BIOETHICS AND HEALTH LAW –LEGAL ISSUES CONCERNING BIOTECHNOLOGY, MEDICINE AND HEALTH CARE SYSTEM–

Koichi SETOYAMA (School of Law)

Objective
  Rapid advancement of Biotechnology has begun to pose controversial ethical, social and legal issues. For instance, while the Human Genome Project brings about tremendous medical benefits such as the possibility of genetic therapy and prevention of human diseases caused by the defects of DNA, on the other hand, it also raises serious social problems such as genetic discrimination in employment and insurance, etc. Advancement of assisted reproductive techniques not only enable infertile couples to have a child by using such medical technology, but also enable couples who don't want to have a baby with handicaps to select fetus based on their preferences. The primary objective of this course is to provide a framework to identify and understand the legal and ethical issues in the present medicine and health care system in comparison between Japan and other countries, especially the USA. No legal and medical background is required. Students' opinions from the viewpoint of their own countries are expected. Students will be expected to participate actively in classroom discussions. Below are some of the topics and issues to be covered in the classes. Topics and the order of the issues may be changed after considering the interests of the students.

Course Outline and Description (Topics and Issues)
   1. Introduction: Advancement of biotechnology and its ethical and legal aspects. A questionnaire will be conducted.
   2. Medical Ethics and Clinical Ethics: Basic principles of Bioethics (Autonomy, Beneficence, and Justice etc.).
   3. Models of the patient-physician relationship: Informed Consent and Right of Self Determination.
   4. Basic principles of legal regulations on Self Determination: Harm Principle, Paternalism, Moralism, etc.
   5. Privacy and Confidentiality of medical information: Human Genome Project and Genetic Discrimination. Right to know and Right not to know ones own medical (genetic) information.
   6. Genetic medicine (Genetic Enhancement) and the so-called "Order-made Medicine".
   7. Brain Death and Organ Transplantation.
   8. Refusal of Blood Transfusion.
   9. Assisted Reproductive Medicine: Surrogate Birth, IVF, Wrongful Life. Prenatal Diagnosis and Abortion.
   10. Basic structure of the Japanese Health Care System: Universal health insurance system and debate over the so-called "multiple medical treatments".
   11. Ongoing medical reform in Japan: Healthcare spending and medical expenditure.
   12. Physician-assisted Suicide (active Euthanasia) and Death with Dignity (withholding life-sustaining treatment), etc.
   13. Medical research and regulations: Experimentation on human subjects.

Textbook and Reference
  There is no assigned textbook. Various reading materials and references will be distributed in each class.

Evaluation/Grading
  Grades will be based on attendance and participation in class as well as class assignments and a paper to be submitted.
  (1) Class attendance (including class assignments): 30%
  (2) Participation in the class discussion: 10%
  (3) Final paper: 60%