谁来上报药品不良反应 Who will report to the adverse drug reaction

　　一个问题让人深思，当一家药企发现本公司的药品存在大量不良反应时，会不会采取各种方法进行掩盖？

A problem let people thinking，When a medicine found that the company's drug high presence of adverse reactions，Will take all kinds of methods for cover？

　　上述一家外资药企的高管告诉记者，基本上大的药企都有一个全球范围内的药品不良反应监测平台，但这个平台是封闭的，在公司内部有着严格的权限限定，对外是不公开的。如果企业真的要掩盖某些事实，在这个层面上可以做到。

The above a foreign medicine enterprises executives told reporters，Basically big medicine enterprises have a global adverse drug reaction monitoring platform，But this platform is closed，Within the company has strict authority limit，Foreign is not open。If the enterprise really to hide some facts，In this level can do it。

　　“但是，在欧美国家，不仅企业要进行药物不良反应的上报，医疗机构、患者都可以进行上报，如果企业瞒报而医疗机构和患者将相关信息报给了监管部门，那么企业将受到非常严厉的处罚。”该外资药企的高管说。

“but，In the European and American countries，Not only enterprise must carry on the reported adverse drug reactions，Medical institutions、Patients can be reported，If the enterprise conceal and medical institutions and patients will offer relevant information on the supervision department，So enterprise will be very severe punishment。”The foreign capital enterprise executives said the drug。

　　从全球范围看，欧美国家对药物不良反应上报的要求是强制性的，其中欧盟的要求最严格，处罚也最为严厉。

Around the world to see，European and American countries for adverse drug reactions reported requirements are mandatory，Among them the most strict requirements of the European Union，Also most severe punishment。

　　不过在一家合资药企的总监看来，在国外，绝大多数的药物不良反应都是由企业上报，所以，如果企业真的敢冒这个风险去掩盖不良事件，监管部门也不可能迅速发现。但好在处罚力度都很大，所以绝大多数企业不敢这么做。

But in a joint venture enterprises of the governor's seems to medicine，In foreign，Most of the adverse drug reactions are reported by the enterprise，so，If the enterprise really dare to take the risk to cover up the adverse events，Regulators also not can quickly find。But the punishment that are very big，So most of the enterprise can't do that。

　　今年就有两家跨国药企被处以巨额罚款。6月，强生因隐瞒药物风险被罚22亿美元；7月葛兰素史克因非法营销处方药物被罚30亿美元。

This year will have the two international medicine enterprises were fined a hefty fine。June，Johnson for concealing risk is a $2.2 billion fine；July ShiKeYin glaxo illegal marketing prescription drugs was fined 3 billion dollars。

　　“在中国，情况就不一样了。”这位总监告诉记者，我国对药物不良反应的监测开展得很晚，而且出于各种原因考虑，采取的是自愿上报原则，企业不愿上报，医院也没动力上报。

“In China，Things are different。”The director told reporters，Our country to adverse drug reaction monitoring develops very late，And for all sorts of reasons to consider，The report is to take voluntary principles，Enterprise is not willing to report，Hospitals also didn't report to power。

　　1999年，我国开始筹建药物不良反应监测体系。当年12月公布了《药品不良反应监测管理办法》，但只是一个原则性的规定，没有配套法规。

1999 years，China began to preparation adverse drug reaction monitoring system。That year December announced《Adverse drug reaction monitoring management approach》，But just a big regulations，No matching regulations。

　　2004年3月4日，卫生部、国家食品药品监督管理局发布《药品不良反应和监测管理办法》，其第一章第五条写道：国家鼓励有关单位和个人报告药品不良反应。对那些隐瞒不良反应报告的，仅处以1000元以上30000元以下的罚款。

On March 4, 2004，health、Issued by the state food and drug administration《The adverse drug reaction monitoring and management methods》，The first chapter article 5 wrote：The state shall encourage units and individuals concerned report adverse drug reaction。For those who hide adverse reaction of the report，Only be fined between 1000 yuan and 30000 yuan of the following amerce。

　　2010年12月，《药品不良反应报告和监测管理办法》进行了修订，并于2011年7月1日起施行。

December 2010，《The adverse drug reaction monitoring report and management methods》Were revised，And in 2011, July 1,。

　　在这个新修订的办法中，依然是“国家鼓励公民、法人和其他组织报告药品不良反应。”处罚力度有所加强，比如并处5000元以上30000元以下的罚款，严重的会不再予以注册。

