China’s burgeoning organ transplant business has been compared to a brand-new highway with no lanes or signs to regulate the traffic. Having realized the severity of the situation, the Ministry of Health issued Temporary Regulations on the Administra-tion of Human Organ Transplants for Clinical Purposes on March 16. It is clearly stipulated for the first time that human organs are not to be traded, that a donor’s written permission is required for medical institutions to use human organs in transplants, and that the donor has the right to revoke that permission.
These rules, which are to take effect on July 1, are the first regulations guiding organ transplants in China and are expected to act as “traffic lights” in the country’s transplant market.
“This provision comes at a time when its promulgation cannot be delayed any more, or there will be disastrous consequences,” Chen Dazhi, a doctor at Beijing’s Chaoyang Hospital and Deputy Director of the Beijing Organ Transplant Center, told Beijing Review.
Organ transplants have been a long-cherished dream of mankind, and regarded as a “peak of medical science.” Clinical trials of organ transplants were first conducted in China as early as in the 1970s and the business began to thrive in the country in the late 1990s. Currently, all kinds of clinical and experimental organ transplants are available in China.
Statistics from the Ministry of Health show that organ transplants have increased by 1,000 cases each year since the 1990s in China. During the 10 years from 1993 to 2002, the number of kidney transplants soared 322 percent on China’s mainland and 141 percent in the United States, showing an annul growth of 14 percent and 4 percent respectively. Today, China is second only to the United States in the total number of transplants performed.
Take the Beijing Organ Transplant Center for instance. The center carried out the first liver transplant in September 1999, and in the following seven years the number increased to 100 annually.
According to Chen, a liver transplant at the Beijing Organ Transplant Center costs 250,000-300,000 yuan, while the same operation in the United States would cost $250,000-$300,000, almost 10 times as much. In South Korea, the cost is almost six times higher than in China. The center usually can find liver donors one or two weeks prior to an operation, and the wait is almost never longer than two months.
“Every organ transplant hospital is connected to organ donation networks. Our center has been engaged in this for a long time, so it’s quite easy for us to find organ donors,” said Chen. However, only a small number of hospitals in China have access to an adequate organ supply and, in general, demand far exceeds the limited supply.
Supply shortage
In China, each year only 3,000 patients are able to have liver transplants, while the total number of patients in need of new livers exceeds 300,000. Every year, China has 120,000 new patients suffering from kidney problems, 97 percent of whom die while waiting for suitable organs to be found. China also has 5 million blind people, but only 1,200 receive corneal transplants annually because of the shortage of donated corneas.
While there is great demand for organs, the sources of supply are extremely limited. In July 2005, Huang Jiefu, Vice Minister of Health, acknowledged at an International Liver Transplant Symposium that in China most transplanted organs are taken from executed prisoners, but he said the permission of the prisoners or their families is required to take their organs. He also said that they are treated in a humanitarian way.
The Chinese Government has recently begun to encourage organ donations from both living and dead donors. Yet, while many people have expressed their willingness to donate their organs after death, few have actually become organ donors.
The relatively conservative attitude of the Chinese toward organ donation is probably rooted in the traditional belief that a person’s body should remain intact in death since God gave him or her a complete body in life. This differs from the Christian view, which values the soul more than the body.
“To donate organs after death is a good deed, but it’s not easy in practice,” said Li Jingyu, a taxi driver in Beijing. When asked why, she answered, “It’s just unacceptable for people to have their organs removed.” She said it was only in recent years that she began to hear of organ donations, but she was sure people’s attitude toward this issue would change with social progress. Li’s view is quite typical among the Chinese.
Apart from the traditional bias against organ removal, due to the lack of helpful laws, even volunteer organ donors find it difficult to locate legitimate channels for donation.
“I often have calls from donors, but my hospital is afraid to accept their offers,” said Chen of Chaoyang Hospital. His fears are not groundless.
A medical institution in Beijing once carried out an organ transplant between relatives, and even though consent forms were signed by both the donor and the recipient, when the patient fell ill after transplant both families brought a law suit against the hospital.
Since there is no explicit legal definition of accountability for hospitals and patients, hospitals are likely to be involved in endless disputes over medical accidents. In this case, the interests of the donor, the recipient and the hospital are all badly hurt.
