中英对照2023人体器官捐献和移植条例.docx

RegulationonDonationandTransplantationofHumanOrgansDocumentNumber：OrderNo.767oftheStateCouncilofthePeople'sRepublicofChinaAreaofLaw：GeneralProvisionsonHealthandSanitationLevelofAuthority：AdministrativeRegulationsIssuingAuthority：StateCouncilDateIssued：12-04-2023EffectiveDale:05-01-2024Status:NotYetEffectiveOrderoftheStateCouncilofthePeople'sRepublicofChina(No.767)TheRegulationonDonationandTransplantationofHumanOrgans,adoptedatthe17thExecutiveMeetingoftheStateCouncilonOctober20,2023,isherebyissued,andshallcomeintoforceonMay1,2024.Premier:LiQiangDecember4,2023RegulationonDonationandTransplantationofHumanOrgansChapterIGeneralProvisionsArticle1ThisRegulationisdevelopedforthepurposesofregulatingthedonationandtransplantationofhumanorgans,中华人民共和国国务院令（第767号）人体器官捐献和移植条例已经2023年10月20日国务院第17次常务会议通过，现予公布，自2024年5月1日起施行。总理李强2023年12月4日人体器官捐献和移植条例第一章总则第一条为了规范人体器官捐献和移植，保证医疗质量，保障人体健康，维护公民的合法权益，弘扬社会主guaranteeingthequalityofmedicalcare,protectingthelegitimaterightsandinterestsofcitizens,andcarryingforwardthecoresocialistvalues.Article2ThisRegulationshallapplytothedonationandtransplantationofhumanorgansintheterritoryofthePeople'sRepublicofChina;andshallnotapplytothedonationandtransplantationofhumantissuessuchashumancells,corneaandbonemarrow.ForthepurposesofthisRegulation,donationofhumanorgansreferstothevoluntaryandfreeprovisionofthewholeorpartofahumanorganwithspecificphysiologicalfunctionssuchasheart,lung,liver,kidney,pancreasorsmallintestinefortransplanlalion.ForthepurposesofthisRegulation,transplantationofhumanorgansreferstotheimplantationofadonatedhumanorganintoarecipient'sbodytoreplacehisorherdiseasedorgan.Article3Supremacyofthepeopleshallbeinsistedonintheworkofdonationandtransplantationofhumanorgans.Thestateshallestablishaworkingsystemfordonationandtransplantationofhumanorgans,promotedonationofhumanorgans,regulatetheacquisitionanddistributionofhumanorgans,improvetheservicecapacityfortransplantationofhumanorgans,andstrengthensupervisionandadministration.Article4Thehealthdepartmentsofthepeople'sgovernmentsatorabovethecountylevelshallberesponsibleforthe义核心价值观，制定本条例。第二条在中华人民共和国境内从事人体器官捐献和移植，适用本条例；从事人体细胞和角膜、骨髓等人体组织捐献和移植，不适用本条例。本条例所称人体器官捐献，是指自愿、无偿提供具有特定生理功能的心脏、肺脏、肝脏、肾脏、胰腺或者小肠等人体器官的全部或者部分用于移植的活动。本条例所称人体器官移植，是指将捐献的人体器官植入接受人身体以代替其病损器官的活动。第三条人体器官捐献和移植工作坚持人民至上、生命至上。国家建立人体器官捐献和移植工作体系，推动人体器官捐献，规范人体器官获取和分配，提升人体器官移植服务能力，加强监督管理。第四条县级以上人民政府卫生健康部门负责人体器官捐献和移植的监督管理工作。县级以上人民政府发展supervisionandadministrationofdonationandtransplantationofhumanorgans.Thedepartmentsofdevelopmentandreform,publicsecurity,civilaffairs,finance,marketsupe,isionandadministration,andmedicalsecurityofthepeople'sgovernmentsatorabovethecountylevelshallberesponsiblefortheworkrelatedtodonationandtransplantationofhumanorganswithinthescopeoftheirrespectiveresponsibilities.Article5TheRedCrossSocietyshallparticipateinandpromotetheworkofdonationofhumanorgansinaccordancewiththelaw,CalTyouttheworkofpublicityandmobilization,willingnessregistration,donationwitness,remembranceandhumanitariancarefordonationofhumanorgans,andstrengthentheconstructionandadministrationofthenetworkofhumanorgansdonationorganizationsandteamsofhumanorgansdonationcoordinators.Article6Anyorganizationorindividualshallneithertradeinanywayhumanorgans,norCarryoutanyactivityrelatedtotradeofhumanorgans.Article7AnyorganizationorindividualshallhavetherighttoreportanyviolationofthisRegulationtothehealthdepartmentandotherrelevantdepartments;andhavetherighttosubmitlip-offsonanyfailuretoperformthesupervisionandadministrationresponsibilitiesbythehealthdepartmentandotherrelevantdepartmentstothepeople'sgovernmentatthesamelevelortherelevantdepartmentofthepeople'sgovernmentatahigherlevel.Thepeople'sgovernment,healthdepartmentandotherrelevantdepartmentsshallverifyand改革、公安、民政、财政、市场监督管理、医疗保障等部门在各自职责范围内负责与人体器官捐献和移植有关的工作。第五条红十字会依法参与、推动人体器官捐献工作，开展人体器官捐献的宣传动员、意愿登记、捐献见证、缅怀纪念、人道关怀等工作，加强人体器官捐献组织网络、协调员队伍的建设和管理。第六条任何组织或者个人不得以任何形式买卖人体器官，不得从事与买卖人体器官有关的活动。第七条任何组织或者个人对违反本条例规定的行为，有权向卫生健康部门和其他有关部门举报；对卫生健康部门和其他有关部门未依法履行监督管理职责的行为，有权向本级人民政府、上级人民政府有关部门举报。接到举报的人民政府、卫生健康部门和其他有关部门对举报应当及时核实、处理，对实名举报的，应当将处理结果向举报人通报。handletip-offsinatimelymanner,andnotifytheinformantsofthehandlingresultsofreal-nametip-offs.ChapterIIDonationofHumanOrgansArticle 8 Thedonationofhumanorgansshallbemadeundertheprincipleoffreewillfreeofcharge.Acitizenshallbeentitledtodonateornottodonatehisorherhumanorgan;andanyorganizationorpersonshallnotforce,cheatorenticeothersintodonatingtheirhumanorgans.Article 9 Acitizenwithfullcapacityforcivilconductshallhavetherighttoindependentlydecidetodonatehisorherhumanorgansinaccordancewiththelaw.Acitizenshallexpresshisorherintentiontodonatehumanorgansinwritingandmayalsoconcludeawill.Acitizenshallhavetherighttowithdrawhisorherintentiontodonatehisorherhumanorgans.Whereacitizenexpresseshisorheroppositiontodonationofhisorhercadavericorgansduringhislifetime,noorganizationorindividualmaydonateorobtainthecadavericorgansofthecitizen;andwhereacitizenhasnotexpressedoppositiontodonationofhisorhercadavericorgansduringhislifetime,afterthedeathofthecitizen,hisorherspouse,adultchildrenandparentsmayjointlydecidetodonatehisorhercadavericorgans,andadecisionondonationshallbemadeinwriting.第二章人体器官的捐献第八条人体器官捐献应当遵循自愿、无偿的原则。公民享有捐献或者不捐献其人体器官的权利；任何组织或者个人不得强迫、欺骗或者利诱他人捐献人体器官。第九条具有完全民事行为能力的公民有权依法自主决定捐献其人体器官。公民表示捐献其人体器官的意愿，应当采用书面形式，也可以订立遗嘱。公民对已经表示捐献其人体器官的意愿，有权予以撤销。公民生前表示不同意捐献其遗体器官的，任何组织或者个人不得捐献、获取该公民的遗体器官；公民生前未表示不同意捐献其遗体器官的，该公民死亡后，其配偶、成年子女、父母可以共同决定捐献，决定捐献应当采用书面形式。Article 10 Anyorganizationorindividualshallnotobtainanylivingorganofacitizenundertheageof18fortransplantation.ArticleIlArecipientofalivingorganshallbelimitedtothelivingorgandonor'sspouse,linealrelativebybloodorcollateralrelativebybloodwithinthreegenerations.Article 12 Thestateshallstrengthenpublicity,educationandknowledgepopularizationofdonationofhumanorgans,andpromotetheformationofasocialfashionconducivetodonationofhumanorgans.Thenewsmediashallcarryoutpublicwelfarepublicityondonationofhumanorgans.Article 