On 14 December 2023, Council and the European Parliament reached a major political agreement on the Substances of Human Origin (SoHO) Regulation.
This Regulation will replace the Blood Directive and the Tissues and Cells Directive, combining both legal texts into one. In addition, the Regulation will extend its protection to any SoHO regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’ to avoid that certain groups of donors or recipients are left unprotected. Thus, the Regulation will also cover donors and recipients of intestinal microbiota, blood preparations that are not used for transfusion, and any other SoHO that may be applied to humans in the future. The Regulation aims to ensure standards of quality and safety for patients and donors of substances of human origin and to harmonise practices amongst Member States.
One of the most sensitive aspects of the reform is the compensation of donors, which is currently not harmonised across EU member states. While there is consensus to keep the principle of voluntary and unpaid donations (VUD), during the negotiations the Commission, the Parliament and the Council had different approaches around how and under which conditions donors may be compensated or reimbursed to not be financially disadvantaged by their donation.
The agreement now reached will likely maintain the VUD principle and prohibit financial incentives to donate, but, within these boundaries, allow living donors to receive compensation or reimbursement as appropriate in line with national legislation. National legislation could include fixed benefits or non-financial forms of compensation.
Another important point of the reform is whether and how any aspect of such compensation may be communicated in recruitment campaigns. While the European Commission’s proposal was silent, the European Parliament and Council’s positions held during the negotiations restricted or even prevented reference to any compensation in recruitment campaigns. It appears that the European Parliament and the Council have now agreed that advertising measures for SoHO donationsdo not refer to possible compensation. This is likely to significantly impact the ability of collection centers to recruit new donors in countries where this is currently allowed or common practice.
The Regulation has not been formally adopted yet and there is no formal agreed text publicly available. Hence, we will need to wait to see what has finally been agreed including with respect to donor compensation and recruitment materials. Once the final text is available, we will provide a further analysis around this important new piece of EU legislation.