한국 DTC 유전자검사 규제의 추이와 특성

Abstract

This study aims to uncover the institutional roots of the recent increase in permissible items for DTC genetic testing in Korea. The shift from strict regulations on DTC institutions to a permissive approach began with the 2015 legal amendment, departing from the previous trend set by the National Bioethics Committee after the 2005 Bioethics and Biosafety Act. The research methodology involved a thorough examination of various sources, including annual reports from the National Bioethics Committee, parliamentary proceedings, Ministry of Health and Welfare press releases, and reports from the medical and DTC sectors. The findings indicate that the 2015 legal amendment was led by the Ministry of Health and Welfare, reflecting the demands of DTC institutions more than the medical community. Also, the amendment allowed testing in the ‘disease prevention’ area, traditionally seen as a medical procedure, and permitted testing for items prohibited by presidential decree. To address future challenges, a reassessment of the National Bioethics Committee's composition and role is necessary.