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KMID : 1234820180190030081
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Korean Society of Law and Medicine
2018 Volume.19 No. 3 p.81 ~ p.120
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Understanding Legal Structure of Direct-to-Consumer Gene Testing
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Kim Na-Kyoung
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Abstract
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DTC(Direct-to-Consumer) gene testing is a gene testing that is sold and provided directly to consumers. With the revision of Bioethics and Safety Act in 2016, a gene testing agency which is not a medical institution, has been able to directly carry out gene testings on items allowed by the Minister of Health and Welfare. Agencies conducting gene testing are currently promoting and selling not only through the internet, but also through pharmacies, cosmetics companies, insurance companies, and medical institutions. However, the regulation of the current law on DTC-gene testing is not yet fully concretized and systematized. Given the nature of gene testing, it is important that gene testing should ensure that the analysis is of a certain level of scientific accuracy, and that the interpretation of the test results is reasonable and that the subject should be possible to have a reasonable reflection on his/her own identity in the process of the interpretaion. However, there always exists a risk in DTC-gene testing that the validity of the test may be distorted by the inherent properties of the DTC genetic test. In DTC-gene testing, the for-profit nature of gene testing is reinforced through 'direct' sales of tests, which creates the risk of distorting the legitimacy structure of gene testing. These risks are already becoming reality, causing the internal incoherence and the logical limitations of the interpretation of the current legal system of DTC-gene testing. In order to overcome this problem, we first need to examine the nature of the test according to the test items in the DTC gene testing, which is especially for comprehensive health care, and based on this, to establish reasonable standards for the scope and method of testing. In order to secure the scientific validity of the testing, more specialized personnel are required to carry out and manage the testing process, and furthermore, it is need to establish a device which can guarantee the minimum scientific trust for the criteria of selection of testing, which may be differentiated by the testing items. In addition, in case the scientific criteria for the selection of testing are weakened, it would be desirable to burden a greater obligation on the inspection body concerning the consumer's understanding of such uncertainties.In particular, since DTC-gene testing lacks face-to-face communication, there is a need to build diverse counseling or other assistance systems that help consumers reflect on the meaning of gene testing in a multifaceted way without being biased toward commercial and commercial interest.
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KEYWORD
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DTC-gene testing, Gene Testing, Genetic Analysis, Bioethics and Safety Act, Genetic Counselling
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FullTexts / Linksout information
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Listed journal information
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