accelerating access initiative - world health...

35
Widening access to care and support for people living with HIV/AIDS PROGRESS REPORT, JUNE 2002 Accelerating Access Initiative WORLD HEALTH ORGANIZATION 7/01/03, 11:26

Upload: dangnhi

Post on 21-Mar-2018

216 views

Category:

Documents


2 download

TRANSCRIPT

Widening access to care and supportfor people living with HIV/AIDS

PROGRESS REPORT, JUNE 2002

AcceleratingAccess Initiative

ISBN 92 4 121012 5

WORLD HEALTH ORGANIZATION

For orders, contact:World Health OrganizationFamily and Community Health ClusterDepartment of HIV/AIDS20, avenue AppiaCH-1211 Geneva 27Switzerland

E-mail: [email protected]

Couv. Accelerating Access... 7/01/03, 11:261

Widening access to care and supportfor people living with HIV/AIDS

PROGRESS REPORT, JUNE 2002

AcceleratingAccess Initiative

WORLD HEALTH ORGANIZATION

Pages de garde Accelerating... 7/01/03, 11:371

WHO Library Cataloguing-in-Publication Data

Accelerating Access Initiative: widening access to care and support for people living with HIV/AIDS:progress report, June 2002.

1.Anti-HIV agents - supply and distribution 2.Drug industry 3.Drug costs 4.International co-operation5.Intersectoral co-operation 6.Developing countries

ISBN 92 4 121012 5 (NLM/LC classification: QV 268.5)

© World Health Organization 2002

© World Health Organization and UNAIDS 2002

All rights reserved. Publications of the World Health Organization can be obtained from Marketing and Dissemination, World Health Organization, 20 AvenueAppia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; email: [email protected]). Requests for permission to reproduce ortranslate WHO publications - whether for sale or for noncommercial distribution - should be addressed to Publications, at the above address(fax: +41 22 791 4806; email: [email protected]).

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the partof the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation ofits frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.

The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World HealthOrganization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products aredistinguished by initial capital letters.

The World Health Organization does not warrant that the information contained in this publication is complete and correct and shall not be liable for anydamages incurred as a result of its use.

Printed in France

Pages de garde Accelerating... 7/01/03, 11:372

ACCELERATING ACCESS III

ContentsAcknowledgements ivAcronyms and Abbreviations vExecutive Summary 1Introduction 3Aims of Accelerating Access 4How the Initiative Works 5Achievements 7Limitations 10Related Activities 13Lessons Learned 15Conclusion 16Further Reading 17Annexes 19

Annex 1: Accelerating access to HIV/AIDS care and treatment in developing countries 19Annex 2: Countries that have expressed interest in Accelerating Access 21Annex 3: Estimated numbers of African patients on antiretroviral therapy 23Annex 4: Prices of ARVs in the Accelerating Access Initiative 28Annex 5: Offers for antiretroviral drugs by proprietary companies for developing countries 29

Pages de garde Accelerating... 7/01/03, 11:373

Acknowledgements

This report was compiled by B. Samb (WHO), J. Perriëns (WHO), H. Tracey (UNAIDS)and J. Fleet (UNAIDS). WHO and UNAIDS would like to acknowledge the help ofG. Dwyer (editing and graphic design) and Segundo dela Cruz, Jr. (typesetting). Annex3 was contributed to this report by the participating companies (Abbott Laboratories;Boehringer Ingelheim GmbH; Bristol-Myers Squibb; GlaxoSmithKline; F. Hoffmann-La Roche Ltd.; and Merck & Co., Inc.).

IV ACCELERATING ACCESS

Pages de garde Accelerating... 7/01/03, 11:374

ACCELERATING ACCESS V

Acronyms andAbbreviationsAcronyms

AIDS acquired immunodeficiency syndromeARV antiretroviralCARICOM Caribbean CommunityECOWAS Economic Community of Western African StatesHAART highly active antiretroviral therapyHIV human immunodeficiency virusMAP Multi-Country HIV/AIDS Programme for AfricaMTCT mother-to-child transmission (of HIV)NGO nongovernmental organizationTB tuberculosisUN United NationsUNAIDS United Nations Joint Cosponsored Programme on HIV/AIDSUNFPA United Nations Population FundUNGASS United Nations General Assembly Special Session on HIV/AIDSUNICEF United Nations Children’s FundWHO World Health Organization

Drug abbreviations

ABC abacavirAPV amprenavird4T stavudineddC zalcitabineddI delavirdineEFZ efavirenz (also abbreviated as EFV)IDV indinavirLPV lopinavirNFV nevirapineNNRTI Non-Nucleoside Reverse Transcriptase InhibitorNRTI Nucleoside Reverse Transcriptase InhibitorPI protease inhibitorRTV, r ritonavirRTV-PI ritonavir boosted protease inhibitorSQV saquinavirTDF tenofovir disoproxil fumarateZDV zidovudine (also known as AZT)

Pages de garde Accelerating... 7/01/03, 11:375

ACCELERATING ACCESS 1

Executive SummaryThe World Health Organization (WHO)and Joint United Nations Programme onHIV/AIDS (UNAIDS) estimate that in 2001about 3 million people died from AIDS, withthe vast majority of these deaths occurringin developing countries. While theavailability of antiretroviral (ARV) therapyhas significantly reduced AIDS morbidityand mortality in the industrialized world,in developing countries, where 95% of HIV-positive people live, the overwhelmingmajority of HIV-positive people do not haveaccess to these life-sustaining medications.

WHO conservatively estimates that in2002, around 6 million people in developingcountries are in need of ARV therapy. Yetonly about 230,000 people living with HIVin those countries have such access today.Half of these live in one country, Brazil.

Access to medicines is dependent on theirrational selection and use, the availabilityof financial resources, the strength of thehealth infrastructure and their affordability.As the high cost of medicines is a majorfactor limiting access to ARVs in developingcountries, in May 2000 five UNorganizations (the United NationsPopulation Fund [UNFPA], United NationsChildren’s Fund [UNICEF], World HealthOrganization [WHO], World Bank andUNAIDS Secretariat) entered into apartnership offered by five pharmaceuticalcompanies (Boehringer Ingelheim GmbH;Bristol-Myers Squibb; GlaxoSmithKline;Merck & Co., Inc.; and F. Hoffmann-LaRoche Ltd. – later joined by AbbottLaboratories) to address the lack ofaffordability of HIV medicines and to worktogether to increase access to HIV/AIDS careand treatment in developing countries.

Since the launch of Accelerating Accessin May 2000, 80 countries have expressedtheir interest in the Initiative. In 39 of thesecountries, national plans to improve accessto care have been or are being developed.These plans have been used as a frameworkfor dialogue with the pharmaceuticalcompanies, and as a consequence, 19countries (Barbados, Benin, Burkina Faso,Burundi, Cameroon, Chile, Republic of theCongo, Côte d’Ivoire, Gabon, Honduras,Jamaica, Mali, Morocco, Romania,Rwanda, Senegal, Trinidad and Tobago,Uganda, and Ukraine) have concludedagreements for the supply of their ARVdrugs with individual companiesparticipating in the Initiative. In each ofthese countries the pharmaceuticalcompanies involved, acting independently,have significantly reduced the cost of theirdrugs. In addition, several companies havealso made their drugs available at reducedcost to governments, nongovernmentalorganizations (NGOs), private sectoremployers and health care organizationsoutside the framework of the AcceleratingAccess Initiative. In May 2002, two majorgroups of countries coalesced to engage innegotiation with the individualpharmaceutical companies, with WHO andUNAIDS support, through the AcceleratingAccess Initiative. These are the EconomicCommunity of Western African States(ECOWAS) and the Caribbean Community(CARICOM). Formal statements of intentbetween ECOWAS and CARICOM,respectively, and the companies, areexpected to be signed in July 2002.

The 19 countries that have concludedsupply agreements within the Accelerating

Since the

launch of

Accelerating

Access in May

2000, 80

countries have

expressed their

interest in the

Initiative.

Int. Accelerating Access... 7/01/03, 11:341

2 ACCELERATING ACCESS

Despite the

major

reductions in

ARV prices, the

annual cost of

ARV treatment

for a person

living with HIV

still exceeds

the annual per

capita gross

domestic

product of

many least

developed

countries.

gross domestic product of many leastdeveloped countries. Thus, procurement ofARVs solely through domestic financingremains almost impossible in manycountries. While far greater investments inhealth and social services infrastructureare needed to expand access to treatmenton a massive scale, many countries haveunderutilized health system capacity that,but for lack of financing and affordability,could be used to expand treatment today.

In spite of the limited number of patientstreated to date, however, the Initiative hascontributed significantly to overcoming theinertia surrounding treatment access indeveloping countries. A marked shift hasoccurred in perceptions of how the HIVepidemic can be tackled. The Declarationof Commitment by the United NationsGeneral Assembly Special Session(UNGASS) on HIV/AIDS reflects this shift,recognizing that care for people living withHIV/AIDS is an integral part of the fightagainst AIDS, and making specific mentionof ARV therapy as an important elementof comprehensive care.

This increased recognition of care as animportant element of the fight againstAIDS is reflected in several recentimportant developments. Supporting accessto treatment is a central part of the agendaof the recently established Global Fund toFight AIDS, TB and Malaria (the GlobalFund). HIV/AIDS accounted for more than60% of the funding committed followingthe first round of proposal submissions inApril 2002. Total funding committed overtwo years in this round of proposals, forAIDS, TB and malaria prevention andtreatment programmes, amounts toUS$616 million. Of the 28 countries thatwill receive funds to fight HIV/AIDS, 21have grants that specifically includefunding to purchase ARV treatments forpeople living with HIV/AIDS. In addition,the World Bank’s Multi-Country HIV/AIDS Programme for Africa (MAP),initiated in 2001, recently decided to re-emphasize support for HIV/AIDS care andtreatment as part of its eligible activities.

Access Initiative have all moved to waiveimport taxes and duties on drugs used inHIV/AIDS treatment, and some countriesintroduced generic ARV drugs in thetreatment of HIV infection at competitiveprices – in one instance for as low asUS$295 for a year’s treatment with a firstline triple ARV therapy regimen.

