「생명윤리 및 안전에 관한 법률」 유전자치료 조항에 대한 개선방안 = A Study on the improvements for the article of Gene Therapy in the 'Bioethics and Safety Acts' in 2008

다국어 초록 (Multilingual Abstract)

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.

목차 (Table of Contents)

• Ⅰ. 들어가며
• Ⅱ. 생명윤리법상 유전자치료 조항에 대한 분석
• 1. 유전자치료에 대한 규율
• 2. 생명윤리법 제2조의 유전자치료 정의 규정
• 3. 유전자치료의 예외적 허용범위의 한계
• 4. 치료기관 설립상의 문제
• 5. 전반적 법률 구조상 체계의 혼선
• Ⅲ. 맺으며
• Abstract

참고문헌 (Reference)

1 한국과학기술정보연구원, "유전자치료제"

2 권복규, "생명윤리와 법" 이화여대 출판부 2008

3 Jeremy Rifkin, "바이오테크 시대" 민음사 2003

4 장영민, "「생명윤리및안전에관한법률」의 유전자치료 및 배아·태아의 유전자 검사에 대한 개선 방안 연구, 보건복지부 정책연구과제“생명윤리 및 안전에 관한 법률의 유전자치료에 관한 운영지침 및 제도보완 방안 마련”보고서" 2006