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10th Edition
July 20072 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

Table of Contents

3

Table of contents

5

Background11

Methodology

Product Cards

Single products

12

How to read the product cards

13

ABACAVIR (ABC)14

ATAZANAVIR (ATZ)

15

DIDANOSINE (ddl)

16

EFAVIRENZ (EFV)

17

EMTRICITABINE (FTC)18

INDINAVIR (IDV)19

LAMIVUDINE (3TC)

20

NELFINAVIR (NFV)

21

NEVIRAPINE (NVP)

22

RITONAVIR (r or RTV)

23

SAQUINAVIR (SQV)24

STAVUDINE (d4T)

25

TENOFOVIR DISOPROXIL FUMARATE (TDF)

26

ZIDOVUDINE (AZT, ZDV)27ABACAVIR/LAMIVUDINE (ABC/3TC)

28

LAMIVUDINE/STAVUDINE (3TC/d4T)

29

LOPINAVIR/RITONAVIR (LPV/r)30

TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE (TDF/FTC)

31

TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE (TDF/3TC)

32

ZIDOVUDINE/LAMIVUDINE (AZT/3TC)

Double fixed-dose combinations

Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions • 3

33

LAMIVUDINE/STAVUDINE/NEVIRAPINE (3TC/d4T/NVP)

34

TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE/EFAVIRENZ (TDF/FTC/EFV)35

TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE/EFAVIRENZ (TDF/3TC/EFV)

36

ZIDOVUDINE/LAMIVUDINE/ABACAVIR (AZT/3TC/ABC)37

ZIDOVUDINE/LAMIVUDINE/NEVIRAPINE (AZT/3TC/NVP)

Double fixed-dose combinations

38

LAMIVUDINE/STAVUDINE + EFAVIRENZ (3TC/d4T+EFV)

in co-blister

38

ZIDOVUDINE/LAMIVUDINE + EFAVIRENZ (3TC/AZT+EFV)

39

PMTCT: NEVITAPINE + ZIDOVUDINE (NVP+AZT)

40

Table 2: Conditions of offer by company

43

Table 3: Summary of prices in US$ quoted by companies for eligible developing countries

Triple fixed-dose combinations

Annexes47

Annex 1: Least developed countries (LDCs)

47

Annex 2: Human Development Index (HDI)

47

Annex 3: Sub-Saharan countries

48

Annex 4: World Bank classification of economies

48

Annex 5: Bristol-Myers Squibb eligible countries

48

Annex 6: Abbott eligible countries

49

Annex 7: Gilead eligible countries

49

Annex 8: Suggested resources for further information

50

Annex 9: Company contacts

52

Annex 10: The Clinton Foundation ARV list

55

Notes and References

56

Glossary

4 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

BACKGROUNDThis is the tenth edition of Untangling
the web of price reductions: a pricing
guide for the purchase of ARVs fordeveloping countries. The report was
first published by Médecins Sans
Frontières (MSF) in October 2001[1] in
response to the lack of transparent andreliable information about prices ofpharmaceutical products on theinternational market – a factor which
continues to significantly hamper accessto essential medicines in developing
countries.
The purpose of this document is toprovide information on prices andsuppliers that will help purchasers
make informed decisions when buying
antiretrovirals (ARVs). This report is apricing guide and does not include
detailed information about the qualityof the products listed. For further
information on quality, please see box 1.
Since the first edition of “Untangling,”
prices of some ARVs have fallen
significantly, mainly due to competition
between multiple producers. However,
MSF finds that there are still common
problems affecting the availability of themost needed essential medicines forboth adults and children. These include:(1) that in the absence of competitionBox 1: Quality issues
This report is a pricing guide and does not include detailed information about thequality of the products listed. However, price should not be the only factor
determining procurement decisions. Readers and purchasers wishing to obtain
more information about drug quality are therefore encouraged to consult“Prequalification programme manufacturers and suppliers whose HIV-related
medicines have been found acceptable, in principle, for procurement by UN
agencies,” (known as the WHO prequalification list), a project initiated by theWorld Health Organization (WHO) and developed in collaboration with other
United Nations organisations. This project evaluates pharmaceutical manufacturers
and products according to WHO recommended standards of quality andcompliance with Good Manufacturing Practices. It is part of an ongoing processthat will expand as the participation of suppliers increases. Not all the products
listed in this report have been prequalified by WHO, and only some of them areused by MSF in its own projects. Products included in the last edition of the WHO
prequalification list (Revised 55th edition, published 22 June 2007) appear in boldin the tables. Please consult the WHO website (http://mednet3.who.int/prequal/)
for the latest list of prequalified products and for information on the status ofdossier assessment.
from multiple producers, companies
may charge prohibitive prices, (2) that
there are considerable limitations andproblems linked to differential prices,and (3) that in the particular case of
paediatric ARVs, the lack of an
attractive pharmaceutical market andthe slow process in the preparation ofstandardized guidelines for treatment
has led to the fact that many adapted
formulations continue to be lacking.
These problems are particularly pressingin the case of the most recent ARVs,

1WHO guidelines state “FTC is an equivalent alternative to 3TC as it is structurally related to 3TC, shares the same efficacy against HIV and Hepatitis B
virus and has the same resistance profile” [2]2 Clinton foundation has negotiated a price of US$ 339 ppy for the FDC TDF/3TC/EFV (Annex 10)
3 At time of publication, standardized regime is going to press

including those recommended in the2006 WHO treatment guidelines[2] forboth first- and second-line.
New WHO treatment guidelines andtheir impact on price
Whereas most of the regimens
previously recommended included
stavudine (d4T) or zidovudine (AZT), the2006 WHO treatment guidelines haveadded an improved first-line treatment
based on combinations including
Abacavir (ABC) and tenofovir disoproxil
fumarate (TDF) as new NRTI options.
TDF is now becoming an emerging
preferred first-line option because of its

toxicity profile and increased availability
in developing countries (including as
FDC). It should be administered in
combination with two drugs – one
being either lamivudine (3TC) or
emtricitabine (FTC)1, the other being
either efavirenz (EFV) or nevirapine(NVP).
The improved first-line regimen
therefore represents only a change in
one drug – replacing d4T or AZT with
TDF. But using such an improved
first-line, based on TDF+ 3TC+NVP,
would increase the annual cost oftreating an adult for one year in adeveloping country from US$ 99 (withthe triple FDC of 3TC /d4T/NVP) to
US$ 426 in the best case2.
In 2007, a technical consultation wasconvened by WHO in order to propose
simplified treatment protocols anddevelop standardised second-line
regimens based on the options
currently recommended in 2006 ART
guidelines3. In the case of failure to thed4T- or AZT-based first-line of treatment,
the preferred recommended second-line
regimens are now TDF + 3TC + heatstable protease inhibitor (lopinavir/
ritonavir (LPV/r) or atazanavir/ritonavir(ATZ/r)) or ABC + ddI + heat stable
protease inhibitor (LPV/r or ATZ/r).
However, if TDF or ABC has been usedin the first-line regimen, AZT + 3TC +Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions • 5

Graph 1: Sample of ARV triple-combination: stavudine (d4T) + lamivudine (3TC) +nevirapine (NVP). Lowest prices per patient per year. Improved first line: tenofovir (TDF) +emtricitabine (FTC) + efavirenz (EFV)

Originator middle-income countries(US$1,033)

1000US$
800US$

Originator low-income countries(US$613)600US$
400US$
200US$

Generic best price (US$487)

0
Dec 03

Jan 04

Jun 04

Jun 05

Jun 06

Generic best price US$99
Lowest Originator $727

8000US$

Brazil $2767

Lowest Originator $343
Cipla $132

Aurobindo $209

Jun
01

Mar
01

Oct
01

Jun
02

Dec
02

May
03

Ranbaxy $99

Hetero $168

Hetero $201

200oUS$

Jun
00

Lowest Originator $556

Cipla $350

4000US$

0Price negotiated by Clinton
Foundation (US$385)

Lowest Originator $10439

10000US$

6000US$

Jun 07

TDF/FTC/EFV
improved 1st-line

3TC/d4T/NVP

12000US$Jun 07

Dec
03

Apr
04

Feb
05

Jun
06

Jul
06

Jun
07

6 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

heat-stable protease inhibitor (LPV/r or
ATV/r) was considered as the mostsuitable 2nd line combination.
The establishment of simplified andstandardised second-line guidelines
represents a major breakthrough as it
gives a clear message to manufacturers
to focus on developing a relatively
small range of products. This is
expected to have an impact on theprice. However, contrary to 3TC and AZT,
boosted protease inhibitors are underpatent in most countries and therefore
priced significantly higher because of alack of competition.

(1) ARVS AND COMPETITION: THE
RETURN OF THE PRICE CRISIS?
Competition among multiple
manufacturers is the main factor thathas made prices of older ARVs comedown. Treating an adult patient for one
year with a triple antiretroviral first-line
regimen may now be as low as US$
99. Such reduced prices were anecessary prerequisite for the scaling
up of AIDS treatment to the levels we
see today. Graph 1 provides a good
illustration of how prices charged byoriginator manufacturers fall ascompetitors enter the market.
However, the improved first-line andsecond-line regimens now

Graph 2: The chart shows how WHO recommendations impact price. The standardizationof second-line contributes to the decrease in price as compared to last year; second-line
in LDCs ranged from US$700 to 1,200 depending on the regimen used and over
US$5,000 in non-LDCs. Another reason for the drop in prices of second-line is the
reduction of the price of LPV/r (see chart 3). However, the use of an improved first-line
significantly increases the price.
Ist line: 3TDF/3TC/EFV (improved 1st line)
2nd line: AZT/3TC+LPV/r

Ist line: 3TC/d4T/NVP
2nd line: TDF/3TC+LPV/r$1,426x14$926$1,134

x2.6

x1.5

$634

$426

x9

$99

Ist line:

2nd line (LDCs)

2nd line (Non-LDCs)

Ist line:

2nd line (LDCs)

