untangling the web 6th edition english version

19th April 2004

a pricing guide for the purchase of ARVs for developing countries

price Untangling the web of price reductions:

6th Edition

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3 Table of contents4 General background and objectives4 Methodology5 Prices5 Barriers to accessing price offers6 Evolution of prices since August 2001 of WHO recommended first line regimens7 The challenges of paediatric formulations7 Research and development for HIV/AIDS8 How to use these tables?9 Practical example: price and eligibility of three products from three different companies in four countries11 Tables

11 Table 1: Summary of best ARV price offers by selected pharmaceutical companies for eligible developing countries11 Table 1a – Nucleoside Reverse Transcriptase Inhibitors (NRTIs)12 Table 1b – Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)13 Table 1c – Nucleotide Reverse Transcriptase Inhibitors (NtRTIS)14 Table 1d – Protease Inhibitors (PIs)15 Table 1e – Fixed Dose Combinations (FDCs)16 Table 1f – Combined blisters17 Table 1g – Paediatric Formulations18 Table 2: Company ARV offers and restrictions for developing countries, adult and paediatric formulations18 Table 2a – Nucleoside Reverse Transcriptase Inhibitors (NRTIs)22 Table 2b – Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)23 Table 2c – Nucleotide Reverse Transcriptase Inhibitors (NtRTIs)24 Table 2d – Protease Inhibitors (PIs)27 Table 2e – Fixed Dose Combinations (FDCs)29 Table 2f – Selected generic companies’ ARV offers and restrictions for developing countries

30 Annexes30 Annex 1: Least Developed Countries (LDCs)30 Annex 2: Human Development Index (HDI)31 Annex 3: Sub-Saharan countries31 Annex 4: World Bank low-income and low-middle-income countries31 Annex 5: Company contacts

33 Glossary 35 References

Table of contents

Médecins Sans Frontières • www.accessmed-msf.org • April 2004 • Untangling the Web of Price Reductions • 3

General background and objectives

This is the sixth edition of“Untangling the web of pricereductions: a pricing guide for thepurchase of ARVs for developingcountries”. The first edition waspublished in October 2001[1].

The lack of clear information onpharmaceutical prices on theinternational market is a significantbarrier to improving access toessential medicines in developingcountries. The situation isparticularly complex in the case ofantiretrovirals (ARVs).

The data in this guide on ARV pricesoffered by originator companies andsome generic companies in low- andmiddle-income countries are meantto provide potential buyers withclear and verified data. Thisinformation is intended for use bygovernment and non-profitprocurement agencies, as well asother bulk purchasers of ARVs,including health facilities and non-governmental organisations (NGOs).

This document includes pricinginformation on both adult andpaediatric formulations, and ismeant to be used in tandem with

Not all the products in thisdocument have been pre-qualifiedby WHO or approved by MSF.Therefore, procurement agenciesshould follow their own proceduresin this respect. Ultimately it isnational regulatory authorities thatare responsible for approving theuse of a given drug from a givenmanufacturer.

Pricing information on otheressential drugs and diagnostics usedfor HIV/AIDS can be found in thelast version of “Sources and Pricesof Selected Medicines andDiagnostics for People Living withHIV/AIDS”[3].

We have indicated fixed-dosecombinations (FDCs) in this reportsince MSF has found that usingthese products facilitates programimplementation and patient

the pre-qualification report called“Pilot Procurement, Quality andSourcing Project: Access to HIV/AIDSDrugs and Diagnostics of AcceptableQuality”, a project initiated by WHOand developed in collaboration withother United Nations Organisations(UNAIDS, UNICEF, UNFPA). This pre-qualification project evaluatespharmaceutical manufacturers andproducts according to WHOrecommended standards of qualityand compliance with GoodManufacturing Practices. WHO pre-qualification is given to specificproducts produced by specificcompanies at specific manufacturingsites. It is part of an ongoingprocess that will expand as theparticipation of suppliers increases.

An updated list of products isregularly posted on the websites ofWHO and other UN-collaboratingagencies[2]; products on this list arecommonly referred to as “WHO pre-qualified”. This list of “pre-qualified”drugs is an important tool for NGOsand Governments to assist themwith drug procurement.

In all the tables in this report, pre-qualified products are indicated inbold and with an asterisk.

compliance. For further informationsee MSF Briefing Note on FDCs[4]. Thenew edition of WHO TreatmentGuidelines specially mentions theusefulness of FDCs in resource-poorsettings. Not only are FDCsadvantageous from a medical pointof view, but they are also the mostaffordable option in most cases. Thetriple FDC d4T/3TC/NVP from twogeneric manufacturers has recentlybeen pre-qualified by WHO.

Methodology

In order to obtain accurateinformation on discounted priceoffers by both originator and genericcompanies, firms were contactedand asked to provide informationabout drug, dosage andpharmaceutical form, price per unit(or daily dose), restrictions thatapply to the offers (eligibility), and

This sixth edition provides:

•• updated information on prices for eligible countries, including both priceper unit and price per patient per year for adult and paediatricformulations

•• updated information and clarifications on the conditions and restrictionsapplying to these offers

•• practical examples

4 • Untangling the Web of Price Reductions • April 2004 • www.accessmed-msf.org • Médecins Sans Frontières


additional comments. The list ofgeneric companies included in thisreport is by no means exhaustive[5].All generic drugs included in thispricing guide have at least beencleared for marketing in theircountries of origin.

• All prices are quoted in US dollars and conversions were made on the day the price was received.

• All prices were checked and verified by companies.

• In table 1, prices are rounded. The exact prices including decimals are in table 2.

The annual cost of therapy wascalculated according to WHO[6] andCentres for Disease Control andPrevention (CDC)[7] dosing schedules(for those products not recommendedin the WHO Guidelines).

Prices

Since 2000, the international pricesof some first-line ARVs havetumbled, due to competition fromgeneric companies, sustained publicpressure, discount offers fromoriginator companies, and the

growing political attention paid tothe AIDS epidemic. Several majorevents have played a key role,beginning with a precedent set byBrazil which made a triple drugcombination possible at less thanUS$3000 per patient per year (ppy)in the 90s.

Public pressure on thepharmaceutical companies built upover the following years, and in May2000, five originator companiesannounced a new partnership, theAccelerating Access Initiative (AAI). Itwas the first time that thesecompanies had initiated differentialpricing policies for ARVs. In February2001, the Indian generics firm Ciplashattered the price barrier when itpublicly announced that it wouldsell a triple combination for US$350ppy. Due to this type of competition,prices continue to fall. Today, thecheapest triple combination (FDC)prequalified by WHO costsUS$244/year.

The graph on page 6 shows theevolution of prices since August2001 for WHO recommended firstline regimens.

Other initiatives, like the Andeaninitiative or more recently theClinton Foundation announcement,are also bringing down prices. TheAndean initiative, through regionalnegotiations with pharmaceuticalcompanies, has fixed a referenceprice for all the countries in theregion. The Clinton Foundation hasbrokered a deal with generic makerswhich brings fixed dose triplecombinations down to US$140 peryear. These initiatives although notwidely available will affect somespecific countries.

Prices cited in this document are thebest international offers made bycompanies, but delivery conditionsmust be taken into account. Bothgenerics and originator companiesimpose restrictions on their offers,but only originator companies applygeographical limits (a differentialpricing policy).

Barriers to accessing price offers

Information is presented in a tableformat to facilitate the comparisonof price offers. This format highlightsthe lack of standardisation among

different companies on eligibilityand terms and conditions. Forinstance, some companies useUNCTAD (Least Developed Countries)criteria, others UNDP, some othersWorld Bank classification (HumanDevelopment Index).

It should be noted that somedeveloping countries have beenexcluded by some or all companies.It means that some countries cannotbenefit from any differential price. Inregions like Eastern Europe, only24% of the countries can benefitfrom the best price and in LatinAmerica and Caribbean, only 31%.*

It is important to mention thatgeographical limitations do notconcern FDCs, since most FDCs areproduced by generic companies.

Even when a specific country iseligible, all purchasers within thecountry may not be eligible forreduced prices. The conditions ofsome offers can be restrictive andsometimes only NGOs, Governmentsand national and internationalinstitutions are eligible.

* We refer to best possible prices (those in Table 1), but we note that some companies (Roche and Merck & Co. Inc.) offer also a second differential price. The conditions for these second prices are less restrictive and can be found in Table 2.

