Interpretation on Several Issues on the Applicable Law in Handling Cases Of Crimes Endangering Drug Safety

The Supreme People's Court, The Supreme People's Procuratorate

Full Text of the SPC/SPP Interpretation on Several Issues Regarding the Application of Law in Cases of Crimes Endangering Drug Safety

So as to punish crimes endangering food safety in accordance with law, to ensure the masses' security in their lives and well-being, and to protect the order of the pharmaceutical market, the following interpretation on several issues regarding the application of law in this type of case is made on the basis of the Criminal Law of the People's Republic of China

Article 1: In any of the following circumstances of the following circumstances, production or sale of fake drugs shall be given a heavier sentence as deemed appropriate.

(1) production or sale of drugs primarily used by pregnant women, infants, children, or persons with serious illnesses.

(2) production or sale of fake narcotics, psychotropics, medicinal toxins, radiopharmaceuticals, contraceptives, blood plasma products or vaccines;

(3) production or sale of fake injections or first-aid medicines;

(4) production or sale of fake drugs by medical establishments or their personnel;

(5) production or sale of fake drugs during emergency situations such as natural disasters, accidents, public health incidents or public security situations, where the drugs are to be used to respond to the situation;

(6) where within the past two years, one has already received an administrative punishment or criminal penalty for illegal or criminal activites endangering drug safety.

(7) Other situations where a heavier sentence shall be given as deemed appropriate.

Article 2: Article 2: In any one of the following circumstances, the production or sale of fake drugs shall be considered "causing serious harm to persons health" as provided for in article 141 of the Criminal Law:

(1) causes light or serious injury;

(2) causes a light or mid-level disability;

(3) causes organ tissue damage leading to ordinary dysfunction or severe dysfunction;

(4) other circumstances causing serious harm to persons' health.

Article 3: In any of the following circumstances, the production or sale of fake drugs shall be considered "other serious circumstances" as provided for in article 141 of the Criminal Law:

(1) caused a quite large outbreak public health incident;

(2) Produced or sold a value between 200,000 yuan and 500,000 yuan;

(3) Produced or sold a value between 150,000 yuan and 200,000 yuan and has one of the circumstances in article 1 of this interpretation;

(4) Where it should be considered serious circumstances on the basis of circumstances such as the time, volume or type of fake drugs.

Article 4: In any one of the following circumstances, the production or sale of fake drugs shall be considered "other especially serious circumstances" as provided for in article 141 of the Criminal Law:

(1) Caused serious disabilities

(2) caused three or more persons to be seriously injured or moderately disabled or suffer organ damage causing serious impairments.

(3) causes five or more persons to have minor injuries, or to suffer minor disabilities or organ failure causing general dysfunction.

(4) Caused 10 or more light injuries;

(5) caused a serious or especially serious public health incident;

(6) produced or sold a value of more than 500,000 yuan;

(7) Produced or sold a value between 200,000 yuan and 500,000 yuan and has one of the circumstances in article 1 of this interpretation;

(8) Where it should be considered especially serious circumstances on the basis of circumstances such as the time, volume or type of fake drugs.

Article 5: Where any of the circumstances in Article 2 of this Interpretation are present, the production or sale of shoddy drugs shall be considered "Causing serious harm to people's physical health" as used in article 144 of the Criminal Law.

Where the production or sale of shoddy drugs causes a death, or has any of the circumstances provided for in article 4(1) or article 5 of this Interpretation, it shall be considered "especially serious consequences" as used in article 142 of the Criminal Law.

Production or sale of shoddy drugs shall be given a heavier sentence as deemed appropriate when having any of the circumstances provided for in article 1 of this Interpretation.

Article 6: Carrying out any of the following conduct with the goal of production or sale of fake or shoddy drugs, shall be considered "production" as provided for in Articles 141 and 142 of the Criminal Law.

(1) The synthesis, purification, extraction, storage, or processing raw materials for drug production;

(2) Carrying out batching, mixing, preparing, storing, or packing in the course of making finished products from raw materials, supplementary materials and packaging.

(3) Printing packing materials, labels or instuction manuals.

Acts by medical establishments and medical establishment personnel that clearly know medicine is fake or shoddy but provide it for others' use in exchange for compensation, or purchase or store it for the purpose of sale, shall be considered 'sales' as provided in Article 141, 142 of the Criminal Law.

Article 7: Where a person violates state drug administration laws and regulations and illegally distributes drugs without obtaining drug distribution certificate or using fabricated or altered certificates, and the circumstances of such act is serious, s/he all be convicted of the crime of illegal business operation under Article 225 of the PRC Criminal Law.