In this new revision of the measures，Is still“The state encourages citizens、Legal persons and other organizations report adverse drug reaction。”The punishment was strengthened，Such as concurrently be 5000 yuan of above 30000 yuan of the following amerce，Serious will no longer be registered。

　　由于国家的原则是鼓励上报药品不良反应，客观上造成了我国不良反应报告的先天性不足。

Because the principle of state is to encourage reported adverse drug reaction，Objective in China report adverse reactions caused by lack of congenital。

　　按照世界卫生组织的要求，每100万个病例的不良反应报告不应少于300份，严重不良反应报告则不低于30%。

According to the world health organization's requirements，Every 1 million cases of adverse reaction reports should not be less than 300 copies，Serious adverse reactions report is no less than 30%。

　　来自国家药品不良反应监测中心的数据显示，2002年共收到报告1.7万份， 2005年达到17.3万份，2010年，这个数字则达到85.28万份。

From the national adverse drug reaction monitoring center figures show，2002 a total of 17000 received the report， 2005 up to 173000 copies，2010 years，This number is up to 852800 copies。

　　从2011年的数据看，每百万人口平均病例报告数量637份，已经超过世界卫生组织的要求，但其中新的和严重不良反应(事件)报告数量145769份，占同期报告总数的17.1%，与世界卫生组织的要求相距甚远。

From 2011 years of data to see，Every population average case report the number of 637 copies，Have more than the world health organization's requirements，But among them new and serious adverse reactions(events)Report the number of 145769 copies，Accounting for 17.1% of the total number of reported in the same period，And the world health organization requirements ahead。

　　“不良反应报告的价值就在于其中严重不良反应的比例，这是真正衡量一个药品安全性的关键指标，但我国的不良反应报告价值太低。”孙忠实说，医院在遇到严重不良反应的时候往往不敢上报，害怕患者因此来闹事，而企业更不愿意上报本公司药品的不良反应数据。

“Adverse reaction of the value of the report is that the proportion of serious adverse reactions，This is the true measure of a drug safety of key indicator，But China's adverse reaction report value is too low。”He said the faithful，The hospital with serious adverse reactions are not reported，Fear of patients so to trouble，And enterprise more reluctant to report to the company drug adverse reaction of data。

　　从来源上看，2011年，我国不良反应报告中来自医疗机构的占83.1%，来自药品生产、经营企业的占13.7%，来自个人的报告占3.2%。

Look from the source，2011 years，Our country adverse reactions in the report from the medical institutions accounted for 83.1%，From drug production、Business enterprise accounted for 13.7%，The report from the personal accounts for 3.2%。

　　而在欧美国家，来自企业的不良反应报告基本占到80%。

And in Europe and the United States，From enterprise adverse reaction of basic report accounted for 80%。

　　“全球不良反应报告也仅仅是冰山一角，可能只占实际不良反应的5%，很多药品不是没有不良反应，而是我们根本不知道。”孙忠实说，国外每年都要枪毙几十种药品，绝大部分还是企业主动要求的，而我国一个都没有。

“Global adverse reaction report also is only the tip of the iceberg，May account for only 5% of the actual adverse reaction，Many drug is not without adverse reactions，But we don't know。”He said the faithful，Abroad every year shot dozens of drugs，Most of the or enterprise active request，And our country not a one。

　　不过，国家食品药品监督管理局在没有公示任何有关罗氏公司产品在中国的不良反应报告数据，就两次表态“未见异常情况”。

but，The state food and drug administration in no public any relevant roche products in China adverse reactions report data，Just two comment“Has not seen the abnormal situation”。

　　刘俊海说，如果药监局要下结论，就应该公示详实的数据，在目前大量数据细节都没有公开的情况下，这样的表态太轻率。

LiuJunHai said，If the administration's will to conclusions，Should public detailed data，In the present details are not public huge amounts of data，Such a statement is imprudent。

　　在刘俊海看来，从对公众负责的角度看，应该把自愿上报药品不良反应的制度改为强制性制度，在这个问题上不能仅仅靠企业自愿和良心发现，要靠法律强制、舆论监督，如果有企业敢漏报就要定性为瞒报，就要处罚得该企业倾家荡产。(记者 李松涛)

In LiuJunHai seems，From the point of view of responsible for the public，Should the voluntary reporting adverse drug reaction system to the compulsory system，In this problem can't just rely on enterprise voluntary and conscience found，Want to rely on law enforcement、Supervision by public opinion，If there is a enterprise can omission will withhold the qualitative for，Will punishment to the enterprise's purse。(Reporter LiSongTao)