"Gene-edited baby" case: scientific research under the guise of illegal practice of medicine

Xinhua News Agency, Shenzhen, December 30, issue: scientific research under the guise of illegal practice of medicine, the fact that profit and interest driven malicious evasion of supervision - focus on the "gene editing baby" case
Xinhua News Agency "Xinhua Viewpoint" reporter Wang Pan, Xiao Si, Zhou Ying
He Jiankui was sentenced to three years' imprisonment and a fine of 3 million yuan; Zhang Renli was sentenced to two years' imprisonment and a fine of one million yuan; and Yan Jinzhou was sentenced to one year and six months' imprisonment, suspended for two years, and a fine of 500,000 yuan.
he Jiankui and others in the guise of scientific research and innovation, illegal practice of medicine? What sanctions are they subject to for malicious evasion of regulation? What are the cautionary implications of a case between encouraging scientific innovation and legal supervision? Xinhua news agency reporters listened to the verdict and interviewed legal experts and medical, scientific and technological experts on these issues.26, 2018, He Jiankui, a former associate professor at Southern University of Science and Technology, announced the birth of a pair of gene-edited babies. The incident caused widespread shock and strong condemnation in China's medical and scientific research community. Guangdong Province immediately set up a "gene editing baby incident" investigation team to investigate.
July 31, 2019, the Nanshan People's Procuratorate of Shenzhen city filed a lawsuit with the Nanshan People's Court. In view of the privacy involved in the case, on 27 December, the Nanshan District Court heard the case in private in accordance with the law.
has been engaged in human genetic sequencing research for many years and is the legal representative or investor of several biotechnology enterprises. Prosecutors allege that since 2016, He Jiankui learned that human embryo gene editing technology can obtain commercial benefits, that is, with a medical institution in Guangdong Province Zhang Renli, a medical institution in Shenzhen, Yan Jinzhou and others, in the knowledge of violating the relevant provisions of the state and medical ethics, in order to edit human embryo CCR5 gene can be immunized
infants in the name of safety, effectiveness of human embryo gene editing technology used in assisted reproductive medicine. To this end, He Jiankui developed a business plan for gene-editing babies and raised funds.
In March 2017, at the beth of He Jiankui, Yu Jinzhou and other characters were 8 couples infected with
virus, and arranged for others to pretend to replace 6 of them, disguised as normal patients for assisted reproduction, through the hospital's
virus antibody test. After He Jiankui directed Zhang Renli and others to forge medical ethics examination materials, and arranged for others to purchase from abroad only allowed for internal research, strictly prohibited for human diagnosis and treatment of reagents raw materials, the deployment of gene editing reagents.
August 2017, at the beth of He Jiankui, Zhang Renli illegally injected gene-editing reagents into the fertilized eggs of six couples, and then sent samples of the cultured blastocysts for examination. He Jiankui according to the test results selected blastocyst, by Zhang Renli concealed
, through unsuspecting doctors will be blastocyst transplanted into the mother, so that A, B one after another pregnant. In 2018, A gave birth to a twin baby girl. In 2019, B gave birth to a baby girl. Between May and June 2018, He Jiankui and Yu Jinzhou also arranged for two other couples to travel to Thailand, where one of the couples' fertilized eggs was injected with gene editing reagents and the embryo transfer operation was performed by a local Thai hospital, which failed and bent on infertile.
Cai Weiping, director of the Infection Center at the Eighth People's Hospital in Guangzhou, said that
viral mother-to-child blocking can be achieved entirely by taking antiviral drugs, "from a practical point of view, there is no need to achieve the so-called blocking goal through genetic editing of this '
' means."In accordance with the Ethical Guidelines for Human Embryonic Stem Cell Research jointly issued by the Ministry of Science and Technology and the former Ministry of Health in 2003, human blastocysts that have been used for research may not be implanted into the reproductive system of humans or any other animal;
but He Jiankui and three others in order to pursue personal vanity, deliberately violated the above provisions. There is a number of evidence that three people clearly know that gene-editing infants violate the relevant provisions of the State and medical and scientific research professional ethics, but still insist on advancing the plan, and forged ethical examination materials, arranged for others to impersonate for medical examination, CCR5 gene edited embryos illegally transplanted into the mother.
The court heard that He Jiankui and other three people in the law does not allow, ethics do not support, the risk is not controllable, take deception, fraud means, maliciously evade the supervision of the competent state departments, many times the gene editing technology applied to assisted reproductive medicine, resulting in the birth of a number of genes edited babies, seriously disturbed the medical management order, should be serious circumstances. If left unaliened, or even emulated, it poses an unpredictable risk to human genetic safety.
