Human Embryo Gene Editing in China: The Uncertain Legal Status of the Embryo

Abstract

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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Notes

  1. 1.

    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.

  2. 2.

    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).

  3. 3.

    The reason for the big demand may lie in the lack of contraceptive measures at that time (Long 2012).

  4. 4.

    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).

  5. 5.

    “Later, longer, fewer” programme means later marriages, longer interval between births, fewer children (See Zhang 2006).

  6. 6.

    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).

  7. 7.

    http://www.chinadaily.com.cn/china/2012-06/15/content_15503761.htm.

  8. 8.

    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).

  9. 9.

    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.

  10. 10.

    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).

  11. 11.

    According to the seventh national population investigation, 12445 out of every 100,000 people had in 2016 an undergraduate degree (He 2016).

  12. 12.

    This case was discussed in greater detail in: Jiang (2016).

  13. 13.

    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).

  14. 14.

    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.

  15. 15.

    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.

  16. 16.

    This case was discussed in greater detail in Jiang (2016).

  17. 17.

    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).

References

  1. 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.

  2. Beijing Times. 2015. More than 70% of 10,000 embryos left from IVF were discarded by their parents. 27 September. p. 8. (in Chinese)

  3. 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)

  4. 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 

  5. 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.

  6. Callaway, E. 2016. Gene-editing research in human embryos gains momentum. Nature 532 (7599): 289–290.

    Article  Google Scholar 

  7. Cheng, L., R.Z. Qiu, H. Deng, Y.A. Zhang, Y. Jin, and L. Li. 2006. Ethics: China already has clear stem-cell guidelines. Nature 440 (7087): 992–992.

    Article  Google Scholar 

  8. 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.

  9. Cookson, C. 2005. Country report: China. Financial Times, 17 June: 1.

  10. 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 

  11. Cyranoski, D. 2015. What China’s latest five-year plan means for science. Nature 531 (7595): 424–424.

    Article  Google Scholar 

  12. Francis Crick Institute. 2016. HFEA approval for new “gene editing” techniques. https://www.crick.ac.uk/news/science-news/2016/02/01/hfea-decision/.

  13. Greenhalgh, S., and E.A. Winckler. 2005. Governing China’s population: From Leninist to neoliberal biopolitics. Stanford, CA: Stanford University Press.

    Google Scholar 

  14. 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)

  15. 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.

  16. Jasanoff, S. 2005. Designs on nature: Science and democracy in Europe and the United States. Princeton, NJ: Princeton University Press.

  17. Jiang, L. 2016. Regulating human embryonic stem cell in China—A comparative study on human embryonic stem cell’s patentability and morality in US and EU. German: Springer.

    Google Scholar 

  18. 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 

  19. 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.

  20. Lanphier, E., F. Umov, S.E. Haecker, M. Werner, and J. Smolenski. 2015. Don’t edit the human germ line. Nature 519 (7544): 410–411.

    Article  Google Scholar 

  21. Ledford, H. 2015. CRISPR, the disruptor. Nature 522 (7554): 20–24.

    Article  Google Scholar 

  22. Liang, P.P., Y.W. Xu, X.Y. Zhang, C.H. Ding, R. Huang, Z. Zhang, J. Lv, et al. 2015. CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes. Protein & Cell 6: 363–372.

    Article  Google Scholar 

  23. 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 

  24. 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.

  25. 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.

  26. Matthews, K.R., and M.L. Cuchiara. 2014. Gene patents, patenting life and the impact of court rulings on US stem cell patents and research. Regenerative Medicine 9 (2): 191–200.

    Article  Google Scholar 

  27. 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.

  28. Nie, J.B. 2005. Behind the silence: Chinese voices on abortion. Lanham, MD: Rowman & Littlefield Publishers.

    Google Scholar 

  29. 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.

  30. 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.

  31. 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.

  32. Raz, J. 1972. Legal principle and the limits of law. Yale Law Journal 81 (5): 823–842.

    Article  Google Scholar 

  33. 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).

  34. 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).

  35. Savulescu, J., J. Pugh, T. Douglas, and C. Gyngell. 2015. The moral imperative to continue gene editing research on human embryos. Protein & Cell 6 (7): 476–479.

    Article  Google Scholar 

  36. Servick, K. 2017. First U.S. team to gene edit human embryos revealed. Science (July 27, 2017), https://doi.org/10.1126/science.aan7170.

  37. 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 

  38. Sleeboom-Faulkner, M. 2014. Global morality and life science practices in Asia: Assemblages of life. London: Palgrave MacMillan.

    Google Scholar 

  39. 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 

  40. Song, G.B. 1933. Medicine ethics. Beijing: Guoguang Press. (in Chinese)

  41. 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.

  42. 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.

  43. 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)

  44. 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.

  45. 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 

  46. Sun, H.B. 1990. The History of Family Planning in China. Northern China Women & Children Publishing House.

  47. 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)

  48. 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.

  49. 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.

  50. 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.

  51. 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.

  52. Wahlberg, A. 2016. The birth and routinization of IVF in China. Reproductive Biomedicine & Society Online 2: 97–107.

    Article  Google Scholar 

  53. 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 

  54. 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)

  55. 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)

  56. Yang, L.X. 2014. The legal status of frozen human embryo and its inheritance. People’s Judicature 13: 25–30. (in Chinese)

    Google Scholar 

  57. Yang, L.X. 2015b. The conservatism and innovation of the judge. The Legal Science Journal 5: 1–10. (in Chinese)

    Google Scholar 

  58. Zhai, X.M., V. Ng, and R. Lie. 2016. No ethical divide between China and the West in human embryo research. Developing World Bioethics 16(2): 116–120.

    Article  Google Scholar 

  59. 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 

  60. Zhang, X. 2015. Urgency to rein in the gene-editing technology. Protein & Cell 6 (5): 313–313.

    Article  Google Scholar 

  61. 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 

  62. 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)

  63. Zhou, X. 2012. The right to life of human foetus and its criminal protection. Law Science Journal 8: 51–60. (in Chinese)

    Google Scholar 

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Acknowledgements

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

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Keywords

  • CRISPR
  • Human embryo gene editing
  • Legal status of human embryo
  • Research regulation
  • Morality
  • China