1200US$

1000US$

800US$

600US$

400US$

200US$

0

Evolution of prices since August 2001 of WHO recommended first line regimensco

st o

f trea

tmen

t (U

S$/y

ear)

Aug 01 Oct 01 Dec 01 Feb 02 Apr 02 Jun 02 Aug 02 Oct 02 Dec 02 Feb 03 Apr 03 Jun 03 Aug 03 Oct 03 Dec 03 Jan 04 Feb 04 Apr 04

d4T/3TC/NVP

d4T/3TC+EFV

ZDV/3TC/NVP

ZDV/3TC+EFV


The chart above shows that efavirenz containing regimens are more expensive. In addition there is no EFV containing tripleFDC available on the market yet.

Triple FDC


Delivery conditions also affect prices.In many cases clearance fees,importation taxes (when they exist)and transport are not included.Another barrier to accessing thebest price is drug availability in acountry. Since ARVs are not alwaysregistered and/or available in“selected countries”, many offersfrom pharmaceutical companies mayremain “theoretical”.

In addition, prices cited in thisreport may not correspond to end-user prices (prices to patients),since other factors may increaseprices such as national distributionand handling charges, mark-uprates, and national and/or importand sales taxes.

Patents and use of flexibilitiesexisting in TRIPS and reinforced bythe Doha Declaration on TRIPS andPublic Health (such as compulsorylicence, government use) can alsoinfluence the availability ofmedicines in a country. Patentinformation is not included in the

present analysis. Some informationabout the patent status of ARVs insome countries can be found in“Patent Situation of HIV/AIDSrelated drugs in 80 countries”,WHO/UNAIDS, 2000[8] and the MSFreport “Drug patents under thespotlight: sharing practicalknowledge about pharmaceuticalpatents”, May 2003[9]. For furtherdetails, refer to the practical guide“HIV/AIDS medicines and relatedsupplies: contemporary context andprocurement”, in particular Chapter4 and Annex B (The World Bank,Washington, February 2004).

The challenge of paediatricformulations

There is an urgent need to developfixed-dose combinations for use inchildren. Protocols for paediatricpatients are complicated andexpensive. The prices of paediatricformulations remain higher thanthose for adults, especially forsecond line treatments. Forexample, a paediatric patient would

have to pay USD 284 per year for ad4T+3TC+NVP regimen using threedifferent syrups while an adult willtake the same regimen in a FDC forUSD 244. For a second line(ZDV+ddI+NFV), the cost oftreatment for a child would be USD3150/year while for the adult itwould be USD 1096 per year. In thiscase, none of them would be ableto use a FDC.**

Research and development (R&D) forHIV/AIDS

Paediatric formulations are not theonly area where there is a need forR&D. For both adults and children,new drugs, diagnostic tools, andvaccines are needed for HIV/AIDS.Pharmaceutical investment inresearch and development largelyresponds to market potential in theindustrialised world. We need toensure that R&D also responds tothe needs of patients in developingand least developed countries.

** For these examples we used the case of a 10 kg, 3 year old patient in an MSF project, following the protocols of this project. When comparing prices we used the best possible price for every molecule.

Prices: table 1 shows the best price offers of some generic and originatorproducers for each antiretroviral drug, (including fixed-dose combinations),regardless of eligibility conditions. Figures within brackets indicate price inUS$ per unit (capsules, tablets etc.). Prices per patient per year have beencalculated according to daily doses given either in WHO guidelines or in CDCguidelines (for those products not recommended in WHO guidelines). Pricescan be used as a reference with suppliers. Originator companies set differentprices depending on the country. Which country is eligible and the conditionsto benefit from these differential prices are specified in Table 2.

Restrictions: table 2 shows restrictions imposed by generic (2f ) andoriginator (2a to 2e) companies and provides indications about theavailability of offers in individual countries. There is no uniform differentialpricing system and each originator company sets geographical limits to theirprogrammes. Generic companies have no geographical limits but may havequantity related conditions.

Please refer to Annexes 1, 2 and 4 for updated country classification byUNCTAD (Least Developed Countries), UNDP (Human Development Index) andWorld Bank (Low income Countries). Annex 3 lists sub-Saharan countries.

This document is also available in French and Spanish on www.accessmed-msf.org

The following table (pages 9 and 10) summarises prices and eligibilityconditions of three products from three different companies in four countries.

How to use thesetables


COMPANIES and OFFERS

MALAWIIt is a LDC1

Low HDI2

Low Income Economy3

It is a Sub-Saharan country4

Adult HIV prevalence 15%5

CAMBODIAIt is a LDC1

Medium HDI2

Low Income Economy3

It is not a Sub-Saharan country4

Merck Stocrin® (efavirenz) 600 mg

Prices and eligibility (countries):– US$ 346.75/year for Low HumanDevelopment Index (HDI) countries plusmedium HDI countries with adult HIVprevalence of 1% or greater[10]

– US$ 767/year for medium HDIcountries with adult HIV prevalence lessthan 1%[11]

Delivery of goods: CIF[10]

Eligibility (bodies):Governments, internationalorganizations, NGOs, private sectororganizations (e.g. employers, hospitalsand insurers).Merck and Co., Inc. does not rule outsupplying ARVs to patients throughretail pharmacies.

Is Malawi an eligible country?Yes, for the first priceAm I an eligible purchaser?Yes, if Government, internationalorganization, NGO or private sectororganizationHow much will Stocrin 600 cost in mycountry?US$ 346.75/yearWill delivery conditions increase thisprice?Yes, I have to add clearance fees +importation taxes (when existing) + localtransport

Is Cambodia an eligible country?Yes, for the first priceAm I an eligible purchaser?Yes, if Government, internationalorganization, NGO, private sectororganization

Ranbaxy Triviro LNS® (d4T/3TC/NVP) 40mg+150 mg+200 mg

Prices and eligibility (countries):US$ 292/year. All countries are eligibleDelivery of goods:FOB Delhi/Mumbai (India)[10]

Prices apply to orders for a minimum of1.5 million units. Different prices areoffered for smaller quantities (500 000or 1 million units).Eligibility (bodies):NGOs and Governments or Programssupported by them.

Is Malawi an eligible country?YesAm I an eligible purchaser?Yes, if an NGO, Government or aprogram supported by themHow much will Triviro LNS cost in mycountry?US$ 292/year if I order more than 1.5million unitsWill delivery conditions increase thisprice?Yes, I have to add clearance fees +importation taxes (when existing) + localand international transport

Is Cambodia an eligible country?YesAm I an eligible purchaser?Yes, if an NGO, Government or aprogram supported by them

Roche Viracept® (nelfinavir) 250 mg

Prices and eligibility (countries):– CHF 1194 /year =US$ 942/year for allcountries in sub-Saharan Africa and all UNdefined Least Developed Countries– CHF 4055/year=US$ 3201/year in Lowincome countries and lower middleincome countries – as classified by theWorld Bank.Delivery of goods: Terms and conditions: Effective date 1stMarch 2003. FCA Basel (CH), CAD (CashAgainst Documents) 30 days at sight.Minimum order and delivery amount pershipment is CHF 10,000 (US$ 7891)[10]

Eligibility (bodies):Governments, Non Profit InstitutionalProviders of HIV care, NGOs.

Is Malawi an eligible country?Yes, for the first priceAm I an eligible purchaser?Yes, if Government, Non Profit InstitutionalProviders of HIV care or NGOHow much will Viracept cost in mycountry?US$ 942/yearWill delivery conditions increase thisprice?Yes, I have to add clearance fees +importation taxes (when existing) + localand international transport

Is Cambodia an eligible country?Yes, for the first priceAm I an eligible purchaser?Yes, if Government, Non Profit InstitutionalProviders of HIV care or NGO


Practical examples: Price and eligibility of three products from three different companies in four countries

1 LDC: Least Developed Country according to UNCTAD classification. See annex 1 of this document for full list of LDCs. 2 HDI: Human Development Index according to UNDP classification. Countries are classified on Low HDI, Medium HDI and High HDI (this last one does not concerndifferential prices). Low and Middle HDI lists of countries are in the Annex 2 of this document. 3 World Bank classification depends on income. Countries are classified as Low Income Economies, Middle-Low Income Economies, Middle Income Economies and Upper. Middle Income Economies(these last two do not concern differential prices). Low Income Economy and Lower-Middle Income Economy countries are listed in the Annex 4 of this document. 4 See annex 3 of this document for full list of sub-Saharan African countries published by the World Bank. 5 Merck prices depend on Adult HIV prevalence, which is periodically reviewed by UNAIDS (www.who.int/emc-hiv/fact_sheets/All_countries.html).

