El acceso a los fármacos como objeto de interés del derecho internacional público

AutorXavier Seuba Hernández
Páginas197-243
&$3Ë78/29
EL ACCESO A LOS FÁRMACOS COMO
OBJETO DE INTERÉS POR EL DERECHO
INTERNACIONAL PÚBLICO
I. EL ACCESO A LOS FÁRMACOS: SIGNIFICADO
Y REGÍMENES IMPLICADOS
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B. Situación mundial con respecto al acceso
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gles pertinentes du droit relatif à cette question fait donc partie intégrante
de la tâche d’interprétation conf‌i ée à la Courª
E Principios del Derecho, principios jurídicos y la nueva dimensión
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d’Amérique), Arrêt, CIJ Recueil 2003SiUUS
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Ibid.,S
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 :+2Guidelines for developing national drug policies*HQHYD:+2
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mique du médicamentGH Health reform and drug f‌i nancing: selected topicsGH\D
SDUWLUGHODFROHFFLyQVREUHEconomía de la salud y medicamentos.
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SODQRQDFLRQDOFRPRHQHOSODQR LQWHUQDFLRQDOVHKDRWRUJDGRHIHFWRV
MXUtGLFRVDOLVWDVQDFLRQDOHVGHPHGLFDPHQWRVHVHQFLDOHVDOD/LVWD0R
GHORGHOD 206\ DORV FULWHULRV TXHODDFRPSDxDQ &RPRVHGHWDOOD
PiVDGHODQWHHQGLYHUVRV(VWDGRVVHKDHQWHQGLGRTXHHODFFHVRDORV
PHGLFDPHQWRVHVHQFLDOHVUHFRJLGRVHQVXVOLVWDVQDFLRQDOHVGHPHGLFD
PHQWRVHVHQFLDOHVHVXQ GHUHFKRIXQGDPHQWDO\VHKDQLQVWUXPHQWDGR
\GHVDUUROODGRSROtWLFDVIDUPDFpXWLFDV\ VREUHGHUHFKRVGH SURSLHGDG
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WHUQDFLRQDOQRVRODPHQWHOD206\GLYHUVDVFRQIHUHQFLDVVDQLWDULDVLQ
WHUQDFLRQDOHVKDQDIUPDGRTXHHODFFHVRDORVPHGLFDPHQWRVUHFRJLGRV
HQOD/LVWD0RGHORHVXQGHUHFKRKXPDQRVLQR TXHWDPELpQHO&RP
'(6&GHIRUPDH[SOtFLWD\RWURVFRPLWpVHQFDUJDGRVGHODVXSHUYLVLyQ
GHGLYHUVRVWUDWDGRVGH GHUHFKRVKXPDQRVGHIRUPDDOJRPiVREOLFXD
KDQ FRQVLGHU DGR TXH HO DFFHVR D  GLFKRV IiUPDFRV  QR VyOR LQWHJUD H O
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HOiPELWRGH ODSURSLHGDGLQWHOHFWXDOHO KHFKRGHTXH XQIiUPDFRVH
UHFRMDHQOD/LVWD0RGHORGH0HGLFDPHQWRV(VHQFLDOHVKDVHUYLGRSDUD
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GHTXHHO3$0(\OD/LVWDGHPHGLFDPHQWRVHVHQFLDOHVVRQXQDFRQWULEX
FLyQIXQGDPHQWDOGHOD206SDUDDVHJXUDUHOUHVSHWRHIHFWLYRGHOGHUHFKR
