I. Current legislative situation
The Notice of the General Office of the State Council on Printing and Distributing the Key Work Arrangements for Food Safety in 20 17 (Guo Ban Fa [2065438+07] No.28) clearly puts forward that "all violations of food safety shall be investigated and dealt with", which puts forward new requirements for building a natural person disciplinary system in the field of food safety. Since then, "punishing people" has become an important hot issue in the field of food and drug supervision. The Drug Administration Law was promulgated on August 26th, 20th19th, implemented on February 6th, 20th19th, and promulgated on October 6th, 20th19th. The Regulations for the Implementation of People's Republic of China (PRC) Food Safety Law (the State Council Order No.721) has specific provisions on "punishing people", which has initially formed a scientific institutional arrangement and legislative design.
It is worth noting that two different legislative cases have been passed to punish food and drugs. First, legislative cases with centralized provisions, such as Article 75 of the Regulations for the Implementation of the Food Safety Law, have centralized and unified provisions on punishing people. Second, the legislative cases are scattered, such as 1 18,19, 122, 123, 124 and/kloc-of the Drug Administration Law. Articles 80, 8 1, 82, 85, 86, 87, 88 and 89 of the Vaccine Management Law stipulate the contents of punishment for people. Legislation adopts different legislative models, mainly due to the current situation and specific situation of legislative revision.
Second, about the object of punishment.
In principle, food and drug producers and operators are responsible for the safety of their products. However, directly punishing people breaks the subject qualification of enterprises as the object of punishment, and makes legal responsibility be investigated on natural persons. Therefore, the scope of punishment for people needs to be carefully grasped and restricted by law. After combing, the scope of natural persons punished includes the following categories:
(1) A natural person who engages in illegal production and operation without obtaining a legal production and operation license. As stipulated in Article 122 of the Food Safety Law and Article 1 15 of the Drug Administration Law. For such subjects, it is enough to punish them directly according to law.
(2) The legal representative, principal responsible person, directly responsible person in charge and other directly responsible personnel of the production and business operation entity. For example, the "directly responsible person in charge and other directly responsible personnel" stipulated in Article 123 of the Food Safety Law, the "legal representative, directly responsible person in charge and other directly responsible personnel of food producers and operators whose licenses have been revoked" stipulated in Article 135 of the Food Safety Law, and the "production and sale of counterfeit drugs or inferior drugs" stipulated in Article 118 of the Drug Administration Law, if the circumstances are serious, the legal representative shall be punished. It is mainly the "legal representative, principal responsible person, directly responsible person in charge and other responsible persons" stipulated in Article 123 of the Drug Administration Law who provide false certificates, data, materials and samples or take other means to defraud the license, and the "legal representative, principal responsible person, directly responsible person in charge, key position personnel and other responsible persons" stipulated in Article 82 of the Vaccine Administration Law.
(3) A natural person who directly commits an illegal act. For example, the specific actor who directly hinders the staff of state organs from performing their duties according to law as stipulated in Article 133 of the Food Safety Law, the specific actor who fabricates and disseminates false food safety information as stipulated in Article 141 of the Food Safety Law, and the food safety crime as stipulated in Article 135 of the Food Safety Law are sentenced to more than fixed-term imprisonment. Such personnel are not limited to "directly responsible supervisors and other directly responsible personnel", but need to be judged according to the subjective intention, objective behavior and consequences of specific actors.
(4) Other natural persons who are subject to administrative punishment mainly refer to the heads of technical institutions, food inspection institutions, certification bodies and media, as well as the specific illegal personnel who are directly responsible. For example, in Article 137 of the Food Safety Law, "persons in charge and technicians directly responsible for technical institutions" who provide false monitoring and evaluation information, in Article 138 of the Food Safety Law, "persons in charge and food inspectors directly responsible for food inspection institutions" who issue false inspection reports, and in Article 139 of the Food Safety Law, "persons in charge directly responsible and Certification staff" who issue false certification conclusions, As stipulated in Article 141 of the Food Safety Law, the media who fabricate and disseminate false food safety information are "directly responsible supervisors and other directly responsible personnel".
