New EU rules on substances of human origin adopted by the Council

European Centre for Disease Prevention and Control

The Council has approved new rules to enhance the safety and quality of blood, tissues, and cells used in healthcare and to facilitate the cross-border circulation of these substances within the EU. The regulation on substances of human origin (SoHO) aims to provide better protection for all, including donors and recipients and children born through medically assisted reproduction. 

The new rules seek to strengthen the existing legal framework while allowing for increased flexibility to adapt to scientific and technical advancements. Under the new regulation, member states have the option to impose stricter measures to safeguard their citizens.

The current regulations for blood, tissues, and cells are outdated and do not fully protect patients, donors, and children born from donated eggs, sperm, or embryos. Recognising this urgency, on July 19, 2022, the European Commission proposed a new regulation to address these issues and ensure quality and safety. The Council and the European Parliament reached a provisional agreement on the regulation on December 14, 2023, underlining the importance of these changes.

The new regulation expands the scope of Substances of Human Origin (SoHO) to include human breast milk and intestinal microbiota. This significant expansion is designed to update EU legislation to accommodate potential future SoHO applications and allow for more flexible updates. The regulation encompasses a variety of activities, including the registration and testing of donors, collection and processing, as well as the monitoring of clinical outcomes for substances of human origin that are applied to humans.

It aims to improve the quality and safety of SoHO and facilitate cross-border exchanges. It mandates voluntary and unpaid SoHO donations, prohibits financial incentives for donors, and allows compensation for living donors within national legislation. It also includes a rapid alert system for severe incidents, requiring member states to ensure an adequate supply of critical SoHO. The regulation is awaiting final approval from the Council and the European Parliament.

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