FrancislDelmonico

Boston, USA

Editorial

Organ transplantation in China—the 21st century

FrancislDelmonico

Boston, USA

Introduction

China has emerged as an economic power internationally and it now naturally seeks to influence the conduct of medical affairs—to improve the condition of the Chinese people; but also, for the benefit of mankind throughout the world. Organ transplantation is a field of medicine that epitomizes that advance of medical care; and again, the transplantation experience of China will be an important reflection of China's stature in the conduct of medical affairs internationally. The trajectory of economic might that would impact the practice of medicine worldwide will be influenced in part by an alignment of China policy to well established international standards of medical practice. The suggestion of compliance with international standards as a prerequisite for China's influence in the 21st century does not require an exclusion of the great traditions and history of China that have shaped China's culture. Nevertheless, there are fundamental aspects of practice for successful organ donation and transplantation that now demand China's attention. Encouragingly, China is well-equipped in technical and academic talent; but now outstanding policy leadership has also emerged within China to achieve that goal of an alignment to global standards and it is exemplified by the China Liver Transplant Registry (CLTR).

In a recent national assembly convened in Hangzhou, sponsored by the Ministry of Health and the Red Cross of China an invited keynote presentation was made on behalf of The Transplantation Society (TTS) endorsing the efforts of the CLTR to achieve a transparency of registry events, to develop an ethically proper program of deceased donation as an alternative to the use of organs from executed prisoners, and to develop an equitable system of organ allocation. TTS commends the strategic plan of the CLTR to accomplish these objectives consistent with Declaration of Istanbul and the Resolution of the 63rd World Health Assembly of 2010.

Transparency

The World Health Organization (WHO) has stated clearly in its revised Guiding Principles[1]that "donation and transplantation activities, as well as their clinical results, must be transparent and open to scrutiny, while ensuring that the personal anonymity and privacy of donors and recipients are always protected". The CLTR has an opportunity to make transparent by an annual release of information, a reduction in the practice of liver transplantation from executed prisoners. TTS supports that annual report of data from the CLTR consistent with the China statement made by TTS in 2006 that posed the following question and answer: Should international registries accept data from patients transplanted with organs or tissues from executed prisoners? TTS replied affirmatively yes! The need for transparency and for assembling comprehensive demographic data on the international practice of transplantation dictates that these data should be accepted. The source of the organ or tissue should be clearly identified and recorded as procured from an executed prisoner. Such data should not be incorporated in the total analysis of outcomes of transplantation or other scientific registry studies.

Vice Minister Jie-Fu Huang has recently announced China's direction to phase out recovering organs from executed prisoners and that intention will be validated by the CLTR report.[2]The importance of such a report will be to enable presentations from China transplantprofessionals at international congresses and published in the international medical literature.

The dead donor rule and determining death in deceased organ donation

The dead donor rule maintains that recovery of organs should not cause the death of an individual, and it is the ethical axiom pertaining to deceased organ donation that is practiced worldwide. Determining death by neurologic criteria is also well established internationally and that standard has been embraced by the CLTR. Notwithstanding a Chinese culture that up to now has not been engaged in the brain death concept, it is important to note we are a common humanity that dies similarly, with a decomposition of our bodily organs within hours of our death. Death is indeed a process but there is a finality that can be legally and medically determined; for again, we are a common humanity whose ultimate criterion of life resides in the function of the human brain (responsible for our consciousness) and brainstem (responsible for our spontaneous breathing). That vital function of the brain is not replaceable or transplantable in contrast to the function of other organs such as the heart, liver and kidneys. The irreversible loss of brain function is a clinical condition that is not restorable or resolvable. Thus, the concept of death by neurologic function or brain death affords an opportunity for deceased organ donation in China as well that is unique (versus the heart or liver function) yet common to us all as a common humanity. The scientific (meaning consistently determined) medical and now internationally legally accepted concept of death will require societal education to achieve its acceptance. The CLTR recognizing the importance of the brain death concept in the evolution of deceased organ donation within China has now developed an ethically proper program that adheres to the dead donor rule.