2nd line (Non-LDCs)

recommended by WHO include newer
drugs that are more expensive, as few
generic competitors exist and demandis still low. There is therefore a serious
risk that the price crisis seen five years
ago, with life-saving ARVs priced out ofreach of those in need, is set to return.
A closer look at Graph 1 shows how
the move towards improved first-line asrecommended by WHO may havedrastic consequences in terms of pricesthat must be addressed.
Patent barriers
The main reason why competition was
possible for older ARV products is that
there were no patents in developing
countries with pharmaceuticalproduction capacity, such as Brazil,
India or Thailand. This is no longer thecase. Although Least Developed
Countries (LDCs) are not obliged under
the World Trade Organization (WTO)
rules enshrined in the 2001 Doha
Declaration to grant or enforce
pharmaceutical product patents until atleast 2016, other developing countries
saw this transition period end in
January 2005[5]. This includes countries
with significant manufacturing capacity,such as India, a major source of WHO
prequalified generic ARVs, which wererequired to introduce new
pharmaceutical patent legislation inorder to comply with WTO rules. It is
crucial to note that changes in patentlaws in countries with manufacturing
capacity also affect other countries that
depend on imports from thesecountries.
The new 2005 Indian Patents Act does
not affect medicines that were invented
before 1995. However, patentapplications could be filed in India
from 1995 onwards. The Indian patentoffices have started to examine
thousands of pending patentapplications, and patents on key AIDS
medicines may be granted.
If a patent were granted for a medicine
for which generic versions wereavailable before January 2005, it would
not stop Indian generic manufacturers
who already produce from continuing
to market the medicine, provided they
have made a “significant investment.”Indeed, the 2005 Indian Patents Act
stipulates an automatic licensing
system, which allows for the continued
production of the generic version upon
payment of a “reasonable” royalty.
If a patent were granted for a
medicine, but no generic version wasmarketed before 2005, only patent
holders would have the right toproduce this medicine, unless India,
and other countries where the drug isunder patent, make use of theflexibilities enshrined in the Doha

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 7

Graph 3: Prices for lopinavir/ritonavir offered to Thailand and other middle-income
countries. MOPH, Ministry of Public Health; CL (compulsory license. Note: In May 2007,
the Thai MOPH was still paying the price for LPV/r offered by Abbott in August 2006.
Later offers by Abbott had conditions unacceptable to the Thai MOPH (no further pricereduction and withdrawal of CL).Ford N, Wilson D, Costa Chaves G, Lotrowska M,
Kijtiwatchakul K. Sustaining access to antiretroviral therapy in developing countries:
lessons from Brazil and Thailand. AIDS 2007. 21;4:S21-S29.
2004-06: Price paid
by MSF in Thailand
2004-06: Best Abbott
offer to Thai MOPH
4500
4000

Aug 06: Abbott offer to middle-income
countries under acivist pressure$US per patient per year

3500
3000

Feb 07: Lowest generic priceoffered to Thai MOPH after CL

2500
2000
1500
1000

March 07: Abbott offer toThai MOPH if CL dropped
May 2007: Pooled
procurement price500
0Declaration on the Agreement on TradeRelated Aspects of Intellectual Property
Rights (TRIPS) and Public Health. They
could, for example, authorise
governmental use or issue compulsory
licenses, thereby giving a third party
the right to produce, market, export
and import generic versions of thepatented product. This is the case in
Thailand, which issued compulsory
licenses for three medicines, including
the AIDS drugs EFV and LPV/r in
November 2006 and January 2007,
respectively, and Brazil, which did thesame for EFV in May 2007. Under thepressure of these measures, companies

Box 2: Limiting the scope of patentability
On a more positive note, the 2005 India Patents Act includes key provisions
to ensure that patents are not used to artificially extend monopolies on
medicines at the expense of the public. First, Section 3(d) of the law statesthat patents should not be granted on derivatives of known molecules,
such as salts, polymorphs or combinations, unless efficacy is improved.
Second, in order to make sure that patents are not unduly granted, third
parties can seek to oppose a patent before it is granted, on the basis ofsuch provisions[4]. However, the Swiss pharmaceutical company Novartis
undertook a legal challenge to Section 3(d) of India's Patents Act in theHigh Court in Chennai after one of its patent applications was rejected on
the basis of this provision. 400,000 people worldwide have urged Novartis
to drop the case because of the devastating consequences Novartis's action
could have on access to medicines across the developing world [45]. At thetime of going to press, a ruling was pending.

typically reduce prices of their drugs(See graph 3).
Therefore, the situation for new drugs,
such as second-line ARVs and improved
first line is about to change radically.
Faced with the emergence of resistanceand the arrival of improved productson the market, the new WHO
guidelines include newer ARVs for both
first- and second-line treatment for
which competition, if any, would be
limited. In the absence of competition,
the price of treatment based on thesenewer ARVs is currently extremely high(see graph 2). This is true for boththose therapies recently introduced in
wealthier countries and for any future

8 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

drugs that are still in research anddevelopment – all of which are needed
to tackle the epidemic in developing
countries, too. Unless the price crisis
can be resolved, however, it is unclear
how these recent or newer drugs canbe made available at sustainable andaffordable prices in the developingworld.
(2) THE LIMITATIONS OF COMPANY
DIFFERENTIAL PRICING SCHEMESWhen originator companies apply
discounted prices on ARVs, each hasdifferent eligibility criteria, which is aconsiderable source of confusion forpurchasers.

3000
2500
2000
1500
1000
500
0
3TC NVP

average ori

d4T

AZT ABC TDF

average gen

no. of WHO prequalified
generics

8
7
6
5
4
3
2
1
0
ATV LPV/r LPV/rsgc
tab

no. of WHO prequalified generics

Graph 4: This chart shows real transaction prices as reported by the GPRM from January
2006 to June 2007. It shows that for more recent ARVs, competition is very limited. As aresult, the lowest price offered by the originator remains high, as do generic prices.
Moreover, there are still no generic versions prequalified by WHO for some of the newest
ARVs, limiting demand. In the case of older ARVs for which generic competition is muchless restricted, prices have dropped much lower and price offers by originators more orless match generic prices.(LPV/r sgc: old formulation that requires refrigeration. LPV/r tab:
new tablet form that does not require refrigeration).

Companies' price offers can vary overtime as a result of generic competitionor public pressure. When a competitor
enters the market, originatorcompanies usually drop prices to levels
slightly above the prices offered bygeneric manufacturers. The graph 4
illustrates this case:
Although some patients benefit fromdifferential prices, prices for new drugs
are still too high, mainly because there
is no or not enough competition. In theabsence of competition, prices of new

drugs will never drop to the level offirst-line drugs. Insufficient genericcompetition for newer drugs can be
explained by a number of factors:■ The market for these products is still
relatively small;■ Until now, the lack of a standardised
second-line regimen means the market
is fragmented, making it difficult for
generic companies to make choices as
to which products to prioritise;■ Patents are pending in India and inmany cases have already been granted
in other emerging economies withproduction capacity such as Brazil,
Thailand, China. Even if some of thesepatents are not granted in India,
generic manufacturers are hesitant toinvest in the development of several ofthese new products.
■ Even if several of these patents are
not granted in India and clear recommendations are made for specific products,
experience has shown that it takes atleast two to three years for a genericmanufacturer to produce and several
more years for prices to come down.
A typical example is Abacavir, (seeGraph 5) a drug that has a patentpending in India and for which genericproductions began slowly. In the
beginning, these generic versions weremore expensive than the originator

ABC 300mg

2500

generic pricelowest originator
price

3000

US $ ppy

Certain manufacturers (such as Merck,
Roche and Abbott) also offer second
category prices for some middleincome countries. These are almost
twice as high as the first category
prices. Also, Bristol-Myers Squibb (BMS)
places all southern African countries in
its second category prices, including
countries as poor as Mozambique andothers with the highest prevalence
rates in Africa.

3500

US$/year

Most originator companies offer theirmost discounted prices only to acertain group of countries, usually to
Least Developed Countries (LDCs) andcountries in sub-Saharan Africa. These
prices are referred to in this document
as ‘first category prices’. Other
companies do it differently: Merck
extends first category prices tocountries ranked as ‘low’ and ‘medium’on the Human Development Index with
HIV prevalence rates greater than 1%;
GlaxoSmithKline offers differential
prices for their products to all Global
Fund grantees; and Gilead has
established its own list of eligible
countries using mixed criteria, including
some middle-income countries. Thismeans that if a country qualifies for the
discounted prices offered by one
company, it may not necessarily be
included in the list of eligible countriesof another company.

2628

2000
1500
1000
500

1387

636
439

0
Oct June Dec May Dec Apr Feb June June June
2001 2002 2002 2003 2003 2004 2005 2005 2006 2007

Graph 5: Evolution of the lowest pricequoted for eligible developing countries
since 2001

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 9

product. Once multiple genericproducers entered the market, prices
began to fall. Today there are two WHO
prequalified generics that are cheaper
than the originator version. However
prices today still remain too high.
In addition, products provided underthese schemes frequently remain
unavailable in countries because
products are not registered or
marketed. Registration of a medicine
allows it to be marketed in a country
after evaluation of the product dossierby the relevant National Drug
Regulatory Authority (NDRA). In orderto purchase or import a drug into a
country, it must be registered there.
Non-registered or non-marketed drugs
become unattainable for all but those
who can obtain a special authorisation
for import from the Ministry of Health.
In several countries, including Uganda,
Guatemala, Honduras, Laos andEthiopia, Médecins Sans Frontières'experience has shown that obtaining
such authorisations to import nonregistered drugs can be extremelycomplex and time-consuming.
The problem is compounded by thefact that National Drug Regulatory
Authorities' procedures for registering
the products are often slow, even if
companies do everything necessary to
get approval. Fast-track registration

procedures should be put in place for
new products of relevant interest for
public health, based on WHO
prequalification or on registration inhighly-regulated countries.
The pace of registration of ARVs
(including generic formulations as they
become available), is of criticalimportance. It is strongly recommended
for countries to accelerate registrationof needed ARVs, applying fast-track
procedures for WHO prequalified
products, and thus avoiding
unnecessary delays. Offers ofdifferential prices, however loudly
trumpeted, are meaningless if amanufacturer does not take the step ofregistering the product in countries
where it is needed.
Differential pricing practices alone cantherefore not be considered thesolution for increasing worldwide
access to essential drugs. Access tolife-saving medicines for the poorest
populations should not depend on the
goodwill of private companies.
(3) PAEDIATRIC HIV/AIDS IS NEGLECTED
BY MOST COMPANIES:
Until recently, most small children weretreated with liquid formulations. Thesesyrups or oral solutions are ill-adapted
for use in remote settings, as they arecomplex to reconstitute and administer,

can have an unpleasant taste, and arecumbersome to transport and store.
They are also expensive. A majordifference is also that adult treatment
exists in fixed-dose combinations,whereas production of paediatric FDCs
is just beginning. In the absence ofadapted formulations, some children
are still being treated by opening adultcapsules or breaking adult tablets.
However, this non-standard practicepresents significant risks of under- orover-dosing children.
Developments in the course of the lastyear have brought some improvement.
Several generic manufacturers haveintroduced paediatric FDCs for first-line
therapy (such as the FDC d4T/3TC/NVP
manufactured by both Cipla andRanbaxy). The prices of theseformulations are included in this report.
Not all problems have been resolvedby this move, however. The dosagesof these existing FDCs differ from eachother, since guidance from WHO on
recommended dosages came too late
for manufacturers. The slowness of
WHO in giving clear recommendations
has created a problem that risks
delaying the development of paediatric
FDCs, and, ultimately, theadministration of adequate treatment
for children. Another major problem forwhich no solution is on the horizon is

