Untangling the Web 4th Edition

15th May 2003Fourth edition

a pricing guide for the purchase of ARVs for developing countries

price Untangling the web of price reductions:

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3 Table of contents4 General background and objectives4 Methodology5 Limitations of the current system5 The challenge of paediatric formulations6 Research and development for HIV/AIDS7 The effects of generic competition8 Guide to reading and using tables9 Tables

9 Table 1: Summary of selected pharmaceutical companies’ best ARV price offers for eligible developing countries9 Table 1a – Nucleoside Reverse Transcriptase Inhibitors (NRTIs)10 Table 1b – Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)11 Table 1c – Nucleotide Reverse Transcriptase Inhibitors (NtRTIS)12 Table 1d – Protease Inhibitors (PIs)13 Table 1e – Fixed Dose Combinations (FDCs)14 Table 1f – Paediatric Formulations15 Table 2: Companies’ ARV offers and restrictions for developing countries, adult and paediatric formulations15 Table 2a – Nucleoside Reverse Transcriptase Inhibitors (NRTIs)18 Table 2b – Non-Nucleoside Reverse Transcriptase Inhibitors (NRTIs)19 Table 2c – Nucleotide Reverse Transcriptase Inhibitors (NtRTIs)20 Table 2d – Protease Inhibitors (PIs)23 Table 2e – Fixed Dose Combinations (FDCs)25 Table 2f – Selected Generic companies’ ARV offers and restrictions for developing countries

26 Annexes26 Annex 1: Least Developed Countries (LDCs)26 Annex 2: Human Development Index (HDI)27 Annex 3: Sub-Saharan countries27 Annex 4: World Bank low-income countries27 Annex 5: Company contacts

29 Glossary

31 References

Table of contents

Médecins Sans Frontières • www.accessmed-msf.org • May 2003 • Untangling the Web of Price Reductions • 3

General background and objectives

Lack of clear information onpharmaceutical prices on theinternational market is a significantbarrier to improving access toessential medicines in developingcountries. The situation is particularlycomplex in the case of antiretrovirals(ARVs).

The data in this guide on ARV pricesoffered by originator companies andsome generic companies in low- andmiddle-income countries are meant toprovide potential buyers with clearverified data. This information isintended for use by government andnon-profit procurement agencies, aswell as other bulk purchasers ofARVs, including health facilities andnon governmental organisations(NGOs).

This document includes both adultand paediatric formulations, and ismeant to be used in tandem with thereport of “Pilot Procurement, Qualityand Sourcing Project: Access toHIV/AIDS Drugs and Diagnostics ofAcceptable Quality ”, a projectinitiated by WHO and developed incollaboration with other UnitedNations Organisations (UNAIDS,UNICEF, UNFPA). This project evaluates

contacted and asked to verify theiroffers. The list of generic producersincluded in this report is by no meansexhaustive4. All generic drugs includedin this pricing guide have made priceoffers for developing countries andhave at least been cleared formarketing in their countries of origin.

Manufacturers were asked to providethe following information:

• drug, dosage and pharmaceutical form

• price per unit (or daily dose) of different price offers

• restrictions that apply to the offers, including:

i. country eligibilityii. potential beneficiaries of the offeriii. additional comments on conditions or procedures, such as quantity restrictions, how to access discounts, bureaucratic procedures

pharmaceutical manufacturers andproducts according to WHOrecommended standards of qualityand compliance with GoodManufacturing Practices. It is part ofan ongoing process that will expandas the participation of suppliersincreases. An updated list of productsis regularly posted on the websites ofWHO and other UN-collaboratingagencies1; products on this list arecommonly referred to as “WHO pre-qualified.” This list of “pre-qualified”drugs is not exhaustive.

Pricing information on other essentialdrugs and diagnostics used forHIV/AIDS can be found in the 4thedition of the report “Sources andPrices of Selected Drugs andDiagnostics for People Living withHIV/AIDS” May 20032.

This is the fourth edition of “AccessingAntiretrovirals: Untangling the Web ofPrice Reductions for DevelopingCountries”, the first edition waspublished in October 20013.

Methodology

In order to obtain accurateinformation on discounted price offersby both originator and genericcompanies, companies were

such as memoranda of understanding or special agreementiv. delivery of goods in relation to payment (FOB, CIF etc.)5

Information is presented in a tableformat to facilitate comparison.However, comparison is difficultbecause of the lack ofstandardisation among differentcompanies on eligibility, terms andconditions, and pricing. For productsfor which complete information wasavailable, the annual cost of therapywas calculated according to thedosing schedules reported in WHO“Scaling-up Antiretroviral Therapy inResource Limited Settings:Guidelines for a Public HealthApproach”6, 2002, or the Centres forDisease Control and Prevention(CDC), “Guidelines for the Use ofAntiretroviral Agents in HIV-InfectedAdults and Adolescents”, by thePanel on Clinical Practices for theTreatment of HIV, 20027.

This fourth edition provides:

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

•• updated information and clarifications on the conditions and restrictions applying to these offers

4 • Untangling the Web of Price Reductions • May 2003 • www.accessmed-msf.org • Médecins Sans Frontières


All prices are quoted in US dollarsand conversions were made on theday the price was received.

All prices were checked and verifiedby companies.

It is important to note that theseprices may not correspond to end-user prices (prices to patients), whichmay be further influenced by otherfactors such as national distributionand handling charges, mark-up rates,and national and/or import and salestaxes. Information concerning thepatent status of ARVs was notincluded in the present analysis, andwill differ between countries. Someinformation about patent status ofARVs in some countries can be foundin “Patent Situation of HIV/AIDSrelated drugs in 80 countries”,WHO/UNAIDS, 20008.

