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The rise of genomic technology in the 21st century has enabled individuals to have new insights into their unique makeup, and this raises questions with respect to the principles of ownership and subjectivity from a different perspective. In the rapidly growing use of direct-to-consumer (DTC) genetic testing, for instance, the individuals can demand the genetic information of their own as “consumer subjects.” DTC genetic service companies, such as 23andMe, take a customer’s genetic information and resell it to companies. Being able to generate substantial economic value in and of itself, the genetic information can be commodified. This development leads to the economic and conceptual separation of genetic information from human biological materials, such as cells and tissues, the situation that has posed different kind of contentious issues concerning the individual’s ownership and control over themselves than HeLa Cell raised in the previous century.
This paper explores the role of institutional structures (legal and governmental) in legitimizing the new perspective of de-materialization and assetization in line with the advancement of genomic technology. To this end, this paper examines the laws and regulations implemented in Korea relating to genomic innovation, such as the Biotechnology Support Act, the Bioethics and Safety Act and regulations on DTC genetic testing, in comparison with relevant US laws and cases, including the Greenberg case, and the FDA regulations on DTC genetics. The analysis of cases and relevant legislation, based on the notion of co-production, will offer a window to look into the mutually constitutive interaction between science and law regarding value creation in biomedicine.