制假药为何“有贩毒的利润，无贩毒的风险” Counterfeiting medicine why“A drug trafficking profits，Without the risk of drug trafficking”

早些年，制假药的通用原则是“安全无效”；近年来，不仅“无效”，甚至“有害”！ In earlier years，The general principle is producing medicine“Safety invalid”；In recent years，Not only“invalid”，even“harmful”！

中国医药企业管理协会会长 于明德 China pharmaceutical enterprise management association YuMingDe

　　8月5日，公安部发布消息，31省区市公安机关开展统一收网行动，缴获各类假冒伪劣药品2.05亿片，涉案价值11.6亿元，抓获犯罪嫌疑人1900多名，捣毁制假售假窝点1100多个。

August 5,，The ministry said in a news release，31 provincial public security organs carry out united to draw the net in action，All kinds of fake drugs captured 205 million pieces，Involving the value of 1.16 billion yuan，The criminal suspect arrested more than 1900，Destroyed more than 1100 counterfeit shelter。

　　2.05亿片假药，数字惊人吗？不，不算多。

205 million piece of fake drugs，Digital amazing?？Don't，Isn't much。

　　近年来，药品制假案件已在全国遍地开花，无论经济发达与否，各大省区市都无一幸免，只要有药品，就有假药，只要有药厂，就有制假。

In recent years，Drug counterfeiting cases in the country has blossom everywhere，Whether developed or not，All these are none escape by luck，As long as there are drugs，Have fake drugs，As long as there is pharmaceutical companies，Have counterfeiting。

　　不法分子的制假手段也在逐年升级。早些年，制假手法多是换换标签，把低价药换成高价药；或是减少有效成分，添加淀粉等无害成分，以增加药品数量；再或者以次充好，用药效较差的低价成分替换药效较好的高价成分，从中牟利。总体来说，制假的通用原则是“安全无效”，这也是规避严厉处罚的一种手段。

Outlaws of the counterfeiting means upgrading year by year。In earlier years，Counterfeiting technique is more change tags，High prices for the low medicine medicine；Or reduce the effective component，Add ingredients such as starch harmless，To increase the number of drugs；Then or shoddy，With effect of poor low-cost component replacement efficacy good high composition，Profiting from。overall，The general principle is producing“Safety invalid”，This is also avoid the severe punishment of a kind of means。

　　但近年来，药品制假的性质愈发恶劣。例如，用化工用品或日用化工级别的产品代替药用级别的产品，以此非法牟利，毒胶囊事件就是典型案例。甚至有不法分子收购真药包装材料，利用低档原料药、过期药等自行灌装、勾兑，生产成假药。还有制假者为增强药效，添加国家严令禁止、严重危害人体健康的化学成分，制假猖獗之风由此可见一斑。

But in recent years，The nature of the drug counterfeiting increasingly harsh。For example，With chemical products or daily chemical levels of products instead of medicinal level of product，To profit illegally，Poison capsule is the typical case events。Or even illegal elements really medicine packing material purchase，Use cheap API、Outdated drugs to filling、blending，Production into fake drugs。And to enhance counterfeiters were effects，Add countries enforce its ban on、Serious harm human body health chemical composition，The wind of rampant counterfeiting this shows one spot。

　　制假种类也在不断扩大，从处方药到保健药，从口服片剂到注射针剂，从中草药到西药，从国产药到进口药，可谓应有尽有，此类制假不仅“无效”，甚至“有害”，制假后果更为严重，甚至直接危害服用者的生命。

The kind of producing expanded，From health care medicine to prescription drugs，From an oral pill to injection，From Chinese herbal medicine to western medicine，From domestic medicine to haart，Everything is，Such counterfeiting not only“invalid”，even“harmful”，Producing more serious consequences，Even immediate harm the life of a person。

　　制假之风屡禁不止，我认为，制假药入罪量刑过轻，违法成本过低纵容了不法分子的侥幸心理，“重典治乱”刻不容缓。

The wind of counterfeiting long-standing，I think，The sentencing of the sin of producing medicine is too light，Illegal low cost for perpetuating outlaws of luck，“Heavy revolution Canon”urgent。