Practical information on patents canalso be found in the new MSF report“Drug patents under the spotlight:sharing practical knowledge aboutpharmaceutical patents”, May 20039.

Inclusion in the report does notconstitute pre-qualification or approvalby MSF. National regulatoryauthorities are ultimately responsible

for approving use of a given drugfrom a given manufacturer. Productsthat were “WHO pre-qualified” at thetime of writing are indicated with anasterisk (*)1.

Limitations of the current system

The lack of a uniform preferentialpricing system has resulted in eachcompany defining a unique series ofterms and criteria. For instance,whereas Merck & Co., Inc. takes intoaccount criteria related to resources(Human Development Index) andepidemiology (HIV/AIDS prevalence10)to determine national eligibility(theoretically, nearly 120 countriesbenefit from these offers),GlaxoSmithKline (GSK) uses theclassification of Least DevelopedCountries and the geographicalclassification of sub-Saharancountries (a total of 63 countries).

Most of the originator companies,apart from Merck & Co., Inc. andRoche, do not have a policy forcountries outside sub-Saharan Africa,or are not classified by UNCTAD asLeast Developed Countries. Forexample, Bristol-Myers Squibb (BMS)applies discounts to wholesale andretail purchasers in sub-SaharanAfrica (theoretically, 48 countries

benefit from this offer) but not inCentral America where prices arenegotiated on a case-by-case basisthrough the Accelerated AccessInitiative.

Even when a given country is eligible,all institutions within the country maynot be eligible for reduced prices.Again, eligibility is currently at thecompanies’ discretion. It does notmean that the drugs are registeredand a distribution system exists inthese countries.

In actual practice, MSF has observedthat the most powerful downwardpressure on prices has been asystem of equity pricing. Equitypricing is composed of a series ofsimultaneous strategies: a)stimulating generic competition; b)differential pricing which addressesall developing countries, according toclearly defined policies, or voluntarylicensing of proprietary products; andc) readiness on the part of nationalgovernments to override patents byissuing compulsory licenses ormaking government use of a patentwhen affordable prices are notoffered for patented products. Sincethe adoption of the Doha declarationon TRIPS and Public Health least

developed countries (LDC’s) are notobligated to patent drugs until201611.

Although generic competition is acritical factor in reducing prices (seeGraph 1, where the prices trend of asample ARV triple therapycombination is shown over theperiod May 2000-April 2003), itcannot be a stand-alone strategy asnewer drugs may not be available ingeneric form immediately. There is anurgent need to develop a moresystematic, transparent approach todifferential pricing of originatorproducts in addition to stimulatinggeneric competition.

The challenge of paediatricformulations

Children living with HIV/AIDS are oneof the most neglected populations:paediatric formulations are lackingand/or formulations do not meetchildren’s and caregivers’ needs(unpleasant tasting syrup, tablets toobig to swallow, need to refrigeratesome products, unbreakable tablets,lack of fixed dose combinations(FDCs), and non-adapted dosages.For example there are currently nofixed dose combinations forpaediatric use.


Research and development forHIV/AIDS

Paediatric formulations is not the onlyarea where there is a need for R&D.For both adults and children, newdrugs and diagnostic tools, as well asvaccines are needed for HIV/AIDS.Pharmaceutical investment in researchand development largely correspondsto developed country patient needs,where the epidemic has more or lessstabilized. We need to ensure thatthere is a strong focus on the needsof patients in developing and leastdeveloped countries and that theR&D momentum is not lost.

January 2001-April 2003

May 2000-April 200312000US$

10000US$

8000US$

6000US$

4000US$

2000US$

0

Originator $10439

Originator $931Originator $727

Brazil $2767

May 00 July Sept Nov Jan 01 Mar May July 01 Sept Nov Jan 02 Mar May July 02 Sept Nov Jan03 Mar April03

Jan 01 Mar May July 01 Sept Nov Jan 02 Mar May July 02 Sept Nov Apr 03

Originator $727

Aurobindo $209 Hetero $201

Aurobindo $209 Hetero $201

Ranbaxy $295Hetero $347Cipla $350

Cipla $350

Originator

Generic

The Effects of Generic CompetitionSample of ARV triple-combination: stavudine (d4T) + lamivudine (3TC) + nevirapine (NVP). Lowest world prices per patient per year.

Generic competition has shown to be the most effective means of lowering drug prices. During the last three years, originator companies have often responded to genericcompetition.


Quality: This document strictly relates to prices: products from specificmanufacturers have not necessarily been assessed for quality standards.Therefore, procurement agencies should follow their own procedure in thisrespect.

Prices: table 1 shows the best price offers of some generic manufacturers andoriginator producers for each antiretroviral drug, including fixed-dosecombinations. Figures within brackets indicate price in US$ per unit (capsules,tablets etc.). Prices par patient per year have been calculated according todaily doses given either in WHO guidelines or in CDC guidelines (for thoseproducts not recommended in WHO guidelines). Prices can be used as areference with suppliers.

Restrictions: tables 2a) and 2b) show restrictions imposed by generic andoriginator companies and provide indications about the availability of offers inindividual countries. There is no uniform differential pricing system and eachcompany sets geographical limits to their programmes.

Access: since ARVs are not always registered and/or available in ‘selectedcountries’, many offers from pharmaceutical companies may remain ‘theoretical’until the companies are challenged to follow through on their offers, byregistering the products and creating proper distribution channels at national orregional level.

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

Guide to reading andusing tables


stavudine(d4T)

30

Zerit®(BMS)

2

49*(0.066/unit)

48(0.065/unit)

36(0.049/unit)

Table 1a – Nucleoside ReverseTranscriptase Inhibitors (NRTIs)

All prices are in US$. Prices are givenboth for a yearly adult dose and byunit.

