2月21日，84岁的中国老人张祖宁告赢了总部在德国的拜耳医药保健有限公司(以下简称拜耳公司)。按照北京市朝阳区法院的判决，拜耳公司将向在试验其新药过程中差点丢了性命的张祖宁赔偿5万欧元。

On February 21,,84 - year - old Chinese old man accused Zhang Zuning won the headquarters in Germany bayer healthcare(Hereinafter referred to as bayer).According to the Beijing chaoyang district court's decision,Bayer will almost lost his life in the process of test the new medicine Zhang Zuning compensation of 50000 euros.

　　当庭聆听这一判决的，是张祖宁的儿子廖致杰，廖致杰在长达6年的索赔历程中，始终一个人在战斗。

In court to listen to the sentence,Is the son of Zhang Zuning Liao Zhijie,Liao Zhijie claim process in six years,Always a person in battle.

　　庭审结束后，他不断接待媒体采访。但对所有希望见老母亲一面的请求，他都一概拒绝。从6年前开始索赔，到目前告一段落，他始终保护风烛残年的母亲远离喧嚣的是与非。

After the trial,He continues to receive media interviews.But for all the hope to me mother's side of the request,He has refused.A claim since 6 years ago,Come to an end so far,He always protect frail mother away from the hustle and bustle is right and what is wrong.

　　“我直到前几天才和母亲说这事，我告诉她案件快判了。妈妈对我说了两句话，‘没有你的锲而不舍，就没有今天。但我后悔死了，不要再继续了’。”

"Until a couple of days ago I and my mother said it,I told her the case sentenced to fast.My mother said to me the words,‘Without your perseverance,Just not today.But I regret it dead,Don't continue to again’."

　“突发”的休克 "sudden"The shock of

　　2006年10月17日，张祖宁入住北京大学人民医院，准备做左膝的人工关节置换手术。当时，廖致杰正在外地出差。“如果我在她身边，我肯定不同意参加什么新药试验。”廖致杰说。

On October 17, 2006,Zhang Zuning in Peking University people's hospital,To make the artificial knee joint replacement surgery.At that time,Liao Zhijie was away on a business trip."If I am beside her,I certainly don't agree with what drug test."Liao Zhijie said.

　　廖致杰告诉记者，母亲要做的这种手术，主要防止出现两大问题，一是防感染，二是防血栓，所以要吃抗凝的药物。当时，医生动员张祖宁参加正在该院进行的、由拜耳公司生产的一种预防术后血栓的新药临床试验，张祖宁阅读了《患者须知》和《知情同意书》后，签字同意。

Liao Zhijie told reporters,Mother to do the surgery,Primarily to prevent two problems,One is the infection,2 it is to prevent blood clots,So eat anticoagulant drugs.At that time,The doctor mobilization Zhang Zuning attend is performed at the hospital/Produced by bayer company of a new drug clinical trials to prevent blood clots after surgery,Zhang Zuning read[Patient information]and[Informed consent]after,Sign up.

　　按照朝阳区法院民事判决书的记载，张祖宁签署的《患者须知》对试验过程进行了详细的介绍。其中载明：在第13天，我们将检查您的下肢和骨盆静脉。发现血栓的最可靠的方法是一种X线检查——静脉造影，需要通过静脉造影来评价试验药物的安全性。静脉造影可以显示下肢和骨盆的静脉，发现血栓。

In compliance with the description in the chaoyang district court civil judgment,Zhang Zuning signed[Patient information]The test process in detail introduction.Which indicate the:In 13 days,We will check your lower limbs and pelvic vein.Find the most reliable method of blood clots is a kind of X-ray - vein angiography,Through vein angiography are needed to evaluate the safety of experimental drugs.Vein angiography can show lower limbs and pelvic vein,Found thrombus.

　　对于试验新药过程中可能出现的意外，《患者须知》作了较为笼统的“承诺”：“参加试验时，我们为您进行保险，如果您想了解更详细的信息，请向我们咨询。如果您由于参加本试验受到与试验有关的伤害，保险公司会给您相应的赔付。”在其中载明的，可能发生的与造影有关的不良反应当中，包括此后在张祖宁身上真的发生了的“过敏性休克”反应。

To test new drugs in the process of accident that may occur,[Patient information]Makes a general"commitment":"In a test,We have insurance for you,If you want to know more detailed information,Please consult us.If you are related to test the damage due to participate in this test,The insurance company will give you the corresponding compensation."Therein set forth,The possibility of adverse reactions associated with angiography,Including on Zhang Zuning really happened ever since"Anaphylactic shock"reaction.