10 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

that there are no second-line
formulations in the pipeline forchildren and more formulations areneeded to complete the spectrum of
regimens needed in an AIDS
programme.
Donors and international organisations
need to prioritise paediatric AIDS
therapy, and work proactively to
encourage much-needed R&D for thisneglected group of patients.
Manufacturers should be encouraged
to produce adapted products, as
recommended by WHO. The WHO
prequalification project must prioritise
these products as well, by outlining
the requirements needed for thequalification of the new formulations.
If necessary, support should beorganised to help manufacturers speed
up the completion of their productdossiers.
FINAL CONSIDERATIONS
According to UNAIDS and WHO, anestimated 250,000 to 350,000 deaths
were averted in 2005 because of
expanded access to AIDS treatment.
This picture must be balanced with the
2.9 million people who died of AIDSrelated illnesses in 2006. Of these,
more than 380,000 were children[48].
Proactive efforts must be taken. These
must not only focus on increasing thenumber of patients on treatment, butalso on providing them with the best
possible treatment, which includes
ensuring that those who begin
treatment will receive second- andeven third-line treatment at affordable
prices, when they eventually need it.
95% of the people living with HIV live
in developing countries. Research anddevelopment (R&D) for diagnostics,
medicines, preventive therapies andvaccines, for children, mothers, andadults must be conducted to develop
products that are affordable andsuitable for use in remoter settings.
The need for these specific medical
tools is clear. This echoes the recent
decision by the 2006 World Health
Assembly to draw up a strategy andplan of action to secure an enhanced
and sustainable basis for needs-driven,
essential health R&D.
Patents should not be a barrier toaccessing affordable medicines,
increasing generic competition andassuring that the appropriate FDCs,
including those for children, aredeveloped. Flexibilities in bothinternational and national patent rules
exist to allow for this and there is no
excuse for obstructing the use of thesesafeguards. However, despite themedical urgency, it seems that thepolitical will to do so is often lacking.

METHODOLOGY
As with previous editions, MSF sent
questionnaires to both originator andgeneric companies, asking them toprovide the following information about
ARV prices for developing countries:
price per unit (or per daily dose),
restrictions that apply to each of theprices quoted (eligibility criteria), andany additional specificity applicable tothe quoted prices. The data werecollected up to 15 June 2007.
All originator companies marketing
ARVs were included in the survey. But
the list of generic producers is by nomeans exhaustive[7]. Indeed, only thosegeneric companies having at least one
antiretroviral prequalified by WHO on
the date the questionnaires were sentout are included in the survey.
Some important preliminary remarkson the data presented in this report:■ The information on prices given inthis document only relates to ARVs. It
does not include other costs linked toantiretroviral treatment, such as
diagnosis, monitoring or treatment ofopportunistic infections. For
information on the prices of theseproducts, please consult the mostrecent edition of “Sources and pricesof selected drugs and diagnostics forpeople living with HIV/AIDS,”

published yearly by UNICEF, UNAIDS,
WHO, and MSF [8].
■ The prices listed here are thosequoted as sale prices by the
manufacturers. The prices paid by the
consumer might be higher because of
add-ons (such as import taxes anddistribution mark-ups), or may belower if subsidised.
■ Companies might use different tradeterms (known as incoterms[9]). Prices
quoted by all generic companies, inaddition to Roche, Abbott and Gilead
are “FCA” or “FOB,” meaning thattransport, international freight andinsurance costs are not included.
Remaining companies listed in thisreport do include freight and insurance
in their prices. Prices havenevertheless not been adjusted. As
recently demonstrated by the US
General Accountability Office, thesedifferences do not undermine theiressential comparability [10].
■ Originator companies have different
eligibility criteria for countries andentities, as explained in the
introductory chapter. The different
categories of prices are detailed in the
product cards. Please, refer to table 2
for explanations on different eligibility
criteria quoted by companies.

■ Generic companies normally do not
impose restrictions on prices, except
for Aspen and Cipla. But occasionallygeneric companies may negotiate
prices different from those quoted
here.
■ The Clinton HIV/AIDS Initiative,[11] forexample, negotiates prices for ARVs
and diagnostic tests with genericcompanies on behalf of national AIDS
programmes included in theirconsortium. To date, the Clinton
Foundation has reached agreementswith six ARV manufacturers to lower
the prices of 20 ARV formulations, bothpaediatric and adult (see annex 10).
■ Information on patents is only
indicative and should be checked withnational authorities. It should in noway form the basis of a procurement
decision.
■ Information on the WHO prequalification status must always bechecked in the WHO website(http://mednet3.who.int/prequal/).

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 11

How to read the product cards?
General information:
For each of the ARVs, general information on the history of the product andrelevant WHO guidance is provided [2,14].
Table 1: Prices quoted by companies for eligible developing countries
All prices are quoted in US$. Conversions have been made on the day the priceinformation was received using the currency converter site: www.oanda.com.
Prices are rounded up to the third decimal for unit price and to the nearest
whole number for yearly price per patient.
The annual cost of treatment per patient (ppy) has been calculated according to
WHO dosing schedules, multiplying the unit price (one tablet or capsule) by the
number of units required for the daily dose and by 365. The price of thesmallest unit is included in brackets.
For paediatric treatments, prices are calculated for a 10 kg child using
recommended dosing based on weight bands as it appears in the WHO
treatment guidelines[2]. This is an estimate, as the weight of a child increases
during any given year. When it was not possible to calculate the dose for a 10
kg child, only the unit price is indicated.
To know whether a country is eligible for a given price of a given company,
please refer to table 2 and the list of countries for each category given in theannexes.

Products included in the most recent edition of the WHO prequalification list
(Revised 55th edition, published 22th June 2007) appear in bold in the tables.
Readers and purchasers wishing to obtain more information about the quality of
ARVs are encouraged to consult the WHO prequalification project website(http://mednet3.who.int/prequal/) as this list is updated very frequently. Initiatedby WHO in 2001, and developed in collaboration with other United Nations
agencies, this project evaluates pharmaceutical manufacturers and products
according to WHO recommended standards of quality and Good Manufacturing
Practices.
Chart 1: Evolution of the lowest price quoted by companies for eligible countries
since 2001
This chart shows the price evolution over time, for both originator and genericproducts, as quoted to MSF surveys since 2001. When they exist, only genericproducts that are WHO prequalified are considered for the graph. If no generic is
WHO prequalified yet, the lowest possible price is taken into account.
Spotlight on access issues
In this new edition, we have tried to summarise the most salient issues related
to access to each product, with the aim of facilitating informed decisions atcountry level, taking into account the problems and obstacles that may be
encountered when trying to gain access to a product at the best price.

12 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

ABACAVIR (ABC)
General information

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily dose

GSK

Aurobindo

Cipla (CF)HeteroMatrix (CF)Ranbaxy

See table 2

none

none

none

none

none

548 (0.750)

439 (0.602)473 (0.648)• Therapeutic class: HIV-1 and HIV-2
nucleoside reverse transcriptase inhibitor(NRTI)

Eligibility restrictions• Indicated for first- and second-line, foradults, adolescents and children (WHO2006 guidelines[2])(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in their consortium. See
Annex 10 for details.

ABC 300 mg tablets

2636 (0.871)

429 (0.587)

456 (0.625)

ABC 20 mg/ml oral solution

10 ml

380 (0.104/ml)

310 (0.085/ml)

420 (0.115/ml)

lowest originator price• Originator company, and product brand
name: GlaxoSmithKline (GSK), Ziagen• Included in the WHO Model List of
Essential Medicines (EML)[14]• World sales of originator product for2006 US$ 230 million,[15] 2005 US$ 268
million,[15] and 2004 US$ 290 million.[16]US $ ppy

2628

2000

Since 2001 the Originator price has reduced by 53% while the generic pricehas reduced by 83%

1500
1000

Evolution of the lowest price quoted for eligible developing countries
since 2001
As of June 2007, there are four WHO pre-qualified generic sources of ABC andthe lowest product is considered here

3000
2500

• First approval by US Food and Drug
Administration (FDA): 17th December
1998

generic priceABC 300mg

636

1387

500

439

0
Oct June Dec May Dec Apr Feb June June June
2001 2002 2002 2003 2003 2004 2005 2005 2006 2007

Spotlight on access issues:
There is a need for greater competition between manufacturers to reduce prices further. At US$ 636 ppy, the current lowest price for the originatorproduct (for ABC alone) is over six times the price of the triple FDC used in most first-line regimens today (3TC/d4T/NVP).
In addition, because of GSK's eligibility restrictions, potential non-African buyers of ABC that are not funded by the Global Fund have no access to thelowest prices for the GSK product.
In 2006, 24 countries reported in the WHO GPRM purchasing ABC 300 mg tablets. [13] Over 70% of these countries reported paying an average unit
price higher than GSKs lowest price offer - El Salvador for example paid over US$ 2,227 ppy, more than three times GSK's lowest price offer.
Although the ABC molecule was developed in the 1980s, GSK applied for a patent in 1997 on abacavir sulphate. This may hamper genericcompetition. If the Indian patent office grants the patent, Indian manufacturers who did not have their product marketed before January 2005 may
have to withdraw their products from the market. Indian NGOs and patient groups have filed an opposition to the patent application for ABC sulphate.
[46]
Although ABC was included as part of first-line NRTI backbone in the most recent WHO recommendations for paediatric treatment, no company has
yet developed a child-friendly version. GSK has recently scored the ABC tablet to increase accuracy of halving the tablets, but more work still needs tobe done for children.
Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions • 13

