Preface

Organ transplantation is a major biomedical development in the 20th century. This technique has gradually matured from clinical experiments to clinical applications and has become an effective medical procedure for treating terminal organ failure. This has saved thousands of patients with organ failure and promoted biomedical science development in China. As organ transplantation requires organs for transplantation from either cadavers or living relatives, it involves social, religious, ethical, political, and legal problems and is intimately associated with a country’s traditional culture and socio-economic development.

Organ transplantation needs to take root in China’s traditional culture, matches China’s state of social development, and comply with globally recognized ethical principles. On March 16, 2006, the former Ministry of Health issued the “Interim Provisions on Clinical Application and Management of Human Organ Transplantation” (Ministry of Health [2006] No. 94) requiring transplantation hospitals to conduct technology access review, unify standards, and stringent management. In the same year, the National Human Organ Transplantation Clinical Application Management Summit was held in Guangzhou and medical staff in the transplantation community reformed the consensus on organ transplantation and issued the “Guangzhou Declaration”. This officially heralded the start of reorganization of national organ transplantation medical institutions. The Chinese government pays much attention to the development of human organ donation and transplantation. In May 2007, China’s first “Regulations on Human Organ Transplantation”(hereinafter referred to as “regulations” were officially promulgated by the State Council of the People’s Republic of China. This symbolizes the gradual improvement in the construction of a human organ donation and transplantation working system in China. In the same year, the former Ministry of Health issued the “Notice of the General Office of the Ministry of Health on the Issues concerning the Application by an Overseas Person for Human Organ Transplantation” (Ministry of Health [2007] No. 11) stipulating the foreign citizens are prohibited from coming to China for organ transplantation tourism. In 2010, the former Ministry of Health and the Red Cross Society of China jointly initiated the “Pilot Program for Organ Donation for Citizens after Death”. China’s social development stage and traditional culture were used as a basis to establish an organ donation mobilization and witness system in which the Red Cross Society of China is a third-party and international general rules and China’s condition were used to propose three types of death judgment criteria for organ donation after citizens have died: Class I (organ donation after brain death); Class II (organ donation after cardiac death); and Class III (organ donation after brain and cardiac death). This laid the theoretical foundation for determining voluntary organ donation after Chinese citizens have died. In 2011, China issued the “Amendment (VIII) to the Criminal Law”that strictly prohibits organ trading and added an “organ trading crime” to further strengthen the legalization of organ donation. In 2011, the China Organ Transplant Response System (COTRS) became operational online. A computer system is used for autonomous allocation with regional priority, critical condition priority, tissue type priority, child priority, matched blood type priority, priority for direct relative of organ donor, rare opportunity priority, waiting sequence priority, and other international organ procurement and allocation principles were complied and an organ donation coordination team was constructed in an orderly manner.

After more than 3 years of efforts, the pilot program achieved success and a more mature work system was developed and a national organ donation management center by the Red Cross Society of China was constructed. On 25 February 2013, the former Ministry of Health and the Red Cross Society of China officially launched voluntary organ donation by citizens after death at the national level. All organ transplantation hospitals must be authorized by the health administrative department to set up organ procurement organizations (OPOs) and organ donation offices. In August 2013, the former National Health and Family Planning Commission promulgated “Human Organ Procurement and Allocation Management Regulations (Interim)”, which required all transplantation medical institutions to strictly use COTRS for organ allocation. All institutions, organizations, and individuals are not allowed to allocate donated organs outside of the organ allocation system to ensure that donated human organs are allocated in an open, fair, equal, and traceable manner. In addition, the “Hangzhou Resolution” was announced in the transplantation community. On December 19, 2013, the General Office of the Chinese Communist Party and the General Office of the State Council issued the “Opinions on Party Members and Cadres in Leading Funeral Reform” that encouraged party members and cadres to donate organs and cadavers after death. According to the “Rule of Law” spirit of Fourth Plenary Session of the 18th Central Committee of the Communist Party of China, on December 3, 2014, the National Human Organ Donation and Transplantation Committee officially announced a complete ban in using organs from death row prisoners. This reform received a positive response from the whole of society and recognition from international transplantation societies. As the Chinese saying “It takes 10 years to forge a sword” goes, China has undergone reform to establish 5 major organ donation and transplantation systems (organ donation system, organ procurement and allocation system, organ transplantation medical service system, organ transplantation quality control system, and organ transplantation monitoring system) and has greatly promoted a loving spirit of organ donation in society and a fair, transparent, and cheery atmosphere of voluntary organ donation by citizens has gradually developed in the whole of society.

