According to the provisions of Articles 48 and 49 of the Drug Administration Law, this binary distinction between counterfeit drugs and inferior drugs is reasonable on the surface, but in practice, it is not difficult to find that the provisions of the Drug Administration Law on counterfeit drugs and inferior drugs are neither scientific nor rigorous, and it is even more difficult to operate, which is not conducive to the criminal law protection of drug safety. Article 3 of 200 1 Interpretation on Several Issues Concerning the Specific Application of Laws in Handling Criminal Cases of Producing and Selling Fake and Inferior Commodities touches on related issues. However, with the development of complex and changeable situation, this judicial interpretation is far from meeting the needs of judicial practice. In May 2009, the Interpretation on Several Issues Concerning the Specific Application of Laws in Handling Criminal Cases of Producing and Selling Fake Drugs and Inferior Drugs was promulgated. However, this explanation only solves some problems from the technical level, but does not fundamentally solve the rationality of distinguishing and characterizing counterfeit drugs and inferior drugs. Therefore, it is necessary to reflect on the definition of counterfeit drugs and inferior drugs in China's criminal law and put forward corresponding suggestions for improvement.
First of all, reflect on the defects of the dual definition of counterfeit drugs and inferior drugs in China's criminal law
(1) It is unscientific and unreasonable to make a binary distinction between counterfeit drugs and inferior drugs in criminal law.
First of all, the binary distinction between counterfeit drugs and inferior drugs in China's criminal law has not achieved a reasonable division of its social harm. According to the degree of counterfeit drugs and inferior drugs, the criminal law divides unqualified drugs into counterfeit drugs and inferior drugs, which can be seen from the differences in conviction and sentencing of producing and selling counterfeit drugs and inferior drugs. Subconsciously, the social harm of inferior drugs is not as great as that of counterfeit drugs, but in judicial practice, the social harm of counterfeit drugs and inferior drugs is often difficult to distinguish, and the crime of producing and selling counterfeit drugs is only one word apart from the crime of producing and selling inferior drugs. As long as the production and sale of counterfeit drugs are "serious enough to endanger human health", the maximum penalty is death, while the production and sale of inferior drugs need to be "serious enough to endanger human health" to be punished as a crime, and the maximum penalty is life imprisonment. Two kinds of behaviors with equal social harm are not only different in charges, but also different in constitutive requirements and penalties. At this point, it is difficult to embody the principle of suiting crime to punishment in criminal law. It is unscientific for China's Drug Administration Law to make a binary distinction between counterfeit drugs and inferior drugs according to the degree of counterfeit drugs and inferior drugs, and it has not achieved a reasonable division of the social harm degree of the two behaviors, and it is unfair to crack down on the manufacture and sale of counterfeit drugs and inferior drugs.
The second is counterfeit drugs; The actual result of binary distinction between inferior drugs violates the original intention of distinguishing counterfeit drugs from inferior drugs. "Drug Administration Law" defines the situation that the content of ingredients does not match as inferior drugs, which is intended for the production phenomenon of insufficient feeding but little difference. Take a drug for example. According to the national drug standard, the content of a certain ingredient needs to reach 98% to be qualified. If the manufacturer cuts corners and only invests 95% of this ingredient, this medicine is inferior. From this point of view, this definition is effective in ensuring drug quality in administrative law. However, because the Drug Administration Law does not clearly stipulate whether the content of inferior drugs meets the legal limit, some unscrupulous operators may take advantage of it. Let's assume a more extreme situation. For example, the legal content of a certain ingredient in a certain medicine is above 85%, but the medicine of a certain manufacturer does not contain this ingredient at all, that is, the actual content of the ingredient is 0%, so the medicine is undoubtedly a counterfeit medicine. However, if unscrupulous merchants change the composition of this drug to 2% in order to make huge profits and evade the law at the same time, there is no substantial difference in curative effect between the drug containing 2% and the drug without this ingredient, but the treatment is very different. The content of 0% belongs to counterfeit drugs, and the content of 2% belongs to inferior drugs, which may face completely different results in the criteria of constituting a crime and investigating responsibility.