As of December 2001, the cost of ARVdrugs offered individually by thepharmaceutical partners in theAccelerating Access Initiative for the leastdeveloped countries had decreasedsignificantly, in some cases to 10–20% oftheir price in industrialized countries.About 27 000 people had gained access toARV therapy in the 19 countries in Africa,Eastern Europe, and Latin America and theCaribbean that had concluded supplyagreements within the Accelerating AccessInitiative framework. This represents anearly 10-fold increase in the number ofpatients treated in those countries.

In addition, the public offer of lowerprices led to an increased uptake of ARVsin Africa outside the Accelerating AccessInitiative framework. In Africa, the sixcompanies involved in the Initiative hadsupplied treatment to more than 35 500people as at the end of March 2002, partwithin and part outside the AcceleratingAccess Initiative countries. Their data alsoshow that in Africa the proportion ofpatients on triple combination therapy upto that time increased from one third tonearly two thirds, which indicates aconcomitant increase in the quality of ARVtreatment.

While this is significant progress, thesenumbers represent only a fraction of thosein need of ARVs. The failure to reach morepeople with ARV therapy in resourcelimited settings reflects the persistinglimited availability of funding formedicines, diagnostics and infrastructure,as well as continued lack of affordabilityin many countries. Despite the majorreductions in ARV prices, the annual costof ARV treatment for a person living withHIV still exceeds the annual per capita

Int. Accelerating Access... 7/01/03, 11:342

ACCELERATING ACCESS 3

IntroductionThe World Health Organization (WHO)and the Joint United Nations Programmeon HIV/AIDS (UNAIDS) estimated that atthe end of 2001, more than 40 millionpeople were living with HIV/AIDSworldwide. More than 28.1 million werein sub-Saharan Africa, a region thataccounts for about 2.3 million of theestimated 3 million adult and child deathsrelated to AIDS in 2001. In addition, morethan 20 million lives have been lost to AIDSsince the start of the epidemic in the early1980s.

This death toll could have been lower ifhighly active antiretroviral therapy(HAART), which was introduced for thetreatment of HIV in 1996, had beenavailable more widely. EverywhereHAART was introduced, spectacularimprovements in the treatment of HIVpatients ensued, dramatically reducingmortality among treated patients by about70% and improving their quality of life.Where HAART was introduced, itchanged the perception of HIV/AIDS froma death sentence to that of a manageablechronic illness.

However, in many developing countries,people living with HIV/AIDS do not haveaccess even to basic treatment foropportunistic infections, or to palliativecare. The injustice of this treatment gapled to a wide movement for treatmentaccess, led by people living with HIV andby civil society.

In 1998, the UNAIDS Secretariat, withseveral pharmaceutical partners,introduced the Drug Access Initiativewhich explored the feasibility of a

structured introduction of price-reducedARV therapy in a range of developingcountries. The Drug Access Initiative whichestablished that antiretroviral (ARV)therapy could be safely and effectivelyused, even in the least developed countries,led to the first differential pricing for ARVsin developing countries, and demonstratedthat diversion of price-reduced drugs couldbe limited. A first evaluation of its activitiespublished in March 2000 found, however,that in the pilot projects the price of thedrugs was the main obstacle to expandingdrug access up to the maximum capacityof the pilot centres. This led the UNAIDSSecretariat and the managers of the DrugAccess Initiative in Uganda and Côted’Ivoire to explore whether the drugs couldbe obtained more cheaply, first from theresearch-based companies that werepartners in the initiative, and later fromgeneric manufacturers. Further action wasalso prompted by public information aboutprices of locally produced ARVs in Braziland Thailand.

Building on this experience, five UNorganizations (the United NationsPopulation Fund [UNFPA], United NationsChildren’s Fund [UNICEF], World HealthOrganization [WHO], World Bank andUNAIDS Secretariat) entered in apartnership offered by five pharmaceuticalcompanies (Boehringer Ingelheim GmbH;Bristol-Myers Squibb; GlaxoSmithKline;Merck & Co., Inc.; and F. Hoffmann-LaRoche Ltd.) in May 2000, joined later byAbbott Laboratories Inc. The presentpaper reports on the progress achievedthrough this partnership.

Where HAART

was introduced,

it changed the

perception of

HIV/AIDS from

a death

sentence to

that of a

manageable

chronic illness.

Int. Accelerating Access... 7/01/03, 11:343

4 ACCELERATING ACCESS

Aims of AcceleratingAccessThe Accelerating Access Initiative was setup to explore practical and specific waysof working together more closely toaccelerate access to HIV/AIDS-relatedcare and treatment in developing countries.

The objective of the Accelerating AccessInitiative is to make HIV/AIDS drugs moreaffordable and accessible in developingcountries and to improve technicalcollaboration in the development ofnational programme capacities to delivercare, treatment and support.

The partners in the Initiative agreed toa Joint Statement of Intent (see Annex 1),which sets out the expected benefits of theInitiative, as follows:

■ for people in developing countries, toaccelerate their sustained access to,and increase their use of, appropriate,good quality interventions for theprevention, treatment and care ofHIV/AIDS-related illnesses, and theprevention of perinatal transmissionof HIV;

■ to ensure that care and treatment reachsignificantly greater numbers of peoplein need, through new alliancesinvolving committed governments,private industry, the UN system,development assistance agencies, non-governmental organizations (NGOs)and people living with HIV/AIDS; and

■ to implement public-private co-operation in ways that respond to thespecific needs and requests of

The objective

of the

Accelerating

Access

Initiative is to

make HIV/AIDS

drugs more

affordable and

accessible in

developing

countries...

individual countries, with respect forhuman rights, equity, transparencyand accountability.

The following fundamental principlesunderlie the Initiative:

(i) unequivocal and ongoing politicalcommitment by national governmentsis essential for success;

(ii) strengthened national capacity iscrucial for delivering care andtreatment on an equitable basis;

(iii) engagement of all sectors of nationalsociety and the global community isessential in facilitating access totreatment;

(iv) efficient, reliable and securedistribution systems are necessary toensure that medical supplies and otherconsumables are made available topeople who need them;

(v) significant additional funding fromnew national and internationalsources is necessary for long-termsuccess; and

(vi) continued investment in research anddevelopment by the pharmaceuticalindustry on innovative newtreatments for HIV/AIDS is critical toexpanding the global response toHIV/AIDS. Therefore, intellectualproperty rights should be protected,in compliance with internationalagreements, since society depends onthem to stimulate innovation.

Int. Accelerating Access... 7/01/03, 11:344

ACCELERATING ACCESS 5

At global level, the Accelerating AccessInitiative was structured in three workinggroups: (i) country support (in which, inaddition to the pharmaceutical companies,the UNAIDS Secretariat, UNICEF andWHO participated); (ii) communications (inwhich all partners participated); and (iii)procurement (in which the UNAIDSSecretariat, UNFPA, UNICEF and WHOparticipated).

Following the announcement of theAccelerating Access Initiative, govern-ments were informed about the Initiativethrough the UN Theme groups on HIV/AIDS, which is the co-ordinating mechanismin countries for UN action on AIDS at thenational level. Governments were offeredUN input in their planning of care andsupport for people living with HIV/AIDSand requested to signify their possible interestin the Accelerating Access Initiative to theExecutive Director of UNAIDS, who thenensured that the country was approachedby UN staff participating in the countrysupport working group. The latter exploredthe intent of the government, and thenorganized support to the government for thedevelopment of a plan for access to ARVdrugs while promoting comprehensive careand informing the government about allprocurement options, including informationon the availability and cost of generic ARVs.After finalization, with approval of thegovernment, the plan for access to ARVdrugs was transmitted by the UN to thosepharmaceutical companies with which the

government wished to open discussions onprices and transactions. The discussionsinvolved representatives of the governmentand individual pharmaceutical companies,and were facilitated by the UN staff in thecountry support working group. As regionaland sub-regional collaborations developed,at the initiative of governments, the sameprocedure was used to ensure they weretechnically supported.

At global level, there was regularconsultation with the stakeholders in theAccelerating Access Initiative, includinggovernments and NGOs, through theestablishment of the Contact Group onAccelerating Access to HIV/AIDS-relatedCare. The Contact Group provided a forumfor consultation and exchange of views onthe Initiative, as well for a regular updateon progress (Box 1).

How the InitiativeWorks

Box 1 Contact Group — Accelerating Access to HIV/AIDS related care

The Contact Group provides a forum for representatives of governments, people living with and affectedby HIV/AIDS, NGOs and other parties, including the pharmaceutical industry. Through this, they canexchange information and views, engage in consultation and articulate needs and expectations, especiallythose emanating from governments, and provide advice and guidance to the UNAIDS Secretariat, WHO,UNICEF, UNFPA and the World Bank on principles, policy and practice that will apply to the AcceleratingAccess Initiative.

The discussions in the Contact Group are intended to ensure a well-informed co-ordinated, participatoryand transparent approach to the Initiative.

The Contact Group is convened by the UNAIDS Secretariat and Co-sponsors and established by theChair of the UNAIDS Programme Coordinating Board (PCB), in consultation with the UNAIDS Secretariatand members of the PCB.

Int. Accelerating Access... 7/01/03, 11:345

6 ACCELERATING ACCESS

The procurement working group definedvarious options for procurement1 for

pharmaceuticals that the Initiative mightpursue. Unfortunately, the partners wereunable to agree initially on an option otherthan individual country-by-countrynegotiation, which proved a labour-intensive and time-consuming process.

1 Such options included procurement by individual countriesor organizations within countries, pooled procurement bycountries or organizations, including on a regional basis,and procurement through a central global agent.

Int. Accelerating Access... 7/01/03, 11:346

ACCELERATING ACCESS 7

AchievementsIncreasing accessAt present, of the 80 countries that haveexpressed interest in the AcceleratingAccess Initiative, 39 countries havedeveloped plans of action for HIV/AIDScare. These plans have been used as aframework for dialogue with pharma-ceutical companies and have led tosuccessful UN-brokered supply agreementsfor ARVs in 19 out of the 22 countries thatinitiated and finalized such discussions. Thecountries where UN-brokered supplyagreements were concluded and are nowin effect include Barbados, Benin, BurkinaFaso, Burundi, Cameroon, Chile, Republicof the Congo, Côte d’Ivoire, Gabon,Honduras, Jamaica, Mali, Morocco,Romania, Rwanda, Senegal, Trinidad andTobago, Uganda, and Ukraine. Thegovernments of three countries (Ethiopia,Kenya, and Swaziland) opted for a careagenda that does not include ARVs after afirst planning round with the UN, and,while price reductions are available in theirprivate sectors, have so far not initiateddiscussions with the pharmaceuticalcompanies themselves (Annex 2).