DODVDOXG1RVyORHVRVLQRTXHORVLQIRUPHVHLQGLFDGRUHVTXHOD206
DGRSWDVREUHODHYROXFLyQGHODVLWXDFLyQIDUPDFpXWLFDHQORVGLYHUVRVSDt
VHVVRQXQLQVWUXPHQWRSDUDIVFDOL]DUHOUHVSHWRDODVREOLJDFLRQHVGHUL
YDGDVGHOGHUHFKRDODVDOXGHQHO3,'(6&'HKHFKROD206IRUPX
ODSODQWHDPLHQWRVPX\SUy[LPRVDOOHQJXDMHGHORVGHUHFKRVKXPDQRV\
HYRFDQGRORVHOHPHQWRVLQWHUUHODFLRQDGRVGHOGHUHFKRDODVDOXGDIUPD
TXH©SDUDDOFDQ]DUORVREMHWLYRVGHXQDSROtWLFDIDUPDFpXWLFDQDFLRQDOHO
JRELHUQRWLHQHTXHGHVHPSHxDUXQDIXQFLyQSULPRUGLDOFRQVLJXLHQGRTXH
ORVPHGLFDPHQWRVGLVWULEXLGRVHQORVVHFWRUHVS~EOLFR\SULYDGRVHDQGH
FDOLGDGDFHSWDEOHLQRFXRV\HIFDFHV(OJRELHUQRWLHQHWDPELpQODUHVSRQ
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DFFHVRJHRJUiIFR\VXFDUiFWHUDVHTXLEOHDFFHVRHFRQyPLFRVLXQDJUDQ
SDUWHGHODVSREODFLRQHVGHEDMRVLQJUHVRVRGHOXJDUHVGLVWDQWHVGHSHQGHQ
GHOVXPLQLVWURGHPHGLFDPHQWRVSRUHOVHFWRUSULYDG
 (VWHIXHHOFDVRGHOD&RPXQLGDG$QGLQDTXHHQVX'HFLVLyQH[FOX\yODSDWHQWDELOL
GDGGHORVIiUPDFRVUHFRJLGRVHQOD/LVWD0RGHORGH0HGLFDPHQWRV(VHQFLDOHVGHOD206
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 7pUPLQRVLGpQWLFRV DORV©HOHPHQWRV GHOGHUHFKRD ODVDOXGªVid206 ©2SFLRQHVHQ
HOVXPLQLVWUR GHPHGLFDPHQWRV ¢4XpIXQFLRQD PHMRU"ªBoletín de Medicamentos EsencialeV
Q~P\S
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iPELWRGHODFRRSHUDFLyQWpFQLFDKDVLGRODDVLVWHQFLDDORVSDtVHVHQGH
VDUUROORSDUDKDFHUXVRGHODVIH[LELOLGDGHVGHO$'3,&6XLQFLGHQFLDQR
VHFLUFXQVFULEHDOSODQRGHODJHVWLyQIDUPDFpXWLFDVLQRTXHWDPELpQVH
H[WLHQGHDOQRUPDWLYR(QSULPHUOXJDUHVWRHVORTXHKDQDFRUGDGRORV
(VWDGRV0LHPEURVGHOD206TXHHQUHVROXFLRQHVHQHOVHQRGHOD$VDP
EOHD0XQGLDOGHOD6DOXGKDQLQVWDGRDORV(VWDGRVDXWLOL]DUDOPi[LPR
ODVIH[LELOLGDGHVFRQWHQLGDVHQHO$'3,&
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FLRQHVQDFLRQDOHVHQPDWHULDGHSURSLHGDGLQWHOHFWXDOPLHQWUDVTXHRWURV
KDQHQFRQWUDGRHQPLVLRQHVGHOD 206HODSR\R WpFQLFR\SROtWLFRQH
FHVDULRSDUDVXVWHQWDU LQWHUSUHWDFLRQHVMXUtGLFDVGHO$FXHUGRIDYRUDEOHV
DODSURWHFFLyQGHODVDOXGS~EOLFDFXPSOLpQGRVHDVtHOREMHWLYRGHOD
206GH©SURSRUFLRQDUDVHVRUDPLHQWRLQGHSHQGLHQWH\DVLVWHQFLDWpFQLFD
DORVSDtVHVSDUDD\XGDUOHVDGHVDUUROODUDSUR[LPDFLRQHVLQIRUPDGDVSDUD
DERUGDUODVLPSOLFDFLRQHVVREUHODVDOXGGHORVLQVWUXPHQWRVGHFRPHUFLR
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III. LA IRRUPCIÓN DE LA OMC EN EL ÁMBITO
DE LOS FÁRMACOS
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UDOGHOFRPHUFLRDGPLQLVWUDGRSRUOD20&RFXSDXQOXJDUFHQWUDOHQWUHORV
