Amendment (XI) to the Criminal Law of the People’s Republic of China


Amendment (XI) to the Criminal Law of the People’s Republic of China

Adopted at the 24th Session of the Standing Committee of the 13th National People’s Congress of the People’s Republic of China on December 26, 2020, it is hereby promulgated and shall come into force on March 1, 2021.  

President of the People’s Republic of China, Xi Jinping, December 26, 2020  

 

Eleventh Amendment to the Criminal Law of the People’s Republic of China

(Adopted at the 24th Session of the Standing Committee of the 13th National People’s Congress on December 26, 2020)

... 

V. Article 141 of the Criminal Law shall be amended to read: “Production and sale” Counterfeit drugs shall be punished by imprisonment of no more than three years or criminal detention, together with a fine; if serious harm is caused to human health or other serious circumstances exist, the punishment shall be imprisonment of more than three years but no more than ten years, together with a fine; if death results or other particularly serious circumstances exist, the punishment shall be imprisonment of ten years or more, life imprisonment, or the death penalty, together with a fine or confiscation of property. “Personnel of drug-use units who knowingly provide counterfeit drugs for others to use shall be punished in accordance with the provisions of the preceding paragraph.”

VI. Article 142 of the Criminal Law shall be amended to read: “Production and sale” Substandard drug Where such acts cause serious harm to human health, the offender shall be sentenced to fixed-term imprisonment of no less than three years but no more than ten years, together with a fine; where the consequences are particularly severe, the offender shall be sentenced to fixed-term imprisonment of no less than ten years or life imprisonment, together with a fine or confiscation of property. “Personnel of drug-use units who knowingly provide substandard drugs to others for use shall be punished in accordance with the provisions of the preceding paragraph.”

VII. Add the following article after Article 142 of the Criminal Law, to be designated as Article 142-1: “ Violation of pharmaceutical management regulations “Where any of the following circumstances exists and is sufficient to seriously endanger human health, the offender shall be sentenced to no more than three years’ imprisonment or criminal detention, and fined either concurrently or separately; where serious harm is caused to human health or other serious circumstances exist, the offender shall be sentenced to no less than three years but no more than seven years’ imprisonment, and fined.”

(1) Producing or selling drugs that are prohibited for use by the drug regulatory authority under the State Council; “

(2) Producing or importing pharmaceutical products without obtaining the relevant approval documents, or selling such products knowing that they fall under the aforementioned category; “

(3) Providing false certificates, data, materials, or samples, or employing other deceptive means in the application for drug registration.

(4) Falsifying production and inspection records. “Where any of the acts specified in the preceding paragraph also constitutes a crime as defined in Articles 141 or 142 of this Law, or any other crime, the offender shall be convicted and punished in accordance with the provision prescribing the heavier penalty.” Article 38: After Article 334 of the Criminal Law, add the following article as Article 334-1: “ Anyone who, in violation of relevant state regulations, illegally collects China’s human genetic resources or illegally transports, mails, or carries such materials out of the country, thereby endangering public health or the public interest, and where the circumstances are serious, shall be punished by Imprisonment of no more than three years, criminal detention, or control, together with a fine or a fine alone. For particularly serious circumstances, impose Imprisonment of no less than three years but no more than seven years, together with a fine. ” 

Article 39: Add the following article after Article 336 of the Criminal Law, to be designated as Article 336-1: “Whoever implants gene-edited or cloned human embryos into the human body or the body of an animal, or implants gene-edited or cloned animal embryos into the human body, and the circumstances are serious, shall be sentenced to fixed-term imprisonment of no more than three years or criminal detention, and fined; if the circumstances are particularly serious, shall be sentenced to fixed-term imprisonment of more than three years but no more than seven years, and fined.”

Article 45: Paragraph 1 of Article 408-1 of the Criminal Law shall be amended to read as follows: “State functionaries who are entrusted with the duties of supervising and administering food and drug safety, if they abuse their authority or neglect their duties and, under any of the following circumstances, cause serious consequences or other serious circumstances, shall be sentenced to fixed-term imprisonment of no more than five years or criminal detention; if they cause particularly serious consequences or other particularly serious circumstances, they shall be sentenced to fixed-term imprisonment of more than five years but no more than ten years.”

(1) Concealing or falsely reporting food safety accidents or pharmaceutical safety incidents;

(2) Failing to investigate and handle, in accordance with regulations, serious violations of food and drug safety laws and regulations that have been discovered;

(3) Granting approval to applications that do not meet the requisite conditions during the examination and review process for drugs and special foods;

(4) Failing to refer cases that, in accordance with the law, should be transferred to the judicial authorities for criminal prosecution;

(5) Any other acts of abuse of power or dereliction of duty.

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