Regulations on Human Organ Transplantation

Updated: 2014-06-05

The competent health department of the people’s government of a province, autonomous region, or municipality directly under the Central Government shall, in a timely manner, make public the list of the medical institutions that have registered a clinical department related to human organ transplantation.

Article 13 When a medical institution that has registered a clinical department related to human organ transplantation no longer meets the conditions prescribed in Article 11 of these Regulations, it shall cease to engage in human organ transplantation and report the matter to the registration department. The registration department shall, within two days from the date of receipt of the report, revoke registration of the clinical department related to human organ transplantation and make such revocation public.

Article 14 The competent health department of the people’s government at or above the provincial level shall, on the basis of the success rate of human organ transplantation operations and the long-term survival rate of the transplanted organs and recipients, arrange for experts to regularly assess the medical institutions in terms of their clinical application of human organ transplantation, and make public the results of such assessment in a timely manner. Where a medical institution fails the assessment, the registration department shall cancel registration of the clinical department related to human organ transplantation. The specific measures therefor shall be formulated by the competent health department of the State Council.

Article 15 A medical institution and its medical personnel shall, in engaging in human organ transplantation, comply with ethical principles and technical rules for administration of human organ transplantation.

Article 16 A medical institution performing a human organ transplantation operation and its medical personnel shall carry out a medical examination on the donor of a human organ to assess the risks of transmission of disease to the recipient due to the transplantation, and take measures to minimize such risks.

Article 17 Before removing a living organ or before the death of a deceased donor, the licensed doctor responsible for human organ transplantation shall apply to the committee on clinical application and ethics of human organ transplantation of the medical institution where he works for examination of the removal of the human organ.

Where the committee on clinical application and ethics of human organ transplantation denies the removal of a human organ, the medical institution shall not make a decision on removing the human organ and its medical personnel shall not conduct the removal.

Article 18 Upon receipt of an application for examination of the removal of a human organ, the committee on clinical application and ethics of human organ transplantation shall make an examination of the following matters and give a written opinion on consenting or denying the removal:

(1) whether the consent of the donor is true;

(2) whether trade in human organs or such trade in a disguised form is involved; and

(3) whether the matching of the human organ and the indications of the recipient conform to ethical principles and technical rules for administration of human organ transplantation.

The committee on clinical application and ethics of human organ transplantation may give its written consent to the removal of a human organ only when two-thirds or more of the members of the committee consent to the removal.