New Regulation on Blood, Blood Products and Plasma

Recommendation

14/15 May 2024
Berlin, Germany

Blood, Blood Products and Plasma
Quality, Safety, SoHO and recent Developments

The existing guidelines on blood, tissues and cells were adopted in response to the transmission of communicable diseases in the 1980s and 1990s. Their recent evaluation has shown that patients, donors and children born from donated embryos or sperm are not fully protected from avoidable risks, as the current framework does not keep up with scientific developments. In addition, Member States have applied different systems of supervision. This has hindered the cross-border exchange of blood, tissues and cells and restricted innovation in this area.

SoHO (Regulation on quality and safety standards for substances of human origin)

In July 2022, the European Commission prepared the proposal for a Regulation on standards of quality and safety of substances of human origin (SoHO) intended for human application. With the repeal of the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC), the Regulation completes the revision of the legal framework for blood, tissues and cells in the light of new scientific, technical and societal developments. The Regulation even extends the scope of the SoHO to human breast milk and gut microbiota. It aims to prioritize and ensure donor safety, patient safety, security of supply and the development of innovative medical procedures in Europe. The spectrum covers the following activities: From donor registration and testing, collection and processing to human use and monitoring of clinical outcomes of substances of human origin. It also aims to future-proof EU legislation by covering other SoHO that could be applied to humans in the future and making future updates more flexible.

Following the meeting of the Committee of Representatives on January 30, 2024, at which the final compromise text was approved with a view to reaching an agreement, delegations were informed that the Presidency had forwarded the letter and its annex to the Chair of the European Parliament's Committee on the Environment, Public Health and Consumer Protection. The Regulation will enter into force after its publication in the Official Journal of the EU. For more detailed information please see the full regulation.