69 Regulations of Shenzhen Special Economic Zone on the Donation and Transplantation of Human Organ[深圳经济特区人体器官捐献移植条例（2003）]

(Adopted at the Twenty-sixth meeting of the Standing Committee of the Third Shenzhen Municipal People's Congress on August 22, 2003.)

Chapter Ⅰ General Provisions

Article 1 In order to recover the function of human organ or rescue the life, standardize the donation and transplantation of human organ, and safeguard the lawful rights and interests of the donator of the human organ and the person accepting the transplantation of human organ, these regulations are formulated in accordance with the basic principles of the laws and administrative regulations.

Article 2 These regulations are applicable to the donation and transplantation of the human organ (human tissue), except the following human tissues:

(1) the blood and its products;

(2) the sperm and the ovum;

(3) the embryo;

(4) other tissues provided in laws and regulations.

Article 3 The donation of human organ shall observe the principles of voluntariness and no compensation. It is prohibited to purchase or sell the human organ by any means.

It is encouraged that the individual donates the human organ after his death.

Article 4 The transplantation of human organ shall observe the principles of justice and equity.

The transplantation of human organ shall observe the generally acknowledged medical principles, accord with the developing level of the national medical science and technology, and preferentially consider other more suitable methods of medical treatment.

The transplantation of human organ shall not violate relevant laws and regulations.

Article 5 The administrative department of health of Shenzhen Municipality (hereinafter referred to as the municipal department of health) is the competent department for donation and transplantation of human organ.

Chapter Ⅱ Exenteration and Implantation of Human Organ

Article 6 To donate the human organ after one died shall meet one of the following requirements:

(1) the dead has agreed to donate the human organ with written will or other written forms before his death;

(2) the close relative of the dead has agreed in writing and the dead has no expression of disagreeing to donate the human organ during his lifetime;

(3) the dead’s awareness is sober before death and has the oral expression of agreeing to donate the human organ, at the same time more than two physicians who will not participate in the exenteration or implantation of human organ testify those conditions in writing, and his close relative is not opposed.

Article 7 To donate the human organ before one died shall satisfy the following conditions:

(1) he has reached 18 years old and has the complete civil capacity;

(2) he has the true expression of agreeing to donate the human organ in writing;

(3) the donation won’t endanger his life;

(4) the human organ except the human tissue shall be transplanted to the lineal kinship and the collateral relatives within 3 generations.

The minor who has not reached 18 years old, with the consent of his parents or the guardian, may donate the marrow to the close relative.

If the donated human organ is transplanted to the spouse, the spouse shall have procreated the child with the person who donates the human organ or have been married with him for more than two years, except that the spouse has been ill after marriage and needs to receive the transplantation of human organ indeed.

Others who donate the human organs before death shall file applications to the municipal department of health. The donation may be implemented only after having been approved.

Article 8 The donator of human organ (hereinafter referred to as the donator) and the person receiving the transplantation of human organ (hereinafter referred to as the patient) have the right to learn the truth and make decisions. They have the right to know about the feasibility and outcomes of the transplantation of human organ, the process of the surgical operation and the influence to the their health, have the right to decide whether or not to donate the human organ or receive the transplantation of human organ, and have the right to revoke the decision of donation or acceptance of the transplantation orally or in writing.

For the patients without or with limited civil capacity who may not fulfill the right to learn the truth or make decisions, whether they accept the transplantation of organ or not shall be decided by their legal representations or guardians.

Article 9 The hospital and physician shall tell the donator and patient the right to know about the feasibility or make decisions they shall enjoy, and make true and comprehensive explanations to the matters that they shall know.

Article 10 If the human organ is exenterated from the remains, it may be done only after at least two physicians who have not participated in the treatment and have the qualifications of higher than vice director have made the written judgment to confirm the death of the donator.

The physicians who have made the judgment to confirm the death of the donator shall not participate in the exenterating or implanting operation of the human organ mentioned above.

Article 11 If the remains needs to be appraised according to law or it is necessary to go on examining after appraisal, the human organ shall not be exenterated from it.

