Article 141 and Article 142 of the Criminal Law of our country respectively stipulate the crime of producing and selling fake drugs and the crime of producing and selling inferior drugs, which can be seen from the expression of the crime is the adoption of a blank crime, with direct reference to the provisions of Article 48 and Article 49 of the Drug Administration Law.

Article 48 of China's Drug Administration Law stipulates that any of the following circumstances is a counterfeit drug:

(1) The ingredients contained in the drug do not conform to the ingredients specified in the national drug standards; (2) Passing off a non-drug as a drug or passing off another drug as such drug. A drug under any of the following circumstances shall be classified as counterfeit: (1) The drug regulatory department under The State Council prohibits its use; (2) producing or importing without approval, which is required by this Law, or selling without inspection, which is required by this Law; (3) metamorphic; (4) contaminated; (5) using a raw material drug whose approval number must be obtained in accordance with this Law but is not obtained; (6) The indications or functions indicated exceed the prescribed scope.

Article 49: Drugs whose contents do not meet the national drug standards are substandard drugs. A drug under any of the following circumstances shall be treated as inferior: (1) the period of validity is not indicated or the period of validity is changed; (2) do not indicate or change the production batch number; (3) Expiration date; (4) The packaging materials and containers in direct contact with the drug are not approved; (5) adding colorants, preservatives, fragrances, flavoring agents and auxiliary materials without authorization; (6) Other drugs that do not meet the requirements of drug standards. It can be seen that China's drug administration Law regards the drug ingredients that do not meet the national drug standards as fake drugs, and the drug ingredients that do not meet the national drug standards as inferior drugs, and lists a series of circumstances for identifying fake drugs and inferior drugs by enumerating the method. According to the provisions of Article 48 and Article 49 of the Drug Administration Law, this binary distinction between fake and substandard drugs in the criminal Law is reasonable on the surface, but in actual operation, it is not difficult to find that the provisions of the drug Administration Law on fake and substandard drugs in the criminal law are neither scientific nor rigorous, and are more difficult to operate, which is not conducive to the realization of criminal law protection of drug safety. In 2001, the third article of the "Two-High" "Interpretation on Several Issues concerning the Specific Application of Law in Handling Criminal Cases Involving Production and Sale of Fake and Inferior Commodities" dealt with relevant issues, but with the development of the complex and changeable situation, the judicial interpretation has been far from meeting the needs of judicial practice. In May 2009, the "Two Highs" issued the "Interpretation on Several Issues concerning the Specific Application of the Law in Handling Criminal Cases involving the Production and Sale of fake and inferior Drugs", and in 2014, the "Two Highs" issued the "Interpretation on Several Issues concerning the Application of the Law in Criminal Cases endangering Drug safety", but the above explanation only solved some problems from the technical level. It does not fundamentally solve the problem of the rationality of distinguishing and qualitatively distinguishing fake and inferior drugs.

Therefore, it is necessary to reflect on the definition of fake and inferior drugs in our criminal law, and put forward corresponding suggestions for improvement.

I. Reflection on the defects of the dual definition of fake drugs and inferior drugs in Chinese criminal law

(1) It is unscientific and unreasonable for the criminal law to make a binary distinction between fake and substandard drugs

First of all, the dual distinction of fake drugs and inferior drugs in our criminal law has not realized the reasonable division of their social harm degree. The criminal law classifies substandard drugs into fake drugs and substandard drugs according to the degree of fake and inferior drugs, which can be seen from the difference in conviction and sentencing of the production and sale of fake drugs and substandard drugs. In the subconscious mind of the law, the social harm of substandard drugs is not as great as that of fake drugs, but in judicial practice, the social harm of fake drugs and substandard drugs is often difficult to distinguish. Although there is only one word difference between the crime of producing and selling fake drugs and the crime of producing and selling inferior drugs, there is a big difference in the conviction and sentencing of the crime. The production and sale of fake drugs can be convicted and punishable by death as long as they are "enough to seriously harm human health", while the production and sale of substandard drugs need to "cause serious harm to human health" to be punished as a crime, and the maximum penalty is life imprisonment. The two kinds of behaviors with similar social harm are not only different in charges, but also different in elements of crime construction and punishment, so it is difficult to embody the principle of the compatibility of crime, responsibility and punishment in criminal law. It is unscientific to distinguish fake drugs and inferior drugs in the drug administration law of our country based on the degree of fake and inferior drugs, and it does not realize a reasonable division of the social harm of the two behaviors, and it is unfair to crack down on the manufacturing and sale of fake drugs and inferior drugs.

