1

世界保健総会州orld Health ASS師bly)

においてこれまで採択された血液関係の主な決議

28回世界保健総会決‘

削A28.72 Ut”ization and

0 主な加盟国ヘの勧告

「無償の献血に基づく国家血液事業の設置を推進すること。」

『to promote the deve1叩ment

nonr肌Unerated donation of

58回世

WHA58.13 Blood

2.

(1975年) (別添1)

Supply of human blood and blood products

0 主な加盟国ヘの勧告

「必要に応じ、医療上必要な場合を除き、有

また、そのような (有償の供血を実施する)

ームドコンセントを得ること。」

会決議 (20価年) 偶‘、 2)

Safety: proposal to establish world Blood Donor Day

Of national blood services based on voluntary

blood』

『to introduce legislation, where needed, to eliⅢinate paid blood donation

except in nmitedcircumstancesofmedical neC郎Sityand, insuchcases, to

req山re informed assent of the transfusion recipi印t』

63回世界 総会‘ ‘

WHA63.12 Availabinty,

3.

0 主な加盟国ヘの勧告

「特別な場合を除き、国内自給を達成することを目的として、資源の入手可能性に

基づき、 国家的に調整され、効率的に管理された、持続可能な血液および血擬プロ

グラムを実施するためのすべての必要な措置をとること。」

の供血を廃止する法整備を行うこと。

場合は、 血を受ける患者のインフォ

(2010年) (別添3)

Safety and quality of blood products

『to take a” the necessary steps to establish, implement and support

nationa11y－coordinated,

Plasmapr0套ra1叩esaccordingtotheavailability ofresources, withtheaim

Of achievin宮 Seげ一sufficiency, unless special circumstances preclude it』

efficientlyイnana宮ed and sustainable blood and

資料3－3

削

TWENTY.EIGHTHWORLDHEALTHASSEMBLY, GENEVA, 13゙ OMAY1975WHA28.72 Utilization and supplyofhuman blood and blood products

IheTwenw・e地h壮IworldHe田thAssembly,

Consciousoftheincreashlguseofbloodatldbloodproducts

HaV伽gconsidered血e infomlationprovidedbytheDitector・GeneralontheU廿lizationa11dsupplyOfhum抑blood抑dbloodproducts;

Bearing inmindresolU壮onxV1110fthexX111ntemationalconferenceof廿leRedcross‘

Noting theextensivea11dhlcreasing activides ofpdvate丘nns in try証1呂 to eS仏blish commercialbloodc011ection釦dplasmapheresisprojects indevelopin容Countries;

Expressing sedous concem that such acti

vities may in如rfere wi廿l effbrts to establish e缶Cientnationalblood訂atlS員IsionseNicesbasedonvoluntarynonremunerateddonations}

Being awareofthe h屯herhsk oftra11Smitting diseaseswhen blood products have been ob仏ined丘om paid rather廿la11hom volun仏rydonors, 如d oftheharm且11 Consequences t0 仕le he址th ofdonorsofto0丘‘equentblooddonations(oneofthecausesbeingNmuneradon),

TflANKS 壮le Director－General for 血e actionS 仏ken to study 廿le problems related toCon血erci祉Plasmapheresis indevelopingcoun訂ies;

1、

2. URGESMemberS仇tes:

U) to romote 廿le develo ment of nation田nonremunerateddonationofblood:

(別添1 )

(2) to enact ea‘ecuve legislation goveming 壮le operation ofblood serviceS 釦d to takeOther acuons necessary to pr0比Ct 帥d promote the hea1廿1 0fblood donorS 飢d ofrecipientsofbloodarldbloodproducts;

REQUESTstheDirector・General

(D to increaseassiS仏11CetoMemberSねtesinthedevelopmentofnationalbloodseNicesbased on voluntarydonauons, 、Nhenappropdate in c0Ⅱaboration withthe League ofRedcrosssocieties;

(2) to a$sist 血 establish血g cooperauon between countries to secure adequate supply ofbloodproductsbasedonvoluntarydonations;

(3) t0 会lmler S加dy the P吸Ctice of commercial plasmapheresis including the healulhazardsa11dethical implicadons,particularlyindevelopingcountries

