Direct-to-consumer genetic test (DTC-GT) has been developing into an enormous market in China. Though no existing laws are directly applicable to DTC-GT, relevant laws and regulations are gradually being improved. In this study, we discuss how China's legislative and juridical practices in the field of DTC-GT have led to it being strictly constrained. The continuous improvement of relevant private and public laws is increasingly strengthening the informed consent and data protection issues that are involved with DTC-GT.
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References
1.
IhA, JsabC, MsA, et al.A review of the legislation of direct-to-consumer genetic testing in EU member states. Eur J Med Genet, 63(4):103841.
2.
LuoZ, ZaytsO, ShipmanH. ‘His story is truly vivid…’: The role of narratives of vicarious experience in commodification and marketisation of genetic testing in Chinese social media. J Pragmatics, 2020; 155:111–122.
3.
2018 China DTC-GT Market Research Report. Available from: https://www.iyiou.com/intelligence/report605.html [Last accessed: October12, 2022].
4.
https://www.askci.com. Forecasting of China's Direct-to-Consumer Genetic Testing Service Market Scale and Development Trends in 2021 [EB/OL]. Available from: https://baijiahao.baidu.com/s?id=1708871648887171724&wfr=spider&for=pc [Last accessed: December3, 2022].
5.
https://www.askci.com. Research Report on the Market Prospect and Investment Opportunities of China's Genetic Testing Industry. [EB/OL]. Available from: https://www.askci.com/news/chanye/20220614/0902091889296.shtml [Last accessed: December16, 2022].
6.
KangK, SunX, WangL, et al.Direct-to-consumer genetic testing in China and its role in GWAS discovery and replication. Quant Biol, 2020; 9(2):201–215.
7.
MengFY, GuoFZ, ZhangBY. Legal regulation of direct-to-consumer genetic testing. China Health Law, 2022; 30(1):5.
8.
GuanJ.Legal and ethical issues involved in the application of molecular genetics examination in the genomic era. Chin Med Ethics, 2018;(3).
9.
DuL, WangM. Genetic privacy and data protection: a review of chinese direct-to-consumer genetic test services. Front Genet, 2020; 11:416.
10.
HaKO. A Reporter Took DNA Tests in the U.S. and China. The Results Left Her Worried. FORTUNE. 2019. Available from: https://fortune.com/2019/11/30/dna-tests-us-china-results [Last accessed: November20, 2022].
11.
ChenYC, TaoSR, LiW, et al.After He Jiankui's case: Chinese legislative modifications in human embryo gene editing. Hum Gene Ther, 2022; 33(21-22):1121–1125.
12.
WangQ, DingXR, DuanJY, et al.A study of China's policies and regulations on ethical supervision of genetic testing—Based on the perspective of precision medicine. Stud Sci Sci, 2019; 37(4):577–581, 596.
13.
National Center for Clinical Laboratories. Clinical Testing Item Directory List and Retrieval for Medical Institutions. [EB/OL]. Available from: https://www.nccl.org.cn/showRuleDetail?code=07&id=21g.cn [Last accessed: December26, 2022].
14.
LiuTX, PuXL. License to practice required for genetic testing. Legal Daily 2021-8-25(007).
15.
LiW, ChenJJ. Institutional framework for the management of human genetic resources in China. Hum Gene Ther, 2021; 32(23–24):1495–1500.
