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KMID : 1011120090030010053
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Bioethics Policy Studies
2009 Volume.3 No. 1 p.53 ~ p.68
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A Study on the improvements for the article of Gene Therapy in the "Bioethics and Safety Acts" in 2008
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Kim Hyeon-Cheol
Kim Hwi-Won
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Abstract
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Due to the success of the treatment for ADA patient, gene therapy has been presented as a new treatment for serious diseases. Nowadays gene therapy is used more than 90 times a year around the world(2006). Though it has many benefits, as many studies has pointed out, it has various kinds of ethical problems, including its scientific uncertainty, clinical risks, and the potential violation of human dignity. The Bioethics and Safety Act has been established in order to address these problems in Korea in 2005. However two provisions relevant to gene therapy in the act are not regarded as proper measure to respond these problems. The aims of this paper is to review legal aspects of gene therapy in the Bioethics and Safety Act in 2008, and to find a way to improve the article of gene therapy in the act.
First of all, vague and ambiguous expression of the definition of gene therapy should be crystallized into the definite one. Second, the gene therapy is in general prohibited, and in particular the gene therapy with respect to a spermatozoon, ovum, embryo or fetus is prohibited. There are three exceptional circumstances which allow gene therapy. The exceptional cases contain serious diseases such as hereditary diseases, cancers, and AIDS which may threaten life or cause any serious disability, and diseases whose gene therapy would be deemed considerably more effective than any other treatment. But, the range of these exceptions is too broad to regulate the use of gene therapy. Third, although gene therapy is not regarded as a tried and reliable remedy yet, the establishment and registration of gene therapy institution is easy and simple. The last, there are two kinds of laws relevant to gene therapy which are the Bioethics and Safety Act and Pharmaceutical Affairs Act. There are some inconsistency and confusions in implementing these two laws. This paper will address legal problems, articulate inconsistencies within these laws, and find better oversight system of gene therapy in Korea.
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KEYWORD
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gene therapy, the Bioethics and Safety Act, Pharmaceutical Affairs Act, clinical trial, clinical trial institution, definition of gene therapy
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