Development Status of Organ Donation and Transplantation in China

Organ donation and transplant cause in China has achieved remarkable achievements through unremitting efforts for several generations. Our work has been understood and recognized by the international community. However, misunderstandings and criticisms, even misinterpretations and denigrations are also available. Our predecessors blazed the trail under arduous conditions, and we explored to move forward under difficult circumstances. Organ transplantation has gone through three development stages in China: the initial exploration stage, the development and construction stage as well as the scientific standardization stage.

Initial exploration stage (1960~2005)

Peking University First Hospital completed the first kidney transplantation in China in 1960, and the First Affiliated Hospital of Sun Yet-sen University completed the first living kidney transplantation in China in 1972, thereby starting organ transplantation in China. All activities of organ donation and transplantation were explored, and the previous generation has done a lot of animal experiments and preliminary preparations for clinical transplantation at the initial stage. Many transplant surgeons, who were young at the time, went abroad to study and brought back advanced experience from Europe and the United States. We had no norms and guidelines, no registration system and no administrative supervision during the period. Executed prisoners serve as main sources of organ donors.

Development and construction stage (2005~2015)

Huang Jiefu, former vice minister of Ministry of Health, pledged the follows on behalf of the Chinese government that China would vigorously promote the reform of the organ transplant system, develop voluntary free organ donation by citizens, gradually reduce and eventually stop using organs donated by executed prisoners in 2005. China begun to establish a legal and standardized system for organ donation and transplantation. Organ donation and transplantation in China was constructed since the legislation in the field of organ transplantation. The former Ministry of Health of the People's Republic of China issued Interim Provisions on The Management of The Clinical Application of Human Organ Transplantation Technology in 2006, thereby establishing a technical access system among organ transplantation institutions. The State Council promulgated Regulations on Human Organ Transplantation on the basis, which was implemented nationwide since May 2007. Suggestions from experts in medicine, law, ethics, sociology, human rights and other fields were accepted for many times during legislation, and WHO was consulted. The laws and regulations of 11 countries and regions on human organ transplantation all over the world were referred in the Regulations. The administrative matters involved in the process of human organ transplantation are stipulated. It is reiterated in the Regulations that organ transplant in China must follow the world health organization guidelines on human organ transplantation, the will of the human organ donors should be respected, it is forbidden to buy and sell human organs, the sorting of patients applying for human organ transplant surgeries should be determined in accordance with the just, fair and open requirements, etc., thereby keeping consistent with the international practice. The promulgation and implementation of the regulations marked the legalization and standardization of organ transplantation in China. The former Ministry of Health reviewed and admitted organ transplant hospitals in 2008 according to the regulations, thereby reducing the number of transplant-qualified medical institutions from more than 600 to 164 (in 2008). A registration system for liver and kidney transplant recipients was established to register and assess the medical quality of transplant programs in the same year. China further promulgated Amendment (VIII) to The Criminal Law in 2011, organ trading is included as a punishment under the criminal law, and the 'crime of organ trading' is increased, thereby strengthening the legal construction in the field of transplantation.