Finally, the binary distinction between counterfeit drugs and inferior drugs has also caused the situation that counterfeit drugs and inferior drugs are difficult to distinguish in practice, which has brought great inconvenience to judicial practice. The Drug Administration Law lists the manifestations of counterfeit drugs and inferior drugs by enumerating, but these manifestations are prone to concurrence in the process of identifying counterfeit drugs and inferior drugs, and it is difficult to distinguish and define them in the specific operation process. For example, according to Article 49 of China's Drug Administration Law, expired drugs are inferior drugs, and drugs deteriorated according to Article 48 are counterfeit drugs. However, the nature of expired drugs is very different. Some expired drugs are still in the stable period of drugs and have not failed or deteriorated, but some expired drugs have deteriorated and even produced toxic and harmful substances. In this way, there may be competition between counterfeit drugs and inferior drugs that have expired, that is, if the drugs that have expired have deteriorated, then the drugs are both counterfeit drugs as stipulated in Article 48 of the Drug Administration Law and inferior drugs as stipulated in Article 49 of the Law. Some scholars here pointed out that the principle of emphasizing the law is better than neglecting the law can be adopted to solve this problem of concurrence, that is, when the drugs that have expired have deteriorated, the heavy law should be applied to treat them as counterfeit drugs, and if they are still in the stable period of drugs, they should be treated as inferior drugs. (1) Although the principle can solve this problem, it also brings new problems. On the one hand, the application of this principle makes the provisions of the law on the situation of "drugs exceeding the validity period" in the case of inferior drugs meaningless to some extent. On the other hand, this principle has brought inconvenience to the judiciary in practice. Whether the vast majority of drugs beyond the expiration date have reached the deterioration level is difficult to identify and identify with the naked eye, and can only be identified by certain testing methods. According to the Interpretation of Several Issues Concerning the Specific Application of Laws in Handling Criminal Cases of Producing and Selling Fake Drugs and Inferior Drugs issued by the "Two Highs", it tends to entrust drug inspection institutions set up or determined by drug supervision and administration departments at or above the provincial level for inspection, which brings great operational difficulties to law enforcement, and even standards or inspection methods in different places may have different conclusions on deterioration.
(2) The definition of counterfeit drugs and inferior drugs in Drug Administration Law is not strict enough.
Articles 48 and 49 of the Drug Administration Law list a series of cases in which counterfeit drugs and inferior drugs are identified by enumeration, but the provisions and expressions of some cases lack corresponding rigor and standardization.
First of all, the provisions on the concept and scope of counterfeit and inferior drugs are not specific, rigorous and lack of operability. It is embodied in the following aspects: First, it is not specific enough about the deterioration and pollution of counterfeit drugs. There is no clear regulation on the degree of deterioration and pollution, and this regulation with insufficient operability is often just a formality and difficult to implement. This paper holds that deterioration and pollution should have a qualitative and quantitative index, and specify what situation and degree belong to deterioration and pollution. In addition, some scholars believe that according to the provisions of Article 78 of the Drug Administration Law, it is unscientific to state the results of drug quality inspection in the penalty notice, and it should be directly defined as counterfeit drugs, not counterfeit drugs; (2) Second, Article 11 of China's Drug Administration Law stipulates that "the raw materials and auxiliary materials needed for the production of drugs must meet the requirements for medicinal use", but there is no specific provision on what the so-called medical requirements in this law are, so this provision has brought difficulties to practical operation without legal interpretation. Thirdly, the content of the concept of "inconsistent content" used to define inferior drugs in China's Drug Administration Law is not clear, and the distance from the standard content is not specified, so that drugs with very different contents can be classified as the same nature.
Secondly, the provisions on the concept and scope of counterfeit drugs and inferior drugs are not comprehensive enough, and there are legal loopholes. In the case of identifying counterfeit drugs, the sixth item stipulates that "the indications or functional indications are beyond the prescribed scope", which only stipulates the situation of exceeding and completely ignores the situation of reduction. In real life, the situation of overstaffing is really common, but the situation of reducing points can not be ignored. In real life, there are many phenomena that deliberately exaggerate a certain feature or function by narrowing the indications or functional indications, so as to achieve the purpose of strengthening. It may not promote the main function of drugs, but cater to the needs of the market.
Thirdly, the expression of the concepts of counterfeit drugs and inferior drugs does not meet the requirements of strict logic of criminal law. For example, Item 5 of Article 49 of the Drug Administration Law stipulates that "adding colorants, preservatives, spices, correctants and excipients without authorization" belongs to inferior drugs, and Article 102 of the Drug Administration Law also stipulates that "excipients refer to excipients and additives used to produce drugs and prepare prescriptions". Additives are the general name of all additional materials except the main drug, including colorants and flavoring agents, so auxiliary materials are included with colorants, preservatives, spices and flavoring agents. Article 49 of the Drug Administration Law lists inferior drugs side by side, which has logical problems.
Second, the legal definition of counterfeit drugs and inferior drugs by foreign countries and international organizations.
