Organ donation and transplant surgery in China began in the 1950s as an advanced medical technology introduced from Europe and the US. Due to the backwardness of Chinese legislation in the medical field and ideological prejudice towards the technology, the development of legislation in organ donation and transplant made very slow progress, and failed to meet the actual need. It will help people in all walks of life to understand the development in China’s organ donation and transplantion proceedures by introducing the legislation which has been created for the field.
Research in organ donation and transplantation began in China in the 1950s. The pioneer was Professor Qiu Fazu at Tongji Medical University (predecessor of Wuhan Medical School), who carried out organ transplants on animals. In 1960, Academician Wu Jieping performed the first kidney transplant surgery with a cadaver. In 1972, Professor Mei Hua at Zhongshan Medical College performed the first kidney transplant surgery with a living doner. In 1977, Professor Lin Yanzhen performed the first liver transplant operation in Asia, at Shanghai Ruijin Hospital. With the continuous progress in technology and techniques, China’s organ transplant surgery had become mature by the early 21st century. At present, China has become the 2nd largest country in terms of the number of organ transplant surgeries.
Almost all of the early transplants were carried out with organs from condemned prisoners, as few ordinary citizens were willing to voluntarily donate organs. As a result, legislation in this field made little progress. In 1984, the Supreme People's Court, the Supreme People’s Procuratorate, Ministry of Public Security, Ministry of Justice, Ministry of Health and Ministry of Civil Affairs jointly released the Interim Regulations on the Dead Bodies and Organs of executed Prisoners, which allowed hospitals to make use of the cadavers or organs of condemned prisoners under certain conditions. It also stipulated that the donation should be with the consent of the relatives and hospitals should report to the medical authorities on the sources of the organs. Yet in practice, there were some irregularities in the implementation of the law which meant some operations were not in line with global medical ethics. As a result, several international organizations listed China among countries with unidentified sources of transplanted organs. Some hostile groups took advantage of this to attack China’s organ transplants by fabricating stories of illegal imprisonment and live organ harvesting to make slanderous accusations that the Chinese government infringed on human rights. Organ transplantation thus became a sensitive issue and the Chinese government has made unremitting efforts in overcoming the social, ethical and legal difficulties.
1. Introduction to the Legislation in Organ Transplant
China’s earliest law on organ transplantation was the Regulations on Human Organ Transplant enacted in 1987 in Taiwan. Then in 1995, Hong Kong also enacted the Regulations on Human Organ Transplant.
In the mainland, the Shanghai Regulation on Body Donation was promulgated in 2000. In 2003, the Shenzhen Special Economic Zone’s Regulation on Human Organ Donation and Transplant was issued and in 2003, Fujian Province enacted the Fujian Regulation on Body and Organ Donation in 2005.
In March, 2006, the Ministry of Health issued the Interim Regulations on the Safety Management of Clinical Application of Human Organ Transplant, which took effect on July 1, 2006.
In the same year, the Ministry released the Notice on Qualification Certification of Medical Institutions and Staff Performing Organ Transplant.
In September, 2006, the Standing Committee of the National People's Congress passed the Decision on the Revision of Organ Law of People's Court of PRC, which stipulates that the right of approval of the death penalty be executed solely by the Supreme People's Court from 2007.
In 2007, the State Council issued the Human Organ Transplant Regulations, which is a milestone in the legislation in this field in China, which created the legal process for Chinese human organ transplantation.
In June, 2007, the Ministry of Health issued the Notice on the Application of Organ Transplant by Overseas Personnel, and standardized organ transplant activities inside and outside China.
In 2009, the Ministry of Health issued the Notice on Intensifying Regulation of Human Organ Transplant and promulgated a nuber of provsions on living organ transplant.
In 2010, the Ministry of Health issued the Notice on Direct Network Report of Data on Human Organ Transplant and formulated the Trial Work Plan on Organ Donation in China.
In 2011, the Standing Committee of the National People's Congress passed the Amendment to Criminal Law VIII Ban on Human Organ Trafficking, clarifying that human organ trade is illegal and adding the crime of human organ trading.
On the same year, the Ministry of Health and Red Cross Society of China jointly issued the Rules on the Management of Registration of Human Organ Donation (Trial) and Management of Human Organ Donation Coordinators (Trial) to further regulate the related fields.
In 2012, the Ministry of Health and Red Cross Society of China jointly issued the Opinion on Further Promoting Human Organ Transplantation.
In the same year, the Sub-association of Organ Transplant of the Chinese Medical Association issued the Operating Guidelines on Organ Donation after Cardiac Death.
In 2013, the National Health and Family Planning Commission issued the Regulations on Procurement and Allocation of Donated Human Organs (Trial)
In the same year, it issued the Brain Death Determination and Technical Standards.
In the same year, the General Office of the CPC Central Committee and the General Office of the State Council issued the Funeral Reform Led by Officials to encourage organ donation of Party members and officials.
In 2015, the Organ Procurement Organization of the Chinese Hospital Association issued the Guidelines on Organ Donation In China.
2. Chinese Government Making Unremitting Efforts in Meeting the Legal and Ethical Principles of International Medical Science on Human Organ Donation and Transplant
In 2005, at the higher level meeting of the WHO on human organ transplantation held in Manila, Huang Jiefu, the former Minister of Health, admitted that all human organ donations in China were from condemned prisoners and he pledged to the world that China was at a transitional time from donation of condemned prisoners to voluntary donation from citizens.
In 2006, the Ministry of Commerce established the Organ Transplant Committee. In November, it convened the Summit Forum on Clinical Application and Management of Organ Transplantation and issued the Guangzhou Declaration, calling on medical staff nationwide to carry out reforms.