Where a person violates state regulations, and manufactures or sells non-pharmaceutical raw materials or auxiliary materials which do not conform to medicinal use requirement, with the intention of supplying [these materials] to others to manufacture or sell drugs, and where the circumstances of such act is serious, s/he should be convicted of the crime of illegal business operation under Article 225 of the PRC Criminal Law.

Where a person commits the acts set out in the previous two paragraphs, and whose illegal business income is above 100,000 yuan, or whose illegal income is above 50,000 yuan, such act should be considered to be "serious circumstance" as under Article 225 of the PRC Criminal Law. Where the illegal business income is above 500,000 yuan or illegal income is above 250,000 yuan, such act should be regarded as "particularly serious circumstance" under Article 225 of the PRC Criminal Law.

Where a person commits the act set out paragraph 2 of this article, and such act in the same time constitutes crimes such as manufacturing or selling shoddy products and endangering public security in a dangerous way, s/he shall be convicted of the crime that carries a heavier sentence.

Article 8: In any of the following circumstances where clearly knowing that others are producing or selling fake or shoddy goods, it shall be handled as a joint crime.

(1) Providing capital, loans, accounts, bills, proofs or approval documents.

(2) providing the places or equipment for production or business, or supplying facilitation requirements such as transportation, storage, bailment, mailing and online sales channels.

(3) Providing production techniques or original materials, supplementary materials, packaging materials, labels or instruction books;

(4) Providing advertisement publicity or other assisting conduct.

Article 9: Advertisers, Advertising agents, and advertisement publishers violating national provisions to use advertisements to give false or misleading publicity on drugs, where the circumstances are serious, are tried and punished in accordance with the provisions on false advertisements article 222 of the Criminal Law.

Article 10: Where commission of the crime of production or sale of false or shoddy drugs simultaneously constitutes crimes such as production or sale of shoddy goods, violation of intellectual property rights, illegal business operations, illegal practice of medicine, or illegal collection or sale of blood, it is tried and punished under the provisions for the more serious offense.

Article 11: Criminal law provisions for suspended sentences and waiver of criminal penalties should be rigidly applied for criminals perpetrating the crimes provided for in this interpretation. Where a suspension of sentence is applicable [to the criminal], a restraining order should also be declared in order to prohibit the criminal from engaging in drug production, sales and other relevant activities during probation period.

[The act of] selling a small amount of privately manufactured drug based on traditional folk recipes or selling a small amount of foreign or overseas drug not approved for importation, which has not resulted in injuries to others or delayed diagnosis and treatment and whose circumstances are obviously minor and has caused no serious harm, is not considered a crime.

Article 12: Where the crime of manufacturing and selling fake drugs is committed, generally a fine exceeding twice the manufacturing and sales amount should be imposed according to law. Where joint crime is committed, the combined fines imposed on each individual joint criminal should exceed twice the manufacturing and sales amount.

Article 13: Where a work unit commits the crimes provided for by this Interpretation, a fine should be imposed on the work unit and its executive personnel directly in charge and other personnel directly in charge should be punished according to the conviction and sentencing criteria of a natural person set out by this Interpretation.

Article 14: Where it proves difficult to determine whether [a drug] is a "fake drug" or a "shoddy drug" under articles 141 and 142 of the Criminal Law, judicial organs could carry out identification according to identification opinions and other relevant documents provided by drug supervision and administration departments above municipal level. When necessary, [judicial organs] could authorize drug inspection institutions established and/or determined by drug supervision and administration departments above the provincial level to carry out inspection.

Article 15: The "manufacturing and sales amount" as used in this Interpretation means the overall illegal income that is gained and could be gained during the manufacturing and sales of fake or shoddy drugs.

Article 16: "Light injuries" and "serious injuries" as stipulated in this Interpretation should be appraised according to "Human Body Damage Degree Appraisal Standard".

"Light disability", "moderate disability", and "severe disability" as stipulated in this Interpretation are to be assessed according to the relevant evaluation criteria of the levels of disability.

Article 17: After this Interpretation has been issued and takes effect, the "Supreme People's Court and Supreme People's Procuratorate Interpretation on Several Issues on the Specific Application of Law in Handling Criminal Cases of production or sale of Fake or Shoddy Medicine" (Judicial Interpretation 2009 No. 9) is at that the sime time abolished; and where judicial interpretations or normative documents differ from this document, this document controls.