Substances of Human Origin (SoHO) legislation

EHA 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, play 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

Learn more on the European Commission’s SoHO questions and answers page.

EHA’s role and engagement

EHA has been a constructive and influential voice in shaping the new SoHO Regulation. Our main asks have been included in the final text:

  • Reinforced quality and safety standards for blood, tissues, and cells
  • Stronger donor protection, including health assessment, privacy, and non‑discrimination
  • EU‑level coordination to prevent safety gaps across Member States

As a result of our continuous and reliable engagement at EU level, EHA:

  • Is represented in EMA’s Medicine Shortages Single Point of Contact (SPOC) Working Party
  • Participates in the advisory group testing the newly introduced SoHO Platform
  • Acts as an official reviewer of the list of (hematology) substances covered by the SoHO Platform and, by extension, governed by the SoHO Regulation
  • Works closely with EDQM, ECDC, and the SoHO Coordination Board to promote interoperable and coherent national and pan‑European SoHO guidelines and exchange best practices

EHA is a partner in IMPLEMENT-SoHO

EHA aids the implementation of the SoHO Regulation through its participation in IMPLEMENT‑SoHO, a project commissioned by the European Health and Digital Executive Agency (HaDEA).

Our consortium of nine partners, including the European Society for Blood and Marrow Transplantation (EBMT) and the European Blood Alliance (EBA), seeks to prepare SoHO professionals and entities across the EU for the new regulatory framework.

Running from March 2026 until September 2028, IMPLEMENT-SoHO will deliver:

  • Awareness-raising activities
  • Targeted training
  • Cross-border exchange visits
  • Evidence-based scientific guidance

Our role in the SUPPLY project

From 2022 until 2024, EHA was a partner in the EU-funded SUPPLY project. SUPPLY was aimed towards increasing and strengthening the resilience of plasma collection in the EU, to enable a stable and adequate supply of medicines in Europe.

A substantial part of plasma collection in the EU is conducted by non-profit blood establishments (BEs) from voluntary non-remunerated donors, but not at the necessary level. This project focused on how BEs can improve and build up voluntary non-remunerated plasma collection programs, and make them more efficient.

Within this project, EHA led the work on the “Final recommendations to achieve appropriate and prioritised use of immunoglobulins in Europe”.

Endorsement of the EGALiTE project

EHA has also endorsed the EGALiTE (European Group for Accreditation and Liaison of Blood-Tissues and Cells Establishments) project. It aims to:

  • Promote the harmonization of practices among donation centers and blood and tissue establishments
  • Encourage stakeholder collaboration
  • Foster the implementation of strategies required to improve accessibility and sufficiency of SoHO at EU level

 

EU projects page
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