The Study Of Gene Therapy’s Legalization

21st century is the biotechnology century.With the development of genetechnology, human ability to intervene gene becomes stronger and stronger.So as tocure disease, gene therapy, as one of the modern gene technologies, will putexogenous genes into the body to adjust and replace the defective ones. While genetherapy brings hope to patients, it also raises problems about society, ethic and law.This needs urgent law intervene. Currently, there are few rules and laws closelyrelated to human gene technology in China, such as ‘genetic engineering safetymanagement approach’,‘involving human biomedical research ethics reviewapproach (Trial)’,‘human gene therapy research and quality control of the preparationtechnology of guiding principles’ and ‘human somatic cell therapy and gene therapyclinical research quality control points’. These norms were established early, at thesame time, they have set rules to technology standards, operation specification andethic review. But there are no rules about the law issues related to gene therapy,suchas, how to protect the right to know gene, patent gene and keep private ofgene.Combining with the characters of gene technology, this essay discusses thenecessity to protect the right to know gene, patent gene and keep private of gene byreferencing to the practice of the legalization of gene technology in foreign countriesin order to structure our own ‘gene therapy approach’. Therefore, the writer willdiscuss this topic from four sides. The first part, we will discuss the general situation of gene therapy, starting fromthe discovery of gene, and then the relationship between diseases and gene proclaim,and also the produce and development of gene therapy. This part emphasizes the legalnature of gene, whether gene is the right of personality or the right of fortune. Thewriter thinks human gene is the combination of the right of personality and the rightof fortune.The second part, we will analysis of the control patterns of gene therapy inAmerica, Austria and Germany and our references from theirs. American mode is toput gene therapy into the system of medical laws. Austrian mode is to set up speciallaw for gene therapy. German mode is also to set up special laws like Austria, but theydo not have rules about gene therapy in their ‘gene technology approach’, while theyput it into medical laws. Up to now, there are no specific legalizations aiming at genetherapy in China, but we can borrow the experience of these countries’ rules andmanagements of gene therapy.The third part, we will put up the necessity to build the ‘gene therapy approach’by the analysis of our current rules and laws of gene therapy. This part will mainlydescribe the legalization pattern, basic principle, basic structure and main contents of‘gene therapy’ in our country. Meanwhile, we will not only focus on the regulatoryorganization, control procedures and legal responsibilities, but also the protection ofright to know gene, patent gene and keep private of gene during the gene therapy process.The fourth part, we will summarize what we should pay attention to during ourlegalization of gene therapy. We should base on the national condition, proceed fromthe reality and never borrow experience of foreign countries without thinking. Onlyby doing so can we perfect the legal system of gene therapy of our country step bystep, so that we can promote the development of gene therapy technology in ourcountry.