Substances of Human Origin (SoHO)
EHA has been involved in the evaluation and revision of EU legislation on human blood and blood components, from the start of process in 2016 to the presentation of the European Commission’s proposed Substances of Human Origin (SoHO) Regulation in the summer of 2022 and the discussions of the proposal in the European Parliament in the first half of 2023.
‘Patient and donor safety first’ has been the message at the core of EHA’s advocacy from the start. In addition to setting important standards for guaranteeing the safety and quality of blood and its products, the modernization of the EU’s old Blood Tissues and Cells directives, now set to be replaced by the SoHO Regulation, is also aimed at improving the sustainability and quality of supplies.
Strong measures to boost plasma collection are another priority for EHA and its partners, as plasma-derived medicinal products and immunoglobulins in particular are becoming increasingly important for the development of innovative therapies in hematology. EHA has therefore joined the SUPPLY consortium, coordinated by the European Blood Alliance, for which is leads the development recommendations on the clinical use of immunoglobulins and the prioritization of such use in times of crisis.
For more information on EHA’s positions on the SoHO Regulation and on the SUPPLY project, see:
- https://ehaweb.org/organization/newsroom/news-and-updates/immunoglobulin-shortages-in-the-spotlight-ema-supply-and-the-soho-regulation/ (March 2023)
- EHA response to proposed SoHO Regulation (September 2022): EHA on draft SoHO Regulation_Sep22
- https://ehaweb.org/organization/newsroom/news-and-updates/eha-to-participate-in-an-eu-funded-project-supply/ (Aug 2022)
- SUPPLY project (September 2022-February 2024): https://supply-project.eu/
EHA has also endorsed another EU4Health-funded project, EGALiTE (European Group for Accreditation and Liaison of Blood-Tissues and Cells Establishments). The EGALiTE consortium aims to promote the harmonization of practices among Donation centres (DC) and Blood and Tissue Establishments (BE/TE), as well stakeholder collaboration and implementation of strategies more broadly to improve accessibility and sufficiency of SoHO at European level. See the project website: https://www.egalite-europe.eu/SUPPLY-EHA-Desk.pdf