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A Study on the Legal System for Bioethics in the Fourth Industrial Revolution

  • Legal Theory & Practice Review
  • Abbr : LTPR
  • 2019, 7(4), pp.105-129
  • Publisher : The Korea Society for Legal Theory and Practice Inc.
  • Research Area : Social Science > Law
  • Published : November 30, 2019

Oh, Ho-Cheol 1,  Han Ie Kim 1

1신경대학교

Candidate

ABSTRACT

On March 1, 2019, Japan revised Guidelines for Handling Specific Embryos and Law Enforcement Regulations regarding regulation of human cloning technology. The revision has made it possible to study the use of human ES cells or iPS cells in fertilized embryos in Japan. Through this regulation, Japan has approved the study of transplanting iPS cells into mouse embryos to make pancreatic cells, and the study is emerging as an alternative to addressing organ transplantation through heterogeneous organs. In Korea, there were many demands and discussion for the revision of the Bioethics and Safety Act in 2017. As the market of biopharmaceuticals grew, the demand for legislation or revision was increased to promote the Bio industry. Korea's bioethics law has been revised three times since early December 2017, but it did not reflect any of the numerous demands in the life sciences sector. But, on August 2, 2019, the Act on the Safety and Support of Advanced Renewable Medical and Advanced Biopharmaceuticals was enacted to support the development of new drugs in the field of regenerative medicine. In Korea, as in Japan, many patients suffer from the lack of donors in organ transplantation. Therefore, it is necessary to establish the groundwork that allows the study of xenotransplantation using iPS cells as an alternative to organ transplant deficiency. However, in Korea, there is no regulation to prohibit the study of heterogeneous organs, and IRB approved the research using iPS cells recently. Therefore, it is desirable to enact regulations to allow the study of heterogeneous organs using iPS cells that are considered to be relatively free of ethical issues, and to avoid various ethical and safety management problems that may arise through heterogeneous organ research.

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