Quality and safety for substances of human origins: scientific evidence and the new EU regulations

The new European Union (EU) ‘Regulation on standards of quality and safety for substances of human origin (SoHOs) intended for human application’ is based on a long-standing diffidence towards offering compensation to donors of SoHOs. We point to recent, growing empirical evidence indicating that carefully designed compensation can increase the supply of SoHOs without negatively affecting quality and safety. We also elaborate arguments that address some of the moral concerns that motivate the aversion to payments. As member states proceed to adopt the new EU regulation, our article may provide insights on how to achieve both self-sufficiency and safety.