Achieving a sustainable blood ecosystem in Europe

The EU Regulation governing the field of Substances of Human Origins (SoHO) must examine factors impacting blood demand and opportunities to reduce the drain on health systems, says Prof. Antonis Kattamis, who is involved in Blood and Beyond

The European Commission published in July its proposal for the revision of the EU Blood, Tissue, and Cells Directives: the new SoHO Regulation. This revision offers a timely opportunity to help countries improve health systems through policies that benefit patients, thereby improving the resilience and sustainability of blood ecosystems.

Patient Blood Management (PBM) and innovation are central to safety, quality & sustainability issues:

The regulation aims to tackle issues related to availability, quality and safety of blood and blood products. This requires looking at the broader context of blood sustainability, including factors that impact allogenic blood demand, and opportunities to improve use, such as optimal blood use and PBM. Endorsed by WHO, PBM is a patient-centred, evidencebased approach to improve patient outcomes by preserving a patient’s own blood, while promoting patient safety and empowerment. As such, PBM positively contributes towards achievement of UN Sustainable Development Goal 3 to “ensure healthy lives and promote well-being for all at all ages”.

To achieve the set objectives to improve the safety and quality of blood products, the regulation should align with the WHO guidance to urgently implement PBM across countries. PBM, including therapeutic innovation, and optimal blood use offer solutions to some of the main challenges addressed in the Regulation, including mitigating risks of blood shortages, relieving pressure on the donor population, and safety aspects. These should be given prominent attention – even more when considering the impact of the the COVID-19 pandemic. In a series of new videos, which I had the pleasure to contribute to, experts involved in Blood and Beyond share perspectives on challenges and opportunities of the new SoHO regulation.

Harnessing the power of data:

The proposed regulation sets hope for robust evidence moving ahead, with a new mandatory EU-wide data system in the SoHO sector, which covers clinical application. This would improve health systems, care delivery and the management of patients, including those with anaemia. As anaemia affects a large group of patients, and its prevalence will increase due to an ageing society, it will be essential to ensure standardized monitoring of at-risk populations, early diagnosis and effective management across the EU including with greater implementation of PBM. These efforts should be linked to the European Health Data Space to be sustainable on the long-term, and provide comparable and quality data across Europe. As a health professional working at the bedside of patients, I am looking forward to a new regulation that is future-oriented and allows to improve health and quality of life for patients, the functioning of blood systems, while embracing innovation. In this spirit, the Blood and Beyond recommendations aim to inform the legislative process and strongly encourage policymakers to have a holistic approach through the revision.

Blood and Beyond is a multi-stakeholder initiative developed and funded by Celgene, now part of Bristol Myers Squibb, involving experts from the fields of haematology and patient blood management, nursing, patient advocacy, health economics and hospital management.

“As a health professional working at the bedside of patients, I am looking forward to a new regulation that is future-oriented and allows to improve health and quality of life for patients, the functioning of blood systems, while embracing innovation. ”

“Of course, the EU blood directive, by its very nature, is about securing and improving the donor blood system, the supply with allogenic blood products. However, it would be very important that in this directive the role of Patient Blood Management is seen important, not only to improve patient outcomes, but also to relieve the pressure on the donor population and to reduce the number of or the amount of blood utilization.” – Axel Hofmann, Visiting Professor, Institute of Anaesthesiology, University Hospital Zürich