(4) t0 仏ke steps to develoP 号ood ma11U金Cturm g practices speci”ca11y 血r blood a11dblood components in order to protect 血e hea1血 ofboth donors a11d recipients‘ a11d

blood Voluntbased 0nServlces

to repodtothe、voddHe址壮IAssemblyondevelopments tlthesemattersi

Hahd6. Res. ン01. ι 1.5.2.2;8.2.4nirteenthplenarymeeting 29May 1975(committeeA,島UrⅡlrep0πノ

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84

Bloodsafety: proposal toestablishworldBloodDonorDay

TheFifり1・eighthworldHealthAssembly,

Reca11ingresolutionwHA28.72Whichurgedthedevelopmentofnationalblood seNicesbasedOnthevolU11t笹y,n011remune工ateddonationofblood;

WHA5S.13

Havin号Consideredthereportonbloodsafety;1

Alarmed by the chronic shor仇呂eof saf毛 blood and blood products, P飢iculady in low・ a11dmedium・incomec0如廿ies;

Mindful that preventin容 the 廿ansmission of HIV 肌d other bloodbome path0底ens throU8hUnsafebloodandblood・product transf、1Sions requiresthe c011ection ofbloodonly fromdonors at the10westriskofcanyingsuch infヒCtious agents;

Recognizing that v01如徐ry, n01辻emunerated blood donation is the come鵄tone ofa safe 如dadequatenationalbloodsupplythatmeetsthetransfusionrequirementsofa11Patie址S;

Noting thepositive responses toworldBloodDonorDay, 14 June 2004, for the promotionofVoluntary,n0址emuneratedblooddonation,

DocumentA58/38.

FIFIY、EIGHTHWORLDHEALTHASSEMBI‘Y

1. AGREEs to tbe establishment of an a世Iua1 込rorld Blood Donor Day, to be celebrated on14juneeachyear;

2、 RECOMMENDs that this blood donor day should be an integal part of the national blood、donorrecNitmentprogalmle;

(別添2)

URGESMemberstates:

(り topromoteandsupp0丘thearmualcelebrationofwoddBloodDonorDay;

(2) to establish or strengthen systems fot the recNi伽ent and retention of voluntary,nonremuneratedblooddonorsandthe implemenねtionofstdn8ent criteriafordonorselection;

(4) to provideadequate6nancin8forhi帥gualityblooddonation services and forextensionOfS1ιChservicestomeettheneedsofthepatients;

(5) to promotemultisectoral c011aborationbetweengoven11nentministdes,blood廿釦SfusionServices,professionalbodies, non号Oven血e爪al organizations, civn societya11dthemedia in thePromotionofvoluntary,nonremuneratedblooddonation;

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(6) to ensuretheproper use ofblood壮‘anS員.1Sion in clinical practice s0鮎 to avoid abuse ofblood伽nS員Ision,WMchmayNsult血ashorta8eofbloodandhencest血Ulatetheneed如rpaidblooddonadQn;

(フ) to supp0丘 由e 員111 implementation of we11心rgani鵡d, n飢iomⅡy coordinated 釦dSustaiMblebloodptogran血eswi山appropdateregulatorysystenlS血rough,inpa血Cular:

(a) governnlentcolm11iⅡnentandsuppon血ranadonalbloodprogalmnewithq山liw－m如a窟ementsystems,bymeansofa le号田 ftat”ework, anational blood－saf己typolicyandP1飢,andadequa妃resources

(b)廿ansf山ionservice

or8anization, management andi

nfシastNcture to permit a suS捻inable blood

RESOLUTIONSANDDECISIONS

(の equi桧bleaccesstoblood釦dbloodproducts

(d) voluntary,n0世em山leratedblooddonorS6‘omlow－dskpopulations

(の appropriatetestinga11dprocessiⅡ套ofa11dona如dblood肌dbloodproduC蛤

(o approP金ateclinicaluseofblood飢dbloodproduC船;

(8)availabiliりr based on e伽nl considerations, 伽nsP甜ency, assessment of national needs,Scientificevidence,anddswbenefit釦alysis、,

to eS仏blish a qua1武y procesS 加r policy・ 如d decision・ma血g fbr blood safヒリ, and

f

(9) to share infbrmation nationa11y and 山temadona11y in order tomake dearthe scienufic,econb加C飢dsocialbasisofnation址Policydecisi0那relatedtobloodsa企WatldaV毎labiliw;