Generally speaking, the person who is punished is the person who is directly responsible for food and drug safety violations, including four categories of personnel, namely legal representative, principal responsible person, directly responsible person in charge and other directly responsible personnel. In addition, the object of application is limited to natural persons, including individual industrial and commercial households and sole proprietorship enterprises, but excluding companies and other legal persons.
Among them, the applicable object of food punishment is the natural person of food producers and operators. The object of application of drug punishment to people is the directly responsible person in charge and other directly responsible personnel of drug production and trading enterprises or other units. Other units mainly refer to medical institutions, disease prevention and control units and inoculation units.
In practice, there are still doubts about which directly responsible persons should be included in the occupational ban punishment. The legal representative and the specific person directly responsible are easy to determine, but the identification of the directly responsible person in charge is relatively vague. For example, in enterprises with complex organizational structure and meticulous division of labor, especially group companies and large cross-regional chain enterprises, it is difficult to identify the person in charge who is directly responsible. The author believes that the definition of the person directly responsible should be based on direct organization, command and participation in related illegal acts. Although he is the main person in charge, he has no intention, no fault or even ignorance of specific illegal acts, and should not be included in the scope of occupational prohibition and punishment.
Third, about legal responsibility.
To build a hierarchical responsibility system, we should distinguish minor illegal acts, general illegal acts and serious illegal acts according to the illegal acts and harmful consequences, and set different levels of legal responsibilities. Specifically, it mainly includes:
Minor illegal act
Inform and admonish minor violations. Including tips, warnings and administrative guidance, responsibility interviews and other measures. According to the provisions of Article 27 of the Administrative Punishment Law, if the illegal act is minor and corrected in time, and no harmful consequences are caused, no administrative punishment will be imposed. At this time, administrative guidance should be given to the parties in time, and reminders and warnings should be given to avoid more serious illegal acts. In addition, according to Article 114 of the Food Safety Law, if there are food safety hazards in the process of food production and operation, and measures are not taken in time to eliminate them, you can interview the legal representative or principal responsible person of the food producer or operator. Responsibility interviews and rectification are included in the food safety credit file. According to Article 66 of the Measures for the Supervision and Administration of Pharmaceutical Production, the frequency of supervision and inspection should be increased for drug marketing license holders and pharmaceutical production enterprises with bad credit records, and joint punishment can be implemented in accordance with state regulations.
(2) General illegal acts
For general violations, a lighter punishment is applicable. Include warnings, fines, etc. There are different ideas about the specific design of the penalty range of the punisher in legislation. One is the amount system, that is, the amount of fines is directly set. For example, Article 125 of the Drug Administration Law stipulates that "the legal representative, principal responsible person, directly responsible person in charge and other responsible personnel shall be fined between 20,000 yuan and 200,000 yuan"; The other is the multiple system, that is, a certain multiple fine is set according to the value of goods, illegal income or wage income. For example, Article 118 of the Drug Administration Law stipulates that "the income of the unit during the illegal act is confiscated and a fine of more than 30% and less than three times the income is imposed".
The author thinks that it should be treated differently according to the specific situation. If the determination of illegal acts does not directly involve the value of goods, and the value of goods has no influence on the determination of illegal acts, the fine range can be directly set. The identification of illegal acts is directly related to the value of commodities. If it is necessary to determine the amount of fines according to the value of goods, illegal income and wage income, the multiple system can be adopted, but the base and multiple of fines should be set reasonably based on the principle of over-penalty, so as not to be wasted and vertical.
(3) serious violations.
