Recommendations for the implementation of European Union regulations on the donation and use of human-derived substances
Authors:
Hana Konečná
Authors‘ workplace:
Ústav humanitních studií v pomáhajících profesích JČU v Českých Budějovicích
Published in:
Čas. Lék. čes. 2025; 164: 166-168
Category:
Overview
In July 2024, a European Union regulation on substances of human origin came into effect, which is to be implemented into the legislation of member states by August 2027. The fundamental ethical principle remains voluntary and unpaid donation, but the responsibility for addressing related ethical issues is left to the member states. Ethical topics that should be considered during implementation, such as methods of obtaining and compensating donors of substances of human origin, donor anonymity, and the content of informed consents, were addressed in our research project "Quality and Sustainability of Body Part Donation Programs in the Czech Republic – TA ČR No. TL05000144", which took place between 2021 and 2023.
Keywords:
substances of human origin, donation, safety, ethical aspects, legislation
Sources
- Nařízení Evropského parlamentu a Rady Evropské unie 2024/1938 ze dne 13. června 2024 o standardech kvality a bezpečnosti pro látky lidského původu určené k použití u člověka a o zrušení směrnic 2002/98/ES a 2004/23/ES. Úřední věstník Evropské unie, 17. 7. 2024. Dostupné na: https://eur-lex.europa.eu/legal-content/CS/TXT/PDF/?uri=OJ:L_202401938
- Evaluation of the EU blood and tissues and cells legislation. Dostupné na: https://health.ec.europa.eu/document/download/19e9a3f4-98f4-49c0-9272-8edcbad0fb50_en?filename=swd_2019_375_summary_en.pdf
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