Publication of SoHO Regulation
- 18/07/2024
- News
Yesterday, on 17 July 2024, the Official Journal of the European Union published Regulation (EU) 2024/1938 of the European Parliament (Parliament) and of the Council of 13 June 2024 “on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC” (SoHO Regulation). Attached is a copy of the Regulation.
The SoHO Regulation was proposed by the European Commission on 14 July 2022 (see, Van Bael & Bellis Life Sciences News and Insights of 15 July 2022) and aims to ensure better protection for donors and recipients of substances of human origin (SoHOs) as well as children born following medically assisted reproduction. SoHOs are defined as “any substance collected from the human body, whether it contains cells or not and whether those cells are living or not, including SoHO preparations resulting from the processing of such substance”. Accordingly, the term includes substances such as blood (plasma), cells, tissues, human breast milk and intestinal microbiota.
Following a deal struck between the Parliament and the Council on 14 December 2023, the SoHO Regulation was approved by the Parliament on 24 April 2024 and adopted by the Council on 27 May 2024 (see, Van Bael & Bellis Life Sciences News and Insights of 15 December 2023 and 5 February 2024). The voluntary and unpaid nature of SoHO donations has been one of the most debated topics in the inter-institutional discussions.
The SoHO Regulation will apply from 7 August 2027, with an extra year for certain provisions.
