Medical registration fraud to jail, how to set? The most authoritative argument has come

Pharmaceutical Network November 20 hearing the Supreme People's Court, the Supreme People's Procuratorate jointly developed "on the handling of drugs, medical equipment, application of criminal record counterfeiting criminal cases a number of issues of interpretation" (hereinafter referred to as "interpretation"), respectively, by 2017 4 Approved at the 1714th meeting of the Supreme Court Judicial Review Commission on the 10th of the month and the Supreme Examination of the 8th of June 2017 at the 65th meeting of the 12th Procuratorial Committee, announced on August 15, 2017, as of September 1, 2017 To facilitate the accurate understanding and application of "interpretation" of the relevant provisions of the "interpretation" of the background and the main content is described below:

"Explain" a total of 10. Mainly to solve three problems:

First, drug non-clinical research institutions, drug clinical trial agencies, contract research organizations and their staff, fraud, providing a report of serious misconduct constitutes a crime, can provide false documents conviction and punishment.

Second, drug registration applicants falsified, the use of false non-clinical research or clinical trial reports and related materials, fraudulent approval documents and the production and sale of drugs constitute a crime, you can produce and sell fake drugs conviction and punishment.

Third, for the registration of medical devices in the clinical trial data fraud, with reference to the relevant provisions of the fraud data, to investigate the corresponding criminal responsibility.

(A) of the drug clinical trial agencies and other 'intermediary organizations' conviction and punishment standards

The Explanatory Provisions deal with the criminalization of the crime of providing false documents as three categories of non-clinical research institutions, drug clinical trial institutions and contract research organizations with two provisions.

Article 1 stipulates that non-clinical drug agencies, drug clinical trial agencies and contract research organizations' personnel serve as the subject of providing false certificates and their "serious" standards.

The first one is a qualitative definition of 'deliberately providing false documents,' and also resolves the issue of the principal status of non-clinical drug agencies, drug clinical trial agencies and contract research organization staff.

Article 229 of the Criminal Law is the stipulation of the intermediary organization that undertakes the duties of assets appraisal, capital verification, verification, accounting, auditing and legal services, and so on, which embodies the characteristics of the criminal subject stipulated in the article, namely, establishing and connecting according to law Various types of market entities (including government) and to engage in their related activities to provide services to specific organizations.

In the course of market economy, whether the relevant units and personnel belong to the 'intermediary organizations' or 'intermediary organizations' stipulated in the criminal law should not be defined from the name of the unit concerned, the nature of ownership, the principal business, etc., Related business activities are intermediary to determine whether or not.

Drug non-clinical research institutions, drug clinical trial institutions, contract research organizations and their staff according to commissioned to carry out research and provide non-clinical drug reports, drug clinical trial reports and related materials, and 'asset appraisal, capital verification, verification, accounting, auditing , As a legal service ', is in the intermediary position of intermediary certificate. The specific services it entrusted and provided to clients are intermediary services and meet the main characteristics of the intermediary organizations stipulated in Article 229.

In the second paragraph, there are altogether six items specifying the intentional provision of the 'serious circumstance' of the falsified supporting documents.The first item specifies the case of 'intentional use of false test drugs' in the course of clinical non-clinical studies or drug clinical trials.

For example, do not use the drug to be registered as a drug for research, testing, reference test to replace the test group or to replace the reference drug test group, the market to buy drugs instead of self-developed test drugs, will inevitably affect the drug Safety, effectiveness evaluation results, is the worst practice in data fraud.

The second stipulates the case of "concealment of serious adverse events related to drugs used in clinical trials of drugs." According to Article 68 of the "Code of Good Practice for Clinical Trials of Drugs" (hereinafter referred to as "Clinical Management Practices"), "serious ill- Incident, refers to the occurrence of clinical trials required hospitalization, prolonged hospitalization, disability, affecting the ability to work, life-threatening or death, leading to congenital malformations.