ATAZANAVIR (ATZ)
General information• Therapeutic class: HIV-1 and HIV-2
protease inhibitor (PI)• Indicated for second-line, for adults
and adolescents (WHO 2006 guidelines[2])• Originator company, and product brand
name: Bristol-Myers Squibb (BMS),
Reyataz• First approval by US Food and Drug
Administration (FDA): 20th June 2003
• Not included in the WHO Model List of
Essential Medicines (EML)[14]• World sales of originator product for2006 US$ 931 million,[17] 2005 US$ 696
million,[17] 2004 US$ 369 million,[18]2003 US$ 81 million.[18]Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
BMS

Daily dose
Category 1

Category 2
See table 2

Eligibility restrictions
ATZ 150 mg caps

2*353 (0.484)425 (0.582)

ATZ 200 mg caps--

(0.602)(0.732)* The dose of ATZ must be boosted with RTV 100 mg once a day[2]Spotlight on access issues:
ATZ is one of the protease inhibitors recommended by WHO for second-line treatment, and is the most patient-friendly PI as it requires thepatient to take only two 150 mg pills once a day.
Until recently, no differential price existed and the price, at more than US$ 5,000 per adult patient per year, was prohibitive for developing
countries.[40] The required addition of ritonavir (RTV) as a booster must also be considered in the final cost of using ATZ.
In 1997-98, BMS applied for patents on ATZ in many countries, including in India. Indian NGOs and patient groups have filed an opposition to
the patent application for ATZ. [46] Unrestrained generic competition from Indian companies will only be possible if the patent is rejected by the
Indian patent office or if the Indian government is willing to grant compulsory licenses to Indian generic manufacturers.
BMS has granted a voluntary license to two generic manufacturers (Emcure and Aspen) to manufacture and sell ATZ. Under the conditions of
the license, sales of these products are restricted to Sub-Saharan Africa. As yet, no ATZ products are available from these companies. [41]ATZ is not yet licensed for children, so there are no paediatric formulations available.

14 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

DIDANOSINE (ddI)

Price information:

Table 1: Prices in US$ quoted by companies for eligible developing countries

General information• Therapeutic class: HIV-1 and HIV-2
nucleoside reverse transcriptase inhibitor(NRTI)• Indicated for second-line, for adults,
adolescents and children (WHO 2006
guidelines[2])• Originator company, and product brand
name: Bristol-Myers Squibb (BMS), Videx,
Videx EC
• First approval by US Food and Drug
Administration (FDA): October 1991 forchewable tablets; October 2000 for entericcoated capsules.
• Included in the WHO Model List of Essential
Medicines (EML)[14]

BMS
Daily
dose

Category 1

Cipla (CF)Ranbaxy
(CF)

None

None

None

Category 2

See table 2

Eligibility restrictions

Aurobindo

ddI 25 g tablets

5

212 (0.116)

416 (0.228)(0.063)

ddI 50 mg tabletsxx(0.158)(0.228)(0.079)ddI 100 mg tablets

4

310 (0.212)

352 (0.241)

234 (0.160)

171 (0.117)

ddI 150 mg tabletsxx(0.308)(0.334)(0.235)(0.167)

ddI 200 mg tabletsxx(0.425)(0.315)(0.232)(0.210)ddI 250 mg entericcoated capsules1

223 (0.611)

239 (0.655)

127 (0.350)

103 (0.283)

156 (0.427)

ddI 400 mg entericcoated capsules1

288 (0.789)

309 (0.846)

208 (0.570)

132 (0.363)

248 (0.679)

138 (6.295/2g)

148 (6.748/2g)

47 (2.160/2g)

12ml
ddI 2 g powder forreconstitution (10 mg/ml)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations forcountries in their consortium. See Annex 10 for details.

• World sales of originator product: 2005,
US$ 174 million. 2004, $274 million.
2003, US$ 354 million[21]ddI EC 400mg

Spotlight on access issues:

Generic Prices
Lowest Originator Price

350
300

US $ ppy• The National Institutes of Health (NIH), a US
government research institute, developed ddI.
The NIH licensed the drug to Bristol-Myers
Squibb, in exchange for a 5 to 6 % royalty on
sales[22]. NIH basic patents on ddI are expired
in US, but BMS holds patents on improved
formulations, which run until 2012 and 2018.

321 (0.220)

250
200

288

278

271

150
100

132

50
0
May
2003

Dec
2003

Apr
2004

Feb
2005

June
2005

June
2006

June
2007

Evolution of the lowest price quoted for developing countries since 2001
As of June 2007, there are no WHO pre-qualified generic sources of ddI 400 mg EC.
The lowest available generic price is therefore given here. In the absence of strong
pre-qualified competition, originator prices have not changed in the last few years.

The use of the enteric-coated (EC) ddI is increasing, as it is one of thedrugs included in WHO treatment guidelines for second-line treatment.
[2] There is an urgent need to have generic versions prequalified by
WHO, and to improve access to these products as scaling up occurs.
With only 66 countries, the list of countries eligible for Bristol-Myers
Squibb's differential prices is too limited - it also excludes middleincome countries, for which BMS has no pricing policy. Crucially, theproduct is not always available in the countries that are defined as
eligible.
In 2006, 18 countries reported in WHO GPRM purchasing ddI 400 mg
enteric-coated capsules [13] Almost half reported an average unit pricegreater than the BMS lowest price offer, with Bolivia and El Salvador
reporting prices over six times this value.
In addition, ddI EC 125 mg, which is the best-adapted option forchildren, has no differential price yet. The price at more than US$ 1000
ppy is prohibitive for the developing world. [40] There are currently no
generic companies manufacturing this product. For children, the only
options are therefore buffered tablets that come with a high pill burden,
or ddI powder for reconstitution that requires multiple dilutions to
obtain the final concentration, must be refrigerated after reconstitution
and must be discarded after 30 days.

Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions • 15

EFAVIRENZ (EFV)
General information

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily
dose

• Therapeutic class: HIV-1 non-nucleosidereverse transcriptase inhibitor (NNRTI)• Indicated for first- and second-line, foradults, adolescents and children (WHO 2006
guidelines[2])• Originator companies, and product brandnames: Bristol-Myers Squibb (BMS), Sustiva,
or Merck, Stocrin• First approval by US Food and Drug
Administration (FDA): 17th September 1998
• Included in the WHO Model List of Essential
Medicines (EML)[14]Merck
Category 1

HeteroMatrix(CF)

Ranbaxy(CF)

Strides
(CF)

None

None

None

None

None

None

EFV 50 mg capsule--EFV 100 mg capsule--EFV 200 mg capsule3394 (0.360)

821 (0.750)

233 (0.267)

226 (0.206)

219 (0.200) 187 (0.512) 185 (0.506) 219 (0.600)

EFV 600 mg tablet

1

237 (0.650)

657 (1.800)

201 (0.550)

218 (0.597)

201 (0.550)

EFV 30 mg/ml
suspension--(0.094/ml)(0.151/ml)(0.069/ml)(0.210)(0.120)(0.100)(0.185)210 (0.192) 219 (0.200)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in their consortium. See
Annex 10 for details.

• World sales of originator product: 2006 US$
791 million[17], 2005 US$ 680 million, 2004
US$ 621 million and 2003 US$ 544 million[21]Generic PriceEFV 600mg

Lowest Originator Price

500
450
400

462

350

US $ ppy• Efavirenz was developed by Dupont Pharma
and is now marketed by BMS. Merck has themarketing license in several countries.

Cipla (CF)Category 2

See table 2

Eligibility restrictions

Aurobindo

300
250

237

346

200
150
100

185

50
0
Dec 2002 May 2003 Dec 2003 Apr 2004 Feb 2005

June
2005

June
2006

June
2007

Evolution of the lowest price quoted for eligible developing countries
since 2001
As of June 2007, there were four WHO prequalified generic sourcesof EFV 600 mg. The lowest WHO prequalified generic product isgiven here.

Spotlight on access issues:

EFV is a key drug for first-line treatment. Although EFV has been marketed fora considerable period already, its price is still very high, with the single
originator product (EFV alone) priced at more than twice the price of the mostwidely used triple FDC (3TC/d4T/NVP).
All generic products are almost three times cheaper than Merck's second
category price. Some countries are still purchasing the originator product,
however. In 2005, according to GPRM, some countries reported purchasing
EFV at more than US$ 800 ppy. In 2006, the highest transaction reported
was El Salvador at US$ 706 ppy.[13]In Brazil, where this product is under patent, EFV alone took up 14% of the
National Aids Budget in 2005. [23] Today, 38% of patients on antiretroviraltherapy in Brazil take this drug. Despite these growing patient numbers andnumerous negotiations with Merck, the price of EFV had remained at US$ 576
ppy since 2003. In early 2007, Brazil therefore issued a compulsory license toimport generic EFV from India - the country has now received its first delivery
of a WHO prequalified generic, at a cost of US$ 165 ppy. This represents a
reduction in the forecasted budget to 2012 of over US$ 226 million.[49]Despite having received FDA approval in 1998, EFV has still not been studiedin children under three years of age.

16 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

EMTRICITABINE (FTC)
General information

Spotlight on access issues:• Therapeutic class: HIV-1 nucleosidereverse transcriptase inhibitor (NRTI)FTC is neither registered nor marketed in developing countries, but is available co-formulated with TDF.

