Bioethics and Health Law: Legal Issues Concerning Biotechnology, Medicine and Health Care System

Koichi SETOYAMA

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 present biotechnology and health care system in comparison between Japan and other countries, especially the USA.

Requirement / Prerequisite
   No legal and medical background is required.

Course Schedule
   Below are the topics and issues planned to be covered in the classes. Topics and Issues, and the order of the issues may be changed after considering the interests of the students.

   1. Introduction: Advancement of biotechnology and its ethical and legal issues
   2. Medical Ethics and Clinical Ethics: Basic principles of Bioethics (Autonomy, Beneficence, and Justice etc.)
   3. Basic principles of legal regulations on Self Determination: Harm Principle, Paternalism, Moralism
   4. Informed Consent and Right of Self Determination (Right to know and not to know ones own medical information)
   5. Physician-assisted Suicide (active Euthanasia)
   6. Death with Dignity (withholding life-sustaining treatment)
   7. Brain Death and Organ Transplantation, Organ Trafficking
   8. Refusal of Blood Transfusion based on the religious reason
   9. Assisted Reproductive Medicine (Surrogate Birth, Prenatal Diagnosis and Abortion, etc.)
   10. Japanese Health Care System: Universal health insurance system and restriction on multiple medical treatments
   11. Privacy and Confidentiality of medical information (concealment of fatal diagnosis and prognosis)
   12. Human Genome Project and Genetic Discrimination
   13. Genetic medicine (Genetic Enhancement) and the so-called "Order-made Medicine"
   14. Medical research and regulations: Experimentation on human subjects, Role of the Institutional Review Board   

Textbook and Reference
   There is no assigned textbook.
   Various reading materials will be distributed in each class.
   Several short video films planned to be shown.   

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

Other Remarks
   Students' opinions from the viewpoint of their own countries are encouraged. Students will be expected to participate actively in classroom and group discussions.