Policy update on the SoHO Regulation

On 3 February, the Rapporteur, Member of the European Parliament (MEP) Colin-Oesterlé, published her Draft Report on the European Commission proposal for a Substances of Human Origins (SoHO) Regulation. The draft report includes Patient Blood Management (PBM) as a standard of care and a best practice. It encourages greater implementation of PBM, highlights its impact on use of SoHOs and patients’ health, and outlines the role of innovation in the field. Amongst other, the report also recommends measures to facilitate cross-border exchange of SoHOs in Europe, better protect donors and recipients through the highest quality and safety standards, and to build EU self-sufficiency on SoHOs notably with the development of an EU strategy.
Next steps  (European Parliament):

26 June: Vote in ENVI (Environment, Public Health and Food Safety) committee

11 September: Vote in Plenary

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    Blood & Beyond is a multi-stakeholder initiative funded by CSL, involving experts from the fields of haematology, transfusion medicine, anaesthesiology, patient blood management, nursing, patient advocacy, health economics, and hospital management, with support from policymakers committed to driving improvements in this area. The aim of the initiative is to raise awareness of the importance of good blood health and of the impact of anaemia on patients, healthcare systems and society at large, with the overarching goal to help advance policies and practices that improve patient outcomes by supporting patient-centricity in anaemia prevention, diagnosis, and management through patient blood management (PBM) and innovation.

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    For further information and queries, please contact the Blood and Beyond Secretariat: javier.lopezpanos@dgagroup.com

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