China Has Tightened Genetics Regulation - Rules Ban Human Cloning; Moves
Could Quiet Critics Of Freewheeling Research
By Karby Leggett, The Asian Wall Street Journal
Monday, 13 October 2003

SHANGHAI - China's days of freewheeling research into reproductive medicine and cutting-edge genetics could be numbered.

After years of indecision and half-hearted attempts at regulation, Beijing has quietly implemented a sweeping new directive aimed at regulating research into the human reproductive system and the role that genetic science plays in it, according to officials at the Ministry of Health. The new rules took effect Oct. 1 but were only announced on the Ministry of Health's Web site on Friday.

Among the most strident points of the new regulations are a blanket ban on human cloning and new controls on genetic experimentation on human eggs and sperm for fertility purposes. It also outlaws for-profit trading in human eggs and sperm -- a move that is likely to restrict access to the raw materials that scientists need to conduct research and practice fertility medicine.

"It's a very strict set of regulations," said one genetic scientist in Shanghai. "The biggest impact is that government [hospitals] will no longer fund research that is deemed sensitive."

The new rules, if enforced, could help quiet foreign critics who have faulted China in recent years for permitting a range of controversial genetic research. It is likely to be viewed positively by ethicists and conservative politicians in other nations, including the US.

Though still a relatively young field, genetic science has made vast strides in recent decades, particularly in the realm of human reproduction. Genetic discoveries have helped reduce the risk of congenital birth defects and other disorders, such as Down Syndrome. New research in promising fields such as embryonic stem cells - a sort of master cell that can develop into a wide range of human tissues - has raised the possibility of cures for many other illnesses, as well as for potentially commercial benefits.

Yet along with progress has come controversy, nowhere more than in the science of human reproduction. Some aspects of embryonic stem-cell research, for instance, have relied on techniques that could also be used to clone a human being. Just to obtain embryonic stem cells, scientists often have to create - and destroy - human embryos.

All that has raised important ethical concerns and questions about how the industry should be regulated.

Until now, Beijing appeared largely unmoved by such concerns, showing more interest in supporting domestic efforts to unlock the secrets of genetic science. From the human reproductive system to the genetic structure of cucumbers, rice and cotton, government funds have flowed freely to the industry in recent years, reflecting Beijing's view that the science holds vast economic benefits and could eventually propel China to scientific greatness.

Indeed, in some fields recent progress has been so great that Chinese scientists have already caught up with counterparts in the US and other developed countries. In Guangzhou, one scientist reports he has created more than 100 hybrid embryos by combining DNA from human skin cells with rabbit eggs. In central Hunan province, a team of scientists are using a technique similar to one that could be used to clone a human being, but for the purpose of harvesting embryonic stem cells for research. In recent years, nearly 500 fertility clinics have sprouted up across China, more than a
third of them specializing in in vitro fertilization.

Now, Beijing appears to have adjusted its position. Some Chinese researchers said the decision to issue industry guidelines reflects Beijing's concern that China was becoming a magnet for foreign scientists, some of whom had begun moving research to China as a way to get around restrictions in their own countries. That raised the possibility that scientists could veer into sensitive ethical areas without the government's knowledge.

That now appears far less likely. The new rules, at least on paper, leave China with a regulatory framework for genetic science that could potentially be more restrictive than those in the U.S. and the United Kingdom, both of which are also laboring to keep pace with such technology.

China's rules still differ in many ways from those in the U.S. Beijing, for instance, didn't address the issue of research funding, leaving the industry open to both foreign and domestic capital, including government funding.

Beijing also left vast stretches of the industry wide open, such as stem-cell research, as long as human cloning isn't involved and scientists don't apply their findings on a commercial basis. That, experts say, suggests genetic research in China is likely to continue to thrive.

Even so, Chinese genetic researchers and scientists say the rules, if aggressively implemented, are likely to have a chilling effect on research and the human-fertility industry that until now has been growing by leaps and bounds amid a near complete absence of regulation. At a minimum, these researchers say, they are likely to give Beijing far greater say over what type of genetic research is undertaken in China.

"This is good for the long-term development of this scientific field," said Chen Xigu, a scientist in Guangzhou. "Otherwise, it's possible there could be a disaster before we figured out how this science can benefit mankind."

The big question now is how aggressively Beijing implements the new rules. As in other parts of China's economy and society, Beijing's previous attempts to regulate reproductive science and human genetics have been largely ineffective. Just over two years ago, for instance, China's Ministry of Health announced an official ban on all commercial trading in human eggs and sperm.

Yet that rule has been widely ignored, with dozens of fertility clinics and even some hospitals collecting, storing and selling sperm and eggs without government approvals or licenses. Even many well-established fertility clinics that don't trade in eggs or sperm operate without formal approval.

One of them is the Guangdong Jiai Genetics & IVF Institute China-USA Center. Backed by technical support from a U.S.-based fertility clinic in Fairfax, Virginia, Jiai Genetics has been operating for about three years without a formal license issued by the Ministry of Health, said Wu Jingzhi, the clinic's director of operations.

But Dr Wu shrugged that off. Jiai Genetics, she said, is in the process of applying for a central-government license, and local officials have continued to allow the clinic to operate while the license is under review.

"It's not a problem," she said.

Questions over how Beijing implements the regulations are likely to linger. Some of the rules, such as the ban on human cloning, are straightforward and unlikely to be challenged. But other aspects, such as a ban on altering the genetic structure of eggs and sperm and then applying those changes during individual fertility procedures, are less clear and potentially open to interpretation, experts said.

Yet for many Chinese scientists, Beijing's message is already clear. "The core issue," says the prominent Shanghai scientist, "is to prevent human cloning . . . China naturally doesn't want to become a legal loophole for the world."