泰和泰研析丨两高《关于办理危害药品安全刑事案件适用法律若干问题的解释》（2022）中与药企打击假劣药工作相关的要点
2019年《药品管理法》做了较大的修订，其中对“假药”的认定转向了实质性认定标准（以药品的质量功效为标准），这进一步改变了药品行业市场监督管理的格局。受《药品管理法》影响，2020年《刑法修正案（十一）》也对《刑法》第一百四十一条和一百四十二条做了修正。修正后的刑法第一百四十一条罪名调整为“生产、销售、提供假药罪”，第一百四十二条调整为“生产、销售、提供劣药罪”，同时增加了一百四十二条之一“妨害药品管理罪”。要正确适用《刑法修正案（十一）》，亟需对如何鉴定“假劣药”、什么是“对人体健康造成严重危害”、何为“提供”等重要概念进行解释。2022年2月28日，最高人民检察院、最高人民法院《关于办理危害药品安全刑事案件适用法律若干问题的解释》（以下简称“《司法解释》”）正式发布，回应了修正后的刑法第一百四十一条和一百四十二条的法律适用问题。在此，仅就《司法解释》中与药企打击假劣药工作联系最为紧密的几个问题进行介绍。
In 2019, the Drug Administration Law of the PRC was made major amendments, in which the determination of “counterfeit drug” was replaced by the standard of substantive identification, namely by the standard of quality and efficacy. The market supervision and management of drugs was therefore leaded to another direction. In 2020, in accordance with the Drug Administration Law 2019, the Article 141 and Article 142 of the Criminal Law of the PRC were amended by the Amendment (XI) to the Criminal Law of the PRC. The crime name in Article 141 of the Criminal Law 2020 was amended to “Crime of Producing, Selling or Providing Counterfeit Drugs”. In Article 142, the crime name was amended to “Crime of Producing, Selling or Providing Inferior Drugs”. Meanwhile, provisions of “Crime of Impairing Drug Administration” were added in Article 142. Hence, the interpretation of “counterfeit/inferior drugs”, “serious damage to the people's health”, “providing” and other important concepts were necessary in the application of Amendment (XI) to the Criminal Law. In February 28 of 2022, the Supreme People's Procuratorate (SPP) and the Supreme People’s Court (SPC) published Interpretation of Several Issues Concerning the Application of Law in Handling Criminal Cases of Endangering Drug Safety 2020 (hereinafter referred to as “the Interpretation”), which answered questions related to the application of Article 141 and Article 142 of the Criminal Law. This article herein introduces some points in the Interpretation, which are closely related to pharmaceutical companies’ fights against the counterfeit and inferior drugs.
一、对于假药、劣药的认定规则
The Rules of Determining Counterfeit Drugs and Inferior Drugs.
《刑法修正案（十一）》第一百四十一条、一百四十二条虽然删除了假药、劣药的认定须依照《药品管理法》认定的规定，但此次《司法解释》在第十九条明确了“刑法第一百四十一条、第一百四十二条规定的‘假药’、‘劣药’，依照《药品管理法》的规定认定”，即假药、劣药基本的认定规则还是和《药品管理法》紧密挂钩。
由于实践中，对涉案药品进行司法机关认可的检验是非常困难，区分哪些情况下不需要对涉案药品进行检验、仅做事实判断就认定假、劣药显得尤为重要。
Though Article 141 and Article 142 of the Amendment (XI) to the Criminal Law delete the provision that determination of counterfeit drugs and inferior drugs must be in accordance with the definitions in the Drug Administration Law, Article 19 of the Interpretation confirms that “counterfeit drugs” and “inferior drugs” mentioned in Article 141 and Article 142 of the Criminal Law are in accordance with their definitions in the Drug Administration Law, which means the determination of “counterfeit/inferior drugs” are still linked with the Drug Administration Law.
Since it is difficult in practice to carry out the drug ingredient tests acceptable by judicial authorities, distinguishing the circumstances under which the involved drugs can be decided as “counterfeit” or “inferior” by fact-finding without testing is particularly important.
（一）通常情况下，仅需做事实认定，不需要对涉案药品进行检验的情形
The circumstances when the involved drugs can be decided by fact-finding without testing:
《司法解释》第十九条特别明确，对于以下情形，能够根据现场查货的原料、包装，结合犯罪嫌疑人、被告人供述等证据材料作出判断的，可以由地市级以上药品监督管理部分出具认定意见。即，下述情形通常情况下仅需要做事实认定，不需要对涉案药品进行检验。
1.以非药品冒充药品或者以他种药品冒充此种药品（如用面粉冒充药品，在制药现场发现面粉而无其他药品原料的；及以感冒药冒充治疗高血压的药品的）；
2.药品所标明的适应症或者功能主治超出规定范围。
1.未标明或者更改有效期的药品；
2.未注明或者更改产品批号的药品；
3.超过有效期的药品；
4.擅自添加防腐剂、辅料的药品。
Article 19 of the Interpretation confirms that, under following circumstances, if it is possible to make a judgment based on the raw materials and packaging of the goods seized on site, combined with the evidence such as the confession of the criminal suspects or the defendants, a determination opinion could be issued by a drug supervision and management department at or above the prefecture level.
