The effect of the EU Tissues and Cells Directive on bonebanking in Denmark: a case study

Sofie Birk, Klaus Hoeyer

1 Citation (Scopus)

Abstract

As a result of the EU Tissues and Cells Directive (2004/23/EC), therapeutic tissue banking is currently being restructured throughout Europe. The stated objectives are to enhance a safe and stable supply of bone and tissue in Europe and to facilitate internal exchange. We conducted an interview study to explore the effect of the Directive on Danish bone banks in terms of (1) organizational restructuring, (2) supply and range of exchange, (3) economic costs. We found that the Directive stimulated extensive reorganization of bone banks with a substantial adjoining workload; that it is doubtful whether it will increase supply and range of exchange; and that the transposition of the Directive is associated with considerable extra cost. Additionally, we found that elements in the documentation of safety were fabricated by surgeons to avoid what was seen as unnecessary questioning of potential donors.

Original languageEnglish
JournalCell and Tissue Banking
Volume11
Issue number3
Pages (from-to)225-232
Number of pages8
ISSN1389-9333
Publication statusPublished - Aug 2010

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