Germline gene editing research is allowed, but establishing a pregnancy with a genetically engineered embryo is prohibited under multiple regulations. Gene editing requires approval by an ethics committee of a hospital or IVF clinic, but approval from national regulatory agencies is not required. Research ethics committees are responsible for ensuring compliance by performing ethical review of their institutions’ biomedical research activities involving human research participants. However, there is uncertainty about whether these regulations are subject to the force of law and penalties and enforcement mechanisms are unclear.
In 2015, Chinese researchers were the first to edit human embryos using CRISPR, which some researchers thought was premature, and in 2017 Chinese researchers were first to use CRISPR to edit viable human embryos. In 2018, a Chinese scientist altered the DNA of human embryos that were carried to term. The announcement sparked an international controversy, and as a result, the Chinese government says it will impose stricter human gene editing regulations.
In November 2018, scientist He Jiankui, who was then employed by the Southern University of Science and Technology in Shenzhen, China, used CRISPR-Cas9 to successfully edit the embryos of twin girls that were carried to term, in an effort to make them resistant to HIV. The Chinese government has since renounced the experiments, as did 122 Chinese scientists, and He is expected to face criminal charges for forged documents. China’s vice-minister of science and technology claimed he “blatantly violated China’s relevant laws and regulations”.
In 2019, a new draft of civil code was submitted to the National People’s Congress Standing Committee, which, if approved, would bring medical and scientific germline research into civil legislation. The draft states that human clinical research, including gene editing, must get approval from China’s Ministry of Health (instead of only requiring approval from a hospital’s ethics committee). In addition, scientific and medical studies pertaining to human genes or embryos must “follow the relevant regulations and cannot harm people’s health, breach moral or ethical standards, or violate public interests”. The draft mentions fines and blacklists, but enforcement mechanisms are unclear. The civil code is expected to be adopted in March 2020.
Medical research is regulated by the National Health and Family Planning Commission (NHFPC), formerly known as the Ministry of Health and the National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA). NMPA is the regulatory authority responsible for clinical trial oversight, approval, and inspections for drugs to be registered in China. However, national agencies tend only to give general guidance that is then interpreted by local organizations and committees, instead of developing and enforcing strict laws and regulations. Two regulations (that have the legal status of ministerial guidelines, not laws) issued by the Ministry of Health in 2003, prohibit the manipulation of human embryos for reproduction. A regulation issued the same year by both the Ministry of Health and the Ministry of Science and Technology states that embryos created through genetic modification must be destroyed after 14 days of development and must not be implanted into the reproductive system of a human or any other animal. It is also prohibited to create IVF embryos for research only. IVF clinics and Assisted Reproductive Technology centers can lose their license if they violate these guidelines.
Products/Research
- HIV: In 2018, He Jiankui, a Chinese scientist, received international condemnation after announcing that he had edited the germline of multiple embryos, two of which were carried to term, in an attempt to make the embryos resistant to HIV, the disease that causes AIDS. His actions spurred an international call in 2019 for a global moratorium on all clinical uses of germline editing.
- Marfan Syndrome: Chinese scientists published research detailing use of CRISPR to correct a single mutant amino acid in 16 out of 18 attempts in human embryos, providing evidence for the corrective value of gene therapy for the FBN1 mutation that causes Marfan syndrome in both somatic (adult) and germline cells.
Regulatory Timeline
2020: Expected date of adoption of new civil code in China, which includes personal protections for human genes and stricter regulations for human gene editing.
2019: New civil code draft submitted that states studies involving human genes and embryos must follow the relevant regulations and cannot harm people’s health, breach moral or ethical standards or violate public interests.
2019: He Jiankui, who altered the DNA of human embryos that were carried to term, is censured by the Guangdong health ministry and fired from Southern University of Science and Technology.
2018: China’s National Health Commission orders an investigation into the work of He Jiankui.
2018: Chinese government orders temporary halt to human gene editing research in response to He Jiankui editing embryos that were carried to term.
2018: He Jiankui offers details about his work using CRISPR to edit human embryos at a gene-editing summit in Hong Kong and is roundly criticized.
2017: China first to use CRISPR on viable human embryos.
2016: National Health and Family Planning Commission issues Measures for the Ethical Review of Biomedical Research Involving Humans, which clarify the responsibilities of medical ethics committees and specify the basic scope of informed consent.
2015: Chinese researchers first to edit genes using CRISPR in a human embryo. A gene associated with a fatal blood disorder was modified, but the embryos were not implanted. The editing was not successful in most embryos in the experiment.
2008: Medical Ethics Expert Committee in the Ministry of Health created and Guidelines for Hospital Management Evaluation released.
2007: Ministry of Health releases Measures for the Ethical Review of Biomedical Research Involving Humans (For Trial Implementation).
2003: China’s science ministry bans the implantation of genetically modified embryos for reproductive purposes and prohibits altered embryos developing past 14 days. No punishments are attached to the regulation.
2003: State Food and Drug Administration (SFDA) issues the revised Norms on Quality Management of Drug Clinical Trials, requiring all medical institutions conducting clinical trials to be certified and establishing independent research ethics committees filed with the SFDA to “safeguard the rights and interests of all applicants for participation and participants in clinical trials”.
2003: Ministry of Health and the Ministry of Science and Technology jointly develop the Ethical Principles of Research of Human Embryonic Stem Cells, which state that embryos derived by genetic modification must not be allowed to develop for more than fourteen days and that once they have been used for research, they cannot be implanted into humans or other species.
2001: Ministry of Health releases the Administrative Measures for Assisted Human Reproduction.
1999: SFDA issues the Norms on Quality Management of Drug Clinical Trials.
1997: Minister of Health orders establishment of research ethics committees at medical research institutions.
1988: Chinese Society of Medical Ethics of the Chinese Medical Association founded.
NGO Reaction
He Jiankui’s alteration of the DNA of human embryos that were carried to term has drawn international condemnation from scientists, researchers and organizations. Some scientists argue that germline gene editing is not only an unethical practice, but a potentially dangerous one that could lead to irreversible harm and a new era of eugenics.
Additional Resources
- Genetic Literacy Project’s FAQ on gene editing
- Library of Congress summary of China gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
- NIH ClinRegs: Aggregating clinical research regulations, China
- The Chinese Ethical Review System and its Compliance Mechanisms
- Heritable Genome Editing and the Downsides of a Global Moratorium