• Indicated for first-line, for adults (WHO2006 guidelines[2])• Originator company and product brand
name: Gilead, Emtriva

According to WHO treatment guidelines, 'FTC is an equivalent alternative to 3TC as it is structurally related to 3TC, shares the same efficacy
against HIV and hepatitis B virus and has the same resistance profile.' [2]When making the choice between FTC and its closest equivalent 3TC, national AIDS programmes and others should therefore take into accountthat there are potential intellectual property issues that could affect this product in some countries - while its older therapeutic equivalent,
3TC, could be free of such restrictions.

• First approval by US Food and Drug
Administration (FDA): July 2003
• Included in the WHO Model List of
Essential Medicines (EML)[14]• World sales of originator product: 2006
US$ 36.3 million, 2005 US$ 47.4 million,
2004 US$ 57.6 million[24].
• Emtricitabine was developed by Emory
University in 1996. The University agreed
to waive their right to a royalty on sales
within the Gilead Access Program[25].
• Patents on the basic molecule are due
to expire in 2010-2011.

Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions • 17

INDINAVIR (IDV)
General information

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily
dose

• Therapeutic class: HIV-1 and HIV-2 proteaseinhibitor (PI)• Indicated for second-line, for adults (WHO2006 guidelines)[2]Merck
Category 1

4*400 (0.274)

Cipla

Ranbaxy

None

None

None

432 (0.296)

321 (0.220)

639 (0.292)

Category 2

Eligibility restrictions
400 mg caps

Aurobindo

686 (0.470)• Originator company and product brand
name: Merck, Crixivan*The dose of IDV must be boosted with RTV 100 mg twice a day[2]• First approval by US Food and Drug
Administration (FDA): March 1996

Note from Merck: Crixivan is indicated for use at 800 mg every eight hours. Data from published studies and treatment
guidelines suggest that Crixivan can also be used in combination with ritonavir in the following dosing regimens: 800/100 mg,
800/200 mg or 400/100 mg, both administered orally twice daily.

• Not included in the WHO Model List of
Essential Medicines (EML)• Merck applied for patents in 1992 for theuse in the treatment of AIDS.

Spotlight on access issues:
In 2006, 34 countries reported transactions in WHO GPRM, with nine reporting average purchases over US $ 700 ppy. [13]18 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

LAMIVUDINE (3TC)
General information• Therapeutic class: HIV-1 and HIV-2
nucleoside reverse transcriptase inhibitor(NRTI)• Indicated for first- and second-line for
adults and adolescents, and for first-line only
for children (WHO 2006 guidelines[2])• Originator company, and product brand
name: GlaxoSmithKline (GSK), Epivir• First approval by US Food and Drug
Administration (FDA): November 1995
• Included in the WHO Model List of Essential
Medicines (EML)[17]

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily
dose
Eligibility restrictions

GSK

Aspen

Aurobindo

Cipla (CF)HeteroMatrix(CF)

Ranbaxy

Strides

See table 2

See table 2

None

None

None

None

None

None

69 (0.095)xx

47 (0.064)

51 (0.070)

53 (0.073) 49 (0.067) 43 (0.059) 46 (0.063)

55 (0.150)

3TC 150 mg tablet

2

3TC 300 mg tablet

1

56 (0.155)

3TC 10 mg/ml oral
solution

10 ml 102 (0.028/ml)

44 (0.012/ml) 66 (0.018/ml)

3TC 25 mg granules--(2.20)

3TC 50 mg granules--(2.70)xx

66 (0.180)

XX For prices on these products please contact Aspen directly(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in their consortium.
See Annex 10 for details.

• World sales of originator product: 2006 US$
398 million, 2005 US$ 398 million[26], 2004
US$ 549 million[15].

3TC 150mg• Patent status: the patent holder is IAF
Biochem International SA (Canada). GSK pays
a 14 % royalty to the Canadian firm[30].

Spotlight on access issues:

generic pricelowest originator price

Lamivudine is a product in high demand, whose price has substantiallydecreased over recent years. As of June 2007, there are seven genericversions prequalified by WHO.

250

US $ ppy

200

234

150
100

91
69

In 2006, most countries reported to the WHO GPRM having paid thelowest price available, whether for the generic or the originator product.
Some transactions, however, were reported at double the price or more
– El Salvador for example paid US$ 180 ppy for GSK´s product.[13]50430Oct June Dec May Dec Apr Feb June June June
2001 2002 2002 2003 2003 2004 2005 2005 2006 2007

Evolution of the lowest price quoted for eligible developing countries
As of June 2007, there are seven WHO prequalified generic sources of 3TC
150 mg. The lowest priced WHO prequalified product is given here.

In China, 3TC is still unaffordable – at more than US$ 1,600 per patient
per year - due to GSK's monopoly rights on the drug.
No company produces a child-friendly low dosage pill, and adapted
dosages, for example 75 mg tablets, are urgently required. It was only
in 2007 that GSK scored their adult tablet to facilitate the use inchildren. Some fixed-dose combination formulations for children
containing 3TC have been developed by generic companies and shouldreach the market very soon.

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 19

NELFINAVIR (NFV)
General information

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Roche• Therapeutic class: HIV-1 and HIV-2 proteaseinhibitor (PI)

Daily
dose

Aurobindo

Cipla

Hetero

None

None

None

1379 (0.420)

1486 (0.407)

1011 (0.277)

2ndcategory

1stcategory• Indicated only for second-line in adults,
adolescents and children (WHO 2006
guidelines)[2]Eligibility restrictions
NFV 250 mg tablets

101069 (0.293)

2201 (0.470)• Originator company, and product brand
name: Roche, Viracept

NFV 50 mg/g oral
powder

24 g

1927 (0.220/g)

2234 (0.255/g)

See table 2• First approval by US Food and Drug
Administration (FDA): 14th March 1997
• Included in the WHO Model List of Essential
Medicines (EML)[14]• World sales of originator product: US$ 259
million in 2004[16]• Agouron Pharmaceuticals Inc. developed
nelfinavir, in collaboration with thepharmaceutical division of Japan Tobacco Inc.
In Europe and a few other countries outside
the United States, Agouron/Pfizer has licensed
Roche to market nelfinavir.[28] Patents on
nelfinavir are due to expire in 2014.

NFV 250mg

Spotlight on access issues:

generic pricelowest originator price

3500
3000
2500
2000

3139
2924

1500

1069

1000

1011

500
0

Oct June Dec May Dec Apr
Feb June June June
2001 2002 2002 2003 2003 2004 2005 2005 2006 07

Evolution of the lowest price quoted for eligible developing countries
As of June 2007, there was no WHO prequalified generic source of NFV. The
lowest available generic price is therefore given here.

NFV is the only PI that does not require boosting withritonavir (RTV). Although this makes it a less potent option
when compared with a boosted PI,[29] the fact that it can beused without RTV means that using a NFV based regimen
also comes without the refrigeration requirement that is amajor limitation associated with RTV.
This therefore makes the drug an attractive option for somedeveloping countries. In 2006, 23 countries reported
transactions in WHO GPRM.[13]Nevertheless, a large pill burden and the high price of NFVmake it a less preferable option. In addition, the use of NFVin children is extremely complex, due to the significant
amounts of powder that have to be taken on a daily basis(12 g of powder twice a day for a 10 kg child). Not only is
this formulation ill-adapted, but its price remains prohibitive.
In June 2007, Roche recalled all batches of NFV due to thepresence of a contaminate. As a result, WHO has temporally
suspended the product from the prequalification list.[42]There is no generic production of adapted paediatricformulations.

20 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

NEVIRAPINE (NVP)
General information

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries• Therapeutic class: HIV-1 non-nucleosidereverse transcriptase inhibitor (NNRTI)• Indicated for first- and second-line, foradults, adolescents and children (WHO 2006
guidelines)[2]• Originator company and product brand
name: Boehringer-Ingelheim (BI) Viramune• First approval by US Food and Drug
Administration (FDA): 21st June 1996

Daily
dose
Eligibility restrictions2

NVP 200 mg tablets

20 ml
NVP 10 mg / ml or
50 mg / 5ml suspension

BI

Aspen

Aurobindo

Cipla (CF)HeteroRanbaxy

Strides

Matrix
(CF)

None

None

Category 1

Category 2

None

None

None

None

219 (0.300)

438 (0.600) XX

51 (0.070)

55 (0.075)

48 (0.660)

52 (0.071) 50 (0.070) 54 (0.074)

380(0.052/ml)

533(0.073/ml)

95 (0.013/ml) 131(0.018/ml)

NVP granules 25 mg--(2.50)

NVP granules 50 mg--(3.00)XX For prices on this product please contact Aspen directly

Spotlight on access issues:

NVP 200mg

generic pricelowest originator price

438
219
150

20
03
Ap
r2
00
4
Fe
b
20
05
Ju
ne
20
05
Ju
ne
20
06
Ju
ne
20
07

Until May 2007, the price of Boehringer-Ingelheim's 200 mg NVP tablets
had remained unchanged since the first publication of this report in 2001.
On 15th May 2007, BI announced a price reduction of 50%. However, thisis arguably too little too late, as even after the price reduction, the fivegeneric versions prequalified by WHO are still more than four times cheaper
than BI's NVP.
Despite these prequalified generics, the BI product is still being bought inmany developing countries. In 2006, 25% of countries reportingtransactions in WHO GPRM were still purchasing the BI product. This
included countries such as Tanzania, Nigeria, Uganda and Kenya.[13]Crucially, BI did not grant a price reduction on the one formulation where aprice drop would have had considerable impact: for the NVP 10 mg/ml
suspension used for children.

ec
D

02
20

M
ay

Ju

ne

01
20
t
c
O

20
03

48

02

500
450
400
350
300
250
200
150
100
50
0

ec

US $ ppy• Patents on the nevirapine molecule are due
to expire in 2010 in most countries, but BI
also holds patents on the syrup formulationof nevirapine, which could run until 2018.

20• World sales of originator product: 2006 US$
370 million,[30] 2005 US$ 386 million,[31] 2004
US $ 378 million[32](CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in their consortium. See
Annex 10 for details.

D• Included in the WHO Model List of Essential
Medicines (EML)[14]

Evolution of the lowest price quoted for eligible developing countries
since 2001
As of June 2007, there are eight WHO prequalified generic sources of
NVP. The lowest available WHO prequalified generic price is therefore
given here.

