制药企业主动报告不良反应是国际惯例 Pharmaceutical enterprise active report adverse reaction is international convention

　　在卫生部全国合理用药监测网专家孙忠实看来，罗氏公司可能是因为对这个患者援助项目还没有进行完全的评估，所以不愿意将收集到的不良反应病例向监管部门上报。不过，这也正是该公司做的不规范之处。

In the rational drug use monitoring network of health experts sun faithful opinion，Roche may be because the patients to aid projects have not been completely evaluation，So don't want to will collect to adverse reactions to report cases supervision department。but，It is the company of non-standard place。

　　“制药企业有责任、有道义主动报告药物的不良反应，这是国际惯例。”孙忠实说，从目前公开的信息来看，不要因为这15161个死亡病例恐慌，因为还没有定论证明这些死亡病例跟药物有直接联系。但这给企业敲响了警钟，应该随时对药物不良反应病例进行评估，即使是一个跨度多年的项目，也要分阶段的进行评估、上报数据，而不能封存不报。

“Pharmaceutical enterprise have responsibility、The report has a moral active drug adverse reactions，That's international practice。”He said the faithful，From the current public information and see，Don't because it 15161 cases of panic，Because is not settled yet proof that these deaths have direct contact with drugs。But this was a wake-up call to the enterprise，Should always to adverse drug reactions cases for the evaluation，Even a span of years of project，Also want to stage assessments、Report data，And not the seal。

　　美国食品药物管理局要求，新药上市3年就要做一次评估，7年就要再次进行评估。

The us food and drug administration required，New drug to market 3 years will do an assessment，7 years to evaluate again。

　　当看到罗氏隐瞒大量不良反应报告的消息时，中国人民大学商法研究所所长刘俊海说：“在没有外在压力的情况下，不论大企业还是小企业都不愿披露对自己不利的信息。”到目前，依然看不到罗氏公司披露详细信息。如果总是不披露信息的话，就涉嫌欺诈，按照我国法律，不仅要对消费者进行双倍赔偿，还要赔偿其他各种损失。

When see roche hidden mass adverse reaction when the news of the report，The people's university of China, director of commercial law LiuJunHai said：“In no external pressure，No matter big or small business enterprise are not willing to disclosure of information to its advantage。”To present，Still can't see roche detailed information disclosure。If always not to disclose information words，About the alleged fraud，According to China's laws，Not only to consumers for double compensation，And all kinds of other loss compensation。

　　在刘俊海看来，罗氏公司的做法意味着不诚信。

In LiuJunHai seems，Roche's approach means that no good faith。

　　去年，中国社科院曾经进行了一项企业社会责任的调查，结果显示，跨国公司的得分不仅低于国有企业，而且低于民营企业。

Last year，By the Chinese academy of social sciences ever conducted a survey of corporate social responsibility，The results show，Multinational company not only the score lower than state-owned enterprises，And in fact, lower than the private enterprise。

　　罗氏公司成立于1896年，目前是世界最大的生物科技公司。2010年，该公司的利润为63亿英镑。

Roche company was established in 1896，Now is the world's biggest biotech company。2010 years，The company's profits for 6.3 billion pounds。

　　此次事件并不是罗氏公司第一次涉嫌“不规范”。2010年，在中国，该公司的抗肿瘤药品安维汀就因超适应症用药引起恐慌。安维汀在国内申请的适应症是转移性直肠癌，但在国内不少医院却进行超适应症推广，用于治疗眼睛黄斑变性，上海数十位老人因此引发暂时性失明。

The incident is not the first time roche suspected“Don't regulate”。2010 years，In China，The company's antitumor drugs through the AnWeiTing indications drug use causing panic。AnWeiTing domestic application in the indications are metastatic colorectal cancer，But in some Chinese hospitals are super indications for promotion，Used in the treatment of eyes macular degeneration，Shanghai dozens of old man so cause temporary blindness。