Song Hualin: Execution in the field of drug law enforcement is reversed

Author: Song Hualin, Professor, School of Law, Nankai University, 10th National Outstanding Young Jurist

Source: Journal of the National Prosecutors College

Summary

Paragraph 2 of Article 113 of the Drug Administration Law stipulates the reverse connection mechanism between drug administrative law enforcement and criminal justice, which is a vivid embodiment of the principle of modesty in criminal law, and is also the application of the regulatory pyramid theory. In the field of drug safety, it is necessary to determine which circumstances constitute "no need to pursue criminal liability in accordance with the law" or "exemption from criminal punishment", which needs to examine the general provisions in the Criminal Law and the Criminal Procedure Law, and also needs to be based on the drug administrative legal norms and administrative treatment, and it is necessary to reasonably determine uncertain legal concepts such as "causing serious harm to human health" and "sufficient to seriously endanger human health". When reviewing the reverse connection of executions, it is necessary to review whether there is a clear basis for administrative punishment, whether there is a qualified administrative department, whether the conduct involved in the case is still within the time limit for pursuing responsibility, and whether the conduct involved in the case has already been punished or may not be punished. Procedures for the reverse transfer of drug executions should be determined, case files and evidentiary materials should be handed over completely, and the administrative organs should make follow-up decisions in accordance with law, so as to promote the combination of administrative regulation and criminal justice governance.

The convergence of administrative law enforcement and criminal justice, also known as the "convergence of the two laws", includes the positive connection between the administrative law enforcement organs and the judicial organs in the transfer of suspected criminal cases, and also includes the reverse connection in the transfer of administrative punishment cases from the judicial organs to the administrative law enforcement organs. At present, mainland academia and judicial practice often focus on positive cohesion, and relatively little attention is paid to reverse convergence.

Article 5 of the Opinions on Strengthening the Legal Supervision of Procuratorial Organs in the New Era, issued by the Central Committee of the Communist Party of China on June 15, 2021, emphasizes that "improve the linkage mechanism between administrative law enforcement and criminal justice...... Complete systems for procuratorates to lawfully transfer criminal suspects who decide not to prosecute to the relevant competent organs to be given administrative punishments, governmental sanctions, or other sanctions. "On September 6, 2021, the Supreme People's Procuratorate promulgated the "Provisions on Promoting the Convergence of Administrative Law Enforcement and Criminal Justice" (Gao Jian Fa Ban Zi [2021] No. 84) (hereinafter referred to as the "Provisions of the Supreme People's Procuratorate on the Convergence of Executions"), which stipulates the procedures for the reverse transfer of executions applied by the people's procuratorates. In 2023, the Supreme People's Procuratorate promulgated the "Opinions on Promoting the Two-way Connection of Criminal Punishment and Supervision of Administrative Violations and Building a System of Convergence between Procuratorial Supervision and Administrative Law Enforcement", focusing on promoting the construction of a mechanism for the reverse connection of executions, and striving to prevent the problems of not punishing without punishment, not moving when should be transferred, and not punishing when should be punished.

In the field of drug safety, the Drug Administration Law of the People's Republic of China (hereinafter referred to as the "Drug Administration Law") and the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the "Vaccine Administration Law") amended in 2019 have set up more comprehensive drug administrative legal responsibilities. With the adjustment of the concepts of counterfeit drugs and shoddy drugs in the Drug Administration Law, the classifications of "punished according to counterfeit drugs" and "punished according to inferior drugs" have been deleted, and in the Amendment (11) to the Criminal Law passed on December 26, 2020, the crime of "producing and selling counterfeit drugs" stipulated in Article 141 of the original Criminal Law has been abolished, and the crime of "production, sale and use of counterfeit drugs" has been abolished, and the crime of "production, sale and use of shoddy drugs" has been abolished, and the crime of "production, sale and use of shoddy drugs" has been abolished Article 142-1 adds the crime of "obstructing the administration of medicines". The revision of the Drug Administration Law and the promulgation of the Criminal Law Amendment (11) mean that the criminal policy of drugs has changed, and the scope of the crackdown on drug-related crimes in the criminal legal norms has become reasonable, avoiding the treatment of certain behaviors in the field of drug safety that should not be criminally punished as crimes, but when the procuratorate makes a decision not to prosecute, the court sentences not guilty or exempts from criminal punishment, When the public security organ files a criminal case and then withdraws the case, it is still necessary to investigate the administrative responsibility of the perpetrator, and at this time, it is even more necessary to improve the reverse connection mechanism between drug administrative law enforcement and criminal justice.

Paragraph 2 of Article 113 of the Drug Administration Law stipulates that "where there is no need to pursue criminal liability or be exempted from criminal punishment in accordance with the law, but administrative responsibility shall be pursued, the public security organs, people's procuratorates and people's courts shall promptly transfer the case to the drug regulatory department". On January 10, 2023, the State Drug Administration, the State Administration for Market Regulation, the Ministry of Public Security, the Supreme People's Court, and the Supreme People's Procuratorate jointly issued the "Measures for the Convergence of Drug Administrative Law Enforcement and Criminal Justice" (hereinafter referred to as the "Measures for the Convergence of Drug Execution"), which briefly stipulates the substantive requirements, transfer procedures and follow-up treatment of drug cases by public security organs, people's procuratorates and people's courts. This helps to ensure that all drug violation cases found can be properly handled, and avoid the omission of illegal acts due to the drug regulatory authorities, public security organs, people's procuratorates, and people's courts due to work connection problems, so as to more comprehensively and reasonably practice drug legal responsibilities in accordance with the law, form a joint force, and better crack down on illegal and criminal acts in the field of drug safety.

It is necessary to reasonably allocate the measures and intensity of drug administrative penalties and drug criminal penalties. As a typical administrative offense, drug safety crimes tend to expand in practice, and even breed "unreasonable" hot cases. For example, the procuratorate decided not to prosecute the "Lu Yong case" and other cases involving the purchase of imported drugs with a large number of people and a huge amount of money, and the court decided to exempt from criminal punishment in the case of "Tiema Binghe" illegally selling clobazam and other prescription drugs sold abroad. However, as far as the follow-up handling of such cases is concerned, it may involve the reverse connection between drug administrative law enforcement and criminal justice. It is not easy to define the boundary between crime and non-crime in drug-related cases, and what key elements should be examined when reverse connection, what are the reverse transfer procedures, what evidence materials should be transferred, and how to build the corresponding drug administrative law enforcement and criminal justice information sharing platform, there is often a lack of uniform legal rules, which also constitutes the direction of system improvement.

