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新修订《药品管理法》中假劣药相关条款的主要变化及对执法的影响研究
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| 篇名： | 新修订《药品管理法》中假劣药相关条款的主要变化及对执法的影响研究 |
| TITLE： | Study on Main Changes of Counterfeit and Inferior Drugs ’Relevant Provisions in the Newly Revised Drug Administration Law and Their Impact on Law Enforcement |
| 摘要： | 目的：为有关部门进一步明确假药和劣药的定义及执法，保障公众用药安全和合法权益提供参考。方法：通过对比研究、文献研究与新法解读，从假劣药定义、罚则和认定依据等方面对新修订《药品管理法》中假劣药相关条款进行全面分析和研究，并从药品执法实践的角度，提出假劣药相关条款的主要变化对药品执法带来的挑战与影响。结果与结论：在定义方面，新修订《药品管理法》对假劣药进行了重新的定义，形式上由修订前的15种情形缩小到11种但内容上更为丰富，取消了按假劣药论处的概念，增加了禁止使用假劣药情形，违反药品管理秩序的行为不再按假劣药论处，删除了2种按假药论处的情形，将被污染的药品由假药调整为劣药，进一步明确了辅料的定义。在罚则方面，新修订《药品管理法》中假劣药法律责任的条款综合运用了多种处罚措施，大幅提高了罚款的额度，区分生产、批发和零售劣药的情形并分别设定了不同的处罚幅度，适当降低了生产销售不符合药品标准中药饮片的处罚幅度，增加了违反药品管理秩序罚则且处罚幅度与假劣药相当，对严重违法行为实行“双罚制”并处罚到人，明确了药品使用单位使用假劣药的处罚，增加了生产、销售假劣药从重处罚的情形，增加了首负责任制和惩罚性赔偿以保障消费者合法权益。在认定依据方面，新修订《药品管理法》删去了可不载明质量检验结论的具体情形，仅作出原则规定。新修订《药品管理法》假劣药相关条款对执法的挑战与影响包括如何对假药定义中“成份”的理解、如何区分变质的药品和被污染的药品、未经批准的行为如何查处、假劣药案件是否均需出具药品检验报告、如何理解尚不影响安全性和有效性的情形、假劣药的行刑衔接等。笔者建议进一步加大普法的力度，尽快出台新修订《药品管理法》释义，明确立法原意，指导基层执法；尽快出台《刑法修正案（十一）》，增加对违反药品管理秩序的违法行为的罪名，做好行刑衔接，严厉打击药品领域违法犯罪行为，促进依法行政。 |
| ABSTRACT： | OBJECTIVE：To provide reference for further clarifying the definition of counterfeit and inferior drugs and law enforcement for revelent departments ，and guaranteeing the safety of drug use and legitimate right for the public. METHODS ： Through comparative research ，literature research and interpretation of the new law ，comprehensive analysis and research was conducted for the relevant provisions of counterfeit and inferior drugs in the newly revised Drug Administration Law in respect of the definition ，penalty rules and identification basis of counterfeit and inferior drugs. The challenges and impacts of these changes on drug law enforcement were put forward from the perspective of drug law enforcement practice. RESULTS & CONCLUSIONS ： In terms of definition ，the newly revised Drug Administration Law redefined the counterfeit and inferior drugs ，which was reduced from 15 cases before the amendment to 11 kinds，but the content was more abundant. It cancelled the concept of punishing counterfeit and inferior drugs ；increased the prohibition of the use of counterfeit and inferior drugs ；punished violation behavior of drug administration order not according to counterfeit and inferior drugs ；removed two items that being punished as counterfeit drugs；adjusted the definition of contaminated drugs from counterfeit drugs to inferior drugs ；clarified the definition of excipients. In terms of penalty provisions ，the provisions of legal liability for counterfeit and inferior drugs in the newly revised Drug Administration Law comprehensively used a variety of punishment measures ，greatly increased the amount of fine ；differentiated the situation of production ，wholesale and retail of inferior drugs ，and set different punishment ranges ；appropriately reduced the punishment range of producing and selling TCM decoction pieces that did not meet the drug standards ；increased the punishment for the violation of drug management order ，and the scope of punishment was similar to that of counterfeit and inferior @qq.com drugs. The “double penalty system ”was implemented for serious illegal acts and punished to individuals. The punishment for drug users who used counterfeit and inferior drugs was clarified. The situation of heavier punishment for producing and selling counterfeit and inferior drugs was increased ，and the first responsibility system and punitive compensation were added to protect the legitimate rights and interests of consumers. In terms of identification basis ，the newly revised Drug Administration Law had deleted the provisions that specific situation of quality inspection conclusion may not be specified ，and only provided the principle provisions. The challenges and impacts of the newly revised Drug Administration Law on law enforcement included how to understand the “ingredients”in the definition of counterfeit drugs；how to distinguish between deteriorated drugs and contaminated drugs ；how to investigate and deal with unauthorized acts ； whether drug inspection reports were required in all cases of counterfeit and inferior drugs ；how to understand the situation that did not affect the safety and effectiveness ，and connecting administrative law enforcement with criminal justice for counterfeit and inferior drugs ，etc. It is suggested to further strengthen the law popularization ，and introduce the interpretation of the newly revised Drug Administration Law as soon as possible ，clarify the legislative intent ，and guide the grassroots law enforcement ；issue Amendment Ⅺ to the Criminal Law of the People ’s Republic of China as soon as possible ，increase the charges of illegal acts against the order of drug administration ，do a good job in connecting administrative law enforcement with criminal justice and crack down on the illegal and criminal acts in the field of drugs ，and further promote the administration according to law. |
| 期刊： | 2020年第31卷第17期 |
| 作者： | 梁云，邵蓉 |
| AUTHORS： | LIANG Yun ，SHAO Rong |
| 关键字： | 药品管理法；新修订；假药；劣药；定义；罚则；认定依据；执法；用药安全 |
| KEYWORDS： | Drug Administration Law ；Newly revised ；Counterfeit drugs ；Inferior drugs ；Definition；Penalty provisions ； |
| 阅读数： | 753 次 |
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