ECDC framework relating to substances of human origin (SoHO)
This framework describes the building blocks being laid down by the European Centre for Disease Prevention and Control (ECDC) to support and empower European Union (EU)/European Economic Area (EEA) countries and the European Commission in achieving microbial safety for substances of human origin (SoHO).
Executive summary
ECDC activities related to SoHO are coordinated by the SoHO staff within the section on sexually transmitted infections, blood-borne viruses and tuberculosis (SBT), with close collaboration and input from other ECDC sections and units, EU/EEA countries, the European Commission, EU agencies and a broad range of key external stakeholders.
The focus of the framework is on implementing the relevant parts of Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control, Regulation (EU) 2022/2370 of the European Parliament and the Council of 23 November 2022 amending Regulation (EC) No 851/2004 establishing a European Centre for Disease Prevention and Control, and Regulation (EU) 2022/2371 of the European Parliament and the Council of 23 November 2022 amending Regulation (EC) of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. In other words, it focuses on operating dedicated networks and networking activities, monitoring threats and performing public health risk assessment, and response coordination. It also refers to the relevant parts of the Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation and the Regulation on standards of quality and safety for substances (SoHO Regulation) − i.e. providing advice on serious adverse reactions, launching rapid alerts, and developing guidelines to protect SoHO donors, recipients and their offspring.
A substance of human origin is defined in the SoHO Regulation as any substance collected from the human body, whether it contains cells or not and whether those cells are living or not, including SoHO preparations resulting from the processing of that substance.
ECDC’s work on SoHO encompasses those countries which come under the ECDC mandate, namely the EU/EEA, although some aspects of this work will be relevant to and include EU enlargement and neighbourhood policy countries.
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