For serious violations, heavier punishment is applicable. Including administrative detention, qualification punishment and other punishment measures. If a crime is constituted, criminal responsibility shall be investigated according to law. For some serious violations, credit restraint measures should also be implemented. For example, Article 135, paragraph 1, Article 135, paragraph 2 of the Food Safety Law, and Article 75 of the Drug Administration Law stipulate the punishment for the qualification of industry prohibition. In addition, it is necessary to implement the restrictions on engaging in the pharmaceutical and food industries put forward in the Opinions of the Central Office and the State Council on Accelerating the Construction of Credit Supervision, Warning and Punishment Mechanism for the Executed with Dishonesty. That is to say, the person who is untrustworthy is engaged in the pharmaceutical and food safety industries to give strict approval; Restrict the person who is untrustworthy from engaging in authentication, testing and inspection activities; Restrict the person who has been executed for breach of trust from being the main person in charge, director, supervisor or senior manager of the above-mentioned industrial units, and if he has already held relevant positions, he shall be changed according to the requirements of the prescribed procedures.
Fourth, improve the law enforcement mechanism.
Efficient and cooperative law enforcement linkage mechanism and joint credit punishment are the necessary conditions to realize punishment to people. The establishment of efficient and cooperative law enforcement convergence and credit punishment mechanism mainly includes the following contents:
(1) As far as administrative cases are concerned, improve the transfer mechanism with other departments, with the focus on improving the mechanism of transferring food safety violations subject to administrative detention to public security organs. At present, Article 77 of the Regulations on the Implementation of the Food Safety Law stipulates the transfer and connection of administrative cases requiring administrative detention. To implement the application of "substituting punishment for others" in administrative detention, we can refer to the Interim Measures for Administrative Departments to Transfer Cases of Illegal Environmental Detention, and study and formulate the Interim Measures for Administrative Departments to Transfer Cases of Illegal Administrative Detention of Food and Drug Safety.
(2) As far as criminal cases are concerned, the connection between the two laws should be further improved. To conscientiously implement the five departments jointly issued the "food and drug administrative law enforcement and criminal justice convergence approach" (US Food and Drug Administration [2015] No.271), timely sort out and study the administrative law enforcement and criminal justice authority, legal application, evidence convergence standards, expert opinions and other content.
(3) Improve the credit punishment measures. Article 66 of the Regulations on the Implementation of the Food Safety Law stipulates: "The food safety supervision and management department of the State Council shall establish a joint incentive mechanism for trustworthiness and a joint disciplinary mechanism for dishonesty with the relevant departments of the State Council, and establish a blacklist system for serious illegal producers and operators in combination with the credit files of food producers and operators, linking the food safety credit status with access, financing, credit and credit reporting, and making it public in time." In terms of horizontal cross-departmental cooperation, a national credit information sharing platform was established, and specific measures for cooperative supervision and joint disciplinary cooperation of untrustworthy enterprises were studied. In the construction of vertical depth system, it is necessary to improve specific standards and norms such as credit information collection, credit information evaluation, credit constraint and credit repair.
Five, standardize the punishment procedure
At the same time, the law enforcement procedure of punishing production and business units and natural persons in the case of "double punishment" has become the focus of improvement. The author believes that the law enforcement procedures such as filing a case, investigation, punishment and transfer, the production and standardization of law enforcement documents, and the disclosure and enjoyment of punishment information need to be improved urgently. The author expounds the simple administrative punishment procedure and the criminal case punishment procedure respectively.
(1) Procedures for administrative punishment
It is suggested that the "double punishment" imposed by the market supervision department (or drug supervision department) should be investigated and dealt with at the same time, and the punishment decisions should be made for enterprises and individuals respectively and delivered at the same time. Where different departments are involved in the implementation of double punishment, a decision on punishment shall be made first, and then transferred to the relevant authorities for handling.
(2) Punishment procedures involving criminal acts
The punishment procedure of criminal cases mainly refers to the specific procedure of occupational prohibition punishment stipulated in the second paragraph of Article 135 of the Food Safety Law and Article 118 of the newly revised Drug Administration Law of 20 19.
The current law does not stipulate the implementation procedure of occupational prohibition punishment, and there is no unified opinion in practice. Its application procedure is actually related to its nature. At present, there are three practices in practice: application in administrative punishment, application in criminal punishment and application after criminal punishment.
