ਸ਼79৚෵ᡳ‫ۊں‬ଢ଼஢ভ
2015ফ6া27঩‫ق‬ଅ‫ك‬ मगीपഷัহ঵पঢ়घॊ
(8੐ഥभ໪ਏ (8ഷั੐ഥपඹॊऽदभ৽༬ (8ഷั੐ഥभ৔ઍOutline of the EU-Directive on Blood Services ऽधी᭔ੈপ৾১৾৖
Faculty of Law, Dokkyo University

ถखऎम...

ᇰံَEUपउऐॊ঄ॺഷั఺लഷัਛীभષସध਍৸ਙभఏ૆ਝ৒पঢ়घॊ੐ഥ‫ق‬EUഷั੐ഥ : அ2009ফ੝ਫ৔ઍ‫ُك‬ಯળপ৾১৆ଢ଼஢18ඕ1=2ಀ‫ق‬2014‫ك‬146-108ᅚၳઇ౸‫؞‬ઋ஝ౘ঳
K. Jimba, Associate Prof.

12ഷั઀୹঻॑൳ॉ‫્ق‬प૮೥दষॎोॊ୹ഷَ॑൴ഷُधःअ‫؜ك‬जभ঻ऊैഷั఼॑਄खञ঱द‫؜‬जो॑ਉમधखथഷัଲදಉ॑੿ਛख‫؜‬ୢ௜ਃঢ়प୹ஔघॊ঳৴भૌங॑ःअ‫؛‬‫ق‬1‫ك‬मगीप਼ੀ৸৬भഷัଲષ৘ৃम‫؜‬2014ফभ302੏৪ॻঝऊै4.9%भCAGR‫ق‬ফ਴಑ਛশ
૨‫ك‬द௓୎ख‫؜‬2019ফपम383੏৪ॻঝभ
৘ৃૠெप୸घॊध੒೾औोथःॊ‫؛‬34 ૶சऩୢ௜ૼ୒भ৅னध১भ૬ྍ৲ਠ଴‫؞‬৮ভ਑ড়਌਌ଝभశ஍૨ਙ‫ۊں؞‬पेॊਃ৿৓ऩ৹ତ ௎ପ૚ব৑पउऐॊୢ௜ત୷भਖ਻ःऊप৹ତघॊऊ‫ء‬5EUূ௎෠ऒभ஠૫ਙ॑఻৬৓पኇइॊध…
୻इय‫ূ؜‬਎ব੠૬௃भফ৑৅ାਯम
38ਐ4000੯
जभ0.06٫मَফ৑230੯ُपৼਊघॊ
3঩भ৔2঩म੎পহ௛ऋ৅ে!!!

WHO, Global Database on Blood Safety, Summary Report 2011, p. 6

7WHO, Global Database on Blood Safety, Summary Report 2011, p. 4

6

Directive 2002/98/EC of 27 January 2003
on setting standards of quality and safety
for the collection, testing, processing,storage and distribution of human bloodand blood components঄ॺഷั఺लഷัਛীभઽૐ‫؜‬ਫ਼ਪ‫؜‬ਸੵ‫؜‬৳ଵ఺लଦীपঢ়घॊષସ఺ल਍৸
ਙभఏ૆भਝ৒पঢ়घॊ੐ഥ
EUഷัহ঵पउऐॊಟ੐ഥ‫ق‬Mother Directive‫ك‬8

1981ফपग़ॖ६೩঻ऋ॔ওজढ़द৅ৄऔो
ॊ‫ق‬ऒभৎम‫؜‬ਉ౤ਂ৥दँढञ‫؛ك‬83ফ৐৏पम‫؜‬क़ॖঝ५ऒज৅ৄऔोथः
ऩःुभभ‫॔؜‬ওজढ़भ৆ਿਃঢ়ऊैग़ॖ
६ऋഷัଲද॑ৢखथ૎ഉघॊન૨ऋৈऎ‫؜‬శਸ೸भഷัଲදभઞ৷म஠૫दँॊधः
अਾઔऋᄄ෬पলऔोथःञ‫؛‬ऒभ॔ওজढ़ऊैभୟোഷัଲදपेॉ‫؜‬
1980ফ৻प‫؜‬௎ପ੔ਤব॑রੱपఇ૩ग़ॖ६ምऋఁপ৲खञ‫؛‬‫ق‬2‫ك‬EUഷั੐ഥप
ඹॊऽदभ৽༬
9௎ପુ৊৬ਝয়૖৺‫ق‬ঐ‫ش‬५ॺজ঄ॺ૖৺ග‫ك‬
ਸ਼129૖ਸ਼1ඨਸ਼1ધુ৊৬म‫؜‬ਸೇব৑भੈৡ॑တཫघॊऒधपेॉ‫ྼ؜‬म૑ਏपૢगथਸೇব৑भষ৿੍॑ରघॊऒधपेॉ‫؜‬ৈ২ऩ਷૆पउऐॊয৑भ௏೨৳૧॑৳௽घॊऒधपఞଖघॊ‫؛‬

