Human Embryo Gene Editing in China: The Uncertain Legal Status of the Embryo
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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.
KeywordsCRISPR Human embryo gene editing Legal status of human embryo Research regulation Morality China
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
- Adams, V., K. Erwin, and P. Le. 2010. Governing through blood biology, donation, and exchange in urban China. In Asian biotech: Ethics and communities of fate, eds. A. Ong, and N.N. Chen, 167–190.Google Scholar
- Beijing Times. 2015. More than 70% of 10,000 embryos left from IVF were discarded by their parents. 27 September. p. 8. (in Chinese) Google Scholar
- Biological Discovery Network. 2015. National Natural Science Foundation of China in 2015: 57 CRISPR Projects grasp gold. http://mt.sohu.com/20150824/n419588626.shtml. Accessed 21 January 2017. (in Chinese)
- Bosley, K.S., M. Botchan, A.L. Bredenoord, D. Carroll, R.A. Charo, E. Charpentier, R. Cohen, J. Corn, J. Doudna, G. Feng, and H.T. Greely. 2015. CRISPR germline engineering—the community speaks. Nature 33 (5): 478–486.Google Scholar
- Bound, K., T. Saunders, J. Wilsdon, and J. Adams. 2013. China’s absorptive state: research, innovation and the prospects for China-UK collaboration. Online Book. http://sro.sussex.ac.uk/47851/1/chinas_absorptive_state.pdf, accessed 21 January 2017.
- Commission of Legislative Affairs (CLA). 2010. The development and morality of human embryonic stem cell. The State Intellectual Property Office of P.R.C. http://www.sipo.gov.cn/mtjj/2006/200804/t20080401_362185.html. Accessed Online 21 January 2017.
- Cookson, C. 2005. Country report: China. Financial Times, 17 June: 1.Google Scholar
- Cong, Y. 2008. From Chinese values of life to exploring the ethical aspects of stem cell research in mainland China. Contemporary Chinese Thought 39 (2): 18–31.Google Scholar
- Francis Crick Institute. 2016. HFEA approval for new “gene editing” techniques. https://www.crick.ac.uk/news/science-news/2016/02/01/hfea-decision/.
- Greenhalgh, S., and E.A. Winckler. 2005. Governing China’s population: From Leninist to neoliberal biopolitics. Stanford, CA: Stanford University Press.Google Scholar
- He, X. 2016. Report of the National Bureau of Statistics: The national education level of the population increased significantly. 20 April, http://money.163.com/16/0420/15/BL3THR3K00253B0H.html. Accessed 21 January 2017. (in Chinese)
- Hu, C.L. 2009. Comments on the best practice in ethical governance of biological and biomedical research collaboration between Chinese and European scientists. Speech to final conference—Ethical governance of biological and biomedical research: Chinese-European Co-operation. London, 3 September.Google Scholar
- Jasanoff, S. 2005. Designs on nature: Science and democracy in Europe and the United States. Princeton, NJ: Princeton University Press.Google Scholar
- Jin, X., G. Wang, S. Liu, M. Liu, J. Zhang, and Y. Shi. 2013. Patients’ attitudes towards the surplus frozen embryos in China. BioMed Research International 7: 1–8.Google Scholar
- LaBarbera, A.R. 2016. Proceedings of the international summit on human gene editing: A global discussion—Washington, DC, December 1–3, 2015. Journal of Assisted Reproduction and Genetics 33(9): 1123–1127.Google Scholar
- Long, W. 2012. Illegal abortion: The crime of abortion in Republic of China and its practice. Modern Chinese History Studies 1: 92–104. (in Chinese) Google Scholar
- Mann, C.C. 2003. The first cloning superpower. Wired Com, 11 January, http://www.wired.com/wired/archive/11.01/cloning_pr.html. Accessed 20 January 2017.
- Mans, R., H.M. Rossum, M. Wijsman, A. Backx, N.G. Kuijpers, M. van den Broek, P. Daran-Lapujade, J.T. Pronk, A.J. van Maris, and J.M.G. Daran. 2015. CRISPR/Cas9: A molecular Swiss army knife for simultaneous introduction of multiple genetic modifications in Saccharomyces cerevisiae. FEMS Yeast Research 15(2): fov004.Google Scholar
- Mitzkat, A., E. Haimes, and C. Rehmann-Sutter. 2010. How reproductive and regenerative medicine meet in a Chinese fertility clinic. Interviews with women about the donation of embryos to stem cell research. Journal of Medical Ethics 36(12): 754–757.Google Scholar
- Nie, J.B. 2005. Behind the silence: Chinese voices on abortion. Lanham, MD: Rowman & Littlefield Publishers.Google Scholar
- Ong, A. 2010. An analytics of ethics and biotechnology at multiple scales. In Asian biotech: Ethics and communities of fate, eds. A. Ong, and N.N. Chen, 1–55.Google Scholar
- Pan, L.T. 2006. The 1st five-year plan (1953–1957). 5 April, http://www.gov.cn/english/2006-04/05/content_245703.htm. Accessed 21 January 2017.