BI applied for a patent on the syrup formulation of NVP, which if granted,
would hamper future generic competition. Patient groups opposed the
granting of this patent before the Indian patent office on 9th May 2006.
The final decision was still pending at the time of publication
Some fixed-dose combination tablet formulations containing NVP for
children have been developed by generic companies and will be soon on
the market.

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 21

RITONAVIR (r or RTV)
General information

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily dose usedas booster• Therapeutic class: HIV-1 and HIV-2 proteaseinhibitor (PI)• Indicated for second-line as a booster, foradults, adolescents and children (WHO 2006
guidelines)[2]• Originator company, and product brand
name: Abbott Laboratories, Norvir• First approval by US Food and Drug
Administration (FDA): March 1996 for the oral
solution and 29th June 1999 for capsules

Eligibility restrictions

Aurobindo

Cipla

HeteroStrides

See table 2

None

None

None

None

336 (0.460)

313 (0.429)

190 (0.260)

365 (0.500)

100 mg capsule2

83 (0.114)

80 mg/ml oral
solution--(0.093/ml)

RTV 100mg

Spotlight on access issues:

generic price• Included in the WHO Model List of Essential
Medicines (EML)[14]

RTV is of crucial importance for scaling up, as all proteaseinhibitors with the exception of NFV, must be boosted withthis drug. The importance of the drug is all the clearer at thetime of going to press, following the recall of all batches of
NFV from Roche in June 2007.[42]lowest originator price
3504

190

20
03
Ap
r2
00
4
Fe
b
20
05
Ju
ne
20
0
Ju
ne 5
20
06
Ju
ne
20
07

ec

20
03
D

2
20
0

M
ay

ec

Ju
n

e

1
00
2
ct
O

02

83

20

500
450
400
350
300
250
200
150
100
50
0

650

D

• World sales of originator product: 2004 US$
194 million, 2003 US$ 93 million, 2002
US$ 122 million. [36]AbbottEvolution of the lowest price quoted for eligible developing countries since2001
As of June 2007, there was no WHO prequalified generic source ofritonavir. The lowest available generic price is therefore given here.
The price of ritonavir, both originator and generic, fell dramatically in2001.

22 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

Abbott has developed a heat-stable fixed-dose combinationof RTV combined with LPV. Crucially though, the heat-stableversion of ritonavir alone is not yet available. Manufacturing
this formulation is urgently needed, as it would free other PIs
such as ATZ, of refrigeration constraints when they need tobe combined with RTV. Generic firms are working on thedevelopment of RTV heat-stable tablets.
Abbott has applied for various patents on improved
formulations on RTV, which renders the extent of future
generic competition unclear. Oppositions have been filed tothese derivative patents in India. The outcome of these
oppositions in India will have consequences on the extent ofgeneric competition and any price decrease that can be
expected from the arrival of competition.
There is a need for WHO prequalification of generic versionsof RTV, in particular for middle-income countries which do nothave access to Abbott's lowest price.

SAQUINAVIR (SQV)
General information

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries• Therapeutic class: HIV-1 and HIV-2 proteaseinhibitor (PI)• Indicated for second-line, to be usedboosted by ritonavir, for adults, adolescentsand children. (WHO 2006 guidelines)[2]• Originator company, and product brand
name: Roche, Invirase

Roche

Daily dose

Cipla

HeteroNone

None

1825 (0.500)

986 (0.270)

1st category

2nd category
See table 2

Eligibility restrictions
SQV 200 mg hard
capsules

10*1051 (0.288)

2201 (0.603)

SQV 500 mg tablets

4*968 (0.663)

2205 (1.51)• First approval by US Food and Drug
Administration (FDA): December 1995

* The dose of SQV must be boosted with RTV 100 mg twice a day [2]• Included in the WHO Model List of Essential
Medicines (EML).[14]SQV 200mg

generic pricelowest originator priceoriginator 2nd price

2500
2362

2000

2201

1335

1500

As of June 2007, there was no WHO prequalified generic sourceof saquinavir.
The lowest available generic price is therefore given here.

1051

1342

1000

Evolution of the lowest price quoted for eligible developing
countries since 2001

986

500
0
Oct
2001

June Dec
2002 2002

May
2003

Dec Apr2003 2004

Feb June2005 2005

June June
2006 2007

Spotlight on access issues:
SQV capsules are very difficult to administer, as they need to be boosted with ritonavir and come with a high pill burden (ten capsules a day).
However, since 2004, Roche has been marketing in the USA a new 500 mg tablet version of SQV. This formulation reduces the pill burden fromten to four tablets, but is not widely marketed in developing countries. Nevertheless, the product is still recommended by WHO.
Seven countries reported transactions in 2006 in WHO GPRM, all for the originator product. However, only Bulgaria reported a transaction for
the newer 500 mg tablet - at a price of US$ 4,000 ppy. [13]The high price of SQV and the need for boosting with RTV continue to be a barrier. Competition between producers remains severely limited,as its use is fairly limited.
Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 23

STAVUDINE (d4T)
General information

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
BMS• Therapeutic class: HIV-1 and HIV-2
nucleoside reverse transcriptase inhibitor(NRTI)• Indicated for first-line, for adults,
adolescents and children (WHO 2006
guidelines)[2]

1st category

Daily
dose

2nd category

See table 2

Eligibility restrictions

Aspen
(CF)

Aurobindo

See table 2 None

Cipla (CF)Hetero(CF)

Matrix(CF)

Ranbaxy(CF)

Strides
(CF)

None

None

None

None

None

15 mg capsule--(0.082)(0.089)20 mg capsule--(0.094)(0.089)• In 2006, WHO updated its treatment
guidelines to recommend a reduction in thedose of d4T from 40 mg to 30 mg, for all
weight categories of patients[43]30 mg capsule2

48 (0.066)

40 mg capsule2

1 mg / ml powder for
syrup

20 ml

• Originator company, and product brand
name: Bristol-Myers Squibb (BMS), Zerit

5 mg granules(2.00)

10 mg granules(2.50)• First approval by US Food and Drug
Administration (FDA): December 1994

XX For prices on these products please contact Aspen directly• Included in the WHO Model List of Essential
Medicines (EML)[14](CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in their consortium. See
Annex 10 for details.

• World sales of originator product: 2006
US$ 155 million,[17] 2005 US$ 216 million,
2004 US$ 272 million and 2003 US$ 354
million[21](0.048)(0.032)xx(0.034)(0.050)(0.034)65 (0.089)

xx

28 (0.039) 39 (0.053)

20(0.027)

28 (0.039)

28 (0.039) 31 (0.042)

55 (0.075)

65 (0.089)

xx

29 (0.040) 42 (0.057)

24 (0.033) 29 (0.040)

34 (0.047) 33 (0.045)

51(0.007/ml)

58(0.008/ml)

D4T 40mg

146
73(0.010/ml) (0.020/ml)

60
50
40
30
20
10
0

55

55

44
29

Oct
2001

June Dec May
2002 2002 2003

Dec
Apr
Feb June June June
2003 2004 2005 2005 2006 2007

Evolution of the lowest price quoted for eligible developing countries since 2001:
As of June 2007, there are four WHO prequalified generic sources of d4T. The
lowest available WHO prequalified generic price is therefore given here.

24 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

73 (0.010/ml)

Spotlight on access issues:

generic pricelowest originator price

US $ ppy• Stavudine was the result of US public sector
research. It was originally synthesised by theMichigan Cancer Foundation in 1966 on a
grant from the National Cancer Institute.
Researchers from Yale University first
discovered its activity against HIV/AIDS andfiled the patent for this specific indication in
the USA in December 1986. Yale licensed its
marketing and distribution rights to BMS in1988.[22](0.032)

Bristol-Myers Squibb has no policy for middle-income countries,
and prices are negotiated on a case-by-case basis. The new criteria
chosen by BMS to establish eligibility for discounted prices aims toprotect certain markets, and imposes a premium (over 25% more
expensive) that applies even to countries as poor as Mozambique.
Despite the existence of many WHO prequalified generics, in 2006
some countries recorded transactions of the BMS product in WHO
GPRM at elevated prices. Morocco, Thailand, Georgia and Bulgaria
for example purchased the originator drug at US$ 284, US$ 810,
US$ 1,314 and US$ 2,965 ppy respectively. [13]The price of BMS's paediatric formulation has decreased
significantly since 2005. This product has limitations however, as itis supplied as a powder, requiring reconstitution and once
reconstituted must be refrigerated.

TENOFOVIR DISOPROXIL
FUMARATE (TDF)

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries

General information

Daily dose Gilead
See table 2

Eligibility restrictions

Aspen

Cipla (CF)HeteroMatrix (CF)See table 2

See table 2

None

None

268 (0.733)

199 (0.546)• Therapeutic class: HIV-1 nucleotide reverse
transcriptase inhibitor (NtRTI)TDF 300 mg tablets• Indicated for first- and second-line, foradults and adolescents (WHO 2006
guidelines)[2]• Originator company, and product brand
name: Gilead, Viread• First approval by US Food and Drug
Administration (FDA): October 2001
• Included in the WHO Model List of Essential
Medicines (EML)[14]• World sales of originator product: 2006
US$ 689 million, 2005 US$ 778 million, 2004
US$ 783 million[24]• Although tenofovir was discovered andpatented in 1985, Gilead later applied for
additional patents on a new form of the drug,
tenofovir disoproxil fumarate. These later
patents are due to expire in 2018.[33]1207 (0.567)

XX

Category 1

Category 2

195 (0.534)

340 (0.932)

XX For prices on this product please contact Aspen directly.
(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in theirconsortium. See Annex 10 for details.

Spotlight on access issues:
The use of TDF is likely to increase as it is now part of the WHO recommended firstline treatment. The addition of TDF to first-line regimens will have a substantial
impact on the budgets of AIDS programmes. Previously recommended d4T based
first-line regimens now cost as low as US$ 100 per patient per year (see the productcard for the triple FDC containing 3TC/d4T/NVP). In Sub-Saharan African and othercountries eligible for Gilead's lowest price for TDF, the use of the new first-line
regimen will increase the cost of treating a patient for a year by four to six times.
The impact will be even more dramatic in countries that are excluded from thelowest prices.
Some middle-income countries, such as Brazil, nevertheless possess negotiating
capacity with Gilead, and can threaten to issue compulsory licenses allowing local
production or importation of the drug. As a result, Gilead recently agreed to halve
the price from US$ 2,766 to US$ 1,380 per patient per year in Brazil. his new price -TDF 300mg

generic priceChart 1: Evolution of the lowest price quoted for
eligible developing countries since 2001
As of June 2007, there was no WHO prequalified
generic source of TDF. The lowest available genericprice is therefore given here.