In addition, in May 2002, two majorgroups of countries coalesced to engage innegotiation with the individualpharmaceutical companies, with WHOand UNAIDS support, through theAccelerating Access Initiative. These arethe Economic Community of WesternAfrican States (ECOWAS) and theCaribbean Community (CARICOM).Formal statements of intent betweenECOWAS and CARICOM, respectively,and the industry companies are expectedto be signed in July 2002. Fifteen

Caribbean countries and 15 West Africancountries are involved in these regionaldiscussions.

In the first 19 countries in Africa,Eastern Europe, and Latin America and theCaribbean to conclude supply agreements,as of December 2001, about 27 000 peoplehad gained access to ARV therapy,representing an almost 10-fold rise in thenumber of patients treated.

Reduced pricesAchieving lower prices for ARVs has beena significant achievement of theAccelerating Access Initiative, asaffordability is a fundamental starting pointfor increasing access.

When HAART was introduced in 1996,conventional wisdom held that it wouldremain financially and logistically beyondthe reach of most HIV-positive people indeveloping countries for the foreseeablefuture. The Accelerating Access Initiativechanged this perception: within months thecost of ARV drugs offered individually bythe pharmaceutical partners in theAccelerating Access Initiative for the leastdeveloped countries decreased, in somecases to 10–20% of their price inindustrialized countries. Emergingcompetition from generic manufacturersfor some drugs also was a critical factor,in particular on the cost of first lineregimens that do not include proteaseinhibitors, as illustrated by the evolutionof the price of a first line ARV regimen inUganda (Figure 1 overleaf).

However, the Accelerating AccessInitiative for the first time brought abouttransparent differential pricing for ARVs

Achieving lower

prices for ARVs

has been a

significant

achievement of

the

Accelerating

Access

Initiative.

Int. Accelerating Access... 7/01/03, 11:347

8 ACCELERATING ACCESS

Figure 1 Price reductions of a first line ARV regimen in Uganda

WHA Technical Briefing 2002.

in the least developed countries, and led tothe first significant move in transactedprices in its target countries and beyond,on the African continent. Mainly as aconsequence of this transparent pricingpolicy, Africa was able to significantlyincrease the number of people treated, bothwithin and outside the framework of UNbrokered supply agreements within theAccelerating Access Initiative. Accordingto estimates compiled on behalf of the sixcompanies involved in the AcceleratingAccess Initiative, about 35 500 people inAfrica were being treated with ARVssupplied by the six companies by the endof March 2002, a four-fold increase in 18months. In addition, the data show that theproportion of patients on triplecombination therapy over that periodincreased from one third to nearly twothirds, which indicates a concomitantincrease in the quality of ARV treatment.

Annex 3 gives an overview of sales inAfrica by the companies that participatein the Accelerating Access Initiative. Thecost of ARV drugs supplied by theresearch-based companies in agreementsbrokered under the Accelerating AccessInitiative, is given in full in Annex 4. It

should be noted that none of these supplyagreements contain undue restrictions.They are typically concluded for a periodof one year, but leave the buyer the optionto buy from other (i.e., generic) supplysources, consistent with regulatoryrequirements and international agree-ments.

Announcements of price reductionscontinue to be made, the most recent beingAbbott Laboratories’ announcement of19 June 2002 of additional price reductionsfor its anti-HIV drugs lopinavir / ritonavirand ritonavir. The UN will continue to pressfor further decreases where possible, whilerecognizing that the policy of mostcompanies is to cover the costs ofproduction. The UN will also continue topress for increased transparency andaccess to a wider formulary. While pricesin Africa are transparent now, in countriesoutside Africa lack of transparencycontinues to hamper price comparisons,which holds up the ability of those in chargeof treatment programmes to agree on someof the proposed supply agreements. Also,as is evident from the table in Annex 4,supply agreements concluded under theAccelerating Access Initiative between

Int. Accelerating Access... 7/01/03, 11:348

ACCELERATING ACCESS 9

countries and the individual pharmaceuticalcompanies outside Africa cover only 11drugs out of the 17 offered by the companiesparticipating in the initiative, as countrydialogues do not yet involve all companies.

Mobilization for careThe demands of treatment activists and civilsociety for equitable access to HIV care havebeen a major factor in drawing worldattention to the gap in treatmentaccessibility. With reduced prices,perceptions about the feasibility ofproviding care to all those who need it havedramatically changed. The inertiasurrounding action on HIV/AIDS carecould be rationalized when prices were farbeyond the reach of people in developingcountries.

But when the price of a first line regimenfell from US$10 000 to around US$350 ayear during the course of two years, peopleliving with HIV/AIDS in developingcountries could see that the medicines anddrugs they needed were almost within theirreach. As is evident from the UNGASScommitments on care, the internationalcommunity has responded to thisconvergence of forces, committing toprovide care including ARV therapy tothose in need.

Without the greatly reduced prices ofARVs in the least developed countriesbrought about through the AcceleratingAccess Initiative, and the significant mediacoverage that ensued, the unwaveringresolve of civil society to address thedisparity between treated and untreatedmight have continued to meet resistancefrom the international developmentcommunity. Instead, the perception thatcare is now possible changed the directionof major international commitments, asreflected, for example, in The Plan of Actionthat came out of the African Development

Forum organized by the EconomicCommission for Africa (ECA) in AddisAbaba, in December 2000; in the AbujaDeclaration on HIV/AIDS, Tuberculosisand other related Infectious Diseases issuedby Organization of African Unity (OAU)Heads of State in April 2001; and in theDeclaration of Commitment on HIV/AIDSadopted at the UN Special Session on HIV/AIDS (UNGASS) in June 2001. Theinclusion of the possibility of purchasingARV drugs within the scope of the GlobalFund to Fight AIDS, TB and Malaria,included in the Framework Agreement ofthe Fund and demonstrated in concreteterms in the first round of grants, and theavailability of World Bank financing forcare and treatment, is further evidence ofthe changed attitude of donors to financingthe purchase of ARVs.

Taxes and dutiesAll 19 countries that entered supplyagreements for ARVs in the AcceleratingAccess Initiative have moved to eliminateor waive import taxes and duties on drugsused in HIV/AIDS treatment.

Other resultsIn addition to offering reduced-pricemedicines, several companies havecontinued or expanded their support for thetraining for health care professionals,strengthening health infrastructure andcapacity.

Boehringer Ingelheim GmbH has offerednevirapine free of charge to developingcountries for the prevention of mother-to-child transmission (MTCT) of HIV, andAbbott Laboratories joined this effort inJune 2002 with an offer of free rapid testsfor MTCT programmes.

With reduced

prices,

perceptions

about the

feasibility of

providing care

to all those

who need it

have

dramatically

changed.

Int. Accelerating Access... 7/01/03, 11:349

10 ACCELERATING ACCESS

WHO estimates

that, overall,

only about

230 000 people

have access to

ARV therapy in

low- and

middle-income

countries.

LimitationsToo few patients benefitWHO estimates that, overall, only about230 000 people have access to ARVtherapy in low- and middle-incomecountries (half of them in Brazil alone),while about 6 million are estimated to bein need. Building on the commitments madeat UNGASS in June 2001, WHOadvocates that at least 3 million people inneed should be on ARV drugs by 2005.

Measured against this scale of need, thenumber of beneficiaries of the AcceleratingAccess Initiative remains disappointinglylow. The reasons for this are many. Thefailure to reach more people with ARVtherapy in resource limited settings reflectsthe persisting limited availability of fundingfor medicines, diagnostics and infra-structure, as well as continued lack ofaffordability in many countries.

Despite the major reductions in ARVprices, the annual cost of ARV treatmentfor a person living with HIV still exceedsthe annual per capita gross domesticproduct of many least developed countries.

Thus, procurement of ARVs solelythrough domestic financing remains almostimpossible in many countries. However,the weakness of health systems indeveloping countries is also a majorconstraint. Voluntary counselling andtesting for HIV infection is, for example,not widely available, and staff to prescribeand supervise treatments are in short supplyin most developing countries.

Lack of fundingand resourcesVarious financial mechanisms have beenutilized by countries with supplyagreements under the Accelerating AccessInitiative framework. These range fromout-of-pocket payment by individualpatients to full government subsidyinvolving national subsidy schemes,revolving funds, work-based schemes,private insurance, debt relief, and bilateraland multilateral aid. So far only a fewcountries, including Barbados, Chile,Gabon, Morocco, Romania, and Trinidadand Tobago, have been able to commit tofully subsidize the cost of ARV therapy. Theother 13 countries with supply agreementsin place could not do so for lack of funding.

A number of recent global resourcemobilization developments opens the wayfor greater progress in funding increasedaccess to care. In particular, theestablishment in January 2002 of theGlobal Fund to Fight AIDS, TB andMalaria as a result of concerted action bya wide range of stakeholders, includingbilateral donors, the UN system, civilsociety and the private sector offers amajor opportunity to scale up HIV/AIDScare and support treatment. The Fundexplicitly includes provision for drugs andmedicines, including ARVs, within itsscope. The first round of grants announcedby the Global Fund in April 2002 commitsa total of US$616 million in grants (for all

Int. Accelerating Access... 7/01/03, 11:3410

ACCELERATING ACCESS 11

three diseases) for two years forprogrammes in more than 30 countries.About 60% of the first two years offunding will go to HIV/AIDS programmes,and 21 countries will use part of these fundsto purchase ARVs.

The World Bank’s Multi-Country HIV/AIDS Programme for Africa (MAP),initiated in 2001, is providing support forHIV/AIDS prevention, care and treatmentprogrammes, with an emphasis onvulnerable groups, by assistinggovernments, communities and civil societyorganizations in Africa as they implementnational multi-sectoral HIV/AIDSstrategies. About US$400 million a year inconcessional lending, with a correspondinggrant value of US$275 million–300 million,is projected through 2005. A similarinitiative is under way in the Caribbean.Totalling US$155 million, the Multi-Country HIV/AIDS Prevention andControl Project for the Caribbean worksas a five-year loan programme that allowscountries to obtain separate loans orcredits to finance their national HIV/AIDSprevention and control projects. By April2002, about US$40 million had beenallocated to projects, including treatmentaccess, in Barbados and the DominicanRepublic. Several Caribbean countrieshave agreed that parts of these loans maybe assigned to the purchase of ARV drugs.Barbados is the first country that has metthe required criteria and drawn on thesefunds to finance ARV access. The secondphase of MAP will more directly addresstreatment access.

