ASEAN regional workshop on bilateral Free Trade Agreements
Francisco Rossi.
IP and access to drugs capacity building project.
UNDP - International poverty centre. Brasilia. Brazil.
Lessons fromLessons fromLatin americanLatin american
experienceexperience
ASEAN Regional workshop on bilateral Free Trade
Agreements
The stronger the intellectual The stronger the intellectual property rights, the better.property rights, the better.
Negotiations with USA = Pharma.Negotiations with USA = Pharma. Lessons from Latin AmericaLessons from Latin America On impact of IPOn impact of IP Next stepsNext steps
Trips plus measures are totally Trips plus measures are totally legal.legal.
Countries on FTA’s believe on IP Countries on FTA’s believe on IP Countries on FTA’s decided Countries on FTA’s decided
sovereigntysovereignty FTA’s do not undermine Doha FTA’s do not undermine Doha
DeclarationDeclaration Trips plus is unadequate term;Trips plus is unadequate term;
TRIPS TRIPS PRECISSIONS.PRECISSIONS.
Drug makers go furthest to Drug makers go furthest to sway Congresssway Congress By Jim Drinkard, USA TODAY By Jim Drinkard, USA TODAY (26/04/05)(26/04/05)
By the numbers$158 By the numbers$158 million*million*Spending in 2004 to lobby the Spending in 2004 to lobby the federal government.federal government.
$17 million$17 millionCampaign contributions in Campaign contributions in 2004 to federal candidates 2004 to federal candidates (67% to Republicans).(67% to Republicans).
$7.3 million$7.3 millionSupport for the 2004 political Support for the 2004 political party conventions (64% to party conventions (64% to Republicans).Republicans).
* estimate; Sources: Center for * estimate; Sources: Center for Responsive Politics, Campaign Responsive Politics, Campaign Finance Institute, Center for Finance Institute, Center for Public IntegrityPublic Integrity
DIARIO LA REPUBLICA, JUEVES 16 DE SETIEMBRE DEL 2004DIARIO LA REPUBLICA, JUEVES 16 DE SETIEMBRE DEL 2004.
Intellectual Property Rights, Free Intellectual Property Rights, Free Trade Agreements and Public Trade Agreements and Public
HealthHealth
TRIPS PLUS MEASURES IN RECENT FREE TRIPS PLUS MEASURES IN RECENT FREE TRADE AGREMENTSTRADE AGREMENTS
APROXIMATE DATEAPROXIMATE DATE 12/200112/2001 12/200212/2002 05/200305/2003 01/200401/2004 02/200402/2004 03/200403/2004 07/200407/2004
JORDANJORDAN CHILECHILE SINGAPORESINGAPORE CAFTACAFTA AUSTRALIAAUSTRALIA MOROCCOMOROCCO BAHREINBAHREIN
DATA PROTECTIONDATA PROTECTION
++ ++ ++ ++ ++ ++ ++ LINKAGES LINKAGES BETWEEN HEALTH BETWEEN HEALTH REGISTRATION AND REGISTRATION AND PATENTS.PATENTS.
++ ++ ++ ++ ++ ++ ++PATENT TERM PATENT TERM RESTORATIONRESTORATION ++ ++ ++ ++ ++ ++ ++RESTORATION BY RESTORATION BY REGISTRATIONREGISTRATION ++ ++ ++ ++ ++ ++ ++ENFORCEMENTENFORCEMENT
++ ++ ++ ++ ++ ++ ++GENERIC NAME USE GENERIC NAME USE RESTRICTIONS. RESTRICTIONS. -- ++ ++ ++ ++ ++ ++PATENTABLE PATENTABLE MATTER MATTER EXPANSION EXPANSION ++ -- -- -- ++ ++ ++COMPULSORY COMPULSORY LICENCES LICENCES RESTRICTIONSRESTRICTIONS ++ -- ++ -- ++ -- --PARALLEL IMPORTS PARALLEL IMPORTS LIMITATIONSLIMITATIONS -- -- ++ -- ++ ++ --
Restrictions on INN (generic names) useRestrictions on INN (generic names) use
TRIPS 20Other Requirements
The use of a trademark in the course of trade shall not be unjustifiably encumbered by special requirements, such as use with another trademark, use in a special form or use in a manner detrimental to its capability to distinguish the goods or services of one undertaking from those of other undertakings. This will not preclude a requirement prescribing the use of the trademark identifying the undertaking producing the goods or services along with, but without linking it to, the trademark distinguishing the specific goods or services in question of that undertaking.