I. The jurisprudence of the construction of the mechanism for the reverse connection of executions

(1) The practice of the principle of modesty in criminal law

The legal interest of drug crime is the life and health of the public, but the legal interest is characterized by the drug management order. Under the theory of risk criminal law, it is possible to use criminal law as a tool of social control because any act that hinders human security is regarded as an illegal act. But it may be, as Adam Smith put it: "An inappropriate punishment, that is, a punishment that should not be punished at all, or a punishment that exceeds the fault of the crime, is an injury to criminal law." ”

The principle of modesty in criminal law not only constitutes the conceptual basis of the doctrine of legality of crimes, but also consolidates the foundation for the establishment and implementation of legal norms for drug crimes. Criminal law is modest or embodied in the complementarity, incompleteness and leniency of criminal law. Under this principle, the distinction between drug administrative punishment and drug criminal punishment should be examined, and the principle of "criminal priority" should be reflected. Only when the social harm of the perpetrator is far greater than that of ordinary administrative violations, the punishment required exceeds the degree of administrative punishment, and the failure to impose criminal punishment is not sufficient to achieve the effect of punishment, then criminal punishment is unavoidable.

Drug administrative punishment plays a more important role in the process of protecting the order of drug management. The drug regulatory departments at all levels in mainland China have corresponding human, financial and material resources, and have accumulated relatively rich experience in professional supervision. Compared with the judicial procedure, the drug administrative penalty procedure is faster, more timely and more efficient. Drug administrative punishment carries the functions of punishment, maintenance of order, education, prevention and remediation, which can not only punish and eliminate existing illegal acts, but also constitute a deterrent to potential violators. Although Article 114 of the Drug Administration Law stipulates that "if a violation of the provisions of this Law constitutes a crime, criminal liability shall be investigated in accordance with the law", drug administrative punishment is still the main battlefield of drug regulatory law enforcement, and it is aimed at acts that violate drug administrative laws and regulations with relatively minor circumstances, while drug criminal penalties are aimed at acts that are more serious and criminal than those that violate the law. For example, in 2020, drug regulatory departments at all levels investigated and dealt with a total of 61,700 drug cases, and 327 cases were transferred to judicial organs, accounting for only 0.53% of the drug cases investigated and dealt with by judicial organs in that year, which highlights the function of administrative law enforcement and administrative punishment, and objectively reflects the structural, functional and proportional relationship between drug administrative legal norms and drug criminal legal norms.

The incompleteness and permissiveness of criminal law is reflected in the fact that criminal law does not intervene in all corners of citizens' lives, and even if citizens' freedoms are violated and other means of control are not effective, there is no need to resort to criminal punishment. Article 142 of the Criminal Law stipulates that the crime of "producing, selling, and providing inferior drugs" is established on the premise of "causing serious harm to human health"; Article 142-1 of the Criminal Law establishes the crime of "obstructing the administration of medicines", that is, on the premise that "it is sufficient to seriously endanger human health". When it does not meet the requirements of "causing serious harm to human health" and "sufficient to seriously endanger human health", even if it may constitute an act that violates the order of drug administration, it should not be punished.

(2) The regulatory pyramid theory and the integrated thinking of execution and performance

In the theories of "responsive regulation" and "regulatory pyramid" proposed by well-known scholars Ayres and Braithwaite, a ladder is given for the setting and implementation of regulatory tools. The above theory assumes that in the regulatory pyramid, persuasive education at the bottom of the pyramid should be preferred, and then more stringent and punitive interventions should be gradually designed and implemented. Persuasion and education, warnings, civil liability, etc., should be followed by a hierarchy of higher levels, and when less intrusive methods are ineffective, more stringent enforcement measures should be imposed, up to the point of criminal punishment. The ordering of regulatory tools in the regulatory pyramid is not only to provide a lower enforcement cost, less coercion, and more respectful of the parties' choices, but also to resort to more stringent regulatory tools when they have already tried less intrusive regulatory tools and still failed to work. In a sense, the rise of the regulatory pyramid represents a shift from a compliance strategy to a deterrent enforcement strategy, and criminal law can be seen as a measure at the top of the regulatory pyramid that can be activated to deter notorious offenders. The institutional arrangement of the regulatory pyramid seeks to stimulate the subjective consciousness and civic spirit of the regulated objects, so that they can actively fulfill their responsibilities.

As far as the crackdown on drug violations and crimes is concerned, the step-by-step from administrative punishment to criminal punishment reflects the diversity and proportionality of regulatory tools in the regulatory pyramid, that is, the application of various forms of punishment is based on the seriousness of illegal regulatory acts. For specific drug violations, a warning system has been set up in the drug administrative laws and regulations to urge the penalized person to correct the illegal acts; for profit-making drug violations, administrative fines are often set in the form of interval multipliers, and property penalties such as confiscation of illegal gains and illegal property are also set; in addition, administrative penalties such as orders to stop production and business, order to close down, revoke licenses, restrict practice, and administrative detention are also set in turn.

Taking the drug violation cases investigated and dealt with nationwide in 2020 as an example, the amount of fines amounted to 531 million yuan, 87.3536 million yuan of illegal gains were confiscated, a total of 91 drug production licenses and drug business licenses were revoked, 262 households were ordered to suspend production and business, and 72 households were ordered to close. In 2020, a total of 61,697 drug violation cases were investigated and dealt with nationwide, of which only 327 cases were adjudicated by judicial organs, 31 criminal judgments were made, and 119 people were criminally punished. This objectively shows that punishment, as a deterrent strategy at the top of the regulatory pyramid, reflects the last resort of punishment.

The revised Drug Administration Law amends the definition of counterfeit drugs and inferior drugs, and the behaviors that violate the drug management order are no longer treated as fake and inferior drugs, so that the definition of the substance itself is relatively returned to the truth and falsehood, the good and the inferior, which is not only a slimming of the concept of "fake drugs" and "inferior drugs", but also a more scientific and reasonable definition of its concept. Therefore, after the implementation of the Criminal Law Amendment (11), the number of cases in which the crimes of "producing, selling, and providing counterfeit drugs" and "producing, selling, and providing shoddy drugs" have decreased considerably, and the setting of "obstructing drug administration" does not fully include the "punishment as counterfeit drugs" and "punishment as inferior drugs" in the Drug Administration Law before the 2019 amendment. Through the selection and reconstruction of the drug crime circle, the number of drug crime cases tends to decline.

Under such circumstances, if there is an act of producing, selling, or providing inferior drugs, or an act that obstructs the order of drug administration, but does not meet the requirements of "causing serious harm to human health" or "sufficient to seriously endanger human health" as stipulated in the Criminal Law, or when there are other illegal obstructive reasons, it does not constitute a crime. It is necessary to rationalize the path of exculpation in drug criminal justice.

However, the existence of a criminal cause does not mean that it is exempt from the corresponding administrative legal responsibility for drugs. "Let the administrative land belong to the administration, and let the judicial land belong to the judiciary", which not only reflects the basic value requirements of the constitution of the unity of law and order, but also embodies the essence of "smart regulation", which advocates a rich combination of policy tools, and the anomie of drug safety order has different scenarios, and administrative governance and criminal punishment have their own strengths and weaknesses. Efforts should be made to complement each other's advantages and achieve the best regulatory effect through diversified combinations.