Mobilizing more resources to scale upaccess to HIV care is a major priority forthe UN system. It is estimated that aboutUS$2 billion a year is needed to reach theWHO target of treating 3 million peoplewith ARVs by 2005.

UN capacityOne of the disadvantages of the country-by-country approach adopted by theAccelerating Access Initiative is that it has

been relatively slow and labour intensive.The resources of the UN system haveconsequently been stretched to respond tothe demands for assistance from countriesto participate in the Accelerating AccessInitiative. In some cases, the UN has notbeen able to respond positively to requestsfrom countries in a timely manner, andresources have not been available toprovide technical support once supplyagreements had been reached.

In order to increase the human resourcebase serving the Initiative, 60 consultantswere briefed on the Initiative and used toassist countries with their planning. Thetransfer of the responsibility for technicalassistance for the Initiative from theUNAIDS Secretariat to WHO, inNovember 2001, will also increasecapacity. At the time of writing, fourregional offices of WHO (AFRO, PAHO,SEARO and WPRO) have assigned full-time staff to access to care, and tworegional offices (EMRO and EURO) arebuilding up networks of experts to supportplanning at country level. Nationalprofessional officers dealing with essentialdrugs in the offices of WHO rep-resentatives in anglophone and franco-phone Africa have also been trained and willhelp out in the future, and similar training isforeseen in collaboration with PAHO.National HIV focal points in WHO officesin Africa will be the next group of trainees.

Box 2 Funding mechanisms

A variety of financial mechanisms has been put in place to provide care and support to a largernumber of people living with HIV/AIDS in the countries where the Accelerating Access Initiative ledto supply agreements. Some governments are devoting increased public funds towards preventionand care. For example:

• Côte d’Ivoire, Cameroon, Gabon, Mali, Morocco and Senegal are allocating funds to subsidize accessto ARVs to people who are unable to afford the drugs.

• Burundi and Rwanda have established a revolving fund dedicated to the procurement of HIVmedicines to allow continuous purchasing of drugs.

• Cameroon and Mali have converted part of their debt relief proceeds into a fund for care andtreatment.

• Some governments have invited private companies to subsidize access to drugs for their employeesand families.

Int. Accelerating Access... 7/01/03, 11:3411

12 ACCELERATING ACCESS

Through the

Accelerating

Access

Initiative,

various public

and private

health

providers in

developing

countries have

accessed ARV

drugs and

gained some

experience

with their use.

Regional approaches offer anopportunity to decrease the demand fortechnical support and increase itsefficiency. Recently, progress has beenmarked in developing regional approachesin the Caribbean and in Western Africa.During the last World Health Assembly inMay 2002, CARICOM and ECOWAS metrepresentatives of the pharmaceuticalindustry, and agreed to work on furtherreduction of prices within regionalapproaches. Such regional initiatives offerthe possibility of bulk purchasing, sharedtechnical assistance and joint resourcing,and thus can significantly expand thebenefits of increased access to care.

Capacity buildingThrough the Accelerating Access Initiative,various public and private health providersin developing countries have accessed ARVdrugs and gained some experience withtheir use. Generally, however, thisexperience was not supported bynationally-developed ARV managementguidelines.

The Initiative aims to support capacity,but places the responsibility for it withcountries, as there are no funds in theInitiative for this purpose.

The constraints on capacity building,parallel to those for access to drugs, havemeant that little capacity building hasoccurred.

MonitoringReports on progress with AcceleratingAccess Initiative have been presentedregularly, at the Contact Group and atother relevant consultations, by keypartners in the Initiative. A structuredframework for systematically collectingand presenting data on the Initiative’sperformance has not yet been developed.

WHO and the UNAIDS Secretariat havedeveloped indicators for a wide range ofcare activities, with a large number ofinstitutional partners. These indicators arenow being pilot tested in Cambodia,Ethiopia and Kenya. They will be usedwithin the framework of second generationsurveillance of the HIV epidemic, and couldalso be applied in the evaluation of theInitiative.

Focus on governmentsA limitation of the Accelerating AccessInitiative has been the tendency to workmainly with ministries of health incountries. The intention to engage otherimportant partners has not always beenmet. NGOs and large employers are keypoints of entry for ARVs. In the interestsof inclusiveness and efficiency, all peopleand organizations at country level need tofeel empowered to support treatmentaccess. This shortcoming will be tackledincreasingly in the future, mainly throughwider partnerships.

Lack of promotion ofgeneric pharmaceuticalpartnersDuring the course of the past two years,the collaboration in the AcceleratingAccess Initiative has been focused largelyon the six research-based pharmaceuticalcompanies and the UN. While the Initiativehas been open to generics companies, withsome countries accessing generic ARVs,and while a representative of the genericsindustry recently joined the Contact Group,greater efforts must be made to supportgeneric competition (consistent withinternational agreements) and to engagegeneric producers.

Int. Accelerating Access... 7/01/03, 11:3412

ACCELERATING ACCESS 13

The Accelerating Access Initiative is notthe only UN activity supporting access tocare for people living with HIV/AIDS.

The potential impact of patents and theAgreement on Trade-Related Aspects ofIntellectual Property Rights (TRIPS) onaccess to medicines has been a continuingconcern for the WHO and the UNAIDSSecretariat. WHO and UNAIDS haveplayed pivotal roles in raising awarenessabout the potential impact of the TRIPSAgreement on access to medicines. For anoverview of these concerns the reader isreferred to the document Globalization andAccess to Drugs: Perspectives on theWTO/TRIPS Agreement published in1998, and one of the 128 publications onthis topic by the WHO since 1998, as wellas the statements of WHO and UNAIDSat the World Trade Organization (WTO)Ministerial Conference in Seattle (1999)and Doha (2001), available on theirrespective websites.

As access to HIV drugs has been one ofthe main concerns in the debate around theinterpretation of the TRIPS Agreement,WHO published, supported by theUNAIDS Secretariat, a study on the patentsituation of HIV-related drugs in 80countries in 1999, which will be updatedin 2002–2003. This document providesimportant information for the procurementof the drugs considered in the study.

In December 2000, the UN systemreleased a call for expressions of interestfrom manufacturers committed toproviding HIV/AIDS products atdifferential prices to developing countries.This call has been repeated twice sincethen. The data collected through thisprocess have been used for two purposes:first, to document the existence of supply

sources of medicines of interest to peopleliving with HIV/AIDS that are difficult tofind on the international market; andsecond, in an effort to improve the qualityof the drugs considered. The annual surveyof Sources and Prices of Selected Medicinesand Diagnostics for People Living withHIV/AIDS, produced by UNICEF, WHO,the UNAIDS Secretariat and Médecins-Sans-Frontières, which provides marketinformation to help procurement agenciesmake decisions on the source of drugs andto help them negotiate better prices, is oneof the outputs of this effort. The 2002edition of this survey was due to belaunched during the InternationalConference on AIDS in Barcelona in July2002.

A second output is prequalification ofthose manufactures that provided detailedinformation on the quality of their productsand whose production facilities successfullypass an inspection site visit. A first list ofprequalified products and suppliers waspublished in April 2002.

A further output is the production ofgeneric quality standards for ARVs. Formost ARVs, such standards are notavailable in the public domain, and thisimpedes the ability of quality assurancelaboratories to provide independentcertification of the quality of the productsthey test.

An important step towards reversingcommon misperceptions about thecomplexity of ARV treatment was thepublication by WHO in April 2002 ofGuidelines for Scaling Up AntiretroviralTherapy in Resource Limited Settings.This guidance on the rational selection anduse of ARV drugs in resource limitedsettings acknowledges the relative

Related Activities

WHO and

UNAIDS have

played pivotal

roles in raising

awareness

about the

potential

impact of the

TRIPS

Agreement on

access to

medicines.

Int. Accelerating Access... 7/01/03, 11:3413

14 ACCELERATING ACCESS

complexity of HIV treatment but addressesthe need to scale up treatment by presentinga framework for selecting the most potentand feasible ARV regimens as part of anexpanded national response. Theframework aims to standardize andsimplify ARV therapy, without comp-romising the quality and outcomes of thetreatment offered, presenting options forfirst and second line regimens that bear inmind that health systems in resource poorsettings often lack sophisticated personneland monitoring facilities. WHO ispromoting the wide acceptance of theseguidelines and adapting them for differentregions. This regional adaptation is ongoing— in South East Asia, the adaptationprocess by SEARO has been completed; in

the Americas, the process by PAHO isalmost complete.

The preparation of these guidelinesprovided an important impetus for theinclusion of 12 ARVs in WHO’s Model Listof Essential Medicines. The Model Listprovides an example from which countriescan develop their own essential medicineslists, according to their priority healthneeds. The inclusion of ARVs in the list willfacilitate their registration in countries byall producers and their procurement bymajor distributors of essential medicines.The list is based on a careful analysis ofcurrent evidence of ARV efficacy indeveloping countries, which shows thatthese medicines can be used effectively andsafely in poor settings.

Int. Accelerating Access... 7/01/03, 11:3414

ACCELERATING ACCESS 15

Lessons LearnedAfter some two years of work on theAccelerating Access Initiative in countries,it has become clear to all partners thatincreasing access to treatment is a dauntingtask that has only just begun. Millions ofpeople will need to gain access to ARVtherapy in the coming years. WHOadvocates that, by 2005, 3 million peopleshould have access to ARVs. A number oflessons have been learned that can furthersupport efforts to scale up access.

First and foremost, access to ARVtherapy is possible in resource poorsettings. Building on the results of theUNAIDS/WHO Drug Access Initiative, theexperience of the Accelerating AccessInitiative has further reinforced thefeasibility of delivering ARV treatment indeveloping countries. A number ofdeveloping countries have committedthemselves to universal access.

Advocacy for access to ARVs facilitatesefforts to introduce comprehensive care forpeople living with HIV/AIDS. For example,Uganda, Côte d’Ivoire and Senegal haveintroduced national policies for preventionof opportunistic infections along with theintroduction of ARVs. National authoritiesoften favour access to ARVs because oftheir dramatic impact on survival and oftenlink other important care interventions toARVs.

