NEWS CENTER

According to the judicial interpretation, in the application for medical apparatus registration, those who deliberately provide or use false medical apparatus clinical trial reports and related materials will be convicted and punished for the crime of "intentionally providing false supporting documents" or "producing and selling counterfeit drugs."

Among them, those who "intentionally provide false supporting documents" can be sentenced to up to 10 years depending on the circumstances; those who "produce and sell counterfeit drugs", according to the Criminal Law, if the circumstances are particularly serious, will be sentenced to more than 10 years, life, or even the death penalty.

In addition, the new judicial interpretation stipulates that state officials who abuse their power or neglect their duties, resulting in the registration of medical apparatuses that use false certification materials, will also be held criminally liable for the crime of "abuse of power" or "dereliction of duty."

The direct sentencing of clinical trial counterfeiters by the two highs is undoubtedly the heaviest punishment, and its deterrent power far exceeds the administrative punishment of the Drug Administration.

In 2016, it was the "first year" of the Drug Administration's "bright sword" for the fraud of medical apparatus clinical trials. CFDA extracted 20 registration application items from 20 companies, and nearly half of the results had authenticity problems. A large number of companies voluntarily withdrew their registration applications, causing strong repercussions in the industry.

In 2017, the Drug Administration inspected the clinical trials of medical apparatus to "re-shine the sword", and related work is in full swing.

Last month, the CFDA launched a nationwide 2017 medical apparatus clinical trial supervision and sampling work, and the first list of 10 selected registration projects has been announced.

At the local level, the Food and Drug Administration of Hunan and Fujian provinces has also started the verification of clinical trials of medical device products under review in their provinces. Among them, the scope of verification in Fujian Province also includes retrospective inspection of certified products. Once the data is found to be fraudulent, the registration certificate will be revoked, and the application of relevant enterprises will not be accepted within 5 years.

This year, it is unknown which companies will be fined for allegedly falsifying clinical trials.

Just at this juncture, the two high schools issued a new judicial interpretation, clarifying that falsification of medical apparatus registration application materials, including clinical trial data, will be investigated for criminal responsibility, and clarifying how to convict and sentence. This added a particularly heavy deterrent to the clinical trial verification of medical apparatus in 2017.

The supervision is becoming stricter and stricter, and the punishment is getting heavier and heavier. Don't fake it, and there will be no good results for counterfeiting!

Annex

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

(Adopted at the 1714th meeting of the Judicial Committee of the Supreme People's Court on April 10, 2017, and the 65th meeting of the 12th Procuratorial Committee of the Supreme People's Procuratorate on June 8, 2017, and effective from September 1, 2017)

In order to punish the criminal act of falsifying application materials for registration of medicines and medical apparatus in accordance with the law, and to safeguard the people's rights and interests in life and health, in accordance with 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, the law is hereby applied to the handling of such criminal cases. Several issues are explained as follows:

Article 1 If a staff member of a drug non-clinical research institution, drug clinical trial institution, or contract research organization intentionally provides false drug non-clinical research reports, drug clinical trial reports and related materials, it shall be identified as Article 229 of the Criminal Law "Deliberately providing false certification documents".

Those who commit the acts specified in the preceding paragraph under any of the following circumstances shall be identified as "serious circumstances" as stipulated in Article 229 of the Criminal Law, and shall be sentenced to fixed-term imprisonment of not more than five years or criminal detention for the crime of providing false supporting documents, and shall also be fined:

(1) Deliberately using false experimental drugs during non-clinical drug research or drug clinical trials;

(2) Concealing serious adverse events related to drugs used in clinical trials;

(3) Deliberately destroying the original drug non-clinical research data or drug clinical trial data;

(4) Fabricating test animal information, subject information, main test process records, research data, test data and other drug non-clinical research data or drug clinical trial data, affecting the results of drug safety and efficacy evaluation;

(5) Having been subject to criminal punishment or administrative punishment within two years for providing false certification materials during the application for registration of drugs or medical apparatus, and providing false certification materials;

(6) Other circumstances with serious circumstances.

Article 2 Whoever commits the acts specified in Article 1 of this Interpretation and solicits or illegally accepts other people's property shall, in accordance with the provisions of Paragraph 2 of Article 229 of the Criminal Law, be sentenced to not less than five years but not more than ten years for the crime of providing false supporting documents. Fixed-term imprisonment and a fine; those who also constitute the crime of providing false supporting documents, the crime of accepting bribes, and the crime of acceptance of bribes by a non-state functionary shall be convicted and punished in accordance with the provisions with heavier penalties.

Article 3 If a staff member of a drug registration application unit intentionally uses false drug non-clinical research reports, drug clinical trial reports and related materials that comply with the provisions of Paragraph 2 of Article 1 of this Interpretation to defraud drug approval documents to produce and sell drugs, It shall be convicted and punished for the crime of producing and selling counterfeit drugs in accordance with Article 141 of the Criminal Law.

Article 4 If the staff of the drug registration application unit instructs the staff of drug non-clinical research institutions, drug clinical trial institutions, and contract research organizations to provide false drug non-clinical research reports and drug clinical trials as specified in Paragraph 2 of Article 1 of this Interpretation If the report and related materials are used, the crime of providing false supporting documents shall be punished as a common crime.

Under any of the following circumstances, it may be deemed to be the "instruction" stipulated in the preceding paragraph, unless there is evidence to the contrary:

(1) Knowing that the relevant institutions and organizations do not have the corresponding conditions or capabilities, they still entrust them to conduct non-clinical drug research or drug clinical trials;

(2) The price paid is obviously different from the normal fee.

The staff of the drug registration application unit and the staff of the drug non-clinical research institution, the drug clinical trial institution, and the contract research organization jointly carry out the acts specified in the first paragraph, defraud the drug approval certificate to produce and sell drugs, and at the same time constitute the provision of false certification documents. Those who commit the crime and the crime of producing or selling counterfeit drugs shall be convicted and punished in accordance with the provisions with heavier penalties.

Article 5 In the application for registration of a medical apparatus, those who intentionally provide or use false medical apparatus clinical trial reports and related materials shall apply the provisions of Articles 1 to 4 of this Interpretation by reference.

Article 6 If a unit commits the crimes specified in Articles 1 to 5 of this Interpretation, the unit shall be fined, and the directly responsible person in charge and other directly responsible persons shall be convicted and punished in accordance with the conviction and sentencing standards for the crime of the corresponding natural person stipulated in this Interpretation.

Article 7 If a staff member of a state organ who is responsible for verifying an application for registration of a drug or medical apparatus abuses his power or neglects his duties, resulting in the registration of a drug or medical apparatus using false certification materials, resulting in heavy losses to public property, the state and the interests of the people, he shall be investigated for criminal responsibility for the crime of abuse of power or dereliction of duty in accordance with Article 397 of the Criminal Law.

Article 8 It is difficult to determine whether the drug non-clinical research report, drug or medical apparatus clinical trial report and related materials are false, whether they affect the safety and efficacy evaluation results of the drug or medical apparatus, and whether they are serious adverse events. If it is difficult to determine, it may be determined based on the opinions issued by the drug and medical apparatus review and other institutions set up or designated by the State Drug Administration, combined with other evidence.

Article 9 The term "contract research organization" as mentioned in this Interpretation refers to the unit entrusted by the drug or medical apparatus registration application unit, the drug non-clinical research institution, and the drug or medical apparatus clinical trial institution to engage in the design of the trial plan, data statistics, analysis and testing, Monitoring and inspection and other non-clinical research or clinical trial-related activities.

Article 10 This Interpretation shall come into force on September 1, 2017.