La regulación internacional de la innovación farmacéutica y el desarrollo de medicamentos
Autor | Xavier Seuba Hernández |
Páginas | 73-113 |
&$3Ë78/2,,
LA REGULACIÓN INTERNACIONAL
DE LA INNOVACIÓN FARMACÉUTICA
Y EL DESARROLLO DE MEDICAMENTOS
I. DIMENSIÓN INTERNACIONAL DE LA FASE INICIAL
DE LA CADENA DEL FÁRMACO
(QHVWHHStJUDIHVHLQWURGXFHQORVFRQFHSWRVGHOD©FDGHQDGHOPHGL
FDPHQWRªODLQQRYDFLyQIDUPDFpXWLFD\HOGHVDUUROORGHIiUPDFRV8QD
YH]SUHVHQWDGRV VH DERUGDQORVSULQFLSDOHV SUREOHPDV TXHHQUHODFLyQ
FRQORV PLVPRVVH VXVFLWDQGHVGHHOSXQWRGH YLVWDGH ODVDOXG\GHVX
UHJXODFLyQLQWHUQDFLRQDO8QSULPHUDSDUWDGR VHGHGLFD DOD LQQRYDFLyQ
IDUPDFpXWLFD\DVXUHODFLyQFRQORV GHUHFKRVGH SURSLHGDGLQWHOHFWXDO
(OVHJXQGRDSDUWDGRDERUGDHQFDPELRHOGHVDUUROORGHIiUPDFRVVXWUDV
FHQGHQFLD\ HOIHQyPHQR FRQWHPSRUiQHRGH OD©H[SRUWDFLyQ GHORVHQ
VD\RVFOtQLFRVª6HHVWDEOHFHQDVtODV EDVHVTXH HQVXFHVLYRV DSDUWDGRV
\FDStWXORVSHUPLWHQDGHQWUDUVHFRQPD\RUGHWDOOHHQODUHJXODFLyQGHOD
LQQRYDFLyQIDUPDFpXWLFD\HOGHVDUUROORGHPHGLFDPHQWRV
$ ,1129$&,Ï1)$50$&e87,&$
1. La innovación farmacéutica y sus mecanismos de estímulo
D La innovación en el marco de la cadena del medicamento
/Dcadena del medicamento HVOD ©VHFXHQFLDGH SDVRVLQWHUUHODFLR
QDGRVTXHGHVFULEHODYLGDGHXQPHGLFDPHQWR²VXSDVRSRUODFRPXQL
Ů
;$9,(56(8%$+(51È1'(=
GDG²GHVGHTXHHVFRQFHELGR\GHVDUUROODGRKDVWDTXHHVXWLOL]DGRª6H
LQLFLDFRQODLQYHVWLJDFLyQ\ODFRQFHSFLyQGHOIiUPDFRFRQWLQ~DFRQORV
HQVD\RVSUHFOtQLFRV\ FOtQLFRV\VLJXHFRQHOUHJLVWURTXH SUHFHGHDOD
IDEULFDFLyQFRPHUFLDOL]DFLyQGLVWULEXFLyQSUHVFULSFLyQ\GLVSHQVDFLyQ
(OSXQWRIQDOHVSUHYLVLEOHPHQWHHOXVRGHOPHGLFDPHQWR'HWHQHUHQ
FXHQWDODPXOWLWXG GH DFWRUHV H LQWHUHVHV TXH LQWHUYLHQHQ HQ FDGD XQR
GHODVIDVHVGHODFDGHQDGHOPHGLFDPHQWRVHHQWLHQGHODDIUPDFLyQGH
*/Ï3(=&$6$129$6HQHOVHQWLGR GHTXH©QRKD\WHUUHQRPiVFRPSOH
MRHQODSROtWLFDVDQLWDULD DFWXDOTXHHOGHOPHGLFDPHQWR(QJHQHUDO VX
HVWXGLRRIUHFHXQ LPSRUWDQWH FDOLGRVFRSLR GH ODYLGDVRFLDOSROtWLFD \
HFRQyPLFDª
(QWpUPLQRVJHQHUDOHVVHVHxDODTXHODLQQRYDFLyQUHVXOWDGHODLQWH
UDFFLyQGHQRUPDVPHUFDGRV LQFHQWLYRVH LQIUDHVWUXFWXUDSDUD ODFUHD
FLyQ\XVRGHWHFQRORJtD(QHOiPELWRGHODVDOXGS~EOLFD\IUXWRGHHVWD
LQWHUDFFLyQODLQQRYDFLyQVHGHVFULEHFRPR©ODLQWURGXFFLyQGHQXHYRV
PpWRGRVSURJUDPDV LGHDV\SROtWLFDV SDUDPHMRUDU ODVLWXDFLyQVDQLWD