Second, fake drugs; The actual result of the binary distinction of inferior drugs violates the original intention of dividing fake drugs and inferior drugs. The drug Administration Law defines the situation of inconsistent ingredient content as inferior medicine, which is originally proposed for the production phenomenon of insufficient feeding but very small difference. Take a certain drug as an example, according to the national drug standards, the content of a certain ingredient needs to reach 98% to be qualified, and if the manufacturer only invests 95% of the ingredient in corners, so that the dose is insufficient and the efficacy is slightly reduced, then the drug is inferior. From this point of view, the definition in administrative law is effective in ensuring the quality of drugs. However, because the drug administration Law does not make specific provisions on whether the content of inferior drugs meets the legal limit range, some illegal operators may have the opportunity to take advantage of it. May wish to assume a more extreme situation, such as the legal content of an ingredient of a drug is more than 85%, but a manufacturer's drug does not contain the ingredient, that is, the actual content of the prescribed ingredient is 0%, there is no doubt that the drug is a fake drug. However, if illegal businesses, in order to obtain huge profits and circumvent the law at the same time, change the ingredient of this drug to 2%, there is no substantial difference in the efficacy of the ingredient 2% drug and the drug that does not contain the ingredient, but there is a great difference in the treatment. If the content is 0%, it is a counterfeit drug while the content is 2%, it is a substandard drug, and it may face completely different results in the establishment of criminal standards and accountability.

Finally, the dual distinction between fake and inferior drugs also causes the situation that it is difficult to distinguish between fake and inferior drugs in practice, which brings great inconvenience to judicial practice. The drug administration Law lists the manifestations of fake and substandard drugs by enumeration, but these manifestations are prone to competition in the process of identifying fake and substandard drugs, which makes it difficult to distinguish and define in the specific operation process. For example, according to Article 49 of the Drug Administration Law of China, drugs that have exceeded their validity period are classified as inferior drugs, and drugs that have deteriorated according to article 48 are counterfeit drugs. However, the nature of drugs that have exceeded their validity period is very different, and some drugs that have exceeded their validity period are still in the drug stability period, have not lost their efficacy or have not deteriorated. However, some drugs that have exceeded their expiration date have deteriorated and failed, and even produced toxic and harmful substances. In this way, there may be competition between counterfeit and substandard drugs, that is, if the drug that has exceeded its expiration date has deteriorated, then the drug is both a counterfeit drug as stipulated in Article 48 of the Drug Administration Law and a substandard drug as stipulated in Article 49 of the Law. Some scholars have pointed out that the principle that the heavy method is superior to the light method can be adopted to solve this problem, that is, when the drugs that have exceeded the expiration date have deteriorated, the heavy method is applied to treat them as fake drugs, and if the drugs are still in the stable period, that is, they have not deteriorated, they are treated as inferior drugs. Although the principle can solve this problem, it also brings new problems. On the one hand, the application of the principle makes the provisions of the law on the situation of "drugs beyond the expiration date" in the case of inferior drugs lose meaning to some extent. On the other hand, this treatment principle brings inconvenience to the judicial personnel in actual operation. It is difficult to identify and confirm with the naked eye whether the vast majority of drugs that have exceeded the expiration date have reached the degree of deterioration, and can only be identified by certain detection means. According to the "Interpretation on Several Issues concerning the Specific Application of Law in Criminal Cases involving the Production and Sale of fake and inferior drugs" issued by the "Two Highs", it is inclined to entrust drug inspection institutions set up or determined by drug supervision and administration departments at or above the provincial level, which brings great operational difficulties to law enforcement. Even local standards or testing methods may differ in the identification of deterioration conclusions.

(2) The definition of counterfeit and substandard drugs in the Drug Administration Law is not rigorous and standardized

Article 48 and 49 of the Drug Administration Law list a series of situations in which fake and substandard drugs are identified by enumeration, but the provisions and expressions of some situations lack the corresponding rigor and standardization.

