Substances of Human Origin (SoHO) legislation
EHA’s involvement
EHA has been involved in both the evaluation and subsequent revision of the EU legislation on human blood and blood components.
The evaluation of these rules, which dated back to 2002, began in 2016. It led to them being reworked in the new Regulation on 'standards of quality and safety for substances of human origin intended for human application.'
EHA’s main message throughout the evaluation and revision process has been patient and donor safety first, followed by an appeal to strengthen plasma collection measures. This is because plasma-derived medicinal products, and immunoglobulins in particular, are playing an increasingly bigger role in the development of innovative therapies in hematology.
The new SoHO Regulation
The proposal for a new Regulation was tabled in July 2022. EHA provided feedback on this in September 2022, which you can read in our formal response to the EC on the SoHo Regulation.
The final text of the Regulation was adopted in May 2024. You can find out more about this by visiting the EC's SoHO questions and answers page.
The revised legislation provides a 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
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. This consortium, which received funding from the EU4Health program and was coordinated by the European Blood Alliance, was made up of 20 diverse stakeholders. From September 2022 to February 2024, they worked together to evaluate legal frameworks and policies on plasma collection in Europe.
EHA led the SUPPLY work package on:
- Developing recommendations on the clinical use of immunoglobulins
- The prioritization of such use in times of crisis
The final recommendations, with input from EHA experts Cynthia So-Osman (transfusion medicine) and Isabelle Durand-Zaleski (public health and health economics), can be found in the report on SUPPLY work package 6.
All the reports resulting from the project are available on the SUPPLY resources webpage.
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 centres (DC) and blood and tissue establishments (BE/TE)
- Stakeholder collaboration and implementation of strategies more broadly, to improve accessibility and sufficiency of SoHO at European level
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