첨단재생바이오법과 생명윤리법의 갈등과 조화: 새로운 규범적 재배열을 향하여

초록

The Advanced Regenerative Bio Act, aimed at promoting advanced regenerative medical technologies, and the Bioethics Act, aimed at protecting human dignity, are special and general laws, respectively. However, conflicting legislative purposes and other factors have caused regulatory gaps and ethical dilemmas in implementation. This paper thoroughly examines the nature of the conflict between the two laws using the analytical framework of “structural conflict” and “intrinsic conflict.” Structural conflict stems from a dual review system. The national-level Review Committee replaces the Institutional Review Board(IRB), weakening continuous oversight functions at the research site and causing serious cracks in the legal framework. Intrinsic conflict arises from the fundamental clash of values embedded in the two laws. In particular, the advanced regenerative medical treatment system under the Advanced Regenerative Bio Act blurs the ethical boundaries between research and treatment, leading to “therapeutic misunderstandings” and shifting the financial risks of unsafe technologies onto patients. To resolve these conflicts, this paper proposes “normative realignment.” This dual approach structurally strengthens national bioethics governance and, internally, revises legal content to prioritize the protection of research subjects. The goal is establishing a trustworthy legal framework for harmonizing technological innovation and ethical values.

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