The use of tissue and cell-based medical treatments is rising in both number and frequency thanks to significant advances in biotechnology.
Blood-forming stem cells are transplanted from bone marrow donors (or cord blood) to patients with blood cancer, and/whereas gametes are used for in-vitro fertilisation (IVF). Both are well known medical therapies that use human cells. Other invaluable uses of human tissues include skin grafting for burn victims, or corneal grafting to restore sight.
Bone marrow (haematopoietic stem cells) and gametes (sperm, egg cells) for IVF can be donated by living donors, while replacement tissues (like skin, bone, cornea or heart valves) can be donated after death.
The legal framework defining the safety and quality standards for tissues and cells is set out in Directive 2004/23/EC, also referred to as the European Tissues and Cells Directive, adopted in 2004 by the European Parliament and Council. It covers all steps in the transplant process from donation to distribution, including procurement, testing, processing, preservation and storage.
To help implement this basic act, the Commission proposed and adopted, in close collaboration with EU countries, the following implementing Directives:
Read more on: https://ec.europa.eu/health/blood_tissues_organs/tissues_en