The legal system construction of transplantation was strengthened, and the Chinese government started the experiment of organ donation after citizen death since 2010 in order to fulfill the promise of stopping the use of donor organs from executed prisoners as soon as possible, follow the call in WHO's resolution WHA63.22 'all national governments should promote function of domestic institutions and/or multinational institutions, strengthen the supervision, organization and coordination of organ donation and transplantation'. A propaganda, coordination and witness mechanism is established according to actual Chinese social economic development stage and cultural background, wherein Red Cross Society of China participates in organ donation as a third party. The Red Cross Society of China has set up a human organ donation center, which is responsible for participating in the related work of human organ donation and promoting the concept of organ donation through various channels and means. Organ donation depends on an efficient and professional team of coordinators. So far, China Organ Donation Management Center has held a total of organ donation coordinator training courses for 34 times till present, and 2516 professional coordinators have been trained and certified till present. The organ coordinator should accept inspection and qualification each year, certification and access systems are implemented strictly, thereby gradually establishing an efficient and professional organ donation coordinator team all over the country, and it becomes the main force of organ donation front. Organ donation involves social, religious, ethical, political, legal and other aspects. The organ donation should not only conform to international principles, but also be based on national conditions and cultural basis China has innovatively proposed three standards for organ donation after the death of Chinese citizens . in order to better promote the development of organ donation in China, namely category I (organ donation after brain death), category II (organ donation after cardiac death) and category III (organ donation after brain and heart death). Meanwhile, the criteria and clinical norms for brain death identification have been updated and revised. Criteria and Technical Specifications for Brain Death Determination (including adult version and children version) were issued in August 2013, thereby promoting the orderly and standardized development of brain death determination in China. National Health Commission approved Xuanwu Hospital of Capital Medical University to set up 'Brain Injury Quality Control And Evaluation Center', which is responsible for training and certifying physicians and surgeons qualified to judge brain death. A total of 3,643 qualified professionals in brain death determination were trained from 2013 to 2019 covering all provinces, municipalities and autonomous regions on Chinese mainland. They are certified to work, who create suitable conditions for organ donation based on brain death.

The scientific and ethical organ transplant system has important characteristic that organs donated by citizens voluntarily must be allocated to transplant recipients transparently, fairly and openly through a scientific distribution system. Chinese organ allocation and sharing computer system was developed and put into operation in 2011. Advanced international experience is referred for the priority of allocation. The following priority principles are adopted, namely region, severity of disease, blood type matching, tissue matching, rare opportunities, immediate family of organ donors, etc. Administrative department of health issued Management Regulations for Acquisition and Distribution of Human Donor Organs (Trial) in August 2013 on the basis of summarizing the distribution system operation experience. It is regulated that all donor organs must be allocated through CLTRS system, no organization or individual is allowed to distribute donor organ randomly outside the system without authorization, thereby ensuring that the donor organ is fair, just, open and traceable. Voluntary organ donation was officially promoted nationwide on February 25, 2013 after pilot for three years according to the experience of the pilot program on organ donation after citizen death, and organ acquisition organizations (OPO) and organ donation offices were established in various transplant medical institutions.

Scientific standardization stage (2015~2019)

The team of coordinators is growing and mature with the construction and improvement of the organ donation system, the organ donation industry has been on the track of sound development after the death of Chinese citizens. Free voluntary organ donation after the death of citizens began since 2010 as a pilot project, and 34 cases were completed that year. The number has increased every year since then, which reaches 1,702 cases in 2014. They gradually occupy an important part of the transplant organ source. National Human Organ Donation And Transplantation Commission announced that China would stop the use of organs from executed prisoners from January 1, 2015, and voluntary organ donation by citizens would become the only legal source of organ transplantation in China based on the above facts. The measure was enthusiastically respond by the whole society and praised by the international transplant community.

Organ donation and transplant system in China is constructed under long-term support and assistance from international organ donation and transplant community. Many experts of organ transplantation all over the world came to China for assistance and guidance since 2006. Experts from Spain, France, Italy, Germany, the United States and other countries played a constructive role in the donation policy and propaganda, training coordinator, organ procurement organization operation, etc. They published a series of articles for driving reform with Chinese experts jointly in the international authority journals of organ transplant and participate in the China organ transplant reform. More than 10 universities and many medical institutions jointly applied to European Commission Erasmus + Project for knowledge Transfer and Leadership in Organ Donation from Europe to China (KeTLOD) in 2016 under the guidance of Joint Statement of China-EU Education Cooperation. Chinese organ donation supervisors were trained in the project, who carried out undergraduate education on organ donation in Chinese universities by 2019, thereby raising the awareness of organ donation among Chinese college students.

