Informed Consent and Patients' Rights in Japan: 2001 Epilogue

Abstract

Japan is on a steeper trajectory toward the incorporation of informed consent principles into medical practice than the “gradual transformation” observed in a 1996 article, Informed Consent and Patients’ Rights in Japan. Among the most significant recent developments from 1996 to 2001 have been these seven: (1) the 1997 enactment of the Organ Transplantation Law permitting the use of brain death criteria in limited circumstances in which informed consent is present; (2) the strengthening of patients’ rights in clinical drug trials; (3) the continued trend toward increasing disclosure to patients of cancer diagnoses; (4) initiatives by the health ministry toward recognition of patients’ rights at a measured pace; (5) increasing public concern about medical error and patients’ rights; (6) the gradual, grudging acceptance by the medical establishment of aspects of patients’ rights in the areas of informed consent and access to medical records; and (7) most important as a legal matter, the recognition by the Supreme Court of Japan of the right to accurate advance information about physicians’ treatment intentions concerning life-and-death decisions during surgery, enabling the patient to reject the proposed treatment if she chooses.

Keywords: Informed consent, Japan, medical records, organ transplants, brain death, clinical trials, cancer disclosure, informed refusal, patients' rights

JEL Classification: I18, K13, K32, N45