On 14 December 2023, European Parliament (Parliament) and Council of the EU (Council) negotiators informally agreed on the text of the proposed Regulation on standards of quality and safety for substances of human origin intended for human application (SoHO) (SoHO Regulation). The SoHO Regulation will replace the rules for safety and quality set out in Directive 2002/98/EC for blood and blood components and in Directive 2004/23/EC for tissues and cells.

The SoHO Regulation was proposed by the European Commission (Commission) in July 2022 (see, Van Bael & Bellis Life Sciences News and Insights of 15 July 2022) and adopted in first reading by the Parliament in September 2023 (see, Van Bael & Bellis Life Sciences News and Insights of 22 September 2023). The Council agreed on its negotiating mandate on 25 October 2023. Attached is a copy of the “four column table” reflecting the respective positions of the Commission, Parliament and Council before these institutions reached yesterday’s agreement.

Once adopted and implemented in all EU Member States, the SoHO Regulation will ensure better protection for donors and recipients of blood, tissues, cells and any other substances of human origin like human breast milk and intestinal microbiota, as well as for children born following medically assisted reproduction. The SoHO Regulation covers a wide range of activities such as donor recruitment, processing of SoHO, distribution, import and export of SoHO and human application of SoHO.

Although the provisionally agreed text is not yet publicly available, the Council’s press release (see, attached copy) notes that it requires donations of SoHO, such as blood plasma, to be “voluntary and unpaid as a matter of principle” and that “donors must not be provided with financial incentives to donate”. However, still according to the press release, this does not preclude living donors from “receiv[ing] compensation or reimbursement as appropriate in line with national legislation”.

Significantly, the SoHO Regulation will create the institutional and procedural architecture that facilitates cross-border exchanges and access to SoHO.

The provisionally agreed text was welcomed by the Commission and will now have to be formally adopted by the Council and the Parliament to become EU law. This process is expected to be concluded before the European Parliament elections of June 2024.