Untangling the Web 3rd Edition

1st December 2002Third edition

a pricing guide for the purchase of ARVs for developing countries

price Untangling the web of price reductions:

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2 Table of contents

3 General background and objectives

3 Methodology

4 Limitations of the current system

4 The challenge of paediatric formulations

5 The effects of generic competition

6 Guide to reading and using tables

7 Tables

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

7 Table 1a – Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

8 Table 1b – Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

9 Table 1c – Protease Inhibitors (PIs)

10 Table 1d – Fixed Dose Combinations (FDCs)

11 Table 1e – Paediatric Formulations

12 Table 2: Originator companies’ ARV offers and restrictions for developing countries

12 Table 2a – Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

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

15 Table 2c – Protease Inhibitors (PIs)

16 Table 2d – Fixed Dose Combinations

17 Table 2e – Selected Generic companies’ ARV offers and restrictions for developing countries

18 Annexes

18 Annex 1: Least Developed Countries (LDCs)

18 Annex 2: Human Development Index (HDI)

19 Annex 3: Sub-Saharan countries

19 Annex 4: World Bank low-income countries

19 Annex 5: Company contacts

21 Glossary

23 References

Table of contents

2 • Untangling the Web of Price Reductions • December 2002 • www.accessmed-msf.org • Médecins Sans Frontières

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 toinform buyers. This information isintended for use by government andnon-profit procurement agencies, aswell as other bulk purchasers ofARVs, including health facilities andNGOs.

This document is meant to be usedin tandem with the report of PilotProcurement, Quality and SourcingProject: Access to HIV/AIDS Drugsand Diagnostics of AcceptableQuality, a project initiated by WHOand developed in collaboration withother United Nations Organisations(UNAIDS, UNICEF, UNFPA). Drugs onthis list are commonly referred to as‘pre-qualified’. This pilot projectevaluates pharmaceutical productsaccording to WHO recommended

Methodology

In order to obtain accurateinformation on discounted priceoffers by both originator and genericcompanies, we repeated themethodology of the first twoeditions. Companies were re-contacted and asked to verify theiroffers. The list of generic producersincluded in this report is by nomeans exhaustive[4].

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

standards of quality and compliancewith Good Manufacturing Practices. Itis part of an ongoing process thatwill expand as the participation ofsuppliers increases. It is important tonote this list of ‘pre-qualified’ drugsis not exhaustive and exclusion fromthe list does not mean that a drughas not been approved by one ormore national drug regulatoryauthorities. In fact all generic drugsincluded in this pricing guide have atleast been cleared for marketing intheir countries of origin.

The most up-to-date list of ‘pre-qualified’ products/suppliers of HIV-related medicines can be found onthe WHO and other UN-collaboratingagencies[1].

Pricing information on other essentialdrugs and diagnostics used forHIV/AIDS can be found in the 3rdedition of the report Sources andPrices of Selected Drugs andDiagnostics for People Living withHIV/AIDS May 2002[2].

This is the third edition of, AccessingAntiretrovirals: Untangling the Web ofPrice Reductions for DevelopingCountries, the first and secondeditions were published in October2001 and June 2002 respectively[3].

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

For products for which completeinformation was available, the annualcost of therapy was calculatedaccording to the dosing schedulesreported in WHO Scaling-upAntiretroviral Therapy in ResourceLimited Settings: Guidelines for aPublic Health Approach[6] or theCentres for Disease Control andPrevention (CDC) Guidelines for theUse of Antiretroviral Agents in HIV-Infected Adults and Adolescents, bythe Panel on Clinical Practices for theTreatment of HIV, 2002[7].

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

All prices were checked and verifiedby companies.

This third edition provides:•• updated information on prices for eligible countries, including both price

per unit and price per patient per year•• updated information and clarifications on the conditions and restrictions

applying to these offers•• new information on paediatric formulations

Médecins Sans Frontières • www.accessmed-msf.org • December 2002 • Untangling the Web of Price Reductions • 3

It is important to note that theseprices may not correspond to end-user prices (prices to patients),which may be further influenced byother factors such as nationaldistribution and handling charges,mark-up rates, and national and/orimport and sales taxes. Informationconcerning the patent status of ARVswas not included in the presentanalysis, and will differ betweencountries. Some information aboutpatent status of ARVs in somecountries can be found in PatentSituation of HIV/AIDS related drugsin 80 countries, WHO/UNAIDS,2000[8].