11

10

¾
¾
¾
¾

௎ପુ৊৬ୠ৔पउऐॊഷัभ਍৸ਙ఺लഷ
ัभঽஔঽଌपঢ়घॊ1994ফ12া21঩હ௎ପ੻৩ভৢੴ
ુ৊৬ୠ৔पउऐॊഷัभ਍৸ਙ఺लഷัभ
ঽஔঽଌपঢ়घॊ1995ফ6া2঩હ௎ପ৴়
৶হভৠ৮௎ପુ৊৬ୠ৔पउऐॊഷัभ਍৸ਙ఺लഷ
ัभঽஔঽଌभञीभਅറपঢ়घॊ1996ফ
11া12঩હ௎ପ৴়৶হভৠ৮
1993ফ9া14঩હ ‫؜‬1993ফ11া18঩હ ‫؜‬
1995ফ7া14঩હ ‫؜‬1996ফ4া17঩હ भ௎ପુ৊৬ୠ৔पउऐॊഷัभ਍৸ਙपঢ়घॊ
௎ପ৮ভৠ৮12௎ପુ৊৬ਝয়૖৺‫॔ق‬঒५ॸঝॲ঒૖৺ග‫ك‬
ਸ਼152૖ਸ਼4ඨഷัহ঵भૠ਑पঢ়घॊ১൅
Gesetz zur Regelung des Transfusionswesens:
Transfusionsgesetz – TFG

1998ফ5া19঩ਛয়‫؞‬7া7঩઱ষэ EU෠৔पउःथਈुଫःৎ਋प਑৒औो
ञഷัহ঵पঢ়घॊෆฐ৓ૠ਑১
ถखऎमᇰံَॻॖॶपउऐॊഷัহ঵भ১৓ೳੌ‫ق‬அ‫؟‬ਠষॻॖॶ
َୟഷ১ُ૖ધ๨‫ُك‬ಯળপ৾১৆ଢ଼஢ඕಀ‫كق‬ᅚ

13௎ପ৴়৶হভम‫؜‬251૖पૠ৒औोञুਢप
జः‫؜‬ऊण‫঺ੋ৽؜‬ভ௬৮ভ఺ल৉ୠ௬৮ভध
भੈ৮भ৏‫؜‬ম૖पૠ৒औोञਰৣभೈ઼఼॑
උघॊऒधपेॉ‫؜‬जभ৯৓भ୸ਛपఞଖघॊ‫؛‬(a) ঄ॺ૓ਟभටஓ఺लੌ௶ధलपഷั఺लഷัଲදभञीभષସ఺ल਍৸ਙपঢ়घॊৈ
২ऩఏ૆॑ਝ৒घॊೈ઼‫؛‬ऒभೈ઼म‫؜‬ਸೇবऋಌपడતऩ৳૧৓ೈ઼॑೐੅ख‫ྼ؜‬म଑োघॊऒध॑࿉ऑॊुभदमऩः‫؛‬14

 Directive 2001/83/EC of the European
Parliament and of the Council of 6 November
2001 on the Community code relating tomedicinal products for human use঄ॺୢఇષपঢ়घॊુ৊৬ഹ୩पঢ়घॊ2001
ফ11া6঩હ௎ପ৮ভ఺ल௎ପ৴়৶হভप
उऐॊ2001/83/EC੐ഥ Directive 2004/23/EC of 31 March 2004 on setting
standards of quality and safety for the donation,procurement, testing, processing, preservation,storage and distribution of human tissues঄ॺੌ௶఺ल಍ཝभ઀୹‫؜‬৹୸‫؜‬ਫ਼ਪ‫؜‬ਸੵ‫؜‬৳ோ‫؜‬৳ଵ఺लଦীपঢ়घॊષସ఺ल਍৸ਙभఏ૆भਝ৒पঢ়घॊ੐ഥ঄ॺഷั఺लഷัਛী૓ਟभਓ঵৷ୢఇષभષସ఺ल਍৸ਙ॑ૠ਑ৌ଴঄ॺ૓ਟभ৸ഷ఺लഷัਛীঽ৬म‫؜‬जभి৷෇೧ऊै৥નप௾ਗ
ୟഷपঢ়घॊષସ఺ल਍৸ਙ॑ન৳घॊૠ৒म‫؜‬EUୠ৔पउःथோ૔खऩऊढञ

 Directive 2010/45/EU of the European Parliamentand of the Council of 7 July 2010 on standards ofquality and safety of human organs intended fortransplantation୎೘॑৯৓धघॊ঄ॺටஓभષସ఺ल਍৸ਙपঢ়घॊ੐ഥ
16

2002ফEUഷั੐ഥष!!!

