DIREKTIVA EVROPSKOG PARLAMENTA I SAVETA 2004/23/EZ O USPOSTAVLjANjU STANDARDA KVALITETA I BEZBEDNOSTI, ZA DONIRANjE, DOBIJANjE, TESTIRANjE, OBRADU, OČUVANjE, SKLADIŠTENjE I DISTRIBUCIJU LjUDSKIH ĆELIJA I TKIVA

Đukanović Anđela (Институт за међународну политику и привреду, Београд), andjela@diplomacy.bg.ac.rs

Increasing use and exchange of human cells and tissues for therapeutic purposes within the EU, created the need for unified framework in order to ensure high standards of quality and safety of human tissues and cells at EU level. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells sets minimum standards in this field. Main principle governing tissue and cell donation is principle of voluntary and unpaid donations of tissues and cell. Because of the significant differences in the ethical cultures of the Member States, regulating the application of new technologies on human tissues and cells as well as the application of advanced therapies is quite challenging. Because of these differences, some provisions of Directive 2004/23/EC leave more freedom to the Member States. This is the case with the provisions regarding the donor’s consent and data protection, and most importantly, Member States have the freedom to allow or ban use of a certain type of human tissue or cells.

Ključne reči: Human tissues and cells, quality and safety, donation, traceability, procurement, testing, processing, preservation