US $ ppy

lowest originator price
500
450
400
350
300
250
200
150
100
50
0

475

365
207
195

May
2003

Dec
2003

Apr
2004

Feb
2005

June
2005

June
2006

June
2007

at almost seven times the price of the Gilead offers to countries in the Access
Program - remains extremely inflated. The lack of progress on the registrationof the drug is a further problem. Indeed TDF is barely available in developing
countries at all. As of June 2007, Gilead's TDF was registered in only 25 of the
97 countries that Gilead deems eligible for its preferential prices.[34] TDF is notregistered in either Zimbabwe or Malawi for instance, where HIV/AIDS
prevalence exceeds 20% and 14% respectively.
Competition between generics and originators for TDF is now underway, as
generic products have already been marketed in India for several months. But
the future of such generic competition will depend on the patent status of TDF
in India. Gilead patent applications are currently under examination at the
Indian patent office. Indian patient groups opposed the granting of this patenton 9th May 2006 [35].
As a result of this opposition, Gilead has offered voluntary licenses to many
Indian manufacturers in a move that was widely welcomed. It must be
stressed however that there are certain key limitations to these agreements.
Firstly, Indian manufacturers that signed the license cannot sell the product allover the developing world, as the terms of the license limit the production andexport of generic versions to LDCs and a few developing countries only. Big
markets such as China or Brazil are for example specifically excluded. Indian
licensees are also prevented from selling the active pharmaceutical ingredientoutside India.
Secondly, most of the Indian generic manufacturers did not need any technicalsupport from Gilead to make generic versions. All they needed was theassurance that Gilead would not use patent rights to stop them fromproducing and exporting in countries where the product was needed. Finally,and perhaps most crucially, it is important to remember that Gilead had notbeen granted a patent in India and therefore did not hold any IP rights there
when the voluntary licensing agreements were concluded - nor does it at thetime of going to press. Gilead's offer of voluntary licenses can therefore beseen as a pre-emptive attempt to retain control over the marketing and sellingof TDF in certain key markets, when the future patent status of TDF in India is
still undetermined.
Crucially, TDF has not yet been tested in children, despite urgent needs.

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 25

ZIDOVUDINE (AZT, ZDV)General information• Therapeutic class: HIV-1 and HIV-2
nucleoside reverse transcriptase inhibitor(NRTI)

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily
dose
Eligibility restrictions

GSK

Aurobindo

Cipla (CF)HeteroMatrix (CF)Ranbaxy

See table 2

None

None

None

None

None

110 (0.150)

110 (0.150)

115 (0.157)

Strides• Indicated for first- and second-line, foradults, adolescents and children (WHO 2006
guidelines)[2]

AZT 300 mg tabs

2

212 (0.290)

120 (0.165)

104 (0.142)

AZT 100 mg caps--

(0.158)(0.110)(0.075)AZT 250 mg caps--

(0.332)• Originator company, and product brand
name: GlaxoSmithKline (GSK), Retrovir

AZT 10 mg/ml syrup

20 ml

263 (0.036/ml) 95 (0.013/ml) 102 (0.014/ml)

AZT 25 mg granules--(2.85)• First approval by US Food and Drug
Administration (FDA): March 1987

AZT 50 mg granules--(3.35)• World sales of originator product: 2005
US$ 84 million, 2004 US$ 80 million[26]• Zidovudine was first discovered in 1964 as
an anti-cancer medicine. The US National
Institutes of Health did the majority of theresearch that showed the drug's effectivenessas an antiretroviral. Nevertheless, GlaxoWellcome obtained a patent for zidovudine forthe treatment of AIDS and brought the drug
onto the market in 1987 as one of the mostexpensive ever sold. Patents have expired inmost countries now.

(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in their consortium. See
Annex 10 for details.

AZT 300mg

Spotlight on access issues:

generic pricelowest originator price

US $ ppy• Included in the WHO Model List of Essential
Medicines (EML)[14]

800
700
600
500
400
300
200
100
0

684

193

212
104

Oct June Dec May Dec Apr Feb June June June
2001 2002 2002 2003 2003 2004 2005 2005 2006 2007

Evolution of the lowest price quoted for eligible developing countries since2001
As of June 2007, there are five WHO prequalified generic sources of AZT 300
mg. The lowest available WHO prequalified generic price is therefore given
here.

26 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

Despite the existence of generic competition and the availabilityof WHO prequalified products, some countries, including Least
Developed Countries such as Kenya and Zimbabwe, were in 2006
still purchasing the originator version of AZT. Countries havereported to the WHO GPRM that they were purchasing GSK
products at prices between US$ 212 and US$ 241 (almost double
the generic price).[13]ABACAVIR/LAMIVUDINE(ABC/3TC)

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries

General information• Therapeutic class: 2 NRTIs in a double fixeddose combination, for HIV-1 and HIV-2

Daily dose
Eligibility restrictions
ABC/3TC 600/300 mg

1

GSK

Cipla

See table 2

None

678 (1.858)

256 (0.700)• Indicated for first-line, for adults,
adolescents and children (WHO 2006
guidelines)[2]• Originator company, and product brand
name: GlaxoSmithKline (GSK), Kivexa (in theEU), Epzicom (in the USA)
• First approval by US Food and Drug
Administration (FDA): August 2004
• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations[14]• World sales of originator product: 2006
US$ 475 million, 2005 US$ 233 million.[26]Spotlight on access issues:
To date, no transactions have been reported in the WHO GPRM
database.
GSK only very recently quoted a specific price for this double
fixed-dose combination for developing countries. Genericproduction is very recent.

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 27

LAMIVUDINE/STAVUDINE(3TC/d4T)

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries

General information• Therapeutic class: 2 NRTIs in double fixeddose combination, for HIV-1 and HIV-2• Indicated for first-line, for adults,
adolescents and children (WHO 2006
guidelines)[2]• WHO updated the 2006 guidelines torecommend a reduction in dose of d4T 40 mg
to d4T 30 mg for all weight categories ofpatients[43]• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations[14]• Generic manufacturers in India where noneof the individual medicines are under patentdeveloped the product. It is not available
from originator companies.

Aurobindo

Cipla

HeteroMatrixRanbaxy

Strides

Eligibility restrictions

None

None

None

None

None

None

3TC/d4T 150mg/30mg tablet 2

72 (0.099)

64 (0.088)

91 (0.125)

61 (0.083)

73 (0.100)

61 (0.083)

3TC/d4T 150mg/40mg tablet 2

74 (0.101)

67 (0.092)

93 (0.127))

64 (0.088)

79 (0.108)

63 (0.087)

Daily
dose

3TC/D4T 150mg +lowest originator price withseparate products
generic price FDC

350
300
250
200
150
100
50
0

289
124
139
64
Oct June Dec May Dec
Apr
Feb June June June
2001 2002 2002 2003 2003 2004 2005 2005 2006 2007

Evolution of the lowest price quoted for eligible developing countries since 2001
As of June 2007, there are two WHO prequalified generic sources of 3TC/d4T.
The lowest available WHO prequalified generic price is therefore given here. As
there is no originator FDC, the price used is the combination of the two single
products.
The first generic to be WHO prequalified was from Strides in February 2005.
Prices of generic drugs have been decreasing since that date.

28 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

Spotlight on access issues:
Although this fixed-dose combination is included in
the WHO recommendations for children, there are
currently no adapted formulations available. Somegeneric manufacturers are however working on
developing this FDC for children, to complement
their triple FDC for children.
With the recent change in WHO recommendations
concerning the dose of d4T, products using d4T 40
mg should gradually disappear.

LOPINAVIR/RITONAVIR(LPV/r)Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries

General information• Therapeutic class: boosted Protease
Inhibitor (PI) in double fixed-dose
combination, for HIV-1 and HIV-2• Indicated for second-line for adults,
adolescents and children (WHO 2006
guidelines)[2]• First approval by US Food and Drug
Administration (FDA): soft-gel capsules wereapproved in September 2000. Heat-stable
tablets were approved in October 2005.
• Originator company, and product brand
name: Abbott Laboratories, Kaletra, Aluvia• Included in the WHO Model List of Essential
Medicines (EML) - only soft-gel capsules[14]• World sales of originator product: LPV/r isthe most commonly used PI in the USA,
representing 34% of total PI prescriptions. In
four years, from 2001 to 2004, sales
amounted to US$ 2.5 billion (US$ 292 million
in 2001, US$ 551 million in 2002, US$ 754
million in 2003 and US$ 897 million in2004).[36] Cumulative sales are estimated toreach US$ 7 billion over the years 2001 to
2008[36]• Abbott patents on soft-gel capsules are due
to expire in 2018. Patents were also filed toprotect the heat-stable tablets, which if
granted, could run until 2024.

AbbottEligibility restrictions

Category 2

Category 1

Daily dose

Cipla
None

HeteroMatrix (CF)

None

None

1338 (0.611)

1140 (0.520)

See table 2
LPV/r 133 / 33 mg
soft gel capsule6

LPV/r 200 / 50 mg
tablet (heat-stable)

4

LPV/r 80 + 20 mg / mloral solution

4 ml

500 (0.228)1000 (0.457)

500 (0.342)

1000 (0.685)

1034 (0.708)

200 (0.137/ml) 400 (0.274/ml)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries
in their consortium. See Annex 10 for details.