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

Products on the WHO list of PilotProcurement, Quality and Sourcing Project:Access to HIV/AIDS drugs and diagnostics ofacceptable quality (Sixth edition, 5th May2003) are in bold and have an asterisk * nextto the price. Always check website for mostrecently updated list. Best prices are in bold& underlined. Incoterms vary according tomanufacturers.

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) and/or the ‘Guidelinesfor the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents’ from thePanel on Clinical Practices for the Treatmentof HIV (2002).

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

(§) BMS sells ddI (Videx®) in other doses (per mg price remains the same)


NRTI(Abbreviation)

Strength (mg)

Trade nameEurope/US

Daily dose

BMS(US)

GSK(UK)

Aurobindo(India)

Cipla(India)

GPO(Thailand)

Hetero(India)

Ranbaxy(India)

Combinopharm(Spain)

abacavir(ABC)

300

Ziagen®(GSK)

2

986*(1.350/unit)

821(1.125/unit)

1325(1.815/unit)

didanosine(ddI)

100 (§)

Videx®(BMS)

4

310*(0.212/unit)

197(0.135/unit)

426(0.292/unit)

650(0.445/unit)

185(0.127/unit)

didanosine(ddI)

EC 400

Videx®(BMS)

1

Notapplicable

271(0.741/unit)

335(0.917/Unit)

lamivudine(3TC)

300

Epivir®(GSK)

1

124(0.340/unit)

lamivudine(3TC)

150

Epivir®(GSK)

2

128*(0.175/unit)

66(0.090/unit)

126*(0.172/unit)

163(0.223/unit)

65(0.089/unit)

100*(0.137/unit)

stavudine(d4T)

40

Zerit®(BMS)

2

55*(0.075/unit)

31(0.043/unit)

53(0.072/unit)

73(0.100/unit)

31(0.042/unit)

47(0.064/unit)

zidovudine(ZDV or AZT)

300

Retrovir®(GSK)

2

274*(0.375/unit)

140(0.192/unit)

198*(0.271/unit)

277(0.380/unit)

175(0.240/unit)

180*(0.246/unit)

292*(0.400/unit)

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



Products on the WHO list of PilotProcurement, Quality and Sourcing Project:Access to HIV/AIDS drugs and diagnostics ofacceptable quality (Sixth edition, 5th May2003) are in bold and have an asterisk * nextto the price. Always check website for mostrecently updated list. Best prices are in bold& underlined. Incoterms vary according tomanufacturers.


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

Strength (mg) 200 600 200

Trade name Stocrin® or Sustiva® Stocrin®or Sustiva® Viramune®in Europe/US (Merck & Co., Inc.)(**) (Merck & Co., Inc.)(**) (Boehringer-Ingelheim)

Daily dose 3 1 2

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

Merck & Co., Inc. 500 346.75(US) (0.457/unit)(†) (0.950/unit)(†)

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

Cipla 462 462 208*(India) (0.422/unit) (1.267/unit) (0.285/unit)

GPO 244(Thailand) (0.334/unit)

Hetero 548 105(India) (0.500/unit) (0.144/unit)

Ranbaxy 578 166*(India) (1.583/unit) (0.228/unit)

(**) Known as Sustiva® (BMS) in US, Canada, UK, Republic of Ireland, France, Spain, Italy and Germany.(†) Prices given in this table are for Low Human Development Index (HDI) countries plus medium HDI countries withadult HIV prevalence of 1% or greater. In table 2c, prices for medium HDI countries with adult HIV prevalence less than 1%, are given.


Table 1c - Nucleotide ReverseTranscriptase Inhibitors (NtRTIs)

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 2c.

Products on the WHO list of PilotProcurement, Quality and Sourcing Project:Access to HIV/AIDS drugs and diagnostics ofacceptable quality (Sixth edition, 5th May2003) 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.


NtRTI tenofovir (TDF)

Strength (mg) 300 mg

Trade name inEurope/US Viread®(Gilead)

Daily dose 1

Gilead (US) 475(1.30/unit)


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

(SQV hgc)

Strength (mg) 400 250 100 200

Trade name Crixivan® Viracept® Norvir® Invirase®in Europe/US (Merck & Co. Inc.) (Roche) (Abbott) (Roche)

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

Abbott 83*(US) (0.114/unit)

Merck & Co., Inc. 400(US) (0.274/unit)

Roche 880* 920*(Switzerland) 0.241/unit(†) 0.252/unit(†)

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

Cipla 406 2026 1084(India) (0.278/unit) (0.555/unit) (1.485/unit)

Hetero 387 1500 219 1335(India) (0.265/unit) (0.411/unit) (0.300/unit) (0.366/unit)

Ranbaxy 467(India) (0.320/unit)

Table 1d - Protease Inhibitors (PIs)



Products on the WHO list of PilotProcurement, Quality and Sourcing Project:Access to HIV/AIDS drugs and diagnostics ofacceptable quality (Sixth edition, 5th May2003) 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.


For Roche, prices are given in Swiss Francsand were converted in US$ (1 US$ = 1.40CHF on 15 April 2003)

(**) The daily dose referred to is 800mg IDV twice daily with ritonavir 100mg twice daily as booster. The prescribing information givenby 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 booster medication. This dose is not indicated in the manufacturer’s label.(#) Invirase 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. In table 2c, also prices for LowIncome and Lower Middle Income Countries, as classified by the World Bank, are given.