CAFTA CAFTA ARTICLE 15.2 TRADEMARKSARTICLE 15.2 TRADEMARKS
In view of the obligations of In view of the obligations of Article 20 of the TRIPS Article 20 of the TRIPS Agreement, each Party shall Agreement, each Party shall ensure that provisions ensure that provisions mandating the use of the term mandating the use of the term customary in common language customary in common language asas
the common name for a good the common name for a good (“common name”) including, (“common name”) including, inter aliainter alia, requirements , requirements concerning the relative size, concerning the relative size, placement or style of use of the placement or style of use of the trademark in relation to the trademark in relation to the common name, do not impair common name, do not impair the use or effectiveness of the use or effectiveness of trademarks used in relation totrademarks used in relation to
such goods.such goods.
Intellectual Property Rights, Intellectual Property Rights, Free Trade Agreements and Free Trade Agreements and
Public HealthPublic Health
Latin American Free Trade Latin American Free Trade Agreements negotiations. Agreements negotiations.
Lessons learned.Lessons learned.
Intellectual Property Rights, Free Intellectual Property Rights, Free Trade Agreements and Public Trade Agreements and Public
HealthHealth
ON PROCESSON PROCESS
USTR: Agreements administrator.USTR: Agreements administrator.
ConfidentialityConfidentiality U.N. support. Carlos Correa Veto.U.N. support. Carlos Correa Veto. C.S.O.C.S.O. CONGRESSCONGRESS Health sector commitment : relations Health sector commitment : relations
with trade negotiatorswith trade negotiators
The agreement is not the endThe agreement is not the end
Chilean experience with second Chilean experience with second uses. uses.
Intellectual Property Rights, Free Intellectual Property Rights, Free Trade Agreements and Public Trade Agreements and Public
HealthHealth
AFTA PROPOSALSAFTA PROPOSALSEverything.Everything.
Patents for plants, Patents for plants, animals, diagnostic, animals, diagnostic, chirurgical and chirurgical and therapeutic therapeutic methods.methods.
Patents for usesPatents for uses C.L. restrictions. C.L. restrictions. National exhaustion National exhaustion
of rightsof rights
AFTA PROPOSALSAFTA PROPOSALSEverything.Everything.
Patent term Patent term restorations.restorations.
LinkageLinkage Data protectionData protection Restriction on Restriction on
generic namesgeneric names
Intellectual Property Rights, Free Intellectual Property Rights, Free Trade Agreements and Public Trade Agreements and Public
HealthHealth
AFTA PROPOSALSAFTA PROPOSALS
USA PROPOSAL. USA PROPOSAL. ANDEAN PROPOSAL. ANDEAN PROPOSAL. TRIPS-DOHATRIPS-DOHA 11 ROUNDS.11 ROUNDS. ANDEAN SECOND PROPOSAL ANDEAN SECOND PROPOSAL
DATA PROTECTIONDATA PROTECTION TRANSPARENCYTRANSPARENCY PATENT TERM RESTORATIONPATENT TERM RESTORATION
Colombian IP Negotiator impasseColombian IP Negotiator impasse Final political decision?Final political decision?
IMPACT OF TRIPS PLUS MEASURES .IMPACT OF TRIPS PLUS MEASURES .
RETROSPECTIVE STUDIESRETROSPECTIVE STUDIES
COUNTRYCOUNTRY ISSUEISSUE IMPACT 1IMPACT 1 IMPACT 2IMPACT 2 REMARKSREMARKS
AMIR ATTARANAMIR ATTARAN AFRICAAFRICA PATENTSPATENTS NONO POVERTYPOVERTY
FEDESARROLLOFEDESARROLLO COLOMBIACOLOMBIA
I.P. I.P. PRICESPRICES NONO
ENTRY DELAYSENTRY DELAYSIMPORTANT IMPACT OF TRADE IMPORTANT IMPACT OF TRADE MARKSMARKS
APOYO CONSULTORESAPOYO CONSULTORES PERUPERU FTAFTACONSUMERS WELFARE CONSUMERS WELFARE 5 M.5 M.