At this time, it is more necessary to construct a reverse connection mechanism between drug administrative law enforcement and criminal justice, which is an inherent requirement for judicial organs to actively perform their duties in accordance with the law and maintain social fairness and justice. The reverse connection of executions avoids the problem of omission of administrative responsibility by the parties, and is more conducive to achieving a balance between efficiency and fairness in law enforcement and judicial links. The reverse connection of executions is conducive to the participation of judicial organs in social governance and the release of judicial efficiency. The reverse connection of execution and the positive connection of execution have jointly formed a law enforcement network that effectively cracks down on illegal acts, promoted the combination of punishment and prevention, paid equal attention to crime and governance, promoted the modernization of misdemeanor governance, and also promoted the modernization of drug safety governance.

(3) Weighing the reasons for illegal obstruction and legal interests

In criminal justice cases, if we adhere to the formal interpretation of the criminal law text and the criminological system, and follow the principles of criminal law to carry out highly sophisticated and systematic formal judgments, it is possible to produce conflicts between legal principles and ethics in individual cases, and to draw conclusions that contradict national feelings and general recognition, and in essence violate the general value judgment of society.

For example, in recent years, the Lu Yong case and the clobazam case are related to the "purchasing wave" of overseas drugs that have emerged in recent years, and drugs imported without approval have become the hardest hit areas of "counterfeit drug crimes", which contradicts the actual demand of the public for some foreign drugs that have not been approved for marketing in China. For example, in the case of Lu Yong, the Yuanjiang Municipal People's Procuratorate attached the "Explanation of the Law and Reasoning on the Decision not to prosecute Lu Yong in the case of obstructing credit card management and selling counterfeit drugs", which pointed out that Lu Yong's actions objectively benefited leukemia patients when legal anti-cancer drugs were expensive in the domestic market. The degree of harm caused by Lu Yong's behavior to the national drug management order is lower than the right to life and health of leukemia patients, and if it is determined that Lu Yong's purchasing behavior that subjectively and objectively benefits leukemia patients is a crime, then "it is obviously contrary to the values of justice for the people".

This may be explained from the perspective of emergency hedging jurisprudence. Emergency avoidance refers to the act of having to damage another minor or equivalent legal interest in order to protect the state, the public interest, the person, property and other rights of the person or others from the ongoing danger. Emergency avoidance is characterized by the avoidance of real danger and the protection of greater or equivalent legal interests. In terms of the production, processing, import, and sale of drugs that formally violate the order of drug administration and are for the purpose of self-use, self-help, and mutual assistance under specific circumstances, they may impede the right to health due to drug safety risks, but in fact they meet the accessibility and availability of "life-saving drugs" for patients who have no financial resources to purchase drugs, and from the perspective of the act as a whole, the act does not infringe on legal interests.

In addition, the causes of the crime of endangering drug safety involve the cause of illegal obstruction and the cause of liability obstruction. Some elements that do not increase the risk of infringement of legal interests or are permissible by social concepts and moral norms are also accepted by the theoretical community as illegal obstruction reasons beyond the laws and regulations, so "privately processing drugs or selling drugs according to traditional folk formulas" may involve "local medicines" that are privately processed by folk remedies, earthworks, and secret recipes Although it has not been approved by the relevant departments, the local people may generally recognize its efficacy, which may be regarded as a traditional custom generally accepted by the public, and under certain conditions, it can constitute a criminal cause for endangering drug safety. In response to the situation where the perpetrator provides drugs in violation of the law for self-treatment or to help others to save them, this involves the balance between the right to life and health and the safety and order of drugs, and "self-help and mutual assistance" is a cause for reducing the possibility of law-abiding, and "not for profit" is a cause for reducing the responsibility for subjective malice. Therefore, "not carrying out acts of producing, importing, or selling drugs with the nature of self-help or mutual assistance for the purpose of profit" is not found to be a crime.

Therefore, including the above-mentioned relevant acts in the scope of criminal regulation would seriously deviate from the public's legal feelings. However, when the above-mentioned acts endangering drug safety are established, criminal liability is not investigated, which does not mean that there is no need to impose administrative penalties for the corresponding acts that violate the drug administrative laws and norms. For acts that are deemed necessary to impose administrative penalties on the parties, the reverse transfer mechanism should also be improved and transferred to the drug regulatory department for processing. This facilitates the unambiguous punishment of drug offences and those responsible.

2. Determinations that do not need to be pursued for criminal responsibility or waived from criminal punishment in accordance with law

As an administrative offense, drug crimes have the dual illegal attributes of administrative illegality and criminal illegality. In the area where administrative illegality and criminal illegality intersect, and certain acts do not have substantive punishability or the necessity of punishment, at this time, based on the position of substantive rule of law, comprehensively examining the consequences of behavior, criminal justice should uphold modesty, especially in the case of legislative expansion, through judicial limitation of the determination of crimes, in order to form a restraint and balance on criminalization.

Paragraph 1 of Article 27 of the Administrative Punishment Law stipulates that "where it is not necessary to pursue criminal responsibility or be exempted from criminal punishment in accordance with the law, but an administrative penalty shall be given, the judicial organ shall promptly transfer the case to the relevant administrative organ". First of all, it is necessary to refer to the general provisions in the Criminal Law and the Criminal Procedure Law, as well as the provisions of substantive legal norms such as the Drug Administration Law and the 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 Drug Safety (hereinafter referred to as the "Interpretation on the Application of Criminal Cases of Drug Safety") and other substantive legal norms, to determine which circumstances constitute "no need to pursue criminal responsibility in accordance with the law" or "exemption from criminal punishment" in the field of drug safety. This constitutes the premise for judging whether to initiate the reverse linkage mechanism for drug execution.

(1) Provisions in the general law

Article 16 of Chapter 1 "Tasks and Basic Principles" of Part I of the Criminal Procedure Law "General Provisions" provides for six situations in which "criminal responsibility is not pursued". Among them, there may be three situations that are most closely related to the causes of drug crimes: (1) "the circumstances are obviously minor and the harm is not great, and it is not considered a crime". For example, "processing or selling the above-mentioned drugs according to traditional folk formulas, the quantity is not large, and it does not cause harm to others or delay diagnosis and treatment". (2) "The statute of limitations for prosecution has expired for the crime". Article 87 of the Criminal Law stipulates the statute of limitations for crimes, and the statutory maximum penalty for "producing, selling, and providing counterfeit drugs" and "producing, selling, and supplying shoddy drugs" is 20 years. The statutory maximum penalty for "obstruction of drug administration" is 7 years, and the statute of limitations for prosecution is 10 years under article 87 of the Criminal Code. (3) "Other laws provide exemption from criminal liability". "Other laws" here refer to laws other than the Code of Criminal Procedure.