Clear and transparent information aboutdrug pricing facilitates the development ofplans for access to care, fosteringpredictability of implementation costs and,in turn, greater specificity in fundraisingefforts.

Countries are committed to scaling uptreatment urgently. At the UNGASS, allUN Member States committed themselves

to expanding access to comprehensivecare, including ARVs. Within theAccelerating Access Initiative, governmentshave waived import tariffs and taxes onHIV medicines and mobilized domesticresources to increase procurement.

Although they have decreasedsignificantly in many cases, the prices ofARVs in developing countries remain toohigh in relation to local purchasing power.Despite the major reductions in ARVprices, the annual cost of ARV treatmentfor a person living with HIV still exceedsthe annual per capita gross domesticproduct of many least developed countries.Thus, procurement of ARVs solely throughdomestic financing remains almostimpossible in many countries. A massiveincrease in international financial supportfor HIV/AIDS care is crucial. While fargreater investments in health and socialservices infrastructure are needed toexpand access to treatment on a massivescale, many countries have underutilizedhealth system capacity that, but for lackof financing and affordability, could beused to expand treatment today.

Broader partnerships are essential toscale up access to care. For example, whenNGOs dealing with HIV/AIDS wereinvolved in the Accelerating AccessInitiative to support treatment prepared-ness, such as in Morocco, the level ofknowledge about and interest in accessingtreatment improved considerably. In manycountries, NGO advocacy has advancedpolitical commitment to treatment. In somecountries, such as Burundi, Côte d’Ivoire,Rwanda and South Africa, employers havesupported treatment access among theirworkforces.

The experience

of the

Accelerating

Access

Initiative has

further

reinforced the

feasibility of

delivering ARV

treatment in

developing

countries.

Int. Accelerating Access... 7/01/03, 11:3415

16 ACCELERATING ACCESS

ConclusionThe Accelerating Access Initiative wasestablished in May 2000 to help increaseaccess to HIV/AIDS care and treatment indeveloping countries.

The Initiative, building on the politicalcommitment of governments, intensetreatment advocacy of civil society andearlier UN initiatives, has helped the worldto move from inertia to action in workingon improving access to HIV care andtreatment in developing countries. It hasencouraged many countries to think aboutand plan for expanded efforts in HIV careand support. It has helped all stakeholdersconcerned with access to HIV/AIDS careand treatment to learn about newpossibilities. It has also catalyzed newefforts – by the countries themselves,international donors, private sectorenterprises, NGOs, and others – to extendcare to more of those living with HIVinfection in the developing world.

As a result of Accelerating Access andrelated efforts, with companies independ-ently entering into discussions withcountries and other purchasers, the pricesof ARV medicines have declinedsignificantly in developing countries in thepast two years. In some cases the prices ofthese medicines have decreased by morethan 90% during this time. These pricereductions have acted as a catalyst instimulating efforts to increase access toARVs in developing countries. Never-

theless, to date few people have been ableto benefit from these price reductions.

While further price reductions will leadto an increase in the number of people onARV therapy, it is clear that significantlyexpanding such access will require workon the other barriers to care and treatmenttoo.

This will require two main approaches:unequivocal and ongoing politicalcommitment from national governments;and greater financial resources fromnational resources and the internationalcommunity (including the new Global Fundto Fight AIDS, TB and Malaria) to fundthe drugs and diagnostics needed, and tostrengthen health infrastructure anddelivery systems in developing countries.In addition, greater engagement of allstakeholders (including people living withHIV/AIDS and the private sector), guid-ance on the rational use of treatment, andcontinued investment in the developmentof improved medicines will be needed.

Clearly, there is still much more workto be done, given the scope of thechallenge. While in absolute terms thenumbers are still small, we have seenencouraging progress in the past two yearsand a steady increase in patients receivingARV treatment through AcceleratingAccess and related initiatives.

This experience offers strong hope forthe future.

We have seen

encouraging

progress in the

past two years

and a steady

increase in

patients

receiving ARV

treatment

through

Accelerating

Access and

related

initiatives.

Int. Accelerating Access... 7/01/03, 11:3416

ACCELERATING ACCESS 17

United Nations General Assembly,Twenty-sixth Special Session, Doc:A/s-26/L.2, adopted 27.06.2001, NewYork.

UNAIDS. Accelerating Access to HIV/AIDS Care, Treatment and Support.Background Paper. September 2001.w w w. u n a i d s . o r g / p u b l i c a t i o n s /d o c u m e n t s / h e a l t h / a c c e s s /AAprogress1001.doc

UNAIDS/WHO. Sources and Prices ofSelected Medicines and Diagnostics forPeople Living with HIV/AIDS, May2002. www.who.int/medicines

WHO. HIV/AIDS Drugs Pre-qualificationPilot Procurement, Quality and SourcingProject: Access to HIV/AIDS Drugs ofAssured Quality. www.who.int/

medicines/organization/qsm/activities/pilotproc/pilotproc.shtml

WHO. Globalization and Access to Drugs:Perspectives on the WTO/TRIPSAgreement. Geneva 1998. WHO/DAP/98.9. www.who.int/medicines

WHO. Scaling Up Access to AntiretroviralTherapy. Guidelines for a Public HealthResponse. Geneva, April 2002.www.who.int/hiv_aids

WHO/UNAIDS. Key Elements in HIV/AIDS Care and Support. Draft WorkingDocument, 8 September 2000.www.who.int/hiv_aids

WHO/WTO. Report of the Workshop onDifferential Pricing and Financing ofEssential Drugs. April 2001, Hosbjor,Norway. www.who.int/medicines

Further Reading

Int. Accelerating Access... 7/01/03, 11:3417

ACCELERATING ACCESS 19

A Joint Statement of IntentBuilding on the work undertaken by theJoint United Nations Programme on HIV/AIDS (UNAIDS), its Cosponsors and otherpartners worldwide in responding to thegrowing demand for care and treatmentof HIV/AIDS-related illnesses indeveloping countries, a new effort is beingundertaken to enhance progressively thecapacity of countries to increase accessto, and use of, sustainable, comprehensiveand quality HIV/AIDS interventionsacross the entire spectrum of prevention,treatment, patient care and support(including prevention of perinataltransmission).

Five pharmaceutical companies —Boehringer Ingelheim GmbH, Bristol-Myers Squibb; Glaxo Wellcome; Merck &Co., Inc.; and F. Hoffmann-La Roche Ltd.— are responding to calls from UNSecretary-General Kofi Annan (inlaunching the International Partnershipagainst AIDS in Africa, in December1999); Dr Gro Harlem Brundtland,Director-General of the World HealthOrganization (in her address to the WHOExecutive Board in January 2000), whereshe invited the pharmaceutical companiesto ‘take a fresh and constructive look athow we can increase access to relevantdrugs’, and to the invitations of Dr PeterPiot, Executive Director of UNAIDS,James D. Wolfensohn, President of theWorld Bank, Carol Bellamy, ExecutiveDirector of the United Nations Children’sFund, and Nafis Sadik, Executive Director,United Nations Population Fund, to theprivate sector to engage in partnerships forexpanding the global response to HIV/AIDS.

Accelerating access to HIV/AIDS careand treatment in developing countries

ANNEX 1

The five companies have begunconstructive discussions with UNAIDS,WHO, the World Bank, the United NationsChildren’s Fund (UNICEF), and the UnitedNations Population Fund (UNFPA) toexplore practical and specific ways ofworking together more closely toaccelerate access to HIV/AIDS-relatedcare and treatment in developing countries.This endeavour is expected to expand toinclude other partners from all sectors.

Participants acknowledge thataffordability of HIV/AIDS-related care andtreatment is an issue in developingcountries — though only one among manyobstacles to access including social/political/structural and economic issues,healthcare financing, physical barriers, andinformation gaps — and are willing towork with committed governments,international organizations and otherstakeholders to find ways to broadenaccess while ensuring rational, affordable,safe and effective use of drugs for HIV/AIDS-related illnesses. The companies,individually, are offering to improvesignificantly access to and availability ofa range of medicines.

Intended to benefit people in developingcountries, this public/private co-operation

■ is designed to accelerate theirsustained access to, and increase theiruse of, appropriate, good qualityinterventions for the prevention,treatment and care of HIV/AIDS-related illnesses, and the preventionof perinatal transmission of HIV.

■ strives to ensure that care andtreatment reach significantly greaternumbers of people in need, throughnew alliances involving committed

Int. Accelerating Access... 7/01/03, 11:3419

20 ACCELERATING ACCESS

governments, private industry, theUN system, development assistanceagencies, non-governmental organ-izations (NGOs) and people livingwith HIV/AIDS.

■ will be implemented in ways thatrespond to the specific needs andrequests of individual countries, withrespect for human rights, equity,transparency and accountability.

The following principles reflect acommon vision of how the HIV/AIDSepidemic can more effectively be tackledin developing countries:

(i) Unequivocal and ongoing politicalcommitment by national governmentsis essential for successful efforts toreduce the impact of HIV/AIDS inline with poverty reduction andbroader development strategies.

(ii) Strengthened national capacity,including well-designed HIV/AIDSprevention and care strategiesand a strengthened health-careinfrastructure, is crucial for deliveringcare and treatment to people withHIV/AIDS on an equitable basis.

(iii) Engagement of all sectors of nationalsociety and the global community –including governments of developingand industrialized donor countries,international NGOs, industry, othersegments of civil society (particularlypeople living with HIV) andmultilateral organizations – is essentialin facilitating access to treatment ofHIV/AIDS-related illnesses.

(iv) Efficient, reliable and securedistribution systems are necessary toensure that medical supplies and otherconsumables procured by the publicsector or NGOs are made available

to people who need them at theappropriate contact points withinhealth systems.

(v) Significant additional funding fromnew national and internationalsources, commensurate with thehealth challenges posed by the HIVepidemic, is necessary for long-termsuccess, so that current health andsocial sector priorities can bemaintained.

(vi) Continued investment in research anddevelopment by the pharmaceuticalindustry on innovative newtreatments for HIV/AIDS and otherdiseases affecting the developingworld – the best hope for new andbetter future medicines and vaccines– is critical to expanding the globalresponse to HIV/AIDS and toadvancing world health. Therefore,intellectual property rights should beprotected, in compliance withinternational agreements, sincesociety depends on them to stimulateinnovation.