ONLY ON DATA PROTECTIONONLY ON DATA PROTECTION
PUBLIC INSTITUTIONS PUBLIC INSTITUTIONS 1.3M1.3M
PRICE RISING 94-114%PRICE RISING 94-114%
NATIONAL INDUSTRY NATIONAL INDUSTRY 2,3M2,3M
PROSPECTIVE PROSPECTIVE STUDIESSTUDIES
COUNTRYCOUNTRY ISSUEISSUE IMPACT 1IMPACT 1 IMPACT 2IMPACT 2 REMARKSREMARKS
PAHO/IFARMAPAHO/IFARMA COLOMBIACOLOMBIA FTAFTA DATA 300M 4% 2010DATA 300M 4% 2010 AIDS DEATHSAIDS DEATHS PROSPECTIVE MODELPROSPECTIVE MODEL
USES 500M 14% 2014USES 500M 14% 2014 90/ 2005-4223/202090/ 2005-4223/2020
PAT REST. 500M 14% PAT REST. 500M 14% 20252025 HOUSEHOLDS SPENT HOUSEHOLDS SPENT
ST. 1 - 16%ST. 1 - 16%INN REST. 700M 12% INN REST. 700M 12% 20102010
PPU 12%PPU 12%
INDECOPIINDECOPI PERUPERU FTAFTA 1182M/YEAR 1182M/YEAR HOUSEHOLDS SPENTHOUSEHOLDS SPENT
INDECOPIINDECOPI PERUPERU FTAFTA 472M DEFICIT 2005 472M DEFICIT 2005 KNOWLEDGE BALANCEKNOWLEDGE BALANCE
602 M FTA 2015602 M FTA 2015
VALLADARES-MOHVALLADARES-MOH PERUPERU FTAFTA PRICE RISING 55-100%PRICE RISING 55-100% TAX EXEMPTIONTAX EXEMPTION COMPENSATION MEASURESCOMPENSATION MEASURES
TOTAL SPENT 300 MTOTAL SPENT 300 M 1 M/YEAR1 M/YEAR
COMPETITION EFFECT
COMPETITION EFFECT
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
Average spent on medicines by stratum. Col $. 1997
Series1 13,367 14,231 16,627 17,637 26,054 24,512 64,449
SIN ESTRATO
ESTRATO 1 ESTRATO 2 ESTRATO 3 ESTRATO 4 ESTRATO 5 ESTRATO 6
Fuente: Ramirez M. et al. El gasto en salud de los hogares Colombianos. Universidad del Rosario. 2002.Fuente: Ramirez M. et al. El gasto en salud de los hogares Colombianos. Universidad del Rosario. 2002.
45.90%
36.70% 33.60%
21.90%16.50%
11.30%18.30%
0.00%
10.00%
20.00%
30.00%
40.00%
50.00%
60.00%
70.00%
80.00%
90.00%
100.00%
SIN ESTRATO ESTRATO 1 ESTRATO 2 ESTRATO 3 ESTRATO 4 ESTRATO 5 ESTRATO 6
Fuente: Ramirez M. et al. El gasto en salud de los hogares Colombianos. Universidad del Rosario. 2002.Fuente: Ramirez M. et al. El gasto en salud de los hogares Colombianos. Universidad del Rosario. 2002.
Spent on medicines as a % of income . Households survey. Colombia 1997
In developed countries the state In developed countries the state pays, in developing the pays, in developing the individual!individual!
Private spending on drugs as % of total spending
0 20 40 60 80 100 120
Philippines
Cote d'Ivoire
Egypt
Belize
Malaysia
Gabon
Greece
Australia
France
Ireland
United Kingdom
Luxembourg
Developed countries Developing countries
IMPACT OF TRIPS PLUS MEASURES .IMPACT OF TRIPS PLUS MEASURES .
RETROSPECTIVE STUDIESRETROSPECTIVE STUDIES
COUNTRYCOUNTRY ISSUEISSUE IMPACT 1IMPACT 1 IMPACT 2IMPACT 2 REMARKSREMARKS
AMIR ATTARANAMIR ATTARAN AFRICAAFRICA PATENTSPATENTS NONO POVERTYPOVERTY
FEDESARROLLOFEDESARROLLO COLOMBIACOLOMBIA
I.P. I.P. PRICESPRICES NONO
ENTRY DELAYSENTRY DELAYSIMPORTANT IMPACT OF TRADE IMPORTANT IMPACT OF TRADE MARKSMARKS
APOYO CONSULTORESAPOYO CONSULTORES PERUPERU FTAFTACONSUMERS WELFARE CONSUMERS WELFARE 5 M.5 M.
