The regular supply of safe blood is crucial for health systems worldwide. In this article, the Blood Transfusion Association explains how the EU’s updated SoHO Regulation is impacting the sustainable and safe supply of life-saving blood products
Blood donations are crucial for Europe’s healthcare system as they support a wide range of medical treatments, from regular surgeries to emergency care and chronic disease management, including anaemias and cancer. Recent figures show the EU is experiencing a shortage of 5.15 million litres of plasma needed for producing life-saving plasma-derived medicinal products (PDMPs). About 38% of the plasma used for manufacturing PDMPs for EU patients comes from the US.
Despite the challenges ahead, research into artificial blood products is yielding promising results and could help with blood supply, particularly in emergency situations. In the EU, roughly 1,400 blood establishments oversee the collection and distribution of blood and its components – red cells, platelets, and plasma- and use over 18 million blood bag annually (including apheresis sets and whole blood sets). Ensuring a safe, sufficient, and sustainable blood supply faces various challenges, including safety concerns, demand management during crises, and the environmental impact of the supply chain.
The role of the SoHO Regulation in enhancing blood safety
Recognising these challenges, the EU has recently updated its legal framework after 20 years, defining the quality and safety standards for substances of human origin (SoHO), such as blood and its components, tissues, and cells. In a landmark move for public health across Europe, the European Union is set to implement the SoHO Regulation. This new framework aims to significantly enhance the safety and sustainability of the EU’s blood supply, a critical resource for both routine medical procedures and emergency care.
Enhancing blood safety through the SoHO Regulation
The SoHO Regulation represents a significant development from the previous directives. It updates the Directive 2002/98/EC on safety and quality of human blood and blood components and the Directive 2004/23/ EC on safety and quality of human tissues and cells.
The new SoHO Regulation introduces a harmonised, comprehensive and flexible framework for managing SoHOs in the EU. For blood transfusions, this involves enforcing stricter standards for collection, testing, processing, and distribution while still allowing sufficient flexibility to encourage innovation among the Member States. The Regulation mandates comprehensive safety protocols to prevent contamination, reduce the risk of infection, and ensure that every unit of blood is of the highest quality.
The COVID-19 pandemic underlined the need for a reliable blood supply for routine medical procedures and emergency responses. The SoHO Regulation addresses this need by establishing consistent practices and standards across EU Member States. This harmonisation is key to ensuring that blood supply systems are robust and capable of meeting demand, particularly during health crises or pandemics.
Addressing sustainability, climate change, and emerging health risks
An innovative aspect of the SoHO Regulation is its integration of climate change considerations. The rise of vector-borne diseases and pathogens due to climate change necessitates stronger measures to ensure a safe blood supply in the EU. Warmer temperatures allow vectors, including mosquitoes and ticks, to thrive, increasing the spread of diseases like dengue fever, West Nile virus, Lyme disease and potentially yellow fever. These diseases pose new risks and challenges to blood safety, as they can be transmitted through transfusions.
Prioritising processing technologies that can effectively inactivate or reduce pathogens in blood is essential to these efforts. With a robust regulatory framework mandating the use of such technologies, the EU has the opportunity to further enhance its blood safety measures, ensuring the highest standards are consistently met and maintained.
Incorporating these processing technologies into regulations and guidelines is a critical step in addressing the potential impact of climate change on infectious diseases and the blood supply. By safeguarding the safety and availability of these vital medical resources, healthcare systems will be better equipped to meet the challenges posed by climate change.
The SoHO Regulation echoes this by recommending the widespread adoption of these technologies across EU Member States. This integration is essential to maintain a secure blood supply in an era of changing disease patterns due to climate change. By combining advanced safety measures with sustainability initiatives, the SoHO Regulation sets a new benchmark for public health in Europe.
Pandemic preparedness and blood safety
The recent COVID-19 pandemic highlighted the importance of having a resilient and adaptable blood supply system.
The SoHO regulation establishes a rapid alert system to address significant incidents or reactions that could pose risks to recipients or donors, reinforcing the commitment to blood safety. Member States are also encouraged to take appropriate measures to ensure the sufficient, suitable, and resilient availability of critical SoHO within their territories. This includes developing national emergency plans with strategies to effectively manage critical shortages while maintaining the highest standards of blood safety. The regulation emphasises the importance of stakeholder involvement, particularly in meeting the demand for critical SoHOs during emergencies.
As the SoHO Regulation becomes fully integrated across the EU, its impact on blood safety and supply will be closely monitored. The BTA’s role in advocating for and supporting the regulation highlights its ongoing commitment to advancing blood transfusion practices and ensuring a safe blood supply for all.
The regulation not only sets a new standard for blood safety within the EU but also serves as a model for other regions seeking to enhance their own blood supply systems. The BTA’s efforts in implementing and promoting these standards contribute to a more resilient and secure global healthcare system that is ready to face future challenges.
About the BTA
The BTA has long championed secure and effective blood transfusion practices. As the primary advocate for its members, the BTA works to ensure that blood supply systems adhere to the highest standards of safety and reliability. The association’s efforts are now set to align closely with the new SoHO Regulation, promising a new era of enhanced safety protocols and sustainable practices within Europe’s blood supply network.
The BTA’s advocacy for and support of the regulation highlights its ongoing commitment to advancing blood transfusion practices and ensuring a safe blood supply for all.
Blood Transfusion Association
Website: https://bloodtransfusionassociation.org/
