Organ Donation and Transplantation in China

The article by authors from the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, People’s Republic of China describes the outcome of liver transplants at this institution since 2015 and records the medical and legislative history of organ transplantation in China and of organ transplantation in Guangzhou1 (in this issue). An invited commentary on the current and the past practices of organ donation in China reflecting on challenges and achievements appears timely and relevant. The date of 2015 is important for the review of any organ transplantation report from China because of the public proclamation in the media in 2015 prohibiting the use of organs from executed prisoners. Clinical transplantation articles antecedent to 2015 have been consistently rejected by Transplantation and the international community because the source of the transplanted organs was most often an incarcerated prisoner. China took a major step to condemn this practice publicly in 2015. However, because there is no law or regulation that prohibits this unethical practice, there has been ongoing concern that this practice may be continuing. Notwithstanding such a reality, there have been regulations that are citable and may be reflective of the changing experience of organ donation and transplantation in China that are consistent with the World Health Organization (WHO) Guiding Principles.2-5 EMERGING REGULATIONS AND PRACTICES WITH CITABLE REFERENCES The Civil Code of the People’s Republic of China adopted by the 13th National Congress on May 28, 2020, defines voluntary organ donation (Article 1006) and prohibits the purchase or sale of human cells, tissues, or organs (Article 1007).4 The evolution of organ donation and transplantation in China is also evident by the following developments reported in the medical literature: On September 7, 2021, mandated by the Bureau of Medical Administration of the National Health Commission, the China Organ Transplantation Development Foundation established the China Organ Transplant Response System (COTRS) Scientific Committee. This Committee is composed of clinical experts in transplantation, health administrative executives, medical ethics experts, and experts from Organ Procurement Organizations in China. It is modeled after the United Network for Organ Sharing in the US, the National Transplant Organization in Spain, and the National Health Service Blood and Transplant in the United Kingdom. The COTRS Scientific Committee consists of 6 working groups, each focusing on heart, lung, liver, kidney, pancreas, and small bowel transplantation. The national representative committee members come from 74 medical institutions, covering all geographic regions of China, accounting for 83% of total transplant procedures in China. This group is tasked with reviewing transplant activity in China, assessing organ distribution algorithms, and addressing any irregularities that are discovered.6 The professional societies and international community should applaud these developments. WHAT CONTINUES TO BE OBJECTIONABLE The Chinese Red Cross is prominent in the organ donation process and a center of support for deceased donor families designated by the Red Cross as humanitarian aid to donor families.7 However, such humanitarian aid, although not limited to China, should not be misinterpreted to be an effort because it includes payment to elicit consent for donation. The Sun Yat-sen publication suggests that the Red Cross policies follow WHO guidelines while recognizing specific aspects of Chinese culture without elaboration as to the cultural details. A payment to donor families for funeral expenses or other monetary incentives should be recognized as a form of commercialization and would not comply with WHO guidelines. WHAT REMAINS UNKNOWN The report by the Sun Yat-sen group is an important step in providing transparent transplant data. However, data from China (and from many other countries) lack verifiable reporting on demographics of living and deceased donor organs. Other questions remain unanswered: What is the relationship of the donor to the recipient? How are the recipients of the waitlist selected? Does every citizen of China (or of any other country) have access to their respective waiting lists? How is a deceased organ donor defined? Although the Global Observatory of the WHO (with the National Agency of Spain) publishes the reported number of live and deceased donated transplants, source documentation is not uniformly available for verification. Additionally, there are no outcome data. Transparent and validated data are essential for global review as recently elaborated by the proceedings of the Workshop organized by the Pontifical Academy of Sciences and cosponsored by the WHO titled “The role of Science in the Development of International Standards of Organ Donation and Transplantation.”8 A central limitation is that China and many other countries have not addressed important health issues related to the World Health Assembly Resolution 63.22 linked to the United Nations Sustainable Development Goals to quantify the true burden of disease and identify causes of premature death related to noncommunicable disease.5,9 There have been nascent attempts to quantify the burden of end-stage kidney and liver disease,10 but a more complete analysis of the true number of patients with end-stage organ disease as well as robust outcome data after transplantation will be an important reflection of China’s ascendancy as a world leader in transplantation. THE USE OF ORGANS FROM THE EXECUTED PRISONER We commend the Sun Yat-sen group’s historical perspective of the evolution away from the use of prisoners’ organs. However, the written assurance to refute the ongoing assertions that the use of executed prisoners has totally stopped, and has not been achieved. What appears to have transpired in China over the past 7 y is the transition to a donor system based on voluntary citizen donation after death (brain death or cardiovascular death) and the use of live voluntary donors, both under strict government control. It needs to be noted that a prisoner has citizen rights, which requires an in-depth understanding of voluntarism attainable while incarcerated in China. The central role that is emerging for COTRS is significant, with an oversight responsibility that would stop the recovery of organs from any incarcerated individual. THE CONTRIBUTION OF COTRS AND THE CHALLENGES The development of COTRS has been a major advance to streamline the distribution of donated organs, facilitate timely transplantation, and enhance transparency of the transplant process. Further advances that would benefit the greater transplant community would be the formation of a common database with shared definitions to enable the review of a center’s or country’s outcome data in the context of accepted standards. Within that context, we would anticipate a learning curve. Just as we understand that there exists a learning curve in an individual surgeon’s development, we would also anticipate a learning curve as a center or region, or country develops robust comprehensive national transplant activity and reporting. Despite its central role that COTRS plays in donation and transplantation in China, the challenge remains to develop international standards through which we can evaluate and validate viewpoints, outcomes, and approaches. The Sun Yat-sen publication underscores the importance of sharing verifiable transplantation information globally to address clinical, social, and ethical issues.1 The large number of transplants in China (nearly 19 000 reported to the Global Observatory in 2021)11 is the result of a regional distribution of organs, rather than a broader system of sharing. Specific attempts at broader sharing to address the needs of pediatric recipients are being explored, but these efforts have not been expanded for adult patients. Liver distribution is based on Model for End-Stage Liver Disease scoring as reported by the authors from Sun Yat-sen. However, exception points allotted for hepatocellular carcinoma in this system appear to outweigh severity of disease in the distribution scheme outlined, with most liver transplants performed for Hepatocellular Carcinoma. It also appears that there is a large regional distribution under the control of the regional hospital that performs the procurement. In comparing the results of this center, it would be most useful to see an objective assessment of the recipient’s condition (such as Model for End-Stage Liver Disease or other measures of comorbid conditions) to better analyze outcomes. Since the most common diagnosis in patients undergoing liver transplant is hepatocellular carcinoma, it would be useful to correlate the outcomes with the extent of Hepatocellular Carcinoma. Although the authors note that Milan/University of California, San Francisco criteria are used to select patients, the data presented are lacking in the distinction of patients outside these criteria. The authors note improved survival in patients exceeding standard criteria with the use of local/regional therapies but unfortunately do not present this data. THE IMPORTANCE OF CHINA TO THE INTERNATIONAL COMMUNITY The size of the organ donation and transplantation experience of China since 2015 is compelling. China has an important opportunity (and responsibility) to contribute to the scientific development of organ transplantation that addresses the enormous burden of disease that is unfolding not only in China, but also worldwide. The efforts of the Sun Yat-sen group are welcomed and become a preview of the contribution of China that is anticipated in the decade ahead.