The World Health Organization defines counterfeit drugs as drugs that are intentionally or fraudulently labeled with the wrong variety or/and source. Products with similar properties, products with or without standard ingredients, products with insufficient effective ingredients, and products with forged packaging are all counterfeit drugs. ⑶ The International Pharmaceutical Association (1FPMA) and the Commonwealth Pharmaceutical Association have defined counterfeit drugs, and think that counterfeit drugs refer to drugs with wrong varieties or/and sources intentionally or fraudulently marked. Those with standard ingredients, those without standard ingredients, those without effective ingredients and those with forged packaging are all counterfeit drugs. ⑷
In addition, the definitions of drugs in the United States, Germany, Canada and other countries are more scientific and comprehensive. Taking the United States as an example, it has rich experience in drug management system and legal system construction, and has a perfect management system and legal system in drug supervision and management, which has an important position and influence in the world. The Federal Food, Drug and Cosmetic Act (FDCA) of the United States has been revised many times, becoming the most comprehensive drug administration law in the world, and the relevant provisions can be used for reference by China. According to the provisions of the Federal Food, Drug and Cosmetics Act of the United States, the so-called counterfeit drug refers to the unauthorized printing of trademarks, trade names or other marks, imprints and designs similar to those of other drug manufacturers, processors, packers and distributors other than the actual drug manufacturers, packers or distributors on the drug or drug container or label, thus wrongly pointing to the drug or making it be regarded as being produced, packaged or distributed by other drugs. 5. In the Federal Food, Drug and Cosmetic Act of the United States, all unqualified drugs are collectively referred to as counterfeit drugs. According to the substance and form of drugs, counterfeit drugs are divided into adulterated drugs and counterfeit drugs, that is, drugs with internal quality problems are classified as adulterated drugs, and drugs with labels without problems themselves are classified as counterfeit drugs. ⑹
Third, the unification of the concepts of counterfeit drugs and inferior drugs and the perfection of legislation.
As can be seen from the above-mentioned regulations on the definition and scope of counterfeit drugs in relevant international organizations and the United States, there are the following differences in the definition of counterfeit drugs between China and other foreign countries: (1) The identification standards of counterfeit drugs are different. China's judgment standard is the national drug standard, and the ingredients or contents of drugs that are inconsistent with the national drug standard are regarded as counterfeit drugs or inferior drugs, while foreign countries regard whether the labels of drugs are consistent with the actual situation as the main criterion for judging counterfeit drugs. (2) The scope of counterfeit drugs is different between them. According to foreign standards for the identification of counterfeit drugs, it includes not only substantial fraudulent use, but also trademark, drug name, label, appearance and packaging, while the concept of counterfeit drugs in China only refers to substantial fraudulent use of drugs, and the scope of counterfeit drugs in China is much narrower than that in foreign countries. (3) In China, substandard drugs are divided into counterfeit drugs and inferior drugs according to their fake and inferior quality. Most countries do not do this, but divide unqualified drugs into adulterated drugs and counterfeit drugs according to whether the external quality is unqualified or the internal quality is unqualified. Compared with the two classification methods, although this classification method in China is intended to distinguish different punishment methods of counterfeit drugs and inferior drugs according to the degree of harm caused by unqualified drugs to human body, so as to achieve the purpose of effectively punishing crimes of counterfeit drugs and inferior drugs, it is difficult to define the boundary between counterfeit drugs and inferior drugs, and the degree of harm between them is also difficult to be clear, which makes the original intention of legislators difficult to achieve. However, the classification method of unqualified drugs in the United States, because of its clear standards and clear thinking, is convenient for the personnel of drug supervision and management departments to quickly and effectively judge the attributes of unqualified drugs, which has considerable reference significance for such legislation in China.
Based on this, the author believes that in China's criminal law, we can learn from the relevant provisions of foreign countries and unify the two concepts of counterfeit drugs and inferior drugs, collectively known as counterfeit drugs and inferior drugs, without further distinction. The distinction between counterfeit drugs and inferior drugs in criminal law also violates the original legislative intention of this distinction. At the same time, the relevant foreign legislation basically does not distinguish between counterfeit drugs and inferior drugs. If China does not distinguish between counterfeit drugs and inferior drugs, it will be better in line with international standards and help to carry out cooperation and exchange activities such as judicial assistance. At present, the regulations on unqualified drugs in China are limited to basic unqualified drugs, and do not involve regular unqualified drugs, so there is no need to subdivide unqualified drugs. Therefore, through the comparative analysis of the definitions of counterfeit drugs and inferior drugs, the author believes that in China's criminal law, we can learn from the relevant provisions of foreign countries and unify the two concepts, collectively known as counterfeit drugs, without further distinction.
China's legislation divides inferior drugs into counterfeit drugs and inferior drugs, and stipulates different degrees of punishment for the two crimes. Its purpose is to define the degree of harm to human body according to the degree of counterfeit and inferior drugs, so as to divide the responsibility of illegal acts, and then distinguish the severity of crime and punishment. It is unscientific and unrealistic to define fake and inferior drugs as fake and inferior drugs. Although on the surface, a way to divide responsibility is lost, it is unscientific and unrealistic to determine the harm degree of the crime of inferior drugs according to the degree of fake and inferior drugs. Therefore, the crime of producing and selling counterfeit drugs in article 14 1 and the crime of producing and selling inferior drugs in article 142 of our criminal law are combined into one crime, which is collectively called the crime of producing and selling counterfeit drugs and inferior drugs. According to the illegal facts of the actor, with reference to the seriousness of the circumstances, the degree of harm to society objectively, the relative subjective intention and the attitude after the illegal act is discovered, the severity of criminal responsibility is distinguished, and then the sentencing is distinguished. This method is more scientific, avoids the problem of heavy punishment for misdemeanor or light punishment for felony, and realizes the fairness of law.