• The Korean Society of Law and Medicine
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• v.12 no.1
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• pp.227-255
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• 2011

Recently, many nations said "yes" to human embryonic stem cell research, signing an executive order to permit funding for the research in the mame of achieving health and life of humankind. Human Embryo Research is permitted by our Bioethics & Biosafety Act. But, illegal research cannot be divorced from civil liability since it requires the destruction of eggs of fertilized eggs and personal rights of embryo-creator. After all, though we allow to do research embryo, we should control the capacity of abuse of embryo research for embryo-creator. If research violate the law(Bioethics & Biosafety Act or Civil Law, etc), it comes to a delict by pecuniary loss and non-pecuniary loss. When it comes to pecuniary loss, Human Embryo is not body but special property. Supreme Court maintained a stance that mental suffering is generally deemed as compensable for damages for the loss of property where a person's property right is invaded by a tort or non-performance of obligation. Thus, where mental suffering occurs, which cannot be compensated by recovery of property losses, the situation must be a special circumstance and the injured could claim consolation money for such losses only if the offender knew or would have known of such special circumstances(Supreme Court Decision 96Da31574 delivered on Nov, 26, 1996, etc.). That is to say, Supreme Court regards mental suffering through person's property right invaded by a tort as damages that have arisen through special circumstances. According to Civil law article 393 (2), the injured could claim consolation money for such losses only if only if the offender had foreseen or could have foreseen such circumstances. Also our court will solve through damages for non-pecuniary loss by complementary function of consolation money in that pecuniary loss could be difficult to valuate.

• Development and Reproduction
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• v.19 no.2
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• pp.111-118
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• 2015

This article explores the questions regarding PND and PID, especially the concrete legal conditions for the justification of PND and PID. As such, the German law stipulating PND and PID in a very concrete and detailed manner is introduced and explained in comparison with the corresponding South Korean law. The South Korean Bioethics and Biosafety Act (BBA) stipulates various types of gene testing and does not demonstrate a delicate sense of each type of gene testing. In contrast to the South Korean regulation, in Germany, there exist specific regulations for genetic counseling. Especially in the case of PND, GEKO stipulates the process of genetic counseling very concretely, based on GenDG. In the case of PND and PID, it is important that the people concerned understand the meaning of testing in various angles, and restructuralize it by combining it with their own values as the diagnosis is directly combined with pregnancy/abortion, which influences the whole life of a woman (and her partner). In this context, the South Korean BBA needs to be amended as soon as possible. The sections on informed consent also need to be amended to make them more concrete. Furthermore, guidelines for concretizing the regulation of BBA need to be continuously formulated and developed.

• Journal of Genetic Medicine
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• v.4 no.2
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• pp.186-189
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• 2007

More than 6,000 rare disorders including genetic diseases have been reported. Of them, 1,500 diseases (1,211 for clinical diagnosis and 289 for research only) are technically possible for genetic testing. In Korea, since 2005, only 63 genetic diseases is permitted for prenatal genetic testing by the "Bioethics and Biosafety Law". The article 25 in the law prescribes 63 genetic diseases without clear indication for its selection and inclusion criteria. In EU, USA, and other foreign countries, however, there is no provision in the statute on prenatal genetic testing; it is not restricted by a law. Recently, a woman (Mrs. L, 38y) who is a carrier for Menkes disease made an appeal to a government for an amendment of the "Bioethics and Biosafety Law" prohibiting the prenatal diagnosis of her pregnancy at risk for Menkes disease. Menkes disease (MNK) is an X-linked recessive disorder characterized by neurodegeneration, connective tissue defects and hair abnormalities, and no effective treatment is available yet. The prevalence rate of MNK is one in about 250,000 live births. Menkes syndrome patients fail to absorb copper from the gastrointestinal tract in quantities adequate for meeting nutritional needs. These needs seem particularly acute during the initial 12 month of life, when the velocity of brain growth and motor neurodevelopment. Most of pts. die around 3yrs. of age. Mrs. L had a boy with Menkes disease who died at 2y.o. in 2001. Subsequent pregnancy in 2003, she was able to have prenatal genetic testing for mutation of the Menkes (ATP7A) gene and delivered a healthy baby boy. Now, She is pregnant again and wants to have prenatal diagnosis. however, this time, she was not allowed to have any more because Menkes disease is not included in 63 genetic diseases permitted by the law for prenatal genetic testing, in spite of the fact that she is a Menkes disease carrier and her pregnancy is at risk to have an affected baby. This case shows the practical problem of the legal restriction for prenatal genetic testing in Korea. In this study, we report a arguable case and discuss the controversial issues in the legal restriction for prenatal genetic testing in Korea.

• Development and Reproduction
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• v.21 no.3
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• pp.343-349
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• 2017

tWith the development of the third-generation gene scissors, CRISPR-Cas9, concerns are being raised about ethical and social repercussions of the new gene-editing technology. In this situation, this article explores the legislation and interpretation of the positive laws in South Korea. The BioAct does not specify and regulate 'gene editing' itself. However, assuming that genetic editing is used in the process of research and treatment, we can look to the specific details of the regulations for research on humans as well as gene therapy research in order to see how genetic editing is regulated under the BioAct. BioAct differentiates the regulation between (born) humans and embryos etc. and the regulation differ entirely in the manner and scope. Moreover, due to the fact that gene therapy products are regarded as drugs, they fall under different regulations. The Korean Pharmacopoeia Act put stringent sanctions on clinical trials for gene therapy products and the official Notification "Approval and Examination Regulations for Biological Products, etc." by Food and Drug Safety Administration may be applied to gene editing for gene therapy purposes.