Cases of Counterfeit Drugs:
1.Passing non-drugs off as medicines or passing other medicines off as such medicines (for example: passing flour off as medicines, when no pharmaceutical raw materials but flour is found on site; passing cold medicine off as anti-hypertensive drugs);
2.The indications or functions indicated on the drugs are beyond the prescribed scope.
Cases of Inferior Drugs:
1.Drugs with no indications or changed indications of expiry date;
2.Drugs with no indications or changed indications of batch number;
3.Drugs that have expired;
4.Drugs that are added with preservatives and excipients without permission.
（二）需要对涉案药品进行检验的情形
The circumstances when the involved drugs must be tested:
对于以下情形或者对于上述（一）情况中的假药、劣药认定存在争议的，《司法解释》第十九条则要求应当由省级以上药品监督管理部门设置或者确定的药品检验机构进行检验，出具质量检验结论，即需要对涉案药品进行检验。
1.药品所含成份与国家药品标准规定的成份不符；
2.变质的药品。
1.药品成份的含量不符合国家药品标准；
2.被污染的药品；
3.其他不符合药品标准的药品。
Under the following circumstances or disputes concerning the determination of counterfeit or inferior drugs remain in the above-mentioned circumstances, Article 19 of the Interpretation required that the involved drugs must be tested by a drug inspection institution set up or recognized by a drug supervision and management department at or above the provincial level - in brief the test of involved drugs are required.
Cases of Counterfeit Drugs:
1.The pharmaceutical ingredients contained in the drug do not conform to the ingredients specified in the National Drug Standards;
2.Spoiled drugs.
Cases of Inferior Drugs:
1.The content of pharmaceutical ingredients contained in the drug does not meet the National Drug Standards;
2.Contaminated drugs;
3.Other drugs that do not meet the National Drug Standards.
二、妨害药品管理罪中与违法生产、加工药品的“黑窝点”相关的定罪量刑标准
Standards of Crime and Penalty Determination Related to "Criminal Joint" Illegally Producing and Processing Drugs in the Crime of Impairing Drug Administration:
在《刑法修正案（十一）》发布前，违法生产、加工药品的“黑窝点”主要适用的罪名是“生产、销售假药罪”及“生产、销售劣药罪”。由于《药品管理法》中“假药”定义的变化，部分“黑窝点”所涉违法情形改由《刑法修正案（十一）》新增的第一百四十二条之一妨害药品管理罪来规制。以下详细列举该罪名中与“黑窝点”的五个定罪及量刑标准：
相较于之前《刑法》将上述行为纳入生产、销售假药罪等罪名的做法，妨害药品管理罪明显无论在量刑梯度和最高刑等方面都弱了很多，给打击违法生产、加工药品的“黑窝点”带来了很大的考验。
Before the Amendment (XI) to the Criminal Law, the criminal joints illegally producing and processing drugs were mainly charged by the crime of producing and selling counterfeit drugs and the crime of producing and selling inferior drugs. Since the definition of “counterfeit drugs” in the Drug Administration Law was amended, part of the illegal conducts of criminal joints should be ruled by the crime of impairing drug administration, which was added in Article 142 of the Criminal Law by the Amendment (XI) to the Criminal Law. The following is a detailed list of five standards in determining the crime and penalty of the criminal joint when committing the crime of Article 142:
Compared with the previous Criminal Law which included the above-mentioned conducts into the crimes of producing and selling counterfeit drugs, the crime of impairing drug administration was obviously weaker not only in the gradient of punishment but also in the maximum punishment. It hence brought a great challenge to fight against the "criminal joint" of illegally producing and processing drugs.
三、关于生产、销售、提供等行为的认定
The determinations of the acts of producing, selling and providing.