1. Applicable to administrative punishment.
There is a precedent for the application of occupational prohibition punishment in administrative punishment. For example, the administrative penalty decision made by Jilin on 20 18 and 18 (Ji ZiNo. 17) clearly stated: "Gao,,, Li. Zhao Hongyang and Zhang Gong 14 are the persons in charge or other persons directly responsible for the illegal acts of producing and selling inferior drugs in your company, and should bear corresponding responsibilities for the above-mentioned illegal acts of your company. " On the same day, an administrative penalty decision was made according to the Drug Administration Law (20 13) (Ji [2018]17-1to [20 18] 14).
2. Applicable to criminal punishment
The application of occupational prohibition punishment in criminal punishment is increasing. In practice, there are more and more criminal judgments applying occupational prohibition punishment. For example, the county people's court criminal judgment [(20 19) Yu 0726 No.34] and the Luyi county people's court criminal judgment [(20 18) Yu 1628 Yu 792, (20 19) Yu 65438+. Lu 0827No. 187], criminal judgment of Longyan xinluo district People's Court [(20 17) Min 0802 No.464], criminal judgment of shulan city People's Court [(20 18) Ji 0283 No.3].
In addition, there are also cases of protests caused by the non-application of occupational prohibition punishment. When the court of first instance ruled that the penalty of the occupational injunction was not applicable, the procuratorial organ protested on the grounds that "the defendant was not sentenced to the occupational injunction according to law, and the sentencing was inappropriate, and the court of second instance changed the sentence to apply the occupational injunction." For details, please refer to criminal judgment [(20 18) Yu 0 1 Final SentenceNo. 12 14] of Zhengzhou Intermediate People's Court, and sentence the appellant not to engage in food production and operation for life, nor to be a food safety manager of food production and operation enterprises.
3. Apply after criminal punishment
However, in criminal punishment, the application of occupational prohibition punishment is still relatively small in general, and the situation of non-application is relatively common. For example, criminal judgment of Shaanxi Higher People's Court [(20 19) Shaanxi Criminal Final WordNo. 14] and criminal judgment of Heilongjiang Higher People's Court [(20 16) Black Criminal Final Word No.7] only found the defendant guilty of producing and selling counterfeit drugs, but the occupational imprisonment penalty was not applicable. This will lead to the fact that the punishment of occupational prohibition can only be supplemented by administrative punishment after the criminal judgment takes effect, which will undoubtedly increase the cost of law enforcement and waste law enforcement resources.
In the author's view, among the above three practices, the punishment of professional prohibition should be applied in criminal judgment. If it does not involve a crime, it shall be applied in administrative punishment. If the criminal judgment is not applicable, the administrative punishment must be applied by the regulatory authorities after the criminal judgment takes effect. This includes three situations: first, it is considered by the court not to constitute a crime; Second, although it constitutes a crime after being tried by the court, it still needs administrative punishment without criminal punishment; Third, the court judgment is omitted. But this is a supplementary application, not the best choice.
Sixth, the lack of legislation.
The deficiency of legislation mainly lies in the loopholes in the provisions of punishment standards. For example, Article 75 of the Regulations on the Implementation of the Food Safety Law stipulates: "The legal representative, principal responsible person, directly responsible person in charge and other directly responsible personnel of the unit shall be fined more than 1 times the income of the unit in the previous year and less than 10". If the above-mentioned personnel entered the unit in that year, they did not actually earn income in this unit in the previous year and cannot be fined.
Therefore, it is suggested that there are two ways to improve: First, based on the income obtained by our company this year, we will increase "those who did not obtain income in our company in the previous year will be fined for income obtained in our company this year 1 times or more 10 times or less". Second, based on the income obtained from the unit during the illegal act, refer to the calculation method stipulated in the Drug Administration Law, such as Article 118 of the Drug Administration Law, "confiscate the income obtained from the unit during the illegal act and impose a fine of more than 30% and less than three times the income".