Tsutsumi Haruhiko, Kumaido Kuniyoshi, Yamaguchi Atsushi, Sawano Makoto, Sugiyama Satoru
Department of Emergency and Critical Care Medicine, Saitama Medical Center, Saitama Medical University.
Nihon Rinsho. 2010 Dec;68(12):2202-9.
In accordance with the revision of the "Organ Transplantation Law", the ordinances and the guideline for the law were also revised. The revision of the guideline, which finds legal basis on the circular notices, raises some issues about its position in the Japanese legislative system. It is quite ambiguous whether we should comprehend the guideline as the interpretation of the law, as the procedural guidance, or as the instruction within the administrative body. Thus, the legal obligation for the healthcare professionals to observe the guideline is also unclear. There are many issues about the transplantation law, the ordinances and the guideline. They include (1) Legal implication of the "brain death" (Is "brain death" absolutely synonymous with "death" ?), (2) Scientific relevance of the criteria for diagnosis of brain death, (3) Definition of the "adequate treatment" which is the prerequisite for diagnosis of brain death, (4) The time of death for the cases who were declared legally brain-dead but did not donate the organs, (5) By whom and when should the organ donation be proposed, and more. The ambiguity about the legal position of the guideline shall cause confusion in the scenes of clinical practice.
根据《器官移植法》的修订，相关条例及该法律的指导方针也进行了修订。以通知为法律依据的指导方针修订，引发了其在日本立法体系中地位的一些问题。对于是应将该指导方针理解为法律解释、程序指南还是行政机构内部指令，相当模糊不清。因此，医疗专业人员遵守该指导方针的法律义务也不明确。关于移植法、条例和指导方针存在诸多问题。它们包括：（1）“脑死亡”的法律含义（“脑死亡”是否绝对等同于“死亡”？）；（2）脑死亡诊断标准的科学相关性；（3）作为脑死亡诊断前提条件的“适当治疗”的定义；（4）被合法宣布脑死亡但未捐赠器官的病例的死亡时间；（5）应由谁以及何时提出器官捐赠，等等。指导方针法律地位的模糊性将在临床实践场景中造成混乱。