(1の tostrengthenP釘賀le6hゆSata111evels inordertoaccomplish山eserec011血endedacti0郎;

4. CALLS UPONinten埠tional orga11izationS 如d bodies concemedwi血 global blood saf毛りl toC011abotateinpromot血套andsupponhlgwoddBloodDonorDay;

5. 1NVITEs donor a客encies to provide adequate 員lnd血宮 拓r initiauves to promote volUⅡ捻lyn0世em如e捻tedblooddonation;

85

6. REQUESTs theDirector心ene始1:

(D toworkwi山otheror容anizationsof山eunitedNauonssystem,multilatera1田ldbilateMIagencies,andnongove如nentalorga11izations toprom0如WoddBloodD0ⅡorDay;

(2) to work wi小 Concemed or部nizauons to provide support to Member stateS 血Strengtbening their capacity to screen a11 donated blood aga

i

11St major i11fectious diseases inOrd就如ensurethata11bloMC011ected如d tranS兪IsedisM企.

(Ei容hthplenalymeetin&23May2005－Com加tteeB,flrstrep0π)

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126thsession

A名enda託em4.16

Availability, safe切‘ and qua1詫y ofblood productsl

TheExecudveBoard,

HaV血gconsideredtheルPortonavailability,safe島,飢dqualiりrofbloodproduC鴨,2

RECOMMENDs to the siX島,.ιhi

rd world He址血 A部embly the adoP廿on of 血e f0110W血3resolution:

Thesixw.thirdworldHea11hAsse血bly,

Reca11血号 resolution wl{A58.B on blood safew: propoS祉 to establish world BloodDonor Day 飢d preced血g re1飢ed resolU而ons S血Ce resolution 訊11{A28.72 0n uti!ization a11dSupply ofhU血釦 blood狐d blood products,which 山gedMember st甜es to pr0血ote ιhe 6111mplemen捻廿on ofweⅡ.org釦ized, nauona11y coord血ated 飢d susta

i

nableblood programmesWithappropriateregulatolysystemS肌d toenacteffectivelegislation80vem血gtheoperauonofblood services;

i

(別添3)

Recogni力n8dlat achieV血g selFsuf丘Ciency, unless special cirC1血St飢Ces preclude it, hldlesupplyofsafebloodcomponenιSbasedonvolun仏ry,non・1e血Uneratedblood don飢ion,飢d心lesecU瓢勺rofalalsupply 笹e血P0武antnauona1倉oalstopteYentblood shodageS狐d血eet低le壮飢S61Sionrequire皿entsoflhepa匝entpopulation;

仙at plasma、dedvedmediC血alproduC駕 fbr t11e o‘ea血ent ofhaemophilia飢d祉e血Cluded血 thewHOModel ListofEssen而al Medic

i

rleS3如d oftheneedtofacili仏teacNsstotheseproductsbydeveloP血8C0山1廿ies;

Consciousimmune diseases

Concemed by小elulequal accessglobι‘1y to bloodproducts,P紅ticU1印‘1y plaS皿a・dedvedmediC血alproducts,1eaV註lg血飢ypa壮entS血n舵dof廿町S丘Isio”飢dwiⅡIseverecongenit田飢dreddisorderswithoutadequatetwat皿ent;acqui

EB126.R14

22J抑Ⅱary2010

IThetemBloodproduC始isdennedby血ewHOExpencommiⅡeeonBi010郡

伽Ist抑dardization舶R)110WS:

“引oodproduC駕且rede6ned舶飢ylheNpeuliC釦bswlcesdedvedflomhⅡm釦blood,includin8Wholeblood,1abilebloodcomponentS如dplasma－derivedmedicinalproduC始”

ユDocumentEB126n9.