ULDª(QHOVHFWRUIDUPDFpXWLFRHVWDLQWURGXFFLyQHVDVXYH]IUXWRGHXQ
FRPSOHMRSURFHVR7UDVDQDOL]DUODVQHFHVLGDGHVWHUDSpXWLFDV\HOPHUFD
GRSRWHQFLDOVHLQLFLDHOSURFHVRGHLQQRYDFLyQIDUPDFpXWLFD'HFLGLGD
ODLQGLFDFLyQVHJHQHUDODKLSyWHVLVGHDFWXDFLyQVREUHODHQIHUPHGDGD
WUDYpVGH ODGLDQD WHUDSpXWLFD\ HPSLH]DODHYDOXDFLyQPDVLYDGH FRP
SXHVWRVTXtPLFRVHQUHODFLyQFRQGLFKDGLDQD
6XSHUDGRHVH HVWDGLR HQ ODIDVHSUHFOtQLFD VH UHDOL]DQ HVWXGLRVVR
EUHDQLPDOHVTXHSHUPLWHQDQWLFLSDUSRVLEOHVHIHFWRVVREUHODVSHUVRQDV
'HVSXpVGHOD IDVHSUHFOtQLFDVHDYDQ]DKDFLD HOHQVD\RFOtQLFRXQRGH
ORVPpWRGRVH[LVWHQWHVSDUDODLQYHVWLJDFLyQFDXVDOHQPHGLFLQD(OHQVD
\RFOtQLFRHVODLQYHVWLJDFLyQHIHFWXDGDHQVHUHVKXPDQRVSDUDGHWHUPLQDU
ORVHIHFWRVFOtQLFRV IDUPDFROyJLFRV\R IDUPDFRGLQiPLFRVGHWHFWDUUH
DFFLRQHVDGYHUVDV\HVWXGLDUODDEVRUFLyQGLVWULEXFLyQPHWDEROLVPR\
HOLPLQDFLyQGHXQR RYDULRVIiUPDFRV SDUDGHWHUPLQDUVXVHJXULGDG\R
HIFDFLD
/DLQYHUVLyQQHFHVDULDSDUDODFRQGXFFLyQH[LWRVDGHHVHSURFHVRKD
GDGROXJDU DHVWLPDFLRQHV PX\GLVSDUHVTXH HQDOJXQRV FDVRVXWLOL]DQ
PpWRGRVTXHSHUPLWHQLPSXWDUXQFRVWHDOGHVDUUROORGHXQIiUPDFRPX
-5/$3257(Principios básicos de investigación clínica%DUFHORQD$VWUD=HQHFD
S
*/Ï3(=&$6$129$6©/DSROtWLFDGHOPHGLFDPHQWRHQHOFRQWH[WRGHXQVLVWHPDVDQLWDULR
PXOWLMXULVGLFFLRQDOªHQ50(1(8\63(,5ÏGLUVElementos para la gestión de la prescripción
y la prestación farmacéutica, %DUFHORQD0DVVRQS
.(0$6.86Reforming the US Patent Policy. Getting the Incentives Right, :DVKLQJWRQ
'&&RXQFLORQ)RUHLJQ5HODWLRQVCSRQ~PS
$06Derechos de propiedad intelectual, innovación y salud pública. Informe de la Secre-
taría,GHPD\RGH$SiUU
$OUHVSHFWRvid.(9$/(17Ë©&DUDFWHUtVWLFDV GHOD,QQRYDFLyQ)DUPDFpXWLFDªCuadernos
de Derecho Farmacéutico,Q~PS
Ů
/$5(*8/$&,Ï1,17(51$&,21$/'(/$,1129$&,Ï1)$50$&e87,&$
FKRPD\RU GHO TXH RWURV HVWLPDQ DMXVWDGRDOD UHDOLGDG (Q FXDOTXLHU
FDVRDSHVDUGHTXH ORVFiOFXORVH[LVWHQWHVLPSRVLELOLWDQFRQFUHWDUXQD
FLIUDHVLQGXGDEOHTXHODLQYHVWLJDFLyQIDUPDFpXWLFDH[LJHXQDFXDQWLR
VDLQYHUVLyQ%XHQDSDUWHGHGLFKD LQYHUVLyQHV VXIUDJDGDFRQ UHFXUVRV
S~EOLFRVHVSHFLDOPHQWHFXDQGRVHWUDWDGHLQYHVWLJDFLyQEiVLFDDXQTXH
WDPELpQHVIUHFXHQWHODIQDQFLDFLyQS~EOLFDGHODLQYHVWLJDFLyQDSOLFDGD
(QORVSDtVHVGHVDUUROODGRVHOSRUGHODLQYHUVLyQHQLQYHVWLJDFLyQ
\GHVDUUROORHQPDWHULDGHVDOXGSURFHGHGHIRQGRVS~EOLFRVXQSRU
GHOVHFWRUSULYDGRVLQiQLPRGHOXFUR\XQSRUGHOVHFWRUSULYDGR