New protocol of deceased donation

In collaboration with Professor Hue of Guangzhou, the CLTR has been a leader in the development of a new program of deceased donation that entails the determination of death by neurologic criteria. Even though brain death is not legally recognized yet in China, the "DBCD" (donation after brain and cardiac death) program facilitates organ donation with brain death recognized in the hospital intensive care unit. Futile pressor and ventilator support can be withdrawn from such patients after consultation with family that separately derives consent for organ donation. The implementation of an extracorporeal membrane oxygen device enhances the opportunity of successful organ recovery. Minister Huang has termed this program of determining brain death yet proceeding to organ recovery after asystole as "deceased donation with China characteristics". TTS endorses the implementation of this DBCD program throughout China as the alternative to the use of organs from executed prisoner as it is noteworthy for its ethical propriety and consistent with international standards.

Equitable allocation of organs

Drs. Haibo Wang and Sheung Tat Fan, representing the CLTR, have developed an objective ranking index of medical criteria for organ allocation in China to include disease severity, donor recipient age matching, blood type and HLA matching, and waiting time of the candidate. To encourage organ donation, ranking priority is also granted to those who were living donors or any of the immediate family members was a deceased donor. This direction fulfills international standards again set forth by the WHO that "the allocation of organs, cells and tissues should be guided by clinical criteria and ethical norms, financial or other considerations. Allocation rules, defined by appropriately constituted committees, should be equitable, externally justified, and transparent".[1]The WHO has also suggested that there be ministerial and public oversight of updated comprehensive reports regarding the system of organ allocation verifying that it is equitable and transparent. Distribution of the organs is done geographically, initially to the transplant center within the organ procurement organization, then to other regional transplant centers within the province, and then finally to a national list.

Societal support of organ donation

Consent for organ donation will only be derived from society if oversight establishes organs to be equitably allocated to a waitlist of patients developed objectively through a computerized process with each organ donor. If the public has the perception that corruption is involved with the organ donation program of the country it will not donate organs. Transparency again becomes paramount to success. In that regard, the CLTR has developed an objective and verifiable computerized program to accomplish this goal. TTS supports the CLTR efforts to implement a national system of organ allocation verifiable to the community.The international standard that prohibits the buying and selling of organs becomes the most important component of the allocation system. It also requires for a program of deceased donation that does not seem to bribe families for consent by the provision of cash benefits restricted to families that consent. Deceased organ donation is a community effort and a reflection of the solidarity of the Chinese people to benefit their fellow man. Again, corruption of the program that would enable foreign patients to illegally undergo transplantation in China will doom the system to fail. TTS supports the regulations of China that prohibit organ trafficking, the buying and selling of organs, the illegal transplantation of organs to foreign patients. The CLTR program is a beacon of propriety consistent with international standards that brings China into the 21st century of organ donation and transplantation with much anticipation of success.

Contributors:DFL proposed the study, wrote the whole article, and is the guarantor.

Funding:None.

Ethical approval:Not needed.

Competing interest:No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article.

May 10, 2012

Accepted after revision June 17, 2012

Author Affiliations: Department of Surgery, Massachusetts General Hospital, Harvard University, Boston, Massachusetts, USA (Delmonico FL)

FrancislDelmonico, MD, Department of Surgery, Massachusetts General Hospital, Harvard University, Boston, Massachusetts, USA (Tel: 617-726-2825; Email: francis_delmonico@neob. org)

? 2012, Hepatobiliary Pancreat Dis Int. All rights reserved.

10.1016/S1499-3872(12)60191-X

1 World Health Organization. WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation. Accessed at www.who.int/transplantation/Guiding_PrinciplesTransplant ation_WHA63.22en.pdf on 24 September 2010.

2 Huang J, Millis JM, Mao Y, Millis MA, Sang X, Zhong S. A pilot programme of organ donation after cardiac death in China. Lancet 2012;379:862-865.