According to the judicial interpretation, in the medical device registration application, those who deliberately provide and use false medical device clinical trial reports and related materials will be convicted and punished as the crime of "intentionally providing false certification documents" or the crime of "producing or selling fake drugs" .
Among them, the “crime of deliberately providing false certification documents” can be sentenced to a maximum of 10 years depending on the circumstances; the “crime of producing or selling counterfeit drugs”, according to the Criminal Law, causes death or the circumstances are particularly serious, it is to be sentenced More than 10 years, life sentence, or even death sentence.
In addition, the new judicial interpretation stipulates that if the staff of state agencies abuse their power or neglect their duties, leading to the registration of medical devices that use false certification materials, they will also be held criminally liable for “abuse of power” or “crime of negligence of duty”.
It is undoubtedly the heaviest punishment to be directly sentenced to clinical trial fraudsters by the two masters, and its deterrence far exceeds the administrative punishment of the drug administration.
2016 was the "first year" of the Drug Administration's "bright sword" for medical device clinical trials. CFDA selected 20 registration applications from 20 companies. As a result, nearly half of them had authenticity problems, and a large number of companies voluntarily withdrew their registration applications. , Which caused a strong response in the industry.
In 2017, the drug administration "re-bright sword" for the clinical trial verification of medical devices, and related work is in full swing.
Last month, CFDA launched the nationwide 2017 medical device clinical trial supervision and spot check, and the list of the first 10 selected registration items has been announced.
At the local level, Hunan and Fujian Food and Drug Administration have also initiated the verification of clinical trials of medical device products under review in the province. The scope of verification in Fujian Province also includes retrospective inspection of certified products. Once data is found to be falsified, the registration certificate will be revoked, and applications from related companies will not be accepted within 5 years.
It is still unknown which companies will be fined for suspected clinical trial fraud within this year.
Just at this moment, the two high-level universities issued a new judicial interpretation, clarifying that false medical device registration application materials including clinical trial data will be held criminally responsible, and how to convict and sentence them. This adds a particularly heavy deterrent to the 2017 medical device clinical trial verification work.
The supervision is becoming more and more strict, and the punishment is getting heavier and heavier. Don't fake it, it will be fruitless!
Interpretation of the Supreme People’s Court and the Supreme People’s Procuratorate on Several Issues Concerning the Application of Law in the Handling of Criminal Cases of Falsification of Registration Application Materials for Drugs and Medical Devices
(Adopted at the 1714th meeting of the Judicial Committee of the Supreme People’s Court on April 10, 2017, and adopted at the 65th meeting of the 12th Procuratorial Committee of the Supreme People’s Procuratorate on June 8, 2017, effective as of September 1, 2017)
In order to punish the criminal acts of falsifying drug and medical device registration application materials in accordance with the law, and to protect the people’s lives and health rights, 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 now applicable to the handling of such criminal cases Some of the problems are explained as follows:
Article 1 The staff of non-clinical drug research institutions, drug clinical trial institutions, or contract research organizations who deliberately provide false drug non-clinical research reports, drug clinical trial reports and related materials shall be recognized as the 229th of the Criminal Law "Intentionally providing false certification documents" as stipulated in the Article.
If the conduct specified in the preceding paragraph falls under one of the following circumstances, it shall be deemed to be "serious" 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 be fined :
(1) Intentionally using false experimental drugs in the process of drug non-clinical research or drug clinical trials;
(2) concealing serious adverse events related to drugs used in clinical trials of drugs;
(3) Deliberately destroying original drug non-clinical research data or drug clinical trial data;
(4) Fabricating non-clinical drug research data or drug clinical trial data such as test animal information, subject information, main test process records, research data, test data, etc., which affects the results of drug safety and effectiveness evaluation;
(5) Those who have received criminal penalties for providing false certification materials in the process of applying for drug or medical device registration or have received administrative penalties within two years, and have provided false certification materials;
(6) Other serious circumstances.
Article 2 Anyone who carries out the act specified in Article 1 of this Interpretation, solicits or illegally accepts property from others, shall be punished for the crime of providing false certification documents for a period of not less than five years but not more than ten years in accordance with the provisions of paragraph 2 of Article 229 of the Criminal Law Imprisonment and fines; at the same time it constitutes the crime of providing false certification documents and the crime of accepting bribes, and the crime of accepting bribes by non-state personnel shall be convicted and punished in accordance with the provisions of heavier punishment.
Article 3 The staff of the drug registration application unit deliberately use false non-clinical drug non-clinical research reports, drug clinical trial reports and related materials that meet the requirements of Article 1, paragraph 2 of this Interpretation to defraud the drug approval documents to produce and sell drugs, They shall be convicted and punished for the crime of producing and selling counterfeit drugs in accordance with the provisions of Article 141 of the Criminal Law.
Article 4 The staff of the drug registration application unit instructs staff of non-clinical drug research institutions, drug clinical trial institutions, and contract research organizations to provide false drug non-clinical research reports and drug clinical trial reports as specified in Article 1 of this Interpretation. And related materials shall be treated as a joint crime of the crime of providing false supporting documents.
Under any of the following circumstances, it can be determined as the "instruction" as prescribed in the preceding paragraph, except for evidence to the contrary:
(1) Knowing that relevant institutions or organizations do not have the corresponding conditions or capabilities, they still entrust them to conduct drug non-clinical 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 non-clinical drug research institutions, drug clinical trial institutions, and contract research organizations jointly carry out the actions specified in the first paragraph to defraud the drug approval documents to produce and sell drugs, and at the same time constitute the provision of false certification documents Those who commit crimes and the crime of producing or selling counterfeit medicines shall be convicted and punished in accordance with the provisions of heavier punishments.
Article 5 In the medical device registration application, if false medical device clinical trial reports and related materials are deliberately provided or used, the provisions of Articles 1 to 4 of this interpretation shall apply.
Article 6 If a unit commits the crimes stipulated in Articles 1 to 5 of this interpretation, the unit shall be fined, and the directly responsible persons in charge and other directly responsible persons shall be convicted and punished in accordance with the corresponding conviction and sentencing standards for crimes committed by natural persons as stipulated in this interpretation .
Article 7: The staff of the state agencies who are responsible for the verification of drug and medical device registration applications abuse their power or neglect their duties, resulting in the registration of drugs and medical devices using false certification materials, resulting in major losses to public property, the country and the people’s interests If the crime is committed, criminal responsibility shall be investigated for the crime of abuse of power or dereliction of duty in accordance with the provisions of Article 397 of the Criminal Law.
Article 8: It is difficult to determine whether a non-clinical drug research report, drug or medical device clinical trial report and related materials are false, whether it affects the safety and effectiveness evaluation results of drugs or medical devices, and whether it is a serious adverse event or other special issues. If it is determined, it may be determined based on the opinions issued by the drug and medical device review institutions set up or designated by the State Drug Administration and other evidence.
Article 9 The term "contract research organization" as used in this interpretation refers to the commissioned by the drug or medical device registration application unit, drug non-clinical research institution, drug or medical device clinical trial institution, to engage in trial plan design, data statistics, analysis and testing , Supervision and inspection and other units related to non-clinical research or clinical trials.
Article 10 This interpretation shall come into force on September 1, 2017.