regul ec european parliament council decemb orphan medicin product european parliament council european union regard treati establish european commun articl thereof regard propos commiss regard opinion econom social committe act accord procedur laid articl treati condit occur infrequ cost develop bring market medicin product diagnos prevent treat condit recov expect sale medicin product pharmaceut industri unwil develop medicin product normal market condit medicin product call quot orphan quot patient suffer rare condit entitl qualiti treatment patient stimul research develop bring market medic pharmaceut industri incent develop orphan medicin product unit state america japan european union limit action nation commun level stimul develop orphan medicin product action commun level order advantag widest market avoid dispers limit resourc action commun level prefer uncoordin measur member state result distort competit barrier intra commun trade orphan medicin product elig incent easili unequivoc identifi achiev result establish open transpar commun procedur design potenti medicin product orphan medicin product object criteria design establish criteria base preval condit diagnosi prevent treatment sought preval affect person thousand gener regard threshold medicin product intend life threaten debilit chronic condit elig preval higher thousand committe compos expert appoint member state establish examin applic design committe includ repres patient associ design commiss person design commiss recommend european agenc evalu medicin product hereinaft refer quot agenc quot agenc respons adequ coordin committe orphan medicin product committe proprietari medicin product patient condit deserv qualiti safeti efficaci medicin product patient orphan medicin product submit normal evalu process sponsor orphan medicin product possibl obtain commun authoris order facilit grant mainten commun authoris fee paid agenc waiv part commun budget compens agenc loss revenu occas experi unit state america japan show strongest incent industri invest develop market orphan medicin product prospect obtain market exclus number year part invest recov data protect articl iii council direct eec januari approxim provis laid law regul administr action relat medicin product suffici incent purpos member state act independ introduc measur commun dimens provis contradictori direct eec measur adopt uncoordin manner member state creat obstacl intra commun trade lead distort competit run counter singl market market exclus limit therapeut indic orphan medicin product design obtain prejudic exist intellectu properti right interest patient market exclus grant orphan medicin product prevent market similar medicin product signific benefit affect condit sponsor orphan medicin product design regul entitl full benefit incent grant commun member state support research develop medicin product diagnosi prevent treatment condit includ rare diseas specif programm biom fourth framework programm research technolog develop support research treatment rare diseas includ methodolog rapid scheme develop orphan medicin product inventori orphan medicin product europ grant intend promot establish cross nation cooper order implement basic clinic research rare diseas research rare diseas continu prioriti commun includ framework programm research technolog develop regul establish legal framework swift effect implement outcom research rare diseas identifi prioriti area commun action framework action field public health commiss commun programm commun action rare diseas framework action field public health decid give rare diseas prioriti public health framework european parliament council adopt decis ec april adopt programm commun action rare diseas framework action field public health includ action provid inform deal cluster rare diseas popul support relev patient organis regul implement prioriti laid programm action adopt regul articl purpos purpos regul lai commun procedur design medicin product orphan medicin product provid incent research develop place market design orphan medicin product articl definit purpos regul quot medicin product quot mean medicin product human defin articl direct eec quot orphan medicin product quot mean medicin product design term condit regul quot sponsor quot mean legal natur person establish commun seek obtain obtain design medicin product orphan medicin product quot agenc quot mean european agenc evalu medicin product articl criteria design medicin product design orphan medicin product sponsor establish intend diagnosi prevent treatment life threaten chronic debilit condit affect thousand person commun applic made intend diagnosi prevent treatment life threaten debilit chronic condit commun incent market medicin product commun gener suffici return justifi invest exist satisfactori method diagnosi prevent treatment condit question authoris commun method exist medicin product signific benefit affect condit commiss adopt provis implement articl form implement regul accord procedur laid articl council regul eec articl committe orphan medicin product committe orphan medicin product hereinaft refer quot committe quot set agenc task committe examin applic design medicin product orphan medicin product submit accord regul advis commiss establish develop polici orphan medicin product european union assist commiss liais internation matter relat orphan medicin product liais patient support group assist commiss draw detail guidelin committe consist member nomin member state member nomin commiss repres patient organis member nomin commiss basi recommend agenc member committe appoint term year renew accompani expert