　　2006年11月7日，医院对张祖宁进行了双下肢静脉造影检查。造影结束时，她突然出现了胸闷憋气、心慌气短、咳嗽、出虚汗、脉搏不清等休克的症状，测血压为70/40mmHg，医院立即给予她抗休克治疗后，确诊为造影剂过敏。

On November 7, 2006,Hospital Zhang Zuning for double lower limbs vein angiography examination.At the end of the procedure,Her chest suddenly appeared rather tight/Palpitate shortness of breath/Have a cough/sweating/Pulse is not clear, such as the symptoms of shock,Measurement of blood pressure is 70/40 MMHG,Hospital immediately give her shock resistance after treatment,Diagnosed with contrast agents.

　　事后，人民医院在该事件的报告中认定：“由于本事件危及到患者生命，导致再次住院，并致使患者左膝功能康复延迟，可能出现功能障碍，因此认为该不良事件为严重不良事件。”

afterwards,People's hospital in the incident report:"Because the events endanger the patient life,Lead to hospital again,And in patients with left knee function recovery latency,Dysfunction may occur,So that the adverse events as a serious adverse event."

　　这一切，廖致杰是事后才得知的。他从外地回来后，姐姐告诉他：“妈妈差点没了。”较真的他开始介入此事。从2006年起，他与拜耳公司方面谈了一年多，后者只同意给付医疗费用人民币3296.17元。后来他得知，拜耳公司的上级德国拜耳集团公司在德国的HDI-Gerling工业保险股份公司(以下简称保险公司)为该药品试验投保，每个受试者的赔偿金额上限为50万欧元。于是，他把拜耳公司告上了法院，请求按照保险合同获赔。

All of this,Liao Zhijie is the fact.After he returned from a trip,My sister to tell him:"Mother was almost gone."He started looking into the matter seriously.Since 2006,,He talked for more than a year with bayer,The latter only agreed to pay health care costs RMB 3296.17 yuan.He later learned that,Bayer's superior Germany bayer corporation in Germany HDI Gerling industrial insurance co., LTD(Hereinafter referred to as the insurance company)To insure the drug test,Each participant compensation limit of 500000 euros.so,He sued bayer court,Request according to the contract of insurance being paid.

　“神秘”的合同 "mysterious"Of the contract

　　主审法官陈晓东在宣判后解释称，鉴于一份关键证据的缺失，使案件的审理一度受阻。“这份关键证据直接决定原告能否得到赔偿，如何计算保险赔偿，以及最终的赔偿数额。”

The judge Chen explained after the verdict,In view of the absence of a key evidence,Make the case was blocked."The key evidence directly determines whether the plaintiff will get compensation,How to calculate the insurance claim,And the final compensation."

　　陈晓东说的关键证据，是廖致杰提出的“拜耳集团公司与保险公司就新药试验签订过的保险合同”。庭审中，廖致杰要求拜耳公司提交这份保险合同。他认为，合同中应有关于严重不良事件的赔偿条款，或其他有利于原告的赔偿条款。对此，拜耳公司称该合同为德文版，以该公司不是投保人，合同文本长且翻译成本高(约2万欧元)，翻译及公证、认证周期长等理由拒绝出示。

Chen said the key evidence,Liao Zhijie is proposed"Bayer corporation with insurance company for new drug trials have signed the insurance contract".In the trial,Liao Zhijie bayer company submitted to the insurance contract.He thinks that,Should be in the contract clause regarding the compensation of serious adverse events,Or other indemnity clause in favour of the plaintiff.For this,According to the contract for the German bayer company,The company is not the applicant,Long contract text and the translation cost is high(About 20000 euros),Translation and notarized/Certification cycle is long, etc reasons to refuse to show me.

　　审理中，法院也一再释明，要求拜耳公司提交，该公司仍拒绝。最终，拜耳公司只提交了一份由保险公司出具的说明。

In the trial,The court also repeatedly cohabitancy,Submission requirements bayer,The company is still refused.In the end,Bayer only submit a copy of the instructions issued by the insurance company.