Products on the WHO list of Pilot Procurement, Quality and Sourcing Project: Access to HIV/AIDS drugs and diagnostics of acceptable quality (Sixth edition, 5th May 2003) are in bold and have anasterisk (*) next to the price. Always check website for most recently updated list. Best prices are in bold & underlined. Incoterms vary according to manufacturers.

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’ (June 2002) and/or the‘Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents’ from the Panel on Clinical Practices for the Treatment of HIV (2002).

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 2a and 2b.

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+300 150 +30+200 150 +40+200 (mg) + 200

Therapeutic PI NRTI NRTI NRTI NRTI + NRTI NRTIs + NRTI +class(es) NNRTI NNRTI NNRTI

Trade name Kaletra® Combivir® Trizivir®in Europe/US (Abbott) (GSK) (GSK)

Daily dose 6 2 2 2 2 2 2 2

Abbott 500*(US) (0.228/unit)

GSK 329** 1241*(UK) (0.450/unit) (1.700/unit)

Aurobindo 204(India) (0.280/unit)

Cipla 162 172 292* 418 304 304(India) (0.222/unit) (0.236/unit) (0.400/unit) (0.573/unit) (0.417/unit) (0.417/unit)

GPO 407 325 358(Thailand) (0.558/unit) (0.445/unit) (0.490/unit)

Hetero 3833 135 141 276 383 1648 281 286(India) (1.750/unit) (0.185/unit) (0.193/unit) (0.378/unit) (0.525/unit) (2.258/unit) (0.385/unit) (0.392/unit)

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


ARV Company Strength/Dosage form Presentation Price per pack Additional information (Abbreviation) (trade name)

zidovudine GSK (Retrovir®) 10mg/ml oral solution 200ml US$ 7.90** Cost per day as indicated by the manufacturer (average paediatric dosage based on 25kg average weight): US$ 1.58.

Cipla (Zidovir®) 50mg/5ml oral solution 100ml US$ 1.53**GPO (Antivir®) 10mg/ml syrup 60ml/200ml US$ 1.17/3.40 Combinopharm 50mg/5ml oral solution 200ml US$ 4.20

lamivudine GSK (Epivir®) 10mg/ml oral solution 240ml US$ 7.45** Cost per day as indicated by the manufacturer (average paediatric dosage based on 25kg average weight): US$ 0.62.

Cipla (Lamivir®) 10mg/ml oral solution 100ml US$ 2.00**GPO (Lamivir®) 10mg/ml syrup 60ml US$ 1.40

didanosine BMS (Videx®) powder: 2g of active principle US$ 16.61 Sold in local currency in Southern Africa – sold as a bottle for (16.61 Euro) Rand and East Africa - shillings. Sold in Euro re-constitution with water and (**) to West African countries.with antacids

efavirenz Merck&Co.Inc 50mg capsules Bottle of 30 US$ 3.47 US$ 0.116/unit.(Stocrin®)

abacavir GSK (Ziagen®) 20mg/ml oral solution 240ml US$ 34.80** Cost per day as indicated by manufacturer: US$ 2.90.

stavudine BMS (Zerit®) 1mg/ml powder for syrup 200ml US$ 10.71 Sold in local currency in Southern Africa - (10.71 Euro)(**) Rand and East Africa - shillings. Sold in Euro

to West African countries. BMS (Zerit®) 15mg capsules Blister pack Not available*

of 56BMS (Zerit®) 20mg capsules Blister pack US$ 5.25* US$ 0.094/unit.

of 56GPO (Stavir®) 15mg capsules Box of 60 US$ 3.50 US$ 0.058/capsule. GPO (Stavir®) 20mg capsules Box of 60 US$ 4.20 US$ 0.070/capsule. GPO (Stavir®) 1mg/ml dry syrup 60ml US$ 0.65GPO (Stavir®) 5mg/ml dry syrup 60ml US$ 0.85

nevirapine BI (Viramune®) 10mg/ml suspension 240ml US$ 17.50* Cipla (Nevimune®) 50mg/5ml suspension 100ml & 25ml US$ 2.45 & US$ 2.00 PMTCT dose: 25ml.

(PMTCT) (PMTCT) ritonavir Abbott (Norvir®) 80mg/ml oral solution 450ml(5x90ml) US$ 41.67**ritonavir + lopinavir Abbott (Kaletra®) 20mg + 80mg/ml oral solution 300ml(5x60ml) US$ 41.67**nelfinavir Roche (Viracept®) 50mg/g, powder for suspension 144g US$ 35* (**) (/)

(**) on 15 April 2003, 1 US$ =1.40 CHF and on 15 April 2003, 1Euro = 1$US. (/) 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 UNdefined. In table 2c, also prices for Low Income and Lower Middle Income Countries, as classified by the World Bank, are given. Products on the WHO list of Pilot Procurement, Quality and Sourcing Project: Access to HIV/AIDSdrugs and diagnostics of acceptable quality (Sixth edition, 5th May 2003) are in bold 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.

Table 1f – Paediatric FormulationsFor details on eligibility and offer restrictions for countries and institutions, please refer to tables 2a and 2b.



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 orthrough the AAI).

Least Developed Countries (LDCs) plussub-Saharan Africa.


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

Table 2 Originator companies’ 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 organisations,charities, international, UNagencies, other not-for-profitorganisations and internationalpurchase funds such as the GlobalFund to fight AIDS, TB and Malaria.

In sub-Saharan Africa employers there who offer HIV/AIDS care and treatmentdirectly to their staff throughworkplace clinics or similararrangements are also eligible.

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

Governments, aid organisations,charities, international, UNagencies, other not-for-profitorganisations and internationalpurchase funds such as the GlobalFund to fight AIDS, TB and Malaria.

