Gene editing technology is drawing attention worldwide as a key growth engine across agriculture, medicine, and the environment. But in Korea, experts say commercialization is constrained, with gene-edited organisms (GEOs) still subject to the same regulations as genetically modified organisms (GMOs). As debate accelerates after the recent inclusion of the phrase "streamline regulatory approval procedures for agricultural biotechnology products" in a U.S.-Korea joint fact sheet, experts gathered to explore policy direction.
On the 20th, Representative Choi Su-jin of the People Power Party held a policy seminar on "Gene editing technology and regulatory innovation" at the National Assembly Members' Office Building in Yeouido, Seoul. ChosunBiz and the Council for the Advancement of the Gene-Editing Bioindustry co-organized the event.
Kim Jin-su, a professor at the KAIST Graduate School of Convergence Science and Technology who presented as a lead speaker, said, "Science and technology create new corporations, jobs, products, and services, contributing to economic development. In this way, science and technology are 'efforts for people's livelihoods,'" and added, "Gene editing technology is one of them."
Gene editing technology precisely modifies only specific genes in living cells "as if fixing a typo," and is considered safer and more versatile because it differs from conventional genetic modification (GMO), which inserts foreign genes in their entirety.
Gene editing is rapidly being applied across fields such as treating genetic diseases, improving crop productivity, and developing plants for biofuels, reshaping the global market. The United States and the European Union (EU) approved the gene-editing-based therapy "Casgevy" at the end of 2023, and Japan has excluded gene-edited tomatoes and pufferfish from GMO regulations and allows their sale.
Korea, by contrast, is in the opposite situation. Kim said, "Under the 'living modified organism (LMO)' law governing organisms whose genes are inserted, removed, or altered, GEOs are treated the same as GMOs, effectively banning their production, cultivation, sale, and export."
Kim pointed out, "GEOs that change only part of internal genes are hard to distinguish from natural mutations or traditional breeding, yet while traditional breeding that induces mutations with radiation or chemicals is not regulated, more precise gene editing is grouped as GMOs—this is like saying 'it's a problem if you know, but fine if you don't.'"
Kim added that rigid regulations are affecting research on the ground. Kim said, "While 'three-parent baby' technology to prevent the inheritance of mitochondrial genetic diseases and embryo gene editing research are advancing worldwide, Korea largely bans human embryo research under the Bioethics Act," and added, "We developed related technologies and even conducted animal testing, but clinical trials are blocked."
Professor Kim Jin-su said, "Gene editing technology is an innovative tool to solve problems facing Korean society, such as disease treatment, food security, and climate change," and added, "We need to overhaul the regulatory framework based on scientific verification and social consensus."
In the second presentation, Cha Jin, a Ph.D. with the Council for the Advancement of the Gene-Editing Bioindustry, drew on experience in establishing GMO safety assessment standards and said, "From the standpoint of evaluating GMOs, gene editing is entirely different from GMOs." Cha added that although Korea holds major patents related to gene editing, the inability to commercialize them is a "national loss."
Cha said, "Expert institutions around the world judge that the safety of GEO crops is on par with traditional breeding by crossing crops," and explained, "Accordingly, regulatory systems are moving to clearly separate them from GMOs."
In particular, major regulatory agencies, including the European Food Safety Authority (EFSA), have assessed that the types and frequencies of genetic changes seen in GEO plants are similar to, or even lower than, changes that occur naturally during traditional mutation breeding or breeding processes.
In line with this, countries around the world are codifying policies that distinguish GEOs from GMOs. Under the EU's new genomic techniques (NGT) rules, Category 1 GEOs are subject not to risk assessment but to verification of whether they fall under regulatory exemptions.
Cha said, "Some worry about 'off-target' cuts where gene editing hits unintended sites; while this can be an issue in human clinical settings, in plants and animals, problematic individuals are naturally removed during breeding," and added, "Since the LMO law was originally set not to apply to GEOs intended for human medicines, it is out of context to carry clinical concerns over to policy discussions on plant, animal, and microbial GEOs."
Cha warned, "Gene editing is different from GMOs and is as safe as traditional breeding—this scientific conclusion has been repeated by multiple international bodies," and added, "If Korea does not reflect this and handle GEOs under a separate, rational framework, it could become isolated internationally."
Cha added, "Europe uses the term NGT to distinguish from existing GMOs, and the United Kingdom uses the consumer-friendly expression 'precision breeding,' but Korea still sticks to the strong-sounding term living modified organism," and said, "This reduces understanding of the system and acceptance."
On the day, Representative Choi Su-jin said, "Gene editing has already established itself as the most important technology in medicine, agriculture, and the environment, but domestically it is difficult to develop as it is tied together with GMOs," and added, "We will work to simplify regulations on gene editing technology so the industry can be invigorated and significant benefits can return to the public."