【作者】 张芬；

【导师】 方鹏骞；

【作者基本信息】 华中科技大学 ， 社会医学与卫生事业管理， 2009， 博士

【摘要】 研究目的建立符合我国国情的药品不良反应损害补偿制度，从而保障患者的生命健康权，是实现社会公平正义功能的一种体现。目前我国尚未见药品不良反应损害补偿制度的系统研究。本研究从药品不良反应概念界定入手，通过比较国内外药品不良反应损害补偿的理论与实践，总结其特点及对我国的借鉴意义；并通过对湖北省药品不良反应现状及损害补偿机制的定性调查，分析存在的问题，了解各利益相关者对建立药品不良反应损害补偿机制的态度及筹资意愿；探讨我国药品不良反应损害补偿的理论基础及责任构成，在此基础上提出我国药品不良反应损害补偿制度设计模式，并对药品不良反应损害补偿资金进行模拟测算，以期能为政府相关部门制定政策提供理论依据和政策建议。研究方法(1)文献研究。主要收集有关药品不良反应损害补偿制度相关文献，经过比较分析后供研究借鉴。(2)现场调查。主要采用预先设计资料收集工具，现场收集相关数据及统计报表；设计访谈提纲，采取个别访谈和小组访谈方法进行访谈；设计专题小组讨论提纲，组成10-12人小组进行讨论；同时填写调查问卷、收集有关的政策文件。(3)定性研究。主要对访谈和问卷调查所获得的资料进行定性分析。(4)定量研究。对现场收集的数据及报表进行统计分析与处理，并以湖北数据作为案例分析，进行药品不良反应损害补偿资金的测算。研究结果1、通过文献分析，国际上药品不良反应损害补偿制度的主要模式有：社会保险模式；补偿基金模式：责任保险模式和行政补偿模式。各种模式适用范围各有不同，但适用条件大抵相同，而且药品不良反应损害补偿都必须经过立法才能执行；对药品不良反应因药品存在“不合理的危险”都采用无过错责任原则，并通过基金或保险形式来分担责任和分散风险；给付范围大致相同，主要包括死亡、严重残障和需人住院或住院延长；补偿给付金额均设有上限，且都不支持精神损害补偿。2、在药品不良反应损害补偿理论研究方面，对药品不良反应进行了界定，对药品不良反应损害补偿的界限进行阐述。对各国药品不良反应损害补偿的理论基础和责任构成进行阐述，为解决为什么要对药品不良反应受害者进行补偿、由谁承担责任提供了理论依据。3、我国药品不良反应现状研究方面，药品不良反应数据统计分析调查，发现报告主要来源于医疗机构，生产和经营企业报告数量极少，企业的报告数只占总数的1％，报告人都是以医生为主，严重不良反应发生的比例占药品不良反应报告总数的2％左右，不同年龄段都有药品不良反应发生，其中年龄大于50岁的中老年人发生的几率最大，在药品不良反应报告总数中，主要是使用一种药品的情形，占90％左右，抗感染药物占各类药物的首位，这与抗感染药物在临床广泛及不合理应用有关，静脉给药一直高居引起药品不良反应给药途径之首。药品不良反应损害补偿机制态度和筹资意愿调查中，通过个人访谈和专题小组讨论，探讨利益相关各方对于补偿管理机构、补偿标准、补偿方式、补偿范围、鉴定机构和认定程序、筹资意愿的态度和看法，在分析总结的基础上，提出我国药品不良反应损害补偿制度的设计方案。4、对于药品不良反应损害补偿制度的设计方案，从社会公平角度出发，应以社会中性第三人的标准考虑来设计补偿制度，补偿的前提要件是对于药品不良反应要采用无过错责任原则，造成了特别损害以及损害与患者使用的药品间存在因果关系。补偿范围仅包括药品不良反应导致的死亡、残障和身体严重受损、需要住院或是住院延长。补偿标准指导原则是适当补偿受害人，按人头实行无差别对待。补偿管理机构现阶段应为药品行政主管理部门，严格审核补偿申请，要设定严格的技术认定的程序。5、在药品不良反应损害补偿资金的筹集和管理研究方面，对国际上筹资方式和渠道进行比较分析，提出我国现阶段适宜的模式即基金模式，并进行模拟测算，同时分析药品不良反应损害补偿基金的管理与监督机制。研究结论与政策建议1、完善相关法律，顺应世界潮流立法建立药品不良反应损害补偿制度。药品缺陷应存在以“不合理危险”为标准；药品不良反应损害补偿责任应为无过错责任原则。2、完善相关政策，保障药品不良反应损害补偿制度的顺利实施。完善药品不良反应报告及监测体系；建立药品不良反应技术认定机构，制定药品不良反应技术认定程序；要进一步完善我国的药品行政审批程序和加强过程管理，提高审批标准。3、科学设计补偿制度，明确药品不良反应损害补偿适用范围，明确补偿的给付范围，建立严格的药品不良反应损害补偿技术认定程序。4、建立药品不良反应损害补偿的稳定筹资渠道及长效机制。我国现阶段对于药品不良反应损害应采取补偿基金模式，筹资渠道以企业为主，筹资水平应具有多层次性，筹资原则应是强制性。5、建立鼓励药品不良反应损害补偿基金社会捐赠的相关政策；6、借鉴国外做法，逐步推行“药品责任保险”；7、加大宣传力度，改变利益相关各方的观念。研究的创新与局限本研究的主要创新点：在理论分析结合现状调查的基础上，提出我国药品不良反应损害补偿制度的模式设计；提出药品不良反应损害补偿资金测算方法和计算公式，并对补偿资金进行了模拟测算。本研究的不足：药品不良反应数据收集比较困难，本研究仅在湖北省进行了现场调查。本论文旨在抛砖引玉，论文所提出的制度框架还需要在实践中不断丰富和发展。更多还原