Adult HIV prevalence 2.7%5

UKRAINEIt is not a LDC1

Medium HDI2

Lower-Middle Income Economy3


Adult HIV prevalence 1%5

COLOMBIAIt is not a LDC1

Medium HDI2

Lower-Middle Income Economy3


Adult HIV prevalence o.4%5

How much will Stocrin 600 cost in mycountry?US$ 346.75/yearWill delivery conditions increase thisprice?Yes, I have to add clearance fees +importation taxes (when existing) + localtransport

Is the Ukraine an eligible country?Yes, for the first priceAm I an eligible purchaser?Yes, if Government, internationalorganization, NGO or private sectororganizationHow much will Stocrin 600 cost in mycountry?US$ 346.75/yearWill delivery conditions increase thisprice?Yes, I have to add clearance fees +importation taxes (when existing) + localtransport

Is Colombia an eligible country?Yes, for the second priceAm I an eligible purchaser?Yes, if Government, internationalorganization, NGO or private sectororganizationHow much will Stocrin 600 cost in mycountry?US$ 767/yearWill delivery conditions increase thisprice?Yes, I have to add clearance fees +importation taxes (when existing) + localtransport

How much will Triviro LNS cost in mycountry?US$ 292/year if I order more than 1.5million unitsWill delivery conditions increase thisprice?Yes, I have to add clearance fees +importation taxes (when existing) + localand international transport

Is the Ukraine an eligible country?YesAm I an eligible purchaser?Yes, if an NGO, Government or aprogram supported by themHow much will Triviro LNS cost in mycountry?US$ 292/year if I order more than 1.5million unitsWill delivery conditions increase thisprice?Yes, I have to add clearance fees +importation taxes (when existing) + localand international transport

Is Colombia an eligible country?YesAm I an eligible purchaser?Yes, if an NGO, Government or aprogram supported by themHow much will Triviro LNS cost in mycountry?US$ 292/year if I order more than 1.5million unitsWill delivery conditions increase thisprice?Yes, I have to add clearance fees +importation taxes (when existing) + localand international transport

How much will Viracept cost in mycountry?US$ 942/yearWill delivery conditions increase thisprice?Yes, I have to add clearance fees +importation taxes (when existing) + localand international transport

Is the Ukraine an eligible country?Yes, for the second priceAm I an eligible purchaser?Yes, if Government, Non ProfitInstitutional Providers of HIV care or NGOHow much will Viracept cost in mycountry?US$ 3201/yearWill delivery conditions increase thisprice?Yes, I have to add clearance fees +importation taxes (when existing) + localand international transport

Is Colombia an eligible country?Yes, for the second priceAm I an eligible purchaser?Yes, if Government, Non ProfitInstitutional Providers of HIV care or NGOHow much will Viracept cost in mycountry?US$ 3201/yearWill delivery conditions increase thisprice?Yes, I have to add clearance fees +importation taxes (when existing) + localand international transport


abacavir(ABC)

300

2

821(1.125/unit)

887*(1.215/unit)

803(1.100/unit)

1314(1.800/unit)

stavudine(d4T)

30

2

48*(0.066/unit)

47(0.065/unit)

60(0.082/unit)

21*(0.029/unit)

36*(0.049/unit)

35(0.048/unit)

Table 1a – Nucleoside ReverseTranscriptase Inhibitors (NRTIs)

All prices are in US$. Prices aregiven both for a yearly adult doseand by unit.

For details on eligibility and offerrestrictions for countries andinstitutions, please refer to table 2aand 2f.

Products on the WHO list of “PilotProcurement, Quality and Sourcing Project:Access to HIV/AIDS drugs and diagnostics ofacceptable quality” (14th edition, 28 January2004)[2] are in bold and have an asterisk *next to the price. Always check website formost recently updated list. Best prices are inbold & underlined. Incoterms vary accordingto manufacturers.[10]

Annual cost is calculated according to thedaily doses given in the WHO “Scaling-upAntiretroviral Therapy in Resource LimitedSettings: Guidelines for a Public HealthApproach” (June 2002)[6] and/or the“Guidelines for the Use of AntiretroviralAgents in HIV-1-Infected Adults andAdolescents”[7], by the Panel on ClinicalPractices for the Treatment of HIV, July 2003.

(§) BMS sells ddI (didanosine) in other

doses (per mg price remains the same)

Table 1: Summary of best ARV price offers by selected pharmaceutical companies for eligible developing countries

NRTI(Abbreviation)

Strength (mg)

Daily dose

Aurobindo(India)

BMS(US)

Cipla(India)

Combinopharm(Spain)

GPO(Thailand)

GSK(UK)

Hetero (India)

Ranbaxy(India)

Strides(India)

didanosine(ddI)

100 (§)

4

197(0.135/unit)

310*(0.212/unit)

292(0.200/unit)

146(0.100/unit)

415(0.284/unit)

didanosine(ddI)

EC 400

1

Notapplicable

270(0.741/unit)

168(0.460/unit)

335(0.917/unit)

lamivudine(3TC)

300

1

102(0.280/unit)

Not applicable

100(0.274unit)

lamivudine(3TC)

150

2

66(0.090/unit)

88*(0.120/unit)

171(0.234/unit)

69*(0.095/unit)

55*(0.075/unit)

100*(0.137/unit)

97(0.133/unit)

stavudine(d4T)

40

2

31(0.043/unit)

55*(0.075/unit)

53(0.072/unit)

77(0.105/unit)

26*(0.035/unit)

47(0.064/unit)

46(0.063/unit)

zidovudine(ZDV or AZT)

300

2

140(0.192/unit)

161*(0.220/unit)

292*(0.400/unit)

290(0.397/unit)

212*(0.290/unit)

140*(0.192/unit)

180*(0.246/unit)


Table 1b – Non-Nucleoside ReverseTranscriptase Inhibitors (NNRTIs)


For details on eligibility and offerrestrictions for countries andinstitutions, please refer to table 2band 2f.



NNRTI efavirenz efavirenz nevirapine(Abbreviation) (EFV) (EFV) (NVP)

Strength (mg) 200 600 200

Daily dose 3 1 2

Aurobindo 438 112(India) (0.400/unit) (0.153/unit)

Boehringer-Ingelheim 438*(Germany) (0.600/unit)

Cipla 462 462 124*(India) (0.422/unit) (1.267/unit) (0.170/unit)

GPO 256(Thailand) (0.350/unit)

Hetero 329 347 80*(India) (0.300/unit) (0.950/unit) (0.110/unit)

Merck 500 347(US) (0.457/unit)(†) (0.950/unit)(†)

Ranbaxy 427 427 166*(India) (0.390/unit) (1.170/unit) (0.228/unit)

Strides 162(India) (0.222/unit)

(†) Prices given in this table are for Low Human Development Index (HDI) countries plus medium HDI countries with adultHIV prevalence of 1% or greater. Table 2b gives prices for medium HDI countries with adult HIV prevalence of less than 1%[11]


Table 1c - Nucleotide ReverseTranscriptase Inhibitors (NtRTIs)

The price is in US$. Price is givenboth for a yearly adult dose and byunit.

For details on eligibility and offerrestrictions for countries andinstitutions, please refer to table 2c.




NtRTI (Abbreviation) tenofovir (TDF)

Strength (mg) 300 mg

Daily dose 1

Gilead (US) 475(1.300/unit)

PI indinavir nelfinavir ritonavir saquinavir(Abbreviation) (IDV) (NFV) (r) hard gel capsules

(SQV hgc)

Strength (mg) 400 250 100 200

Daily dose 4 (**) 10 (***) 2 (§) 10 (#)

Abbott 83*(US) (0.114/unit)

Aurobindo 393 1533 336(India) (0.269/unit) (0.420/unit) (0.460/unit)

Cipla 365 1789 394(India) (0.250/unit) (0.490/unit) (0.540/unit)

GPO 1621(Thailand) (0.444/unit)

Hetero 321* 1132 204 1022(India) (0.220/unit) (0.310/unit) (0.280/unit) (0.280/unit)

Merck 400(US) (0.274/unit)

Ranbaxy 467*(India) (0.320/unit)

Roche 942* 956*(Switzerland) 0.258/unit(†) 0.262/unit(†)

Strides 463(India) (0.317/unit)

Table 1d - Protease Inhibitors (PIs)


For details on eligibility and offerrestrictions for countries andinstitutions, please refer to table 2dand 2f.



For Roche, prices were provided in SwissFrancs and were converted into US$ (1 US$= 1.26720 CHF on 1 April 2004) (**) The daily dose referred to is 800mg IDV twice daily with ritonavir 100mg twice daily as booster. The prescribing information given by the

manufacturer is 800mg three times daily(***) The daily dose referred to is 1250 mg twice daily although the dosage of 9 tablets (3 tablets three times a day) can also be used.(§) The daily dose referred to is 100mg twice daily, for use as a booster medication. This dose is not indicated in the manufacturer’s label.(#) Saquinavir hgc should be used in combination with low-dose ritonavir as saquinavir/ritonavir 1000mg/100mg twice daily(†) Prices given in this table are for sub-Saharan Africa and Least Developed Countries as UN defined. See table 2d for prices for Low Incomeand Lower Middle Income Countries, as classified by the World Bank.