In sub-Saharan Africa employers there who offer HIV/AIDS care and treatmentdirectly to their staff throughworkplace clinics or similararrangements are also eligible.


Price in US$

US$ 986/year1.350/unit

US$ 34.80 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[5]

CIP

CIP

Company

Bristol-MyersSquibb Co.

GlaxoSmithKline

GlaxoSmithKline

Product

didanosine100mg(Videx®)

lamivudine150mg tablet(Epivir®)

lamivudine10mg/ml oralsolution240ml(Epivir®)


Sub-Saharan Africa.

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

LDCs plus sub-Saharan Africa.


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



(For middle income developing countriespublic sector prices negotiated on acase-by-case basis or bilaterally orthrough the 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, international, 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.


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


Price in US$

US$ 310/yearUS$ 0.212/unit

Lower tabletdosages prices inline with this offer

US$ 128/yearUS$ 0.175/unit

UUSS$$ 77..4455 ppeerrbboottttllee

Additional comments

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

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

Delivery ofgoods[5]

DDU togovernmentpurchasingentities.

CIP

CIP



Product

stavudine30mg and40mg caps(Zerit®)

zidovudine300mgtablets(Retrovir®)

zidovudine10mg/ml oralsolution200ml(Retrovir®)

Company

Bristol-MyersSquibb Co.

GlaxoSmithKline

GlaxoSmithKline


Sub-Saharan Africa.

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



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



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

Eligibility (body)

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


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



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


Price in US$

30mg: US$ 49/year(US$0.066/unit)

40mg:US$ 55/year(US$0.075/unit)

US$ 274/year(US$ 0.375/unit)

US$7.90 perbottle

Additional comments

Supply Agreementrequired.

(For NGOs requiringless than 10 patientspacks per month,this requirementmay be waived.)


(For NGOs requiringless than 10 patientspacks per month,this requirementmay be waived.)

Delivery ofgoods[5]

DDU togovernmentpurchasingentities

CIP

CIP

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

Product

efavirenz(Stocrin®)

efavirenz(Stocrin®)

nevirapine200mg tablets(Viramune®)

nevirapine10mg/mlsuspension240ml (Viramune®)

Company

Merck & Co., Inc.

Merck & Co., Inc.

BoehringerIngelheim

BoehringerIngelheim

Delivery ofgoods[5]

CIF

CIF

CIF

CIF


Low Human Development Index(HDI) countries plus medium HDIcountries with adult HIV prevalenceof 1% or greater10.

Medium HDI countries with adultHIV prevalence less than 1%10.

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$ 2.10/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

Delivery ofgoods[5]

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$ 475/year (US$ 1.30/unit)

Additionalcomments

The programmeswill be managedthrough Axios.


Product

indinavir(400mg caps)(Crixivan®)

indinavir(400mg caps)(Crixivan®)

nelfinavir250mg tablets(Viracept®)

Company

Merck & Co.,Inc.

Merck & Co.,Inc.

Roche

Delivery ofgoods[5]

CIP

CIP

Terms andconditions:Effective date1st March2003. FCABasel(Switzerland),CAD (CashAgainstDocuments) 30 days atsight. Minimumorder anddeliveryamount pershipment isCHF 10,000 (US$ 7143)


Low Human DevelopmentIndex (HDI) countries plusmedium HDI countries withadult HIV prevalence of 1%or greater10.

Medium HDI countries withadult HIV prevalence lessthan 1%10.

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

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$



Bottle of 270tablets: CHF 3o0.00 US$ 214.29US$ 2898/year(US$ 0.794/unit)

Additional comments

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

Table 2d Protease Inhibitors (PIs)


Product

nelfinavir 250mgtablets(Viracept®)

nelfinavirpowder for oralsolution 144g50mg/g(Viracept®)

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

Company

Roche

Roche

Roche

Delivery ofgoods[5]

Terms andconditions:Effective date 1stMarch 2003. FCABasel(Switzerland),CAD (CashAgainstDocuments) 30days at sight.Minimum orderand deliveryamount pershipment is CHF 10,000 (US$ 7143)

Terms andconditions:Effective date 1stMarch 2003. FCABasel(Switzerland),CAD (CashAgainstDocuments) 30days at sight.Minimum orderand deliveryamount pershipment is CHF 10,000 (US$ 7143)


All countries in sub-SaharanAfrica and all UN definedLeast Developed Countries.

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


Eligibility (body)




Price in US$

Bottle of 270 tabletsCHF 90.90 (US$ 64.93)US$ 880/year(US$ 0.241/unit)

CHF 55.00 per bottle(US$ 32.29)

CHF 49.00 per bottle(US$ 35.00)

Additionalcomments


Product

ritonavir100mg caps(Norvir®)

ritonavir oralsolution450ml(Norvir®)

saquinavir200mg hardgel capsules(Invirase®)

saquinavir200mg hardgel capsules(Invirase®)

Company

Abbott

Abbott

Roche

Roche

Delivery of goods[5]

FOB

FOB

Terms andconditions: Effectivedate 1st March2003. FCA Basel(Switzerland), CAD(Cash AgainstDocuments) 30days at sight.Minimum order anddelivery amount per shipment is CHF 10,000 (US$ 7143)Terms andconditions: Effectivedate 1st March2003. FCA Basel(Switzerland), CAD(Cash AgainstDocuments) 30days at sight.Minimum order anddelivery amount per shipment is CHF 10,000 (US$ 7143)


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$ 214.29)


Bottle of 270capsules: CHF 95.40(US$ 68.14)


Additionalcomments


Table 2e Fixed Dose Combinations

Product

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

lopinavir/ritonavir oralsolution300ml(Kaletra®)

3TC + ZDV300mg +150mg tablets(Combivir®)

Company

Abbott

Abbott

GlaxoSmithKline

Delivery ofgoods[5]

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 bilaterallyor 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,international, UN agencies, other not-for-profit organisations and internationalpurchase funds such as the Global Fundto fight AIDS, 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$ 500/year(0.228/unit)

US$ 41.67 perbottle


Additional comments


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


Product

abacavir +3TC + ZDV300 + 150 +300mg tablets(Trizivir®)

Company

GlaxoSmithKline

Delivery ofgoods[5]

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 bilaterallyor through the AAI.

