LAW CLASS series Ijiho Kogi (Medical Law)

Ijiho Kogi provides a latest and comprehensive overview of medical law, the legal field relating to clinical medicine and biomedical research. The book is primarily expected to be used as a textbook for students studying at a faculty of law or at a law school, but it might also be useful for medical practitioners confronting various legal issues.
 
In Chapter 1, the general principles and interests that consist of the main system of medical law are explained. The several rights or interests, e.g., life, health, and privacy have a function of principles of medical law, and the chapter concludes that the four principles of bioethics, respect for autonomy, nonmaleficence, beneficence, and justice, should also be regarded as the principles of medical law.
 
Chapter 2 describes several topics of the Act on Physician and the Act on Medical Service that are two major statutes of administrative law on medicine in Japan. The Act on Physician provides the duty clauses of first treatment, reporting on abnormal corpse, making patients’ record, and so on. The Act on Medical Service prescribes many clauses on the regulation of medical institutes, and those on the several current medical policies including adequate allocation of hospitals, medical risk management, operation of emergent ambulatory services, and so on. By analyzing these two statutes, the chapter examines the government regulation of medical practice.
 
Chapter 3 reports the civil and criminal legal issues related to general medical practice, and especially focuses upon medical malpractice. Since tort liability becomes an important issue in many cases of medical malpractice, there are a lot of academic discussions and case laws on negligence, infringement of right or interest, damage, and causation that are peculiar to the malpractice cases. The details of discussions and case laws are explained, and criminal medical malpractice is also examined in the chapter.
 
Chapter 4 discusses the legal issues regarding the several special fields of medicine: terminal care, organ transplantation, psychiatric care, infectious disease care, reproductive medicine, human cloning, and regenerative medicine. While some medical issues are regulated by the special statutes including the Act on Organ Transplantation, the Act on Psychiatric Care and Welfare, and the Act on Infectious Disease, other medical areas do not have clear regulation rules. The chapter concludes by indicating what the specific rules for the special fields of medicine should be.
 
Chapter 5 analyzes the regulation of drugs and medical instruments, and that of biomedical research. In Japan, a few governmental guidelines have regulated most areas of the biomedical research including clinical research, epidemiological research, genome research, and embryo research. Several specific statutes have also regulated the biomedical research as human cloning research or the research on regenerative medicine, but the areas regulated by statutes are limited. In this chapter, the academic discussions on the fundamental principles of research regulation are explained, and the detailed contents of the several guidelines and statutes on research regulation are intensively described and analyzed. The chapter finally insists that in addition to the concrete rules, the fundamental principles of research regulation should be clearly described, because such regulation means restriction on freedom of research that is guaranteed in the Constitution of Japan.

(Written by YONEMURA Shigeto, Professor, Graduate Schools for Law and Politics / 2017)