As far as drug crimes are concerned, the Criminal Law stipulates the circumstances under which it is possible to "exempt from criminal punishment", mainly including the following five situations: (1) Exemption from criminal punishment for accomplices and coerced accomplices as provided for in Articles 27 and 28 of the Criminal Law. (2) Involving "the production, import, and sale of drugs with the nature of self-help and mutual assistance for the purpose of not making profits", this actually reflects the pursuit of social justice, in the mainland, farmers, middle-aged and elderly people, low-income groups, and people suffering from serious diseases may be in a relatively unequal position in terms of access to drug resources, and the behavior they take "with the nature of self-help and mutual assistance" is actually a consideration of the accessibility of drugs outweighs concerns about the safety of drugs, which may constitute the Criminal Law Emergency avoidance as provided for in Article 21. (3) Criminal punishment may be waived for preparatory offenders in drug crimes. However, the raw materials, excipients, packaging materials and production equipment intended by the manufacturer for the production of counterfeit or inferior drugs shall be confiscated. (4) A suspended offense is a form in which the perpetrator actively begins to commit a crime and then stops committing the crime. In the field of drug safety, criminal penalties shall be waived for suspension offenders who have not caused damage. (5) Those who surrender voluntarily may be exempted from punishment if the crime is relatively minor, and those who have made meritorious contributions may be exempted from punishment if they have made major meritorious contributions.

(2) Using administrative norms or administrative disposition as the cause of the crime in determining drug crimes

The crime of drug administration has the characteristics of a typical administrative offense, and has the dual illegality of violating the administrative law and violating the criminal law. The criterion of violation of administrative law to enter the judgment of violation of criminal law constitutes the focus of controversy. Taking the crimes of producing, selling, and using counterfeit drugs and the crimes of producing, selling, and using shoddy drugs as examples, article 19 of the Several Interpretations on Criminal Cases on Drug Safety clearly stipulates that "counterfeit drugs" and "shoddy drugs" as provided for in articles 141 and 142 of the Criminal Law shall be determined in accordance with the provisions of the Drug Administration Law. This reflects the normative effect of administrative law on criminal law, absorbs the concept of administrative law into criminal law, and takes administrative law norms or administrative treatment as the constituent elements of criminal law. After the revision of the Drug Administration Law and the promulgation of the Criminal Law Amendment (11), the scope of violations has been narrowed, and criminal evaluations should no longer be conducted for acts that no longer have the nature of administrative law violations.

The determination of counterfeit and inferior drugs is highly specialized, and the courts are experts in legal issues and may not be able to undertake the task of comprehensively reviewing the administrative field involving specialized knowledge. The drug regulatory department and its subordinate drug inspection institutions have rich regulatory experience and obvious professional and technical advantages, and when the judicial authorities consult the drug regulatory department to provide assistance such as inspection conclusions and identification opinions, the drug regulatory department has the obligation to provide and assist in a timely manner.

Article 19 of the Several Interpretations on Criminal Cases of Drug Safety further refines the circumstances under which the drug regulatory authority shall issue a determination opinion or the drug inspection agency shall issue a quality inspection conclusion in the judicial determination of counterfeit or inferior drugs. (1) When identifying counterfeit drugs, it is necessary to determine whether there are circumstances such as "passing off non-drugs as drugs", "passing off other drugs as such drugs" and "indications or functional indications indicated by drugs exceed the prescribed range" as stipulated in paragraph 2 of Article 98 of the Drug Administration Law; In the case of excipients, the drug regulatory department at or above the prefectural and municipal level may issue a determination opinion. (2) For those identified as counterfeit or inferior drugs under other circumstances stipulated in Article 98 of the Drug Administration Law, or if there is a dispute over whether they are counterfeit or inferior drugs as specified in Item 2 and Item 6 of Paragraph 3 of Article 98 of the Drug Administration Law, the drug inspection agency set up or determined by the provincial drug regulatory department shall conduct the inspection and issue a quality inspection conclusion, and the judicial authority shall make a determination based on the determination opinions, inspection conclusions, and other evidence.

The drug regulatory department has the right to issue opinions on the identification of fake and inferior drugs, and the drug inspection institutions set up or designated by the drug regulatory department shall issue drug quality inspection conclusions in accordance with the law. As "institutional competence" theorists have pointed out, "these more subtle, less visible matters of scientific judgment are completely beyond the institutional competence of our courts." Judicial organs should try their best to respect the findings of facts by administrative organs or organizations authorized by laws and regulations, and try to avoid substituting their own judgments for the judgments of professional bodies. When the identification opinion issued by the drug regulatory department or the quality inspection conclusion issued by the drug inspection agency does not consider a batch of drugs to be counterfeit or inferior drugs, the product is generally not a fake or inferior drug, and the corresponding activities should not be recognized as a crime.

(3) Limiting the element of the crime of producing, selling, or providing shoddy drugs as "causing serious harm to human health".

The establishment of the crime of producing, selling, or providing shoddy drugs must be based on the premise of "causing serious harm to human health". Not all acts of producing, selling, and using inferior drugs constitute crimes, and the "serious harm to human health" with the quantitative function of crimes can not only determine the boundaries of administrative punishment and criminal punishment for inferior drugs, but also help to realize the functions of criminal law moderation and limiting the scope of criminal punishment.

From a theoretical point of view, the provisions of Article 142 of the Criminal Law belong to the general "serious consequences", that is, the legislator only stipulates that "causing serious harm to human health" is an objective element for establishing the crime of producing, selling and using shoddy drugs, but does not explicitly stipulate the specific content of "causing serious harm to human health" in the Criminal Law. "Causing serious harm to human health" is a comprehensive evaluation of the adverse effects of drug-related crimes on the outside world, and is an objective factor of the crime. According to the provisions of Article 5, Paragraph 2 and Article 2 of the Several Interpretations on Criminal Cases of Drug Safety, any of the following circumstances constitutes the circumstance of "causing serious harm to human health" in the crime of producing, selling, or providing inferior drugs: (1) causing minor or serious injury, (2) causing mild or moderate disability, (3) causing organ or tissue damage resulting in general or serious dysfunction, and (4) other circumstances causing serious harm to human health.

Looking at the four situations listed in the above-mentioned judicial interpretations, it can be seen that "causing serious harm to human health" must be based on verifiable "serious harmful consequences", and such consequences are mostly supported by diagnostic opinions issued by medical institutions or appraisal opinions issued by health administrative departments. The crime of shoddy drugs is the actual offender, and "causing serious harm to human health" is one of the necessary elements for the establishment of the crime of shoddy drugs, and if the production, sale, or use of shoddy drugs does not produce the consequences referred to in the "Several Interpretations on Criminal Cases of Drug Safety", it does not constitute a crime, but it should still be investigated for administrative responsibility.

(4) Limiting the criminalization element of the crime of obstructing drug administration as "sufficient to seriously endanger human health".

The Drug Administration Law revised in 2019 no longer treats illegal acts such as the production and import of drugs without approval in violation of the drug management order as counterfeit drugs. In order to connect with the revised Drug Administration Law, on the basis of summarizing the Changchun Changsheng vaccine incident and other cases, Article 142-1 of the Criminal Law separately stipulates that some previous situations that were punished as counterfeit drugs and behaviors with relatively high social harm are separate crimes of obstructing drug administration.

