Solutions Circle 5: Was SoHO Born From HCT/Ps?

Description: In 2024, the new SoHO Regulations were approved in the EU. This replaced the old regulatory framework for blood, blood components, tissues and cells, which had resulted in divergences between national rules. SoHO governs blood and blood components, as well as tissues and cells, including haematopoietic stem cells from peripheral blood, from umbilical-cord blood or from bone marrow, reproductive cells and tissues, embryos, foetal tissues and cells and adult and embryonic stem cells, much like the HCT/Ps in the USA. These products generally require varying degrees of processing prior to dosing or implantation. However, the types and degree of processing, coupled with legal intent, can affect the (degree of) regulation of the product, both in the EU and the USA. This presentation will take a deep dive into the actions which are “not considered processing” under SoHO and allow the product to remain “such HCT/P” in the USA, which are the lighter sets of regulation. Failing these legal tests via processing methods and the intent of that processing results in the manufacturer being regulated and the product subject to a marketing authorisation. Advising clients, such as stem cell clinics, on these matters requires working with scientists and legal counsel on the defensibility of the product against regulatory accusations of either SoHO processing or more than minimal manipulation.