3ThewHOModelListofESS肌tialMedicineside肌li介esindividualmedicinestha110gelh射Couldprovide鈴fe抑deneclivelreaιm飢tformostcommunicable抑dn伽Commu”i伽blediS伽Ses.ThisLisli虹dudesP1鮎ma.dedvedmedicinalProduC捻,n日melyimmun0名10bulinS飢dcoa名Ula鯨on飴Cto”,whichaNnecdedtopreV如t卸d賀eatavadewof鵠dousConditionslhatoccurworldMdo(h負P:/1WMV.who.invmedicineslpublicationye郡飢U且lmedidney帥lindex.html)

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Aware小at a血可or factor limi血g the glob址 aV祉labi販智 ofplaS血a.dedved medicmalProduC船 iS 釦 madequate supply ofplaS皿a血eeting intemationa11y Ncogn伽d swld笹dsfbr丘actiona廿on;

Bear血 g血皿血d血at廿ea壮nentush1名labilebloodc0血Ponen始iS3radua11ybe血8血medical practice l‘develop

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11gcoun廿ieS飢d小atthereby紅Icte郎edqU飢廿壮esof『ecoveredPlaS血a S110uld bec0血e aV毎lab1巳兪rfractionation血e就theirneeds;

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11to plasma・dedved 血edicinal pfoducts to

Concemedt11at 11 develoP血gc0山1訂‘i

es blood c0皿PonentsseP鮎ationteclm010部,釦d丘actionation capaci訂1紅e lackin倉,抑d becauseof i11Sufncient regulatolycon廿0IS勧d f毎IuretoimP1如ent叩Propr

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a妃 PracticeS血 blood establiS1叩ents,plasma from developi

11gc0如Ui郎 isOnenU11acceptablefbrcon廿act丘act

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onalion,wit11ConsiderablewaS始geofplasmaasaresult‘

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ConV血Ced 111at assuri

ng 仕1巳 Suitabiliり, of plasma fbr fiacuonauon reqU辻es thee瓢ablishmentofana壮ona11y cooldina如d如d susta

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11ableplasmaprogram血eW飢h血 apropedyOrg飢i鵡d, 1ega11yestablished飢dregulatednat

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onalbloodprogramme;

Rec0即izing 山at dle capaciw to c011ect plasma iS 1血ited 飢d would not 釦伍Ce toProduceenoughessentialmediC血es tocover呂10balneeds, 蝕 is essentia1Ⅱ1甜 a11Coun廿

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eS 11ave10cal C叩aciり, to c011ect plasma ofaccePねble quality 飢d safeり1 丘0皿 V01如tary飢d 山ιPa

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ddonationS血ordertomeettheirneeds;

Convi

11Ced that丘actionation shouldbesetupasclose t0Ⅱlesource aspossible 飢dth址Wherena匝onalplaS皿afracuonauoncapacitieS紅‘e lack血g,dlereshould be抑Option ‘brsupplyOf 6‘act

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onation capaciりl 1ι0Ⅱler countri

es, itshould beensuredthat thesupply of P1鮎madef

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vedmedicinalproducts C如 be made available to m鴨t local needs in lhe coun訂y of血ePlasmasupplier;

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Recognizi

tlg lhat accesS 如i

11f0血adon about strate豊ies to ensure supplies of bloodProducts sU価Cienttomeetdem釦d, e丘巳Ctive血即h田lismsofregulatolyove郡礁ht, teclm010容iest0帥Sure thequaliり,飢d safeu,ofbloodproducts,guidel

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11eson征leappropdatecli

nicaluseofbloodproductsa11d小edsksof廿釦S61Sionhavebecome皿ore釦dmorenecessaw;

Bear血 g inmi

tldt11atv01叩laly飢d non・remunelaled blood donations C飢Con廿ibute tohigh safeり,st勧dardS血rblood飢dbloodc0血PonentS釦dbein容a、varet11at thesafeり10fbloodProducts deP帥ds on testhlg ofa11 donatedblood fbr住勧Sf、1Sion－tr釦SmissibleitlfectionS 知dConectlabelHng,storage飢d廿飢SportaⅡonofbloodproducts;

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11g 血 皿i

11d 山at padent blood 血釦鴫ement m伽ns that bef0ル SU1套ely evelyreasonable血e郎山e should be t祉【en to oP匝mi鵡the pal

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ent‘s ow nblood volume t0血血imize小epatient‘sblood losS飢d toh釦lesS如dopt血izethepaⅡent－speci丘Cphysi010giC址 toler飢CeOt抑aemiafb110W血3廿lewHO‘S名UidefbroptimalC1血icaluse(111reepiⅡ祉Sofpatientbloodm抑鴫ement);