This public/private co-operation isintended to increase the proportion ofpeople living with HIV/AIDS in thedeveloping world who have safe, equitable,sustained and affordable access to care andtreatment. As a practical response to thecall for multi-sectoral action in the face ofthis global health challenge, it is animportant step in a longer-term process ofincreasing the access to care of women,men and children in developing countries.It aims to contribute to the InternationalPartnership against AIDS in Africa, as wellas efforts to curb the spread of HIV andmitigate its impact in other continents and,more broadly, to support the internationaldevelopment agenda.

Int. Accelerating Access... 7/01/03, 11:3420

ACCELERATING ACCESS 21

Countries that have expressed interest inAccelerating Access (as of March 2002)

ANNEX 2

Continent Country

Africa Algeria

Angola

Benin

Botswana

Burkina Faso

Burundi

Cameroon

Cap Vert

Central African Republic

Chad

Congo

Côte d’Ivoire

Ethiopia

Gabon

Gambia

Ghana

Guinea

Guinea-Bissau

Kenya

Liberia

Malawi

Mali

Mauritius

Morocco

Niger

Nigeria

Rwanda

Sierra Leone

Senegal

Seychelles

Swaziland

Togo

Tunisia

Uganda

Mozambique, Namibia, Lesotho, South Africa

United Replublic of Tanzania, Zambia, Zimbabwe

Status

Mission being planned

No follow-up yet

Plan completed and supply agreements in place

Planning completed, discussions on supply agreements finalized outside the AAI framework

Plan completed and supply agreements in place

Plan completed and supply agreements in place

Plan completed and supply agreements in place

Planning ongoing supported by ECOWAS

Plan completed, no supply agreements sought by government at this stage

Plan completed, supply agreements partly in place

Plan completed and supply agreements in place

Plan completed and supply agreements in place

Plan completed, no supply agreements sought by government at this stage

Plan completed and supply agreements in place

Plan completed and discussions on supply agreements awaited

Planning ongoing supported by ECOWAS

Plan completed and discussions on supply agreements awaited

Planning ongoing supported by ECOWAS

Plan completed, no supply agreements sought by government at this stage.

Planning ongoing supported by ECOWAS

Plan completed. Discussions on supply agreements ongoing outside the AAI framework

Plan completed and supply agreements in place

No follow-up yet

Plan completed and supply agreements in place

Planning ongoing supported by ECOWAS

Plan completed and discussions on supply agreements awaited

Plan completed and supply agreements in place

Planning ongoing supported by ECOWAS

Plan completed and supply agreements in place

No follow-up yet

Plan completed, no supply agreements sought by government at this stage

Planning ongoing supported by ECOWAS

Plan completed and discussions on supply agreements awaited

Plan completed and supply agreements in place

These countries are members of SADC and have so far not decided whether to start collaboration

with AAI. In some of these countries there is important use of ARVs in the private sector.

Int. Accelerating Access... 7/01/03, 11:3421

22 ACCELERATING ACCESS

Continent Country

Latin America and Caribbean Bahamas

Barbados

Belize

Chile

Costa Rica

Guatemala

El Salvador

Honduras

Jamaica

Mexico

Nicaragua

Panama

Trinidad and Tobago

Venezuela

Antigua and Barbuda, Dominica, Grenada, Guyana, Haiti, Montserrat,

St Kitts and Nevis, St Lucia, St Vincent/Grenadines, Suriname

Europe Georgia

Belarus

Moldavia

Romania

Ukraine

Asia China

Indonesia

Malaysia

Thailand

Viet Nam

Middle East Jordan

Egypt

Oman

Lebanon

Syria

Status

Plan completed and supply agreements in place

Plan completed and supply agreements in place

No follow-up yet

Plan completed and supply agreements in place

No follow-up yet

No follow-up yet

Plan completed and discussions on supply agreements ongoing

Plan completed and supply agreements in place

Plan completed and supply agreements in place

Plan completed and discussions on supplies progressing with some companies

No follow-up yet

No follow-up yet

Plan completed and supply agreements in place

Plan completed and discussions on supply agreements awaited

These countries are members of CARICOM and are planning for access to ARVs on a

regional basis

Planning ongoing

No follow-up yet

Plan completed and opening of discussion on supply agreement awaited

Plan completed and supply agreements in place

Plan completed and discussions on supply agreements ongoing

Planning ongoing

A final decision whether to pursue improving access to ARVs through AAI is pending

A final decision whether to pursue improving access to ARVs through AAI is pending

The Thai government opted to continue its planning outside the AAI framework

Plan completed, no supply agreements sought by government at this stage

Follow-up by EMRO started

Follow-up by EMRO started

Follow-up by EMRO started

Plan completed and discussions on supply agreements awaited

Follow-up by EMRO started

Cont’d

AAI = Accelerating Access Initiative

Int. Accelerating Access... 7/01/03, 11:3422

ACCELERATING ACCESS 23

IntroductionThe Accelerating Access Initiative wasestablished in May 2000 to help increaseaccess to HIV/AIDS care and treatment indeveloping countries. The Initiative is thefirst broad-based public / privatepartnership of its kind. It is a partnershipof five United Nations organizations(UNAIDS Secretariat, WHO, UNICEF, theUN Population Fund and the World Bank)and six research-based pharmaceuticalcompanies (Abbott Laboratories;Boehringer-Ingelheim; Bristol-MyersSquibb; GlaxoSmithKline; F. Hoffmann –La Roche; and Merck & Co., Inc.).

In April 2001, the original fiveAccelerating Access companies, nowjoined by Abbott Laboratories, announcedadditional steps to improve access to HIVand HIV-related medicines and diagnosticsfor poor countries.

The purpose of this interim report is toestimate the number of patients who havebeen treated with ARVs supplied by the sixcompanies in the countries of Africa, thegeographic region most affected by theHIV/AIDS epidemic and the region inwhich early efforts by the Initiative wereconcentrated.

Currently, the only available systematicand reliable data for the companies to useto estimate the number of patients treatedare the quantity of drug units supplied tothe countries. These data, however, areconfidential and cannot be shared betweencompanies. For this reason, AxiosInternational, as a third party withexperience in the area of HIV/AIDS carein the developing world and operatingunder an agreement of confidentiality,

received and analyzed the data from thecompanies and compiled results acrosscompanies.

Method of analysisThe data provided are either in packs,tablets or grams of active substancessupplied each quarter. In addition, manyproducts exist as multiple dosages or packsizes. For the sake of consistency, a singleformula relying on the weight of activedrug is applied to convert the figures intoan estimated patient number for eachquarter.

Once these data are converted into theestimated number of patients for eachproduct per quarter, the data are pooledas follows:

■ It is assumed that all patients take atleast two Nucleoside ReverseTranscriptase Inhibitors (NRTI) andall patients follow the standard dailydosages. It is further assumed thatno patients are taking monotherapy.A proportion of the patients aretaking, in addition to their twoNRTI’s, one Non-Nucleoside ReverseTranscriptase Inhibitor (NNRTI) orone Protease Inhibitor (PI). As it is acommon practice to combine Norvir®(ritonavir) with Crixivan® (indinavirsulfate) or with Invirase® /Fortovase® (saquinavir) the analysistook this aspect into consideration. Thecombination of Norvir as a booster toanother PI was considered as one PI.

■ All NRTI figures for data units (perproduct and per quarter) were addedand pooled and divided by two to

Estimated numbers of African patientson antiretroviral therapy

ANNEX 3

Int. Accelerating Access... 7/01/03, 11:3423

24 ACCELERATING ACCESS

obtain the number of patients on2 NRTI. Countries are divided byregions. For Africa, four regions arecategorized, i.e. North Africa, WestAfrica, Southern Africa and EastAfrica. The assumption is that allpatients are on at least 2 NRTI. Someare on double combinations with2 NRTI only and the others are ontriple combination 2 NRTI + 1 PI orNNRTI. Hence the final figures ofpooled NRTI obtained represent thetotal estimated number of patients onARVs.

■ NNRTI and PI data are then pooledand matched with the NRTI figures.The results are therefore presented perquarter and for the whole of Africaand by region as follows:

– Total estimated number of patientson ARVs = patients on at least2 NRTI.

– Estimated number of patients ondouble combination of 2 NRTI.

– Estimated number of patients ontriple combination including2 NRTI+1 NNRTI; 2 NRTI+1 PI.

Breakdown Q3-00 Q4-00 Q1-01 Q2-01 Q3-01 Q4-01 Q1-02

Double combination 5887 5866 6863 9616 7792 10 864 12 669

Triple combination 3377 5174 8371 12 788 18 751 21 790 22 882

Estimated number of patients 9264 11 040 15 234 22 404 26 543 32 654 35 551

Table A3.1 Africa double and triple combination

Figure A3.1 Africa: Estimated number of patients on at least 2NRTIDouble and Triple Combination Therapies Breakdown

Int. Accelerating Access... 7/01/03, 11:3424

ACCELERATING ACCESS 25

At the end of March 2002, Axiosestimates that the six companies involvedin Accelerating Access supplied treatmentto more than 35 500 people in Africa, afour-fold increase over the past 18 months.In addition, the data show that the

proportion of patients on triplecombination therapy over that periodincreased from one third to nearly twothirds, which indicates a concomit-ant increase in the quality of ARVtreatment.

Figure A3.2 Africa by regionEstimated number of patients on at least 2NRTI

The figures above show that the Eastand West Africa regions had the greatestincrease in the rate of numbers of patientsaccessing ARVs. In addition, results forSouthern Africa reveal an anomalousobservation that the number of patientstreated actually decreased between Q4 ’01

and Q1 ’02. Whether this is due to normalwholesaler/distributor buying patterns (seethe similar observation between Q4 ’00 andQ1 ’01) or to other factors will requirefurther investigation.

Q2 ’02 results will be importantadditions to these trend lines.

Regions Q3-00 Q4-00 Q1-01 Q2-01 Q3-01 Q4-01 Q1-02

West Africa 1554 1094 2778 7032 7632 8189 11 064

Southern Africa 6670 8367 8530 11 512 13 549 17 789 16 396

East Africa 866 895 3438 3093 4714 6195 7614

North Africa 174 684 488 767 648 481 477

Estimated number of patients 9264 11 040 15 234 22 404 26 543 32 654 35 551

Table A3.2 Africa by region

Int. Accelerating Access... 7/01/03, 11:3425

26 ACCELERATING ACCESS

LimitationsThe fact that this analysis was based ondrug units supplied and converted intoestimated patient numbers implies anumber of advantages and limitationscompared to formal country surveys.

