Abstract:
Deliberation over the ethical and legal implications of human embryonic stem cell research commenced at a national level in 1998. In recognition that an embryo has an ethical status as “Germ of Human Life”, legislation was introduced in 2000 to prohibit reproductive cloning and non-binding guidelines authorised research on human embryonic stem cells (“hESC”) with surplus embryos. Therapeutic cloning, a prospective technique for avoiding adverse immunological effects in regenerative medicine, was initially prohibited. However, with regulatory experience and promising advancement of hESC research, this prohibition has been lifted. Meanwhile, a tremendous breakthrough has recently taken place in induced pluripotent stem cell technology. A new regulatory framework is being introduced to enable the therapeutic application of human stem cell research. This article provides an overview of the policy and regulatory changes that have taken place in Japan. The rationale and motivations behind these changes are also considered.