Proposed SoHO legislation could transform blood sustainability in Europe and help patients with chronic anaemia

Every year, EU patients are treated with 25 million blood transfusions during surgery or trauma care. World Blood Donor Day reminds us that a blood service that gives patients access to safe blood and blood products in enough quantities is key to a resilient health system.

By Dr. Androulla Eleftheriou and Dr. Vanessa Agostini

Dr. Androulla Eleftheriou is the Executive Director, Thalassaemia International Federation, Cyprus and Dr. Vanessa Agostini is the Director of Transfusion Medicine, San Martino Polyclinic Hospital, and Director, Liguria Region Regional Blood Centre, Italy. The article is written on behalf of Blood and Beyond.

21 Jun 2023

The annual World Blood Donor Day, which was held on June 14th, reminds us that a blood service that gives patients access to safe blood and blood products in enough quantities is key to a resilient health system[1]. We know how important it is to appropriately use blood donations and to support approaches that safeguard blood resources for patients in need and without alternatives.

Blood donations help to improve quality of life and to save lives. Every year, EU patients are treated with 25 million blood transfusions during surgery or trauma care[2]. For people with more severe, chronic anaemia, blood transfusions can help to restore red blood cells to a healthy level. They are an essential part of care, especially when there are no other treatment options.

Yet, there are considerable risks for patients, notably those living with transfusion-dependent chronic conditions if there are blood supply disruptions - beyond the risks inherent in transfusions and transfusion complications. Improving patients’ care requires addressing remaining gaps, promoting patient-centric approaches, and recognising the value of innovation in the field.

In July 2022, the European Commission proposed new rules to further increase the safety and quality of substances of human origin (SoHO). The SoHO Regulation, whose implementation will be binding across EU Member States, aims to ensure that citizens can count on the highest standards of quality and safety for vital products, including blood products. The legislative proposal could have a key role in re-thinking donor blood use in the European Union and stimulating an innovative environment. It can support the implementation of measures fostering patient blood management [3] and optimal clinical use of blood across the EU, contributing to improved patient safety and health outcomes, as well as blood supply resilience.

The COVID-19 pandemic had major implications for blood supply and demand, bringing organisational and logistical challenges for transfusion services[4] and the broader blood ecosystem which highlighted the importance of developing sustainable, forward-thinking solutions for the longer-term challenges in blood use, including preparedness for future pandemics[5].

Greater political priority should be given to achieving good blood health which is vital for the functioning of any human organ. This requires a focus on early detection and optimal management of the root causes of poor blood health. Anaemia affects millions of patients in Europe, including hospitalised patients and patients undergoing surgery (acute anaemia), as well as patients suffering from some prevalent non-communicable diseases, including cancer, cardiovascular disease and various infectious diseases (chronic anaemia).

“Measures supporting patient safety and optimal blood management should be properly covered in future EU legislation.”

MEP Cristian-Silviu Bușoi, Chair, ITRE Committee.

In weighing the proposed SoHO Regulation, EU policymakers have a timely opportunity to improve healthcare outcomes for patients with both acute and chronic anaemia, including patients who need blood transfusions.

Two measures should be given priority as part of the revision. Firstly, patient blood management (PBM) should be in the final text. By detecting often preventable anaemia early, and managing it properly in a way that could reduce reliance on blood supplies, PBM can help to lower blood transfusion rates while improving patient care.

Secondly, optimal blood use supports the safe, efficient and appropriate use of blood components. The World Health Organization (WHO) outlines how “essential it is that blood is only used when needed and clinically appropriate: when the patient’s condition can be improved by blood transfusion, when alternative therapies are not available and when the administration can be properly monitored[6] to avoid unnecessary transfusions and suboptimal clinical practices that compromise patient safety.

Both can help to reduce healthcare costs, supporting the sustainability and resilience of European healthcare systems.

Codifying these measures in the proposed SoHO Regulation would stimulate their uptake across Europe, in line with the guidance of expert bodies. It would help EU Member States to meet their commitments in the 2010 WHO Resolution WHA63.12 and act on the WHO recommendation to urgently implement PBM.

Further, the proposed legislation could improve data collection by monitoring the implementation of the new measures and stratifying blood component use based on indications.

”We need a more accurate picture of the situation, notably of SoHO use, to help anticipate demand and evolutions.”


MEP Tomislav Sokol, Member of the COVI and SANT Committees and Rapporteur for the European Health Data Space.

The SoHO Regulation is an important step towards building a sustainable blood use culture. While education at all levels will be crucial in translating standards into clinical practice, recognising PBM and optimal blood use in the EU legislation would be a landmark.

This article is based on consensual recommendations raised at an EU policy workshop in the European Parliament in Brussels on May 23, 2023. It was co-hosted by MEPs Cristian-Silviu Buşoi and Tomislav Sokol, in partnership with Blood and Beyond.


[1] World Health Organization. World Blood Donor Day.

[2] European Commission. Q&A on the proposal for a new legislation on blood, tissues, and cells. July 2022. 

[3] Patient blood management (PBM) is a patient-centred, systematic, evidence-based approach to improving patient outcomes by managing and preserving patients’ own blood while promoting patient safety and empowerment. Shander A, Hardy JF, Ozawa S, Farmer S. Patient Blood Management, a global definition. Anesth Analg. 2021. The definition has been endorsed by the World Health Organiszation, The urgent need to implement patient blood management: policy brief. World Health Organization 2021

[4] Blood Use in Europe: Learning from the Impact of COVID-19, A Blood and Beyond Policy Briefing.; 2021:12.

[5] Ibid.

[6] Educational modules on clinical use of blood. Geneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO.