기술발전에 대응한 DTC 유전자검사 법제의 개선방향

Improvement of DTC Genetic Testing Legislation in response to technological development

Lower costs of genetic testing, social interest and high added value for genes, and increased awareness of right to informational self-determination are driving DTC genetic testing. However, the problems inherent in the genetic test, such as difficulty in interpretation and risk of leakage of results, and the additional problems of the DTC genetic testing such as expanding the items to be tested, the securing of procedural safety, and the protection of personal information in commercial use need to be considered. Korea permits DTC genetic testing centered on wellness and is attempting to expand testing items to certification pilot projects and regulatory sandboxes. Global bans don t match the trends of the times, and countries that allow them entirely recognize the need for some level of regulation. In this situation, we need to pay attention to the case of the US, which is gradually expanding the items of the DTC genetic testing based on scientific evidence. Based on these discussions, this paper derives a direction to improve the legislation on DTC genetic testing. Efforts should be made to escalate the test items on a scientific basis, to supplement the genetic counseling process, and to minimize regulatory differences between countries. In order to guarantee the right to informational self-determination, individuals should be given the right to manage their own genetic information. The state needs to focus on establishing a system for the protection of sensitive personal information, the genetic information, and for the correct interpretation of test results. When the legislation is complete and the general citizens awareness of genetic testing improves, DTC genetic testing can be used universally as a means of healthy living.