Page 7 - 2020年17期

·药事管理·

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 Δ

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＊
梁 云 ，邵 蓉（中国药科大学国家药物政策与医药产业经济研究中心，南京 211198）
中图分类号 R951 文献标志码 A 文章编号 1001-0408（2020）17-2049-06
DOI 10.6039/j.issn.1001-0408.2020.17.01

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。
关键词 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

Study on Main Changes of Counterfeit and Inferior Drugs’Relevant Provisions in the Newly Revised Drug
Administration Law and Their Impact on Law Enforcement
LIANG Yun，SHAO Rong（National Drug Policy and Medical Industry Economy Research Center of China
Pharmaceutical University，Nanjing 211198，China）

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
Δ 基金项目：国家社会科学基金重大项目（No.15ZDB167）
punishment was similar to that of counterfeit and inferior
＊博士研究生。研究方向：医药政策与法规。E-mail：20239712
@qq.com drugs. The “double penalty system” was implemented for
# 通信作者：教授，博士生导师，博士。研究方向：医药政策与法 serious illegal acts and punished to individuals. The
规。E-mail：shaorong118@163.com punishment for drug users who used counterfeit and inferior

中国药房 2020年第31卷第17期 China Pharmacy 2020 Vol. 31 No. 17 ·2049 ·