Substances of Human Origin (SoHO) legislation
We’ve played a key role in the evaluation and subsequent revision of EU legislation on human blood and blood components.
Our main message throughout has been to prioritize patient and donor safety, followed by an appeal to strengthen plasma collection measures. This is because plasma-derived medicinal products, and immunoglobulins in particular, are playing a growing role in the development of innovative therapies.
The new Regulation
The new Regulation was published in July 2024 and provides harmonization and simplification of SoHO rules, whilst strengthening patient protection.
It contains measures on:
- Harmonized (high) standards for quality and safety, based on technical guidelines
- Common EU-wide authorization procedures for innovative SoHO preparations
- Keeping donations voluntary and unpaid
- Enhancement of reporting and follow-up on adverse reactions
- Safeguarding supply with national SoHO emergency plans
- You can find out more by visiting the EC’s SoHO questions and answers page.
Participation in the EU-funded SUPPLY project
Due to the importance of plasma for hematology, EHA joined the SUPPLY (Strengthening voluntary non-remunerated plasma collection capacity in Europe) project.
Read more about EHA’s role in the project and its outcomes.
Endorsement of the EGALiTE project
EHA has also endorsed a project titled EGALiTE (European Group for Accreditation and Liaison of Blood-Tissues and Cells Establishments). Its aims are to promote the:
- Harmonization of practices among donation centers and blood and tissue establishments
- Stakeholder collaboration and implementation of strategies and to improve accessibility and sufficiency of SoHO at European level