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Loopholes in organ transplant regulation exposed
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Two recent kidney transplant operations have caused Chinese medical experts, lawmakers and ethics advocates to call for a reexamination of the country's human organ transplant regulations.


Less than a month ago, He Yiwen, a 17-year-old girl, and He Zhigang, a 39-year-old man, both from Changde City in central Hunan Province, did not know each other. But they were both suffering from deadly uremia and badly in need of a lifesaving kidney transplant.


They both failed to find suitable kidney matches among their relatives but by chance their blood samples were both sent to the Second Affiliated Hospital of the Guangzhou Medical College, who realized the blood of He Yiwen's father was a good match for He Zhigang, whose cousin was a match for He Yiwen.


The hospital proposed a "cross renal transplant" which required the two families to exchange donors.


However, there was a problem. The country's regulation on human organ transplants, which took effect on May 1 last year, states: "Recipients of living organs are only limited to donors' spouses, blood relatives, or people who have proven a close relationship with the donors."


The proposal was vetoed by the ethics committee, which cited the transplant regulation and said the operations were illegal as the two families were genetically unrelated.


Fortunately for the two patients, a hospital in the southern island of Hainan stepped forward.


On January 7, the Hainan Agricultural Cultivation Bureau Hospital, the only medical institution in the province permitted to carry out organ transplants, successfully performed the two transplants, each lasting nearly ten hours.


Before the operations, the hospital received consent from its ethics council.


Zhou Xiaohua, director of the Changde Kidney Disease Association, who followed the development of the case, said the Hainan hospital's ethics committee had agreed to the operations based on the files submitted by the two families.


The files made clear "details of how the two parties helped each other and had established a close relationship".


Zhou said the transplants were aimed at saving lives, which was in line with the law as no organ trade was involved.


"The Guangzhou hospital was not at fault either because it vetoed the operations based on the regulation, and the hospital returned the 24,000 yuan hospitalization fees to the two families," Zhou said.


Xiao Jinzhu, president of the Hainan hospital, said the Guangzhou hospital had their own considerations and the operation veto reflected a different understanding of the regulation.


"The operations were risky and difficult as they concerned four lives. Extreme caution was practiced and careful arrangements were in place to ensure its success," Xiao said.


"Now the patients are recovering well," he added. "As a doctor, saving life is a priority."




The incident has triggered heated public debate on the choice between law-abiding and life-saving.


The portal website Sina.com surveyed 7,972 netizens, of whom 7,570 voiced their support of the Hainan hospital, saying, "Is there anything more important than life-saving?"


But 211 netizens opposed the transplants. They said the two families were unrelated and their "close relationship" was fake, hence the operations were against the regulation.


If such transplants are legalized, organ dealers could easily dodge the law by forging nonexistent "close relations", they said.


Another 191 people said, "It's hard to say."


Observers believe there is a legal loophole to regulate voluntary living organ donation to non-relatives. Once the highly risky operations failed, disputes would occur between patients' families and hospitals.


Chen Yun, an official with the provincial health department of Hainan, said the transplant dispute resulted from a lack of detailed stipulations in the regulation on how to judge a living organ donor's "close relationship" with recipients.


Similar cases have already occurred five times since last May at a hospital in Wuhan and two military hospitals in Zhengzhou and Guangzhou.


But the five cases were in line with the regulation as they were able to prove organ donors had genuine close relationships with recipients.


Li Jun, a lawyer with the Hainan Fangyuan Law Office, told Xinhua that laws should be "interpreted humanely" as long as it was not driven by economic profit or infringed upon public interests or social morality.


Ministry of Health Spokesman Mao Qun'an told a recent news conference that health departments were investigating the case and would "deal with it in line with laws". But Mao remained evasive, choosing to just reel off the exact wording of the organ transplant regulation.


The ministry had received several public tip-offs about organ transplant violations, sources said, adding investigations were under way and penalties included revoking transplant operation licenses.


Hainan health official Chen said the Hainan hospital that performed the kidney transplants must report the operations to the provincial health department 30 days after they happened. The department would report the latest development of the transplants to the Ministry of Health six months later.


(Xinhua News Agency January 13, 2008)

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