　　按照我国刑法规定，未造成严重危害人体健康的制售假药违法犯罪分子只能处以3年以下刑期，刑期短且缓刑的几率非常高，所以制假药被称为“有贩毒的利润，没有贩毒的风险”。

According to the provisions of the criminal law，Not cause serious harm human health and the illegal criminals can only a fake three years in prison，Short term and risk of probation is very high，So producing medicine is called“A drug trafficking profits，Without the risk of drug trafficking”。

　　另外，我国药典制定并不完善，尤其在辅料成分的相关标准上欠缺很多。据统计，助剂、溶剂等辅料成分共有500多种，但有标准的不足200种，半数以上处于灰色地带，所以问题药品多在辅料上做手脚，但在法律判定上，辅料出问题又往往无法可依，导致现行法律法规与实际执法环境脱节，刑事执法操作难。

In addition，China pharmacopoeia make not perfect，Especially in the composition of the material related standards on many lack。According to the statistics，additives、Solvents and other accessories composition of 500，But has a standard of less than 200 kinds，More than half in the gray zone，So the question in the drug accessories beforehand，But the judge in the law，Accessories and tend to be problems can depend on，Lead to existing laws and regulations, and the actual law enforcement disconnected environment，Criminal law enforcement operation is difficult。

　　从监管角度看，药品监管体系制度漏洞明显，造假行为被一再隐瞒和纵容。从2008年起，药品监管体制从“中央垂直管理”变为“地方负责、部门协管”，各级药品监管部门由地方政府负总责，国家药监局由“领导”变为“指导”。

From the perspective of supervision，Drug regulatory system system vulnerabilities obvious，Frauds have been hide and indulgence。Since 2008，From drug regulatory system“The central vertical management”into“Place is responsible for、Department assistant”，Drug regulators at all levels by the local government overall responsibility，The administration's country by“leadership”into“guidance”。

　　从积极层面看，“地方负责”便于监管到位，缓解各级权责矛盾，但从负面作用看，“地方负责”削弱了监管效力，在地方保护主义盛行的大环境下，各级药品监管部门难以发挥作用。

Perspectives on the positive，“Place is responsible for”Facilitate supervision in place，Ease responsibilities contradiction at all levels，But from the negative effect to see，“Place is responsible for”Weakened regulatory effect，In the local protectionism in the environment，Drug regulators at all levels to play a role。

　　药品制假与其他行业的制假不同，正规厂商也常参与其中，成为“制假大户”。在医药制度不合理，药品价格被无休止压低的情况下，正规厂商也面临“逼良为娼”的风险。

Drug counterfeiting and other industry of producing different，Normal manufacturer also often involved，become“Of producing a large”。In the medical system is not reasonable，Drug prices were down endless，Normal manufacturer also face“BiLiangWeiChang”risk。

　　近年来，我国逐步实行集中招投标的药品采购制度，价格成为决定药品畅销与否的关键因素，甚至成为药品企业生存的重要砝码，降低成本成为所有制药企业共同面临的突出问题，一旦降低成本的压力被传递到原材料的环节，假冒伪劣就必然会出现。

In recent years，Our country has the centralized drug purchasing system of bidding，Prices have become a drug sold or not the key decision factors，Even become the important drug enterprise survival farmar，Reduce the cost be all pharmaceutical enterprise jointly with the problems，Once the lower costs are passed to the raw material of the link，Fake will inevitably will appear。

　　因此，从根本原因上下手，完善法律法规，改革医药监管体系，调整药品采购制度才是打击假冒伪劣药品的有力武器。(《中国经济周刊》记者李妍采访整理)

so，The basic reason from the start，The perfect legal laws and regulations，Reform medical supervision system，Adjust the drug procurement system is the stroke counterfeit false and inferior drugs of powerful weapon。(《China's economic weekly》Reporter LiYan interview arrangement)