Inclusion in the report does notconstitute pre-qualification orapproval by MSF. National regulatoryauthorities are ultimately responsiblefor approving use of a given drugfrom a given manufacturer.WHO pre-qualified drugs areindicated with an asterisk (*).

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(Gross Domestic Product and theHuman Development Index) andepidemiology (HIV/AIDS prevalence) todetermine national eligibility(theoretically, nearly 120 countriesbenefit from this offer),GlaxoSmithKline (GSK) uses theclassification of Least DevelopedCountries and the geographicalclassification of sub-Saharan countries(theoretically, nearly 63 countriesbenefit from this offer).

Most of the originator companies donot have a clear policy for countriesoutside sub-Saharan Africa, or thosewhich are not classified by UNCTAD asLeast Developed Countries. Forexample, Bristol-Myers Squibb (BMS)applies discounts to wholesale andretail purchasers in sub-Saharan Africa(theoretically, 48 countries benefitfrom this offer) but not in CentralAmerica.

Even when a given country is eligible,all institutions within the country may

not be eligible for reduced prices.Again, eligibility is currently at thecompanies’ discretion.

In actual practice, MSF has observedthat the most powerful downwardpressure on prices has been a systemof equity pricing. Equity pricing iscomposed of a series of simultaneousstrategies: a) stimulating genericcompetition; b) differential pricing orvoluntary licensing of proprietaryproducts; and c) readiness on the partof national governments to overridepatents by issuing compulsorylicenses according to existingsafeguards when affordable prices arenot offered for patented products(Interpretation of TRIPS agreementsafeguards according to the Dohadeclaration of Nov 2001[9]).

Although generic competition is acritical factor in reducing prices (seeGraph on page 5, where the pricestrend of a sample ARV triple therapycombination is shown over the periodMay 2000-December 2002), it cannotbe a stand alone strategy as newerdrugs may not be available in genericform. There is an urgent need todevelop a more systematic, transparentapproach to differential pricing oforiginator products in addition tostimulating generic 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 needs (unpleasant tastingsyrup, tablets too big to swallow,need to refrigerate some products,unbreakable tablets).

A ‘classic’ paediatric solution such asa syrup is not always the mostappropriate in resource-limitedsettings. Better options include lowdosage capsules which can beopened and mixed with food or lowdosage dispersible tablets. The lackof fixed-dose combinations forpediatric use is a particular challengefor physicians and care-givers.

This edition introduces best priceoffers for paediatric formulations[10].


January 2000-Dec 2002

May 2000-Dec 200212000US$

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

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

Originator $727

Aurobindo $295 Hetero $201

Aurobindo $209 Hetero $201

Ranbaxy $295Hetero $347Cipla $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 two 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 theiroffers.

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.

Guide to reading andusing tables


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 (edition of 9 September2002) have an asterisk (*) next to the price.

Best prices are in bold & underlined.

Incoterms vary according to manufacturers.

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 Treatment ofHIV (2002)”.

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

NRTI abacavir didanosine lamivudine lamivudine stavudine zidovudine(Abbreviation) (ABC) (ddI) (3TC) (3TC) (d4T) (ZDV or AZT)

Strength (mg) 300 100 (§) 150 300 40 300

Trade name Ziagen® Videx® Epivir® Zerit® Retrovir®in Europe/US (GSK) (BMS) (GSK) (BMS) (GSK)

Daily dose 2 4 2 1 2 2

BMS (US) 310* 55*(US) (0.212/unit) (0.075/unit)

GSK 986* 234* 438*(UK) (1.350/unit) (0.320/unit) (0.600/unit)

Aurobindo 197 66 31 140(India) (0.135/unit) (0.090/unit) (0.043/unit) (0.192/unit)

Cipla 821 426 126 124 53 198*(India) (1.125/unit) (0.292/unit) (0.172/unit) (0.340/unit) (0.072/unit) (0.271/unit)

GPO 650 163 73 277(Thailand) (0.445/unit) (0.223/unit) (0.100/unit) (0.380/unit)

Hetero 1325 185 65 31 175(India) (1.815/unit) (0.127/unit) (0.089/unit) (0.042/unit) (0.240/unit)

Ranbaxy 100* 47 180*(India) (0.137/unit) (0.064/unit) (0.246/unit)

Combinopharm 365(Spain) (0.500/unit)

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


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






Annual cost are 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 Treatment ofHIV (2002)”.

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

Strength (mg) 200 600 200

Trade name Stocrin® Stocrin® 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 574 105(India) (0.500/unit) (0.144/unit)

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

(**) Known as Sustiva® (BMS) in developed countries.


