He Jiankui speaks in Hong Kong on Nov. 28, 2018. Photographer: Anthony Kwan/Bloomberg (Bloomberg)

The headline-making births last November of the world’s first gene-edited babies (twin girls) was unsurprising in one way: The scientist involved was from China. As part of its effort to dominate scientific spheres including biotechnology, China has taken the lead in testing uses of Crispr, a tool newly available to researchers enabling them to alter DNA codes simply and inexpensively. Chinese scientists were the first to test Crispr in monkey embryos, in non-viable human embryos, in adult humans, and now in creating designer babies. Now China is confronting accusations that its regulatory system is overlooking the ethical considerations and medical risks.

1. Did China approve genetic altering of the babies?

The scientist who altered the genes of the twin girls as embryos, He Jiankui, says he had approval from the medical ethics committee at Harmonicare Women and Children’s Hospital in Shenzhen. An investigation by the Chinese government found that He deliberately evaded government regulations and forged ethical review documents, the Xinhua government news agency reported on Jan. 21. The result of that investigation prompted He’s employer, Southern University of Science and Technology, to fire him.

2. What explains the uproar over this case?

Altering the genes of an embryo changes DNA in every cell, including the eggs or sperm, of the resulting person, alterations that will be passed on to progeny. The technique works by making cuts in DNA, some of which may be unintended and bring unknown effects. Normally, participants in clinical research must give their informed consent, something embryos obviously cannot do. The scientist, He, says his goal was to produce babies immune to HIV, the virus that causes AIDS, by altering a gene in the embryos that makes a protein called the CCR5 receptor, which HIV uses to enter cells. To some researchers, that’s insufficient grounds to justify such high risks, since HIV infection is relatively uncommon in China, there are other ways to prevent it and it’s treatable. Even if the gene-editing worked, the twins won’t be invulnerable to HIV, which can also invade cells via a receptor called CXCR4. What’s more, studies suggest that CCR5 deficiencies increase vulnerability to West Nile virus and influenza.

3. What rules does China have in place?

Under guidelines issued by the National Health and Family Planning Commission in 2003, gene editing of embryos isn’t banned, but the use of genetically modified eggs, sperm or embryos for reproduction is prohibited. These guidelines are not laws, and they are enforced through the commission’s ability to withdraw the licenses of fertility clinics.

4. What are the rules elsewhere?

Twenty-nine of the 47 member states of the Council of Europe human-rights organization, including France, Denmark, Switzerland and Spain, have ratified the 1997 Oveido Convention, which prohibits genetic modification of reproductive “germline” cells. The U.S. Congress has banned the Food and Drug Administration from considering germline-editing trials. A 2002 Australian law calls for imprisonment for 15 years for anyone who purposely makes heritable alterations in a human cell. Reports by the U.S. National Academies of Sciences, Engineering and Medicine in 2017 and the U.K.’s Nuffield Council on Bioethics in 2018 concluded that human trials of editing germline cells should be used only to fill unmet medical needs and benefit those whose genes are altered.

5. What explains China’s approach?

China wants to be a leader in the defining technologies of the 21st century and has poured billions into funding research. As a participant chosen for its prestigious Thousand Talents scheme -- a plan to lure back talented Chinese from overseas -- He would have received at least a starting bonus of about $143,000 for his research, with the possibility of additional research grants of roughly $700,000. He also founded a startup called Direct Genomics that makes DNA-sequencing equipment, which also received government funding, according to its website. According to the database clinicaltrials.gov, China has 12 human trials involving the Crispr method. One of these is active, with eight in the recruiting stage. In the U.S., there are eight Crispr-related trials, six of which are recruiting and none of which are active.

6. How is China responding?

The country’s biotech companies and universities have worked hard to counter suspicions that their endeavors are rife with fraud and minimally supervised experimentation. The Genetics Society of China, the Chinese Society for Cell Biology and other groups were quick to condemn He’s gene-editing work, calling it a serious ethical violation. A Chinese branch of the World Health Organization pulled an application to register the gene-editing project in a clinical database.

To contact the reporters on this story: John Lauerman in London at jlauerman@bloomberg.net;Rachel Chang in Shanghai at wchang98@bloomberg.net

To contact the editors responsible for this story: Eric Pfanner at epfanner1@bloomberg.net, ;K. Oanh Ha at oha3@bloomberg.net, Lisa Beyer, Marthe Fourcade

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