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外国药企热衷在中国开展人体试验 分析称因赔偿低--亲稳舆论引导监测室
2013-02-22

  据中国之声《新闻纵横》报道,据《中国青年报》两年前的报道,我国每年有800多种新药进行人体试验,涉及人群约50万人。北京大学医学部卫生法学教研室主任王岳教授说,这其中有相当一部分人体试验来自发达国家的医药公司。

According to the sound of China[News aspect]reports,According to[The China youth daily]Reports of two years ago,Every year in China has more than 800 kinds of new drugs for human trials,About 500000 people in the crowd.Beijing university department of medicine health law professor, director of the teaching and research section WangYue said,There are quite a few human trials pharmaceutical companies from developed countries.

  王岳:这些年,很多外资企业都把中国作为药物临床试验的一个重要的地点,一些发展中国家都有相似的问题。美国国家卫生研究院他有一个统计数字,在美国药物临床试验中,甚至能达到80%都是在发展中国家去实施的。这个是应该引起我们主管部门重视的一个问题。

WangYue:these,A lot of foreign companies in China as a drug clinical trial is an important place,Some developing countries have similar problems.The national institutes of health he has a statistics,In the United States drug clinical trials,Can even reach 80% of them in developing countries to implementation.This is caused by the competent department in charge of our attention should be a problem.

  王岳教授表示,外国药企纷纷在中国开展临床试验,一方面是出于进军中国市场的需求,另一方面则是出于成本考虑。

WangYue professor said,Foreign medicine enterprises in China are in clinical trials,On the one hand is from to enter the Chinese market demand,On the other hand is due to the cost consideration.

  王岳:国内有一个非常大的问题,就是我们的民事赔偿是一个以补偿为原则的,它的标准非常低。

WangYue:China has a very big problem,Is our civil compensation is a compensation for the principle of,The standard is very low.

  全国卫生产业企业管理协会常务副秘书长范浩信在接收新华社记者采访时表示,外国药企选择中国作为临床试验基地,还与中国受试者缺乏维权知识和意识有关,尤其在农村地区,加之国内对药品临床试验的监管力度明显不及欧美国家,导致药企对试验不良后果所承担的成本大大降低。

National health industry enterprises management association executive vice secretary general FanHaoXin in receiving the xinhua news agency reporter to interview said,Foreign medicine enterprises choose China as clinical test base,Also with the Chinese subjects lack of rights protection knowledge and consciousness about,Especially in rural areas,Together with the domestic drug clinical trials for the supervision of significantly less than the European and American countries,Lead to drug to the test negative consequences to greatly reduce the cost.

  事实上,类似拜耳集团人体试验的纠纷并不少见。比如2007年,癌症患者王丽英在服用美国辉瑞公司的试验药物仅仅一个月后就宣告死亡。北京市海淀区人民法院在2011年判决,试验药物与患者死亡之间存在主要因果关系,判决辉瑞公司赔偿人民币30万元。

In fact,Similar bayer group human trials of the dispute is not rare.In 2007, for example,WangLiYing cancer patients taking the Pfizer's test drugs only after a month is declared dead.Beijing's haidian district people's court decision in 2011,Test drugs and patients died between the main causal relationship,Judgment Pfizer compensation of RMB 300000 yuan.

  2003年,34名艾滋病患者参与了地坛医院的一项美国药物试验时,6个月的观察期内4人死亡。患者到底在接受试验前是否完全知情?几位患者的死亡与新药试验之间有着怎样的关系?曾经一度引发巨大争议。

In 2003,,34 patients with HIV/AIDS in ditan hospital of an American drug tests,6 months during observation period four people were killed.The patients accept before the test was fully informed?A few patients of death and new drug test are what kind of relationship?Once caused great controversy.

  如果没有药物的临床试验,就不会有新药研发的成功和科技的进步。这一点毋庸置疑,但在这个工程中怎样保护受试者的利益?北京大学医学部卫生法学教研室主任王岳教授认为,伦理委员会加强审查和专业人士的辅助必不可少。

If there is no drug clinical trial,There can be no new drug research and development success and the progress of science and technology.No doubt about that,But in this project how to protect the interests of the participants?Beijing university department of medicine health law professor, director of the teaching and research section WangYue think,To strengthen the ethics committee review and professional auxiliary indispensable.

  王岳:受试者的权益保护目前还是一个信息不对称的问题,往往受试者并不了解药物的危害性。比较好的方法一个是加强伦理委员会的审查,另外一方面呢在受试者签署知情同意书的过程中,建议有专业人士来辅助受试者。应该有相应的专业的医生,包括律师,去给这些受试者一些帮助。

WangYue:Participants' rights protection is still an information asymmetry problem,Often subjects do not understand the dangers of drugs.A better method is to strengthen ethics committee review,On the other hand it in participants signed consent to familiar with the process,Suggestions have professionals to assist participants.There should be a corresponding professional doctor,Including lawyer,These subjects to some help.

  面对强大的医药企业时,受试者明显处于弱势地位,一旦出现纠纷,又应该如何应对?王岳教授建议,政府应建立保障受试者权益的代理诉讼制度,保护和保障受试者的相关权益,起到对制药企业的震慑作用。

In the face of strong medicine, the enterprise,Subjects were obvious at a disadvantage,When occurrence dispute,And should be how to deal with?WangYue professor suggested,The government shall establish security subjects of rights and lawsuit system,To protect and safeguard the rights of the subjects,Responsible for the pharmaceutical enterprise deterrent effect.

  王岳:个体的受试者和强大的制药企业之间往往在对抗过程中,他们没有这种对抗的能力。政府应该作为受试者利益的代言人,比如由国家药监局,由政府出面作为这种民事诉讼的代理人,建立这样法律上的制度。我想才能从根本上起到一种震慑的作用。让制药企业更加规范的从事药物临床试验。

WangYue:Individual subjects and strong pharmaceutical enterprise are against process,They have no the ability to fight.The government should as subjects interests spokesperson,Such as the country's drug watchdog,By the government as the agent of the civil lawsuit,To establish such a legal system.I want to fundamentally act as a deterrent effect.Let the pharmaceutical enterprise more standard engaged in drug clinical trials.


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