FRQiQLPRGHOXFUR(OFRQRFLGRFRPRPRGHOROLQHDOHQYLUWXGGHOFXDO
ODLQYHUVLyQSULYDGDVHFHQWUDHQODLQYHVWLJDFLyQDSOLFDGD\ODLQYHUVLyQ
S~EOLFDHQ ODLQYHVWLJDFLyQ EiVLFDKD GDGRSDVRD XQDQXHYD VLWXDFLyQ
HQODTXHVHDUWLFXODQUHFXUVRVS~EOLFRV\SULYDGRVHLQWHUYLHQHQDFWRUHV
S~EOLFRV\SULYDGRVWDQWRHQODLQYHVWLJDFLyQEiVLFDFRPRHQODDSOLFDGD
ORTXHUHTXLHUHXQDPD\RULQWHUDFFLyQHQWUHWRGRVHOORV
E Mecanismos de estímulo a la investigación
/DLQYHUVLyQHQLQQRYDFLyQIDUPDFpXWLFDUHVXOWDHQXQELHQGHFDUDFWH
UtVWLFDVHVSHFtIFDVHOFRQRFLPLHQWRXQELHQDOTXHODWHRUtDHFRQyPLFDFOD
VLIFDHQWUHORVGHQRPLQDGRVELHQHVS~EOLFRV/DQRFLyQGH©ELHQS~EOLFRª
UHVXOWDGHXWLOLGDGSDUDHQWHQGHUDOJXQRVGHORVLQVWUXPHQWRVMXUtGLFRVFUHD
GRVSDUDHVWLPXODUODLQQRYDFLyQ6LQWpWLFDPHQWHORVELHQHVS~EOLFRVVRQ
DTXHOORVTXHWRGDVODVSHUVRQDVSXHGHQFRQVXPLUVLQDJRWDUORVQLLPSHGLUVX
FRQVXPRDRWUDVSHUVRQDV'DGDVHVWDVFDUDFWHUtVWLFDVVHSODQWHDODFXHVWLyQ
GHFyPRLQFHQWLYDUVXSURYLVLyQSXHVWRTXHDOEHQHIFLDUDWRGRV\QRSRGHU
OLPLWDUVHQDWXUDOPHQWHVXXVRDSULRULQRH[LVWHQLQFHQWLYRVSDUDHPEDUFDUVH
HQORVFRVWHVGHGLFKDSURYLVLyQ3RUHOORVHKDQLPSXOVDGRPHFDQLVPRVDU
WLIFLDOHVTXHKDJDQLQWHUHVDQWHLQFXUULUHQWDOHVFRVWHV
(QWUHORVHVWXGLRVPiVFLWDGRV-',0$6,5+$16(1\+*5$%2:6.,©7KHSULFHRILQQR
YDWLRQQHZHVWLPDWHV RIGUXJGHYHORSPHQW FRVWVªJournal of Health EconomicsYRO
SS3DUDXQDFUtWLFDDVXPHWRGRORJtDvid 38%/,&&,7,=(1 Critique of the DiMasi/Tufts
methodology and other key prescription drug R&D issues ZZZFLWL]HQRUJFRQJUHVVUHIRUP
GUXJBLQGXVWU\UBGDUWLFOHVFIP",'
$WtWXORGHHMHPSORODV FLIUDVYDQGHORV DORV PLOORQHVGHGyODUHVVidSDUDORV
)06&+(5(5 ©7KH 3KDUPDFHXWLFDO,QGXVWU\ DQG:RUOG,QWHOOHFWXDO 3URSHUW\6WDQGDUGVª
Vanderbilt Law JournalYRO Q~P S\SDUD ORV- ',0$6,5+$16(1 \
+*5$%2:6.,op. cit.
$'()5$1&,6&2\60$7/,1HGVMonitoring Financial Flows for Health Research 2006.
The changing landscape of health research for development, *HQHYD *OREDO)RUXP IRU+HDOWK
5HVHDUFKS[
&RPLVLyQGH'HUHFKRVGH3URSLHGDG,QWHOHFWXDO,QQRYDFLyQ\6DOXG3~EOLFDSalud Públi-
ca, Innovación y Propiedad Intelectual*LQHEUD206SS
-67,*/,7=©.QRZOHGJH DVD*OREDO 3XEOLF*RRGªHQ, .$8/,*581%(5* \067(51
HGVGlobal Public Goods in the 20th Century: International Cooperation in the 20th Century
2[IRUG2[IRUG8QLYHUVLW\3UHVV
Ů
Para continuar leyendo
Solicita tu prueba