If the physician who judges the death of the donator considers that the death of the donator is obviously irrelevant to the exenterated human organ, and the waiting for appraisal according to law will delay the opportunity to exenterate the human organ，with the written consent of the coroner and the close relatives of the dead, the human organ may be exenterated.

Article 12 The physician shall properly deal with the human organ after it has been exenterated from the remains.

Article 13 Within two hours after the human organ has been exenterated, the physician shall report the retails relevant to the exenterated human organ and the donator to the hospital. The hospital shall report the relevant retails to the municipal Red Cross within 24 hours.

Article 14 The hospital carrying out the transplanting operation of the human organ shall construct the preserving storehouse to preserve the exenterated human organ properly.

The construction and management of the preserving storehouse of human organ shall accord with relevant technical standards and administrative provisions.

Article 15 The exenterated human organ that is examined unsuitable for implantation may be used for scientific research or be burnt down, but shall be reported to the municipal department of health for record.

Article 16 All patients shall equally enjoy the right to acquire the transplantation of human organ.

The sequence for the patient to receive the transplantation of human organ shall be determined by the municipal Red Cross according to the time order of applying for registration. Only if the previous candidate patient is unsuitable for accepting the transplantation of human organ, may the candidate patient of the following sequence be selected.

The judgment on whether the patient is suitable for accepting the transplantation of human organ or not shall observe the generally acknowledged medical standards.

The patient whose close relative has already donated the human organ may enjoy the priority when accepting the transplantation of human organ. The sequence of the patients who enjoy the priority at the same time shall be determined by the municipal Red Cross according to the time order of applying for registration.

Article 17 The patient shall pay the normal medical expenses needed for the operation of transplantation only.

Chapter Ⅲ Administration and Supervision

Article 18 The municipal department of health shall administer and supervise the donation and transplantation of human organ and perform the following powers and duties:

(1) to enact the technical standards of the donation and transplantation of human organ and relevant administrative provisions;

(2) to supervise the donation and transplantation of human organ;

(3) to examine and approve (verify) the qualification and classification of the hospitals and physicians that apply to implement the donation and transplantation of human organ;

(4) other powers and duties provided in laws and regulations.

Article 19 The municipal Red Cross shall be responsible for accepting the applications for donating the human organ and setting up the information bank of human organ. It shall register and make statistic to the materials reported by the hospital and link its information net with all the hospitals and relevant departments.

When receiving the application for donating the human organ, the hospital shall make registration and report it to the municipal Red Cross within 5 days.

Article 20 The hospital shall be responsible for accepting the application for transplanting the human organ and registering the information of the patient.

The hospital shall report the registered information to the municipal Red Cross wholly and truly within 3 days.

Article 21 The municipal Red Cross shall catalogue the information of the donator of the human organ and the patient according to the indication, contraindication, suitable age, matching tissue and other medical standards, and record them into the information bank of human organ. The recorded materials shall be feed back to the donator or the close relative of the dead and patient in time and be confirmed by them.

The municipal Red Cross shall guarantee the information and data of the information bank of human organ to be whole and true, which shall not be deleted or altered without the written application of the donator or patient.

Article 22 The hospital and physician performing the operation of transplanting the human organ shall have the qualification determined by the municipal department of health and implement the transplantation according to the verified classification. The hospital, other medical organization and individual having no corresponding qualifications may not perform the operation of exenterating or transplanting the human organ.

Article 23 The municipal department of health shall supervise the sequence of the patient in the information bank of human organ. If relevant parties are not satisfied with the sequence, he may complain to the municipal department of health. The municipal department of health shall investigate and verify the complaint and give written reply within 15 working days from the date on which the complaint is received.

Article 24 The hospital, municipal Red Cross, physician and relevant working staff shall keep the materials of the donator of human organ and the patient confidential.

Chapter Ⅳ Legal Responsibilities

Article 25 If any one violates the provisions of these regulations to purchase or sell the human organ with any means, the municipal department of health shall confiscate the illegal gains. If any one resells the human organ, he shall be fined 10 times of the illegal gains at the same time. If any one purchases the human organ, he shall be fined more than 3 times but less than 5 times of the selling price.

