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논문 기본 정보

자료유형
학술저널
저자정보
이재목 (충북대학교) 김현수 (한국생명공학연구원)
저널정보
충북대학교 법학연구소 과학기술과 법 과학기술과 법 제13권 제2호
발행연도
2022.12
수록면
207 - 232 (26page)

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This paper deals with issues related to the concept and characteristics of synthetic biology(engineering biology), its usefulness and risks, the regulation and management of risks, and the relief of damages caused by the manifestation of risks. In particular, civil liability issues that may arise in the course of synthetic biology research and its industrialization were reviewed. Due to the nature of synthetic biology, it is realistically impossible to prevent all damages incurred in the process even if the operator of the technology fulfills the duty of care in operation. Damage relief through the application of the general illegal liability provisions and the Product Liability Act based on the principle of negligence liability cannot be an effective means due to the difficulty of proof, the limited scope of application, and the possibility of exemption through defense of development risks. It may also be considered to reduce the victim's burden of proof through interpretative theories such as presumption of negligence and shifting the burden of proof. However, in the field of high-level science and technology, it can harm legal stability because there are considerable difficulties in proving fault and making judgments. Damages caused by risks inherent in synthetic biology technology should be compensated through laws of risk liability. In the course of research and technical operation of synthetic biology, a person who controls and manages a risk source (Gefahrquelle) is liable for damages even if he or she is not at fault in the event that the risk materializes and infringes on the legal interests of others, which is consistent with the idea of fairness. Due to the nature of synthetic biology and genetic engineering, unlike product liability, the defense of development risk is excluded, but the assumption of causal relationship must be acknowledged. Regarding the establishment of the maximum amount of liability, considering the structure of the Damages Compensation Act, which takes the principle of limited compensation, it is judged that it is right not to limit it. No legislation has been enacted on risk management and regulation related to synthetic biology. In the LMO Act, there is no provision for liability for damages. Right now, it can be said that it is realistic to establish new regulations in the LMO. In addition to enhancing global industrial competitiveness through the use of synthetic biology technology, it is also a challenge to respond to legislation related to risk management, regulation, and damage relief.

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