Tough new rules slated for genetic experiments.
(LI XIN / FOR CHINA DAILY)
In November 2018, biologist He Jiankui pushed mankind across a controversial threshold when he announced he had created the world's first gene-edited babies in an attempt to make them less susceptible to AIDS.
Genetic editing has been hailed as a revolutionary technology with huge applications in a range of fields, from agriculture to medicine, but its relative simplicity and accessibility mean its abuse could spell disaster for the world.
The gene editing of human embryos for reproductive purposes is widely considered off-limits.
In 2015, two of the world's top scientific journals, Nature and Science, published statements warning against such experiments.
They said edited cells could be used to pass the modifications to future generations, creating ramifications such as designer babies or genetic inequality.
He's experiment was universally condemned. On Dec 30, he was sentenced to three years in prison and given a 3 million yuan (US$428,500) fine for illegal practices, including forging ethical approval documents and practicing medicine without a license.
He also received a lifetime ban from conducting research in the field.
After the controversy, China began tightening the rules related to gene-editing technologies and ordered scientists and institutions to improve ethical oversight.
In an unprecedented move, drafts of the country's new civil code have listed human genes and embryos as fundamental rights that deserve protection.
The code dictates that all medical and scientific research related to human genes and embryos must follow strict rules, laws and regulations. Also, the research should not endanger people's health, violate moral or ethical norms, or undermine public interests.
Experts said the long-awaited regulation is a major step in the nation's efforts to uphold research ethics and hold accountable anyone who manipulates human genetic resources.
They added that improved ethics education for scientists, refined details related to rules and the punishment of violations, plus a multitier ethics review system, are the next steps in improving the effectiveness of China's oversight of scientific research.
Overarching framework
A civil code is an overarching legal framework governing noncriminal disputes related to property, family, personal rights and contracts, among other issues. China's version comprises the general provisions and six other sections.
In April last year, during the second reading of the draft civil code by the Standing Committee of the National People's Congress, members of the legislative body added new regulations on gene editing in humans under the section related to personality rights.
The committee reviewed the code for a third time in August.
The draft states that all medical or research activities involving human genomes and embryos must follow relevant laws and regulations, must not damage human health or transgress moral and ethical norms, or undermine public interests.
Moreover, all clinical experiments for the development of new drugs or medical equipment, along with the creation of new preventive or treatment methods, must be reviewed and approved by ethics committees and qualified authorities in accordance with the law and regulations.
All human test subjects or their guardians must be informed of the goal, application and possible risks of experiments, and they must provide written consent.
Participants should not be charged for taking part in clinical trials, it said.
Shen Chunyao, director of the NPC Standing Committee's Legislative Affairs Commission, said medical and scientific research related to human genes and embryos could present risks to health or violate ethics, so they must be strictly regulated.
Yang Lixin, a law professor at Renmin University of China in Beijing, said the new rules－added as a result of He's controversial experiment－are intended to deter opportunists and provide better protection for the health of individuals, ethnic groups and the entire nation.
"They are the bottom line that should never be crossed during research," he said. "They will also serve as the basis and guiding principles for any future legislation."
Huang Yu, deputy director of the medical genetics department at Peking University, said the lack of clear legal rules used to make it difficult to hold to account those who violated research ethics, but the situation has improved in recent years.
In January last year, the ministries of science and technology and of finance issued a joint document ordering scientists and research institutes to improve ethical oversight and regulation, and establish regulatory committees to ensure ethical practices in research activities.
Two months later, the National Health Commission proposed a draft regulation stating that scientists who conducted high-risk biological and medical research without approval would be fined and barred from future grants. Also, anyone who violated the law would be prosecuted.
"China has worked on similar regulations in the past, but the key is in the fine detail and the severity of the punishment," Huang said.
Assigning clear responsibilities and operating mechanisms for the ethical review process will also be instrumental to enhancing oversight, he added.
Complex issue
There is still no international consensus on the regulation of human germ cells－such as sperm and ovain genetic engineering, even though governments, institutions and international organizations issued more than 60 statements related to the ethics of the technology between 2014 and 2018, according to a study published in the scientific publication The CRISPR Journal.
The study said the problem partly stems from the divergence of germ cell engineering into basic research, clinical research and clinical applications, because they are subject to varying degrees of regulation in different countries.
For example, basic germ cell research is prohibited in Germany, Italy and Switzerland.
