On Tuesday, 23 May, Members of the European Parliament Cristian-Silviu Buşoi (Romania, EPP) and Tomislav Sokol (Croatia, EPP) convened a policy workshop on innovation in the blood sector at the European Parliament in Brussels, in partnership with Blood and Beyond. The workshop was attended by around 60 participants (online and in person), including policymakers, professionals working in the blood sector, patients, clinicians, transfusion specialists, and experts in Patient Blood Management (PBM). The meeting focused on ways to improve blood sustainability and anaemic patients’ outcomes through innovation. Discussions covered the role of the proposed new EU Regulation on SoHO, currently being developed by EU legislators, as well as other opportunities to support blood supply continuity, strengthen blood systems and make them more sustainable.

MEP Cristian-Silviu Buşoi (co-host, Chair of the European Parliament’s Committee responsible for innovation and research) outlined the importance of fostering an innovative ecosystem in Europe to continue to improve patients’ care. He called for greater patient safety and for optimal blood management to be properly covered in future EU legislation.

MEP Tomislav Sokol (co-host, Member of the European Parliament’s Committee on the COVID-19 pandemic, and the Committee in charge of public health), main Rapporteur for the EU’s flagship European Health Data Space data initiative, outlined the value of harmonised data collection across the EU to gain a more accurate overview of the usage of SoHO but also to anticipate future demand and evolutions. He called for more focus on the topics of blood supply and anaemia at EU policy level, as these affect a large patient population and come with significant individual, health-systems, and economic impacts.

Professor Dr Axel Hofmann (Member, Board of Trustees, International Foundation for Patient Blood Management; University of Western Australia Medical School), an active contributor to the Blood and Beyond initiative, discussed the value and urgency of implementing PBM in Europe, outlining the related guidance of the World Health Organization. He outlined the role of PBM not only in helping to improve health outcomes and safety for patients with anaemia, but also in contributing to reducing costs for health systems and to blood supply resilience. He called for “blood health” to become a political goal and for the upcoming legislation to help reduce global demand for blood, by emphasizing the role of PBM.

Dr Androulla Eleftheriou (Executive Director, Thalassemia International Federation) explained the challenges that patients with anaemia face, focusing on the example of haemoglobin disorders and, notably, thalassemia. She highlighted the substantial unmet need to transform the blood ecosystem to focus on patients first, and to address the “unknowns” in order to improve patients’ care and safeguard available blood and blood products to benefit those patients who need these most.

European Commission representative Deirdre Fehily shared insights on the proposal for the new EU SoHO legislation, reminding of the challenges that the new Regulation aims to address, the division of competency between the EU and member states; and the proposed measures that aim to reflect the PBM approach in the legislation.

Dr Vincenzo De Angelis (European Blood Transfusion Committee Chair, EDQM) provided an overview of the EDQM activities in blood transfusion with a focus on the clinical transfusion process and the technical standards in the Blood Guide, as well as data collection activities. He shared views on how to strengthen the proposed EU SoHO Regulation.

Dr Vanessa Agostini (Director, Transfusion Medicine, San Martino Polyclinic Hospital, Italy; Director, Regional Blood Centre, Liguria Region, Italy) reminded of the current high use of blood transfusions at hospital level and of the diseases linked to higher transfusion rates; and the significant variations in transfusion practices across the EU. She summarised the main policy recommendations of Blood and Beyond, which include increasing awareness of and education on PBM and optimal blood use; harmonisation of guidelines; expertise exchange; and networks of excellence.

In a video message, Dr Yuyun Maryuningsih (Team Lead, World Health Organization) gave an overview of the work of the WHO to date in optimal clinical use of blood and PBM, reminding of the steps taken since the WHA Resolution of 2010, per which member states committed to PBM implementation. She explained that the WHO technical guidance on PBM is expected early next year.

Discussions highlighted a consensus on:

• The role that innovation plays in improving care for patients with anaemia and addressing blood systems issues.
• Ensuring implementation of PBM in Europe and a greater harmonization of clinical practice to improve patients’ safety and health outcomes, strengthen blood systems and make them more sustainable.
• The importance of recognizing and supporting PBM, optimal blood use and innovation in the new SoHO legislation, including by referring to the technical guidance of expert bodies, such as EDQM and ECDC, and specifically the “EU Blood Guide”, which includes dedicated chapters on clinical blood use and on PBM. This would allow to drive progress uniformly in Europe and ensure optimal clinical use of blood to reduce unnecessary use and the risks of transfusions.
• The need to address existing data gaps including stratification of clinical use of blood (such as red blood cell transfusions) per indications and gaps related to the monitoring of clinical practice and implementation of PBM across Europe, while continuing to build robust systems to monitor the demand for blood and evolutions of patient populations.

Participating experts contributed practical examples on data systems in place at hospitals or national levels; and, on the practice of PBM at local levels, including in Austria, Germany, and Italy.

A summary report is available here.