Biotechnology Law at South Korea
South Korea has developed a robust and forward-thinking legal and regulatory framework to govern biotechnology, encompassing areas such as genetically modified organisms (GMOs), synthetic biology, bioethics, and biosafety. Here's an overview of the key components:
🧬 Biotechnology Support Act (Revised 2020)
The Biotechnology Support Act, originally enacted in 1983, serves as the foundational legislation for promoting biotechnology in South Korea. The 2020 revision introduced several enhancements:
Policy Integration: Establishes data-driven, evidence-based policies to support biotechnology.
Innovation Promotion: Encourages biotechnology innovation and the commercialization of research outcomes.
Regulatory Science: Advances regulatory science to facilitate the development and application of biotechnologies.
Bioeconomy Acceleration: Aims to accelerate the bioeconomy through systematic support for research, development, and industrialization.
🌱 Act on Transboundary Movements of Living Modified Organisms (LMO Act)
Enacted in 2001, the LMO Act regulates the development, import, export, and distribution of GMOs to ensure environmental and human health safety. Key provisions include:
Risk Assessment: Mandates comprehensive risk assessments for GMOs.
Labeling Requirements: Imposes labeling requirements for GMO-containing products.
No Authorized Cultivation: As of now, there is no authorized GMO cultivation within South Korea.
In 2024, a draft revision was proposed to redefine genome-edited organisms that do not contain foreign genes as a new category, potentially exempting them from certain LMO Act requirements)
🧪 Bioethics and Biosafety Act (2005)
The Bioethics and Biosafety Act, effective since 2005, governs ethical standards in biotechnology research. Key aspects include:
Human Cloning Prohibition: Bans human cloning and somatic cell nuclear transfer (SCNT) for reproductive purposes.
Embryo Research Oversight: Establishes guidelines for the use of human embryos in research.
National Bioethics Committee: Creates a committee to oversee bioethics policy and review research proposals.
Informed Consent: Requires informed consent for human genetic research and embryo-related studies.
🧬 Synthetic Biology Promotion Act (2025)
In April 2025, South Korea became the first country to pass a comprehensive law dedicated to synthetic biology. The Synthetic Biology Promotion Act aims to:
Strategic Development: Position synthetic biology as a national strategic driver for innovation.
Infrastructure Support: Support the creation and operation of public bio foundries.
Policy Coordination: Establish a basic promotion plan every five years and designate specialized institutions for policy development and R&D coordination.
Talent and Funding: Ensure stable funding and nurture professional talent in the field.
🏛️ National Bio Committee (Established 2025)
In January 2025, South Korea launched the National Bio Committee, a presidential advisory body tasked with:
Policy Integration: Coordinating biotechnology policies across ministries, including the Ministry of Science and ICT, Ministry of Health and Welfare, and Ministry of Trade, Industry and Energy.
Public-Private Collaboration: Consolidating public and private sector capabilities in areas such as health, food, energy, and the environment.
🧪 Regulatory Bodies
Ministry of Food and Drug Safety (MFDS): Oversees the regulation of pharmaceuticals, medical devices, and biopharmaceutical products.
Ministry of Environment: Responsible for environmental safety assessments related to biotechnology.
Ministry of Science and ICT: Leads the promotion and coordination of synthetic biology initiatives.
National Bioethics Committee: Provides ethical oversight for biotechnology research
South Korea's biotechnology laws reflect a commitment to fostering innovation while ensuring ethical standards and safety. The legal framework is dynamic, adapting to advancements in biotechnology and positioning the country as a leader in the global bioeconomy.
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