Proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC

Summary:

Legislative initiative tabled by the European Commission on 14 July 2022, concerning standards of quality and safety for substances of human origin intended for human application.

Further information:

Directive 2002/98/EC - also known as Blood Directive - and Directive 2004/83/EC - also known as Tissues & Cells Directive - set out quality and safety requirements as regards blood transfusion, transplantation and medically assisted reproduction. This legislative framework helped ensures the safety of millions of patients in activities spanning from donation to human application.

However, an evaluation carried out on the legislation showed that it no longer addressed the scientific and technical state of the art and required updating. The COVID-19 (coronavirus) pandemic further highlighted some of those shortcomings. The European Commission thus tabled this draft law on 14 July 2022 aimed at revising the legislative framework. Its overall objective is to ensure a high level of health protection for citizens donating or receiving vital substances of human origin (SoHO). The proposal repeals the existing legislation and is seen as the concluding building block in the revision of the framework for blood, tissues and cells.

• Primary Source

News

Reuters, 14/07/2022: EU seeks to upgrade safety rules for blood, tissue, cell donations https://www.reuters.com/business/healthcare-pharmaceuticals/eu-seeks-upgrade-safety-rules-blood-tissue-cell-donations-2022-07-14/

EurActiv, 15/07/2022: New EU rules on blood, tissue, cells to be adapted to evolving science https://www.euractiv.com/section/health-consumers/news/new-eu-rules-on-blood-tissue-cells-to-be-adapted-to-evolving-science/

---

Official

EUR-LEX: SWD(2022)189: Staff Working Document accompanying the Proposal - Subsidiarity Grid https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2022:189:FIN

EUR-LEX: SWD(2022)190: Staff Working Document accompanying the Proposal - Impact Assessment Report https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2022:190:FIN

EUR-LEX: SWD(2022)191: Staff Working Document accompanying the Proposal - Executive Summary of the Impact Assessment Report https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=SWD:2022:191:FIN

European Commission: DG Health: Public Health: Proposal for a Regulation on substances of human origin https://health.ec.europa.eu/blood-tissues-cells-and-organs/overview/proposal-regulation-substances-human-origin_en

European Commission: Press Release, 14/07/2022: European Health Union: Stronger rules for greater safety and quality of blood, tissues, and cells https://ec.europa.eu/commission/presscorner/detail/en/ip_22_4403

European Commission: Questions and answers on the proposal for a new legislation on blood, tissues, and cells (14 July 2022) https://ec.europa.eu/commission/presscorner/detail/en/qanda_22_4404

---