　　该说明显示：保险公司自2002年1月1日起开始承担拜耳在境外的新药试验保险，该保险系责任保险，用于赔偿针对拜耳提出的因试验受试者出现死亡或身体伤害而提出的索赔，保险人针对每一位被保的受试者承担的赔偿金额上限为50万欧元。说明称，保单中没有关于特定伤害情况相对应的赔偿金额标准，赔偿金额按以下原则计算，即在侵害人对受试者/患者负有责任的情况下，保险人应依据试验发生地国家法律的规定赔偿受试者/患者所遭受的具体的、实质性的伤害。说明中，保险公司证实已经于2007年3月16日收到原告提交的索赔申请，并已要求拜耳方面提供证明患者健康损害的有关证据，但该公司尚未收到相关证据，因此无法支付索赔款项。

This shows:Insurance company since January 1, 2002 began to take drugs outside of bayer in test coverage,The department of insurance liability insurance,Is used to compensate for bayer for test subjects appear death or bodily injury claims,Insured against each of the subjects for the compensation amount up to 500000 euros.That said,Policy is not about specific damage corresponding to the standard of compensation,Compensation amount is calculated by the following principles,That the infringer is responsible for the subjects/patients,Insured shall according to national legal provisions for compensation experiment site of specific subjects/patients/Substantial damage.notes,Insurance company confirmed on March 16, 2007, upon the receipt of the claim submitted by the plaintiff,And has asked bayer to provide proof of health damage in patients with relevant evidence,But the company has not received the relevant evidence,So we can not claim payment.

　　针对保险合同缺失这一原告维权的难题，鉴于拜耳公司持有保险合同(德文版)，但在庭审中经法院多次释明，无法定理由拒绝提交，合议庭在审理中适用《最高人民法院关于民事诉讼证据的若干规定》第75条，即“有证据证明一方当事人持有证据无正当理由拒不提供，如果对方当事人主张该证据的内容不利于证据持有人，可以推定该主张成立”的规定，推定该保险合同中有关于发生严重不良事件，即应向受试者赔偿的内容，赔偿数额最高为50万欧元。对于拜耳公司提交了保险公司的说明，陈晓东认为，它仅“归纳”了保险合同的一小部分内容，且没有关于严重不良事件及具体赔偿款项的内容，不能将其作为否定原告诉讼请求的证据采信。

In view of the insurance contract is lack of the plaintiff's rights problem,Given the bayer company insurance contract(German),But many times of hitches in the trial court,Unknown reason refused to submit,A collegial panel applies in the trial[The supreme people's court about civil action evidence certain stipulations]Article 75.,That is"There is evidence to prove that one party concerned holds evidence without justifiable reason to refuse to provide,If the other party claims that the evidence against the content of the holder,This claim may be inferred"The provisions of the,Presumed to be in the insurance contract about the serious adverse events,That should be the content of the compensation to the subjects,Compensation amount up to 500000 euros.For bayer company submitted to the insurance company,Chen thinks,It is only"inductive"The insurance contract is a small part of the content,And no serious adverse events and the content of the compensation payment terms,Can't use it as a negative the plaintiff claims the admissibility of evidence.

　　法院最终认定，张祖宁在新药临床试验中，出现了《患者须知》中描述的不良反应即造影剂反应(过敏性休克)，该不良反应虽与试验药BAY59-7939无直接关系，但属新药试验过程中的严重不良事件，拜耳公司应向受试方进行赔偿。由于拜耳公司未能通过保险公司向原告赔偿严重不良事件的款项，故其应自行向原告赔偿。考虑到原告的受损情况，严重不良事件对其自身的影响以及50万欧元所能赔偿的最坏损害情况，酌定赔偿额为5万欧元。

Court decided,Zhang Zuning in new drug clinical trials,the[Patient information]Described in the adverse reactions to contrast agents namely reaction(Anaphylactic shock),Although the adverse reactions and the drug test BAY59-7939 has no direct relation,But serious adverse events in the process of new drug trials,Bayer to compensation to the subjects.Because of bayer failed the insurance company to compensate the plaintiff for the amount of serious adverse events,It is our responsibility to compensate the plaintiff for the.Considering that the plaintiff's damage,The influence of serious adverse events on its own and that 500000 euros can compensate the worst damage situation,Discretionary compensation for 50000 euros.

　孤立无权的“受试者” Isolation has no right to"The subjects"

　　据法院透露，在寻找这份“神秘”合同的过程中，法官征询过人民医院，在其表示未对保险合同进行留存之后，法官还专程前往国家主管部门查阅相关资料，但该部门最终答复亦未对该保险合同进行留存。保险合同的取证不能，暴露出新药试验在审查与监管等领域存在着明显的疏忽与漏洞。

According to the court,Looking for the"mysterious"In the process of the contract,The judge consulted people's hospital,In the said not retained after the insurance contract,The judge also went to national authorities to consult related information,But finally answer the department or the insurance contract is retained.Evidence of insurance contract,Exposed the drug test in the examination and supervision, etc exist obvious negligence and holes.

