BTA Welcomes SoHO Regulation Vote

On 24 April, the European Parliament plenary voted in favour of the Substances of Human Origin (SoHO) Regulation.The Blood Transfusion Association (BTA) welcomes the Regulation’s adoption.

The SoHO Regulation reflects the values the BTA stands for and highlights the importance of patient safety and innovation. We welcome the inclusion of crucial points related to climate change, pandemic preparedness, and the health, protection, and safety of workers.

Patient Safety and Innovation: The Regulation stands firm in its commitment to prioritising patient safety while facilitating the integration of innovative blood products and processes. By ensuring a safety-focused regulatory framework, the EU can further enhance its safety measures for blood and blood components and ultimately, to ensure that the highest standards are met and maintained.

Climate Change and Pandemic Preparedness: SoHO takes a proactive stance by addressing the impacts of climate change and strengthening preparedness for pandemics. By implementing robust safety and quality mechanisms and safeguarding modern technologies, the Regulation aims to optimise blood supply across the EU.

Worker Health and Safety: The Regulation aligns with existing directives aimed at preserving the health and safety of workers handling SoHOs. By adhering to safety protocols and ensuring compliance with established regulations, the Regulation protects professionals dealing with SoHOs.

Today’s vote marks a crucial moment in improving and strengthening blood transfusion practices across Europe. The BTA remains committed in its dedication to advocating for the highest standards of safety, innovation, and inclusivity for blood transfusions. As we celebrate this milestone, we extend our gratitude to the rapporteur of the file, Nathalie Colin-Oesterlé as well as the shadow rapporteurs Nicolás González Casares, Andreas Glück, Tilly Metz, Joanna Kopcińska and Kateřina Konečná, and all stakeholders who contributed to shaping this Regulation.

Cookie settings

We use cookies on (e.g. tracking and analytical cookies), with which an analysis and measurement of user data is possible. Further information can be found in the