｢합성생물학 육성법｣의 주요 내용과 입법 과제

Synthetic biology is a leading discipline in digital biotechnology, where cutting-edge technologies such as artificial intelligence (AI) and big data converge. As a branch of biotechnology, it involves the engineering-based design, manufacturing, and application of biological components and systems. Due to its transformative potential beyond traditional industries, impacting sectors such as chemistry, environment, and energy, it rapidly emerges as a core domain in the global race for technological supremacy. In response to these developments, the Korean National Assembly has passed the Synthetic Biology Promotion Act, scheduled to take effect in 2025. This legislation aims to strengthen global competitiveness by promoting synthetic biology research and development at the national level and establishing a systematic legal foundation for responsible innovation and governance. This study analyzes the key provisions of the Synthetic Biology Promotion Act, which addresses formulating a national promotion strategy, R&D activities, equipment acquisition, and workforce training. It also outlines the following legislative challenges: First, the overlapping functions between technology impact assessment and technology level assessment must be resolved through institutional integration or clarification of hierarchy. Second, it is crucial to define legal concepts clearly, such as the ownership of research data and the handling of personal information, and to ensure consistency across relevant legislation. Third, the support system for biofoundries should be systematically adjusted by distinguishing between public and private sectors. Fourth, enforcement mechanisms and an operational framework must be established to enhance the effectiveness of R&D guidelines and education. Lastly, to improve administrative efficiency, the delegation and entrustment provisions should be expanded and reorganized to support effective delegation of ministerial authority.