Why the EU should boost Patient Blood Management implementation in Europe and align EU legislation with WHO guidance

There are many reasons for the EU to take a greater role in preserving blood – including one’s blood –  to improve patients’ lives. The window of opportunity is here to support EU countries improve health systems, policies and practices to embrace approaches that support blood sustainability, benefit patients while reducing healthcare costs, write MEP Cristian-Silviu Busoi, MEP Manuel Pizarro and MEP Tomislav Sokol, who co-hosted a recent policy conversation on the issue and reflect on its key take-aways.

MEP Dr Cristian-Silviu Busoi is a physician by training, Chair of the European Parliament’s Committee on Industry, Research and Energy (ITRE) and a substitute member of the Committee on the Environment, Public Health and Food Safety (ENVI), EMA Contact person and the Rapporteur for the EU4Health Programme. MEP Dr Manuel Pizarro is a doctor in internal medicine and a substitute member of the ENVI committee. MEP Tomislav Sokol is a lawyer and has expertise in EU health law and policy, notably cross-border healthcare services. They all work towards healthcare systems strengthening and improved patients’ access to healthcare.

Blood sustainability is not a marginal subject and it is time for a change   

Blood systems are a key component of healthcare systems. European institutions are currently reflecting on how to build a European Health Union, integrating the lessons learnt from the impact of COVID-19 on patients and health systems to improve resilience and preparedness. The pandemic exemplified some existing challenges in the blood sector and in healthcare systems organisation and delivery; and raised new questions.

The blood shortages experienced in a number of EU countries as a result of fewer blood donations highlighted the importance of new approaches to safeguard blood supply, rethink blood use and ameliorate anaemia care – both in the acute and surgical setting and for patients dependent on regular red blood cell transfusions.

The upcoming EU Blood Directive revision provides a unique opportunity to address some of these challenges. As a number of stakeholders responding to a recent consultation argued and as the Commission itself recognized, the current Directive has fallen short in improving the blood sustainability of the region.

The scale of the patient population that could benefit from advances in the area is immense: anaemia affects millions of Europeans, including surgical or hospitalised patients, while it is often a comorbidity in patients with major noncommunicable diseases such as chronic kidney disease, cardiovascular disease, or diabetes; and it is highly prevalent in patients with oncological, haematological malignancies, and infectious diseases.

Patient Blood Management works, it is endorsed by the WHO and needs to be fully recognised and applied across Europe

Greater implementation of Patient Blood Management – a WHO-endorsed standard of care that aims to optimize medical and surgical patient outcomes through the preservation of the patient’s own blood – may hold the key to addressing many of the current challenges, together with optimal blood use. But this requires a behavioural, political and cultural shift from the current focus on blood supply – as outlined by leading PBM experts.

There is plenty of evidence showing that proper implementation of PBM and optimal blood use can reduce mortality and follow up care, lower transfusion rates and unnecessary blood transfusions, thereby reducing transfusion risks and pressure on the blood supply. This ensures that blood is available for those who need it most, but it also reduces significantly healthcare costs.

Yet, there is an important implementation gap in Europe and that is where the European Union can and should play a role, according to the experts.

The World Health Organisation (WHO) recently released a new policy brief entitled “The urgent need to implement Patient Blood Management (PBM)’” that outlines the value of PBM and makes the case for greater recognition and implementation. For this to become a reality in Europe, EU policy frameworks need to be aligned with state of the art clinical practice as defined by WHO, by integrating PBM into the revised EU Blood Directive.

“WHO expects that the revised EU Blood Directive will state the need and importance of PBM as an effort to ensure patient safety and availability of blood for transfusions” stated Dr Yuyun Maryuningsih (World Health Organization).

European cooperation is the best way to enable cross-fertilization and facilitate innovation

As the EU strives to improve collaboration between member states, PBM should become a shared goal for all member states to manage blood effectively and improve patient outcomes.

Beyond legislative change, there are many other ways the EU can act and support change.

National experiences should be leveraged at EU level, such as learnings from Italy as the first European country to integrate PBM into national law a decade ago.

Good clinical practices could be defined and exchanged at EU level, while greater education and awareness initiatives can be promoted across Europe, including improved medical education and curricula that include PBM.

Setting up proper registries and improving the interoperability of data collection systems across countries to address current gaps and divergences is paramount. The EU should speed up efforts to help collect reliable evidence on blood use but also monitoring of current practice in Europe; and the Parliament is committed to realising this.

EU funding should be provided to support the adaptation of healthcare systems to evidence-based clinical practice, including PBM, while at the same time help improve standards of transfusion care uniformly across Europe to avoid unnecessary transfusions. The EU can also help facilitate research & innovation that may reduce transfusion dependency on the long term.

As European policymakers, we are committed to support progress in this area to the benefit of patients, health systems, and societies as a whole.

MEPs Busoi, Pizarro and Sokol co-hosted the policy webinar “Updating policies and practices to support blood sustainability: the role of the EU Blood Directive and patient blood management” that took place on the 11^th of October 2021 and was co-organised by Vifor Pharma and Bristol Myers Squibb.