Eligibility (body)

Governments, aid organisations, charities,international, UN agencies, other not-for-profit organisations and internationalpurchase funds such as the Global Fundto fight AIDS, 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

Supply Agreementrequired.(For NGOs requiringless than 10 patientspacks per month,this requirement maybe waived.)

The manufacturerrecommends that‘prescribers mustensure that patientsare fully informedregardinghypersensitivityreaction to abacavir.Patients developingsigns or symptomsof hypersensitivitymust contact theirdoctor immediatelyfor advice.’


Company

Aurobindo

Cipla

GPO

Hetero

Ranbaxy

Combinopharm

Delivery of goods[5]

FOB Hyderabad(India)

FOB Mumbai(India)

FOB Bangkok(Thailand)

FOB Mumbai(India)

FOB Delhi/Mumbai(India)

FOB Barcelona(Spain)


No restriction

No restriction

No restriction

No restriction

No restriction

No restriction

Eligibility (body)

NGOs and GovernmentalOrganizations.

NGOs and GovernmentalOrganizations.

Not-for-profit organizationsand governments.

Private sector, Publicsector and NGO’s.

NGO’s and Governmentsor Programs supported bythem.

No restriction.

Price in US$

See Table 1.

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).

See Table 1.

Additional comments

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

Payment by letter of credit.

Payment at the confirmation of the order.

Only available directly through Cipla HQMumbai.

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

Payment by signed letter of credit.

Prices could be negotiated on individual basisaccording commercial terms.

Signed letter of credit.

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.

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


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

Annex 2: Human Development Index(HDI)

Source: Human Development Report2002, Making new technologies workfor human development UNDP. Forfull list of Human Development Indexranking seehttp://hdr.undp.org/reports/global/2002/en/pdf/backone.pdf

Medium human developmentAlbania; Algeria; Armenia; Azerbaijan;Belarus; Belize; Bolivia; Botswana;Brazil; Bulgaria; Cambodia;Cameroon; Cape Verde; China;Colombia; Comoros; Congo; Cuba;Dominica; Dominican Republic;Ecuador; Egypt; El Salvador;Equatorial Guinea; Fiji; Gabon;Georgia; Grenada; Ghana; Guatemala;Guyana; Honduras; India; Indonesia;Iran (Islamic Rep. of); Jamaica;Jordan; Kazakhstan; Kenya;Kyrgyzstan; Lebanon; Lesotho; LibyanArab Jamahiriya; Macedonia (TFYR);Malaysia; Maldives; Mauritius;Mexico; Moldova (Rep. of ); Mongolia;Morocco; Myanmar; Namibia;Nicaragua; Oman; Panama; PapuaNew Guinea; Paraguay; Peru;Philippines; Romania; RussianFederation; Saint Lucia; Saint Vincent& the Grenadines; Samoa (Western);São Tomé & Principe; Saudi Arabia;Solomon Islands; South Africa; SriLanka; Suriname; Swaziland; Syrian

Annex 1: Least Developed Countries(LDCs)

Source: UNCTADhttp://www.unctad.org/Templates/WebFlyer.asp?intItemID=2161&lang=1 Forty-nine countries are currentlydesignated least developed countries(LDCs). The list is reviewed everythree 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 Tome andPrincipe; Senegal; Sierra Leone;Solomon Islands; Somalia; Sudan;Togo; Tuvalu; Uganda; UnitedRepublic of Tanzania; Vanuatu;Yemen; Zambia.

Arab Republic; Tajikistan; Thailand;Tunisia; Turkey; Turkmenistan;Ukraine; Uzbekistan; Vanuatu;Venezuela; Viet Nam; Zimbabwe.

Low human developmentAngola; Bangladesh; Benin; Bhutan;Burkina Faso; Burundi; CentralAfrican Republic; Chad; Congo (Dem.Rep. of the); Côte d’Ivoire; Djibouti;Eritrea; Ethiopia; Gambia; Guinea;Guinea-Bissau; Haiti; Lao People’>sDem. Rep.; Madagascar Malawi;Mali; Mauritania; Mozambique;Nepal; Niger; Nigeria; Pakistan;Rwanda; Senegal; Sierra Leone;Sudan; Tanzania (U. Rep. of); Togo;Uganda; Yemen; Zambia.

AAnnnneexxeess


Annex 3: Sub-Saharan countries

Source: World Bankhttp://www.worldbank.org/afr/countries/htm (April 2003)

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 Toméand Principe; Senegal; Seychelles;Sierra Leone; Somalia; South Africa;Sudan; Swaziland; Tanzania; Togo;Uganda; Zambia; Zimbabwe.