Products on the WHO list of “Pilot Procurement, Quality and Sourcing Project: Access to HIV/AIDS drugs and diagnostics of acceptable quality” (14th edition, 28 January 2004)[2] are inbold and have an asterisk * next to the price. Always check website for most recently updated list. Best prices are in bold & underlined. Incoterms vary according to manufacturers.[10]

Annual cost is calculated according to the daily doses given in the WHO “Scaling-up Antiretroviral Therapy in Resource Limited Settings: Guidelines for a Public Health Approach” (June2002)[6] and/or the “Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents”[7], by the Panel on Clinical Practices for the Treatment of HIV, July 2003.

Table 1e – Fixed Dose Combinations (FDCs)

All prices are in US$. Prices are given both for a yearly adult dose and by unit.For details on eligibility and offer restrictions for countries and institutions, please refer to tables 2.

CCombination lopinavir+ 3TC+d4T 3TC+d4T ZDV+3TC ZDV+3TC+NVP ABC+3TC+ZDV 3TC+d4T+NVP 3TC+d4T+NVPritonavir (LPV/r)

Strength 133.3 + 33.3 150 + 30 150 + 40 300 + 150 300 + 150 300 + 150 + 200 150 + 30 + 200 150 + 40 + 200 (mg) + 200

Therapeutic PI NRTI NRTI NRTI 2NRTI + 3NRTI 2NRTI + 2NRTI +class(es) NNRTI NNRTI NNRTI

Daily dose 6 2 2 2 2 2 2 2

Abbott 500*(US) (0.228/unit)

Aurobindo 204(India) (0.280/unit)

Cipla 131 146 197* 365 234 244*(India) (0.180/unit) (0.200/unit) (0.270/unit) (0.500/unit) (0.320/unit) (0.334/unit)

GPO 426 341 375(Thailand) (0.584/unit) (0.467/unit) (0.514/unit)

GSK 237* 1241*(US) (0.325/unit) (1.700/unit)

Hetero 1971 73 80 197* 277 1029 153 168(India) (0.900/unit) (0.100/unit) (0.110/unit) (0.270/unit) (0.380/unit) (1.410/unit) (0.210/unit) (0.230/unit)

Ranbaxy 125* 135* 265** 416 1579 285* 292*(India) (0.171/unit) (0.185/unit) (0.363/unit) (0.570/unit) (2.163/unit) (0.390/unit) (0.400/unit)

Strides 122 133 261(India) (0.167/unit) (0.182/unit) (0.358/unit)


Table 1f – Combined blisters

The three drugs are presented in thesame blister. Drugs must be takenonce a day.

Price is in US$. Price is given bothfor a yearly adult dose and by unit.

For details on eligibility, offerrestrictions for countries andinstitutions, Incoterm and ways toapply, please refer to table 2f.



NNRTI EFV+3TC+ddl (EC) EFV+3TC+ddl (EC)

Strength (mg) 600 + 300 + 250 600 + 300 + 400

Daily dose 1 + 1 + 1 1 + 1 + 1

Cipla 931 949(2.550/unit) (2.600/unit)


ARV Company Strength/Dosage form Presentation Price per pack Additional information

abacavir GSK 20mg/ml oral solution 240ml US$ 31.32** Cost per day as indicated by the manufacturer: US$ 2.61

didanosine BMS powder: 2g of active principle US$ 14.74 Sold in local currency in Southern Africa – sold as a bottle for Rand and East Africa - shillings. Sold in Euro re-constitution with water and to West African countries.with antacids

lamivudine GSK 10mg/ml oral solution 240ml US$ 6.73* Cost per day as indicated by manufacturer. (average paediatric dosage based on 25kgaverage weight): US$ 0.56

Cipla 10mg/ml oral solution 100ml US$ 2.00*GPO 10mg/ml syrup 60ml US$ 1.54

stavudine BMS 1mg/ml powder for syrup 200ml US$ 9.50 Sold in local currency in Southern Africa - Rand and East Africa - shillings. Sold in Euro to West African countries.

BMS 15mg capsules Blister pack Not available* of 56

BMS 20mg capsules Blister pack US$ 5.25* of 56

GPO 15mg capsules Box of 60 US$ 3.50 US$ 0.058/capsule. GPO 20mg capsules Box of 60 US$ 4.20 US$ 0.070/capsule. GPO 1mg/ml dry syrup 60ml US$ 0.65GPO 5mg/ml dry syrup 60ml US$ 0.97

zidovudine GSK 10mg/ml syrup 200ml US$ 7.10* Cost per day as indicated by manufacturer.(average paediatric dosagebased on 25kg average weight): US$ 1.42.

Cipla 50mg/5ml oral solution 100ml US$ 1.53*GPO 10mg/ml syrup 60ml/200ml US$ 1.28/3.85Combinopharm 50mg/5ml oral solution 200ml US$ 4.20

efavirenz Merck 50mg capsules Bottle of 30 US$ 3.47 US$0.116/unitnevirapine BI 10mg/ml suspension 240ml US$ 17.50*

Cipla 50mg/5ml suspension 100ml & 25ml US$ 2.45 & US$ 2.00 PMTCT dose: 25ml. (PMTCT) (PMTCT)

GPO 10mg/ml oral suspension 60ml US$ 0.92nelfinavir Roche 50mg/g, powder for suspension 144g US$ 31.17* (**) (/)ritonavir Abbott 80mg/ml oral solution 450ml(5x90ml) US$ 41.67*ritonavir + lopinavir Abbott 20mg + 80mg/ml oral solution 300ml(5x60ml) US$ 41.67*

(**) On 1 April 2004, 1 US$ = 1.2672 CHF. (/) All prices of Roche products are in Swiss francs (CHF). Prices given in this table are for sub-Saharan Africa and Least Developed Countries as UN defined. See table 2c for prices for Low Income and LowerMiddle Income Countries, as classified by the World Bank.Products on the WHO list of “Pilot Procurement, Quality and Sourcing Project: Access to HIV/AIDS drugs and diagnostics of acceptable quality” (14th edition, 28 January 2004)[2] are in bold and have an asterisk * next to the price. Always check websitefor most recently updated list. Incoterms vary according to manufacturers.[10]

Table 1g – Paediatric FormulationsFor details on eligibility and offer restrictions for countries and institutions, please refer to table 2.



Company

GlaxoSmithKline

GlaxoSmithKline

Eligibility (countries)

Least Developed Countries (LDCs) plussub-Saharan Africa.

All projects fully financed by the GlobalFund to fight AIDS, TB and Malaria.

(For middle income developing countriespublic sector prices negotiated on acase-by-case basis or bilaterally throughthe AAI).



(For middle income developing countriespublic sector prices negotiated on acase-by-case basis or bilaterally throughthe AAI).

Table 2 Company ARV offers and restrictions for developing countries, adult and paediatric formulations

Table 2a Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Product

abacavir300mg tablets(Ziagen®)

abacavir20mg/ml oralsolution 240ml (Ziagen®)

Eligibility (body)

Governments, aid organizations,charities, UN agencies, other not-for-profit organizations andinternational purchase funds suchas the Global Fund to fight AIDS,TB and Malaria.

In sub-Saharan Africa employersthere who offer HIV/AIDS care andtreatment directly to their staffthrough workplace clinics orsimilar arrangements are alsoeligible.

All organizations must supply thepreferentially priced products on anot for profit basis.

Governments, aid organizations,charities, UN agencies, other not-for-profit organizations andinternational purchase funds suchas the Global Fund to fight AIDS,TB and Malaria.

In sub-Saharan Africa employersthere who offer HIV/AIDS care andtreatment directly to their staffthrough workplace clinics orsimilar arrangements are alsoeligible.

All organizations must supply thepreferentially priced products on anot for profit basis.

Price in US$

US$ 887/year(US$ 1.215/unit)

US$ 31.32 perbottle

Additional comments

Supply Agreementrequired (For NGOsrequiring less than 10patient packs permonth, this requirementmay be waived).

The manufacturerrecommends that‘prescribers must ensurethat patients are fullyinformed regardinghypersensitivity reactionto abacavir. Patientsdeveloping signs orsymptoms must contacttheir doctorimmediately for advice.’

Supply Agreementrequired (For NGOsrequiring less than 10patient packs permonth, this requirementmay be waived).

The manufacturerrecommends that‘prescribers must ensurethat patients are fullyinformed regardinghypersensitivity reactionto abacavir. Patientsdeveloping signs orsymptoms must contacttheir doctorimmediately for advice.’

