BREAKING NEWS | TIF Applauds the EU Parliament’s Adoption of the SoHO Regulation

The new rules modernize the existing directives, now two decades old, and are aimed at addressing challenges and weaknesses identified through the years, including, inter alia, the risk of shortages, the heterogeneity of quality standards, the absence of national collection mechanisms and poor oversight and collaboration between EU Member States.

TIF’s Executive Director, Dr. Androulla Eleftheriou, emphasized that the approval of the SoHO legislation is a critical step forward in the protection and wellbeing of both blood donors and recipients throughout the European Union, as well as in strengthening national and EU oversight, establishing SoHO rapid alerts for safety or quality or supply, and expanding patient access to cutting-edge therapies related to transfusion and use of SoHO, while reaffirming the principle of voluntary non-remunerated donation and introducing programmes that would support the reduction of wastage in transfusion services.

“This is of particular importance for the thalassaemia, sickle cell disease and other transfusion-dependent patient communities TIF represents, who face a multitude of challenges concerning the quality, safety, and, even more importantly, the adequacy of blood and its products,” she stated, adding that “considerable effort and synergies will be required at both the European and national levels to implement timely and appropriately this new Regulation within the EU Member States by the established deadlines”.

The Council is set to officially adopt the SoHO Regulation soon, with its publication in the EU’s Official Journal anticipated before summer. The Regulation is slated for implementation in mid-2027—three years post-publication—and will come into full force at that time, with an additional year allowed for specific provisions.

On April 24, the EU Parliament also approved the European Health Data Space (EHDS) Regulation. The EHDS will enable EU citizens to have immediate access to their digital health records anywhere in the EU, irrespective of their location. For example, should a patient require medical attention while abroad, healthcare professionals can access vital health information from the patient’s home country when necessary.

This initiative will help foster evidence-based decision-making, minimize unnecessary repeat tests and examinations, and ultimately improve patient care. It will also pave the way for the establishment of disease-specific registries and the strengthening of healthcare systems in case of emergency situations.