In addition to the premise of violating one of the four circumstances of violating the drug administration order, the establishment of the crime of obstructing drug administration also takes "sufficient to seriously endanger human health" as the basic condition for the establishment of this crime, which is helpful to further exclude cases where the conduct involved has not yet reached the corresponding level of danger, and reasonably determine the distinction between the violation of drug administration order as an administrative offense and the crime of obstructing drug administration order as a criminal offense. The offence of obstruction of drug administration falls under the category of specific dangerous offenders. Article 7 of the Interpretation of Several Criminal Cases of Drug Safety establishes nine specific judgment rules for how to determine "sufficient to seriously endanger human health" under the corresponding circumstances, and the establishment of specific judgment rules mainly focuses on "the safety, effectiveness and quality controllability of drugs", which are mainly judged from the formal point of view, without further demonstration of whether there is substantial danger.

One example is to determine whether the production and sale of drugs prohibited by the drug regulatory department of the State Council is "sufficient to seriously endanger human health", it is necessary to "comprehensively consider the time, quantity, reasons for prohibiting the use of drugs and other circumstances such as the time and quantity of production and sales" to determine whether there is "a real danger of serious harm to human health".

Example 2: "Producing or importing drugs or knowingly selling them without obtaining drug-related approval documents" constitutes the basic pattern of criminal cases of obstruction of drug administration in judicial practice. It is necessary to judge whether a specific act is "sufficient to seriously endanger human health" from factors such as whether it violates the basic requirements of drug administration laws and norms, especially considering the particularity of the object used by the drug involved in the case, the high risk or possibility of abuse of the drug involved in the case, the comprehensiveness and accuracy of the information disclosure of the drug involved in the case, whether the drug involved in the case meets the drug standards, and whether the drug involved in the case has been marketed abroad. The corresponding circumstances of criminalization mainly include: (1) the drugs involved in the case are mainly used by pregnant women, children, or critically ill patients; (2) the drugs involved in the case are narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, or biological products, or the drugs involved in the case are precursor chemicals passed off as other drugs; (3) the drugs involved in the case are injection drugs or first-aid drugs; (4) the indications of the drugs involved in the case, (5) The drug involved in the case does not have national drug standards and no approved drug quality standards, but chemical ingredients are detected; (6) The drug is imported without obtaining the relevant approval documents for the drug or is sold knowing that it is the above-mentioned drug, and the drug involved in the case is not legally marketed abroad.

It should be pointed out that the crime of obstructing drug administration, as a more typical administrative offense, should adhere to the unity of formal and substantive interpretation when determining the crime, and the crime can be determined in conjunction with relevant judicial interpretations, and for cases that only superficially and formally comply with the provisions of Article 141-1 of the Criminal Law, but there is indeed no situation that is "sufficient to seriously endanger human health", it should be avoided as a crime as much as possible to ensure the substantive legitimacy of the criminal punishment. At this time, it is still necessary to pull the trigger of the reverse connection of the execution.

III. Key elements to be considered when reviewing the reverse connection of executions

Judicial organs need to develop relatively systematic identification steps, and determine whether and how to initiate the reverse connection of executions through item-by-item judgment of key elements. The judicial organ shall, in accordance with administrative laws and norms, review whether the conduct of the parties constitutes an administrative violation, and then make a decision on whether to transfer or submit a judicial recommendation to the drug regulatory department. The judicial organs should judge which drug administrative laws and regulations the case violated, which administrative department the case was transferred to, whether the case exceeded the statute of limitations, and whether it was necessary to impose administrative penalties again.

(1) Review whether there is a clear basis for administrative punishment

In cases where drug execution is reversed and transferred, it shall be necessary to carry out administrative punishment, and it shall be premised on the existence of corresponding violations of drug administrative laws and norms. To this end, the judicial department should be able to grasp the legal norms of the corresponding drug administrative punishment and preliminarily identify the corresponding administrative violations. The legal norms of administrative punishment of drug administration are highly professional, which not only involves the provisions of the Drug Administration Law and the Vaccine Administration Law, but also involves administrative regulations such as the Regulations for the Implementation of the Drug Administration Law, the Measures for the Administration of Drug Registration, the Measures for the Supervision and Administration of Drug Production, the Measures for the Supervision and Administration of Drug Operation and Use, the Measures for the Supervision and Administration of Drug Online Sales and other departmental rules, which also put forward higher requirements for the judicial department. Judicial personnel handling drug-related cases should be familiar with the corresponding drug administrative legal norms as much as possible, and be able to understand the composition of administrative punishment behaviors and what kind of administrative legal liabilities they correspond to. If there is no corresponding code of conduct for administrative punishment to regulate the conduct involved in the case, it cannot be transferred to the administrative supervision department for punishment.

(B) review and determine the competent administrative departments

Article 24 of the Administrative Punishment Law establishes the principle of jurisdiction over the place where the illegal act of administrative punishment occurs, which is conducive to the investigation and evidence collection and administrative punishment of the illegal act by the competent administrative department.

Article 23 of the Administrative Punishment Law establishes the principle of hierarchical jurisdiction over administrative penalties. Article 8 of the Drug Administration Law stipulates the drug regulatory system and the responsibilities of drug regulatory departments at all levels. In the new round of institutional reform promoted since 2018, the National and Provincial Drug Administrations have been established. The State Drug Administration is managed by the State Administration for Market Regulation, which is in charge of the national drug supervision and administration, and is responsible for the licensing, inspection and punishment of drug development; At present, the separate drug supervision and administration department is only set up at the provincial level, and the market supervision departments of cities and counties divided into districts are responsible for the licensing, inspection and punishment of drug retail, and carry out the inspection and punishment of drug use. When transferring drug violation cases, judicial authorities need to identify the provisions on the vertical allocation of drug regulatory authority to determine whether the case should be transferred to the department responsible for drug supervision at the national, provincial or municipal and county levels.

Article 23 of the Administrative Punishment Law deals with functional jurisdiction, stipulating that "administrative punishment shall be under the jurisdiction of the administrative organ of the local people's government at or above the county level with the power of administrative punishment". The principle of functional jurisdiction embodies the spirit of each administrative organ performing its own duties and assuming its own responsibility, and is conducive to bringing into play the advantages of administrative organs' professional management. In addition, the competent departments of health, industry and information technology, customs, market supervision and administration, medical security, patent administration, traditional Chinese medicine, and public security organs all assume the corresponding drug regulatory responsibilities in accordance with the law. When transferring a drug case, the judicial organ should examine the original source of the drug case and identify the nature of the corresponding illegal act, so that the case can be transferred to the administrative supervision department with corresponding functional jurisdiction.