If the physician, hospital or other medical organizations undertake or participate in purchasing or selling the human organ, the physician shall be fined 10 times of the transaction volume, be revoked the practicing certificate and be given the administrative punishment of expulsion or be discharged, the hospital and other medical organization shall be fined 20 times of the transaction volume and be canceled the specialized qualification for the operation of transplanting the human organ, and relevant liable persons of the hospital and other medical organization shall be revoked the practicing certificate and be given the administrative punishment of expulsion or be discharged.

If the business of purchasing or selling human organ constitutes a crime, the relevant person shall be prosecuted for the criminal responsibility according to law.

Article 26 If any one violates the provisions of Article 10 of these regulations, the municipal department of health shall give the administrative punishment to relevant parties. If the circumstances are serious, they may be revoked the practicing certificate.

Article 27 If any hospital and physician violate the provisions of Article 15 of these regulations, failing to deal with the human organ that is not suitable for transplantation according to the provided measures, they shall be warned by the municipal department of health and the hospital shall be fined more than 5,000 yuan but less than 30,000 yuan.

Article 28 If the municipal Red Cross violates the provisions of Article 16 and Article 22 of these regulations, having one of the following conditions, the municipal department of health shall order it to make corrections, give the administrative punishment to the person directly liable and fine it 30,000 yuan:

(1) to alter the sequence of the patient arbitrarily;

(2) to delete or alter the materials in the information bank of human organ arbitrarily.

Article 29 If the physician without the qualification violates the provisions of Article 22 of these regulations to perform the operation of transplanting the human organ, the municipal department of health shall give the administrative punishment to him, fine him more than 50,000 yuan but less than 100,000 yuan and revoke his practicing certificate; If the hospital and other medical organizations without the special qualification for transplanting the human organ perform the operation of exenterating or transplanting the human organ, the municipal department of health shall fine them more than 300,000 yuan but less than 500,000 yuan and revoke the practicing certificate of the leading officials.

Article 30 If any one violates the provisions of Article 24 of these regulations, disclosing the materials of the donator or patient, the municipal department of health shall fine the person directly liable 10,000 yuan.

Article 31 If the hospital, other medical organizations, municipal Red Cross and its working staff violates the provisions of these regulation, the municipal department of health shall give the administrative punishments to the leading official and person directly liable of the unit. If damages are caused to the person connected just because of their behaviors, they shall take the compensation liabilities according to law.

Article 32 If the working staff of the municipal department of health fail to perform their duties, abuse their powers, neglect their duties or play irregularities for favoritism in the cause of implementing these regulations, they shall be given the administrative punishments. If their behaviors constitute a crime, they shall be prosecuted for the criminal responsibilities according to law.

Article 33 If the hospital and physician violate the provisions of the law and constitute crimes when carrying out the transplantation of human organ, they shall be prosecuted the criminal responsibilities according to law.

Chapter Ⅴ Supplementing Provisions

Article 34 The municipal department of health shall enact the following provisions to support the donating and transplanting work of the human organ:

(1) the catalogue of the human organ that may be implemented the transplantation;

(2) the standards of installment and administrative measures of the preserving storehouse of human organ;

(3) the measures how to deal with the human organs that are not suitable for implantation;

(4) the administrative provisions and secrete provisions to the information bank of human organ;

(5) the measures on determining the qualification of the hospital and physician that can perform the operation of transplanting the human organ.

Article 35 The scope and sequence of the close relative as referred to in these regulations are the followings:

The first sequence: the spouse, children, parents;

The second sequence: brothers and sisters;

The third sequence: grandparents, grandparents-in-law, grandchildren.

If the close relatives of the dead make written agreement according to these regulations, all close relatives with complete civil capacity of the first sequence shall make written agreement. If there is no close relative of the first sequence or none of the close relative of the first sequence has complete civil capacity, all close relatives with complete civil capacity of the second sequence shall make written agreement. If there is no close relative of the second sequence or none of the near relative of the second sequence has complete civil capacity, all close relatives with complete civil capacity of the third sequence shall make the written agreement.

Article 36 These regulations shall go into effect as of October 1, 2003.