First of all, the provisions on the concept and scope of fake drugs and substandard drugs are not specific, not rigorous, and lack of operability. The concrete embodiment is: first, the provisions on the deterioration and contamination of counterfeit drugs are not specific enough. The extent of deterioration and pollution is not clearly defined, and such insufficiently operational provisions are often mere formalities and difficult to implement. This paper considers that there should be a qualitative and quantitative index for the two cases of deterioration and pollution, and specify what situation and what degree belong to the situation of deterioration and pollution. In addition, some scholars believe that for drugs that have deteriorated or been contaminated to be punished according to counterfeit drugs, according to the provisions of Article 78 of the Drug Administration Law, it is unscientific to state the quality inspection results of drugs on the penalty notice, and it should be directly defined as counterfeit drugs, rather than being punished according to counterfeit drugs. Second, Article 11 of China's drug Administration Law stipulates that "raw materials and auxiliary materials required for the production of drugs must meet the medicinal requirements", but there are no specific provisions on what is the so-called medicinal requirements of the law, so in the absence of legal interpretation, this provision brings difficulties to the actual operation. Third, the content in the concept of "inconsistent content" used to define inferior drugs in China's drug administration law is not clear, and the number of the distance from the standard content is not specified, so that the drugs with different content may be classified as the same nature.

Secondly, the provisions on the concept and scope of fake and substandard drugs are not comprehensive enough, and there are legal loopholes. In the case of clear counterfeit drugs, the sixth provision stipulates that "the indicated indication or function is beyond the prescribed scope", in which only the exceeded situation is specified and the reduced situation is completely ignored. In real life, the exceeded situation is indeed more common, but the reduced situation can not be ignored. In real life, there are many phenomena that deliberately exaggerate certain characteristics or functions in order to achieve the purpose of strengthening in order to narrow the indications or functional indications, and what they vigorously promote may not be the main function of the drug but only meet the needs of the market.

Thirdly, the expression of the concept of fake drugs and inferior drugs does not meet the requirements of the strict logic of criminal law. For example, Item 5 of Article 49 of the Drug Administration Law stipulates that "coloring agents, preservatives, fragrances, taste correction agents and excipients added without authorization" are inferior drugs, and Article 102 of the Drug Administration Law also states that "excipients refer to adjuncts and adjuncts used in the production of drugs and in the formulation of prescriptions." Additive is a general term for all additional materials other than the main drug, including colorants, flavor correction agents, etc., so exciparants and colorants, preservatives, fragrances, and flavor correction agents are inclusive and inclusive, and the drug Administration Act Article 49 describes them side by side when listing the situation of inferior drugs, there is a logical problem.

二、国外及国际组织关于假药、劣药之法律界定

世界卫生组织将假药定义为：故意或欺诈性地标错品种或／和其来源的药品。具有同类性质的产品、含有标准成分或不具有标准成分的产品、不具有活性成分或活性成分含量不足的产品以及伪造包装的产品都属于假药。国际制药协会（1FPMA）联合英联邦制药协会对假药进行了定义，认为假药是指故意或欺诈性地标错品种或／和其来源的药品。其中含有标准成分、不具有标准成分、不具有活性成分以及伪造包装情形都属于假药。

此外美国、德国、加拿大等国家对药品的定义也比较科学和全面。以美国为例，在药品管理体制和法制建设方面具有丰富经验，有着药品监督管理方面完善的管理体系和法律制度，在世界范围具有重要的地位和影响。美国《联邦食品、药品和化妆品法案》（FDCA）经过多次修改，已成为世界上最全面的药品管理法律，其中有关规定我国可以予以参考和借鉴。根据美国《联邦食品、药品和化妆品法案》的规定，所谓假药是指某种药品或药品的容器或标签上，未经授权，带有该药品的实际生产商、包装商或经销商以外的其他药品生产商、加工商、包装商，经销商的或与之相似的商标、商号或其他标识、印记、设计，因而错误地将该药品指向，或使得该药品被认为是由该其他生产、包装或经销商生产、包装或经销的。美国的《联邦食品、药品和化妆品法案》中把所有不合格的药品统称为假药，并且根据药品的实质问题和形式问题把假药划分为掺假药和冒牌药，即把内在质量存在问题的药品归为掺假药，而把药品本身没有问题但标签有问题的药品归为冒牌药。

