Legal Framework on Organ Donation and Transplantation in China

INTRODUCTION Organ donation and transplantation in China have undergone remarkable progress, driven by the dedicated efforts and continuous learning of the Chinese medical community. These efforts culminated in a significant achievement by the end of 2014. Since then, China has made steady advancements in amending regulations, implementing ethics committees and formalizing donor evaluations. Progress has also been made in organ donation and in related fields, such as quality management, machine perfusion, and xenotransplantation. Despite these achievements, misunderstandings, criticism, and misinterpretations continue1-5 raising questions about the sources and legal framework of organ donation and transplantation. In this article, we outline the development and current status of China’s legal framework for organ donation and transplantation, its foundation in the Chinese Civil Code, and the ongoing improvements reflected in the recently updated Regulations on Organ Donation and Transplantation. HISTORICAL BACKGROUND OF ORGAN DONATION AND TRANSPLANTATION BEFORE DECEMBER 2014 Organ transplantation in China began with the first kidney transplant in 1960 and the first successful living donor transplant in 1972 at Peking University First Hospital. Early development lacked legal regulation, standardized practices, and oversight, and organs from executed prisoners were the primary source. Historically, similar practices occurred in France (1950s), the US (1960s–1970s), mainland China (until December 31, 2014), Taiwan China (before July 2020), and remain legally permitted in Singapore. 6-11 To address ethical concerns and align with international norms, China launched systemic reforms. In 2005, it committed to ending organ use from executed prisoners and building a voluntary, unpaid donation system. 12 This was followed by regulatory milestones: the 2006 Interim Provisions, 2007 State Council Regulation No. 491 (defining hospital accreditation, banning trafficking, and requiring fair allocation per World Health Organization WHO guidelines), 13, 14 and the 2011 Amendment (VIII) criminalizing organ trade. 15, 16 Key institutional developments included the national transplant registry (2004), hospital accreditation reduction (from 600+ to 164 by 2007), and the 2010 clinical guidelines. A pilot program for deceased organ donation began in 2010, supported by the Red Cross Society of China (RCSC) and the China Organ Donation Administrative Center (CODAC), which trained >2500 coordinators by 2019. 16, 17 A 3-tier donor classification system was introduced—donation after brain death (DBD; category I), donation after circulatory death (DCD; category II, Maastricht III), and donation after brain-circulatory death (DBCD; category III, Maastricht IV) 17-21—along with national brain death criteria (2013) and a quality control training center at Xuanwu Hospital. 17, 18 Nationwide implementation of the opt-in donation system began on February 25, 2013. Organ procurement organizations (OPOs) and donation offices were established in transplant hospitals nationwide. 17 The China Organ Transplant Response System (COTRS), developed in 2011, became mandatory in 2013 for all voluntary deceased donations, ensuring fair and transparent allocation based on medical urgency, region, and compatibility. 19 By 2013, the pilot reforms were adopted nationally, marking a transition to a law-based, citizen-driven organ donation framework aligned with international ethical standards. LEGAL FRAMEWORK AND REGULATIONS SINCE JANUARY 2015 Since late 2014, China’s organ transplantation system has undergone extensive reform, well-documented in the literature. 13, 15-17, 20-32 On December 3, 2014, the China Human Organ Donation and Transplantation Committee announced that, starting January 1, 2015, organs from executed prisoners would no longer be used; voluntary citizen donation is the sole legal source for deceased donor transplantation established in an opt-in system. 22 Organ transplantation in China is overseen by the National Health Commission and the RCSC, which together formed the National Organ Donation and Transplantation Committee. This body coordinates 5 key areas: donation, procurement, allocation, clinical services, and posttransplant follow-up. System components include the CODAC, trained coordinators, the COTRS, and OPOs. 23 Governance is maintained through systematic audits and data oversight via COTRS. 13 In 2025, the total number of hospitals qualified for organ transplantation is 187 including liver (117), kidney (158), heart (58), lung (36), pancreas (33), and small intestine (24). 