Massimo L, Manfredini L
U.O. Ematologia e Oncologia Pediatrica, IV Divisione di Pediatria, Istituto Giannina Gaslini, Genoa, Italy.
Minerva Pediatr. 2001 Feb;53(1):55-60.
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.
在欧盟，异体骨髓移植是一种常规治疗方法，需要特定法律程序来保护未成年捐赠者。欧洲理事会（1978年5月29日）为成员国颁布了有关器官移植的指导方针。这些指导方针包括获得捐赠者或其监护人的书面同意。《儿童权利国际公约》（1989年11月20日，纽约，第12条）规定，未成年人有权发表意见，其意见必须得到考虑。目前，尽管各成员国的法律指导方针有所不同，但都要求父母或监护人的书面同意。在法国，一个伦理委员会（1976年第76 - 1181号法律）必须告知未成年人该程序的后果，尊重其意愿并获得同意。在卢森堡，卫生部要求书面同意以及包括两名医生在内的三名专家的授权。在西班牙，一个伦理委员会必须获得未成年人的同意，然后由政府当局批准并由一名医生会签。在英国，一项国民健康服务指令（1993年8月1日）规定，16岁以上的捐赠者必须给予同意。在德国，14岁以上的未成年人可以给予同意。当接受者是父母时，需要法律保障以避免利益冲突。在比利时，15至18岁的未成年人需要有证人的书面同意，由监护人会签并经医生批准。21岁以下已婚捐赠者需要成年同意者的批准。在葡萄牙，未成年人和监护人的口头同意就足够了。在丹麦，需要监护人的书面同意。在意大利，正在制定一项法律以更好地保护未成年人。总之，欧洲理事会颁布详细的法律指导方针并要求欧盟各国更加统一是有益的。
