합성생물학 연구데이터 법적 쟁점과 법･제도적 과제

Legal Issues and Regulatory Challenges of Synthetic Biology Research Data

Synthetic biology is emerging as a key driver of the bioeconomy and strategic competition for technological leadership through the redesign and reconstruction of biological systems. In particular, the automation of the Design–Build–Test–Learn(DBTL) cycle via biofoundries generates large-scale research data that serve as critical foundational resources for innovation in synthetic biology. This paper analyzes the legal issues and institutional challenges surrounding synthetic biology research data, focusing on Article 20 of the “Synthetic Biology Promotion Act” (enacted in April 2025, the world's first legislation of its kind). First, the concept of research data is progressively delineated into general research data, biomedical research data, and synthetic biology research data to conduct an in-depth examination of the legislative background, statutory structure, and legal implications of Article 20. The findings reveal that Article 20 seeks to balance public and private interests by establishing joint use between research subjects and operating institutions as the principle for data generated in public biofoundries, while requiring the explicit consent of data creators when data are utilized by third parties. However, significant legal ambiguities emerge regarding intellectual property rights, ownership, and procedures for obtaining third-party consent. Notably, the current legislation alone proves insufficient to adequately address matters such as the attribution of data rights and distribution criteria in collaborative research settings. Accordingly, this paper proposes the necessity of a multi-layered data governance structure in which legislation, policy, and contracts operate in a complementary manner. Specifically, it identifies the following as critical tasks for future institutional design: establishing standard contractual models between research subjects and operating institutions, designing incentive systems for data providers, and maintaining a balanced allocation of rights between public biofoundry operators and researchers.