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

(SQV hgc) (SQV sgc)

Strength (mg) 400 250 100 200 200

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

Inc.)

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

Abbott 83*(US) (0.114/unit)

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

Roche 3172 1008 1573*(US) (0.869/unit) (0.276/unit) (0.431/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 1c - Protease Inhibitors (PIs)






Annual cost are 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)”.

For Roche, prices are given in Swiss Francsand were converted in US$ (1 CHF = 0.69US$ on 14 November 2002).

(**) The daily dose referred to is 800mg IDV twice daily with ritonavir 100mg twice daily as booster. This dose is not indicated in themanufacturer’s label.(***) The daily dose referred to is 1250 mg twice daily although In developed countries the dosage of 9 tablets is frequently used.(§) The daily dose referred to is 100mg twice daily, for use as booster medication. This dose is not indicated in the manufacturer’slabel.(#) According to the WHO, SQV should be used with ritonavir as a booster (1000 mg SQV plus 100 mg ritonavir twice daily); whencombined with ritonavir either the soft gel capsules or the hard gel capsules can be used.


Products on the WHO list of Pilot Procurement, Quality and Sourcing Project: Access to HIV/AIDS drugs and diagnostics of acceptable quality (edition of 9 September 2002) have an asterisk (*) next tothe price. Best prices are in bold & underlined. Incoterms vary according to manufacturers.

Annual cost are 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 1d – 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 ABC+3TC+ZDV 3TC+d4T+ 3TC+d4T+ritonavir (LPV/r) NVP NVP NVP

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 (US) 500*(0.228/unit)

GSK 621** 1624*(UK) (0.850/unit) (2.225/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 US$ 1.17

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

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

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®) 20mg capsules Blister pack tbc of 56

GPO (Stavir®) 15mg capsules Box of 60 US$ 3.50 0.058 US$/capsule

GPO (Stavir®) 20mg capsules Box of 60 US$ 4.20 0.070 US$/capsule

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$ 15.87 (23.00 CHF) (**)

(**) on 14 November 2002, 1 Euro = 1.00 US$ and 1 CHF = 0.69 US$. Products on the WHO list of Pilot Procurement, Quality and Sourcing Project: Access to HIV/AIDS drugs and diagnostics ofacceptable quality (edition of 9 September 2002) have an asterisk (*) next to the price. Incoterms vary according to manufacturers.

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



Company

GlaxoSmithKline

Bristol-MyersSquibb Co.

GlaxoSmithKline

Eligibility (countries)

Least Developed Countries (LDCs)plus sub-Saharan Africa

All projects fully financed by theGlobal Fund to fight AIDS, TB andMalaria

(For middle income developingcountries public sector pricesnegotiated on a case-by-case basisor bilaterally or through the AAI)

Sub-Saharan Africa

(For other developing countries,prices negotiated on a case bycase basis)

LDCs plus sub-Saharan Africa


Table 2 Originator companies’ ARV offers and restrictions for developing countries

Table 2a Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Product

abacavir (Ziagen®)

didanosine(Videx®)

lamivudine(Epivir®)

Eligibility (body)

Governments, aid organisations,UN agencies, other not-for profitorganisations and internationalpurchase funds such as theGlobal Fund to fight AIDS, TBand 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 supplythe preferentially pricedproducts on a not for profitbasis

Both private and public sectororganisations that are able toprovide effective, sustainableand medically sound care andtreatment of HIV/AIDS areeligible

Governments, aid organisations,charities, international, UNagencies, other not-for-profitorganisations and internationalpurchase funds such as theGlobal Fund to fight AIDS,TBand Malaria

Price (US$ peryear and perunit)

US$ 986/year1.350/unit

US$ 310/yearUS$ 0.212/unit

Lower tabletdosages pricesin line with thisoffer

US$ 234/yearUS$ 0.320/unit

Additional comments

Supply Agreementrequired (For NGOsrequiring less than10 patient packs permonth, thisrequirement may bewaived)

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

Delivery ofgoods[5]

CIP

DDU togovernmentpurchasingentities

CIP

Company

Bristol-MyersSquibb Co.

GlaxoSmithKline

Product

stavudine(Zerit®)

zidovudine(Retrovir®)




Sub-Saharan Africa

(For other developing countries,prices negotiated on a case by casebasis)




Eligibility (body)

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

Both private and public sectororganisations that are able toprovide effective, sustainable andmedically sound care andtreatment of HIV/AIDS are eligible

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, employersthere who offer HIV/AIDS care andtreatment directly to their staffthrough workplace clinics orsimilar arrangements are alsoeligible

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


US$ 55/year(US$0.075/unit)

Lower capsuledosages pricedin line with thisoffer.

