[How should we comprehend the guideline for the revised Organ Transplantation Law?].

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.