■ The data are collected precisely andconsistently as they represent unitssupplied and data sales. The analysis istherefore underpinned by reliable data.

■ The calculated number of patientsrepresents only an estimate of thenumber of patients treated by ARVssupplied by the six companies in theAccelerating Access Initiative. It doesnot represent an estimate of the totalnumber of patients treated in Africaas it does not take into account thepatients treated with ARVs suppliedby other companies.

■ It is unlikely that all patients took theexact recommended daily dosages. It

is equally unlikely that patients tookhigher doses than those recom-mended. Usually the problem isincomplete daily dosage. This meansthat the actual number of patients islikely to be higher than thatcalculated.

■ It is possible that a number of patientsare taking one ARV as monotherapyor a combination of 1 NRTI and 1 PIor other combinations. It is estimatedthat this number is limited. However,this also implies that the actualnumber of patients is likely to behigher than the calculated one.

■ Paediatric use has not been includedin the analysis given the difficulty inestimating infant dosages. Usually,these dosages are by the child’s bodyweight, which requires knowledge ofthe age of the child. The absenceof paediatric treatment from theanalysis does contribute to theunderestimation of the actual numberof patients.

WAF = West Africa

Benin

Burkina Faso

Cameroon

Central African Republic

Congo

Gabon

Gambia

Ghana

Guinea

Ivory Coast

Mali

Niger

Nigeria

Senegal

Sierra Leone

Togo

Definition of the regions

SAF = Southern Africa

Angola

Botswana

Lesotho

Mozambique

Namibia

South Africa

Swaziland

Zambia

Zimbabwe

NAF = Northern Africa

Algeria

Chad

Egypt

Libyan Arab Jamahiriya

Morocco

Tunisia

EAF = East Africa

Burundi

Djibouti

Ethiopia

Kenya

Madagascar

Malawi

Mauritius

Rwanda

Seychelles

United Republic of Tanzania

Uganda

Int. Accelerating Access... 7/01/03, 11:3426

ACCELERATING ACCESS 27

■ It is widely admitted that a substantialproportion of patients (20–40%) doesnot regularly take the medications dueto a variety of factors (e.g. drug“holidays”, structured therapyinterruptions, non-adherence toprescribed drug regimens). Thisimplies that the actual number ofpatients is possibly substantiallyhigher than the calculated one.

■ Commonly, a proportion of the drugssupplied does not actually get to thepatients and is wasted either duringdistribution or when the patientsswitch to another combinationtherapy. The estimated number ofpatients does not take into accountthis fact and tends to overestimate theactual number of patients.

■ It is also assumed that a proportionof the amount of drugs sold into acountry simply acts to fill thedistribution pipeline in that country.It is further assumed that thisproportion is roughly equal fromquarter to quarter and, therefore, theincreases seen in estimated numbersof patients on therapy from quarterto quarter are due to actual increasesin the estimated numbers of patientsaccessing therapy.

ConclusionMore than half of the countries involvedin the Accelerating Access Initiative are inAfrica, which provides an importantexample of how this Initiative hascatalyzed efforts to extend HIV care,treatment and support. According to thedata in this interim report – compiled on

behalf of the six companies involved inAccelerating Access – which are consistentwith UN figures, more than 35 500 peoplein Africa were being treated with ARVssupplied by the six companies by the endof March 2002, a four-fold increase in 18months. In addition, the data show thatthe proportion of patients on triplecombination therapy over that periodincreased from one third to nearly twothirds, which indicates a concomitantincrease in the quality of ARV treatment.

Even if the estimated numbers in thisinterim report do not exactly represent thetotal number of patients treated withARVs in Africa, they do provide relevantinformation on:

■ the trends in the quality of treatmentprovided, and

■ the substantial increase in the patientnumbers since the AcceleratingAccess Initiative was launched.

Given that most of the limitations implythat the actual number of patients is higherthan the number calculated in this analysis,it is safe to consider that the numbersconstitute a conservative estimate of thepatients actually treated with ARVssupplied by the six companies in theAccelerating Access Initiative. A 20–50%increase in the calculated number wouldlikely be closer to the real figure

Clearly, there is still much more workto be done, given the scope of thechallenge. While in absolute terms thenumbers are still small, we have seenencouraging progress in the past 18 monthsand a steady increase in patients receivingARV treatment in Africa throughAccelerating Access and related initiatives.

Int. Accelerating Access... 7/01/03, 11:3427

ND: no

disc

ussio

n; S:

syrup

formu

lation

disc

ussed;

no a

dult

formu

lation

sup

plied

; IP: in

prog

ress;

NA:

no p

rice

avail

able; B

lank

cell:

no s

upply

agreeme

nt u

nder t

he A

ccele

ratin

g Access

Initia

tive

for t

his d

rug

in this

coun

try o

n record. (1)

These

drug

s are

billed

in

Swiss

Francs.

In this

table

the

excha

nge

rate

used

is

1.7 S

wiss

Fran

cs to t

he U

S$; (2)

The

hard g

el for

mulat

ion o

f SQ

V shou

ld be

used

only

in comb

inatio

n with r

itona

vir a

s bo

oster

drug

(100

0mg/10

0 mg

BID).

The

price

of riton

avir

is no

t inc

luded

in

the

price

quo

ted; (3)

Clinic

al stu

dies

indica

te that,

when

used

with r

itonavir

as

booster

drug,

the

dose o

f ind

inavir

can

be

decre

ased

to

2*80

0 mg

; (4) W

hen

used

with

rito

navir

as

booster

drug

the

dose o

f saqu

inavir

can

be

redu

ced

to 2

*100

0 mg

or

1*16

00 m

g; (5)

This

price

includ

es a

volu

me-driv

en d

iscou

nt; (

6) N

ot y

et reg

istered

— r

egistratio

n on

going

; (7) S

ource

: Sou

rces

and

price

s of

selec

ted d

rugs a

nd d

iagno

stics

for p

eople

living

with

HIV/

AIDS.

UNICE

F, UN

AIDS

secre

taria

t, WHO

, MSF, G

eneva,

May

2002

. Whil

e some

drugs includ

ed in

this

row

have b

een

pre-q

ualifi

ed b

y WHO

, the

qua

lity

of the

prod

ucts

mention

ed h

ere

has

not

necessa

rily

been

evalua

ted; (8)

Price

for 2

*100

mg

riton

avir, a

s bo

oster

of othe

r protease inh

ibitors.

Pric

es o

f ARV

s (U

S$/d

ay)

in t

he A

ccel

erat

ing

Acce

ss Ini

tiat

ive

This

table

con

tains

infor

matio

n ab

out ad

ult fo

rmula

tions a

nd d

osages o

nly

ANNE

X 4

Sub-Saha

ran Afr

ica

Chile

Moroc

co

Barbad

os

Jamaic

a

Trinid

ad and

Toba

go

Hond

uras

Roma

nia

Ukraine

Media

n price

offe

red by

gen

eric

industry

(FOB

)*

1.60 CIF

1.60

1.60

1.60

1.60

1.60

7.30

2.22

0.9

0.64 CIF

0.64

0.64

0.64

0.64

0.64

1.66

S 3.20

0.46

2.00 CIF

2.00

2.00

2.00

2.00

2.00

2.60

S 2.00 (5)

1.38

3.80 CIF

6.60

ND (6)

3.96

ND 3.96

ND 6.80

ND NA

6.60 CIF

9.30

ND (6)

ND ND ND ND 15.0

ND NA

8.70 CIF

9.60

ND (6)

ND ND ND ND 14.8

ND NA

0.85 (2) D

DU

2.37

0.85 DD

U

1.25 DD

U

0.85 DD

U

0.85 DD

U

0.85 DD

U

4.8 (5

)

IP 1.12

0.15 (2) D

DU

3.29

0.75 DD

U

1.00 DD

U

0.75 DD

U

0.75 DD

U

0.75 DD

U

5.2 (5

)

IP 0.20

0.44 CIF

NA

1.37 CIF

5.18

2.52

IP IP IP IP 1.37

IP 1.55

1.20 CIF

2.47

1.20

1.20

1.20

1.20

1.20

1.58

IP 0.54

0.23 (8) F

OB

NA

1.37 FO

B

NA

1.64 CIF

4.6 2.82

IP IP IP IP 1.64

IP 2.40

2.35 CIF

4.80

6.62 CIF

NA

6.47 (5) C

IF

8.2

ZDV—

600 m

g/d 3TC—

300 m

g/d ZDV/3

TC—2/d AB

C—600 m

g/d ZDV/3

TC/ABC—

2/d

AMP—

2400mg

/d

ddI—

400 m

g/d

d4T—

80 mg/d

ddC (

1)—2.2

5 mg/d

EFV—

600 m

g/d NVP—

200 m

g/d RTV—

200 m

g/d

LPV/R

—6/d

IND—

2400 m

g/d (3

)

SQV H

ard Gel (1)

—2000mg

/d (with RTV)

(2)SQV S

oft Gel (1)

—3600mg

/d (4)

NFV (

1)—2500mg

/d

Int. Accelerating Access... 7/01/03, 11:3428

Offe

rs for

ant

iret

rovi

ral dr

ugs

by p

ropr

ieta

ry c

ompa

nies

for

dev

elop

ing

coun

trie

sAN

NEX

5

Com

men

t

The price

of r

itonavir

is give

n for

its use as b

ooste

r drug

to

be u

sed

with ano

ther protea

se in

hibito

r. No

adju

stmen

t to the do

se and

cost

of othe

r protea

se in

hibito

rs ha

s been ma

de. A

s of 3

May 200

2orga

nization

s in the fol

lowing

cou

ntrie

s have accesse

d lop

inavir

and

riton

avir

at re

duced price

s: Alg

eria,

Ben

in, Botsw

ana,

Burund

i,Camb

odia,

Cam

eroon

, Côte d

’Ivoir

e, Djito

uti, Ga

bon,

Haiti, K

enya,

Mauritius, N

amibi

a, Rw

anda

, Senegal, Si

erra Leon

e, South Afr

ica, T

unisia,

Ugan

da, Z

imba

bwe

Nevir

apine

is availa

ble also

free of c

harge specific

ally for

use in

the

preven

tion of

mother-to

-child

tran

smiss

ion th

roug

h the V

iramu

neDo

natio

n Prog

ramm

e (ww

w.vir

amun

e-don

ation

-program

.org)

As of M

ay 15,

2002

, the

pub

lic se

ctor i

n Sene

gal, Be

nin, Ivory Coa

st,Rw

anda

, Gab

on, C

had,

Repu

blic o

f Con

go, M

ali, C

ameroo

n, Togo

, Burun

di,Gu

inea an

d Bu

rkina

Faso ha

ve availed

them

selve

s of

this

offer.