ONLY ON DATA PROTECTIONONLY ON DATA PROTECTION
PUBLIC INSTITUTIONS PUBLIC INSTITUTIONS 1.3M1.3M
PRICE RISING 94-114%PRICE RISING 94-114%
NATIONAL INDUSTRY NATIONAL INDUSTRY 2,3M2,3M
PROSPECTIVE PROSPECTIVE STUDIESSTUDIES
COUNTRYCOUNTRY ISSUEISSUE IMPACT 1IMPACT 1 IMPACT 2IMPACT 2 REMARKSREMARKS
PAHO/IFARMAPAHO/IFARMA COLOMBIACOLOMBIA FTAFTA DATA 300M 4% 2010DATA 300M 4% 2010 AIDS DEATHSAIDS DEATHS PROSPECTIVE MODELPROSPECTIVE MODEL
USES 500M 14% 2014USES 500M 14% 2014 90/ 2005-4223/202090/ 2005-4223/2020
PAT REST. 500M 14% PAT REST. 500M 14% 20252025 HOUSEHOLDS SPENT HOUSEHOLDS SPENT
ST. 1 - 16%ST. 1 - 16%INN REST. 700M 12% INN REST. 700M 12% 20102010
PPU 12%PPU 12%
INDECOPIINDECOPI PERUPERU FTAFTA 1182M/YEAR 1182M/YEAR HOUSEHOLDS SPENTHOUSEHOLDS SPENT
INDECOPIINDECOPI PERUPERU FTAFTA 472M DEFICIT 2005 472M DEFICIT 2005 KNOWLEDGE BALANCEKNOWLEDGE BALANCE
602 M FTA 2015602 M FTA 2015
VALLADARES-MOHVALLADARES-MOH PERUPERU FTAFTA PRICE RISING 55-100%PRICE RISING 55-100% TAX EXEMPTIONTAX EXEMPTION COMPENSATION MEASURESCOMPENSATION MEASURES
TOTAL SPENT 300 MTOTAL SPENT 300 M 1 M/YEAR1 M/YEAR
IPRCIPRC
The contemporary evidence The contemporary evidence suggests that, because suggests that, because developing countries are developing countries are large net importers of large net importers of technology from the technology from the developed world, the developed world, the globalisation of IP protection globalisation of IP protection will result in very substantial will result in very substantial additional net transfers from additional net transfers from developing to developed developing to developed countriescountries . .
www.iprcommission.orgwww.iprcommission.org
Hood RobinHood Robin
The stronger the The stronger the intellectual property intellectual property
rights, the better.rights, the better.
Benefits of innovation: ARV coverageBenefits of innovation: ARV coverage Innovation orientation: Neglected Innovation orientation: Neglected
diseasesdiseases Innovation or stagnation? FDA Innovation or stagnation? FDA
Report.Report. Pharmaceutical industry: Research or Pharmaceutical industry: Research or
marketing?marketing? IP and development. IP and development. Technology transfer and FDITechnology transfer and FDI
IP and access to drugs IP and access to drugs capacity building capacity building projectproject
No trips Plus (FTAs.)No trips Plus (FTAs.) National legislation on IP sensitive National legislation on IP sensitive
to public health. (Doha)to public health. (Doha)– Full implementation of flexibilitiesFull implementation of flexibilities– Full use of P 6 ResolutionFull use of P 6 Resolution
South – South cooperation on South – South cooperation on generics generics
New international IP RULES?New international IP RULES?
Spent (US $ million) Spent (US $ million) and people on ARV and people on ARV therapy.therapy.
224
305
336
303
232
179 181169
35,9
55,673
87,5104
119,3132,9
148,512
0
50
100
150
200
250
300
350
400
1997 1998 1999 2000 2001 2002 2003 2004*Ano
SOURCE: PN-DST/AIDS
Source :MOH – STD/HIV-AIDS National Program. Brazil.
LPV.r NFV EFZ 12 other ARVs
Sp
ent
121
131
106
215
2003
21%
23%
19%
573
37%
3 imported (patented) 3 imported (patented)
ARVs ARVs
mean 63% of total mean 63% of total
budget. 2003budget. 2003
LPV.r+ EFZ+ NFV
63%
12 other ARVs
37%
Source :MOH – STD/HIV-AIDS National Program. Brazil.
MS/ 2003
3810
48604540
4240
3320
2223 2035
1996 1997 1998 1999 2000 2001 2002
Average cost of ARV Average cost of ARV patient/yearpatient/year1996 - 2003
1630
2003
Source :MOH – STD/HIV-AIDS National Program. Brazil.