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10.6Bioethics, Public Policy and Forms of Government

Besides religion, a country's form of government also affects the way the human body is treated as the subject of life science research. To review how bioethics is being handled, there are two distinctive styles: the American style based on the principles of self-determination and self-responsibility, and the European style based on common order.
"America, the land of freedom" essentially means religious freedom. The United States is a society with many different values in place with emigrants of various religious faiths. And even today, as seen repeatedly at presidential elections, public opinions split and conflicts among different values are exposed, particularly when issues related to religious values are raised, such as the use of human embryos for research directly linked to the issue of abortion and the pros and cons of gay marriage. When handling the human body, it is difficult for such a society to maintain its common value. Therefore, self-determination and self-responsibility based on the concept of freedom become basic principles. Because of such a system, American bioethics underscores the importance of informed consent. Nonetheless, once human tissues are removed, all the procedures are performed with the person's consent, and then they end up becoming mere commercial goods. In Europe, there is a very critical view about this type of commercialization of human body parts (see following section).
On the other hand, the European society today endeavors to place common values for bioethics upon dominant Christian confessions, whether it be Catholicism or Protestantism, which play a large social function as the source of values. This is why European nations are moving towards legislation regarding individual issues of bioethics. Until now, laws such as those related to reproductive technologies, organ transplantation, the protection and use of medical and genetic information, the use of human embryos for research, the protection of human subjects in clinical research, and the use of genetic information for criminal investigation have all come into effect. In a way, Europe is in a rush of passing new laws on bioethics one after another.
With little interest in such trends in Europe, the Japanese society handles all issues with the American style of self-determination. However, the Japanese society is not as diverse as the American society in terms of value systems. Thus, it would be of great benefit for Japan if it studied the European laws on bioethics.

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The Value and Ethical Principles of Animal Testing

Animal testing is indispensable for the advancement of life sciences. In Europe and the United States, there is a long history of prohibition of animal abuse. This led to clear-cut rules for the handling of experimental research animals. During the first half of the 1980s, in particular, radical anti-animal research movements occurred, and during the second half of the 1980s, legal systems that assured the scientific and ethical appropriateness of animal testing were established in Europe and the United States. Through the revision of the public health business law in the United States in 1985 and the EC (now EU) commission in 1986, the handling of experimental animals was specified in detail, which stands on the three R principles: "replacement," replacing animal testing with experimental systems that do not use animals; "reduction," reducing and minimizing the use of animals; and "refinement," refining or improving the systems that help avoid unnecessary animal testing. In Japan, the revision of the Animal Protection Law in 2005 clearly specified that efforts should be made to reduce the use of test animals and that painless treatment measures should be used. To perform animal testing according to this law, Japanese researchers must notify the Ministry of Education, Culture, Sports, Science and Technology, and many universities and research institutions have set up an in-house animal testing committee.

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Ethical, Legal, and Social Issues (ELSI)

In the United States, during the second half of the 1980s, the "human genome project" to decode the total human genome with approximately 3 billion base pairs was proposed at the US Congress. The congress, however, pronounced much concern about the project, indicating that this project might result in large-scale genetic discrimination. In response to this agenda, D. Watson, the person in charge of the project and discoverer of the double-helix model of DNA, gave testimony at Congress with the idea that 3–5% of research funding would be used for ethical, legal, and social issues (ELSI). Consequently, the entire project on the human genome was passed.
The ELSI program was groundbreaking and unprecedented because it conducts research in parallel with measures to cope with predictable problems prior to the start of the research. In 2003, however, when the decoding of the human genome was completed, no serious problems as initially concerned occurred. Because of the ELSI program's intensive investment into bioethics, much progress was made in areas such as handling of genetic information and protection of privacy, integration of genome research and clinical research, and ethics of gene diagnosis and eugenics. Since the human genome project, the ELSI program has not been put into practice. This indicates that the human genome is a special natural occurrence for many people.

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