Bill proposes establishment of ‘National Gene and Cell Therapy Center’

A bill has been proposed to establish the National Gene and Cell Therapy Center, which would support gene therapy research and clinical trials, as well as train specialized personnel in the field.

Rep. Choi Soo-jin of the People Power Party, a member of the National Assembly's Science, ICT, Broadcasting, and Communications Committee, sponsored the bill titled the “Amendment to the Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals (Advanced Regenerative Bio Act),” which contains these provisions.

The amendment mandates the establishment of the National Gene and Cell Therapy Center to support advanced regenerative medical institutions responsible for gene therapy, clinical trials of gene therapy products, and the manufacturing and quality control of these therapies.

The development of gene and cell therapies is a core next-generation bio-health field, essential for patient treatment and securing national competitiveness. However, there is currently no legal basis for establishing such a center.

Gene therapy, in particular, is a technique used to treat genetic diseases inherited from parents. Its scope of application is gradually expanding, now including acquired diseases like cancer.

Genetic disorders account for over 80 percent of the approximately 7,000 rare diseases estimated by the World Health Organization (WHO). Korea also designates and manages about 2,400 rare diseases, with an estimated 500,000 registered patients as of 2023. Many of these are known to be associated with congenital genetic defects.

For example, leukemia, a type of blood cancer, sees approximately 4,000 new patients annually in Korea. Among pediatric cancers, the most common type is acute lymphoblastic leukemia (ALL), accounting for about 30 percent of all childhood cancers.

In pediatric cancer, approximately 1,200 to 1,500 new cases occur annually in Korea, with a significant portion linked to chromosomal abnormalities and genetic mutations. Additionally, numerous rare diseases caused by genetic mutations, such as spinal muscular atrophy (SMA), muscular dystrophy, and Huntington's disease, are being identified.

“Establishing the National Gene and Cell Therapy Center is essential to increase the potential for treating intractable diseases and foster the gene therapy industry, a future high-value-added sector,” Rep. Choi said. “Given that gene and cell therapies represent the only fundamental solution for difficult-to-treat diseases, national-level research support is urgently needed.”