　　南京医科大学卫生法学教研室主任、副教授顾加栋告诉记者，作为人口最多的国家和全球第三大药品消费市场，中国正成为全球新药试验的理想之地。《中国青年报》2010年10月披露的数据显示：我国每年有800多种新药进行人体试验，涉及人群约50万人。对于越来越多的跨国药企将新药试验瞄准了中国患者，业内专家表示，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。全国卫生产业企业管理协会常务副秘书长范浩信曾表示，外国药企选择中国作为临床试验基地，与中国受试者缺乏维权知识和意识有关，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。

Health, nanjing medical university, director of the teaching and research section of law/Associate professor Gu Jiadong told reporters,As the most populous country and the world's third largest drug consumption market,China is becoming a global ideal place for new drug trials.[The China youth daily]In October 2010 to disclose figures show:Every year our country has 800 a variety of new drugs for human trials,Involves the population of about 500000 people.For more and more multinational drug companies will test new drugs aimed at the Chinese patients,Industry experts said,On the one hand is due to enter the Chinese market demand,On the other hand is due to cost consideration.National health industry enterprise management association deputy secretary-general Fan Haoxin has said,Foreign drug companies choose China as a base for clinical trials,Related to Chinese subjects were lack of knowledge and awareness of safeguarding rights,Combined with the domestic for drug clinical trial supervision is obvious less than Europe and the United States,Lead to adverse consequences of drug firms to test cost is reduced greatly.

　　《南方都市报》2005年4月披露了韩国人参丸在华试药事件。从1998年10月起在当地卫生院医生的监护下、每周免费服用两粒人参丸的浙江农民沈新连并不知道，这是韩国一家机构进行的药物试验。到了1999年7月，沈新连突然感到头痛、头晕，检查的结果是高血压。但医生否认了高血压与人参丸的关系，于是她仍旧一次不误地服用人参丸，直到2001年三年试验期满。2002年3月，沈新连已经不能干农活了，她吃饭的时候，连手里的碗都会突然掉下来。还经常出鼻血，很多次早上起来，嘴里都是淤积的鼻血。2004年2月23日，在被病痛折磨了两年多后，沈新连的肾脏彻底坏死，离开了人世。

[Southern metropolis daily]In April 2005, revealed the Korean ginseng pill reagent events in China.Since October 1998, under the local institutes of the doctor's care/Weekly free take two grain of ginseng pill of shen new farmers in zhejiang even don't know,This is a Korean institution for drug testing.In July 1999,Shen new suddenly feel headache/dizzy,Check the result is high blood pressure.But doctors deny the relationship between hypertension and ginseng pill,So she is still not mistakenly taking ginseng pills at a time,Until the expiration of three years experiment in 2001.In March 2002,Shen new even has won't be able to do farm work,Her to dinner,Even the bowl will fall down suddenly.Often a nosebleed,A lot of time in the morning,His mouth is sedimentation of nosebleed.On February 23, 2004,After been suffering more than two years,Shen new kidney necrosis thoroughly,Passed away.

　　据《中国青年报》2010年10月报道，2003年，34名艾滋病患者参与了北京一家医院的一项药物试验，在6个月的观察期内有4人死亡。后来经《中国新闻周刊》的调查，这次试验并没有获得国家药监局的批准。这种来自美国的药物只是在保加利亚和墨西哥完成了人体试验。

According to the[The China youth daily]In October 2010 report,In 2003,,34 HIV/AIDS patients to participate in a drug trial at a hospital in Beijing,In the observation period of 6 months there were four people were killed.Later, the[China news week]The survey,The test is not approved by the state food and drug administration.This drug is from the United States and Mexico in Bulgaria completed human trials.

　　据《南方周末》2012年3月报道，2007年5月，在服用试验药物36天后，受试者王丽英死亡。在被官司折磨了四年后，王丽英的丈夫史德勇终于拿到了试药的主办者辉瑞公司30万元赔偿。这是近年来中国试药者通过法律途径，获得赔偿的为数不多的案例之一。

According to the[Southern weekend]In March 2012 report,In May 2007,In experimental drugs after 36 days,Participants Wang Liying death.After being legal torture for four years,Wang Liying husband Shi Deyong finally got the reagent of Pfizer's $300000 compensation by the organizer.This is China in recent years reagent through legal channels,One of the few cases for compensation.

　　2007年至2013年，廖致杰走出了一条艰难又充满戏剧性的维权路。“始终是我一个人在坚持，我拿到最为关键的证据，证明确有保险合同存在以及50万欧元这一上限数字，都是偶然的，过程充满了戏剧性，也算是老天对我坚持不懈的回报吧。”

From 2007 to 2013,Liao Zhijie walked out of a difficult and full of dramatic way to protect their rights."Has always been my a person sticking to it,I got the crucial evidence,Prove that insurance contract is 500000 euros and the upper limit of the number,Are accidental,Process is full of drama,Is right for me perseverance in return."

