SoHO are substances, such as blood, tissues, cells and organs, used in a wide range of medical treatments to improve the quality of life and to save life. Past decades have witnessed a number of developments in the SoHO field, among others: the increasing use and importation/exportation of SoHO, the globalisation of the sector, the emergence of new risks and the need for systems to remain resilient when facing evolving environments or crisis. For these reasons and also ensure a coherent interplay with the pharmaceutical legislation, SoHO is in in need of an agile and fit for purpose framework.
 In Europe, two organisations play key roles in the field of SoHO: The European Union and its agencies, in particular the European Centre for Disease Prevention and Control (ECDC) and the Council of Europe through its European Directorate for the Quality of Medicines and Healthcare (EDQM). Both have established a long-standing cooperation in the SoHO sector and leveraged on their complementary to ensure the quality and safety of SoHO throughout Europe.
 The outcome of the recent evaluation of the EU Blood, Tissues and Cells (BTC) legislation has further emphasized that this complementarity would be of essential benefit for the sector to be able to face issues it is currently confronted with and that this should lay the ground for an agile and future proof new EU BTC legislation. This is currently being crystalized in the draft BTC legislative proposal (ongoing drafting).
 The proposed session will provide an overview of how coordinated efforts between European organisations can support the development of a more agile and future proof European framework with a view to support stakeholders to better meet requirements, navigate through a rapidly evolving sector and overall ensure the quality, safety and sustainability of SoHO supplies. It will also provide opportunities to identify lesson learnt that can serve the development of future framework in other areas of public health.

Ensuring fitness of the European Substances of Human Origin (SoHO) Framework: Coordinated efforts among European organisation

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