Health is a common goal of mankind and China’s continuous efforts are indispensable to global hygiene and health. Hence, China’s hygiene and health also requires support from other countries. In recent years, China has gradually strengthened exchange and collaboration with many countries and comprehensively demonstrated the top-level design, system construction, laws and regulations, and working system of organ transplantation in China. In addition, China has provided relevant data and analysis results to the international community through the World Health Organization Global Organ Transplantation Monitoring Network and demonstrate China’s achievements in human organ donation and transplantation in an open and transparent manner. China’s reform has obtained recognition and support from the international community. Since 2006, international organ transplantation experts have provided assistance and guidance to China and jointly published a series of papers on reform with Chinese experts in authoritative international organ transplantation journals. These papers included the “Guangzhou Declaration”in 2006, “Hangzhou Resolution” in 2013, and “Kunming Declaration” in 2019. These experts have witnessed China’s organ transplantation reform, and recognized improvements achieved in China’s organ transplantation reform in a factual, objective, and fair manner. In August 2016, the 26th International Congress of The Transplantation Society was held in Hong Kong. This is the first Transplantation Society congress held in China, and this is the first time that the congress invited a Chinese expert team to participate in the congress. Professor Jiefu Huang gave the keynote speech during the opening ceremony of the congress and introduced China’s 10-year organ transplantation reform process to the world. In October 2016, the China Organ Transplantation Development Foundation and many Chinese and international organ transplantation organizations jointly organized the 1st “China-International Organ Donation Congress” in the Gold Hall of the Great Hall of the People in Beijing. Many experts from institution organ transplantation societies attended the congress and witnessed the official entry of China’s organ transplantation into the international community. In February 2017, China was invited to participate in the “Summit on Organ Trafficking and Transplant Tourism” organized by the Pontifical Academy of Sciences. In the face of complex international situation, Chinese representatives factually presented China’s voice and narrated China’s story, which was widely recognized by leaders from many countries. The “Chinese protocol” for organ donation and transplantation was heralded by the World Health Organization as China’s innovation and contribution to transplantation in the world. During the summit, Professor Francis Delmonico, chairman of the WHO Task Force on Donation and Transplantation of Human Organs and Tissues, mentioned that “Your bones are also our bones, your improvement is also our improvement” and China has gradually integrated into the large international organ transplantation community. Professor José Ramón Núñez, a medical officer in charge of transplantation at World Health Organization once said that “China wasn’t on the ship of world organ transplantation, and we had no idea where it headed. But after 2015, China has been standing in the center of the ship.” In March 2018, a declaration on China’s organ transplantation reform experience was released during the “Ethics in Action” meeting jointly organized by the United Nations and the Pontifical Academy of Sciences. In the meeting, the “Pontifical Academy of Sciences Ethics in Action meeting declaration”mentioned that “The basic characteristics of the China model are demonstrated by the determination of the Chinese government in continuous reform and cooperation between transplantation experts led by Professor Jiefu Huang and the government: in efficient implementation of organ transplantation reform measures”. In May 2018, China participated in the 71st World Health Assembly and 100 transplantation experts from China attended the meeting and introduced China’s reform experience. The Director-General of the World Health Organization, Dr. Tedros Adhanom praised and thanked China for its contributions to world transplantation. In August 2018, the WHO Task Force on Donation and Transplantation of Human Organs and Tissues that China suggested to set up was officially formed at the 27th International Congress of The Transplantation Society, which was held in Madrid, Spain. 31 experts form this task force, of which 2 were from China. Jiefu Huang was nominated as a World Health Organization transplantation consultant and China has started contributing its knowledge for global governance of transplantation.

