[Legal regulations to protect under-aged donors issued by E.U. Member Countries. Analysis of the present situation and proposals].
Allogeneic bone marrow transplantation in the E.U. is a routine treatment which requires specific legal procedures to protect under-aged donors. The European Council (5/29/1978) decreed the guidelines concerning organ transplantation for the Member Countries. These guidelines included obtaining written consent from the donor or his/her guardian. The International Convention on children s rights (New York 11/20/1989, art. 12) stated that the minor has the right to give his/her opinion, which must be taken into consideration. Currently, though legal guidelines vary among Member Countries, all require the parents  or guardian s written consent. In France, an ethics committee (L. 76-1181/1976) must inform the minor about the consequences of the procedure, respect his/her will and obtain consent. In Luxembourg, the Department of Health requires written consent as well as authorization by three experts, including two physicians. In Spain an ethics committee must obtain the minor s consent which is then approved by a government authority and counter-signed by a physician. In UK an N.H.S. directive (1st Aug. 1993) states that as of 16 years of age donors must give consent. In Germany minors over 14 are allowed to give consent. A legal guarantee is required when the recipient is a parent to avoid conflict of interest. In Belgium minors between 15 and 18 require witnessed written consent, counter-signed by the guardian and approved by a physician. Married donors below 21 need the consenting adult s approval. In Portugal verbal consent by the minor and the guardian is sufficient. In Denmark the guardian s written consent is needed. In Italy a law is being prepared to best protect minors. In conclusion it would be useful for the European Council to decree the detailed legal guidelines and require greater uniformity among the E.U. Countries.
Massimo
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U.O. Ematologia e Oncologia Pediatrica, IV Divisione di Pediatria, Istituto Giannina Gaslini, Genoa, Italy.
Manfredini
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D000293:Adolescent; D000328:Adult; D000367:Age Factors; D016026:Bone Marrow Transplantation / Q000331:legislation & jurisprudence*; D002648:Child; D004992:Ethics, Medical; D005062:European Union; D005260:Female; D006801:Humans; D007223:Infant; D007258:Informed Consent / Q000331:legislation & jurisprudence; D008297:Male; D014019:Tissue Donors / Q000331:legislation & jurisprudence*