Stem Cell Research in Korea: A Legislative Aspect

AuthorKangchan Jeong
PositionJudge, The Seoul High Court. LL.B.(S.N.U.), Visiting Fellow(Oxon).
Pages153-157

Page 153

1. An Overview

Korea has been among the scientific leaders in the development of stem cell research and reproductive technologies. The fourth to succeed in producing an in-vitro fertilization (IVF) baby, Korea is leading in the culture of a stem cell line from an embryo created through a somatic-cell nuclear-transfer technology.1 The progress in stem cell research in Korea, however, has sparked a vigorous ethical and legal debate. Korea finally adopted the regulations of stem cell research in December 2003 after a vigorous three-year debate triggered by Dolly the Sheep and the assertions of human cloning by Clonaid in Korea, originating from the United Kingdom. Korea passed Bioethics and Biosafety Act (BES Act), which regulates the use of embryonic stem cells for research purposes along with somatic-cell nuclear transfer (SCNT). In addition, Korea enacted Law on Bioethics and Safety and Law on Generative Cells.

BES Act came into effect on January 1,2005. Its detailed regulations were released as either presidential decrees (BES Decree) or ordinances of the Ministry of Health and Welfare (BES Ordinance). Additional provisions and guidelines are still going through the legislative process.2 As a special note, the current legislative process will be discussed herein.

2. What is Permissible?

Stem cell research in Korea could be carried out with a license. The Human Fertilization and Embryology (HFE) Act of 1990 provides that a research plan should be registered at and approved by the government.3 Reproducing clones without a license mayPage 154 constitute a criminal offence.4 Embryos, including those created by SCNT, can be used only before the appearance of the "primitive streak," which ordinarily appears 14 days after the gametes are mixed.5 Korea does not allow payments for embryos or gametes apart from the reasonable expenses that may be incurred in their use for research purposes.6 The fertilization of sperms or eggs of the dead for pregnancy is also forbidden in Korea.7 Embryo creation for research is not even an issue in Korean legislation. In addition, only surplus embryos can be used for research, and embryos may not be created for any purpose other than IVF treatment.8

3. Authorities

There are three bodies that regulate stem cell research in Korea. The first is the Ministry of Health and Welfare (MHW), where researchers must register their stem cell or SCNT research plans for approval.9 The second is the National Bioethics Council (NBEC),10 which has the power to deliberate on important matters specified in BES Act of January 2005.11 It may be pointed out that the NBEC covenant unites government representatives with those from the biotechnology or pharmaceutical industries, enabling them to drive the national policy on biotechnology. Legally, NBEC is only a deliberative council; its recommendations have no legal binding force on the President and on the rest of the executive branch of the government. The Report for BES Act Revision of October 2007(Report for BES Act Revision) provides that the council, however, could stimulate so much social or political pressure that it could determine the agenda for regulatory change and discussion.12 The most significant bodies in Korea in relation to stem cell research are the research-institute-specific bioethics councils (IBECs). All IBECs should have at least one outside member who will review the research's ethics.13 Meanwhile, the World Stem Cell Hub (WSCH) was established in Seoul National University (SNU) Hospital on October 19, 2005. WSCH comes up with systematic regulations or guidelines for the quality control of stem cells. Korea's stemPage 155 cell bank is expected to offer cloned embryonic-stem-cell lines to researchers around the...

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