Since the development of the CRISPR-Cas9 system, the remarkable advances in biotechnology using genome editing have led to astounding achievements in the prevention and treatment of diseases, including the improvement of plant and animal breeds, as well as the treatment of rare congenital genetic disorders and cancers. Following the birth of twin girls whose genes were edited in human embryos, international organizations have been endeavoring to establish international standards and strengthen governance around human genome editing, but to date there are no agreed-upon standards for human genome editing. Many countries regulate human embryo research and human genome editing in a variety of ways, depending on their historical and social contexts. The United States, Japan, the United Kingdom, France, and Germany generally do not regulate somatic humanl genome editing, and have amended their laws or guidelines towards allowing human embryo genome editing under certain conditions.
 
In Korea, the law governing human genome editing is the Act on Bioethics and Safety, which is the basic law for human subjects research. This Act allows limited research on residual embryos, somatic-cell cloning embryos, and parthenogenic embryos for research on rare or incurable diseases, and limits the scope of research on gene therapy to: “Research on a therapy for a hereditary disease, Acquired Immune Deficiency Syndrome (AIDS), or any other disease that threatens one's life or causes a severe disability; Research on a therapy where there is no applicable therapy at present or the effect of a gene therapy is expected to be significantly better than other therapies”, and prohibits gene therapy on embryos, eggs, sperm, and fetuses.
 
After conducting multiple interviews with leading Korean researchers on biology and bioethics, this report points out the problems of ambiguity in the regulations on gene therapy, restrictions on the diseases or treatments that can be studied for gene therapy research, lack of social consensus in the process of enacting and revising bioethics laws as well as shortage of professional reviewers for clinical research and clinical trials on gene therapy, and suggests ways to improve them. In other words, as a way to improve the regulation of human genome editing in Korea, it was proposed to clearly define the meaning of gene therapy; to add precursors of eggs and sperm to the prohibited subjects of gene therapy; to delete the regulation restricting the target disease or treatment method of gene therapy search and instead establish the requirement of gene therapy research on eggs, sperm, embryos, and fetuses, and to obtain permission from an independent permanent professional organization. It was also proposed to explore various ways to build a social consensus and to increase the number of expert reviewers in preparation for the increase in gene therapy clinical research and clinical trials in the future.
 
The Act on Bioethics and Safety has served to protect research subjects in human subjects research and in the handling of embryos and genes; however, it does not yet adequately reflect advances in biotechnology and unduly restrics the academic freedom of researchers and the right of patients to self-determination. It is time for both experts and the public to work together to abolish unreasonable regulations and develop new bioethics laws that are appropriate for the technological advancement and the situation of our society.