Rec0号11izin8 Ⅱlat exNssive a11d urmecessary use of tr如Sfusi0力S, 如d plasma dedvedⅡlediC証lal products,unsafe廿飢S魚IsionpracticeS帥detrors (particularlyat血epatient‘sbedside)Sedouslycompromisepatientsafe島1;

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Concemed thatunsafeatld/orpoor－quali訂lblood products C飢renderpatients 、ulnenbleto avoidablenskbyexpehencednationalorN3ionalregulatolyauthorities;

if仕le bloodpr0名rammesarenot subject to the level ofconu‘ol nowexercised

Alarnled that patientS 血 developing coU11tries continue to be exposed t0 血e risk ofPr飢‘entable 廿飢Sfusion・tr飢Smi廿ed in企Ctions by bloodbome pa血0容e那 Such as hepatitisB叫irus hepatitiscNiNS紬dHIV;

Not血g the increasingm小,eme川 across b0如daries ofblood productsatld blood safe島1related in vitro di鴫nostic devices togetherwith their rapid development飢d inh‘oduction血tohealth・caresystemsofbothdeveloped闘ddevelopingcountdes‘

Rec0号nizhlg t11evalueof血temationalbi010gicalreferencematenals (WHolntemationalSt飢d鮎ds) for the quali切Icontr01 0fblood productS 帥d related in vi廿o dia8nosticdevices fbrdetectionofhlown帥demergingbloodbomepathogens;

ConV血Ced dlat traceability ofa11 Sta号es ofthe preparauon ofblood products, from thedonor to the recipient飢d 、‘iceversa, is essential to identi61nsks, particularly the廿ωIsmissionOf path0客enS 飢d 廿勧Sfusion reacuons, a11d to monitor the efficacy of conective measuresaiming tominimi鵡Suchdsks;

Convinced that good pMctices need to be 血Plemented fbr recNiting voluntary, non・remunerated healthy blood抑d plasma donors from low・risk donorpopulations, 肌d test血g ofandonatedbloodfor廿飢Sf、1Sion一廿抑SmissiblepadloBens,釦dthatthewholechainofprocessesin伽eproductionofbloodproducts, i‘e. conectprocessing, 1abeⅡin3, st0腿ge肌d廿飢叩odationneedstobecoveredbyreleV抑t,reliablequali島、assur帥Cesystems;

RecogniZ血g that S廿ingentre8Ulatorycon廿ol iSⅥtal in assuritlg thequali島,atld safetyofbloodproducts, aswe11 asofrelated invi廿odiagnosticdevices,飢d杜latspeciale丑‘odisneededto S廿engthen glob址ly the teclmical capacib,ofregulatory authorities to assure t11e appropriateCon廿01 、vorldwide;

EB126.R14

Recalnng preYious resolutions of the Health Assembly mention註18 the vital need toS廿engthenbloodestabliS1血entS飢densurethequaliw, safeり1帥de伍Cacyofbloodptoducts

URGESMemberstates

a) to take a11 the necess ste s to establish im lement 飢d suCoordinated ef丘Ciend m飢a ed 即d sustainable blood a11d lasma

accordin to the availabiliUnlesss ecialcircumst飢Ces reclude北

ro ranlmes

of resources. with the aim of achievin self”suf量Cienc

(2) to take a11 the necessaw steps to update their nationa1 1egislation on donorassessment飢ddefe庁al,thec011ection,testh1呂,processing。 stora8e,廿組Sportation抑duseOfbloodproductS如doperationofregulatoryauthori証es toensUル thatregulatorycon廿01血 the area of quali智 a11d safew ofblood products across t11e entire 廿釦Sfusion chainmeetS血temationa11yrecogni如dst飢dards;

Andre8ion丑leco”omicinte且ralionor且抑izations,whefeapplicable

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EB126、R14

(3) to establish quali島I systems, 仏r the processing of whole blood 釦d bloodComponents, good m飢UfactU1証 lg practices for the produCιion of plaS皿a・dedvedmedic

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11alproductS飢dappropli

ateregulatolycon廿01;

