Biosecurity Law of the People's Republic of China

Updated: 2020-10-17

Chapter VII Prevention of Bioterrorism and Biological Weapon Threats

Article 61  The state takes all necessary measures to prevent bioterrorism and biological weapons.

It is prohibited to develop, manufacture or otherwise acquire, or store, possess, or use biological weapons.

It is prohibited to instigate, finance, or assist others to develop, manufacture, or otherwise acquire biological weapons in any way.

Article 62  Relevant departments of the State Council shall formulate, amend and publish the lists of living organisms, biotoxin, equipment or technology that may be used in bioterrorism activities or in the manufacture of biological weapons, and strengthen supervision and control to prevent the listed items from being used for manufacturing biological weapons or for bioterrorism purpose.

Article 63  Relevant departments of the State Council and relevant military organs shall, in accordance with the division of duties, strengthen the monitoring and investigation of activities such as the entry in or exit from China, import or export, obtaining, manufacture, transfer, or release of living organisms, biotoxin, equipment or technologies that may be used in bioterrorist activities or in the manufacture of biological weapons, and shall take necessary prevention and disposal measures.

Article 64  Relevant departments of the State Council, and the provincial people's governments and their competent departments shall be responsible for organizing the rescue and placement of victims inflicted by bioterrorism attacks or biological weapons attacks, environmental disinfection, ecological restoration, security monitoring, and social order restoration.

Relevant departments of the State Council, and the provincial people's governments and their competent departments shall effectively guide the media in rationally and accurately reporting bioterrorist attacks and biological weapons attacks, release in time the information on evacuation, relocation, emergency shelter or otherwise, and conduct long-term monitoring of the environment  and people's health in the contaminated areas during emergency response and rehabilitation.

Article 65  The state organizes investigations into the biological weapons left behind from wars within the territory of China, as well as the harmful consequences caused thereby and the potential effects.

The state organizes the construction of facilities for the storage and disposal of biological weapons left behind from wars in the territory of China to ensure the safe disposal of biological weapons.

Chapter VIII Biosecurity Capacity Building

Article 66  The state shall formulate a development plan for biosecurity undertakings, enhance the biosecurity capacity building, and improve the capacity responding to biosecurity incidents.

People's governments at or above the county level shall support the development of biosecurity undertakings, and in accordance with the division of authorities, incorporate in their government budgets the relevant expenditures supporting the development of the following biosecurity undertakings:

(1) Construction and operation of the monitoring network;

(2) Storage of materials used for emergency response and risk prevention and control;

(3) Construction and operation of key infrastructures;

(4) Research and development of key technologies and products;

(5) Investigation and preservation of human genetic and biological resources; and

(6) Other important biosecurity undertakings prescribed by laws and regulations.

Article 67  The state takes measures to support biosecurity technology research,  promote the development of technology for biosecurity risk prevention and control, optimize resources, establish a interdisciplinary and multidepartmental collaborative mechanism for innovation and research in key issues, and promote the output, transfer and application of core and key biosecurity technologies and major biosecurity defense products, so as to improve the scientific and technological capabilities for safeguarding biosecurity.

Article 68  The state makes an overall layout of national biosecurity infrastructure. Relevant departments of the State Council shall, in accordance with the division of duties, accelerate the development of a national strategic resources platform for preserving biological information, human genetic resources, bacterial (viral) species, and animal and plant genetic resources, as well as the construction of high-level pathogenic microorganism laboratories, etc.; and shall establish a mechanism sharing the aforementioned resources, so as to provide strategic safeguard and support for biosecurity-related scientific and technological innovations.

Article 69  Relevant departments of the State Council shall, in accordance with the division of duties, strengthen training of talents in terms of researchers in the basic science of biology and technicians in the field of biology, so as to promote the development of academic disciplines of the basic science of biology and enhance research in the basic science of biology.

Personnel holding important positions in the entities managing national biosecurity infrastructures shall have the required qualifications, with relevant information filed with the relevant departments of the State Council, and shall receive on-the-job training.

