Blood Donation Law of the PRC — Full English Translation (1997)

Adopted at the 29th Meeting of the Standing Committee of the Eighth National People’s Congress on December 29, 1997

Effective: October 1, 1998

Table of Contents

Article 1 — This Law is enacted in accordance with the Constitution to ensure the supply and safety of blood for medical and clinical use, to safeguard the health of blood donors and blood users, to promote humanitarianism, and to advance the development of the socialist material and spiritual civilization.

Article 2 — The State shall implement a system of voluntary blood donation. The State shall encourage healthy citizens aged 18 to 55 to donate blood voluntarily.

Article 3 — Local people’s governments at all levels shall lead the blood donation work within their respective administrative areas, formulate unified plans, and organize and coordinate relevant departments in jointly carrying out blood donation work.

Article 4 — The health administrative department of the people’s government at or above the county level shall supervise and administer blood donation work. Red Cross societies at all levels shall participate in and promote blood donation work in accordance with the law.

Article 5 — People’s governments at all levels shall take measures to conduct extensive publicity and education on blood donation. News media shall carry out public-interest publicity on blood donation. State organs, armed forces, public organizations, enterprises, public institutions, residents’ committees, and villagers’ committees shall mobilize and organize citizens of appropriate age within their respective units or residential areas to participate in blood donation.

Article 6 — Blood donors must be in good health. The health examination standards for blood donors shall be formulated by the health administrative department under the State Council. Blood stations shall conduct necessary health examinations of blood donors; blood donors whose physical conditions do not meet the blood donation requirements shall not be allowed to donate blood, and blood stations shall explain the situation to such individuals.

Article 7 — Blood stations are institutions that collect and supply blood for clinical use and are public welfare health institutions that shall not be operated for profit. The establishment of blood stations and the collection of blood by blood stations shall strictly comply with relevant State regulations.

Article 8 — Blood stations shall be established with the approval of the health administrative department under the State Council or the health administrative department of the people’s government of a province, autonomous region, or municipality directly under the Central Government. Blood stations that have not been established with proper approval shall not carry out blood collection or supply activities.

Article 9 — Blood stations shall collect blood strictly in accordance with relevant State standards and operating procedures. Blood collection shall be conducted by medical personnel with blood collection qualifications. Disposable blood collection equipment shall be used and destroyed after use to prevent the spread of diseases. Blood stations shall, in accordance with the provisions of the health administrative department under the State Council, make and keep records of blood donors and raw data of blood collection and supply for a period of ten years.

Article 10 — The volume of blood collected from a blood donor shall generally be 200 milliliters per donation, not exceeding 400 milliliters, with an interval between donations of not less than six months. Blood stations shall strictly comply with the blood donation volume and interval prescribed by the State. Blood donors shall donate blood truthfully and shall not conceal their health condition.

Article 11 — Blood donors shall use their real names when donating blood. Blood stations shall verify the identity of blood donors and shall keep confidential the personal information and health information of blood donors that come to their knowledge in the course of blood collection.

Article 12 — Blood collected by blood stations must be tested; untested or substandard blood shall not be supplied to medical institutions. Blood for clinical use shall be subject to testing for pathogens in accordance with State regulations; blood testing positive for pathogens shall not be used for clinical purposes.

Article 13 — Blood for clinical use must comply with State-prescribed standards. The packaging, storage, and transportation of blood for clinical use must comply with the requirements of State-prescribed health standards.

Article 14 — Where a citizen donates blood, the blood station shall issue a certificate of voluntary blood donation to the donor. Blood donors shall have the right to priority access to blood for clinical use when needed. Where a blood donor needs clinical blood use, they shall be exempted from the fees for blood collection, storage, separation, testing, and other costs; where the spouse or lineal relatives of a voluntary blood donor need clinical blood use, they may be exempted or partially exempted from the above fees in accordance with the regulations of the people’s government of the province, autonomous region, or municipality directly under the Central Government.

Article 15 — The State shall encourage citizens to donate blood at the initial stage of national statutory holidays, commemorative days, and other significant occasions. The State shall encourage State functionaries, active military personnel, students in higher education institutions, and other groups to take the lead in donating blood and setting an example for society.

Article 16 — Medical institutions shall verify the source and quality of blood before clinical use, and shall not use blood that does not comply with State-prescribed standards. Medical institutions shall formulate clinical blood use plans in accordance with the law, apply the principle of rational and scientific use of blood, actively promote component blood transfusion, and shall not waste or abuse blood resources.

Article 17 — To ensure the supply of blood for clinical use in emergency situations, medical institutions may temporarily collect blood, provided that blood collection is conducted in strict accordance with the relevant operating procedures and standards prescribed by this Law, and that the health administrative department of the people’s government at or above the county level is notified within ten days of the commencement of blood collection.

Article 18 — Any unit or individual is prohibited from engaging in blood sales. No unit or individual may illegally organize others to sell blood, or introduce or arrange for others to engage in blood sales.

Article 19 — Where a blood station collects blood in violation of the relevant operating procedures and systems, the health administrative department of the local people’s government at or above the county level shall order it to make corrections and may impose a fine of not more than 100,000 yuan; where the circumstances are serious, the health administrative department that approved its establishment shall revoke its blood station practice permit. Where damage is caused to the health of a blood donor, compensation shall be made in accordance with the law.

Article 20 — Where the blood supplied by a blood station for clinical use fails to comply with State-prescribed standards, the health administrative department of the local people’s government at or above the county level shall order it to make corrections and impose a fine. Where the circumstances are serious, the blood station practice permit shall be revoked. Where damage is caused to the health of a blood user, compensation shall be made in accordance with the law, and the directly responsible person in charge and other directly responsible persons shall be subject to disciplinary action in accordance with the law; where the act constitutes a crime, criminal liability shall be pursued in accordance with the law.

Article 21 — The health administrative department and its staff shall, in the supervision and administration of blood donation and blood use, neglect of duties, causing serious consequences that constitute a crime, criminal liability shall be pursued in accordance with the law; where the act does not constitute a crime, disciplinary action shall be taken in accordance with the law.

Article 22 — Where a medical institution’s medical personnel, in violation of the provisions of this Law, use blood in clinical practice that does not comply with State-prescribed standards and cause damage to the health of a patient, they shall bear civil liability for compensation in accordance with the law; the directly responsible person in charge and other directly responsible persons shall be subject to disciplinary action in accordance with the law; where the act constitutes a crime, criminal liability shall be pursued in accordance with the law.

Article 23 — Where the staff of a health administrative department neglect their duties in the supervision and administration of blood donation and clinical blood use, causing serious consequences and constituting a crime, criminal liability shall be pursued in accordance with the law; where the act does not constitute a crime, disciplinary action shall be taken in accordance with the law.

Article 24 — This Law shall come into force on October 1, 1998.