However, in countries such as China, Israel, Singapore, Sweden, the United Kingdom and parts of the United States, scientists are allowed to create genetically modified embryos for research, but they can only be studied during the first 14 days of their development in vitro.
To further complicate matters, many regulations are "unnecessarily vague and obsolete", the journal said. "Limitations must be spelled out in statutory and regulatory instruments that are sufficiently clear to allow scientists to regulate their conduct based on those provisions."
In a column in Guangming Daily last year, Li Xin, director of the Center of Science and Technology Laws at Capital Normal University in Beijing, said the paramount question on any regulation related to human gene editing is how to ensure the technology is used in an appropriate, justified manner.
"Tackling this question is like opening a can of worms, leading to a range of sensitive issues," she said.
For instance, gene editing may be the only solution for patients with severe congenital disorders, but who has the authority to approve such a procedure and conduct experiments to edit the fundamental blueprint of life?
If gene editing is allowed for therapeutic treatments, what is to stop people from abusing it to augment their own bodies or those of their offspring?
"The line between augmentation and treatment is blurred. It depends on whether the procedure is necessary for someone's well-being－but well-being itself is also a vague concept," Li said.
"In this case, the purpose of the law is to fill the gap between theoretical speculation and practical measures with procedures, rights, responsibilities and legal obligations."
Yuan Lanfeng, an associate researcher at the National Research Center for Microscale Material Science in Hefei, Anhui province, said if gene augmentation ever existed, the rich and powerful would inevitably abuse it to gain an unfair biological advantage.
"If China does not have a law related to gene editing, then it will have no legal basis to stop those attempts," he said. "That would be detrimental to building China's image as a responsible nation."
Mao Yonghui, a senior nephrologist and a member of the ethical review committee at The Beijing Hospital, said that with the advent of the CRISPR-Cas9 gene-editing technique－in which the cell's genome can be cut at a desired spot－manipulating genetic material has never been easier or more accessible, because people can get the instructions and equipment from the internet, just like a chemistry set.
"This accessibility also makes regulating the technology incredibly difficult," she said. "We must ensure scientific research and exploration are done responsibly and abide by the law. Only then can we ensure the these endeavors benefit humanity."
Proposed solutions
Mao said one solution would be to establish a multitier ethical review system covering regulatory bodies at different stages－from local institutions to the national level－that could grant approval appropriately, based on the ethical risks of the experiment.
With such a system in place, local hospitals, such as the one in which He forged his ethics approval, would not have the power to green light experiments as risky and controversial as the gene editing of human embryos.
Such approval should only come from the highest authority, Mao said.
Also, research participants in different age groups should be covered by different ethical standards.
"In China, the current bioethical standards for children, adults and seniors are all the same, but in reality, these people can have very different needs and concerns," Mao said.
The Beijing government is testing a diversified ethical standard at The Beijing Hospital by allowing its ethical review board to create specific ethical rules for senior citizens, she added.
Qiao Jie, a noted specialist in reproduction and president of No 3 Hospital of Peking University, said scientists should not break ethical norms or laws during research.
"Genetic engineering has a wide application in disease treatment, plant and crop breeding, and in finding biological targets for drugs," she told Xinhua News Agency in a commentary about the civil code last year.
"But the technology's use in assisting human reproduction is far from mature and requires further research. More important, the technology must be recognized by the public before implementation."
Mao said that in addition to regulation and supervision, ethical education for researchers is also important. "Speaking from personal experience, our scientists' understanding of ethnical research design and practice has seen a noticeable improvement in the past two years," she said.
According to a 2018 survey by the China Association for Science and Technology, nearly 90 percent of the 12,332 scientists surveyed said they believed unethical practices are deeply harmful, though many Chinese scientists still lack knowledge in areas such as bioethics, animal rights and environmental impacts.
In June last year, the General Office of the Communist Party of China and the State Council, China's Cabinet, published a joint guideline that ordered scientists to uphold ethical research practices and improve education on the promotion of scientific integrity and moral standards.
In an analysis of the guideline last year, Wang Zhigang, minister of science and technology, said excellent research practices and a good academic atmosphere are the "lifelines of quality science" that can make or break a project.
"They are also the foundation of building an innovative country and a global scientific and technological powerhouse," he said.
Armed with a series of new guidelines and regulations from various levels of administration, Wang said China will substantially improve its ethical practices and academic environment within three years.
"We hope the scientific spirit can flourish in our society, so more people will respect knowledge, innovation and talent, and more youngsters will dedicate themselves to scientific undertakings," he said.