In August, 2008, Wang Haibo, person in charge of the CLTR system of the Ministry of Health received the NKOL award from the WHO International Organ Transplant Organization.
In the same year, Huang Jiefu, former Minister of Health, received the Special Contribution Award from the organization.
In 2009, entrusted by the Ministry of Health, Hong Kong University developed the Chinese donated organ distribution and sharing system;
In 2010, the Ministry of Health and Red Cross Society of China jointly launched the Voluntary Organ Donation Pilot Program and established the CODC;
In 2011, the China Society for Human Rights Studies released the 2011 China Human Rights Development Report, pointing out that the principle of less use, caution or abolition of the of death penalty is the general trend in China’s social development;
In the same year, approved by the State Council, the Red Cross Society of China established the China Organ Donation Management Center;
Also in the same year, 164 hospitals qualified for organ transplantation were connected to the Chinese donated organ distribution and sharing system;
In 2013, China fully launched the Voluntary Organ Donation Program;
In the same year, participants at the Chinese Medical Association Organ Transplant Conference passed the Hangzhou Declaration and deepened consensus on further promoting the organ transplant system in China. 38 major organ transplant medical institutions signed the agreement of banning the use of organs from executed prisoners;
On March 1, 2014, the OTC and Red Cross Society of China were merged to establish the China Organ Donation and Transplant Council.
On March 20, the OPO was established in Guangzhou, marking that China was integrated with the world in the regulation of human organ transplantation;
In the same year, after reorganization, the China Organ Transplant Development Fund was re-opened;
In December of the same year, at the OPO conference held in Kunming, Huang Jiefu, Director of China Organ Donation and Transplant Council, required the ban of organs from condemned criminals at 169 hospitals qualified for organ transplantation; starting from Jan.1, 2015, only organs voluntarily donated by Chinese citizens after death can be used.
China is building a comprehensive human organ transplant system covering donation, acquisition and distribution as well as clinical service, after-transplant risk management and regulation system.
As President Xi said, “It is our aspiration to pursue what people yearn for, for a better life.” It is the ultimate goal in the organ transplant field in China to make progress in medical work and safeguard people’s health and rights.
Attachment: Procedure for Organ Donation After the Death of Chinese Citizens
Source: 2012 No.39 Ministry of Health and Red Cross Society of China: Opinion on Further Promoting Human Organ Donation. The procedure consists of 8 parts: registration, assessment, confirmation, organ acquisition, distribution, body treatment, commemoration and humanitarian relief.
All citizens living in China can register for donation of organs after death where he or she has Hukou, or in the hospitals with organ donation offices;
They shall fill out the Letter of Voluntary Donation of Organs After Death (It is suggested that they first gain the consent of their spouses, adult children, parents or other close relatives) and mail, fax or give in person the letter to the registration office;
The Human Organ Donation Office or the Registration Office will issue the China Organ Donation Card and record the information of the donors in the management system.
When a potential donor emerges, he, she or their relatives can contact the information officer or coordinator in the responsible hospital and then report to the provincial organ donation office or Red Cross.
The information officers or coordinators at provincial level and the panel for assessment shall carry out the assessment in the hospitals, with the assistance of local medical staff. The professional coordinators shall evaluate whether legal or ethical problems exist and consider the opinion of their family members. They shall also assess whether it is medically feasible.
For the provinces without previous cases of organ donation, the provincial Red Cross shall report to the China Human Organ Donation Office, and the Office will assign personnel from other experienced provincial donation offices for assistance.
After assessment, the death of the donor shall be determined by themedical institution shall in accordance with the Guideline on Donation after Cardiac Death of China and the related standards.
With the coordinator as the witness, the family members of the donor shall sign the China Organ Donation Registry Form, including the donor’s parents, spouse and adult children or the donor can entrust representatives to sign the Form.
The coordinator shall collect the Hukou, ID (Birth Certificate), Marriage Certificate, Death Certificate and the ID of the donor’s parents, spouse and adult children and submit them to the hospital Ethics Council or provincial organ donation office.
After confirmation, the provincial organ donation office shall acquire the donated organ as agreed in the China Organ Donation Registry Form. The coordinator shall be the witness of the process and the organs acquired shall be preserved and transported in accordance with the technical standards formulated by the Chinese Organ Donation Expert Committee.
The organs donated shall be distributed in accordance with the related regulations and the coordinator shall be the witness of the process.
After the organ is transplanted, the coordinator or the designated hospital shall submit the related materials to the provincial organ donation office and they shall fill in the Registry Form of Completion of Organ Donation, and then submit it to China Organ Donation Office.
Medical personnel engaged in human organ collection shall respect the dignity of the donor, and the corpse shall be treated with ethical principles. In addition to donated organs (tissues), the body should be restored to the original appearance.
For people with the intention to donate organs, the provincial organ donation office (Red Cross) shall contact them for organ reception.
In the case of donors who do not have the will to donate their bodies or do not meet the conditions for the reception of the remains, the body will be handed over to their families by the medical institution where they are located, and the Provincial Human Organ Donation Office (provincial Red Cross) will assist in dealing with the aftermath.
The Provincial Office of Human Organ Donation (Provincial Red Cross) should issue a donation certificate to the family of the donor, inscribe the donor's information on the organ donation monument, the memorial or the memorial site, and provide the family members with the places and organizations to carry out memorial activities and commemorate organ donors.
8. Humanitarian Relief
In accordance with the policies of the China Human Organ Donation Working Committee, provinces (autonomous regions and municipalities) can develop the relevant policies to offer poor donor families humanitarian relief based on the economic development of the local area. The spouse, parents, adult children or their agent can submit the application form for aide to the Provincial Office of Human Organ Donation (Provincial Red Cross) in written form. After the assessment, some financial assistance will be provided.
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