- Qiu, R.Z. 2007. The historical, social and philosophical background of Chinese policies regarding human embryonic stem cell research. Paper presented at the BIONET workshop on bio-ethical governance of stem cell research, 10 October 2007 Shanghai, China.Google Scholar
- Rosemann, A., and H.Y. Luo. Attitudes on the donation of human embryos for stem cell research among Chinese IVF patients and students. Journal of Bioethical Inquiry (under review).Google Scholar
- Rosemann, A., L. Jiang, and X.Q. Zhang. The regulatory and legal situation of human embryo, gamete and germ line gene editing research and clinical applications in the People’s Republic of China. Commissioned Background Paper. Nuffield Council of Bioethics (accepted).Google Scholar
- Servick, K. 2017. First U.S. team to gene edit human embryos revealed. Science (July 27, 2017), https://doi.org/10.1126/science.aan7170.
- Shi, Y.C., S.B. Zhang, and X.L. Zhuang. 2014. Parents have the right to monitor and dispose the inherited frozen embryo. People’s Judicaure Application 22: 32–36. (in Chinese) Google Scholar
- Sleeboom-Faulkner, M. 2010. Boundary making and ‘good’ stem cell research (SCR) in mainland China: Including bioethics, excluding debate. East Asian Science, Technology and Society 4 (1): 31–51.Google Scholar
- Song, G.B. 1933. Medicine ethics. Beijing: Guoguang Press. (in Chinese) Google Scholar
- Standing Committee. 2008. Patent law of the People’s Republic of China (as amended up to the Decision of December 27, 2008, regarding the revision of the patent law of the People’s Republic of China) http://www.wipo.int/wipolex/en/text.jsp?file_id=178664. Accessed 21 January 2017.
- State Intellectual Property Office (SIPO). 2010. Guidelines on the examination of patents (promulgated by Order No. 55 of the State Intellectual Property Office (SIPO). http://www.wipo.int/wipolex/en/details.jsp%20?id=6511. Accessed 21 January 2017.
- State Intellectual Property Office (SIPO). 2013. The 5972 re-examination decision by the patent reexamination committee. http://app.sipo-reexam.gov.cn/reexam-out/searchdoc/decidedetail.jsp?jdh=FS5972&lx-fs. Accessed 21 January 2017. (in Chinese)
- Stein, R. 2016. Breaking Taboo, Swedish scientist seeks to edit DNA of healthy human embryos. SHOTS Health News, 22 September, http://www.npr.org/sections/health-shots/2016/09/22/494591738/breaking-taboo-swedish-scientist-seeks-to-edit-dna-of-healthy-human-embryos. Accessed 21 January2017.
- Sterckx, S. 2008. The WARF/stem cells case before the EPO enlarged board of appeal. European Intellectual Property Review 30 (12): 535–537.Google Scholar
- Sun, H.B. 1990. The History of Family Planning in China. Northern China Women & Children Publishing House.Google Scholar
- Sun, L.G. 2015. The legal resolution of frozen human embryo between the couple. Journal of National Prosecutors College 23(1): 110–120. (in Chinese) Google Scholar
- Tatlow, D. 2015. A scientific ethical divide between China and the West. New York Times, 30 June, http://www.nytimes.com/2015/06/30/science/a-scientific-ethical-divide-between-china-and-west.html. Accessed 5 September 2016.
- Thompson, C. 2010. Asian regeneration? Nationalism and internationalism in stem cell research in South Korea and Singapore. In Asian biotech: Ethics and communities of fate, eds. A. Ong, and N.N. Chen, 95–118.Google Scholar
- Tu, L. 2008. Exploration on ethical governance of donated oocytes and embryos for ES cell research. Paper presented at the BIONET Conference on ethical governance of reproductive technologies, therapeutic stem cells and stem cell banks, April 2008, Changsha, PRC.Google Scholar
- Vincent, J. 2015. Scientists in China edit human genome in embryos for the first time. The Verge, 23 April, http://www.theverge.com/2015/4/23/8477491/human-genome-editing-embryo-china-crispr. Accessed 5 September 2016.
- Wang, Y.W. 2006. Estimation on the effects of China’s birth control policy Chinese (in Chinese). Journal of Population Science 5: 23–32. (in Chinese) Google Scholar
- Wu, Z.M. 2013. The 5972 Re-examination decision by the patent reexamination committee-the preparation of pre-implantation embryos for therapeutic cloning use. http://www.bioipr.com/biopharma-ipr/1108/. Accessed 21 January 2017. (in Chinese)
- Yang, N. 2015. JinJia and Zhongshan University signed a technology development cooperation contract. http://www.cs.com.cn/ssgs/gsxw/201512/t20151230_4874293.html. Accessed 21 January 2017. (in Chinese)
- Yang, L.X. 2014. The legal status of frozen human embryo and its inheritance. People’s Judicature 13: 25–30. (in Chinese) Google Scholar
- Yang, L.X. 2015b. The conservatism and innovation of the judge. The Legal Science Journal 5: 1–10. (in Chinese) Google Scholar
- Zhang, Y. 2006. A study of the historical development of China’s population control and its trend. Journal of Guangzhou University (Social Science Edition) 5: 15–22. (in Chinese) Google Scholar
- Zhang, S.B., L. Fan, and X.L. Zhuang. 2014. The analysis of disposal and monitoring of frozen embryo. Journal of Law Application 11: 41–47. (in Chinese) Google Scholar
- Zhang, Q., and J. Sun. 2013. The legal analysis of forced abortion case. Journal of Nanjing College for Population Programme Management 29(3): 71–75. (in Chinese) Google Scholar
- Zhou, X. 2012. The right to life of human foetus and its criminal protection. Law Science Journal 8: 51–60. (in Chinese) Google Scholar