US$ 438/year(US$0.600/unit)

Additionalcomments

Supply Agreementrequired

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

Delivery ofgoods[5]

DDU togovernmentpurchasingentities

CIP


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

Product

efavirenz(Stocrin®)

efavirenz(Stocrin®)

nevirapine(Viramune®)

Company

Merck & Co., Inc.

Merck & Co., Inc.

BoehringerIngelheim

Delivery ofgoods[5]

CIF

CIF

CIF


Low Human Development Index(HDI) countries plus medium HDIcountries with adult HIVprevalence of 1% or greater

Medium HDI countries with adultHIV prevalence less than 1%

All World Bank low-incomecountries and sub-Saharan Africa

(Other countries on a case-by-case basis)

Eligibility (body)

Governments, internationalorganisations, NGOs, privatesector organisations (e.g.employers, hospitals andinsurers)

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

Governments, internationalorganisations, NGOs, privatesector organisations (e.g.employers, hospitals andinsurers).

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

Governments, NGOs and otherpartners who can guaranteethat the programme is run in aresponsible manner.


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

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

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

600mg tablet:US$ 767/year(US$ 2.10/unit)

US$ 438/year(US$ 0.600/unit)

Additionalcomments

Although Romaniadoes not fall underthese categories italso benefits fromthese prices.


Product

indinavir(Crixivan®)

indinavir(Crixivan®)

nelfinavir(Viracept®)

ritonavir(Norvir®)

saquinavir(Fortovase®)soft gel capsules

saquinavir(Invirase®) hardgel capsules

Company

Merck & Co.,Inc.

Merck & Co.,Inc.

Roche

Abbott

Roche

Roche

Delivery ofgoods[5]

CIF

CIF

FOB (must beshipped fromSwitzerland)

FOB




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

Medium HDI countries withadult HIV prevalence lessthan 1%


All African countries and theLDCs outside of Africa



Eligibility (body)

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

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

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

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

Governments, NGOs, Private sectoremployers

Governments, NGOs, UN systemorganisations, and other nationaland international health institutions

Governments, NGOs, private sectoremployers

Governments, NGOs, private sectoremployers

Price (US$ per year andper unit)US$ 400/year(US$ 0.274/unit)


Bottle of 270 tablets:CHF 340.00 (US$234.60) US$ 3172/year(US$ 0.869/unit)

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

Bottle of 180 capsules:CHF 112.50 (US$ 77.63)About US$ 1573/year(US$ 0.431/unit)

Bottle of 270 capsules:CHF 108 (US$ 74.52)US$ 1008/year(US$ 0.276/unit)

AdditionalcommentsAlthough Romania doesnot fall underthese categoriesit also benefitsfrom theseprices.

Table 2c Protease Inhibitors (PIs)


Table 2d Fixed Dose Combinations

Product

lopinavir/ritonavir (Kaletra®)

3TC + ZDV(Combivir®)

abacavir +3TC + ZDV(Trizivir®)

Company

Abbott

GlaxoSmithKline

GlaxoSmithKline

Delivery ofgoods[5]

FOB

CIP

CIP


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


All projects fully financed bythe Global Fund to fightAIDS, TB and Malaria

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


All projects fully financed bythe Global Fund to fightAIDS, 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, aid organisations,charities, international, UN agencies,other not-for-profit organisations andinternational purchase funds such as theGlobal Fund to 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.

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

Governments, aid organisations,charities, international, UN agencies,other not-for-profit organisations andinternational purchase funds such as theGlobal Fund to 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.

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

Price (US$ peryear and per unit)US$ 500/year(0.228/unit)


US$ 1624/year(US$ 2.225 /unit)

Additionalcomments

Supply Agreementrequired(For NGOsrequiring lessthan 10 patientspacks per month,this requirementmay be waived)

Supply Agreementrequired(For NGOsrequiring lessthan 10 patientspacks per month,this requirementmay be waived)


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 (US$ per yearand per unit)

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

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

All companies were invited to verify their offers during November 2002.

Other generic manufacturers producing ARVs exist but are not included in this summary of offers[4].


