The effect of the EU Tissues and Cells Directive on bone banking in Denmark: a case study |
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Authors: | Sofie Okkels Birk Klaus Hoeyer |
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Institution: | (1) Department of Public Health, Unit of Health Services Research, University of Copenhagen, Oester Farimagsgade 5, Building 10, ground floor, 1014 Copenhagen, Denmark;; |
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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 re-organization 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. |
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