【Abstract】 Objectives: Establishing the damage compensation system of the adverse drug reaction (ADR)according to our national condition can guarantee the right of subsistence and health of thepatients and reflect the social equality and justice. At present, our country has not done theresearch in the ADR compensation system. This study defines the ADR compensation, comparesthe domestic and foreign theories and the practice related to the ADR compensation; andsummarizes its characteristic. By qualitatively investigating the status of the ADR compensation inHubei Province, this study has a good knowledge of the different people’s opinions on establishingthe ADR compensation system and how to raise the fund, analyzes the existing problems anddiscusses its theoretical foundation and the responsibilities of the different administrativedepartments in our country. Based on the analyses and investigation, the paper gives the modeldesign of ADR compensation in our country and calculates its fund in hope to provide the theorybasis and the policy suggestions for the government.Methods: (1) Literatures. The study refers to the many literatures related to the ADRcompensation. (2) Spot investigation. We collect the related data and statistical forms, design theoutline of the interview, make the individual interviews and the group interviews, design theoutline of the seminar, carry on the groups(made up of 10-12 persons) discussions andsimultaneously fill in the questionnaires, and collect typical cases and the related policydocuments. (3) Qualitative study: We mainly analyze the materials which obtain from theinterviews and the questionnaires. (4) Quantitative analysis: We carry on the statistical analysis tothe collected data and the questionnaires. Take the case analysis based on the data in Hubei andcalculate the fund of the ADR compensation.Results: (1) By analyzing the literatures, we know the main models of the international ADRinclude: Social security pattern; Compensation fund pattern; Liability insurance pattern andadministrative compensation pattern. Although their applicable scope is different respectively,their suitable condition is just the same. Moreover, the ADR compensation must be taken intoeffect after the legislation. If the drugs have the unreasonable danger, the non-mistakeresponsibility principle will be used and the responsibility and the loss will be shared through the fund or the insurance form. The scope of pays compensation is approximately the same, mainlyincluding the death, serious physical disabilities and pays which the human needs to behospitalized or in hospital extension. The amount of the compensation reaches the upper limit,which does not include the mental damage compensation. (2) We define the ADR and the ADRcompensation in the theory research. The paper goes into detail about the ADR theory basis andthe responsibility constitution of other countries and provides the theory basis in order to make itclear why the victims should get the compensation and who should undertake the responsibility. (3)According to the analysis of the data statistical and the investigation, most reports come from themedical institutions while the reports from the production and operation enterprises are extremelyfew, only making up 1%. The speakers are mostly doctors. The serious ADR is about 2% andoccur at different ages. 50 -year-old middle-aged persons and old persons suffer from the ADReasily. In those reports, the ADR caused by using the one drug is about 90%; the ADR caused bythe anti-infection medicine ranks first due to using it wide in clinical medicine and applyingunreasonably. The intravenous injection easily causes the ADR. Through individual interview andthe seminar, the paper also discusses the establishment of the ADR compensation system and howto raise fund. By analyzing the compensation management, the compensation standards, thecompensation ways, the compensation ranges, the institutions appraising the ADR and identifiedprocedures, the paper proposes the ADR compensation system for our country. (4) The paperdiscusses the ADR fund and management. By comparing the international ways and channels ofraising fund, the paper gives the pattern which is suitable for our country, that is fund pattern, andcarries on the simulation calculation, simultaneously analyzes the ADR compensation fundmanagement and its supervising mechanism. In the above analysis foundation, we put forward thecorresponding policy proposals.Conclusions: 1. Consummate related law and legally establish the ADR compensation system. 2.Consummate related policy and take the system into effect successfully. 3. Design the reasonableand scientific compensation system, define the scopes of the compensation clearly, and formulatestrictly the procedures which can be used to judge the ADR compensation. 4. Make use of thefunds from various channels and establish effective management systems and operation mechanisms. 5. Establish the related policies which encourage the society to donate the fund. 6.Use the experience of other countries for reference and carry out the drugs liability insurancegradually. 7. Give wide publicity and change ideas.Creations and limits: In the paper, we give the modal design of the ADR compensation, putforward its calculating method and formulas and calculate the compensation fund based on thetheoretical analysis and spot investigation.Shortcomings of the study: Since the study has only carried on the investigation in Hubei Province,the statistical data analysis and the rate of the ADR don’t have the representation. The paper is forthe purpose of offering a few ordinary remarks so that others may come up with their valuableideas. The system frame proposed in the paper needs to be improved and consummated accordingto the objective reality.更多还原