Dr He Jiankui, who claimed that the world's first babies had been born with edited genomes, has been sentenced to three years in prison and fined for performing 'illegal medical practices' (see BioNews 977 and 1029).
In November 2018 during the Second International Summit on Human Genome Editing, Dr He shocked the world by announcing that twin girls Lulu and Nana had been born with edited DNA to make them resistant to HIV, which he had achieved using CRISPR/Cas9 genome-editing on embryos.
Many of Dr He's peers have raised ethical questions, including the level of consent obtained from the parents of the twins and the lack of transparency surrounding his experiment. His work has been subjected to intense criticism by the global scientific community.
According to China's state-run Xinhua News Agency, the Shenzhen Nanshan District People's Court sentenced Dr He to three years in jail and imposed a 3 million yuan (US$430,000) fine. Two embryologists with whom he collaborated received lesser sentences; Zhang Renli was sentenced to two years in prison and fined 1 million yuan (US$143,000), while Qin Jinzhou was given a suspended prison sentence of 18 months and fined 500,000 yuan (US$71,600).
The public prosecution agency produced various types of evidence including documents, witness testimonies, electronic data, audiovisual materials and inspection records, Xinhua reported. The court held that the accused did not obtain the relevant qualifications, gained profit and had violated the national regulations on scientific research and medical management.
The nature of their transgression was considered severe enough to constitute the crime of 'illegal medical practice'. According to Article 336 of the Criminal Law of the Chinese People’s Republic, an illegal medical practice refers to a medical activity performed by a person who does not possess a medical licence. Dr He and his collaborators' clinical trial was interpreted as a type of medical activity. As none of the three had the proper certification to practise medicine, they were found guilty of committing illegal medical practice. All three defendants pleaded guilty.
Interestingly, due process was followed in the trial. The defendants were represented by lawyers and were given the opportunity to speak during the hearing. Among those who attended the court were family members of the defendants, representatives of the National People's Congress (legislature), members of the Political Consultation Conference (official consulting body) and journalists.
In 2016, Dr He became aware of monetary gains from the technology according to the court's findings, Xinhua said. And to keep the matter confidential, he paid every couple who participated in the research 280,000 Yuan (about US$40,000), a hefty amount for most Chinese couples (or western couples). This payment and the lack of disclosure would nullify the consent given by the research subjects.
The last few decades have seen China make substantial economic developments and technological advances. Under premier Deng Xiaoping, its economic reform began in 1979 which opened the nation up. As the second-largest economy in the world, the Chinese government has invested heavily in genetic research.
The leading countries in genetic research include the UK, US and China. But, in terms of bioethics, China has a different culture from the developed western nations. In many western societies, editing the genomes of human embryos intended for pregnancy is prohibited. For instance, the UK has had a regulatory framework governing reproductive technologies and embryo research since 1990.
If Dr He had been an Australian researcher, he would face 15 years in prison. There would also be sanctions from his employer and loss of research funding. Section 15 of the Prohibition of Human Cloning for Reproduction Act 2002 states that a person commits a criminal offence if they alter the genome of a human cell in a way that the alteration is heritable by descendants of the human whose cell was changed; and in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered.
On a positive note, the response of the Chinese government indicates they are moving to clarify regulation. Soon after Dr He's announcement that he had created the world's first genome-edited babies, investigators from the Guangdong Province Health Commission conducted an investigation. Its findings were that Dr He had performed the clinical trial in pursuit of fame and fortune with self-raised funds, forged ethical review documents, misled patients about the risks and breached a 15-year-old regulation that prohibits human embryos that have used in research from subsequent reproductive use.
In January 2019, China's President, Xi Jinping, called for stricter laws. In February, the government announced new rules on innovative technologies which would be regulated by the State Council (China's Cabinet). The National Health Commission has prohibited the three scientists from performing assisted reproduction for life and the Ministry of Science and Technology barred them from making applications for research funding. Very importantly, China's Civil Code has been undergoing amendments and its latest version, which is expected to be released in March 2020 aims to address the ethical issues raised by heritable genome editing.