(3) Review whether the conduct involved in the case is still within the time limit for pursuing responsibility

The period for pursuing responsibility for administrative punishment refers to the maximum period for a party who violates the order of administrative management to be given an administrative punishment. After the time limit for accountability is exceeded, no administrative punishment will be given. This is also a requirement of the principle of legal stability. Article 36 of the Administrative Punishment Law stipulates that "if the illegal act is not discovered within two years, no administrative punishment shall be imposed." "As far as the time limit for the reverse connection of drug execution is concerned, it includes the sum of the time spent by the drug regulatory department in investigating and handling the case in accordance with the law, and the time spent by the public security organs, people's procuratorates, people's courts and other judicial departments in judicial procedures. When the relevant judicial department determines whether it is necessary to reverse transfer the case to the drug regulatory authority, if possible, it is necessary to calculate the total time period elapsed for administrative law enforcement and criminal justice procedures, and if the total time period elapsed exceeds two years, the time limit for accountability is exceeded, and there is no need to initiate the transfer procedure.

It should be pointed out that in order to implement the requirements of the Party Central Committee to "increase the intensity of punishment in key areas", the revised "Administrative Punishment Law" will "involve the life, health and safety of citizens...... and the period of accountability for "illegal acts" with harmful consequences has been extended to five years. Although it is true that drug-related cases "involve the life, health and safety of citizens", the five-year period of responsibility cannot necessarily be applied to them, because this must be premised on "harmful consequences", but for the judicial organs not to find that they constitute the crimes of "producing, selling, and providing inferior drugs" and "obstructing the administration of drugs", and in many cases, there are also drug-related acts that do not produce harmful consequences, and the two-year period of accountability should still be applied at this time. Objectively, this also requires the judicial organs to improve the efficiency of case filing, investigation, prosecution and other links, so as to minimize the situation where the conduct involved in the case exceeds the time limit for accountability.

(4) Comprehensive judgments of conduct related to the case

1. Determine whether the relevant conduct has been administratively punished

If the drug regulatory department has found that the perpetrator's behavior violates the drug administrative law norms, it shall impose an administrative penalty. For example, paragraph 2 of Article 11 of the Provisions on the Transfer of Suspected Criminal Cases by Administrative Law Enforcement Organs stipulates that "the administrative punishment decision of an administrative law enforcement organ that has already issued a warning before transferring a suspected criminal case to the public security organ shall not be suspended, ordering the suspension of production and business, temporarily withholding or revoking a license, or revoking a license." "According to Article 15 of the Measures for the Convergence of Drug Administrative Law Enforcement and Criminal Justice, if the drug regulatory department needs to give a warning, circulate criticism, restrict the development of production and business activities, order the suspension of production and business, order the closure, restrict the practice, temporarily withhold or revoke the license, it is not necessary to take the completion of the criminal procedure as the premise. When the drug regulatory authority has given corresponding administrative penalties to the acts involved in the case before transferring the case to the public security organ for filing and investigation, or in the course of criminal proceedings, it is not appropriate to carry out reverse connection in this case, so as to "avoid double evaluation".

2. Determine whether administrative punishment may be waived for the relevant conduct

Article 33 of the Administrative Punishment Law stipulates three types of circumstances in which punishment shall not be imposed or may not be punished: first, if the illegal act is minor and corrected in a timely manner, and no harmful consequences are caused, no administrative punishment shall be imposed; second, if the violation is minor for the first time and the harmful consequences are minor and corrected in a timely manner, no administrative punishment may be imposed; and third, if the party has sufficient evidence to prove that there is no subjective fault, no administrative punishment shall be imposed. Paragraph 3 of Article 124 of the Drug Administration Law stipulates that "if a small amount of drugs that have been legally marketed abroad are imported without approval, and the circumstances are relatively minor", administrative penalties may not be imposed in accordance with the law. For acts judged not to be subject to administrative punishment, the judicial authorities may choose not to transfer them to the drug regulatory authorities.

When determining whether an administrative penalty can be waived for a drug-related act, the following four aspects may be considered: (1) When determining whether a "minor violation" is constituted, the factors to be considered include minor subjective fault, the first violation, a short duration of the violation, a timely suspension of the violation, no illegal gains or a small amount of illegal gains, a small amount of value of the goods involved, the qualified or compliant standards of the drugs involved in the case, and other factors that can reflect the slight violation. (2) When determining what constitutes "minor harmful consequences", the factors to be considered include the degree of harm, the scope of harm, the ease of elimination or mitigation of harmful consequences, the active elimination or mitigation of harmful consequences of illegal acts, the initiative to reach a settlement with the target of illegal acts, and other factors that can reflect the slight harmful consequences. (3) When determining what constitutes "timely correction", it may cover three situations: taking the initiative to make corrections before the drug regulatory authorities discover clues of illegal acts, taking the initiative to make corrections before the drug regulatory authorities order corrections after discovering clues of illegal acts, and correcting as required after the drug regulatory authorities order corrections. (4) When determining whether a party has "subjective fault", it is necessary to consider whether the party knew or should have known about the illegal act, whether the party has the ability to control the illegal act and its consequences, whether the party has fulfilled its statutory production and operation responsibilities, whether the source of the drug involved in the case is legal and traceable, and other factors that can reflect the subjective state of the party.

Combined with the list of non-punishment for minor violations in the field of drug supervision that have been formulated and published by the drug regulatory departments of Henan, Shanxi, Hubei, Guizhou and other provinces, and the existing drug regulatory practices, the minor violations that are not punished in the field of drug supervision are mainly related to failure to comply with drug quality management practices, sales of traditional Chinese medicine decoction pieces that do not meet drug standards, defects in drug labels or instructions, failure to register purchase and sale records in a timely manner for the purchase and sale of drugs, and unauthorized import of a small number of drugs that have been legally marketed abroad. Drug dealers and medical institutions fail to report suspected adverse drug reactions in accordance with regulations. When the judicial organ is inclined to determine that the conduct involved in the case is a minor violation that is not subject to administrative punishment, it may choose not to initiate the transfer procedure.

IV. Procedural Law Construction of Mechanisms for Reverse Connection of Executions

Strengthening the reverse connection between judicial organs and administrative law enforcement organs in transferring administrative punishment cases is the embodiment of the concept of systematic governance. As far as the reverse connection of drug execution and execution is concerned, it helps to promote the integrity of the drug chain of custody and impose more precise and uninterrupted sanctions for violations in the field of drug safety. In the course of case review, if the judicial organ discovers that the suspected drug crime does not constitute a crime, but meets the administrative punishment standard, the case lead shall be promptly transferred to the relevant administrative department.

(1) The institutional framework for the reverse transfer procedure

Paragraph 2 of Article 113 of the Drug Administration Law stipulates the reverse transfer procedure in the connection of drug execution, requiring that "if there is no need to pursue criminal responsibility or be exempted from criminal punishment in accordance with the law" and "administrative responsibility shall be pursued", the public security organs, people's procuratorates and people's courts shall promptly transfer the case to the drug regulatory department.

1. Reverse transfer procedures by public security organs

As far as the public security organs are concerned, if there are no criminal facts after review, or if the criminal facts are found to be significantly minor after filing and investigation, they do not need to be investigated for criminal responsibility, but "if administrative responsibility shall be pursued in accordance with the law", the case and relevant evidence materials shall be transferred to the drug regulatory department with jurisdiction.