Article 26 of the "Code of Clinical Management" stipulates: 'In the event of a serious adverse event during clinical trials, the investigator shall promptly take appropriate treatment measures for the subjects and report to the drug regulatory department, the health administrative department and the bidder And Ethics Committee, sign and date the report.

Concealment here includes cases of underemplaiming and false reports, etc. Concealing serious adverse events will inevitably affect the safety evaluation results of drugs, resulting in the listing of unsafe drugs and endangering the people health What needs to be emphasized is that the concealment here is based on the intentional implementation of the perpetrator, and if the omission is negligent, it does not constitute the crime.

The third regulation states the case of deliberately destroying nonclinical study data or drug clinical trial data of the original drug and it is generally considered that deliberately destroying nonclinical study data or drug clinical trial data of the original drug is a test of resistance and is intended to evade liability Conduct, Article 63 of the Code of Clinical Practice stipulates that 'All observations and findings in clinical trials should be verified and quality control necessary at each stage of data processing to ensure data integrity, Accurate, true and reliable.

Article 52 states: 'All information in clinical trials must be kept and administered as required, and the investigator should keep the clinical trial data for a period of five years after termination of the clinical trial, and the sponsor should keep the clinical trial information until the trial drug is approved for listing In practice, some actors may deliberately destroy (including destroying, deleting) the original materials in order to resist the inspection, resulting in the loss of the original data and the inability to verify the existence of the fake behavior, whereby it can be presumed that the data fraud has occurred.

The fourth item specifies the 'results of compiling the non-clinical research data or clinical trial data of drugs such as the information of the tested animals, the information of the subjects, records of the main testing procedures, research data, testing data and the like, and the results of evaluating the safety and effectiveness of medicines' Situation.The fraud of this kind of data should be dealt with according to the circumstance and consequence of fraud behavior, and only "the result that affects drug safety and effectiveness evaluation" should be based on this crime.

The fifth item stipulates the case of 'having provided criminal evidence of fake evidence in the course of applying for registration of drugs and medical devices or of having received administrative penalties within two years, and also providing false proof materials'.

This provision is stipulated in the Provisions of the Supreme People's Procuratorate and the Ministry of Public Security on Filing Standards for Prosecution of Criminal Cases under the Public Security Bureaus (II) (hereinafter referred to as "the standards for filing a case for prosecution (II)") for two years because of providing false certificates, Administrative penalties more than twice, but also provide false proof of the 'basis of the amendment. This is based on severely punished Drug registration The consideration of fraud behavior stipulates that a person who commits an offense again within two years after receiving an administrative punishment will be guilty of an offense and lower the threshold for admitting a criminal offense to make it more realistic.

The sixth is a backlog to cover the new situations that may arise in the future.

It should be noted that, taking into account the special nature of the application for drug registration fraud, this interpretation did not absorb the "standard filing prosecution standard (b)" of the first to third of Article 81 of the standard amount, such as' illegal The amount of more than 100,000 yuan '.

The main considerations: First, drug non-clinical research or clinical trials of a long cycle, a wide range of links, individual data is inevitable omissions, false, but as long as does not affect the safety of drugs, the effectiveness of evaluation results, should not be criminalized;

Second, the current non-clinical drug clinical trials or clinical testing fees are far more than one hundred thousand yuan, if you insist on the application of "prosecution standards (2)" the amount of the standard, then basically all the fraud can be criminalized In addition, the "prosecutorial prosecution standards (b)" also provides that although the required standard has not yet reached the prescribed value, but has the "request or illegally accepting the property of others," it should also be convicted and punished.

According to the research, no matter how much money is received or not, whether or not it affects the safety of drugs, the results of the evaluation of the effectiveness are both convicted and punished. Once convicted, they may also be subject to application of the second sentence of Article 229 for sentencing over a period of five years The imprisonment above, not reasonable enough, so "the standard of filing prosecution (II)" does not apply to drug registration data fraud cases.

In addition, it needs to be emphasized that the issue of the crime must be solved after the applicant, the applicant for drug registration, must apply for registration with the CFDA.

