The European Commission published this year on the 14th July its proposal for the revision of the EU Blood, Tissue, and Cells Directives, merging them into one regulation: the SoHO Regulation. This revision offers a vital and timely opportunity to help member states improve national health systems through policies and practices that benefit patients, thereby improving the resilience and sustainability of blood ecosystems.
Anaemia affects a large patient population, and its prevalence will increase in the next years due to an ageing society
Patient Blood Management (PBM) and innovation are central to safety, quality & sustainability issues: The new regulation aims to tackle issues related to availability, quality and safety of blood and blood products. This requires taking into account the broader context of blood sustainability, including factors that impact allogenic blood demand, and opportunities to reduce it or improve use, such as optimal blood use and PBM. Endorsed by WHO, PBM is a patient-centred, evidence-based 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 Member States. Including therapeutic innovation, and optimal blood use, offer solutions to some of the main challenges addressed in the draft SoHO Regulation, including mitigating risks of blood shortages, relieving pressure on the donor population. These should be given prominent attention – even more when considering the impact on blood supply and demand during the COVID-19 pandemic.
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,
In a series of new videos by Blood and Beyond, which I had the pleasure to contribute to, experts colleagues working in the field share perspectives on challenges and opportunities of the new SoHO regulation.
Harnessing the power of data: The proposed regulation also 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, blood loss and bleeding disorders.
Nonetheless, as anaemia affects a large patient population, and its prevalence will increase in the next years 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 interoperable 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 released last week aim to inform the legislative process and strongly encourage policymakers to have a holistic approach through the revision.
“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, what would be very important is that in this directive, the role of Patient Blood Management, 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, is seen important.” – Axel Hofmann, PBM expert, Visiting Professor, Institute of Anaesthesiology, University Hospital Zürich (extract from a new video interview)
“Whenever there are other solutions than [red blood cells] transfusion, we should use them, especially as the number of patients who need blood transfusion increases but the number of donors does not increase. […] We need to optimize blood transfusion policy, expecting shortages in the near future.” - Iwona Hus, Head, Polish Society of Haematologists and Transfusion specialists (extract from a new video interview)
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.