The shadowy source of organs has deferred the international community’s recognition of China’s organ transplant business. “China’s organ transplant technology has in fact achieved all the basic international criteria,” said Chen. Consequences of lax control
For quite a long time, hospitals carried out organ transplants without obtaining permission from government health agencies or filing records with medical associations, which resulted in a large number of inadequately equipped hospitals flourishing in this lucrative business.
“This business used to be in a mess and it has encountered many problems,” said Chen.
Partial data show that throughout China, as many as 368 hospitals are engaged in liver transplants and over 200 hospitals perform kidney transplants. However, even in the United States, which boasts the most advanced medical technology, the numbers are only respectively 100 and 200.
Beijing now is home to at least 30 hospitals involved in liver transplants, but only five or six would be adequate. Some hospitals do not have the capability of carrying out organ transplants, and even their doctors are borrowed from other medical institutions. Under the temporary regulations issued by the Ministry of Health, half of the organ transplant hospitals in Beijing are actually unqualified.
Why are so many hospitals interested in organ transplants? A widely recognized reason is that the ability to do this type of surgery is regarded as a key standard in judging a hospital’s medical level. And the Ministry of Health used to stipulate that only those capable of performing this type of surgery were eligible to be certified as a third-level grade-A hospital, a quality certification. Although this rule has long been abolished, it seems to be an invisible driving force pushing hospitals to rush into the organ transplant business.
Chen believes that while small and medium-sized hospitals are performing transplants in order to prove their comprehensive medical level without paying excessive attention to profits, most big hospitals are lured by the prospect of making a lot of money.
A serious consequence of the lax control over the organ transplant business is the waste of medical resources: human, financial, and more importantly, invaluable organs. The lax control has also led to low medical quality. Without proper post-operative nursing care, patients are very likely to develop infections or other complications.
China still lacks a nationwide donor network, an important factor that creates severe competition in the organ transplant business and gives rise to a black market in human organs.
The emergence of a black market raises the cost of organs, and in turn makes such surgery more expensive. Without the restriction of laws and regulations, some people might take advantage of their private relationship networks to take donated organs ahead of those who badly need them, forcing the latter to wait or die.
Legislation can’t be delayed
Experts began to appeal for legislation to regulate the industry long ago.
In 1996, some 108 members of the National Committee of the Chinese People’s Political Consultative Conference (CPPCC) jointly proposed that legislation on organ donations should be first enacted for big cities like Beijing and Shanghai. The appeal for the legislation has been repeated at the National People’s Congress and CPPCC annual sessions. In April 2000, the Ministry of Health began drafting regulations on organ transplants.
While the draft of a nationwide law has been slow to come, local regulations have been developed in some places. In 2003, the Shenzhen Special Economic Zone saw the promulgation of China’s first local regulation on organ transplants, followed by central China’s Sichuan Province and Hunan Province. Nevertheless, local regulations pale in the face of the major problem around the country.
Vice Health Minister Huang, who is an expert on organ transplants, realized the urgency of enacting a nationwide law on this issue and it was with his strong support that the Temporary Regulations were at last worked out after several revisions.
The Temporary Regulations define specific requirements for the organ transplant business and also the accountability of the central and local governments.
According to this regulation, only third-level grade-A hospitals with licensed doctors are eligible to apply to conduct organ transplant surgery, and these medical institutions can only conduct such surgery with the prior approval of the hospital’s transplant ethics committee.
In line with this regulation, the Ministry of Health will deal with organ transplant issues throughout the country and draft clinical criteria for transplants. Provincial government health departments are required to have strong control over the quality and quantity of transplant hospitals.
This regulation also explicitly states that even if the donor is an executed prisoner, written permission is required from either the prisoner or his family. Medical institutions conducting this surgery are also required to inform donors and their families of the risks of organ removal, post-operative care, potential syndromes and preventative measures.
Establishing transplant ethics committees is something most Chinese hospitals never experienced before.
“The Temporary Regulations issued this time are only basic measures, which I’m afraid will not play an effective role,” said Chen Dazhi of the Beijing Organ Transplant Center.
Chen Zhonghua, Vice Chairman of the China Medical Association and an organ transplant expert, believes that while the era of no rules has ended, there is still a long way to go before China has a well-developed legal system for organ transplants