After the study, all parties agreed that this interpretation is intended to punish drug and medical device registration applications for counterfeiting crimes, in principle, the Food and Drug Administration found in the review fraud action before being transferred to the judiciary .But according to the introduction Food and Drug Administration departments according to work arrangements, but also from time to time to carry out supervision and inspection, if found clinical trial data fraud, suspected of crime, should also be transferred to the public security organ.

In addition, the client is also responsible to the client to provide false reports, but also the responsibility.Therefore, this section does not provide false identification of documents to the stage, that no matter at what stage, whether or not to provide food and drug administration, as long as Data fraud, the circumstances are serious, you can constitute the crime.

Article 2 stipulates the issue of conviction and punishment for carrying out acts of intentionally providing false documents and obtaining or illegally accepting the property of others.

In practice, there is a situation that the non-clinical drug agencies, the drug clinical trial agencies, the contract research organizations and their staff have taken or illegally accepted the property of others during the process of data fraud, and how to deal with this involves the two hundred and two Application of the second paragraph of Article 19

The second paragraph of Article 299 of the Criminal Law stipulates: 'Any person required by the preceding Paragraph to claim other people's property or illegally accept others' property shall be sentenced to fixed-term imprisonment of not less than five years and not more than 10 years with a fine of not less than 10 years. " In the course of studying and drafting the Interpretation, there are different views on the application of the second paragraph of Article 229 of the Criminal Law:

The first kind of opinion holds that no matter how small the amount of bribes is, it must be sentenced to more than five years, sometimes penalties will be neglected. On the contrary, regardless of the amount of bribes, ruled out heavier bribery crimes, but also obviously there The problem of crime.

Therefore, it is necessary to make the necessary amount of restrictions on the claim of other people's property or illegally accepting the property of others as stipulated in the second paragraph of Article 229 of the Criminal Law.

The second opinion that the provisions of criminal law is clear, no matter how much the amount of bribes, are aggravating the punishment; and no matter how much the amount of bribes are not punishable by bribery .Article 229 of the Criminal Law should apply the provisions of paragraph Term imprisonment of not less than five years but not more than ten years and fining a fine.

After research, we think there are some problems in both opinions. According to the first opinion, there is no sufficient restriction on the amount of "claiming the property of another person or illegally accepting the property of another" stipulated in the second paragraph of Article 229 of the Criminal Law However, according to the second opinion, regardless of the amount of bribes received, it can only be punished by imposing a term of imprisonment of not less than five years and not more than ten years on the second paragraph of this crime, so that some of the serious crimes may be indulged.

In order to solve the problem of the imbalance of measurement and punishment, and to coordinate the legal punishment of the crime of taking bribes and providing false documents, "interpretation" makes this provision. In practice, we should accurately convict and measure the penalty according to the specific circumstances of the case.

(B) of the drug registration applicant conviction and punishment standards

Article III of the drug registration applicant to determine the nature of the data fraud.

According to Food and Drug Administration said in the clinical trial data fraud cases, the clinical trial agency fake, the contract research organization fraud and the applicant fraud, each accounting for one-third of the drug registration applicants for non-clinical studies, clinical trials , Or did not conduct non-clinical research, clinical trials, fabricated false data, deliberately provide fake documents, can not provide false proof documents of the crime.While the drug registration fraud cheat drug approval documents and the production and sale of drugs , Should be based on the crime of producing and selling counterfeit drugs, the main consideration:

First, the applicant through the provision of false materials to cheat drug approval documents produced drugs, in the case of counterfeit drugs.According to the "Drug Administration Law" Article 82, in violation of the provisions of this Act provides false proofs, documents Materials, samples or other deceitful means to obtain "drug production license", "drug business license", "medical institution preparation permit" or drug approval documents, the revocation of the "drug production license" "drug business license" "Medical Institutional preparation permit "or withdrawal of drug approval documents, the application will not be accepted within five years and a fine of not less than 10,000 yuan but not more than 30,000 yuan.