13 Thestateshallencouragedonationofcadavericorgans.Acitizenmayexpresshisorherwillingnesstodonatehisorhercadavericorgansthrougharegistrationsen,icesystemestablishedbytheRedCrossSocietyofChina.Article 14 TheRedCrossSocietyshallissueadonationcertificatetotherelativesofacadavericorgandonorandmobilizeallsocialforcestosetupmemorialfacilitiesforcadavericorgandonors.Measuresshallbeadjustedtolocalconditionsandattentiontopracticalresultsshallbepaid,intheestablishmentofmemorialfacilitiesforcadavericorgandonors.第十条任何组织或者个人不得获取未满18周岁公民的活体器官用于移植。第-一条活体器官的接受人限于活体器官捐献人的配偶、直系血亲或者三代以内旁系血亲。第十二条国家加强人体器官捐献宣传教育和知识普及，促进形成有利于人体器官捐献的社会风尚。新闻媒体应当开展人体器官捐献公益宣传。第十三条国家鼓励遗体器官捐献。公民可以通过中国红十字会总会建立的登记服务系统表示捐献其遗体器官的意愿。The Red Cross Society of China and the health department of中国红十字会总会、国务院卫生健康部门应当定期组织开第十四条红十字会向遗体器官捐献人亲属颁发捐献证书，动员社会各方力量设置遗体器官捐献人缅怀纪念设施。设置遗体器官捐献人缅怀纪念设施应当因地制宜、注重实效。theStateCouncilshallorganizeactivitiestocommemoratecadavericorgandonorsonaregularbasis.ChapterIIIObtainingandTransplantationofHumanOrgansArticle 15 Amedicalinstitutionobtainingcadavericorgansshallmeetthefollowingconditions:(1) Ithasadepartmentspecificallyresponsibleforobtainingcadavericorgans,aswellasmanagers,medicalpractitionersandothermedicalpersonnelsuitableforobtainingcadavericorgans.(2) ithastheequipment,facilitiesandtechnicalcapacitynecessaryforobtainingcadavericorgans.(3) Ithasanethicscommitteefortransplantationofhumanorgansasprescribedinparagraph1ofArticle18ofthisRegulation.(4) Ithasasoundqualitymanagementandcontrolsystemforobtainingcadavericorgans.Whereamedicalinstitutionengagedinobtainingcadavericorgansisalsoengagedintransplantationofhumanorgans,thedepartmentresponsibleforobtainingcadavericorgansshallbeindependentfromthedepartmentresponsiblefortransplantationofhumanorgans.展遗体器官捐献人缅怀纪念活动。第三章人体器官的获取和移植第十五条医疗机构从事遗体器官获取，应当具备下列条件：（一）有专门负责遗体器官获取的部门以及与从事遗体器官获取相适应的管理人员、执业医师和其他医务人员；（二）有满足遗体器官获取所需要的设备、设施和技术能力；（三）有符合本条例第十八条第一款规定的人体器官移植伦理委员会；（四）有完善的遗体器官获取质量管理和控制等制度。从事遗体器官获取的医疗机构同时从事人体器官移植的，负责遗体器官获取的部门应当独立于负责人体器官移植的科室。第十六条 省、自治区、直辖市人民政府卫生健康 部门根据本行政区域遗体器官捐献情况，制定遗体器官获 取服务规划，并结合医疗机构的条件和服务能力，确定本 行政区域从事遗体器官获取的医疗机构，划定其提供遗体 器官获取服务的区域。Article 16 Thehealthdepartmentofthepeople'sgovernmentofaprovince,autonomousregionandmunicipalitydirectlyundertheCentralGovernmentshall,accordingtothesituationofdonationofcadavericorgansinitsadministrativeregion,developtheserviceplanIbrobtainingcadavericorgans,andinconsiderationoftheconditionsandservicecapabilitiesofthemedicalinstitutions,determinethemedicalinstitutionsobtainingcadavericorgansinitsadministrativeregion,anddesignateareaswheretheyprovidesendeesforobtainingcadavericorgans.从事遗体器官获取的医疗机构应当在所在地省、自治区、直辖市人民政府卫生健康部门划定的区域内提供遗体器官获取服务。Medicalinstitutionsengagedinobtainingofcadavericorgansshallprovideservicesforobtainingcadavericorgansinareasdesignatedbythehealthdepartmentofthelocalpeople'sgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment.医疗机构发现符合捐献条件且有捐献意愿的潜在遗体器官 捐献人的，应当向负责提供其所在区域遗体器官获取服务 的医疗机构报告，接到报告的医疗机构应当向所在地省、 自治区、直辖市红十字会通报。Amedicalinstitutionfindingapotentialcadavericorgandonorwhomeetstheconditionsfordonationandiswillingtodonateshallreporttothemedicalinstitutionresponsibleforprovidingservicesofobtainingcadavericorgansintheregion,andthemedicalinstitutionthatreceivesthereportshallnotifytheRedCrossSocietyoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralgovernmentwhereitislocated.任何组织或者个人不得以获取遗体器官为目的跨区域转运 潜在遗体器官捐献人，不得向本条第三款规定之外的组织 或者个人转介潜在遗体器官捐献人的相关信息。Noorganizationorindividualmaytransferpotentialcadavericorgandonorsacrossregionsforthepurposeofobtainingcadavericorgans,andnoorganizationorindividualmaytransferrelevantinformationonpotentialcadavericorgandonorstoanyorganizationorindividualotherthanthoseprovidedforinparagraph3ofthisarticle.Article 17 Beforeobtainingcadavericorgans,thedepartmentresponsibleforobtainingcadavericorgansshallfileanapplicationforreviewofobtainingacadavericorganwiththeethicscommitteefortransplantationofhumanorgansofthemedicalinstitutionwhereitislocated.Article 18 Theethicscommitteefortransplantationofhumanorgansshallbecomposedofexpertsinmedicine,law,ethics,etc.Thenumberofmedicalexpertsengagedintransplantationofhumanorgansshallnotexceedonequarterofthenumberofmembers.ThecompositionandworkingrulesoftheethicscommitteefortransplantationofhumanorgansshallbedevelopedbythehealthdepartmentoftheStateCouncil.Theethicscommitteefortransplantationofhumanorgansshall,uponreceiptofanapplicationforreviewofobtainingacadavericorgan,reviewthefollowingmattersinatimelymanner:(1) Whethertheintentiontodonateacadavericorganisgenuine.(2) Whetherthereisanytradeordisguisedtradeofacadavericorgan.Onlywiththeconsentofmorethantwothirdsofthemembers,theethicscommitteefortransplantationofhumanorgansmayissueawrittenopinionapprovingobtainingofcadaveric第十七条获取遗体器官前，负责遗体器官获取的部门应当向其所在医疗机构的人体器官移植伦理委员会提出获取遗体器官审查申请。第十八条人体器官移植伦理委员会由医学、法学、伦理学等方面专家组成，委员会中从事人体器官移植的医学专家不超过委员人数的四分之一。人体器官移植伦理委员会的组成和工作规则，由国务院卫生健康部门制定。人体器官移植伦理委员会收到获取遗体器官审查申请后，应当及时对下列事项进行审查：（一）遗体器官捐献意愿是否真实；（二）有无买卖或者变相买卖遗体器官的情形。经三分之二以上委员同意，人体器官移植伦理委员会方可出具同意获取遗体器官的书面意见。人体器官移植伦理委员会同意获取的，医疗机构方可获取遗体器官。organs.Amedicalinstitutionmayobtaincadavericorgansonlyiftheethicscommitteefortransplantationofhumanorgansgrantsapproval.Article 19 Cadavericorgansshallbeobtainedafterthedeathofacadavericorgandonorisdeterminedinaccordancewiththelaw.MedicalpersonnelengagedinobtainingandIranspIanUlionofhumanorgansshallnotparticipateinthedeathdeterminationofcadavericorgandonors.Obtainingofcadavericorgansshallbewitnessedbyhumanorgandonationcoordinators.Beforeobtainingcadavericorgans,themedicalinstitutionengagedinobtainingcadavericorgansshallnotifytheRedCrossSocietyoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentwhereitislocated.Uponreceiptofthenotice,theRedCrossSocietyshallappointtwoormorehumanorgandonationcoordinatorstowitnessobtainingofcadavericorgans.Medicalinstitutionsengagedinobtainingofcadavericorgansandtheirmedicalpersonnelshallsafeguardthedignityofcadavericorgandonors;andafterobtainingorgans,conductmedicaltreatmentoftheremainsethically,andrestoretheirappearance,exceptfororgansintendedfortransplantation.Article 20 Theallocationofcadavericorgansshallmeetmedicalneedsandfollowtheprinciplesoffairness,justiceandopenness.SpecificmeasuresshallbedevelopedbythehealthdepartmentoftheStateCouncil.