　试药该如何规范 How do reagent specification

　　顾加栋说，上述典型案例，不断暴露出中国新药试验领域中存在的缺陷与漏洞。最开始暴露出的是患者知情权缺失，有些人在毫不知情的情况下“被人体试验”，时至今日则是医院的伦理审查(国内临床试验机构设置伦理委员会，对新药临床试验进行伦理审查)流于形式、国家有关部门的把关尚未到位，以及真正出现不良反应之后，患者索赔极端艰难等几大问题。

Gu Jiadong said,The typical case,Constantly exposed weaknesses in China's new drug test field with holes.The most began to expose the patients' right to know is missing,Some people in unwitting circumstance"Be human trials",Today is the ethical review of hospital(Domestic clinical trial institution set up ethics committee,For ethical review new drug clinical trials)Become a mere formality/The control of the relevant state departments have not yet in place,And really after the adverse reactions,Patients claim extreme difficult and so on several big problems.

　　陈晓东法官在针对张祖宁一案的释法中称，国内临床试验机构都设置了伦理委员会，对新药临床试验进行伦理审查。但在实际操作中，其审查则往往流于形式，特别是对试验的风险、受试者的保护措施、受试者的赔偿条款等方面审查不全面。国家药监局作为监管部门，在审批新药临床试验的过程中，对于受试者而言具有重要意义的保险合同及保险条款缺乏实质性的审查，为受试者的健康和权益保护埋下了隐患。

Chen judge Zhang Zuning on a case of interpretation,Domestic clinical trial institution ethics committee has been set,For ethical review new drug clinical trials.But in practice,The review has often become a mere formality,Especially for test risk/Participants' protection/Review not comprehensive subjects of indemnity clause, etc.State food and drug administration as supervision department,In the process of examination and approval of new drug clinical trials,Is of great significance for the subjects of the insurance contract and insurance clause the lack of substantive review,For protection of the rights and interests of participants' health and buried the hidden trouble.

　　在新药试验背后巨大利益的驱动下，在信息严重不对称的现实下，廖致杰以切身经历之艰难，呼吁“医院与主管部门要先把关”，单枪匹马的患者实在难以与强大的跨国药企抗衡。

Behind the drug test driven by huge benefits,Under the reality of serious asymmetric information,Liao Zhijie difficult experiences,Called for"Hospitals and departments need to check first",Single-handedly patients is really difficult to compete with powerful multinational drug companies.

　　廖致杰说，在他维权的几年里，有朋友告诉他，有几家三甲医院的伦理审查委员会意识到了审查保险合同的重要性，有外国公司再有试药申请，对保险合同肯定是要审查和保留的。北京大学受试者保护工作体系自2010年10月开始运转，已经开始培训各大医院的伦理委员会，旨在全方位保护受试者权益。“进步是有的，但目前对受试者的保护系统仍是极不健全的，患者仍是弱势的。”

Liao Zhijie said,In his rights in the years,A friend told him,Several 3 armour hospital ethical review committee is aware of the importance of the review of the insurance contract,Foreign companies have reagent application,To an insurance contract must be review and retention.Beijing university subjects protection system to run since October 2010,Has started training the ethics committees of hospitals,Aimed at comprehensive protection of rights and interests of the subjects."Progress is there,But the current protection system of the subjects is still very healthy,Patients is still weak."

　　如果受试者不幸在新药试验过程中出现不良反应，申请赔偿最需依靠明确的法律规定。2003年9月起施行的《药物临床试验质量管理规范》和卫生部2007年印发的《涉及人的生物医学研究伦理审查办法(试行)》都规定，如发生与试验相关的损害时，受试者可以获得治疗和相应的补偿。然而对于如何赔偿，两项法规都没有作出具体说明。相比之下，据媒体报道，试药在欧美风险极高，甚至可以追溯20年前的临床试验事故，赔偿数额达到了数千万美元。(王丽丽)

If the subjects in the process of new drug trials appear harmful response,To apply for the most need to rely on the clear legal provisions for compensation.Effective as of September 2003[Drug clinical trial and the quality control standard]And in 2007 issued by the ministry of health[Involve people of biomedical research ethics review method(On a trial basis)]All provisions,Such as test related damage occurs,Participants can access to treatment and the corresponding compensation.However, on how to claim,Two regulations are not specified.By contrast,According to media reports,Reagent in Europe and the risk is extremely high,Clinical trials of accident can even back 20 years ago,Compensation amount reached tens of millions of dollars.(Wang lili)