In view of the revoked drug approval documents invalid from the beginning, the original drug production certificate of invalid drugs produced under the "Drugs Act" Article 48, paragraph 3, paragraph 2 'must be approved without Approve the production, import 'situation, counterfeit drugs can place.

Second, knowing that drugs are not safe and effective, but fraudulent production and sales approval documents, and other production and sales of counterfeit drugs there is no substantive difference in the same endanger the health of the people in order to produce and sell counterfeit drugs Office It is emphasized that according to the general theory of criminal law, if it is found during the application for registration or if it has been registered but has not yet been produced or sold, the drug can be produced, Sales counterfeit crime preparatory office.

(C) of the crime of drug registration on the issue of joint crime of fraud

Article 4 stipulates that the staff of the drug registration application unit shall, in consultation with the staff of the intermediary agency, jointly execute the criminalization of faking the application materials for drug registration.

SFDA conducted self-inspection and verification of drug clinical trial data throughout the country and found that some applicants not only knew or even intentionally accused of fraudulent acts concerning the data of relevant agencies and organizations, but also violated the relevant provisions in a serious way and should act in response to their actions as well Be punished, "explain" to be clear.

The first paragraph is the provisions of the drug registration application unit staff to implement the 'finger' act on the common crime of prescription drug registration staff to apply for registration of non-clinical research institutions, clinical trial agencies, contract research organizations to provide this Interpretation of the common offenses of non-clinical research reports, drug clinical trial reports and related materials prescribed in the second paragraph of Article 1 in order to provide false documents.

Under such circumstances, the personnel of the intermediary organizations are well aware of the provision of false data and materials. The staff of the applicant for drug registration subjectively also have the subjective intention, at least the implied mentality, that they should meet the common intentional subjective requirements of the crime committed jointly.

The second paragraph is the "finger" act of the provisions of the first provisions of the 'know the relevant agencies, organizations do not have the appropriate conditions or capacity, still entrusted with non-clinical studies of drugs, clinical trials of drugs' under the' drugs Management Act Implementation Regulations "" Medical Device Supervision Regulations "and other provisions of the drug or medical device clinical trials must have the appropriate qualifications or qualification of clinical trials to ensure the quality of clinical trials.

Knowing that the relevant agencies and organizations do not have the appropriate qualifications or qualifications and are still violating the regulations and entrusting them to carry out clinical trials are one of the important reasons that cause the data to be inaccurate and thus lead to the false identification documents.

"Interpretation" focuses on substantive judgments, stipulates that the relevant agencies, organizations do not have the appropriate conditions or ability, still entrusted with non-clinical research or clinical trials, can be presumed to be subjectively aware (or at least laissez-faire) , False documents, if they still provide false documents to the drug regulatory authorities for the registration of drugs or medical devices, can provide false evidence of the crime of common offenses.

The second stipulates that 'the price paid is significantly different from the normal cost' situation.According to the State Food and Drug Administration introduced the current clinical trial data fraud is an important reason that the principal did not pay the normal fee, resulting in the trustee can not be guaranteed Quantity of clinical trial work, can only make the relevant data, issued a false report.For the trustee issued a false report, the client is not only aware, but also intentionally condoned or even instructed.

In such cases, the common criminal offenses of the crime of false documents may be provided, where "different from" mainly refers to significantly lower than normal costs, but if the applicant for drug registration pays a significantly higher amount than normal, Intermediary agencies issued the relevant reports, may also constitute the crime.

In addition, it should be stressed that having both of these situations is not necessarily identified as a 'finger' but rather as a 'can be asserted' and allows the parties to exclude the evidence to the contrary.

Main considerations: First, according to relevant regulations, the qualification of clinical trial institutions will no longer be determined later. Non-clinical research institutions or clinical trial institutions shall be independently selected by the applicant for registration. Whether the non-clinical research institutions or clinical trial institutions have the relevant conditions and abilities , There may be some difficulty in judging;

Second, there is no clear standard about the price of clinical trials, and judging whether the price paid is obviously lower than the normal cost or may be difficult, therefore, the provisions should have some flexibility so as to adapt to the complicated situation in trial practice. In practice, it should be combined with the specific circumstances of the case and comprehensively judged.