33 In 2017, a major European Union-China collaboration (Knowledge Transfer and Leadership in Organ Donation from Europe to China) was launched to advance education and leadership in organ donation. Supported by the EU Erasmus Programme, 31 it involved key Chinese institutions—including Capital Medical University, Shanghai Jiao Tong University, and the University of Science and Technology of China—and European partners such as the University of Barcelona, University of Bologna, and University of Nice. 34 China’s reforms have received international recognition. On October 19, 2024, the World Medical Association (WMA) adopted a revised resolution acknowledging China’s elimination of organ use from prisoners. 35 PROSECUTION OF MISCONDUCT When individuals who have received an organ come for treatment into a hospital, an automatic check with the COTRS system is performed. In case the individual is not registered in COTRS, an investigation will be initiated. The same situation applies for people dying in a hospital, they will receive a serial number and official stamp, certifying their death. A 2019 incident in China involving Huaiyuan County Hospital (Anhui Province) and Nanjing (Jiangsu Province) highlights the oversight within the Chinese organ donation and transplantation system. “In 2018, a man named Shi became suspicious about his mother’s alleged organ donation after noticing the donation list lacked a serial number and official stamp. When he visited the CODAC in Beijing, he found no official record of her donation, indicating the procedure was unauthorized and not overseen by the Red Cross. Shi’s family had received 200, 000 yuan (approx. 28, 500) as a so-called ‘national subsidy’ following the removal of his mother’s liver and kidney. However, a Red Cross representative clarified that organ donation in China is free and does not involve state subsidies to families. After reporting the case to local health authorities, Shi was allegedly offered 460, 000 yuan in hush money by one of the doctors involved, Yang, which he refused. Following further escalation to a central investigation team, six medical workers, including Yang, were arrested for their involvement in the illegal organ removal. ” Following reports of illegal organ donation from patients in intensive care unit (ICU) departments between 2017 and 2018, authorities conducted forensic evaluations of both provincial transplant centers, leading to suspensions, jail sentences for 6 doctors, and the closure of 2 transplant centers in Nanjing. This case was widely covered in international media documenting a shift in China’s stance on these practices. 36-39 To improve information on the 2015 implemented changes, the China Organ Transplantation Development Foundation (COTDF) launched the “Life Relay Hundred Cities Tour Program” to implement national policies on organ donation and transplantation in 2023 following the end of COVID. 40 The initiative promotes public awareness, civic engagement, and charitable action across municipalities. To date, COTDF has partnered with 13 cities conducting diverse outreach activities such as illuminating landmarks, unveiling themed subway stations, and organizing sports events to encourage organ donation. 40 COTDF has also advanced volunteer engagement. In 2022, it launched the “Love & Hope Organ Donation Volunteer Service Team, ” now active in nearly 90 institutions nationwide. In 2023, with support from the National Health Commission and the Communist Youth League, COTDF established the “National Youth Volunteer Service Corps for Organ Donation in the Health Sector. ” This youth-led effort promotes awareness, encourages participation, and fosters a favorable environment for voluntary donation through coordinated national activities. 40, 41 CHINESE CIVIL CODE AND REGULATIONS ON ORGAN DONATION AND TRANSPLANTATION On May 28, 2020, the 13th National Congress of the People's Republic of China adopted a Civil Code modeled on the German Civil Code. 42 It defines voluntary organ donation in Article 1006 and prohibits the sale of human organs in Article 1007. The latest “Regulation on Donation and Transplantation of Human Organs, ” issued by the State Council of China (No. 767), became effective on May 1, 2024. 43 The China Organ Transplant Development Reports have been published from 2015 to 2023, providing increasingly detailed data, statistics, and quality assessments. 44–50 The annual donation and transplantation data have been officially reported to the Global Observatory of Donation and Transplantation, 51 with a level of data transparency equivalent to that of other WHO member states. 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