15ഷัহ঵पঢ়घॊব৔৬਑भତ૟‫ق‬3‫ك‬‫ق‬1‫ك‬হ঵भ૰୚

¾ ਸೇবम‫؜‬ഷัभષସ‫؞‬਍৸ਙ॑નੳघॊञीभਫ਼ਪਥ଒॑થघॊਚლ઻ૂ॑ਝ઼घॊऒध‫ق‬4૖‫ك‬¾ ഷัহ঵पঢ়घॊણ৿भੳ઒‫؞‬ఃஈ৬਑॑ତ૟घॊऒध‫ق‬5૖‫ك‬EUഷั੐ഥभ৔ઍ

‫ق‬2‫ك‬ഷั਍৸૰ଳ‫ق‬ঊঔঅ४ছথ५‫ك‬৬਑भનয়

17¾ ഷัभ୯඄৹ਪ৬਑॑નয়घॊऒध‫ق‬14૖‫ك‬¾ થ૩হ଴पঢ়घॊਾઔ‫؞‬৴൪৬਑॑નয়घॊऒध‫ق‬15૖‫ك‬

18୹ഷ঻भ৳૧

ਭഷ঻भ৳૧

¾ ୹ഷ঻षभੲਾ઀୹‫ق‬16૖‫ك‬¾ ୹ഷ঻ऊैभ৊ਔभඃ੭‫ق‬17૖‫ك‬¾ ૭ચऩ଒ॉ‫ق‬in so far as possible‫ك‬૮೥भ୹ഷ॑௓ਤ‫ق‬20૖‫ك‬¾ ୹ഷ঻भੲਾ৳૧‫ق‬24૖‫ك‬¾ ୹ഷ঻भిતਙଟਪ‫ق‬18૖‫؞‬19૖‫ك‬¾ ୹ഷभਫ਼ਪ‫ق‬21૖‫ك‬¾ ഷัহ঵पउःथਈৗभୢ৾৓ੴৄऋ
଑োऔोॊऒधभ৬਑ତ૟‫ق‬29૖‫ك‬

1920

¾ Commission Directive 2004/33/EC of 22 March 2004 implementing Directive
2002/98/EC of the European Parliament and of the Council as regards certain
technical requirements for blood and blood components¾ Commission Directive 2005/61/EC of 30 September 2005 implementing
Directive 2002/98/EC of the European Parliament and of the Council as
regards traceability requirements and notification of serious adverse reactions
and events‫ق‬4‫ك‬¾ Commission Directive 2005/62/EC of 30 September 2005 implementing
Directive 2002/98/EC of the European Parliament and of the Council as
regards Community standards and specifications relating to a quality systemfor blood establishmentsऽधी¾ Commission Directive 2009/135/EC of 3 November 2009 allowing temporary
derogations to certain eligibility criteria for whole blood and blood components
donors laid down in Annex III to Directive 2004/33/EC in the context of a riskof shortage caused by the Influenza A(H1N1) pandemic

21঩মपउऐॊഷัহ঵भഄఴ1956ফ‫؟‬఼ഷ఺ल୹ഷँणच॒঵਄ഁ১1964ফ‫؟‬ছॖ३কড‫ش‬হ੯эَ൴ഷभ௓ਤपणःथ‫ق‬ద৮ৠ৒‫ُك‬঩ম஧ેஊ঺पेॊ൴ഷਭো৬਑भનয়ਲ਼ഷभ৸ా਋1983ফ‫؟‬ఇ૩ग़ॖ६ਖ਻
1990ফ‫؟‬2002ফ‫؟‬ড়৑ଲఇ঵঻पेॊથ೥఼᪺ऋরૃэഷัଲදଲୗ৯৓भ఼ഷऋ঩ম஧ેஊ঺प঳੪৲َ਍৸ऩഷัଲදभ਍৒୹ஔभન৳ಉपঢ়घॊ১൅ُэ਌଑ਥम‫؜‬ௐௌ੄षড়৑হ঵पेॊ଺૩ऋেगञ৏पਁ৓ଵ৶धःअ૴ो2322೑ऋবपउःथ‫؜‬০৏‫؜‬঄ॺ૓ਟে੟৾৓౫મ‫؞௶ੌق‬಍ཝ‫؟‬ગেୢ௜भ૑೽ષ‫॑ك‬਄ॉඞअ੠‫؜‬नभेअप‫؜‬जभષସ‫؞‬਍৸ਙ॑ન৳खथःऐयःःभऊ‫ء‬ഷัহ঵भ૔ॉ্म
जभ੦মঔॹঝधਛॉअॊ!!!

24