Delivery ofgoods[10]

CIP

CIP

Company

Bristol-MyersSquibb Co.

Bristol MyersSquibb Co,

GlaxoSmithKline

Product

didanosine100mg(Videx®)

didanosinepowder fororal solution2g+anti-acid(Videx®)

lamivudine150mg tablet(Epivir®)


Sub-Saharan Africa.

(For other developing countries, pricesnegotiated on a case by case basisthrough the AAI.)

Sub-Saharan Africa




(For middle income developing countriespublic sector prices negotiated on acase-by-case basis or bilaterally throughthe AAI.)

Eligibility (body)

Both private and public sectororganisations that are able to provideeffective, sustainable and medicallysound care and treatment of HIV/AIDSare eligible.


Governments, aid organisations,charities, UN agencies, other not-for-profit organisations andinternational purchase funds such asthe Global Fund to fight AIDS, TB andMalaria.

In sub-Saharan Africa employers there who offer HIV/AIDS care and treatment directlyto their staff through workplace clinicsor similar arrangements are alsoeligible.

All organisations must supply thepreferentially priced products on a notfor profit basis.

Price in US$


Lower tabletdosages prices inline with this offer

US$ 14.74 perbottle


Additional comments

Supply Agreementrequired (For NGOsrequiring less than10 patient packs permonth, this requirement may bewaived).


DDU togovernmentpurchasingentities.

DDU togovernmentpurchasingentities.

CIP



Product

lamivudine10mg/ml oralsolution240ml(Epivir®)

stavudine20mg, 30mgand 40mgcaps (Zerit®)

stavudine1mg/mlpowder forsyrup 200ml(Zerit®)

Company

GlaxoSmithKline




LDCs plus sub-Saharan Africa.


(For middle income developing countriespublic sector prices negotiated on acase-by-case basis or bilaterally throughthe AAI.)

Sub-Saharan Africa.


Sub-Saharan Africa.


Eligibility (body)


In sub-Saharan Africa employers there who offer HIV/AIDS care and treatment directlyto their staff through workplaceclinics or similar arrangements arealso eligible.

All organisations must supply thepreferentially priced products on anot for profit basis.



Price in US$

US$ 6.73 perbottle

20mg: US$ 5.25 per 56caps(US$ 0.094/unit)

30mg:US$ 48.18/year(US$ 0.066/unit)

40mg:US$ 54.75/year(US$ 0.075/unit)

US$ 9.50 perbottle

Additional comments

Supply Agreementrequired (For NGOsrequiring less than10 patient packs permonth, this requirement may bewaived).


CIP

DDU togovernmentpurchasingentities

DDU togovernmentpurchasingentities


Product

zidovudine300mgtablets(Retrovir®)

zidovudine10mg/mlsyrup200ml

(Retrovir®)

Company

GlaxoSmithKline

GlaxoSmithKline




(For middle income developingcountries public sector pricesnegotiated on a case-by-case basis orbilaterally through the AAI.)



(For middle income developingcountries public sector pricesnegotiated on a case-by-case basis orbilaterally through the AAI.)

Eligibility (body)


In sub-Saharan Africa, employers therewho offer HIV/AIDS care andtreatment directly to their staffthrough workplace clinics or similararrangements are also eligible.



In sub-Saharan Africa, employers therewho offer HIV/AIDS care andtreatment directly to their staffthrough workplace clinics or similararrangements are also eligible.


Price in US$


US$ 7.10 perbottle

Additionalcomments

Supply Agreementrequired.

(For NGOsrequiring less than10 patient packsper month, thisrequirement maybe waived.)


(For NGOsrequiring less than10 patient packsper month, thisrequirement maybe waived.)


CIP

CIP

Table 2b Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Product

efavirenz(Stocrin®)

efavirenz(Stocrin®)

nevirapine200mg tablets(Viramune®)

nevirapine10mg/mlsuspension240ml (Viramune®)

Company

Merck & Co., Inc.

Merck & Co., Inc.

BoehringerIngelheim

BoehringerIngelheim


CIP

CIP

CIF

CIF


Low Human Development Index(HDI) countries plus medium HDIcountries with adult HIV prevalenceof 1% or greater[11].

Medium HDI countries with adultHIV prevalence less than 1%[11].

All World Bank low-incomecountries and sub-Saharan Africa.

(Other countries on a case-by-casebasis.)

All World Bank low-incomecountries and sub-Saharan Africa.

(Other countries on a case-by-casebasis.)

Eligibility (body)

Governments, internationalorganisations, NGOs, private sectororganisations (e.g. employers,hospitals and insurers).

Merck & Co., Inc. does not ruleout supplying ARVs to patientsthrough retail pharmacies.


Merck & Co., Inc. does not ruleout supplying ARVs to patientsthrough retail pharmacies.

Governments, NGOs and otherpartners who can guarantee thatthe programme is run in aresponsible manner.

Governments, NGOs and otherpartners who can guarantee thatthe programme is run in aresponsible manner.

Price in US$

600mg tablet: US$ 346.75/year(US$ 0.950/unit)

200mg capsule: US$ 500/year(US$ 0.457/unit)

50mg capsule: US$ 0.116/unitUS$ 3.47 per bottleof 30

600mg tablet: US$ 767/year (US$ 2.100/unit)

200mg capsule: US$ 920/year(US$ 0.840/unit)

50mg capsule US$ 0.213 per unitUS$ 6.39 per bottleof 30


US$ 17.50 per unit

Additional comments

Although Romaniadoes not fall underthese categories italso benefits fromthese prices due to agovernmentcommitment to aprogramme ofuniversal access.


Table 2c Nucleotide Reverse Transcriptase Inhibitors (NtRTIs)

Product

tenofovir300mg(Viread®)

Company

Gilead


FOB


53 nations in Africa and 15 otherUN-designated ‘least developed’countries.

Eligibility (body)

Organisations that provide HIVtreatment in the 68 countriescovered by the Viread Accessprogramme will be able toreceive Viread at the accessprice. Applications will gothrough a review process.

Price in US$

US$ 474.50/year (US$ 1.300/unit)

Additionalcomments

The programmeswill be managedthrough Axios.



Table 2d Protease Inhibitors (PIs)

Product

indinavir(400mg caps)(Crixivan®)

indinavir(400mg caps)(Crixivan®)

nelfinavir250mg tablets(Viracept®)

Company

Merck & Co.,Inc.

Merck & Co.,Inc.

Roche


CIP

CIP

Terms andconditions:Effective date1st March2003. FCABasel (CH), CAD(Cash AgainstDocuments) 30 days atsight. Minimumorder anddeliveryamount pershipment isCHF 10,000 (US$ 7891)


Low Human DevelopmentIndex (HDI) countries plusmedium HDI countries withadult HIV prevalence of 1%or greater[11].

Medium HDI countries withadult HIV prevalence lessthan 1%[11].

Least Developed Countries(LDCs) plus sub-Saharan Africa.

Eligibility (body)


Merck & Co., Inc. does not rule outsupplying ARVs to patients throughretail pharmacies.


Merck & Co., Inc. does not rule outsupplying ARVs to patients throughretail pharmacies.

Governments, Non Profit InstitutionalProviders of HIV care, NGOs.

Price in US$

800mg* (plusritonavir 100mg)twice dailyUS$ 400/year(US$ 0.274/unit)

800mg 3 timesdaily not boostedUS$600/year(US$0.274/unit)

800mg* (plusritonavir 100mg)twice dailyUS$ 686/year(US$ 0.470/unit)

800mg 3 timesdaily not boostedUS$1029(US$0.470/unit)

Bottle of 270tablets CHF 88.40 (US$ 69.76)US$ 942/year(US$ 0.258/unit)

Additional comments

Although Romania doesnot fall under thesecategories it alsobenefits from theseprices due to agovernment commitmentto a programme ofuniversal access.

* The yearly and unit price is for indinavir only. See price of booster on page 26.

Product

nelfinavir 250mgtablets(Viracept®)

nelfinavirpowder for oralsolution 144g 50mg/g(Viracept®)

nelfinavirpowder for oralsolution 144g50mg/g(Viracept®)

Company

Roche

Roche

Roche


Terms andconditions:Effective date 1stMarch 2003. FCABasel (CH), CAD(Cash AgainstDocuments) 30days at sight.Minimum orderand deliveryamount pershipment is CHF 10,000 (US$ 7891)

Terms andconditions:Effective date 1stMarch 2003. FCABasel (CH), CAD(Cash AgainstDocuments) 30days at sight.Minimum orderand deliveryamount pershipment is CHF 10,000 (US$ 7891)


Low income countries andlower middle incomecountries - as classified bythe World Bank.