Third, the unification of the concept of fake drugs and inferior drugs and the perfection of legislation

From the above relevant international organizations and the provisions of the United States on the definition and scope of counterfeit drugs, we can see that China and other foreign countries on the definition of counterfeit drugs have the following differences: (1) the identification standards of counterfeit drugs are different. China's judgment standard is the national drug standard, the ingredients contained in the drug or the content of the ingredients is inconsistent with the provisions of the national drug standard is identified as fake or inferior drugs, while foreign countries take the label of the drug is consistent with the actual as the main criterion for judging fake drugs. (2) The scope of the two provisions on counterfeit drugs is different, according to foreign standards for the identification of counterfeit drugs, not only includes substantive impersonation but also includes trademark, drug name, mark, appearance and packaging and other forms of impersonation, and the concept of counterfeit drugs in China, "impersonation" only refers to the substantive impersonation of drugs, the scope of counterfeit drugs in China is much narrower than the scope of counterfeit drugs in foreign countries. (3) According to the degree of substandard drugs in China, unqualified drugs are divided into fake drugs and inferior drugs, most countries are not so divided, but according to the unqualified drugs are unqualified external quality or internal quality unqualified drugs are divided into adulterated drugs and counterfeit drugs. Compared with the two methods, although from the original intention of the makers of this division method in China, the intention is to distinguish the different punishment methods of fake drugs and inferior drugs according to the degree of harm caused by unqualified drugs to the human body, so as to achieve the purpose of effectively punishing the crime of fake drugs and inferior drugs, but because the boundary between fake drugs and inferior drugs is difficult to define, and the degree of harm of the two is difficult to be clear. This makes it difficult for lawmakers to achieve what they intended. The classification method of unqualified drugs in the United States, because of the clear classification standards and clear thinking, is convenient for the personnel of the drug supervision and administration department to quickly and effectively determine the attributes of unqualified drugs, which has considerable reference significance for such legislation in China.

Based on this, Hillhouse believes that in China's criminal law, we can learn from the relevant provisions of foreign countries, unify the concepts of fake drugs and inferior drugs, collectively referred to as shoddy drugs, and no longer distinguish further. The distinction between fake and inferior drugs in criminal law also goes against the original intention of the legislation. At the same time, the relevant legislation in foreign countries basically does not distinguish between fake and inferior drugs, if China does not distinguish between fake and inferior drugs, it can be better in line with international standards, which is conducive to carrying out cooperation and exchange activities such as judicial assistance. At present, China's provisions on unqualified drugs are limited to substantive unqualified drugs, but do not include formal unqualified drugs, so there is no need to subdivide unqualified drugs. Therefore, through the comparative analysis of the definition of fake drugs and inferior drugs, the author believes that in China's criminal law can learn from the relevant provisions of foreign countries, the two concepts of fake drugs and inferior drugs are unified, collectively referred to as shoddy drugs, no further differentiation.

Chinese legislation divides unqualified drugs into fake drugs and inferior drugs, and provides different degrees of punishment for the two crimes respectively, its purpose is to define the degree of harm to the human body according to the degree of substandard drugs, so as to divide the severity of responsibility for illegal acts, and then distinguish the severity of crime and punishment. The unified provision of fake drugs and substandard drugs as shoddy drugs, although it seems to lose a way of dividing the severity of responsibility, but according to the degree of shoddy drugs to determine the degree of harm of unqualified drugs crime is not scientific, nor is it practical. Therefore, the crime of producing and selling fake drugs in Article 141 of China's criminal Law and the crime of producing and selling substandard drugs in Article 142 are combined into one crime, collectively referred to as the crime of producing and selling fake and inferior drugs, according to the illegal facts of the perpetrator, With reference to the severity of the circumstances, the degree of objective harm to society, the degree of relative subjective intention and the attitude after the illegal behavior is found, the severity of criminal responsibility is distinguished, and then the sentencing is distinguished. This method is more scientific, avoids the problem of misdemeanor heavy sentence or felony light sentence, and can realize the justice of the law more.