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FRQORVPHGLFDPHQWRVODDWHQFLyQVHKDFRQFHQWUDGRSULQFLSDOPHQWHHQHO
$FXHUGRVREUHORV$'3,&/DGHQRPLQDGDvis atractiva GHO 'HUHFKRGHO
FRPHUFLRLQWHUQDFLRQDOKDKHFKRTXHHQWRUQRDOPLVPRVHGLVFXWDQFXHV
WLRQHVUHODFLRQDGDV FRQORVGHUHFKRVKXPDQRVHO PHGLRDPELHQWH\OD
VDOXG7UDVSUHVHQWDUHQHOSULPHUHStJUDIHGHHVWHFDStWXOR ORVIDFWRUHV
TXHLQFLGHQVREUHHODFFHVRODVLWXDFLyQHQPDWHULDGHDFFHVR\ODQRFLyQ
GHUHJtPHQHVLQWHUQDFLRQDOHVPDWHULDOHVHLQWURGXFLUHQHOVHJXQGRHSt
JUDIHHOWUDEDMRGHODRUJDQL]DFLyQLQWHUQDFLRQDOTXHHQSULQFLSLRGHEHUtD
RFXSDUHOFHQWURGHODUHJXODFLyQLQWHUQDFLRQDOGHORVIiUPDFRVHVWHWHU
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property rights, innovation and public health,:+$
 &DVRSRUHMHPSORGH7DLODQGLDTXHWUDVODSUHVLyQUHFLELGDSRUODFRQFHVLyQGHGLYHUVDVOL
FHQFLDVREOLJDWRULDVVROLFLWyXQDPLVLyQWpFQLFDGHOD206SDUWLFLSDGDWDPELpQSRUOD81&7$'
HO318'\OD20& SDUDHYDOXDUODVRSFLRQHVDVXDOFDQFHTXH UHVSHWDQGRHO$'3,&OHSHUPL
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Access to Medicines in Thailand. The use of TRIPS Flexibilities, Report of a WHO Mission, 31
January to 6 February 2008%DQJNRN1DWLRQDO+HDOWK6HFXULW\2IIFH
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tionYROQ~PSS
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WLGRODVSULQFLSDOHVFXHVWLRQHVHQPDWHULDGHIiUPDFRV6HHVWDEOHFHQDVt
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ORV$'3,&GHVGHODSHUVSHFWLYDGHODVDOXGFRPRELHQMXUtGLFRDSURWHJHU
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JXQGD*XHUUD0XQGLDOFRQYHQFLyHQODVSRVWULPHUtDVGHODPLVPDGHOD
QHFHVLGDGGHLQVWDXUDUXQVLVWHPDGHFRPHUFLRLQWHUQDFLRQDOEDVDGRHQ
HOOLEUH FRPHUFLR'LFKROLEUHFDPELR VHHQPDUFDUtDHQXQVLVWHPDHFR
QyPLFRPXQGLDOLQWHJUDGRFX\DVSULQFLSDOHVLQVWLWXFLRQHVVHUtDQHO)RQ
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SUHVHQWDGRHQHOTercer Curso Internacional Derechos de Propiedad Intelectual y Salud Pública:
Hacia un Régimen de Propiedad Intelectual que Proteja la Salud Pública y los Derechos de los
Pacientes%XHQRV$LUHVGHPDU]RDOGHDEULOGHSHQORVDUFKLYRVGHODXWRU
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B. Las disposiciones del APDIC relevantes
en materia de fármacos
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SURSLHGDGLQWHOHFWXDO6H WUDWDGHREOLJDFLRQHVTXH WDO\FRPRSUHYpHO
