Human Cloning Legislation in Japan

- Jiro Nudeshima, Ph.D.
Mitsubishi Kasei Institute of Life Sciences,
11, Minami-Ooya ,; Machida-shi, Tokyo 194, Japan

Eubios Journal of Asian and International Bioethics 11 (2001), 2.
The Japanese Parliament enacted the 'Human Cloning Regulation Act' on 30 November, 2000.

The Act prohibits transfer of human embryo and human-animal cloned embryo made by somatic nuclear transfer, as well as human-animal chimeric embryos and human-animal hybrid embryos, to a human or animal uterus. A breach of this prohibition can be punished by up to 10 years' imprisonment and fine of 10 million Japanese yen (about US$93,000). So the Act is considered asa ;'ban on human reproductive cloning'.

But it does not prohibit transfer of cloned human embryo made by splitting and by nuclear transfer from embryonic cells to the uterus. Neither does it prohibit transfer of human-human chimeric embryos, animal-human chimeric embryos, and cloned embryos made by animal somatic cell nuclear transfer to human oocyte.

Further, the Act accepts in-vitro human embryo research very widely. It admits cloning of a human embryo by somatic nuclear transfer, and making human-human, human-animal, or animal-human chimeric embryos. It also admits cloning embryos by animal somatic cell nuclear transfer to a human oocyte. This last exception to the ban surprised conscientious researchers working in this field.

Apparently this Act admits so-called 'therapeutic cloning'.; It does not cover other human embryo research like making human embryonic stem cells.; Neither does the Act contain fundamental ethical principles such as gratuitous embryo and egg donation for research purposes. So selling human embryos and oocytes is not legally prohibited in Japan. It is strikingly contradictory to the fact that sale of human solid organs like heart or liver is legally prohibited by the Organ Transplantation Act in 1997.

Too many important detailed regulations are left to administrative guidelines to be made in 2001, but; their contents are not clarified so far.

I am deeply concerned if this legislation misleads Japanese researchers to easily instrumentarise human embryos and oocytes. The Act requires its revision within three years after its effective date.; I believe we should make proposals to revise this imcomplete Act to make a more comprehensive new law which covers human embryo research in large and contains ethical principles to guide researchers.

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