Nume

rous organ

izatio

ns in

the priva

te secto

r (inc

luding

NGO

s,comm

unities of fait

h, priva

te em

ployers,

retail ph

arma

cies)

inBo

tswan

a, Kenya,

Lesotho,

Malaw

i, Mo

zamb

ique,

Nami

bia, S

outh Africa,

Swazila

nd, U

gand

a, Un

ited

Repu

blic of

Tanzan

ia, Zam

bia a

ndZim

babw

e ha

ve a

lso availed

them

selve

s of

this

offer

As of J

une 20

02, s

ome 95

arra

ngem

ents

have been conclud

ed co

verin

g31

cou

ntrie

s for th

e supp

ly of

prefe

rential

ly price

d AR

Vs. T

he cou

ntrie

sare B

arba

dos,

Benin

, Botsw

ana,

Burkina

Faso,

Burund

i, Came

roon

,Central A

frican Re

publi

c, Ch

ad, C

ongo

(Brazza

ville)

, Chil

e, Eritrea,

Gabo

n, Gu

inea (Co

nakry),

Hait

i, Ho

nduras, Ivory

Coast, Jam

aica,

Kenya,

Mali,

Morocco

, Nam

ibia,

Nigeria

, Rom

ania, Rwa

nda,

Senegal, South Afr

ica,

Tanzan

ia, Togo,

Trinid

ad and

Tob

ago,

Ugan

da, U

krain

e an

d Un

ited

Repu

blic of

Tanzan

ia

Elig

ible

org

aniz

atio

ns

Governme

nts,

NGOs

, UN

syste

m orga

nization

s, an

dothe

r nation

al an

d int

erna

tiona

l health

institutio

ns

In sub-Saha

ran Afr

ican coun

tries and

other co

untries

identifie

d as lo

w-inc

ome in

the W

orld

Bank

Classi

fication

of E

cono

mies, b

oth priva

te an

d pu

blic

secto

r orga

nisation

s that are able

to p

rovid

e eff

ectiv

e,susta

inable

and

med

ically so

und care and

treatm

ent o

fHIV/AID

S are elig

ible

Both p

rivate an

d pu

blic secto

r orga

nisation

s that are

able

to provid

e eff

ectiv

e, susta

inable

and

med

ically

soun

d care and

treatm

ent o

f HIV/

AIDS are eligib

le

Governme

nts,

aid organ

izatio

ns, c

harities

, intern

ation

alan

d UN

agencies

and

inter

natio

nal p

urchase fun

ds. In

sub-Saha

ran Afr

ica, t

he offe

r is o

nly availa

ble to

emplo

yers

who

can

deliver care an

d tre

atme

nt d

irectl

yto th

eir st

aff.

All organ

izatio

ns m

ust s

upply

the

prefe

rential

ly price

d prod

ucts

on a not fo

r profit basis

Pric

e pe

r da

y in

US$

(FOB/

CIF/

DDU)

(DDD

)

0.23 (FO

B)(2*1

00mg

)1.3

7 (FO

B)(2*3

caps)

1.20 (CI

F)(2*2

00 m

g)

0.85 (DDU

)(4*1

00 m

g)0.1

5 (DDU

)(2*4

0 mg

)

3.80 (CI

F)(2*3

00 m

g)0.6

4 (CI

F)(2*1

50 m

g)1.6

0 (CI

F)(2*3

00 m

g)2.0

0 (CIF)

(2*1

tabl)

6.60 (CIF)

(2*1

tabl)

Coun

trie

s ta

rget

ed

Africa

plus

Afgh

anistan

, Ban

glade

sh, B

hutan,

Camb

odia, C

ape V

erde

, Hait

i, Kir

ibati,

Lao

Peop

le’s

Demo

cratic Repub

lic, M

aldive

s, My

anma

r, Ne

pal,

Samo

a, Solom

on Is

lands, T

uvalu

, Van

uatu, Yem

en

Sub-Saha

ran Afr

ica plus

other co

untries id

entified

as lo

w-inc

ome in

the W

orld

Bank

Clas

sifica

tion of

Econ

omies

. For co

untries id

entified

as l

ower-

midd

le an

d up

per-m

iddle

incom

e in

the W

orld

Bank

Clas

sifica

tion of

Econ

omies

, pub

lic se

ctor

price

s are ne

gotia

ted on a case-by case basis,

bilaterall

y or th

roug

h the AA

I

Lowe

st price

for s

ub-Sa

haran Afr

icaDe

velop

ing co

untries outsid

e of

sub-Saha

ran Afr

icane

ed to

disc

uss p

rices on a case-by-c

are ba

sis

Least De

velop

ed C

ountrie

s (LD

Cs) plu

s sub-

Saha

ran Afr

icaFo

r midd

le inc

ome de

velop

ing co

untries pub

licsecto

r price

s are ne

gotia

ted o

n a case-by-c

ase

basis

, bila

terall

y or th

roug

h the AA

I

Prod

ucts

riton

avir

lopina

vir/ri

tona

vir

nevir

apine

didan

osine

stavudin

e

abacavir

lamivu

dine

zidovud

inelam

ivudin

e/zid

ovud

ineab

acavir/

lamivu

dine/zid

ovud

ine

Com

pany

Abbo

tt

Boeh

ringer I

ngelh

eim

Bristol-

Myers S

quibb

GlaxoSmi

th-Klin

e

Int. Accelerating Access... 7/01/03, 11:3429

Com

men

t

Clinic

al stu

dies s

uggest

that w

hen used

with

ritona

vir as b

ooste

r drug,

the do

se of ind

inavir

can

be de

creased

to 2*8

00 m

g

Roma

nia also

ben

efits

from

the low

HDI pric

es as a

n exception

, in

respon

se to

the Go

vernme

nt’s

comm

itmen

t to

provide

univ

ersal

coverage to

all pa

tients (m

ostly

chil

dren

) who

req

uire AR

Vtherap

y

Price

s are in

Swiss

Francs (CHF

) and

were converted

in U

S$ u

sing an

exchan

ge rate of

1.7 CHF

to th

e US

$. Whe

n used

with

rito

navir

as

booster

drug the do

se of s

aquin

avir

(soft

gel c

aps)

can

be red

uced

to2*

1000

mg or 1*1

600 mg

The ne

lfinavir

table

t pric

e inc

ludes a volu

me driv

en disc

ount

Nelfin

avir

table

t pric

e inc

ludes volu

me driv

en disc

ount

Elig

ible

org

aniz

atio

ns

Governme

nts,

interna

tiona

l organ

izatio

ns, N

GOs,

priva

tesecto

r organ

izatio

ns (e

.g., e

mploy

ers,

hospita

ls an

dins

urers

).Me

rck &

Co.,

Inc.

does not ru

le ou

t sup

plying

ARV

s to

patie

nts t

hrou

gh re

tail ph

arma

cies

Governme

nts,

NGOs

, priv

ate secto

r emp

loyers

Pric

e pe

r da

y in

US$

(FOB/

CIF/

DDU)

(DDD

)

1.64 (CI

F)(6*4

00 m

g)

2.82 (CI

F)(6*4

00 m

g)

1.37 (CI

F)(3*2

00 m

g)

2.52 (CI

F)(3*2

00 m

g)

2.35 (CI

F)(2*1

000 mg

to be comb

ined with

2*10

0 mg

RTV))

6.62 (CI

F)(3*1

200 mg

)6.4

7 (CI

F)(2*1

250 mg

)0.4

4 (CI

F)(3*0

.75 m

g)

Coun

trie

s ta

rget

ed

Low

HDI c

ountrie

s plus

med

ium H

DIcoun

tries w

ith adu

lt HIV prevale

nce of

1% or

grea

ter

Mediu

m HD

I cou

ntrie

s with

adu

lt HIV prevale

nce

less t

han 1%

Low

Huma

n De

velop

ment In

dex (HDI) c

ountrie

splu

s med

ium H

DI cou

ntrie

s with

adu

lt HIV

prevale

nce of

1% o

r greater

Mediu

m HD

I cou

ntrie

s with

adu

lt HIV prevale

nce

less t

han 1%

LDCs plus

sub-Saha

ran Afr

ica

Prod

ucts

indina

vir

efavir

enz

saqu

inavir

(hard gel c

aps)

saqu

inavir

(soft

gel

caps)

nelfin

avir

zalcitab

ine

Com

pany

Merck

Roche

Cont

’d

AAI:

Acceler

ating

Access

Initia

tive

FOB:

Free

on B

oard (

supp

lied

in ship

or a

ircraft), price

does

not

includ

e tra

nspo

rt or insuran

ce o

r cle

aran

ce c

harges t

o an

d in

the

coun

try o

f de

stina

tion

CIF:

Cost,

Insuran

ce, F

reigh

t. P

rice

includ

es t

ranspo

rt an

d ins

uran

ce t

o coun

try o

f bu

yer,

but

exclu

des

clearan

ce c

harges, i

mport

tax,

VAT

or s

ales

tax,

and

transpo

rt within

the

coun

try o

f the

buyer

DDU:

Delivered

to D

oor

of User: p

rice

includ

es a

ll costs

of

good

s, fre

ight,

insuran

ce, cle

aran

ce c

harges a

nd t

axes

HDI:

Hum

an D

evelo

pmen

t Ind

ex, in

scale

publi

shed

in

the

annu

al Hu

man

Develop

ment R

eport

by

the

Unite

d Na

tions D

evelo

pmen

t Prog

ram

(UND

P) t

o assess

the

develop

ment s

tatus

of coun

tries

LDCs

: Least

develop

ed c

ountrie

s, according

to

UNCTAD

NGO:

Nong

overnm

ental

orga

nization

Int. Accelerating Access... 7/01/03, 11:3430