Low income countries andLower middle incomecountries - as classified bythe World Bank.

Eligibility (body)




Price in US$

Bottle of 270 tablets: CHF 3o0.00 US$ 236.74US$ 3201/year(US$ 0.877/unit)

CHF 39.50 per bottle(US$ 31.17)

CHF 55.00 per bottle(US$ 43.40)

Additionalcomments


Product

ritonavir100mg caps(Norvir®)

ritonavir oralsolution450ml(Norvir®)

saquinavir200mg hardgel capsules(Invirase®)

saquinavir200mg hardgel capsules(Invirase®)

Company

Abbott

Abbott

Roche

Roche

Delivery of goods[10]

FOB

FOB

Terms andconditions: Effectivedate 1st March2003. FCA Basel(CH), CAD (CashAgainst Documents)30 days at sight.Minimum order anddelivery amount per shipment is CHF 10,000 (US$ 7891)

Terms andconditions: Effectivedate 1st March2003. FCA Basel(CH), CAD (CashAgainst Documents)30 days at sight.Minimum order anddelivery amount per shipment is CHF 10,000 (US$ 7891)


All African countries and theLDCs outside of Africa.

All African countries and theLDCs outside of Africa.

Low income countries andLower middle incomecounries - as classified bythe World Bank.


Eligibility (body)

Governments, NGOs, UN systemorganisations and other national andinternational health institutions.

Governments, NGOs, UN systemorganisations and other national andinternational health institutions.



Price in US$

“Booster dose”:US$ 83/year (US$ 0.114/unit)

US$ 41.67 perbottle

Bottle of 270capsules: CHF 300.00(US$ 236.74)


Bottle of 270capsules: CHF 89.60(US$ 70.71)


Additionalcomments


Table 2e Fixed Dose Combinations

Product

lopinavir/ritonavir133.33 + 33.3mg capsules(Kaletra®)

lopinavir/ritonavir oralsolution300ml(Kaletra®)

lamivudine +zidovudine300mg +150mg tablets(Combivir®)

Company

Abbott

Abbott

GlaxoSmithKline


FOB

FOB

CIP


All African countries and theLeast Developed Countries(LDCs) outside of Africa.

All African countries and theLeast Developed Countries(LDCs) outside of Africa.


All projects fully financed bythe Global Fund to fight AIDS,TB and Malaria.

(For middle incomedeveloping countries publicsector prices negotiated on acase-by-case basis orbilaterally through the AAI.)

Eligibility (body)

Governments, NGOs, UN systemorganisations, and other national andinternational health institutions.

Governments, NGOs, UN systemorganisations, and other national andinternational health institutions.

Governments, aid organisations, charities,UN agencies, other not-for-profitorganisations and international purchasefunds such as the Global Fund to fightAIDS, TB & Malaria.

In sub-Saharan Africa, employers therewho offer HIV/AIDS care and treatmentdirectly to their staff through workplaceclinics or similar arrangements are alsoeligible.


Price in US$


US$ 41.67 perbottle


Additional comments


(For NGOs requiringless than 10 patientpacks per month,this requirement maybe waived.)


Product

abacavir +lamivudine +zidovudine300 + 150 +300mg tablets(Trizivir®)

Company

GlaxoSmithKline


CIP



All projects fully financed bythe Global Fund to fight AIDS,TB and Malaria.

(For middle incomedeveloping countries publicsector prices negotiated on acase-by-case basis orbilaterally through the AAI.

Eligibility (body)

Governments, aid organisations, charities,UN agencies, other not-for-profitorganisations and international purchasefunds such as the Global Fund to fightAIDS, TB & Malaria.

In sub-Saharan Africa, employers therewho offer HIV/AIDS care and treatmentdirectly to their staff through workplaceclinics or similar arrangements are alsoeligible.


Price in US$


Additional comments


(For NGOs requiringless than 10 patientspack per month, thisrequirement may bewaived.)



Other generic manufacturers producing ARVs exist but are not included in this summary of offers

Company

Aurobindo

Cipla

Combinopharm

GPO

Hetero

Ranbaxy

Strides

Delivery of goods[10]

FOB Hyderabad(India)

FOB Mumbai(India) or CIF.Freight chargesseparately onactual.

FOB Barcelona(Spain)

FOB Bangkok(Thailand)

FOB Mumbai(India)

FOB Delhi/Mumbai(India)

FOB Bangalore(India)


No restriction

No restriction

No restriction

No restriction

No restriction

No restriction

No restriction

Eligibility (body)

NGOs and GovernmentalOrganizations.

No restriction

No restriction.

Not-for-profit organizationsand governments.

Private sector, Publicsector and NGO’s.

NGO’s and Governmentsor Programs supported bythem.

Governments, non profitinstitutional providers ofHIV treatment, NGO’s.

Price in US$

See Table 1.

See Table 1.For bulk purchasesprices are negotiable.

See Table 1.

See Table 1.

See Table 1.

Prices given in Table 1apply to orders for aminimum of 1.5 millionunits. Different pricesare offered for smallerquantities (500 000 or1 million units).

US$ per pack unit asgiven in price list.

Additional comments

Prices available for at least 1,000,000 units foreach product per single shipment.

Payment by letter of credit.

No quantity related conditions. Prices are asper table 1 however for larger quantities theprices are negotiable.

Delivery terms 120 days.No minimum order required unless any speciallabelling is required (standard labelling is inSpanish): order of a complete batch. Pack of60 or 300 capsules available for ZDV.

Payment by signed letter of credit.

Prices could be negotiated on individual basisaccording commercial terms.

Signed letter of credit.

Payment by signed letter of credit.

Table 2f Selected generic companies’ ARV offers and restrictions for developing countries

Annex 2: Human Development Index(HDI)

Source: Human Development Report2002, Making new technologies workfor human development UNDP. Forfull list of Human Development Indexranking seehttp://www.undp.org/hdr2003/pdf/presskit/HDR03_PKE_HDI.pdf

Low human developmentAngola; Benin; Burkina Faso;Burundi; Cameroon; Central AfricanRepublic; Chad; Congo (Dem. Rep. ofthe); Côte d’Ivoire; Djibouti; Eritrea;Ethiopia; Gambia; Guinea; Guinea-Bissau; Haiti; Kenya; Madagascar;Malawi; Mali; Mauritania;Mozambique; Nepal; Niger; Nigeria;Pakistan; Rwanda; Senegal; SierraLeone; Tanzania (U. Rep. of );Uganda; Yemen; Zambia; Zimbabwe.

Medium human developmentAlbania; Algeria; Antigua andBarbuda; Armenia; Azerbaijan;Bangladesh;; Belize; Bhutan; Bolivia;Bosnia and Herzegovina; Botswana;Brazil; Bulgaria; Cambodia;; CapeVerde; China; Colombia; Comoros;Congo;; Dominica; DominicanRepublic; Ecuador; Egypt; ElSalvador; Equatorial Guinea; Fiji;Gabon; Georgia; Ghana; Grenada;Guatemala; Guyana; Honduras; India;Indonesia; Iran (Islamic Rep. of );

Annex 1: Least Developed Countries(LDCs)

Source: UNCTADhttp://www.unctad.org/Templates/WebFlyer.asp?intItemID=2161&lang=1Forty-nine countries are currentlydesignated least developedcountries (LDCs). The list is reviewedevery three years.

Afghanistan; Angola; Bangladesh;Benin; Bhutan; Burkina Faso;Burundi; Cambodia; Cape Verde;Central African Republic; Chad;Comoros; Democratic Republic ofCongo; Djibouti; Equatorial Guinea;Eritrea; Ethiopia; Gambia; Guinea;Guinea Bissau; Haiti; Kiribati; LaoPeople’s Democratic Republic;Lesotho; Liberia; Madagascar;Malawi; Maldives; Mali; Mauritania;Mozambique; Myanmar; Nepal;Niger; Rwanda; Samoa; Sao Tomeand Principe; Senegal; Sierra Leone;Solomon Islands; Somalia; Sudan;Togo; Tuvalu; Uganda; UnitedRepublic of Tanzania; Vanuatu;Yemen; Zambia.

Jamaica; Jordan; Kazakhstan;Kyrgyzstan; Lao People’s Dem. Rep;Lebanon; Lesotho; Libyan ArabJamahiriya; Macedonia (TFYR);Malaysia; Maldives; Mauritius;Moldova (Rep. of ); Mongolia;Morocco; Myanmar; Namibia;Nicaragua; Oman; OccupiedPalestinian Territories; Panama;Papua New Guinea; Paraguay; Peru;Philippines; Romania; RussianFederation; Saint Lucia; Samoa(Western); São Tomé & Principe;Saudi Arabia; Solomon Islands;South Africa; Sri Lanka; St.Vincentand the Grenadines; Sudan;Suriname; Swaziland; Syrian ArabRepublic; Tajikistan; Thailand; Togo;Tunisia; Turkey; Turkmenistan;Ukraine; Uzbekistan; Vanuatu;Venezuela; Viet Nam.

