ASEAN regional workshop on bilateral Free Trade Agreements Francisco Rossi. IP and access to drugs capacity building project. UNDP - International poverty.

ASEAN regional workshop on bilateral Free Trade Agreements

Francisco Rossi.

IP and access to drugs capacity building project.

UNDP - International poverty centre. Brasilia. Brazil.

[email protected]

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.


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.


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


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


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


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


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%


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


ASEAN regional workshop on bilateral Free Trade Agreements Francisco Rossi. IP and access to drugs capacity building project. UNDP - International poverty.

Documents

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