(4) to build hum飢 resource capaci6r壮lroU容hale provision of11gofstafftoensurequali島,ofbloodseNiceS釦dbloodproduC船;

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(5) to enh飢Ce lhe qualiりf ofevalU雛ion肌d.re豊Ulatoly acti

ons in t11e area ofbloodProductS釦dassoci飢ed血edicaldevices indudin客血Ⅵ廿odiagnoslicdevices;

(6) to establish or S廿帥gthen systemS加r山e safe飢d松dDnal use ofblood produC船釦d toprovide廿ain血gfbra11 Sta丘involved i11C1血SolunonS 血 order tomin

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血i鵡壮釦Snlsion ed0婚飢d promote pati

ent safeりr, to promotet11e aV祉labili島,, of tratlsnlsion altemativeS 血Clud血& where approp”ate aut010gous廿飢Sfusion釦dpatientblood皿飢a8ement;

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C址住如S61Sion,to imple血entpotenti址

(フ) toenS世edlereliabili島10fmech飢ismS血rrep0札hlg sedousorurlexpectedadversereactions to blood 飢d plasma donation 飢d t0 吐le receipt of blood c0血PonentS 飢dP1鮎ma・dedvedmedicinalPミ0duC船 血Clud血g住釦Smissi0伽ofpa山ogens、

REQUESTSιheD辻ector・Gener可:

(1) to guide Member states lom門ti

11temauona11y Ncognized sta11d釦‘ds in updathlg血e辻le8islalion,nation址St勧dardS飢dre且Ulationsfore丘eclivecon廿010flhequali島1飢dSafe島,ofbloodproduC船a11dassociated血edicaldevices,血C1覗d血g血Vi廿odi姥nostics‘

(2) 如 advise如d build capaciり1血 Member Sιales on leadershゆ肌dma11agement ofblood supply systems 11 0rdertoS住engthennationalcoordina如d肌dsusta

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tlable blood飢dplasmapr03rammes by shar血 g bestpractices aboutdlebestorg帥izadonal st川Ct山e

rlcreasee缶Ciency飢dmin血izeerrot;

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forbloodsupplysystemS血ordertoi

(3) to extend nle support0丘ered toMember states fbr develoP血g如d S訂‘engtheni

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rnational re8UlatolyauthodⅡeS飢d con廿011aboratodes soas t0 血Crease the辻Competence 血 thecontr01 0fblood produC捻 飢d associatedmedical devices,血Vi廿o di姥110stic devices,釦d fbsterhlg小ecreation of re8ional c011ab0松”ve飢dre号U1甜olyneNorkswheルnecessalya11dappropdate;

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nable development 飢d provision of 血temational bi010gicalref己renN 皿atedals (WHo n1如mational st飢d笛ds) for use 血 the qualiりr contr01 釦dregulationofbloodproduclsatldrelated血VitrodiagnosucdeviNS;

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(6) to develop, provide 飢d dissem血ateguid飢Ce飢d teclmical suppon to S紅‘engthennationalcooMinatedblood釦dplasmaprogrammeS如d血troductionofbloodcomponent鵠P紅ation 如d plasma n‘actionadon teclm010幻, t0 血此t local needs, 飢d promotee丘ective ル呂Ulatory ovasigM of blood serviceS 釦d implementation of. good

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Ⅱ1飢Ufacturh lg pracuNS 血 Plasma－fiactionation pr0号rammes, under thetesponsibiliり, ofregulatoryaU山odues;

(フ) to provideguid飢Ce,廿a血 血宮釦d supR0丘toMemberS仏tes on safe飢d松nonaluseOfblood productsto supp0熊仕‘e 血廿oduction of住卸S61Sion址tematives includ血名, whereapproprate, aut010号OUS 住鯲S61Sion, safe 廿飢S61Sion practices a11d pauent blood血飢agement;

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(8) to encour姥e research into new teC111‘010gies forproducin名 Safe飢de丘‘eCιive bloodSubsti加tes;

(9) t0 血f0血 re豊U1笹ly,atle郎tevewf0山ye笛S,theHea1血Assembly,t址OU8hⅡleEX卯UuveB0紅‘d,on aclions takenbyMemberS仏teS釦d otherparme鴬‘

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