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LPSOHPHQWDUGHODIRUPDTXHHVWLPHQPiVDGHFXDGDHQHOFRQWH[WRGHVX
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VLVWHPDVOHJDOHVª India-Protección mediante patentes de los productos farmacéuticos y de los
productos químicos para la agricultura (India-Patentes), :7'6$%5 GHGLFLHPEUH GH
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patente. Memorándum de la Of‌i cina Internacional de la OMPI+/&(,9,1)GHRFWXEUH
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FyPRVRQXWLOL]DGDVODVLQYHQFLRQHV3RU~OWLPRHOPLVPRDUWREOL
JDDSURWHJHUORVPLFURRUJDQLVPRV\SURFHVRVQRELROyJLFRVRPLFURELR
OyJLFRVDORVTXHQRDPSDUDODSRVLELOLGDGGHH[FOXLUODSDWHQWDELOLGDGGH
VHUHVYLYRV \SURFHGLPLHQWRV HVHQFLDOPHQWHELROyJLFRV GLVSRVLFLyQGH
SDUWLFXODUUHOHYDQFLDSUHVHQWH\IXWXUDFRQUHVSHFWRDORVIiUPDFRVIUXWR
GHODELRWHFQRORJtD
(O DUW UHFRJH HO KDELWXDO GHUHFKR GH H[FOXVLyQ TXH FRQIHUH OD
SDWHQWHHVGHFLUXQGHUHFKRGHFRQWHQLGRQHJDWLYRTXHSHUPLWHDOWLWXODU
LPSHGLUDWHUFHURVODIDEULFDFLyQHOXVRODRIHUWDSDUDODYHQWDODYHQWD
RODLPSRUWDFLyQ SDUDGLFKRV IQHVGHO SURGXFWRSDWHQWDGR$VLPLVPR
FXDQGRODSDWHQWHWLHQHSRUREMHWRXQSURFHGLPLHQWRHOWLWXODUSXHGHLP
SHGLUTXH WHUFHURVXWLOLFHQ HOSURFHGLPLHQWRHLPSHGLUWDPELpQHOXVR
OD RIHUWD SDUD OD YHQWD OD YHQWD R OD LPSRUWDFLyQ SDUD HVWRV IQHV GHO
SURGXFWRREWHQLGR(VWDH[WHQVLyQGHODSURWHFFLyQDOSURGXFWRREWHQLGR
PHGLDQWHHO SURFHVRSURWHJLGRVXPDGD DODLQYHUVLyQ GHODFDUJD GHOD
SUXHEDTXH UHFRJHHODUW\HQ YLUWXGGH ODFXDOHOGHPDQGDGRGHEH
SUREDUTXHHO SURFHVRGLIHUHGHOSDWHQWDGRUHIXHU]DQQRWDEOHPHQWHORV
GHUHFKRVGHSDWHQWHVREUHSURFHVRV3RURWURODGRHQUHODFLyQFRQODLP
SRUWDFLyQHODUWVHUHPLWHDODUWTXHDVXYH]UHFRJHODOLEHUWDGGH
ORV0LHPEURVSDUDHVFRJHUHOUpJLPHQGHDJRWDPLHQWRGHORVGHUHFKRV
/DFRPELQDFLyQGHORVDUWV\ FRQIHUHDOWLWXODU GHODSDWHQWH
XQPRQRSROLRGHH[SORWDFLyQGHODLQYHQFLyQGHDxRVGHVGHODIHFKD
GHSUHVHQWDFLyQGHODVROLFLWXG3RURWURODGRHODUWREOLJDDGLYXO
JDUODLQYHQFLyQ GHPRGR VXIFLHQWHPHQWHSUHFLVR FRPRSDUD TXHXQD
SHUVRQDYHUVDGDHQODPDWHULDSXHGDOOHYDUODDHIHFWR\SHUPLWHDGHPiV
H[LJLUODGLYXOJDFLyQGHOPHMRUPRGRFRQRFLGRSDUDOOHYDUODDODSUiFWLFD
$WRGRHOORVHDxDGHODLQYHUVLyQGHODFDUJDGHODSUXHEDHQFDVRGHTXH
VHGHQXQFLHOD YLRODFLyQGHORVGHUHFKRVGHOWLWXODUGHXQDSDWHQWH\OD
REOLJDWRULDH[LVWHQFLDGH XQFDXFHMXGLFLDOTXHSHUPLWDUHFXUULUODUHYR
FDFLyQGHSDWHQWHV
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UHFKRVFRQIHULGRV\Dotros usosVLQDXWRUL]DFLyQGHOWLWXODUGHODSDWHQWH