2. The procuratorate's reverse transfer procedure

As far as the procuratorate is concerned, in the case of a drug case in which a decision not to prosecute, if it is considered that the non-prosecuter needs to be given an administrative penalty or sanction in accordance with the law, or that it is necessary to confiscate his illegal gains, the people's procuratorate shall submit a procuratorial opinion and transfer the case and relevant evidence materials to the drug regulatory department for handling. This is also supported by the "gist of the case" of Case No. 81, the 22nd batch of Guiding Cases released by the Supreme People's Procuratorate in 2021.

The administrative procuratorial department within the procuratorate is responsible for the procuratorate's work on reversing executions. It is advisable to improve and strengthen the communication and connection procedures between criminal prosecution departments and administrative procuratorial departments within procuratorial organs. In the national procuratorial operations application system, the administrative procuratorial departments are provided with the authority to inspect the circumstances of criminal non-prosecution cases, so that the administrative procuratorial departments can promptly grasp the clues of cases in which executions are reversed. It is also possible to explore the mode of joint consultation and simultaneous review and handling of cases in which administrative procuratorial departments and criminal procuratorial departments intend to make a decision not to prosecute, so as to break down information barriers and improve judicial efficiency.

For drug cases in which the procuratorate decides not to prosecute, the criminal prosecution department within the procuratorate shall adhere to the principle of simultaneous review, and within 3 days of the decision not to prosecute, write the review opinion and explain the reasons in the review report on whether it is necessary to give administrative punishment, sanction or confiscation of unlawful gains to the non-prosecuting person, and share or transfer the case review report, prosecution opinion, non-prosecution decision, electronic file and other materials to the procuratorate's administrative procuratorate department for review.

After review, if the administrative procuratorial department finds that it is necessary to give an administrative penalty, it shall submit a procuratorial opinion with the approval of the chief procurator and transfer it to the qualified drug regulatory department for handling. Procuratorial opinions shall clearly indicate circumstances such as the adoption and lifting of criminal compulsory measures, the sealing, seizure, or freezing of assets involved in the case, and the reprimand of the person not prosecuting, or ordering them to make a statement of repentance, make formal apologies, or compensate for losses.

3. Reverse referral procedures by the court

As far as the people's court is concerned, in a case where a judgment of not guilty or waiver of criminal punishment is made, if it finds that an administrative penalty should be given in accordance with the law, it shall transfer the case and relevant evidence materials to the relevant drug administration department for handling, and may make a judicial recommendation. After the court concludes the case, the copy of the case file shall be transferred to the drug regulatory department with jurisdiction, and the drug regulatory department shall impose a penalty in accordance with the evidence provided by the court and in accordance with the administrative punishment procedures.

(2) Reverse connection of transferred materials

When public security organs, people's procuratorates, and people's courts transfer cases to the drug regulatory departments, they shall attach case file materials, which may include a list of transferred materials, a written transfer of the case, evidence materials involved in the case, a list of items involved in the case, and other relevant materials involved in the case. There are two main points that should be paid attention to when transferring materials: First, where it is deemed necessary to confiscate unlawful gains, the judicial organs shall also transfer the sealed, seized, or frozen assets involved in the case to the administrative organs, which will help ensure that the administrative punishment can be carried out correctly and smoothly. Second, the transferred evidence includes both the evidence previously transferred by the drug regulatory authorities and the evidence collected by the people's procuratorate and the people's court in criminal proceedings. At the same time as transferring the case to the drug regulatory department, the relevant evidence materials are transferred simultaneously, which helps to reduce duplicate evidence collection and improve quality and efficiency.

When the public security organ transfers the case, it should attach the corresponding decision not to file the case or withdraw the case, and the people's procuratorate should attach the corresponding decision not to prosecute when transferring the case. The corresponding documents should be interpreted as much as possible to explain the law and reason. First of all, the reasoning of the determination of facts should be strengthened. For example, in the Jiang Procuratorate Public Prosecution Criminal Non-Prosecution [2020] No. 189 Non-Prosecution Decision, the procuratorate believes that "Li Moumou...... The source of the purchased drugs, the destination of the sales, and whether the sample of the appraisal opinion and the drugs sold are the same batch of drugs are uncertain", so it is believed that the facts of the crime determined by the public security organs that Li XX sold counterfeit drugs are unclear and the evidence is insufficient, and does not meet the conditions for prosecution. Second, it is necessary to strengthen the reasoning on the application of law. In particular, the legal norms on which the judicial documents are based and the reasons for the applicable legal norms should be stated. The legal norms cited may be the provisions of general legal norms such as the Criminal Law and the Criminal Procedure Law, or the requirements of professional management laws and norms such as the Drug Administration Law and the Vaccine Administration Law, as well as the provisions of relevant judicial interpretations.

When a judicial organ transfers a case to an administrative organ, it may draft a "Case Transfer Opinion", which clearly states the results and reasons for not pursuing criminal responsibility and waiving criminal punishment, as well as the circumstances recommending administrative punishment for drugs. The recommendations of the judicial power on the follow-up decision of the drug regulatory department should only be a preliminary recommendation, and the judicial power should not replace the administrative judgment of the professional administrative department.

(3) The administrative organ's follow-up procedures for handling transferred cases

1. Make a decision on whether to file a case

Case filing is a procedure whereby the administrative law enforcement agency decides to initiate investigation and verification when it discovers that a party has violated the law or is suspected of violating the law, and decides whether to punish it according to the circumstances. At present, the phenomenon of not filing a case and arbitrarily filing a case and imposing excessively severe penalties for minor violations coexists. Paragraph 2 of Article 54 of the Administrative Punishment Law stipulates that "if the criteria for filing a case are met, the administrative organ shall promptly file the case". When reviewing the transferred case, the drug regulatory department should examine whether the parties involved in the case have violated the law or are suspected of violating the law, and whether the corresponding administrative legal liability has been set for the illegal act in the legal norms of substantive drugs. The Drug Administration Law, amended in 2021, almost without omission, sets corresponding legal liabilities for the provisions of the mandatory code of conduct. The relevant provisions in Chapter 11 of the Drug Administration Law "Legal Liability" should be examined to see whether the parties involved in the case are suspected of falling under the illegal circumstances stipulated in the relevant provisions. If the parties involved in the case are suspected of violating the law, the drug regulatory department shall file a case, otherwise it will not file a case.

2. The evidence is verified

Where a criminal case is transferred to an administrative case, the evidentiary materials collected in the course of handling the criminal case may be used as evidence in the administrative case. The reason why it is possible to convert evidence in criminal proceedings into administrative evidence is as follows: (1) it is generally believed that the standard of proof in criminal proceedings is "beyond reasonable doubt", and the standard of proof for administrative evidence lies between the standard of "beyond reasonable doubt" and the standard of "high probability". The standard of proof for administrative punishment is lower than that in criminal proceedings. (2) The judicial authorities have more advanced technical means, and can even take specific measures to obtain evidence, and their ability to obtain evidence under specific circumstances is stronger than that of the drug regulatory authorities. (3) From the perspective of saving law enforcement resources, administrative organs should be allowed to directly use evidence collected in criminal proceedings.

