China on Friday issued its first regulation on human organ transplants, banning organizations and individuals from trading human organs in any form.

 

Any doctor found to be involved in human organ trade will have their practitioner license revoked. Clinics will be suspended from doing organ transplant operations for at least three years. Fines are set at between eight to ten times the value of the outlawed trade, the new rules said.

 

Officials convicted of trading in human organs will be sacked and kicked out of government.

 

The regulation, issued by the State Council, or China's cabinet, will go into effect on May 1.

 

China has carried out organ transplants for more than 20 years and is the world's second largest performer of transplants after the United States, with about 5,000 transplants completed each year. However, the absence of laws and regulations concerning organ transplants has negatively impacted practice, critics say.

 

Most organs are donated by ordinary Chinese at death after the voluntary signing of a donation agreement.

 

But the country must still contend with a vast gap between the demand for functional organs and the supply provided by donations. About 1.5 million patients need organ transplants each year, but only 10,000 can find organs, according to statistics from the Health Ministry.

 

The regulation stipulates that human organ transplants should respect the principle of voluntary and free donation and makes it a crime to harvest organs without the owner's permission or against his will.

 

People taking organs from anyone under the age of 18 will also face prosecution and can be convicted of murder or intentional assault, according to an official with the Health Ministry interpreting the regulation to the media on Friday.

 

Human organ transplants are defined as the process of taking a human organ or part of a human organ -- such as the heart, lung, liver, kidney and pancreas -- from a donor and transplanting it into a patient's body to replace their sick or damaged organ.

 

The regulation does not apply to transplants of human tissue, such as cells, cornea and marrow.

 

The regulation comprises 32 articles in five chapters, including human organ donations, human organ transplants, legal responsibilities and supplementary points. It covers transplant quality and aims to safeguard citizen's lawful rights.

 

It decrees strict supervision and control for the few medical institutions that are allowed to perform organ transplants, and sets rules to standardize procedures so as to prevent potential human rights abuses.

 

According to the new rules, every transplant must be approved by an ethics committee set up in the the medical institution. A designated mechanism will ensure that medical institutions are competent. Unqualified institutions will be ordered to exit the market.

 

"This is the first regulation of its kind introduced by the central government, and it is a milestone in the country's organ transplant history," said Huang Jiefu, vice health minister, adding that the regulation is in line with international standards of medical ethics and the World Health Organization's guiding principles on the issue.

 

Last year, the country's organ transplant sector was accused by overseas media of using transplanted organs from executed prisoners, who were not necessarily voluntary donors. The accusations were denied by officials.

 

Ni Shouming, a spokesman for China's Supreme People's Court, emphasized that organs of executed prisoners were used for transplants only when the death inmates had voluntarily expressed their intention to donate their organs, or their families had given consent to such usage.

 

"The donation procedure for ordinary people and for those who sit on death row is the same," Ni said.

 

Prisoners should have voluntarily expressed the wish to donate their organs and signed the necessary documents before they die, or their families should have given consent to such usage. Donations went through a strict examination and approval process by judicial departments, court officials said.

 

(Xinhua News Agency April 7, 2007)