AAnnnneexxeess


Annex 3: Sub-Saharan countries

Source: World Bank(April 2003)http://www.worldbank.org/data/countryclass/classgroups.htm

Angola; Benin; Botswana; BurkinaFaso; Burundi; Cameroon; CapeVerde; Central African Republic;Chad; Comoros; Congo (Dem. Rep);Cong (Rep.); Côte d’Ivoire; EquatorialGuinea; Eritrea; Ethiopia; Gabon;Gambia; Ghana; Guinea; Guinea-Bissau; Kenya; Lesotho; Liberia;Madagascar; Malawi; Mali;Mauritania; Mauritius; Mozambique;Namibia; Niger; Nigeria; Rwanda;São Tomé and Principe; Senegal;Seychelles; Sierra Leone; Somalia;South Africa; Sudan; Swaziland;Tanzania; Togo; Uganda; Zambia;Zimbabwe.

Annex 4: World Bank low-incomecountries

Source: World Bank(September 2003)http://www.worldbank.org/data/countryclass/classgroups.htm

Low-income economiesAfghanistan; Angola; Azerbaijan;Bangladesh; Benin; Bhutan; BurkinaFaso; Burundi; Cambodia; Cameroon;Central African Republic; Chad;Comoros; Congo (Dem. Rep.), Congo(Rep.); Côte d’Ivoire; EquatorialGuinea; Eritrea; Ethiopia; Gambia;Georgia; Ghana; Guinea; Guinea-Bissau; Haiti; India; Indonesia;Kenya; Korea, Dem. Rep.; KyrgyzRepublic; Lao PDR; Lesotho; Liberia;Madagascar; Malawi; Mali;Mauritania; Moldova; Mongolia;Mozambique; Myanmar; Nepal;Nicaragua; Niger; Nigeria; Pakistan;Papua New Guinea; Rwanda; SãoTomé and Principe; Senegal; SierraLeone; Solomon Islands; Somalia;Sudan; Tajikistan; Tanzania; Timor-Leste; Togo; Uganda; Uzbekistan;Vietnam; Yemen (Rep.), Zambia;Zimbabwe.

Lower-middle-income economiesAlbania; Algeria; Armenia; Belarus;Bolivia; Bosnia and Herzegovina;Brazil;Bulgaria; Cape Verde; China;Colombia; Cuba; Djibouti; DominicanRepublic; Ecuador; Egypt, Arab Rep.;El Salvador; Fiji; Guatemala; Guyana;Honduras; Iran, Islamic Rep.; Iraq;Jamaica; Jordan; Kazakhstan; Kiribati;Macedonia, FYR; Maldives; MarshallIslands; Micronesia, Fed. Sts.;Morocco; Namibia; Paraguay; Peru;Philippines; Romania; RussianFederation; Samoa; Serbia andMontenegro ;South Africa; Sri Lanka;St. Vincent and the Grenadines;Suriname; Swaziland; Syrian ArabRepublic; Thailand; Tonga; Tunisia;Turkey; Turkmenistan; Ukraine;Vanuatu; West Bank and Gaza.

Upper-middle-income economiesAmerican Samoa; Antigua andBarbuda; Argentina; Barbados;Belize; Botswana; Chile; Costa Rica;Croatia; Czech Republic; Dominica;Estonia; Gabon; Grenada; Hungary;Isle of Man; Latvia; Lebanon; Libya;Lithuania; Malaysia; Malta; Mauritius;Mayotte; Mexico; Oman; Palau;Panama; Poland; Puerto Rico; SaudiArabia; Seychelles; Slovak Republic;St. Kitts and Nevis; St. Lucia;Trinidad and Tobago; Uruguay;Venezuela, RB.

Annex 5: Company contacts

Abbott: Rob DintruffEmail: [email protected]

AXIOS International manages theapplication process and serves asthe central contact: The Programme ManagerAccess to HIV Care ProgrammeAXIOS InternationalP.O. Box 6924Kampala, Uganda.Tel: +256 75 693 756Fax:+256 41 543 021Email:[email protected] Website : www.accesstohivcare.org

Aurobindo Pharma Ltd:Mr. A.Vijaykumar Head– Anti Retrovirals Project Tel: +91 40 2304 4070 Or +91 98481 10877 (Mobile)Fax: +91 40 23044058Email: [email protected]

Bristol-Myers Squibb Co: West Africa:information can be obtained fromMs Marie-Astrid Mercier, BMS AccessCoordinator in BMS Paris office([email protected])


East Africa: information can be obtained fromBMS main distributor in East Africa -M. Mukesh Mehta at PhillipsPharmaceuticals in Nairobi([email protected]).

Southern Africa: information can be obtained from MsTamany Geldenhuys in BMS officesin Johannesburg([email protected]).

Boehringer Ingelheim: Laurence Phillips (for preferentialprices)CD Marketing Prescription MedicinesHIV-Specialists/VirologistsPhone: + 49 6132 772081Fax: +49 6132 773829Email: [email protected]

Hélène Clary (for the Viramune MTCTdonation program)Marketing Prescription MedicinesCG HIV-Specialists/VirologistsTel: + 49 6132 7734 36 Fax: + 49 6132 7738 29 Email: [email protected]

Cipla Ltd:Mr. Sanjeev Gupte, General Manager-Exports, and Mr. Shailesh PednekarExecutive-Exports, Cipla Limited

Tel: +91 22 3021397 (Direct)3095521 3092891Fax: +91 223070013/3070393/3070385Email: [email protected] [email protected]

Combinopharm:Ms. Assumpció GiraltExport ManagerCombinopharmTel: + 34 93 48 08 833Fax: + 34 93 48 08 832Email: [email protected]

Gilead:Programme Access (primary contact)Gilead Access ProgramAxios InternationalPlot 1 Pilkington Road6th Floor Workers House Building P.O. Box 6924 KampalaUganda Tel: +256 41 340806/7Fax: +256 41 340642 Email: [email protected]

Company contactJoe SteeleSenior Director, CommercialDevelopmentGilead Sciences333 Lakeside DriveFoster CityCalifornia 94404-1147Tel: +1 650 522 5740


GlaxoSmithKline: Mr. Jon Pender Director, Government AffairsAccess Issues & IPTel: + 44 (0) 20 8047 5489 Fax: + 44 (0) 208 047 6957Email: [email protected]

GPO: Mr. Sukhum Virattipong Export Manager Tel: + 662 248 1482, + 662 2038808Fax: + 662 248 1488Email: [email protected]

Hetero Drugs Ltd:Mr M. Srinivas ReddyHetero HouseH.No. 8-3-166/7/1Erragadda, Hyderabad - 500 018IndiaTel: +91 40 23704923/24Tel (direct): +91 40 2381 8029Fax: +91 40 23704926Email: [email protected]

Merck & Co. Inc: Dr Jeffrey L. SturchioVice President, External AffairsHuman Health Europe, Middle East& Africa Merck & Co. Inc/WS2A-55One Merck DriveWhitehouse StationNJ 08889-0100 USATel: +1 908 423 3981

Fax: +1 908 735 1839 Email: [email protected]

Ranbaxy:Mr. Sandeep JunejaRanbaxy Laboratories LimitedTel: + 91 11 2600 2120 (Direct) or + 91 11 2645 2666 72Fax: + 91 11 2600 2121Email: [email protected]

Roche: For information regarding quotationsand deliveries to customers contact: Hanspeter Walchli Logistics Sales InternationalCustomers Dept. PTBS-IM 4070 Basel / SwitzerlandTel: +41 61 688 1060Fax: +41 61 687 1815 Email: [email protected]

Strides Arcolab Ltd:Mrs. Aloka SenguptaAsst. Vice President ATMStrides House, BilekahalliBannerghatta RoadBangalore 560 076, INDIATel: 91 80 26581343/44/46Fax: 91 80 26583538/26584330Email id: [email protected]

3TC lamivudine; nucleosideanalogue reverse transcriptaseInhibitor

AAI United Nations AcceleratingAccess Initiative; Accelerated Accessemerged out of the partnershipinitiated in May 2000 between theUN (UNFPA, UNICEF, WHO, the WorldBank and UNAIDS Secretariat) andfive pharmaceutical companies(Boehringer-Ingelheim GmbH,Bristol-Myers Squibb,GlaxoSmithKline, Merck & Co., Inc.,and F. Hoffmann-La Roche Ltd(Roche); Abbott Laboratories Ltd.joined the initiative later) toincrease access to HIV/AIDS care,treatment and support. AAI plays arole in facilitating price negotiationsbetween developing countrygovernments and ‘originator’ drugcompanies that are participating inthe AAI.