It is well known that organ transplants in China are internationally criticized due to the source of donor organs. Chinese government has invited the international experts to China to personally witness the whole process of organ donation since 2015 in order to clarify the fact. Organ donation work is transparent and open in China, thereby leaving a deep impression on the visit testimony experts, it also prompted sceptical experts of organ transplantation to acknowledge construction and reform of Chinese organ transplantation system. The United Nations and the Vatican Pope Academy of Sciences jointly held conference on 'Practice Ethical Action' in March 2018. Professor Huang Jiefu introduced experience and practice about organ transplantation reform in China to the world for the first time, which was well received by the participating experts. It is referred to as: 'China model'. It was concluded in the conference that the experience of organ donation and transplantation reform in China may be adopted as reference for countries all over the world with similar social and cultural background as well as social economic development level.

The 4th China - International Conference on Organ Donation- 'The Belt and Road' Organ Donation International Cooperation Development Forum was held in Kunming, Yunnan from December 6 to 8, 2019. Representatives from World Health Organization (WHO), International Association of Organ Transplantation (TTS), transplant associations of all continents and transplant associations of 62 countries attended the forum. Experts at the Conference praised China's achievements in the development of organ donation and transplantation reform, who affirmed the important role of 'Chinese Experience' in the construction of the transplant system. The forum follows the principles of 'extensive consultation, joint contribution and shared benefits'. Kunming Consensus on International Cooperation Development of 'The Belt and Road' Organ Donation and Transplantation was issued. China conveyed the belief of establishing an ethical organ transplant system consistent with criterion of World Health Organization to the world. It also provides the world transplant with 'Chinese experience', China will actively promote international exchanges and cooperation of organ donation and transplantation cause in the field of humanities and health organ among countries along 'The Belt and Road', thereby facing problems and challenges in the human development jointly.

China has gradually established a complete system of organ donation and transplantation, including organ donation, organ acquisition and distribution system, organ transplantation medical service system, organ transplantation quality control system and organ transplantation supervision system, etc. after arduous reform for 10 years. China has introduced and established regulations and mechanisms beneficial for organ donation in recent years. For example, six departments of transport, aviation and railway, etc. in China jointly established a green channel mechanism for organ transfer to ensure smooth transfer of donated organs in 2016. Law of The Red Cross Society of the People's Republic of China was revised in May 2017. It is clearly stipulated that organ donation should be promoted, humanitarian relief mechanisms should be explored by charities, etc. A fair, transparent and sunlight citizen voluntary organ donation is gradually formed in the whole society. Organ donation reached 6302 cases in Chinese mainland in 2018. The number of organ donors reached No. 2 all over the world, the million-people donation rate rose to 4.53 from 0.03 at the beginning of the pilot, thereby laying a solid foundation for high speed development of organ donation and transplantation.

More patients benefit from the transplant operation with the promotion of organ donation by citizens. A total of 20,201 organ transplants were performed in 2018 ranking No. 2 all over the world. Meanwhile, the quality of organ transplant medical care is also improving in China, and the 1-year and 5-year survival rates have reached the world advanced level. Innovative techniques for organ transplantation were developed continuously, autologous liver transplantation, non-ischemic liver transplantation and other liver transplantation technologies reached internationally advanced level. Breakthrough is made in kidney transplantation for recipients with incompatible blood types; single-center children liver transplantation and heart transplantation clinical service capacity are in the internationally advanced level. Lung transplant alliance is established. Organ preservation and donor organ maintenance technology are continuously improved. The clinical experience of liver transplantation for liver cancer and hepatitis b has been gradually recognized by the international community. China is climbing to the peak of world transportation technology.

We will make unremitting efforts to build a perfect organ donation and transplantation system consistent with ethics and criteria of World Health Organization. We will make efforts to climb the science and technology peak of organ transplantation disciplines, thereby actively promoting international cooperation of the 'The Belt and Road' organ donation and transplantation, showing the image of a responsible political power to the international community, and making own contribution to the construction of 'human destiny community'.