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/hdr2002/back.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; SyrianArab Republic; Tajikistan; Thailand;

Annex 1: Least Developed Countries(LDCs)

Forty-nine countries are currentlydesignated least developed countries(LDCs). The list is reviewed everythree years. Source:http://www.unctad.org/Templates/WebFlyer.asp?intItemID=2161&lang=1

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.

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’s Dem.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:http://www.worldbank.org/data/databytopic/CLASS.XLS (July 2002)

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; Mayotte; Mozambique;Namibia; Niger; Nigeria; Rwanda; SãoTomé and Principe; Senegal;Seychelles; Sierra Leone; Somalia;South Africa; Sudan; Swaziland;Tanzania; Togo; Uganda; Zambia;Zimbabwe.

Annex 4: World Bank low-incomecountries

Source:http://www.worldbank.org/data/databytopic/CLASS.XLS (July 2002)

Afghanistan; Angola; Armenia;Azerbaijan; Bangladesh; Benin;Bhutan; Burkina Faso; Burundi;Cambodia; Cameroon; Central AfricanRepublic; Chad; Comoros; Congo(Dem. Rep.), Congo (Rep.)Côte d’Ivoire; 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; Rwanda; São Toméand Principe; Senegal; Sierra Leone;Solomon Islands; Somalia; Sudan;Tajikistan; Tanzania; Togo; Uganda;Ukraine; Uzbekistan; Vietnam; Yemen (Rep.), Zambia; Zimbabwe.

Annex 5: Company contacts

Abbott:Rob DintruffEmail: [email protected] International manages theapplication process and serves as thecentral contact: The Programme ManagerAccess to HIV Care ProgrammeAXIOS InternationalP.O. Box 6924KampalaUganda.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-Astrid Mercier,BMS Access Coordinator in BMS Parisoffice ([email protected])

East Africa: information can beobtained from BMS main distributor inEast 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:John WeckerTel: +49 61 32 770 Fax: +49 61 32 272 3000 Email: [email protected] AXIOS InternationalEmail: [email protected]: +353 1 820 84 04

Cipla Ltd:Sanjeev Gupte, General Manager-ExportsCipla Limitedand Shailesh PednekarExecutive-Exports, Cipla LimitedTel: +91 22 3021397 (Direct) 30955213092891Fax: +91 22 3070013/3070393/3070385Email: [email protected] [email protected]


GlaxoSmithKline:Kathleen LayaDirector External RelationsTel: + 44 (0) 208 047 5488Fax: + 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 New MarineLines, 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 sub-Saharan African countriescontact Maturin TchoumiTel: +27 11 928 88 73 Fax: +27 11 94 63 54 Email: [email protected]

For Least Developed Countriesoutside sub-Saharan Africa contact:Hans-Ruedi WiedmerTel: +41 61 688 83 29 Fax: +41 61 688 15 25 Email: [email protected]

Combinopharm:Silvia GilManaging directorCombinopharmTel: + 34 93 48 08 833Fax: + 34 93 48 08 832E-mail: [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

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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 sgc saquinavir soft gel capsules(Fortovase®); protease 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

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

PMTCT Prevention of Mother-To-ChildTransmission

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

SQV hgc saquinavir hard gelcapsules (Invirase®); proteaseinhibitor


company, Northeast GeneralPharmaceutical Factory (China);Biogen (Colombia); Stein (CostaRica); Zydus Cadila Healthcare,SunPharma, EAS-SURG, Strides, MacLeods (India); LG Chemicals,Samchully (Korea); Protein, Pisa(Mexico); Andromaco (Spain); T.O.Chemecal (Thailand).

[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 acceptablequality, Third Edition 11th September2002http://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 2002(WHO/EDM/PAR/2002.2).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

[4] Generic manufacturers known tobe producing one or more ARVs are:Richmond Laboratorios, Panalab,Filaxis (Argentina); Pharmaquick(Benin); Far Manguinhos, FURP,Lapefe, Laob, Iquego, IVB (Brazil);Apotex, Novopharm (Canada);Shanghai Desano Biopharmaceutical

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

[10] For more information onpaediatric treatment in resource-limited settings see WHO Guidelines“Scaling Up Antiretroviral Therapy inResource-Limited Settings” (June2002)

[11] Abbreviations for the ARVs aretaken from the WHO draft guidelines“Scaling-up Antiretroviral Therapy inResource Limited Settings: Guidelinesfor a Public Health approach”http://www.who.int/HIV_AIDS/HIV_AIDS_Care/ARV_Draft_April_2002.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.org

a pricing guide for the purchase of ARVs for developing countries

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