. paid.

Nevertheless, both the European Union, with the EU Blood Directive 2002/98/EC and the WHO support that an adequate and reliable supply of safe blood can only be assured by a stable base of regular, voluntary, unpaid blood donors.

In fact the WHO Global Consultation on 100% Voluntary Non-Remunerated Blood Donation (VNRBD) of Blood and Blood Components, endorsed the Melbourne Declaration of June 2009. The Declaration states that evidence supports that regular, voluntary, non-remunerated blood donors are the cornerstone of a safe and sustainable national supply of blood and blood products sufficient to meet the transfusion requirements of the patient population.

Read the Melbourne Declaration (2009)

Data from the WHO indicates that already 71 countries collect over 90% of their blood supply from voluntary unpaid blood donors.

Read more:

EU Commission report on Voluntary and Unpaid Donation of Blood and Blood Components (2011)
European Blood Alliance Position Paper on Voluntary Non-Remunerated Donations (2009)
European Blood Alliance website

Blood Safety

All blood donations should be compulsory screened for HIV, hepatitis B, hepatitis C and syphilis prior to use, the WHO recommends.

In addition, and as a means to address global concerns about the availability, safety and accessibility of blood for transfusion the WHO established in 1998 the Global Database on Blood Safety (GDBS)

Moreover, the 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.

Additionally, through its Blood Transfusion Safety Programme, the WHO supports countries in developing national blood systems to ensure timely access to safe and sufficient supplies of blood and blood products and good transfusion practices to meet the patients’ needs.

Read here about the WHO Global Consultation on Haemovigilance (2012) Recommendations & Priorities for Action

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:

Directive 2002/98/EC
Directive 2004/33/EC
Directive 2005/61/EC
Directive 2005/62/EC

WHO Resolutions on Blood Safety & Donation

WHA63.12. Availability, safety and quality of blood productsWHA63.15. Viral hepatitis
WHA28.72 – Utilization and supply of human blood and blood productsEB79.R1 – Blood and blood products

Back to top button