In recent years, China has successively promulgated and established regulations and systems for organ donation. For example, in 2016, 6 national departments such as the Ministry of Transport, Civil Aviation Administration, and National Railway Administration jointly set up a green channel for organ transportation to gain precious time to save lives. In May 2017, the “Law of the People’s Republic of China on the Red Cross Society” was revised to clearly promote organ donation and explore charity organizations and other humanitarian relief mechanisms. The quantity and quality of organ donations and transplantations in China is undergoing rapid development. From 2015 to 2018, the number of organ donations increased continuously at a rate of 22%-47.5%. In 2015, 2016, 2017, and 2018, the number of deceased organ donations was 2766, 4080, 5146, and 6302, respectively. In addition, there were 2200-2500 living relative donations every year. In 2018, 20201 organ transplantation surgeries were carried out, which was ranked second globally. In 2019, the National Health Commission mentioned that China’s organ donation and transplantation work will transition from rapid increase to high quality development and mainly focus on structural reform at the supply end. While aggressively promoting organ donation, organ transplantation clinical service quality layout will be further optimized; donation, procurement, and allocation management will be strengthened; the procedure for determining brain death will be regulated; and capabilities in reducing systematic risk will be strengthened to achieve effective growth in quantity while increasing quality. This will enable high quality, more efficient, fairer, and sustainable development. In 2019, 5813 deceased organ donations were completed. Up till November 2020, 4768 deceased organ donations were completed even though coronavirus disease 2019 affected donation. Organ transplantation medicine quality has continuously improved and the 1-year and 5-year survival rates have reached global advanced levels and many innovative organ transplantation techniques have emerged. Examples include: liver auto transplantation and non-ischemic organ transplantation, which China is leading internationally. Breakthroughs were also achieved in incompatible blood type renal transplantation. China's single-center pediatric liver transplantation and heart transplantation clinical services are also top in the world. China has also established a liver transplantation alliance and has made continuous improvements in organ storage and donor organ maintenance techniques. China’s clinical experience in liver cancer liver transplantation and hepatitis B liver transplantation have also gradually received international recognition. After many years of efforts, active progress was made in China’s organ donation and transplantation industry to basically form an organ donation and transplantation working model that is scientific and fair, complies with ethics, and in line with China’s condition and culture. The China National Organ Donation and Transplantation Committee was set up for top-level design. The committee confirm the basic thought processes for human organ donation and transplantation work and established a “government-led, department-coordinated, industry-promoted, and society-supported” working model.

On October 2019, the Fourth Plenary Session of the 19th Central Committee of the Communist Party of China proposed to maintain and improve China’s system of socialist characteristics and promote modernization of the national governance system and governance capabilities. We will actively heed the call of the party, improve modernization in organ transplantation reform, strengthen system and capacity building, face challenges in a bold and steadfast manner, and continuously improve ourselves to protect reform achievements that were not easily obtained. We will strive to establish a complete organ donation and transplantation system that complies with ethics and World Health Organization principles, strive to reach the science and technology peak in organ transplantation medicine, actively promote “Belt and Road Initiative” international collaboration in organ donation and transplantation, and demonstrate a responsible major political country to the international community, and contribute to establishing a “Community with shared future for mankind”.

This report records the achievements in the new phase of China’s organ transplantation history and development to demonstrate China’s organ transplantation reform experience to the world. Every year, the China Organ Transplantation Development Foundation will draft new editions and both English and Chinese versions will be simultaneously released.

Editorial Committee

December, 2020