（一）“销售”和“提供”行为的区分
The differences between the act of “selling” and “providing”:
《刑法修正案（十一）》增加了提供假药和劣药的罪名，一定程度上进一步限制了假药、劣药在市场上的流通。此次《司法解释》就如何区分销售和提供行为进行了说明。《司法解释》第六条二款规定药品使用单位及其工作人员明知是假药、劣药而有偿提供给他人使用的，应当认定为“销售”行为；无偿提供给他人使用的属于“提供”。即，以交易中获取假劣药的相对方是否支付对价来区分“销售”和“提供”行为。
The crime of providing counterfeit drugs and inferior drugs were added in the Amendment (XI) to the Criminal Law, which restricts the circulation of counterfeit and inferior drugs in the market to some extent. The Interpretation explained the differences between the act of “selling” and “providing”. In the Article 6(2) of The Interpretation, it is stipulated that: if the drug owners and their staff knowingly provide counterfeit and inferior drugs for use by others with consideration, it is an act of “selling”; if they provide for use by others without consideration, it is an act of “providing”. In other words, distinguishing between "selling" and "providing" is based on whether the counterparty pays consideration when obtaining counterfeit and inferior drugs.
（二）“生产”的认定
The determination of “producing”:
《司法解释》第六条规定，以生产、销售、提供假药、劣药为目的，合成、精制、提取、储存、加工炮制药品原料，或者在将药品原料、辅料、包装材料制成成品过程中，进行配料、混合、制剂、储存、包装的，应当认定为刑法第一百四十一条、第一百四十二条规定的“生产”。前述规定基本保留了原《司法解释》第六条第二款第一、二项的内容，没有特别大的变化。
Article 6 of the Interpretation stipulates that, with the purpose of producing, selling and providing counterfeit and inferior drugs, synthesizing, refining, extracting, storing, processing and processing pharmaceutical raw materials, or batching, mixing, making preparations, storing, and packaging in the process of making pharmaceutical raw materials, excipients, and packaging materials into finished products should be determined as the act of “producing” in accordance with Article 141 and Article 142 of the Criminal Law. The above-mentioned provision reserves the contents of Article 6(2)[1][2] of the previous Interpretation (2014) with minor changes.
（三）对违反国家规定，提供原、辅料的上游供应商的刑法规制
Regulations on upstream supplier who provide raw materials and excipients in violation of State regulations:
符合药用要求的原料、辅料的上游违法行为，之前的司法解释规定“情节严重的，依照非法经营罪定罪处罚”，但本次《司法解释》明确了“符合刑法第一百四十条规定的，以生产、销售伪劣产品从重处罚”。对违法的上游原料、辅料供应商适用的罪名进行了调整。
Regarding upstream providing raw materials and excipients which meet the requirements of pharmaceutical use, the previous Interpretation (2014) stipulated that “if the circumstances are serious, it should be convicted and punished according to the crime of illegal business operations”. However, the Interpretation (2022) confirms “if the circumstance meets the provision of Article 140 of the Criminal Law, it should be given a heavier punishment for the crime of producing or selling fake or shoddy products”. The crime of the upstream supplying raw materials and excipients is hereof adjusted.
（四）对生产、销售、提供假劣药罪及妨害药品管理罪的主观故意的认定
The determination of the subjective intentions in the crime of producing, selling and providing counterfeit/inferior drugs and that in the crime of impairing drug administration:
在药品犯罪（尤其是销售、提供假劣药罪）中，犯罪嫌疑人为脱罪经常会否认其犯罪的主观故意，本次《司法解释》特别明确了以下几种足以认定其具有主观故意的情形，给推定“故意”提供了指导：
a.药品价格明显异于市场价格的;
b.向不具有资质的生产者、销售者购买药品，且不能提供合法有效的来历证明的;
c.逃避、抗拒监督检查的;
d.转移、隐匿、销毁涉案药品、进销货记录的;
e.曾因实施危害药品安全违法犯罪行为受过处罚，又实施同类行为的;
f.其他足以认定行为人主观故意的情形。
In the crimes of endangering drug safety, especially the crime of selling and providing counterfeit/inferior drugs, the suspects often deny their subjective intentions of the crime for defending. The Interpretation particularly affirms the following situations are sufficient to determine the existence of subjective intentions, which provides guidance on presumption of “intension”:
a.The price of the involved drug is significantly different from the market price;
b.Purchasing drugs from unqualified manufacturers and sellers, and failing to provide legal and valid proof of source;
c.Evading or resisting supervision and inspection;
d.Transferring, concealing and destroying the involved drugs and the records of purchasing and selling;
e.Ever been punished for committing crimes of endangering drug safety, and committing similar crimes again;
f.Other circumstances sufficient to determine the subjective intention of the actors.
总体来说，此次《司法解释》给《刑法修正案（十一）》中药品安全犯罪法律适用进行了较为详细的解释，也为因《药品管理法》大改而产生的打击假劣药困境指明了方向。
In general, the Interpretation brings a more detailed explanation on the legal application of crimes of endangering drug safety in the Amendment (XI) to the Criminal Law, and also indicates possible solutions to the disputes caused by the major amendment of the Drug Administration Law.
作者简介
刘莹 律师
业务领域：知识产权、争议解决等
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