Evidence also shows that the He Jiankui team in the recruitment of
virus infection and signed an informed notice, said that "no risk" "technology is very mature" "pre-test results are very safe", some other possible risks are not clearly informed, not enough safety notification obligations.thecourt heard that He Jiankui gathered Zhang Renli, Yan Jinzhou, trying to edit the human embryo gene, with the help of assisted reproductive technology, to give birth to babies who can be immune to
, for this reason organized a number of people in the hospital medical examination, fertilized eggs injection is strictly prohibited for clinical gene editing reagents, and blinded unsuspecting medical staff to the gene-edited embryo into the mother, and then give birth to babies. The above behavior seriously exceeds the boundary of scientific experiments and should be considered as medical behavior.
Has been engaged in gene editing research, Sun Yat-sen University affiliated first hospital deputy
, professor of obstetrics and gynecology reproductive medicine Zhou Canquan said that human assisted reproductive technology is the benefit of the vast number of infertile patients clinical technology, the world must be implemented under strict supervision, He Jiankui and others to apply high-risk technology to human assisted reproductive medical activities, is extremely irresponsible medical behavior.
court found that He Jiankui and three others had not obtained medical qualifications and were still engaged in a series of medical activities, in violation of the Law of the People's Republic of China on Medical Practitioners and other state regulations, and were illegal practitioners.
Article 336 of the Criminal Law of the People's Republic of China stipulates that a person who has not obtained the qualification of practicing a medical practitioner shall be sentenced to fixed-term imprisonment of not more than three years, criminal detention or control, and shall be punished with a single fine if he or she is seriously injured in the health of the patient;
" three defendants in the absence of medical qualifications to carry out medical acts, in violation of the state prohibition provisions, the illegal use of immature technology on human beings, has been a serious case, in line with the composition of the crime of illegal practice of medicine. The court's judgment of the defendant for the crime of illegal practice of medicine conforms to the basic principles of criminal law which are appropriate to the crime and punishment. Even a person who is qualified to practise as a doctor shall not commit any act in violation of the provisions of medical administration, and if the act in this case is committed, resulting in serious consequences or other adverse circumstances, he shall be investigated for legal liability in accordance with the provisions of the Criminal Law. Chen Xingliang, an expert in criminal law and a professor at Peking University Law School, said. The industry believes that gene editing is a new technology with wide application prospects in the field of life sciences, providing new methods for treating various diseases in humans, and that rational application can improve human well-being, but improper application will have an uncertain impact on human health. The State supports and encourages genetic science research. Scientific research conducted in an honest, responsible and ethical manner shall be supported and protected in accordance with the law. The ruling helps to draw a clear line between legal and illegal.
" medical technology can not be separated from scientific research and innovation, but we can not make technological progress for the benefit of collective health of the good wishes, based on disregard for individual health and safety. It is the consensus of the medical community not to violate the bottom line of scientific research ethics. Zhou Canquan said.
July 1, 2019, the Regulations of the People's Republic of China on the Management of Human Genetic Resources, which stipulate that the collection, preservation, utilization and external provision of human genetic resources in China shall conform to ethical principles and conduct ethical reviews in accordance with the relevant provisions of the State
; The Committee considered and adopted the Plan for the Formation of the National Science and Technology Ethics
Council, which stated that scientific and technological ethics is the value criterion that must be observed in scientific and technological activities, and on August 22nd, at the t22nd meeting of the 13th National
Three National Congress, the draft code of personality was continued to be considered, increasing the provision that medical and scientific research activities related to human genes should not harm the public interest.
reporter learned from the relevant parties, the health and health administration departments in their guardian's knowledge and consent, continue to do a good job of medical observation and follow-up work.
Nexhed China
believes that there are still many scientific and technological, social and ethical aspects of gene editing of human reproductive systems, the safety risks of its application can not be assessed at present, once the edited genes into the human gene pool, the impact is irreversible, and not subject to geographical restrictions. Because the current clinical application of gene editing in human reproductive system may bring harm to individuals and society, it should be strictly prohibited. It is suggested to improve the relevant laws and regulations of our country, increase the punishment for violating laws and regulations, establish several regional ethics review
meetings on the basis of the formation of the National Science and Technology Ethics
Conference, and strengthen the examination and supervision of similar research and clinical applications with ethical breakthroughs. At the same time, scientific research personnel in the development of scientific research activities must be careful, ethical first, strictly abide by China's laws, regulations and ethical norms.
China Academy of Engineering
, Peking University Third Hospital
Qiao Jie reminded medical workers and researchers in the study and application, must bear in mind that must not violate ethics and touch the bottom line of the law. "Gene editing technology is widely used in disease treatment, genetic breeding, drug target prediction and crop condition improvement. However, the application of this technology in human assisted reproductive technology is far from mature, and further basic and preclinical research is needed. More importantly, technology implementation needs to be widely recognized by the public. "We want
to follow the doctor's original heart and not violate ethics or the law when conducting research. ”