Article 70  The state increases the reserves of materials for preventing and controlling the outbreak of major emerging infectious diseases, animal and plant disease epidemics, and other biosecurity risks.

The state enhances the research and development of  medicines and equipment, among others, for biosecurity emergency response,and the development of  technology in case of need. Relevant departments of the State Council shall, in accordance with the division of duties, take relevant measures for launching the aforementioned research and development.

Relevant departments of the State Council, and the people's governments at or above the county level and their relevant departments shall guarantee the production, supply, and allocation of the materials required for responding to biosecurity emergencies, such as medical equipment, drugs, and medical devices; and the competent departments of transportation shall organize and coordinate in time the transport business entities to deliver such materials in priority.

Article 71  The state provides effective protection and medical guarantee for personnel engaging in highly pathogenic microorganisms experiments, on-site response to biosecurity incidents, and other high risk biosecurity work.

Chapter IX Legal Liabilities

Article 72  Where a staff member performing the duties of biosecurity management, in violation of the provisions hereof, abuses power, neglects duty, or engages in malpractices for personal gain or commits any other illegal act in biosecurity management, sanctions shall be imposed thereupon in accordance with law.

Article 73  Where a medical institution, specialized institution or any of its staff member, in violation of the provisions hereof, conceals, makes a false report on, or delays or omits the report on an infectious disease, an animal or a plant epidemic, or any other disease cluster, or instructs others to conceal, make a false report on, delay or omit a report on such a case, or obstructs others from reporting such a case, the institution or staff member shall be ordered to make rectification and be given a warning by the relevant department of the people's government at or above the county level; the legal representative, the leading person, the person in charge who is directly responsible, and other persons who are directly responsible shall be sanctioned in accordance with law, and they may also be punished ranging from suspension of practice for a certain period up to revocation of relevant practicing certificates.

Where anyone, in violation of the provisions hereof, fabricates or spreads false biosecurity information, which constitutes a violation of public security administration, public security administration penalty shall be imposed thereupon by the public security organ in accordance with law.

Article 74  Where anyone, in violation of the provisions hereof, conducts biotechnological research, development, or application activities prohibited by the state, the competent departments of health, science and technology, or agriculture and rural affairs of the people's government at or above the county level shall, pursuant to the division of duties, give the order ceasing the illegal activities, confiscate the illegal gains, technical materials, tools, equipment, raw materials and other items used therefor, and impose a fine of not less than one million yuan but not more than ten million yuan. If the illegal gains are one million yuan or more, a fine of not less than ten times but not more than twenty times the illegal gains shall be imposed, and the relevant biotechnology research, development or application activities may be prohibited for a certain period of time and the relevant practicing certificates may be revoked in accordance with law. The legal representative, the leading person, the person in charge who is directly responsible, and other persons who are directly responsible shall be sanctioned in accordance with law, be fined not less than 100,000 yuan but not more than 200,000 yuan, and be banned from engaging in relevant biotechnological research, development and application activities for a period of ten years or even for life with their relevant practicing certificates revoked in accordance with law.

Article 75  Where anyone, in violation of the provisions hereof, fails to conduct research or development of biotechnology in compliance with the national security management norms for biotechnology research and development, the relevant departments of the people's government at or above the county level shall, in accordance with the division of duties, order the violator to make rectification, impose a warning, and may also impose a fine of not less than 20,000 yuan but not more than 200,000 yuan. Where the violator refuses to make rectification or causes serious consequences, an order ceasing the research and development activities shall be given, and a fine of not less than 20,000 yuan but not more than 200,000 yuan yuan shall be imposed.

Article 76  Where anyone, in violation of the provisions hereof, fails to conduct a pathogenic microorganism experiment in a laboratory at the required level, or conducts, without approval, a highly pathogenic or suspected highly pathogenic microorganism experiment in a high-level pathogenic microorganism laboratory, the competent departments of health as well as agricultural and rural affairs of the people's government at or above the county level shall, in accordance with the division of duties, order the violator to cease the illegal acts, see to it that the violator destroys the pathogenic microorganisms used for experiment or delivers them to a preservation institution, and impose a warning. Where the aforementioned violation causes the spread or prevalence of an infectious diseases or any other serious consequence, the legal representative, the leading person, the person in charge who is directly responsible, and other persons who are directly responsible  shall be removed from their posts or discharged from employment in accordance with law.