committe elect chairman term year renew repres commiss execut director agenc repres attend meet committe agenc provid secretariat committe member committe requir duti ceas disclos inform kind cover oblig profession secreci articl procedur design remov regist order obtain design medicin product orphan medicin product sponsor submit applic agenc stage develop medicin product applic market authoris made applic accompani particular document corpor perman address sponsor activ ingredi medicin product propos therapeut indic justif criteria laid articl met descript stage develop includ indic expect commiss consult member state agenc interest parti draw detail guidelin requir format content applic design agenc verifi valid applic prepar summari report committe request sponsor supplement particular document accompani applic agenc ensur opinion committe dai receipt valid applic prepar opinion committe endeavour reach consensu consensu reach opinion adopt major third member committe opinion obtain written procedur opinion committe applic satisfi criteria set articl agenc forthwith inform sponsor dai receipt opinion sponsor submit detail ground appeal agenc refer committe committe opinion revis meet agenc forthwith forward final opinion committe commiss adopt decis dai receipt opinion except circumst draft decis accord opinion committe decis adopt accord procedur laid articl regul eec decis notifi sponsor commun agenc compet author member state design medicin product enter commun regist orphan medicin product year sponsor submit agenc report state develop design medicin product design orphan medicin product transfer sponsor holder design make specif applic agenc consult member state agenc interest parti commiss draw detail guidelin form applic transfer made content applic particular sponsor design orphan medicin product remov commun regist orphan medicin product request sponsor establish market authoris grant criteria laid articl longer met respect medicin product concern end period market exclus laid articl articl protocol assist sponsor orphan medicin product prior submiss applic market authoris request advic agenc conduct test trial demonstr qualiti safeti efficaci medicin product accord articl regul eec agenc draw procedur develop orphan medicin product cover regulatori assist definit content applic authoris mean articl regul eec articl commun market authoris person respons place market orphan medicin product request authoris place medicin product market grant commun accord provis regul eec justifi medicin product qualifi part annex regul special contribut commun distinct provid articl regul eec alloc year agenc contribut exclus agenc waiv part total fee payabl commun rule adopt pursuant regul eec detail report made special contribut present execut director agenc end year surplu occur year carri forward deduct special contribut year market authoris grant orphan medicin product cover therapeut indic fulfil criteria set articl prejudic possibl appli separ market authoris indic scope regul articl market exclus market authoris respect orphan medicin product grant pursuant regul eec member state grant market authoris accord procedur mutual recognit laid articl direct eec articl council direct eec approxim provis laid law regul administr action relat medicin product prejudic intellectu properti law provis commun law commun member state period year accept applic market authoris grant market authoris accept applic extend exist market authoris therapeut indic respect similar medicin product period reduc year end year establish respect medicin product concern criteria laid articl longer met inter alia shown basi evid product suffici profit justifi mainten market exclus end member state inform agenc criterion basi market exclus grant met agenc initi procedur laid articl sponsor provid agenc inform purpos derog paragraph prejudic intellectu properti law provis commun law market authoris grant therapeut indic similar medicin product holder market authoris origin orphan medicin product consent applic holder market authoris origin orphan medicin product unabl suppli suffici quantiti medicin product applic establish applic medicin product similar orphan medicin product authoris safer effect clinic superior commiss adopt definit quot similar medicin product quot quot clinic superior quot form implement regul accord procedur laid articl regul eec commiss draw detail guidelin applic articl consult member state agenc interest parti articl incent medicin product design orphan medicin product provis regul elig incent made commun member state support research develop avail orphan medicin product aid research small medium size undertak provid framework programm research technolog develop juli member state commun commiss detail inform measur enact support research develop avail orphan medicin product medicin product design inform updat regularli januari commiss publish detail inventori incent made commun member state support research develop avail orphan medicin product inventori updat regularli articl gener report januari commiss publish gener report experi acquir result applic regul account public health benefit obtain articl entri forc regul enter forc dai public offici journal european commun appli date adopt implement regul provid articl articl regul bind entireti directli applic member state brussel decemb european parliament presid fontain council presid hemilä oj oj opinion european parliament march oj council common posit septemb oj decis european parliament decemb publish offici journal oj direct amend direct eec oj oj oj regul amend commiss regul ec oj oj direct amend council direct eec oj