China's Biotech Regulatory Transition: Responding to the CRISPR Backlash
Biophysicist He Jiankui's revelation of the Clustered Regularly Interspaced Short Palindromic Repeats (“CRISPR”) babies triggered international uproar and led to the subsequent reform of Chinese law.[1] Prior to this, Chinese law was ill-equipped to address advances in biotechnology, particularly in the field of human genome editing.[2] The existing laws were overly specialized, primarily addressing niche fields, and were largely ineffective in addressing the relevant issues; most biosafety regulations in the country were infrequently enforced, managed by lower-tier agencies as a temporary measure, and there was a notable absence of a dedicated professional agency to guide the establishment and operation of a bio-risk assessment system.[3]
Before 2018, China had established a three-tier ethics governance system for overseeing biomedical research involving human subjects: (1) the National Medical Ethics Expert Committee researched major bioethical issues and offered policy guidance to provincial medical ethics expert committees; (2) provincial medical ethics expert committees standardized the ethics review procedures for biomedical research in their regions; and (3) local health administrative departments, at or above the county level, were responsible for overseeing and administering the ethics review of such research within their jurisdictions.[4] While this system was in place, China implemented several regulations that prohibited the use of genome modification in human embryos for reproductive intentions.[5]
Following the revelation of the CRISPR babies in 2018, the National People’s Congress, China's top legislative body, along with the Ministry of Science and Technology (“MoST”) and the National Health Commission (“NHC”), initiated a comprehensive regulatory overhaul regarding human genome editing..[6] In October 2019, China established the National Science and Technology Ethics Committee (“NSTEC”).[7] That year, the NHC released a draft regulation on new biomedical technologies for public feedback.[8] The proposed regulation mandated obtaining government approval before conducting any clinical research or application involving new biomedical technologies, including gene editing.[9] It further stipulated that new biomedical technologies be categorized as low, medium, or high risk.[10] Gene editing, which alters genetic material expression, was designated as high risk and directly overseen by the NHC — exclusively at the national level.[11]
In May 2020, China launched the Chinese Civil Code (“CCC”), outlining regulations for research on human genes and embryos.[12] Under the CCC, such research must adhere to state laws and regulations, safeguard human health, uphold moral principles, and protect public interests.[13] Importantly, those who failed to meet these standards could face civil liability under the CCC.[14] In addition to civil liability under the CCC, China enacted the Criminal Law Amendment XI, explicitly prohibiting human cloning and human germline genome editing for clinical purposes.[15] This criminalization underscores China's commitment to ethical considerations and preventing unauthorized genetic interventions. Furthermore, in 2020, the introduction of the China Biosecurity Law (“CBL”) reflected a heightened emphasis on ethical standards in biotechnological research.[16] The CBL not only addresses ethical concerns but also advocates for increased biosecurity awareness among professionals and students in relevant fields.[17] These legal developments signify China's recognition of the importance of balancing technological advancement with ethical and security considerations in the realm of biotechnology.
These comprehensive legal reforms represent a pivotal stride in aligning China with international ethical standards and tackling the challenges posed by groundbreaking biotechnological advancements. China's commitment is evident through the incorporation of civil liability under the CCC and the criminal prohibition outlined in Amendment XI, reinforcing accountability for unethical practices.[18] Additionally, the CBL introduces an additional layer of protection, emphasizing ethical standards and promoting awareness of biosecurity measures.[19] As the global community grapples with the ethical implications of biotechnological progress, China's legal responses actively contribute to the ongoing international dialogue on responsible innovation in the field. While the recent reforms bring China closer to Western standards, mitigating the perceived disparity between the East and the West, questions persist regarding the thorough enforcement and efficacy of these changes.[20]
Vivikth Vemula is a staff member of Fordham International Law Journal Volume XLVII.
[1] Liang Huigang et al., History of and Suggestions for China’s Biosafety Legislation, 1 J. of Biosafety and Biosecurity 134, 134-39 (2019).
[2] Id.
[3] Id.
[4] See Jing-ru Li et al., Experiments that led to the first gene-edited babies: the ethical failings and the urgent need for better governance, 20 Journal of Zhejiang University-Science B 32, 32-38 (2019).
[5] Id.; See also Henry T. Greely, CRISPR’d Babies: Human Germline Genome Editing in the ‘He Jiankui Affair’, 6 Journal of Law and the Biosciences 111, 111-83 (2019).
[6] Lingqiao Song & Yann Joly, After He Jianku: China's Biotechnology Regulation Reforms, 21 Medical Law International 174, 174-92 (2021).
[7] Yaojin Peng et al., Responsible Governance of Human Germline Genome Editing in China, 107 Biology of Reproduction 261, 261-68 (2022).
[8] Id.
[9] Id.
[10] Id.
[11] Id.
[12] Id.
[13] Id.
[14] Id.
[15] Id.; See also supra note 6, at 174.
[16] Id.
[17] Id.
[18] See supra note 7; See also supra note 6, at 174.
[19] See supra note 7
[20] Qingxiu Bu, Reassess the Law and Ethics of Heritable Genome Editing Interventions: Lessons for China and the World, 34 Issues in Law and Medicine 115, 133 (2019).
This is a student blog post and in no way represents the views of the Fordham International Law Journal.