Annex 4: World Bank low-incomecountries

Source: World Bankhttp://www.worldbank.org/data/countryclass/classgroups/htm (April2003)

Low-income countriesAfghanistan; Angola; Armenia;Azerbaijan; Bangladesh; Benin;Bhutan; Burkina Faso; Burundi;Cambodia; Cameroon; Central AfricanRepublic; Chad; Comoros; Congo(Dem. Rep.), Congo (Rep.); Côted’Ivoire; Equatorial Guinea; Eritrea;Ethiopia; Gambia; Georgia; Ghana;Guinea; Guinea-Bissau; Haiti; India;Indonesia; Kenya; Korea, Dem. Rep.;Kyrgyz Republic; 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; Ukraine;Uzbekistan; Vietnam; Yemen (Rep.),Zambia; Zimbabwe.

Lower-middle-income economiesAlbania; Algeria; Belarus; Belize;Bolivia; Bosnia and Herzegovina;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; South Africa; SriLanka; St. Vincent and theGrenadines; Suriname; Swaziland;Syrian Arab Republic; Thailand;Tonga; Tunisia; Turkey; Turkmenistan;Vanuatu; West Bank and Gaza;Yugoslavia, Fed. Rep.

Upper-middle-income economiesAmerican Samoa; Antigua andBarbuda; Argentina; Barbados;Botswana; Brazil; 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 as thecentral contact: The Programme ManagerAccess to HIV Care ProgrammeAXIOS InternationalP.O. Box 6924Kampala, Uganda.Tel: +256 75 693 756Fax:+256 41 543 021Email: [email protected] : www.accesstohivcare.org

Aurobindo Pharma Ltd:VenkateshanRegional Manager (Latin America &Europe)Tel: +91 40 373 7332 (Direct)Or +91 98480 257 64 (Mobile)Fax: +91 40 374 10 80Email: [email protected]

Bristol-Myers Squibb Co: Robert D. LefebvreSenior Director, Project AccessBristol-Myers SquibbP.O. Box 4000Princeton, NJ 08543-4000, USATel: +1.609.252.4592Fax: +1.609.252.4819E-mail: [email protected]


West Africa: information can beobtained from Ms Marie-AstridMercier, BMS Access Coordinator inBMS Paris office ([email protected])

East Africa: information can beobtained from BMS main distributorin East Africa – M. Mukesh Mehta atPhillips Pharmaceuticals in Nairobi([email protected]).

Southern Africa: information can beobtained from Ms Tamany Geldenhuysin BMS offices in Johannesburg([email protected]).

Boehringer Ingelheim:Laurence Phillips (for preferentialprices)CD Marketing Prescription MedicinesHIV-Specialists/VirologistsPhone: + 49 6132 77-2081Fax: +49 6132 77-3829Email: [email protected]

Hélène Clary (for donations)Marketing Prescription MedicinesCG HIV-Specialists/VirologistsTel: + 49 6132 77-34 36 Fax: + 49 6132 77-38 29 Email: [email protected]

Cipla Ltd:Sanjeev Gupte, General Manager-ExportsCipla Limitedand Shailesh PednekarExecutive-Exports, Cipla LimitedTel: +91 22 3021397 (Direct) 30955213092891Fax: +91 223070013/3070393/3070385Email: [email protected] [email protected]

Combinopharm:Silvia GilManaging DirectorCombinopharmTel: + 34 93 48 08 833Fax: + 34 93 48 08 832Email: [email protected]

GileadProgramme 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 City, California 944041-650-522-5740

GlaxoSmithKline:Jon Pender Director External RelationsGlobal Access Issues Tel: + 44 (0) 20 8047 5489 Fax: + 44 (0) 208 047 6957Email: [email protected]

GPO: Sukhum Virattipong Export Manager Tel: + 662 248 1482, + 662 203 8808Fax: + 662 248 1488Email: [email protected]

Hetero:Dharmesh ShahDirector International BusinessDevelopment, Hetero International408 Sharda Chambers, 15 NewMarine Lines, Mumbai 400 020, IndiaTel: +91 22 563 318 68Tel (direct): +91 22 563 318 61Fax: +91 22 220 660 99Email: [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 39 81Fax: +1 908 735 1704 Email: [email protected]

Ranbaxy:Sandeep JunejaRanbaxy Laboratories LimitedTel: + 91 11 600 2120 (Direct) or + 91 11 645 2666-72Fax: + 91 11 600 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]

3TC lamivudine (Epivir®); 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); AbbottLaboratories Ltd. joined the initiativelater) to increase access to HIV/AIDScare, treatment and support. AAIplays a role in facilitating pricenegotiations between developingcountry governments and ‘originator’drug companies that areparticipating in the AAI.

ABC abacavir (Ziagen®); nucleosideanalogue reverse transcriptaseinhibitor

AIDS Acquired Immune DeficiencySyndrome

ARVs Antiretroviral drugs

BMS Bristol-Myers Squibb

CDC Centres for Disease Control andPrevention

CIF[5] ‘Cost Insurance and Freight’means that the seller delivers whenthe goods pass the ship’s rail in theport of shipment. The seller must paythe costs and freight necessary tobring the goods to the named port ofdestination BUT the risk of loss ordamage to the goods, as well as anyadditional costs due to eventsoccurring after the time of delivery, aretransferred from the seller to thebuyer.

CIP[5] ‘Carriage and Insurance paid to...’means that the seller delivers thegoods to the carrier nominated by himbut the seller must in addition pay thecost of carriage necessary to bring thegoods to the named destination. Thismeans that the buyer bears all therisks and any additional costsoccurring after the goods have beenso delivered. However, in CIP theseller also has to procure insuranceagainst the buyer’s risk of loss of ordamage to the goods during thecarriage. Consequently, the sellercontracts for insurance and pays theinsurance premium.

d4T stavudine (Zerit®); nucleosideanalogue reverse transcriptaseinhibitor

ddI didanosine (Videx®); nucleosideanalogue reverse transcriptaseinhibitor

Glossary12 DDU[5] ‘Delivered duty unpaid’ meansthat the seller delivers the goods tothe buyer, not cleared for import,and not unloaded from any arrivingmeans of transport at the namedplace of destination. The seller hasto bear the costs and risks involvedin bringing the goods thereto, otherthan, where applicable, any ‘duty’(which term includes theresponsibility for the risks of thecarrying out of the customsformalities, and the payment offormalities, customs duties, taxesand other charges) for import in thecountry of destination. Such ‘duty’has to be borne by the buyer as wellas any costs and risks caused by hisfailure to clear the goods for theimport time.

