The Legal Regulation Of DTC Genetic Testing

DTC gene testing service has been accompanied by a lot of controversy since its inception,but this has not affected the pace of development of the DTC gene testing industry.Today,China’s gene testing company has reached more than 200,and the number is still rising.Faced with such a rapid development of the DTC gene detection industry,China’s special legislation for it has been in a state of absence,and an effective regulatory system has not yet been formed.Against this background,there are still some sharp problems in the current DTC gene testing industry,such as the dispute over the actual value of products,the over-marketing to mislead consumers,and the lack of uniform standards in the industry.At the same time,genetic testing as a science and technology is a double-edged sword,which brings benefits but also risks.In the absence of relevant legal regulations,human rights issues such as the right to know and the right not to know,the right to gene self-determination,and the right to privacy may arise,and social phenomena such as gene discrimination may easily occur.However,we cannot completely deny the rationality of the existence of DTC because of the industry chaos in the development of the industry itself and the human rights issues faced by the subject in the test at the present stage.DTC gene detection includes detection items for disease risk prediction.After receiving the risk indication,the subjects can reduce the probability of disease by adjusting living habits and psychological state,which means that the early risk indication for certain specific diseases is very meaningful.In general,clinical gene detection applications mostly belong to diagnostic gene detection that can accurately calculate the detection rate,while risk predictive gene detection is not applied to clinical practice due to its low clinical significance.Therefore,the value of DTC gene detection lies in that it makes an important supplement on project types for clinical detection application in health,and meets the diversified demands of people who wish to pursue health by using their own gene information.In order to promote the healthy development of the DTC gene detection industry and allow the subjects to enjoy the health dividends brought by the technical development,and at the same time avoid the problems of human rights,the government is necessary to regulate the industry.In order to achieve the goal of reasonable and moderate regulation of the DTC gene detection industry,we must conduct a comprehensive investigation on the legal regulation of DTC gene detection from the perspective of comparative law,It is found that the legislative regulation of DTC gene detection in various countries and regions nowadays mainly focuses on the pre-marketing audit of DTC gene detection project,gene data security and detection procedure specification.However,there still exist such problems as scattered legal provisions,low legal effect level and lagging legal content in the legislation of these three aspects in China.In order to solve these problems,we must combine the ideological essence of extraterritorial legal regulation with the valuable experience in the practice of legal regulation in our country to find a legal regulation way suitable for DTC gene detection in our country.In order to complete the improvement and construction of DTC legal regulation system in China,first of all,in the overall idea of regulation,it should be clear that it is appropriate to adopt the overall regulation mode with administrative supervision as the leading factor and industry self-discipline as the supplement at this stage,and the introduction of special genetic testing legislation is the future development direction.As far as the specific countermeasures are concerned,we should focus on the regulation and supervision of regulatory authorities,industry access conditions,relevant standards of industry testing procedures,and genetic data monitoring.At the same time,we should actively guide the industry to form some common recognized basic principles and give full play to the important complementary role of industry self-discipline in the regulatory system.