In this article, we examine processes of ethical deliberation, legislative developments, and social and political factors that have contributed to the emergence of human embryo gene editing as a field of life science research in China. For this purpose, we examine conceptions of the legal status of the human embryo in three domains of China’s legal system: in patent law, in the jurisdictional domain of birth control, and in civil law. Each of these legal domains handles a different conception of the human embryo’s moral and legal status, and in all three the embryo’s status is contested and subject to changes. Our findings suggest that definitions of the legal status of the human embryo in China are at present in the midst of a renegotiation progress, which is driven by a variety of developments and causes. In this paper, we focus on three types of controversies that underlie this renegotiation process and we illustrate the conflicting aspirations, ethical arguments, and moral priorities that inform these conflicts. We end this article with three lines of consideration that might structure future studies on this issue.
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Tripronuclear (3PN) zygotes result from fertilization of two sperms and one egg. Since tripronuclear zygotes lose the ability to reproduce as it contains 3 sets of chromosomes, Liang et al. (2015) argued that the use of these zygotes for research purposes is permissible from an ethical perspective.
It is relevant to point out in this regard that the Chinese Health and Family Planning Commission (which is the former Ministry of Health) and the China Food and Drug Administration have in 2009, 2012, and 2015 also introduced guidelines for stem cell therapies. In theory, these regulatory instruments also affect the clinical use of genetically modified embryos or gametes, at least at a later point in time, provided clinical use of modified embryos will ever be approved. (See in this regard: Rosemann et al. accepted).
The reason for the big demand may lie in the lack of contraceptive measures at that time (Long 2012).
The First Five Year Plan was drafted under the direction of the Central Committee of the Communist Party of China, and aimed to concentrate efforts on the construction of 694 large and medium-sized industrial projects to develop agricultural producers’ cooperatives to help in the socialist transformation of the agriculture and handicraft industries and to put capitalist industry and commerce on the track of state capitalism (Pan 2006).
“Later, longer, fewer” programme means later marriages, longer interval between births, fewer children (See Zhang 2006).
Professor Wang Jinying’s research indicated that between 1972 and 2006 between 264 and 320 million births were prevented as a result of the birth control policy (Wang 2006).
Primate Embryonic Stem Cell, U. S. Patent No. 5,843,780 (filed 18 Jan 1996)(issued 1 Dec 1998); Primate Embryonic Stem Cell, U.S. Patent No. 6, 200,806 (filed 26 Jan 1998)(issued 13 Mar 2001); Primate Embryonic Stem Cell, U.S. Patent No. 7, 029,913 (filed 18 Oct 2001)(issued 18 Apr 2006).
The application is involved with the destruction of human embryo, which is contrary to the article 53(a) – European patents shall not be granted in respect of inventions the commercial exploitation of which would be contrary to interest public or morality, see G-02/06 of the Enlarged Board of Appeal of the European Patent Office.
Part II of Chapter 1 of the Guidelines on the Examination of Patents by the State Intellectual Property Office of China further explained that “the connotation of the laws, administrative regulations, social morality and public interest is quite broad, which may vary with time and from region to region. Sometimes certain restrictions may be added or removed because of enactment and implementation of a new law or administrative regulation or amendment to or abolishment of a preceding law or administrative regulation. Therefore, the examiner shall pay special attention to this point in conducting examination according to Article 5” (SIPO 2010).
According to the seventh national population investigation, 12445 out of every 100,000 people had in 2016 an undergraduate degree (He 2016).
This case was discussed in greater detail in: Jiang (2016).
The argument includes first that, although the embryo includes human genetic information, it is a human-animal hybrid, not a human embryo. Thus, the invention is not related to the industrial or commercial use of a human embryo. Second, the embryo created by this method has no possibility of becoming human because claims 1–10 of the application contain no human-cloning steps. Third, the invention represents one aspect of human organ transplantation technology. Therefore, the invention is properly classified as therapeutic cloning. Neither its aim nor its method involves human cloning. In conclusion, the invention is not against the law, social morality, or the public interest (Wu 2013).
See the FS14444 re-examination decision by the patent reexamination committee (In Chinese). http://app.sipo-reexam.gov.cn/reexam_out1110/searchdoc/decidedetail.jsp?jdh=FS14444&lx=fs, accessed 23 January 2017.
See the FS24343 re-examination decision by the patent reexamination committee (In Chinese). http://app.sipo-reexam.gov.cn/reexam_out1110/searchdoc/decidedetail.jsp?jdh=FS24343&lx=fs, accessed 23 January 2017.
This case was discussed in greater detail in Jiang (2016).
This distinction of the court was based on the work of the legal scholar Yang Lixin, who divided things into three groups: (1) the ethical thing, (2) the special thing, and (3) property, in which the ethical thing is worth of the highest moral standard (Yang 2014).
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The work of the first author has been funded by the Jiangsu Philosophy and Social Science Foundation (17ZXC003), the Ministry of Justice of People’s Republic of China (17SFB3028), and the project “the alienation of biotechnology patent” approved by Philosophy and Social Science Research Fund of Colleges and Universities in Jiang Su Province (2017SJB1330). The work of the second author has benefitted from research support provided by the ERC (283219), the ESRC (ES/I018107/1), and the Wellcome Trust (204799/Z/16/Z). We would also like to thank the editorial team of BioSocieties and the three anonymous reviewers of this paper for their constructive and very helpful comments. We confirm that the manuscript is composed of original material that is not under review elsewhere, and that the study on which the research is based has been subject to appropriate ethical review. We confirm that there are no competing interests—intellectual or financial—in the research detailed in the manuscript
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Jiang, L., Rosemann, A. Human Embryo Gene Editing in China: The Uncertain Legal Status of the Embryo. BioSocieties 14, 46–66 (2019). https://doi.org/10.1057/s41292-018-0116-1
- Human embryo gene editing
- Legal status of human embryo
- Research regulation