Following the above mechanism, the evidence collected by the public security organs, people's procuratorates and people's courts in accordance with the law when investigating, prosecuting and trying cases of drug violations and crimes can be directly used as evidence for the administrative law enforcement of the drug regulatory departments after they are transferred to the drug regulatory departments. However, the administrative law enforcement organs shall exclude evidence excluded during the investigation, review for prosecution, and trial phases. Evidence must be verified to be true before it can be used as the basis for determining the facts of the case. The evidence should be true; Article 54 of the Administrative Punishment Law stipulates that when an administrative organ discovers that an administrative counterpart has committed an act that should be given an administrative penalty in accordance with the law, it has the obligation to conduct an objective, comprehensive and impartial investigation and collect relevant evidence. Therefore, when dealing with transferred cases, the drug regulatory authorities can use evidence not only to criminal litigation evidence, but also to collect new evidence.

3. Make an administrative punishment decision

For conduct that does not constitute a crime, but should be subject to administrative punishment in accordance with law, the corresponding administrative punishment shall still be imposed. Articles 115, 116 and 117 of the Drug Administration Law set corresponding administrative legal liabilities for the production and sale of drugs without a license, the production and sale of counterfeit drugs, and the production and sale of inferior drugs. Articles 122 to 135 of the Drug Administration Law set corresponding legal liabilities for various violations of drug administration laws and norms, such as forging or altering licenses or drug approval documents, fraudulently obtaining drug licenses, producing or importing drugs without obtaining drug approval documents, carrying out drug clinical trials without approval, and violating various quality management practices, according to the facts, nature, circumstances and degree of social harm.

For drug-related cases that are transferred from the judicial authorities to the drug regulatory authorities, the corresponding acts have been excluded from the adjustment of the criminal circle of drug-related crimes. After investigating and collecting relevant evidence and ascertaining the actual facts of the case, the drug regulatory department needs to determine the facts of the case obtained from its investigation, which are consistent with all the constituent elements of which legal norm and which legal provision in the Drug Administration Law, the Regulations for the Implementation of the Drug Administration Law and other laws, and then within the scope of the type and range of administrative punishment specified in the legal provisions, impose corresponding legal responsibilities, so that the administrative punishment imposed is equivalent to the facts, nature, circumstances and degree of social harm of the illegal act.

For cases that are transferred to the drug regulatory authorities, the drug regulatory authorities should promptly impose administrative penalties for the illegal acts in conjunction with judicial recommendations, so as to prevent the vacuum of execution due to inaction. When a fine is imposed on the production or sale of counterfeit or inferior drugs, the range of the fine is often based on the value of the illegal production and sale of drugs, and then a fine of a certain magnitude is imposed. At this time, the value of the goods shall be calculated according to the marked price of the illegally produced and sold drugs, and if there is no marked price, it shall be calculated according to the market price of similar drugs.

Paragraph 2 of Article 28 of the Administrative Punishment Law stipulates that if a party has illegal gains, they shall be confiscated except for those that shall be returned in accordance with law. Most of the illegal acts in the field of drug safety are profit-seeking violations, and for cases that are transferred to the drug regulatory authorities, the drug regulatory authorities shall confiscate the illegal gains of the illegal parties in accordance with the law. The amount of illegal gains is highly concealed, and it is relatively difficult to determine, and it is constrained by various subjective and objective factors. Paragraph 2 of Article 28 of the Administrative Punishment Law stipulates that "illegal gains refer to the funds obtained from the commission of illegal acts". Generally speaking, the "illegal income" stipulated in the legal norms of drug administration refers to "all the operating income from the commission of illegal acts". The object of drug supervision is illegal matters related to personal life and physical health, and the calculation of illegal income adheres to the "total amount theory" rather than the "difference theory", and does not consider the cost of illegal acts and taxes and fees, etc., so it is relatively easy to define the illegal income obtained by the parties in one or more illegal acts, and better play the role of confiscation of illegal income sanctions.

V. Conclusion: Improve the institutional strategy for combining administrative regulation and governance with criminal justice governance

This paper attempts to analyze the legal theory and system of the reverse connection of drug execution in the field of drug safety. The implementation of the reverse linkage mechanism is inseparable from the cooperation between the executive branch and the judicial department. Drug regulatory departments at all levels and judicial organs shall strengthen coordination, unify the application of law, and improve working mechanisms such as circulars, case transfers, disposal of items involved in cases, case consultations, information sharing, and information release. There are four main institutional strategies:

First, establish a coordination mechanism between judicial organs and administrative organs, drug regulatory departments at all levels, public security organs, people's procuratorates and other departments should establish a departmental joint meeting system, promote the establishment of an inter-departmental drug safety investigation and handling linkage mechanism, report on the handling of cases, study and analyze the situation of drug violations and crimes, conduct consultations on major cases, and study issues such as the disposal of items involved in the case.

Second, complete and improve the case consultation and opinion communication mechanism in the reverse connection of drug executions. The judicial authority may consult the drug regulatory department on professional issues in the handling of the case, which may involve the characterization of the relevant case, the consultation on the determination of relevant facts, the application of law, the operation of judicial discretion and other issues, and the drug regulatory department consulted has the obligation to carefully study and reply in a timely manner. For example, before making a decision not to prosecute, the procuratorate may take the initiative to contact the drug regulatory department, report the case, and listen to the opinions of the drug regulatory department on issues such as the proposed decision not to prosecute and the feasibility of administrative punishment.

Third, give full play to the role of an information-sharing platform for the convergence of administrative law enforcement and criminal justice. Refine the handling process and transfer standards for cases of reverse connection of drug executions, and gradually realize the online transfer and online supervision of relevant cases.

Fourth, strengthen the follow-up and supervision of the procuratorial organs to the drug regulatory departments. For cases that are transferred by the procuratorate to the drug regulatory department, the drug regulatory department shall notify the people's procuratorate of the handling or results within 2 months from the date of receipt of the procuratorial opinion. The procuratorial organs shall strengthen the follow-up and supervision of the response and handling of the drug regulatory department, and if it is found that the drug regulatory department has illegally exercised its powers or not exercised its powers, it may formulate and issue procuratorial suggestions in accordance with the provisions of the law to urge it to make corrections.

In short, the practice of the reverse connection mechanism of drug execution is inseparable from the cooperative governance of drug regulatory authorities and judicial departments. The construction of the reverse connection mechanism between drug administrative law enforcement and criminal justice is helpful to overcome the inertia of "mandatory punishment" in the judiciary, and to combine administrative regulation and governance with criminal justice governance, which is not only conducive to the more active application of the criminal policy of blending leniency and severity, but also reflects the division of labor between different departmental laws and different social systems, so as to more comprehensively crack down on drug violations and crimes and protect the safety and legitimate rights and interests of the public.

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