China’s Ministry of Health recently drafted a new organ transplant directive called “Management for the Acquisition and Allocation of Organs.” The directive should be implemented soon in the hope of setting up a fairer and more transparent organ distribution system as well as a national database.

A national organ database is an institution specifically set up for the procurement of human organs. It is independent from hospital organ transplant services, and is responsible for medical evaluation, data collection, organ procurement, distribution, transport, and the handover to the hospital undertaking the transplant operation.

In other countries around the world, a national organ database makes up an integral part of the transplant system. Previously in China, the death determination, organ procurement and transplant operation were generally all carried out at the same hospital. It lacked transparency. This is not only about the rights and interests of the donors and the fairness of the organ distribution system, but also about the possible conflicts of interest at the hospitals involved.

Huang Jiefu, the Vice Minister for Health, told Caixin that the creation of a sustainable organ donation system that conforms with social ethics is imminent. He revealed that a national database to record and distribute human organ donations was being established so that “hospitals are completely prevented from interfering in the procurement and distribution” of organs.

A convict's *donation*

China is the only country that systematically uses organs procured from executed convicts. A statistic from the Ministry of Health shows that, up to the end of 2009, 65% of transplanted organs came from cadaver donors (dead people). Among which, 90% were from executed prisoners. 35% of transplanted organs come from live donors.

In order to change this, in 2010, the Ministry of Health commissioned the Red Cross Society of China to launch a pilot trial of the organ donation program to raise awareness for voluntary organ donation. In 2011, the Ministry of Health carried out a one-year trial with voluntary donors who had been victims of cardiac arrests. It encouraged qualified hospitals to be incorporated into the operation so as to experience independent procurement and distribution of donated organs and offered the organs to the pilot hospitals.

As a new concept, the national organ donation system is gradually finding its place in China. Among its various functions, the public is most concerned about whether the donor’s rights, interests and dignity have been vigorously protected, and whether the donated organs have been distributed in a fair and transparent manner.

According to China’s policy provisions, there are currently 164 qualified hospitals accredited by China’s Ministry of Health as organ transplant hospitals. They are part of a network supporting the creation of the national organ database. This will maintain the transparency of organ procurement and cut off any direct link between procurement and allocation.

Even though under the current regulation China’s national organ database is not independent from the network of qualified transplant hospitals, the procurement and distribution of organs will be supervised by a committee headed by the Red Cross Society of China.

“This line of thought comes from the Spanish model,” Wang Haibo, who oversees the national organ donation allocation system, told Caixin.

Indeed, two models prevail internationally. One of them is represented by the American system, where the organization is set up independently from medical institutions. The other is the Spanish system, where a donating coordination team is established within the transplant hospitals, and remains independent from the hospital’s transplant team.

The American model involves a more complex system, has a higher operational cost, and higher requirements of professional qualification for staff and equipment. For China, which is still at the initial stage of creating a new system, the Spanish model is clearly more suitable.

Network effect

Therefore, the hospital simply has to set up an independent procurement team funded by the hospital. Wang Haibo stressed that with the relative independence of the procurement team and the transplant team, even if they are composed of the same people, it won’t affect the fairness of the operation.

“The procurement team is also the most ideal transplant team, because the doctors can better determine which blood vessels need to be kept longer, or if other components are needed,” Wang said.

As for distribution, the new regulation requires that they should be allocated and shared under a unified system. The study and set-up of the system was commissioned in 2009 to Hong Kong University and was launched in April last year. The allocation system is based on the principles of medical ethics and scientific reason in line with international practice. It takes into comprehensive account the patient data from the entire database so as to assign the organs to the patients who most need them, as well as to those who best meet the conditions.

As a result, the procurement organization can in no way intervene directly in the allocation. Neither the procuring doctor nor the transplant doctor can decide the order of distribution. Neither can the hospital have direct access to organs of unknown origin and distribute them privately.

However, according to expert opinion, it’s still a long road before Chinese transplant hospitals can develop into mature organ procurement organizations. A proper procurement organization is very complex and requires integrated cutting-edge technology and advanced management.

For the moment, China still does not have a comprehensive network for donation and transplants. There are over 20,000 hospitals nationwide, whereas only 164 hospitals are accredited for organ procurement and transplants. They remain subject to geographical distance limits in their day-to-day operations. From the sudden death of a donor to his family’s agreement, the completion of relevant procedures often exceeds the acceptable organ warm ischemic time and affects the use of the organs. As Wang Haibo pointed out, such an organ procurement network is obviously needed to improve efficiency.

In the United States, 58 independent organ procurement organizations (OPOs) coordinated the donation process. Each of these organizations is a member of the organ procurement and transplantation network (OPTN). Hospitals are also asked to cooperate with OPOs so that no matter whether patients are dying or have just died, they will notify the organizations in the most timely manner.

The Ministry of Health is encouraging more hospitals in China to apply as accredited organ procurement organizations. At the same time, a set of standards are to be established so as to assess the quantity as well as quality of operations of the accredited hospitals and avoid the waste of the very limited organ resources.