EML Essential Medicines List. Firstpublished by WHO in 1977, it ismeant to identify a list of medicines,which provide safe and effectivetreatment for the infectious andchronic diseases, which affect thevast majority of the world’spopulation. The 12th Updated Listwas published in April 2002 andincludes 12 antiretrovirals.

EFV efavirenz (Stocrin®); non-nucleoside analogue reversetranscriptase inhibitor


SQV hgc saquinavir hard gel capsules(Invirase®); protease inhibitor

SQV sgc saquinavir soft gel capsules(Fortovase®); protease inhibitor

TDF tenofovir (Viread®); nucleotidereverse transcriptase 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 and theWorld Bank. UNDCP joined in April1999

UNDP United Nations DevelopmentProgramme

UNFPA United Nations PopulationFund

UNICEF United Nations Children’sFund

WHO World Health Organization

ZDV zidovudine (Retrovir®);nucleoside analogue reversetranscriptase inhibitor

EXW[5] ‘Ex-works’ means that theseller delivers when he places thegoods at the disposal of the buyer atthe seller’s premises or anothernamed place (i.e. works, factory,warehouse etc.) not cleared forexport and not loaded on anycollecting vehicle.

FOB[5] ‘Free on board’ means that theseller delivers when the goods passthe ship’s rail at the named port ofshipment. This means that the buyerhas to bear all costs and risks ofloss or damage to the goods fromthat point. The FOB term requires theseller to clear the goods for export.

Generic drug 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

HHIIVV Human Immunodeficiency Virus

IDV indinavir (Crixivan®); proteaseinhibitor

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 (Viracept®); proteaseinhibitor

NNRTI Non-Nucleoside ReverseTranscriptase Inhibitor

NRTI Nucleoside Analogue ReverseTranscriptase Inhibitor

NtRTI Nucleotide ReverseTranscriptase Inhibitor

NVP nevirapine (Viramune®); non-nucleoside analogue reversetranscriptase inhibitor

PMTCT Prevention of Mother-To-ChildTransmission

r ritonavir (Norvir®), low doseritonavir used as a booster; proteaseinhibitor


Stein (Costa Rica); Zydus CadilaHealthcare, SunPharma, EAS-SURG,Strides, Mac Leods, IPCA (India); LGChemicals, Samchully, Korea UnitedPharm Inc. (Korea); Protein, Pisa(Mexico); Andromaco (Spain); T.O.Chemecal (Thailand); LaboratorioDosa S.A. (US).This list is not exhaustive.

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

[6] “Scaling-up Antiretroviral therapyin Resource Limited Settings:Guidelines for a Public Healthapproach”, June 2002http://www.who.int/HIV_AIDS/CARE/ScalingUp_Guidelines_Final021002.pdf

[7] “Guidelines for the Use ofAntiretroviral Agents in HIV-InfectedAdults and Adolescents, by the Panelon Clinical Practices for the Treatmentof HIV”, 2002 http://www.hivatis.org

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

References [1] Pilot Procurement, Quality andSourcing Project: Access to HIV/AIDSdrugs and diagnostics of acceptablequalityhttp://www.who.int/medicines/organization/qsm/activities/pilotproc/pilotproc.shtml

[2] Sources and prices of selecteddrugs and diagnostics for peopleliving with HIV/AIDS. A joint UNICEF,UNAIDS Secretariat, WHO, MSFproject. May 2003(WHO/EDM/PAR/2003.2).http://www.who.int/medicines/library/par/hivrelateddocs/sourcesandpricesmay.doc

[3] Accessing ARVs: Untangling theWeb of Price Reductions forDeveloping Countries, first edition,October 2001 and second edition,June 2002 and third edition,December 2002

[4] Other generic manufacturersknown to be producing one or moreARVs but not included in thisdocument are: RichmondLaboratorios, Panalab, Filaxis(Argentina); Pharmaquick (Benin); FarManguinhos, FURP, Lapefe, Laob,Iquego, IVB (Brazil); Apotex,Novopharm (Canada); ShanghaiDesano Biopharmaceutical company,Northeast General PharmaceuticalFactory (China); Biogen (Colombia);

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

[10] To find the HIV prevalence statusof countries seehttp://www.unaids.org/epidemic_update/

[11] More information about the WorldTrade Organisation (WTO) Agreementon Trade-related aspects ofintellectual property rights (TRIPS) canbe found athttp://www.wto.org/english/tratop_e/trips_e/trips_e.htm. The full declarationis also available on the WTO site.

[12] Abbreviations for the ARVs aretaken from the WHO draft guidelines“Scaling-up Antiretroviral therapy inResource Limited Settings: Guidelinesfor a Public Health approach”, June2002http://www.who.int/HIV_AIDS/CARE/ScalingUp_Guidelines_Final021002.pdf


Campaign for Access to Essential MedicinesMédecins Sans Frontièresrue du lac 12, CP 60901207 Geneva, Switzerland

Tel : + 41 22 849 84 05Fax : + 41 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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reductions

price

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Untangling the Web 4th Edition

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Transcript of Untangling the Web 4th Edition