第十九条获取遗体器官，应当在依法判定遗体器官捐献人死亡后进行。从事人体器官获取、移植的医务人员不得参与遗体器官捐献人的死亡判定。获取遗体器官，应当经人体器官捐献协调员见证。获取遗体器官前，从事遗体器官获取的医疗机构应当通知所在地省、自治区、直辖市红十字会。接到通知的红十字会应当及时指派2名以上人体器官捐献协调员对遗体器官获取进行见证。从事遗体器官获取的医疗机构及其医务人员应当维护遗体器官捐献人的尊严；获取器官后，应当对遗体进行符合伦理原则的医学处理，除用于移植的器官以外，应当恢复遗体外观。第二十条遗体器官的分配，应当符合医疗需要，遵循公平、公正和公开的原则。具体办法由国务院卫生健康部门制定。Where,forapatientapplyingfortransplantationofhumanorgans,hisspouse,linealrelativebybloodorcollateralrelativebybloodwithinthreegenerationshavedonatedcadavericorgans,heshallbeprioritizedunderthesameconditions.Article 21 CadavericorgansshallbeuniformlydistributedthroughthedistributionsystemestablishedbythehealthdepartmentoftheStateCouncil.Medicalinstitutionsengagedinobtainingandtransplantationofcadavericorgansshalltruthfullyrecord,andupdateinatimelymanner,therelevantmedicaldataofcadavericorgandonorsandpatientsapplyingfortransplantationofhumanorgansinthedistributionsystem,withoutfalsifyingortamperingwiththedata.Medicalinslitulionsandtheirmedicalpersonnelshallimplementtheallocationresultsinthedistributionsystem.Medicalinstitutionsandtheirmedicalpersonnelshallbeprohibitedfromusingcadavericorgansthathavenotbeenallocatedbythedistributionsystemorhumanorgansofunknownoriginfortransplantationofhumanorgans.ThehealthdepartmentoftheStateCouncilshallpublishinformationonthedonationandallocationofcadavericorgansonaregularbasis.Article 22 ThehealthdepartmentoftheStateCouncilshall,inconjunctionwiththepublicsecurity,transport,railway,civilaviationandotherdepartmentsoftheStateCouncilandtheRedCrossSocietyofChina,establishaworkingmechanismforthegreenchannelforthetransportofcadavericorganstoensureefficientandsmoothtransportofcadavericorgans.患者申请人体器官移植手术，其配偶、直系血亲或者三代以内旁系血亲曾经捐献遗体器官的，在同等条件下优先排序。第二一条遗体器官应当通过国务院卫生健康部门建立的分配系统统一分配。从事遗体器官获取、移植的医疗机构应当在分配系统中如实录入遗体器官捐献人、申请人体器官移植手术患者的相关医学数据并及时更新，不得伪造、篡改数据。医疗机构及其医务人员应当执行分配系统分配结果。禁止医疗机构及其医务人员使用未经分配系统分配的遗体器官或者来源不明的人体器官实施人体器官移植。国务院卫生健康部门应当定期公布遗体器官捐献和分配情况。第二十二条国务院卫生健康部门会同国务院公安、交通运输、铁路、民用航空等部门和中国红十字会总会建立遗体器官运送绿色通道工作机制，确保高效、畅通运送遗体器官。Article 23 AmedicalinstitutionengagedintransplantationofhumanorgansshallfileanapplicationwiththehealthdepartmentoftheStateCouncil.ThehealthdepartmentoftheStateCouncilshallorganizeexpertreviewwithinfiveworkingdaysfromthedateofacceptinganapplication,andmakeadecisionwithin15workingdaysafterthecompletionoftheexpertreviewandnotifytheapplicantinwriting.Uponexaminationandapproval,thehealthdepartmentoftheStateCouncilshallnotifythehealthdepartmentofthepeople'sgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralgovernmentwheretheapplicantislocatedofregisteringthediagnosisandtreatmentsubje