 (VGHFLUVHH[FOX\H ODSRVLELOLGDGGHQHJDUOD SDWHQWHFXDQGRSRUHMHPSOR VHUtDHQLQ
WHUpVGHORV SDFLHQWHVHODFFHVRDXQ IiUPDFRFX\DSDWHQWHVH VROLFLWD\VHFXHVWLRQDDOHJDQGR HO
DUW
 &RQDQWHULRULGDG DO$'3,&SDtVHV GHVDUUROODGRV\HQ GHVDUUROORSURWHJtDQODV SDWHQWHV
SRU R DxRVPLHQWUDVTXH HQDOJXQRVSDtVHV HQGHVDUUROOR FRPROD,QGLD ODVSDWHQWHVVH
FRQFHGtDQSRUSHULRGRVGH DDxRV:+2©,QWHOOHFWXDO SURSHUW\SURWHFWLRQLPSDFWRQSXEOLF
KHDOWKªop. cit.,S
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GHPDQHUDLQMXVWLIFDEOHD ODH[SORWDFLyQQRUPDOGHODSDWHQWHQLFDXVDU
XQSHUMXLFLRLQMXVWLIFDGRDORVLQWHUHVHVOHJtWLPRVGHOWLWXODUGHODSDWHQ
WH3RUVXODGRHODUWUHFRJHODIJXUDGHODOLFHQFLDQRYROXQWDULD\
SUHYpODVFRQGLFLRQHVSDUDRWRUJDUODFXDQGRODVOHJLVODFLRQHVQDFLRQDOHV
ODSHUPLWDQ(O$'3,&UHFRJHWDPELpQHOSULPHUHVWiQGDU LQWHUQDFLRQDO
VREUHSURWHFFLyQGHGDWRVGHSUXHEDIDUPDFpXWLFRV(ODUWLQVWDDSUR
WHJHUOD©LQIRUPDFLyQQRGLYXOJDGDªHQWUHODTXHIJXUDQHQHODUW
ORVGDWRVGHSUXHEDH[LJLGRVSDUD ODDSUREDFLyQFRPHUFLDOGH IiUPDFRV
TXHFRQWHQJDQXQDQXHYDHQWLGDGTXtPLFD\FX\DREWHQFLyQKD\DVXSXHV
WRXQHVIXHU]RFRQVLGHUDEOHFRQWUDODFRPSHWHQFLDGHVOHDOFX\RVLJQLI
FDGRTXHVHHQFXHQWUDHQHO&RQYHQLRGH3DUtVSDUDOD 3URWHFFLyQGHOD
3URSLHGDG,QGXVWULDOQR LQFOX\HQHFHVDULDPHQWHODSURWHFFLyQ WHPSRUDO
H[FOXVLYD
(O$'3,&HVWiDGPLQLVWUDGRSRUHO&RQVHMRVREUHORV$'3,&FX\DV
IXQFLRQHVVRQVXSHUYLVDUHO$FXHUGRDVLVWLUDORV(VWDGRVHQHOPDUFRGH
ODVROXFLyQGHGLIHUHQFLDV\VHUYLUGHIRURSDUDFRQVXOWDV(O&RQVHMRQR
HVVLQHPEDUJRHOIRURSDUDODVROXFLyQGHGLIHUHQFLDVHQVX3DUWH9HO
$'3,&HVWLSXODODUHPLVLyQGHODVFRQWURYHUVLDVDOÏUJDQRGH6ROXFLyQ
GH'LIHUHQFLDVULJLpQGRVHSRUWDQWRSRUODVQRUPDVUHFRJLGDVHQHO(Q
WHQGLPLHQWRVREUH6ROXFLyQGH'LIHUHQFLDV(6'+D\TXHVHxDODUSRU
~OWLPRTXHDVtFRPRHO$'3,&REOLJDDSURWHJHUMXGLFLDOPHQWHODVGLVSR
VLFLRQHVPiVUHOHYDQWHVUHODWLYDVDODSURWHFFLyQH[FOXVLYDTXHFRQFHGHQ
ORVGHUHFKRVGHSURSLHGDGLQWHOHFWXDO\TXHODYLRODFLyQRQRLQFRUSRUD
FLyQOHJLVODWLYDGHODVPLVPDVSXHGHUHVXOWDUHQXQSURFHVRDQWHHOÏUJD
QRGH6ROXFLyQGH'LIHUHQFLDVODVGLVSRVLFLRQHVTXHSRGUtDQ EHQHIFLDU
DORVFRQVXPLGRUHVGHWHFQRORJtDFRPRODVUHODWLYDVODWUDQVIHUHQFLDGH
WHFQRORJtD\FRRSHUDFLyQWpFQLFDDXQTXHWDPELpQYLQFXODQWHVHVWiQUH
GDFWDGDVHQWpUPLQRVYDJRVVXLQFXPSOLPLHQWRHVGLItFLOGHSUREDU\HQ
ODSUiFWLFDQRHVWiVRPHWLGRDQLQJXQDVDQFLyQ
 5HVSHFWRDODUWvidsupra,SSvidWDPELpQinfra,SS
 318'Cómo lograr que el comercio global sea benef‌i cioso para la gente,/RQGUHV6WHU
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