Medical equipment and drug registration fraud will face severe punishment
On April 10, the Plenary Session of the Supreme Judicial Committee reviewed and approved in principle the Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Application of Laws in Handling Criminal Cases of Drugs and Medical Device Registration Applications (hereinafter referred to as "Explanation").
The fraudulent behavior of drug and medical device registration application data seriously affects the quality and safety of drugs and the authority of drug supervision, endangering the health and safety of the people, and is strongly reflected in all sectors of society. The Party Central Committee attaches great importance to drug safety supervision and has made important instructions on many occasions, requiring strictest standards, strictest supervision, the most severe punishment, and the most serious accountability, and strictly guarding every line of defense from the laboratory to the hospital. Therefore, the Supreme People's Court began drafting the Interpretation in July 2016 by the Supreme Law. During the formation of the draft for review, it also sought the revision opinions of the Supreme People's Procuratorate, the Ministry of Public Security and the State Food and Drug Administration, and conducted a study on the interpretation. Discussion, revision and improvement, and finally form a draft for review.
The interpretation of the "interpretation" is divided into three cases to clarify the relevant registration fraud:
1. If a drug non-clinical research institution, a drug or medical device clinical trial institution or a contract research organization deliberately provides a false non-clinical research report or a clinical trial report, it may be convicted and punished according to the crime of providing false certification documents;
2. For drug registration applicants to falsify themselves, provide false non-clinical research or clinical trial reports and related materials, and defraud the drug approval certificate, they may be convicted and punished according to the crime of producing and selling fake drugs;
3. Drug non-clinical research institutions, drug or medical device clinical trial institutions, contract research organizations and drug registration applicants collude, provide false non-clinical research or clinical trial reports and related materials, defraud drug approval documents, and constitute the provision False certification documents and the crime of producing and selling counterfeit drugs shall be convicted and punished by penalties for heavier crimes.
How is the punishment for “providing false certification documents†and “crime for producing and selling fake drugs†mentioned above? According to the Criminal Law, the two sentences are divided as follows:
Providing false certification documents: Article 229 of the Criminal Law provides for the crime of material misrepresentation: the personnel of the intermediary organization that undertakes the duties of asset assessment, capital verification, verification, accounting, auditing, legal services, etc. deliberately provide false certification documents. If the circumstances are serious, they shall be sentenced to fixed-term imprisonment of not more than five years or criminal detention, and shall be fined. The personnel prescribed in the preceding paragraph shall, if they seek the property of others or illegally accept the property of others, commit a crime of the preceding paragraph, and shall be sentenced to fixed-term imprisonment of not less than five years and not more than ten years. The personnel specified in the first paragraph are seriously irresponsible. If the supporting documents issued are seriously inaccurate and cause serious consequences, they shall be sentenced to fixed-term imprisonment of not more than three years or criminal detention, and shall be punished with a fine.
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