Handling of Criminal Cases of False Application Materials for Registration of Drugs & Medical Devices

 2018-05-16  38


Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on the Several Issues regarding the Application of Law in the Handling of the Criminal Cases of False Application Materials for the Registration of Drugs and Medical Devices


· Document Number:Interpretation No. 15 [2017] of the Supreme People's Court

· Area of Law: Health and Sanitation Criminal Law

· Level of Authority: Judicial Interpretation

· Date issued:08-14-2017

· Effective Date:09-01-2017

· Status: Effective

· Issuing Authority: Supreme People's Court Supreme People's Procuratorate

 

Announcement of the Supreme People's Court and the Supreme People's Procuratorate
The Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on the Several Issues regarding the Application of Law in the Handling of the Criminal Cases of False Application Materials for the Registration of Drugs and Medical Devices, as adopted at the 1714th Session of the Judicial Committee of the Supreme People's Court on April 10, 2017 and at the 65th Session of the 12th Procuratorial Committee of the Supreme People's Procuratorate on June 8, 2017, is hereby issued and shall come into force on September 1, 2017.
Supreme People's Court
Supreme People's Procuratorate
August 14, 2017
Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on the Several Issues regarding the Application of Law in the Handling of the Criminal Cases of False Application Materials for the Registration of Drugs and Medical Devices
(Interpretation No. 15 [2017] of the Supreme People's Court, adopted at the 1714th Session of the Judicial Committee of the Supreme People's Court on April 10, 2017 and at the 65th Session of the 12th Procuratorial Committee of the Supreme People's Procuratorate on June 8, 2017, and to come into force on September 1, 2017)
For the purposes of punishing the criminal behaviors of submitting false application materials for the registration of drugs and medical devices and protecting the life and health rights and interests of the people, under the relevant provisions of the Criminal Law of the People's Republic of China and the Criminal Procedure Law of the People's Republic of China, several issues concerning the application of law in the handling of such criminal cases are hereby interpreted as follows:
Article 1 A staff member of a non-clinical drug research institution, an institution for clinical drug trial, and a contract research organization that intentionally provides a false non-clinical drug research report, clinical drug trial report and related materials shall be determined as falling under the circumstance of “intentionally providing false certification documents” as prescribed in Article 229 of the Criminal Law.
Whoever commits any of the acts as prescribed in the preceding paragraph and falls under one of the following circumstances shall be determined as falling under the circumstance of “serious circumstance” as prescribed in Article 229 of the Criminal Law, and shall be convicted of the crime of providing false certification documents and be sentenced to a fixed-term imprisonment of no more than five years or criminal detention according to law, in addition to a fine:
(1) He or she intentionally uses false drugs for trial during the process of non-clinical drug research or clinical drug trial.
(2) He or she conceals serious adverse events relating to the drugs for clinical drug trial.
(3) He or she intentionally damages to the data of the original non-clinical drug research or clinical drug trial.
(4) He or she fabricates information on the animals for trial, information on the trial subjects, records of the main trial process, research data, test data and other data of non-clinical drug research or data of clinical drug trial, thus affecting the assessment results on the safety and effectiveness of the drugs.
(5) He or she has been imposed criminal penalties for providing false certification materials during the process of applying for the registration of drugs and medical devices or has been imposed criminal penalties within two years, and provides false certification materials once again.
(6) Any other serious circumstance.
Article 2 Whoever commits any of the acts as prescribed in Article 1 of this Interpretation and seeks or illegally accepts any other person's money or property shall, under the provisions of paragraph 2 of Article 229 of the Criminal Law, be convicted of the crime of providing false certification documents and be sentenced to a fixed-term imprisonment of no less than five years but no more than ten years in addition to a fine; and whoever concurrently constitutes the crime of providing false certification documents, the crime of accepting bribes, and the crime of accepting bribes by a non-state functionary shall be convicted and punished according to the provisions on heavier punishment.
Article 3 A staff member of an entity applying for the registration of a drug who intentionally uses a false non-clinical drug research report, clinical drug trial report or related materials as prescribed in paragraph 2 of Article 1 of this Interpretation, and manufactures and sells drugs by obtaining drug approval certification documents by fraudulent means shall be convicted of the crime of manufacturing or selling fake drugs and be punished according to Article 141 of the Criminal Law.
Article 4 A staff member of an entity applying for the registration of a drug who instigates a staff member of a non-clinical drug research institution, an institution for clinical drug trial, or a contract research organization to provide a false non-clinical drug research report, clinical drug trial report or related materials as prescribed in paragraph 2 of Article 1 of this Interpretation shall be punished as an accomplice in the crime of providing false certification documents.
Whoever falling under one of the following circumstances may be determined as “instigating” as prescribed in the preceding paragraph, except as proved by any contrary evidence:
(1) Being evidently aware that the relevant institution or organization does not meet the appropriate conditions or have the appropriate capacity, he or she nonetheless entrusts it to conduct non-clinical drug research and clinical drug trial.
(2) The price paid is obviously different from the normal expenses.
A staff member of an entity applying for the registration of a drug and a staff member of a non-clinical drug research institution, an institution for clinical drug trial, or a contract research organization that jointly commit the act as prescribed in paragraph 1, that manufacture and sell drugs by obtaining drug approval certification documents by fraudulent means, and that are concurrently convicted of the crime of providing false certification documents and the crime of manufacturing or selling fake drugs shall be convicted and punished according to the provisions on heavier punishment.
Article 5 The provisions of Article 1 to Article 4 of this Interpretation shall apply mutatis mutandis to those who intentionally provide and use false clinical trial reports or relevant materials on medical devices.
Article 6 An entity that commits a crime as prescribed from Article 1 to Article 5 of this Interpretation shall be imposed a fine, and the directly responsible person in charge and other directly liable persons shall be convicted and punished according to the corresponding conviction and sentencing standards for natural person criminals as prescribed in this Interpretation.
Article 7 A functionary of a state authority assuming the verification responsibility for applications for the registration of drugs and medical devices who abuses his power or neglects his duties so that the drugs and medical devices using false certification materials are registered, and that causes material losses to the public property and the interests of the state and the people shall be held criminally liable for the crime of abuse of power and the crime of neglect of duty under the provisions of Article 397 of the Criminal Law.
Article 8 Whether a non-clinical drug research report, and a clinical trial report or related materials on a drug or medical device are false, whether the safety and effectiveness assessment results of a drug or medical device are affected, whether it is a serious adverse event, and other special issues that are difficult to be determined may be determined according to the opinions issued by the drugs and medical devices assessment agencies and other institutions established or designated by the state drug administration and in consideration of other evidence.
Article 9 For the purposes of this Interpretation, “contract research organizations” means entities engaged in the design of trial program, data statistics, analysis and testing, monitoring and inspection, and other activities relevant to non-clinical drug research or clinical trial upon commission of the entities applying for the registration of drugs or medical devices, non-clinical drug research institutions, and clinical drugs or medical devices trial institutions.
Article 10 The Interpretation shall come into force on September 1, 2017.