China Food and Drug network news (reporter Wang Xiaodong) does not obtain a drug production license, drug distribution license or medical institution preparation license to produce and sell drugs, in accordance with the provisions of the Drug Administration Law, can be fined more than 15 times the value of the value of 30 times less。So, 15 times the minimum, or 30 times the maximum?The same illegal behavior, even in the same city, between regulatory departments at all levels, will be punished "a bowl of water"?
近日,Beijing Drug Administration gives administrative counterpart a "reassuring pill",In order to avoid administrative punishment,The application of the discretion power of Administrative punishment and the benchmark of drug supervision discretion have been issued - the "Regulations on the Application of the Discretion Power of Administrative Punishment of Beijing Municipal Drug Administration (Trial implementation)" and the "Benchmark of Administrative Punishment Discretion of Beijing Municipal Drug Supervision (Trial implementation)" (hereinafter referred to as the "Regulations" and "Benchmark").,Make the regulatory departments at all levels to achieve "excessive penalties equal" and "the same punishment",This is at the forefront of the country。
Introduction background and process
According to the Beijing Municipal Bureau of Drug Administration, the relevant person in charge of regulations,The Guiding Opinions of the General Administration of Market Regulation on Regulating the Discretion of Administrative Penalties in Market Supervision and Management, and the Guiding Opinions of Beijing on Standardizing the Implementation of the Benchmark System of Administrative Penalties Discretion,All of them put forward requirements for standardizing the implementation of punishment discretion benchmark system,We will strictly regulate the discretion of administrative penalties in the fields of drugs, medical devices and cosmetics。In this context, the Municipal Council drafted the "Regulations" and "Benchmarks".。Through the simultaneous development and implementation of the "Provisions" and "Benchmarks", the work goal of unifying administrative penalties, legal basis, application principles of discretion and standards of discretion range in the drug field is achieved, and a strong institutional guarantee is provided for standardizing law enforcement behaviors of drug regulatory departments。
The "Provisions" and "benchmarks" were consulted internally three times in 2019 and 2020 respectively, and after being relatively mature, from April 17 to May 6, 2020, they were also open to the public for opinions。The "Regulations" and "Benchmarks" were officially implemented on June 24 and June 30 respectively。
Embodies the "four strictest" and "responsibility to people"
The person in charge of the law and regulations department of the Beijing Municipal Drug Administration told reporters,The "Provisions" and "Benchmarks" have made specific provisions on the exercise of the discretion of administrative punishment, such as the principle, standard, range and so on,To ensure that drug regulatory departments at all levels for the nature of the illegal acts of the circumstances are basically the same or similar cases,When imposing administrative punishment and exercising discretion,The applicable legal basis, the types and ranges of penalties determined are basically the same or similar。
The Provisions contain six chapters: "General Provisions", "Rules", "calculation methods and application", "procedures", "guidance and supervision" and "Supplementary provisions",It provides the subject, grade, method, principle and responsibility investigation of discretion,The range of discretion is standardized,The principle of discretion standard is refined and quantified,The application condition and decision procedure of discretion are also clarified。
The Benchmark contains 313 articles,It is the administrative penalty clause in the current effective laws, regulations and rules of drug supervision,Check one by one,And clarify the name of the illegal act, the basis of punishment, the content of punishment, the order of basic discretion, the benchmark and the level of exercise,In order to refine and quantify the scope of the applicable discretion of each penalty;In particular, the standard and range of the penalty range for "serious circumstances" in the "Vaccine Administration Law" and "Drug Administration Law" and the penalty range for personal property are specified,In order to fully reflect the legal spirit of "four strictest" and "responsibility to people" in the field of drug supervision,Crack down on shock-related illegal activities。
The "punishment discretion" is divided into five levels
According to the "Regulations" and "benchmark", the punishment discretion of drug violations in Beijing is divided into five levels。If there are serious circumstances, the amount of fine and the number of years of ban will be further divided according to the light, general and heavy discretionary circumstances。
-- Heavier punishment means that within the categories and ranges of punishment that can be selected according to law, heavier or more categories of punishment or a higher range of punishment are applied。Among them, the amount of the fine shall be the higher part of 30% of the range from the minimum to the maximum。
- General punishment means that the illegal act does not have a heavier, lighter or mitigated, no punishment, etc., and shall be punished in accordance with the law at the medium limit of the statutory penalty range。
- Lenient punishment means that within the categories and ranges of punishment that can be selected according to law, a lesser or lesser category of punishment or a lower range of punishment shall be applied。Among them, the amount of the fine shall be at the lower 30% of the range from the minimum to the maximum。
- Mitigation of punishment means the type or range of punishment below the minimum statutory administrative penalty。Including the choice of a lesser type of punishment than the one or more types of punishment that should be imposed for the violation, or the choice not to impose them when they should be imposed;It also includes determining the amount of the fine below the statutory minimum fine limit。
No punishment means that no administrative punishment is given for specific illegal acts due to legal reasons。
Refine the fine amount to "several tenths"
In terms of the amount of fines and the number of years of suspension, the "Provisions" and the "benchmark" have detailed the following three situations。
The first is the amount of the fine specified in the penalty rules。Taking Article 71 of the "Measures for the Supervision and Administration of Drug Production" as an example, for the provisions of "imposing a fine of more than 10,000 yuan and less than 30,000 yuan", in accordance with four different penalty discretion circumstances of mitigation, light, general, and heavy, it is divided into "0-10,000 yuan fine" and "10,000 yuan (including) -1" according to the prescribed proportion.60,000 yuan fine ", "1.60,000 yuan (including) -2.40,000 yuan fine ", "2.40,000 yuan (including) - 30,000 yuan fine "four basic discretionary orders。
Second, the penalty provisions are calculated by the amount of the value of the fine multiple。Take Article 115 of the Drug Administration Law as an example,Drugs that are also illegally produced and sold (including sold and unsold drugs) are targeted,The same below) a fine between 15 times and 30 times the value of the goods",According to the four different circumstances of punishment discretion: mitigation, light, general and heavy,According to the prescribed proportion, it is divided into "0-15 times the value of the goods (excluding) penalty" and "15-19 times the value of the goods..5 times (excluding) penalty ", "Value amount 19.5倍-25.5 times (including) fine ", "the value of the goods amount 25.5 times -30 times (including) penalty "four basic discretion levels。
Third, the penalty stipulates the period of prohibition。Take Article 126 of the Drug Administration Law as an example,For "serious circumstances,...The legal representative, the principal responsible person, the person directly in charge and other responsible personnel shall be concurrently...10 years to life prohibition of drug production and marketing activities.,If the circumstances are serious, the three different circumstances of punishment discretion are light, ordinary and heavy,According to the prescribed proportion, it is divided into three basic discretion levels: "No employment for more than 10 years and less than 20 years", "no employment for more than 20 years (including) and less than 30 years (including)", and "no employment for more than 30 years (excluding) and life"。
In short, the key word of the introduction of "Regulations" and "benchmarks" is "norms", regulating the law enforcement behaviors of regulatory departments at all levels, so that administrative counterparts no longer worry about "the same illegal behavior, the penalty is worlds apart".。Regarding the administrative punishment of medical devices and cosmetics, the Beijing Municipal Drug Administration is also widely seeking the opinions of all sectors of society, and will introduce relevant discretionary benchmarks (trial).。 |