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1、华中科技大学博士学位论文药品不良反应损害补偿制度研究姓名：张芬申请学位级别：博士专业：社会医与卫生事业管理指导教师：方鹏骞20090501华中科技大学博士学位论文华中科技大学博士学位论文3研究结论与政策建议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
2、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
3、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。关键词：关键词：药品不良反应损害补偿模式设计资金筹集华中科技大学博士学位论文华中科技大学博士学位论文4ABSTRACTABSTRACTObjectives：Establishingthedamagecompensationsystemoftheadversedrugreaction(ADR)accordingtoournationalconditioncanguaranteetherightofsubsistenceandhealt
4、hofthepatientsandreflectthesocialequalityandjustice.AtpresentourcountryhasnotdonetheresearchintheADRcompensationsystem.ThisstudydefinestheADRcompensationcomparesthedomesticandforeigntheoriesandthepracticerelatedtotheADRcompensationandsummarizesitscharacteristic.Byqualitativelyinvestigatingthestatuso
5、ftheADRcompensationinHubeiProvincethisstudyhasagoodknowledgeofthedifferentpeoplesopinionsonestablishingtheADRcompensationsystemandhowtoraisethefundanalyzestheexistingproblemsanddiscussesitstheoreticalfoundationandtheresponsibilitiesofthedifferentadministrativedepartmentsinourcountry.Basedontheanalys
6、esandinvestigationthepapergivesthemodeldesignofADRcompensationinourcountryandcalculatesitsfundinhopetoprovidethetheorybasisandthepolicysuggestionsforthegovernment.s：(1)Literatures.ThestudyreferstothemanyliteraturesrelatedtotheADRcompensation.(2)Spotinvestigation.Wecollecttherelateddataandstatistical
7、sdesigntheoutlineoftheinterviewmaketheindividualinterviewsandthegroupinterviewsdesigntheoutlineoftheseminarcarryonthegroups(madeupof10-12persons)discussionsandsimultaneouslyfillinthequestionnairesandcollecttypicalcasesandtherelatedpolicydocuments.(3)Qualitativestudy:Wemainlyanalyzethematerialswhicho
8、btainfromtheinterviewsandthequestionnaires.(4)Quantitativeanalysis:Wecarryonthestatisticalanalysistothecollecteddataandthequestionnaires.TakethecaseanalysisbasedonthedatainHubeiandcalculatethefundoftheADRcompensation.Results:(1)ByanalyzingtheliteraturesweknowthemainmodelsoftheinternationalADRinclude
9、:SocialsecuritypatternCompensationfundpatternLiabilityinsurancepatternandadministrativecompensationpattern.Althoughtheirapplicablescopeisdifferentrespectivelytheirsuitableconditionisjustthesame.MoreovertheADRcompensationmustbetakenintoeffectafterthelegislation.Ifthedrugshavetheunreasonabledangerthen
10、on-mistakeresponsibilityprinciplewillbeusedandtheresponsibilityandthelosswillbesharedthroughthe华中科技大学博士学位论文华中科技大学博士学位论文5fundortheinsurance.Thescopeofpayscompensationisapproximatelythesamemainlyincludingthedeathseriousphysicaldisabilitiesandpayswhichthehumanneedstobehospitalizedorinhospitalextension.
11、Theamountofthecompensationreachestheupperlimitwhichdoesnotincludethementaldamagecompensation.(2)WedefinetheADRandtheADRcompensationinthetheoryresearch.ThepapergoesintodetailabouttheADRtheorybasisandtheresponsibilityconstitutionofothercountriesandprovidesthetheorybasisinordertomakeitclearwhythevictim
12、sshouldgetthecompensationandwhoshouldundertaketheresponsibility.(3)Accordingtotheanalysisofthedatastatisticalandtheinvestigationmostreportscomefromthemedicalinstitutionswhilethereportsfromtheproductionandoperationenterprisesareextremelyfewonlymakingup1%.Thespeakersaremostlydoctors.TheseriousADRisabo
13、ut2%andoccuratdifferentages.50-year-oldmiddle-agedpersonsandoldpersonssufferfromtheADReasily.InthosereportstheADRcausedbyusingtheonedrugisabout90%theADRcausedbytheanti-infectionmedicineranksfirstduetousingitwideinclinicalmedicineandapplyingunreasonably.TheintravenousinjectioneasilycausestheADR.Throu
14、ghindividualinterviewandtheseminarthepaperalsodiscussestheestablishmentoftheADRcompensationsystemandhowtoraisefund.ByanalyzingthecompensationmanagementthecompensationstandardsthecompensationwaysthecompensationrangestheinstitutionsappraisingtheADRandidentifiedproceduresthepaperproposestheADRcompensat
15、ionsystemforourcountry.(4)ThepaperdiscussestheADRfundandmanagement.BycomparingtheinternationalwaysandchannelsofraisingfundthepapergivesthepatternwhichissuitableforourcountrythatisfundpatternandcarriesonthesimulationcalculationsimultaneouslyanalyzestheADRcompensationfundmanagementanditssupervisingmec
16、hanism.Intheaboveanalysisfoundationweputforwardthecorrespondingpolicyproposals.Conclusions:1.ConsummaterelatedlawandlegallyestablishtheADRcompensationsystem.2.Consummaterelatedpolicyandtakethesystemintoeffectsuccessfully.3.DesignthereasonableandscientificcompensationsystemdefinethescopesofthecompensationclearlyandulatestrictlytheprocedureswhichcanbeusedtojudgetheADRcompensation.4.Makeuseofthefundsfromvariouschannelsandestablisheffectivemanagementsystemsandoperation华中科技大学博士学位论文华中科技大学博士学位论文6mec