The third paragraph is the drug registration application unit staff and drug non-clinical research institutions, clinical trial agencies, contract research organization staff common crimes and the number of crimes.For the applicant to instruct or conspire to participate in drug registration application information fraud, After the use of fake drug registration application materials fraudulent certification documents and the production and sale of drugs, while providing false evidence of the crime and the production and sale of counterfeit drugs offenses, should be selected a felony penalty.

(D) reference to the application of medical device registration data fraud

Article V stipulates the handling of data fraud in the medical device registration application process.

The regulation of medical devices and drugs is similar. In particular, the application procedures for the registration of medical devices of the third category are basically the same as the application procedures for the registration of drugs. For example, Article 19 of the Regulations on the Supervision and Administration of Medical Devices stipulates that the third category of medical devices Clinical trials of human high risk should be approved by the State Council Food and Drug Administration ', it will be in the medical device registration application, the deliberate provision, use of false medical device clinical trial reports and related materials, with reference to "explain "The provisions of articles 1 to 4 criminalize.

It is important to emphasize that this interpretation does not regulate nonclinical studies of medical devices, given that the Medical Device Regulations do not specifically regulate nonclinical medical device research.

In addition, according to "Regulations on the Supervision and Administration of Medical Devices", medical devices are divided into three categories. The first type of medical devices is subject to record management and does not require clinical trials. The second and third types of medical devices are exempt Clinical trials, clinical trials should be conducted.Therefore, this article applies only to the need for clinical trials of the second category, the third category of medical devices.

(5) Provisions on Unit Crimes and Related Duty Crimes in the Process of Counterfeiting of Registration Application Data

Article 6 of the Provisions on Drugs, Medical Device Registration Application Materials Fake units should be punished for the crime of "double fine system." "Interpretation" provides that the unit guilty of the provisions of Article 1 to Article 5, the unit sentenced to a fine , And shall punish directly responsible supervisors and other personnel directly responsible for the conviction and sentencing standard of natural persons in accordance with the provisions of this interpretation.

Article 7 stipulates that the application for the registration of medicines and medical devices constitutes a crime of dereliction of duty in state organs and staffs.It clearly states that staff members of state organs that have the responsibility of verifying the registration of drugs and medical devices abuse their powers or neglect their duties and that false certificates Where materials, medicines and medical devices are registered, resulting in serious losses to the public property, the interests of the state and the people, criminal responsibility shall be investigated in accordance with the provisions of Article 397 of the Criminal Law for abusing power or negligence.

(F) of the relevant terminology requirements

In view of the many specialized issues involved in the application for registration of medicines and medical devices, "Interpretation" stipulates related professional medical terms such as' drug safety, evaluation of effectiveness', 'serious adverse events' and' contract Research organization ', etc. In order to unify the judicial application, "explanation" to explain this.

Article VIII of the provisions of whether a false non-clinical study reports, drug or medical device clinical trial reports and related materials, whether the impact of drugs, medical devices, the effectiveness of the evaluation results, as well as whether the serious adverse events and other specialties Difficult to determine the problem, according to the State Drug Administration set or designated drugs, medical equipment review and other agencies issued opinions, combined with other evidence to make the determination.

Article 9 stipulates that the term "contract research organization" as used in this interpretation refers to the subject drug or medical instruments Registration application units, drug non-clinical research institutions, drug or medical device clinical trial institutions commissioned to engage in experimental program design, data statistics, analysis and testing, audits and audits and other non-clinical research or clinical trials related units.

This is based on the views of medical and pharmaceutical experts, with reference to relevant provisions at home and abroad to make a specific definition of contract research organizations to unify and regulate the application of law. Regulations Regulations have been provided, the explanation is no longer clear.

(G) the "interpretation" of the effective date

Article 10 provides that this Interpretation shall come into force on September 1, 2017.