ABC abacavir; nucleoside analoguereverse transcriptase inhibitor

AIDS Acquired Immune DeficiencySyndrome

ARVs Antiretroviral drugs

BMS Bristol-Myers Squibb

CDC Centres for Disease Control andPrevention

CIF[10] ‘Cost Insurance and Freight’means that the seller delivers whenthe goods pass the ship’s rail in theport of shipment. The seller mustpay the costs and freight necessaryto bring the goods to the namedport of destination BUT the risk ofloss or damage to the goods, aswell as any additional costs due toevents occurring after the time ofdelivery, are transferred from theseller to the buyer.

CIP[10] ‘Carriage and Insurance paidto...’ means that the seller deliversthe goods to the carrier nominatedby him but the seller must inaddition pay the cost of carriagenecessary to bring the goods to thenamed destination. This means thatthe buyer bears all the risks and anyadditional costs occurring after thegoods have been so delivered.However, in CIP the seller also hasto procure insurance against thebuyer’s risk of loss of or damage tothe goods during the carriage.Consequently, the seller contracts forinsurance and pays the insurancepremium.

d4T stavudine; nucleoside analoguereverse transcriptase inhibitor

ddI didanosine; nucleoside analoguereverse transcriptase inhibitor

Glossary[12] DDU[10] ‘Delivered duty unpaid’means that the seller delivers thegoods to the buyer, not cleared forimport, and not unloaded from anyarriving means of transport at thenamed place of destination. Theseller has to bear the costs andrisks involved in bringing the goodsthereto, other than, whereapplicable, any ‘duty’ (which termincludes the responsibility for therisks of the carrying out of thecustoms formalities, and thepayment of formalities, customsduties, taxes and other charges) forimport in the country of destination.Such ‘duty’ has to be borne by thebuyer as well as any costs and riskscaused by his failure to clear thegoods for the import time.

EML Essential Medicines List. Firstpublished by WHO in 1977, it ismeant to identify a list ofmedicines, which provide safe andeffective treatment for the infectiousand chronic diseases, which affectthe vast majority of the world’spopulation. The 12th Updated Listwas published in April 2002 andincludes 12 antiretrovirals.

EFV or EFZ efavirenz; non-nucleoside analogue reversetranscriptase inhibitor

EXW[10] ‘Ex-works’ means that the


SQV sgc saquinavir soft gelcapsules; protease inhibitor

TDF tenofovir; nucleotide reversetranscriptase inhibitor

UNAIDS United Nations Joint Co-sponsored Programme on HIV/AIDS,created in 1996, to lead, strengthenand support an expanded responseto the HIV/AIDS epidemic. The sixoriginal Cosponsors are UNICEF,UNDP, UNFPA, UNESCO, WHO andthe World Bank. UNDCP joined inApril 1999

UNDP United Nations DevelopmentProgramme

WHO World Health Organization

ZDV zidovudine; nucleosideanalogue reverse transcriptaseinhibitor

seller delivers when he places thegoods at the disposal of the buyerat the seller’s premises or anothernamed place (i.e. works, factory,warehouse etc.) not cleared forexport and not loaded on anycollecting vehicle.

FOB[10] ‘Free on board’ means thatthe seller delivers when the goodspass the ship’s rail at the namedport of shipment. This means thatthe buyer has to bear all costs andrisks of loss or damage to thegoods from that point. The FOBterm requires the seller to clear thegoods for export.

GGeenneerriicc ddrruugg According to WHO, apharmaceutical product usuallyintended to be interchangeable withthe innovator product, which isusually manufactured without alicense from the innovator company.Generic products may be marketedeither under a non-proprietary orapproved name rather than aproprietary name.

GPO Governmental PharmaceuticalOrganization (Thailand)

GSK GlaxoSmithKline

HIV Human Immunodeficiency Virus

IDV indinavir; protease inhibitor

LDCs Least Developed Countries,according to United Nationsclassification

MSD Merck Sharp & Dome (Merck &Co., Inc.)

MSF Médecins Sans Frontières

NGO Non Governmental Organization

NFV nelfinavir; protease inhibitor

NNRTI Non-Nucleoside ReverseTranscriptase Inhibitor

NRTI Nucleoside Analogue ReverseTranscriptase Inhibitor

NtRTI Nucleotide ReverseTranscriptase Inhibitor

NVP nevirapine; non-nucleosideanalogue reverse transcriptaseinhibitor

PMTCT Prevention of Mother-To-ChildTransmission

r ritonavir, low dose ritonavir usedas a booster; protease inhibitor

SQV hgc saquinavir hard gelcapsules; protease inhibitor


Laboratorios, Panalab, Filaxis(Argentina); Pharmaquick (Benin);Far Manguinhos, FURP, Lapefe, Laob,Iquego, IVB (Brazil); Apotex,Novopharm (Canada); ShanghaiDesano Biopharmaceutical company,Northeast General PharmaceuticalFactory (China); Biogen (Colombia);Stein (Costa Rica); Zydus CadilaHealthcare, Emcure, SunPharma,EAS-SURG, Mac Leods, IPCA (India);Cosmos (Kenya); LG Chemicals,Samchully, Korea United Pharm Inc.(Korea); Protein, Pisa (Mexico);Andromaco (Spain); Aspen (SouthAfrica); T.O. Chemecal (Thailand);Laboratorio Dosa S.A. (US), Varichem(Zimbabwe).This list is not exhaustive.

[6] Scaling up antiretroviral therapyin resource-limited settings:Treatment guidelines for a publichealth approach 2003 Revisedversion.http://www.who.int/hiv/pub/prev_care/en/ARVGuidelinesRevised2003.pdf

[7] Guidelines for the Use ofAntiretroviral Agents in HIV-1-Infected Adults and Adolescents, bythe Panel on Clinical Practices forthe Treatment of HIV, March 23,2004.http://aidsinfo.nih.gov/guidelines/adult/AA_032304.pdf

References [1] Accessing ARVs: Untangling theWeb of Price Reductions forDeveloping Countries, first edition,October 2001 and second edition,June 2002, third edition, December2002, fourth edition, June 2003 andfifth edition, December 2003.

[2] Pilot Procurement, Quality andSourcing Project: Access to HIV/AIDSdrugs and diagnostics of acceptablequality, 14th edition 28 January2004. http://www.who.int/medicines/organization/qsm/activities/pilotproc/pilotproc.shtml

[3] Sources and prices of selecteddrugs and diagnostics for peopleliving with HIV/AIDS. A joint UNICEF,UNAIDS Secretariat, WHO, MSFproject. May 2004(WHO/EDM/PAR/2003.2).http://www.who.int/medicines/organization/par/ipc/sources-prices.pdf

[4] Two Pills a Day Saving Lives:Fixed-dose combinations (FDCs) ofantiretroviral drugs. MSF BriefingNote, February 2004.http://www.accessmed-msf.org/documents/factsheetfdc.pdf

[5] Other generic manufacturersknown to be producing one or moreARVs but not included in thisdocument are: Richmond

[8] Patent Situation of HIV/AIDSrelated drugs in 80 countries,WHO/UNAIDS, 2000.http://who.int/medicines/library/par/hivrelateddocs/patentshivdrugs.pdf

[9] http://www.accessmed-msf.org/documents/patents_2003.pdf

[10] Incoterms 2000.http://www.iccwbo.org/index_incoterms.asp

[11] To find the HIV prevalence statusof countries seehttp://www.who.int/hiv/pub/epidemiology/pubfacts/en/

[12] Abbreviations for the ARVs aretaken from the WHO draft guidelinesScaling-up Antiretroviral therapy inResource Limited Settings: Guidelinesfor a Public Health approach, 2003Revision.http://www.who.int/hiv/pub/prev_care/en/ARVGuidelinesRevised2003.pdf


Campaign for Access to Essential MedicinesMédecins Sans FrontièresRue de Lausanne 78, CP 116CH-1211 Geneva 21, Switzerland

Tel: + 41 (0) 22 849 84 05Fax: + 41 (0) 22 849 84 04

email: [email protected]://www.accessmed-msf.orgDesign and artwork: Twenty 3 Crows Ltd +44 (0) 1848 200401

a pricing guide for the purchase of ARVs for developing countries

price Untangling the web of price reductions:

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untangling the web 6th edition english version

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countries11 tables11

dose combinations fdcs16

dose combinations fdcs29

f combined blisters17

generic companies arv

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income countries31 annex