SHANGHAI, China – China's Health Ministry has explicitly banned sales of human organs in an apparent attempt to clean up the country's lucrative but laxly regulated transplant business.
New regulations viewed on the Health Ministry's Web site Tuesday forbid the buying and selling of organs and require that donors give written permission for their organs to be transplanted.
While China has long defended its transplant business as legal, little information about it is publicly available. Critics contend it is profit-driven with little regard for medical ethics.
Chinese legislators have been pushing for years for a law to regulate and promote voluntary organ donations. However, the Health Ministry regulation — to take effect on July 1 — was officially titled a "temporary regulation," suggesting that further legislation could follow.
The Health Ministry had no comment. Foreign Ministry spokesman Qin Gang told reporters a more permanent regulation on organ transplants was being drafted.
The true number of transplants carried out annually isn't known, although a professional group, the Chinese Society of Transplantation, says about 5,000 kidney transplants and 1,500 liver transplants were carried out in 2003.
Human rights groups say many organs — including those transplanted into wealthy foreigners — come from executed prisoners who may not have given their permission, claims China routinely denies. Voluntary donations remain far below demand, partly because of cultural biases against organ removal.
Safety concerns about the transplant industry also have surfaced. Last month, Japan announced it was examining cases involving at least eight Japanese patients who received organ transplants in China and later fell seriously ill or died from infections and other problems after returning home.
The Foreign Ministry spokesman repeated China's insistence that all organ transplants were conducted with the permission of the donor.
"It is a complete fabrication, a lie or slander to say that China forcibly takes organs from the people convicted of the death penalty for the purpose of transplanting them," Qin said.
The new Chinese rules limit transplant surgery to top-ranked institutions that must verify the organs are from legal sources and that the procedure is safe and justified.
Transplant hospitals must keep specialists on staff and have all the required medical equipment, according to the rules. Hospital transplant ethics committees must approve all such surgeries in advance, and institutions where patients die shortly after having transplants will be banned from conducting such surgeries.
"The rule explicitly states that human organs cannot be bought or sold; medical institutions must obtain written permission from donors for any transplant of organs for clinical purposes; donors have the right to refuse to donate organs prior to the organ transplant," the ministry said in an introduction to the rules.
The rules "aim to organize and strengthen management of human organ transplant technology for clinical use, assure the quality and safety of treatment and protect patient health," it said.