Article 77  Where anyone, in violation of the provisions hereof, releases the used laboratory animals into market, the competent department of science and technology of the people's government at or above the county level shall order the violator to make rectification, confiscate the illegal gains, and impose a fine of not less than 200,000 yuan but not more than one million yuan, or a fine of not less than five times but not more than ten times the illegal gains if the illegal gains are 200,000 yuan or more; if the case is serious, the relevant permits shall be revoked by the issuing department.

Article 78  Where anyone, in violation of the provisions hereof, commits any of following acts, the relevant departments of the people's governments at or above the county level shall order the violator to make rectification, confiscate the illegal gains, and impose a warning, and may also impose a fine of not less than 100,000 yuan but not more than one million yuan:

(1) Purchasing or importing important equipment or special biological factors specified in the control lists without registration or reporting to the relevant departments of the State Council for record;

(2) Purchasing or possessing in the name of an individual person, important equipment or special biological factors specified in the control lists ;

(3) Establishing pathogenic microorganisms laboratories or engaging in pathogenic microorganism experiments in the name of an individual person; or

(4) Entering into high-level pathogenic microorganism laboratories without approval of the director of laboratories.

Article 79  Where anyone, in violation of the provisions hereof, collects or preserves the human genetic resources of China or conducts international joint research using the human genetic resources of China without approval, the competent department of science and technology of the State Council shall order the violator to cease the illegal acts, confiscate the illegal gains and the human genetic resources illegally collected or preserved, and impose a fine of not less than 500,000 yuan but not more than five million yuan, or a fine of not less than five times but not more than ten times the illegal gains if the illegal gains are more than one million yuan; if the circumstances are serious, the legal representative, the leading person, the person in charge who is directly responsible, and other persons who are directly responsible shall be sanctioned and prohibited from engaging in corresponding activities within five years  in accordance with law.

Article 80  Where an overseas organization or individual, or an institution established by or under the de facto control of such an organization or individual, in violation of the provisions hereof,  collects and preserves China's human genetic resources within the territory of China or provides China's human genetic resources for anyone outside China, the competent department of science and technology of the State Council shall order the aforesaid organization, individual or institution to cease the illegal acts, confiscate the illegal gains and the human genetic resources illegally collected and preserved, and impose a fine of not less than one million yuan but not more than ten million yuan, or a fine of not less than ten times but not more than twenty times the illegal gains if the illegal gains are one million yuan or more.

Article 81  Where anyone, in violation of the provisions hereof, introduces alien species into China without approval, the relevant departments of the people’s government at or above the county level shall, in accordance with the division of duties, confiscate the alien species introduced and impose a fine of not less than 50,000 yuan but not more than 250,000 yuan.

Where anyone, in violation of the provisions hereof, releases or discards alien species without approval, the relevant departments of the people’s governments at or above the county level shall, in accordance with the division of duties, order the violator to recapture or recover the alien species released or discarded within the specified time limit, and impose a fine of not less than 10,000 yuan but not more than 50,000 yuan.

Article 82  Anyone acting in violation of the provisions hereof, which constitutes a crime, shall be held criminally liable; where bodily harm, property damage or any other harm is caused, the violator shall bear civil liability according to law.

Article 83  Where there are biosecurity violations of this Law but entails no corresponding legal liability under this Law, other relevant laws or administrative regulations, if applicable, shall apply in accordance with the provisions thereof.

Article 84  Where an overseas organization or individual, by transporting, mailing, or carrying dangerous biological factors into China or by other means endangers China's biosecurity, the said organization or individual shall be held legally liable in accordance with law and, may be subjected to other necessary measures.

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