"Substances of human origin intended for human application" (SoHOs) include substances of human origin such as blood, plasma, skin, cornea, embryos, sperm, breast milk and microbiota - these substances are essential for life-saving medical procedures. In December 2023, the Council of the European Union (EU) and the European Parliament reached a consensus on a new "Regulation on standards of quality and safety for substances of human origin intended for human application". The law has now been passed. This has brought a controversial topic back to the fore: compensation for donors of human substances.
In the article "Quality and safety for substances of human origins: scientific evidence and the new EU regulations", WiSo Professor Dr Axel Ockenfels, together with his co-authors Julio J. Elias, Nicola Lacetera, Mario Macis and Alvin E. Roth discuss the effectiveness of the new EU regulation, as well as ethical concerns.
The regulation has two main objectives: to ensure the EU's self-sufficiency and to ensure safety. The aim of ensuring the EU's self-sufficiency in SoHOs is a direct response to the EU's heavy reliance on imported plasma, particularly from the US, where plasma donors are compensated. However, the EU sees voluntary and unpaid donations as essential to ensure a safe supply. Accordingly, the regulation only provides for compensation in exceptional cases. The proposed measures are based on the principle of non-commercialisation of the human body. The EU is concerned that the increasing commercialisation of blood plasma could increase the pressure on individuals to donate, which would have a negative impact on the safety of supply.
However, the regulation is not in line with current knowledge, especially not the knowledge about the safety and efficacy of paid plasma donations. It is largely at odds with the goals of achieving self-sufficiency in SoHOs and serving the donors and patients who rely on these vital resources - according to Professor Ockenfels and his co-authors. The available evidence suggests that it is unlikely that EU members will be able to achieve self-care without stronger individual motivations and incentives. Furthermore, an increase in shortages in the EU due to a decrease in donations as a result of the new regulation would drive up international prices and reduce the affordability of plasma. This would have serious implications for lower-income countries. Alternative strategies to increase motivation or reduce barriers include setting up additional collection centres, making mobile trips more frequent, reducing waiting times and improving scheduling. However, these measures are costly and take time to become effective. Moral concerns such as coercion, exploitation and commercialisation are also discussed in the article.
Professor Ockenfels and his co-authors state: „(…) it is imperative to adopt a balanced, empirically sound and research-backed approach that considers multiple aspects and promotes policies to safeguard the interests of donors and patients.”
