Legislated Statute for Cord Blood Banks in Korea

초록

In Korea, the cord blood stem cell transplantation (CBSCT) and cord blood (CB) banking projects was introduced since 1996 and 1997, respectively. We, in Korea, performed about 200 cases of CBSCT until May, 2005 and banked about 80,000 units of CB for public purposes, 170,000 units for private purposes. However, until yet we do not have had any national guideline nor regulations for CB banking to qualify the CB banks and assess the quality of stored CBs. We organized the Cord Blood Committee in the Korean Society of Hematopoietic Stem Cell Transplantation at March, 2002. Based on the political research reports of our committee, the Ministry of Health and Welfare officially noticed the national guideline for CB banking on August, 2005. Also, the legislation was just drafted in the National Assembly by about 30 members of National Assembly. The essentials of the legislation drafted in this year are as follows: The purchase and sale of CB is prohibited (Article 3). The Cord Blood Committee is consisted in the Ministry of Health and Welfare to review the overall items regarding quality control as well as safety of CB. (Article 4). The CB bank associates should get permission to establish CB banks from an Administrator of the Ministry of Health and Welfare (Article 5). The Administrator of the Ministry of Health and Welfare could establish or assign public CB banks to manage donated CBs (Article 6). The Public Cord Blood Data Center should be established to manage the informations regarding donated CBs, and to coordinate and supply CBs (Article 7). Mother, spouse or legal deputy should assign to permit CB collection and could abandon their consent at any time before collection (Article 8). The CB banks should adhere to the guidelines from the Ministry of Health and Welfare and provide donated cord bloods to the transplantation centers with nonprofit program (Article 11). The CB bank associates should keep the documents regarding CB banking until 10 years after releasing cryopreserved CB (Article 15, 16). The government could provide budgets for public CB banking and networking projects, even the CB banks could claim the appropriate banking fees for private CBs (Article 27). Based on this statute, we could establish the National Public Cord Blood Banks as well as Networking System to supply the qualified CBs for domestic as well as foreign patients.