Spotlight on access issues:
Abbott has developed a new formulation of the LPV/r that isheat-stable. The new formulation presents advantages over
the older soft gel capsules: it has a lower pill count (reducing
the burden from six to four pills per day), there is no need forrefrigeration, and there are no dietary restrictions.
Its availability remains severely limited in developing countries
however. The LPV/r heat stable tablet is only registered in 13
out of the 68 countries who can access the US $500 ppy
price.[37] It is only after Médecins Sans Frontières (MSF) in
LPV/r 133.3mg / 33.3mg

Generic Price
Lowest Originator Price

4500
4000
3500
3000
2500
2000
1500
1000
500
0

3833

1150
1140
500

June
2002

500

Dec
2002

May
2003

Dec
2003

Apr
2004

Feb
2005

June
2005

June
2006

June
2007

Evolution of the lowest quoted price for eligible developing
countries since 2001 As of June 2007, there was no WHO
prequalified generic source of lopinavir/ritonavir. The lowest
available generic price is therefore given here.

early 2006 publicly placed an order for LPV/r heat stable tablets, supported by a petition letter
signed by more than 300 scientists and organisations, that Abbott allowed the drug to be delivered
to MSF programmes in African countries where it is not registered. Initially Abbott declined to fill theorders placed for MSF projects in Guatemala or Thailand. As a result of public pressure, Abbott finally
announced a price for middle-income countries.
Due to the impossibility of obtaining the product at an affordable price, Thailand made use of theflexibilities of the TRIPS Agreement and issued a compulsory license in early 2007 to import andproduce LPV/r in its older, soft gel capsules formulation. Abbott retaliated by withdrawing theapplications for registration for all their new medicines in Thailand, including the newer LPV/r heatstable tablets. By refusing to register these drugs and thereby restricting access to life-saving drugs in
Thailand, Abbott's actions have attracted the condemnation of many, including MSF and patientgroups. [38]In Brazil, where this product is under patent, the cost of LPV/r alone took up 27% of the National
AIDS Programme budget in 2005. After repeated negotiations with the company, Abbott eventually
reduced the price to US$ 1,380 ppy for the older soft-gel version and US$ 1,518 ppy for the heatstable tablets. [23] After Thailand issued a compulsory license, Abbott further reduced the price for
middle-income countries, including Brazil, to US$ 1,000.
The Clinton Foundation's HIV/AIDS Initiative, after negotiation with generic manufacturers, has recently
announced a price of US$ 695 for the LPV/r heat-stable tablet for countries in their consortium. [11] Thisis a positive indication that the price of the generic formulations will continue to drop as the market
grows. This is already 30% below the new reduced price for middle-income countries offered by
Abbott. However, the availability of these more affordable generic versions will depend on theupcoming patent decisions in India.
Indeed, generic competition from Indian sources, which would be expected to drive prices down as
demand increases, is under threat. Abbott has applied for patents on the combination and on
improved formulations of the individual drugs in India, which, if granted would hamper production ofgeneric sources. Indian patient groups have opposed the grant of these patents before the Indian
patent offices. The final decisions were still pending at the time of publication.
The majority of transactions recorded in 2006 in the WHO GPRM were for LPV/r 133.3/33.3 mg soft-gel
capsules. Only three countries (Uganda, Zambia and Mozambique) reported transactions of the newheat-stable 200/50 mg tablet. Many countries reported paying more than 10 times Abbott's lowest
offer for the soft-gel capsules (e.g. Jordan US$ 5,212 ppy and Honduras US$ 7,775 ppy). [13]The paediatric formulation of LPV/r is a liquid that requires refrigeration. Adapted formulations forchildren are urgently needed.

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 29

TENOFOVIR DISOPROXIL
FUMARATE/ EMTRICITABINE(TDF/FTC)
General information• Therapeutic class: one NtRTI + one NRTI in
double fixed-dose combination, for HIV-1• Indicated for first-line, for adults andadolescents (WHO 2006 guidelines)[2]• Originator company, and product brand
name: Gilead, Truvada

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily dose
Eligibility restrictions
TDF/FTC
300/200 mg tablets

1

GileadAspen

See table 2

See table 2319 (0.875)

xx

Cipla (CF)Category 1

Category 2

See table 2

See table 2

300 (0.822)

503 (1.379)

Matrix (CF)None

274 (0.750)

XX For prices on this product please contact Aspen directly.
(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations forcountries in their consortium. See Annex 10 for details.

• First approval by US Food and Drug
Administration (FDA): August 2004
• Included in the WHO Model List of Essential
Medicines (EML) [14]• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations [14]• World sales of originator product: 2006 US$
1,194 million, 2005 US$ 568 million, 2004
US$ 68 million[24]• Patent holders of both TDF and FTC haveagreed to waive their right to a royalty on
sales within Gilead's Access Program.

30 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

Spotlight on access issues:
As of June 2007, this combination isregistered in only 20 of the 97 countries
eligible within Gilead's
Access Program. [34]
In 2006, only four countries reported
transactions in WHO GPRM with the
majority accessing Gilead's access price,although Armenia reported paying US$
561. [13]The final patent status of TDF in India will
have implications on the availability ofgeneric versions of this FDC (see TDF
product card).

TENOFOVIR DISOPROXIL
FUMARATE/ LAMIVUDINE(TDF/3TC)
General information• Therapeutic class: NtRTI + NRTI in double
fixed-dose combination, for HIV-1• Indicated for first-line, for adults andadolescents (2006 WHO guidelines)[2]• Included in the WHO Model List of Essential
Medicines (EML) [14]• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations [14]• Only generic companies manufacture thisproduct but its final availability will dependon the pending patent decision of TDF in
India. It is not available in Western countries
because of various patents on TDF and 3TC.

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily dose
Eligibility restrictions
1

TDF/3TC
300/300 mg tablets

Cipla (CF)Category 1

Category 2

See table 2

See table 2

265 (0.726)475 (1.301)

Matrix (CF)None

237 (0.650)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices
on some formulations for countries in their consortium. See Annex 10 for details.

TDF/3TC 300mg/300mg

Lowest originator price withseperate productsThis combination is likely to be widely used in developing countries asa backbone in first and second line regimes, even more so than theoriginator combination of TDF/FTC.[2] This is for two reasons. Firstly, thecombination contains 3TC instead of FTC. 3TC is equally effective andsafe but comes with fewer patent restrictions and is available atcheaper prices. Secondly, the fact that generic companies alreadyproduce this combination is likely to have an impact on the price ascompetition develops. Gilead patent applications on TDF are however
pending in India, threatening the future production of this FDC.

generic price

1200
1034

1000
800
600
400

276

200

276
237

0
June 2006

Spotlight on access issues:June 2007

The Clinton Foundation's HIV/AIDS Initiative, after negotiation withgeneric manufacturers, has recently announced a price of US$ 179 forthis combination for countries in their consortium. This is a positive
indication that the price of the generic formulations will continue todrop as the market grows. [11]Evolution of the lowest quoted price for eligible developing countries
since 2001
As of June 2007, there was no WHO prequalified product. The lowest
available generic price is therefore given here.

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 31

ZIDOVUDINE/LAMIVUDINE(AZT/3TC)

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries

General information• Therapeutic class: 2 NRTI in double fixeddose combination, for HIV-1 and HIV-2• Indicated for first- and second-line for
adults and adolescents, and only for first-line
in children (WHO 2006 guidelines) [2]• Originator company, and product brand
name: GlaxoSmithKline (GSK), Combivir

Aspen

Aurobindo

Cipla (CF)HeteroMatrix (CF) Ranbaxy

Eligibility restrictions

See table 2

See table 2

None

None

None

None

AZT/3TC 300 / 150 mg 2

237 (0.325)

XX

140 (0.192)

134 (0.183) 161 (0.220) 128 (0.175) 140 (0.192) 270 (0.233)• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations [14]• World sales of the originator: 2006
US$ 1,042 million, 2005 US$ 1,150 million,
2004 US$ 1,125 million [15]• Patent status: GSK announced thewithdrawal of all patents and patentapplications for this combination in tablet
form in all countries of the world on 9th
August 2006 [50] Patent rights may still exist on
the 3TC alone however.

None

None

XX For prices on this product please contact the company directly(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in their consortium. See
Annex 10 for details.

• First approval by US Food and Drug
Administration (FDA): September 1997
• Included in the WHO Model List of Essential
Medicines (EML) [14]Strides

GSK

Daily
dose

AZT/3TC

Spotlight on access issues:

generic pricelowest originator price

800
700
600
500
400
300
200
100
0

730

270

237
134

Oct June Dec
2001 2002 2002

May
2003

Dec
Apr
2003 2004

Feb
2005

June
2005

June
2006

June
2007

Evolution of the lowest price quoted for eligible developing countries since 2001
As of June 2007, there are five WHO prequalified generic sources of AZT/3TC. The
lowest available WHO prequalified generic price is therefore given here.
Competition among WHO prequalified sources continues, and has led to a steadydecrease in prices.

Competition between originator and generics exists for adultformulations. Indian sources of the generic product cameunder threat in 2006 however when GSK applied for a patenton the combination. Civil society in India opposed the patentapplication on 30th March 2006. [39] In August 2006, GSK
withdrew the patent application in India in response to this
opposition. [46]Despite GSK withdrawal of all patents related to the
combination, generic versions of the FDC are still notavailable in some countries because of GSK's remaining rights
on 3TC. In China for example, only the originator product isavailable at US$ 2,876 ppy because of GSK's exclusive rights
on 3TC alone.
WHO GPRM 2006 data show that the majority of countries
reported purchasing the generic products, although somecountries, such as Algeria and Cameroon still paid prices overUS$ 200. Countries like Russia and Jordan reported purchasesof the GSK product as high as US$ 1,248 and US$ 2,694
respectively. [13]To date, no formulation adapted for children is marketed.
This is urgently needed. GSK have recently scored their adult
AZT/3TC product to ease the use in children, but there is stillno paediatric strength of this product available.

32 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

LAMIVUDINE/STAVUDINE/NEVIRAPINE (3TC/d4T/NVP)
General information

Price information:

Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily
dose
Eligibility restrictions

Aurobindo

Cipla (CF)Hetero(CF)

Matrix(CF)

Ranbaxy(CF)

Strides

None

None

None

None

None

None

• Therapeutic class: two NRTI + one NNRTI in
triple fixed-dose combination, for HIV-1

30 / 6 / 50 mg dispersible tablets

4*

158 (0.108)

60 / 12 / 100 mg dispersible tablets

2*

91 (0.125)• Indicated for first-line, for adults,
adolescents and children (WHO 2006
guidelines) [2]

20 / 5 / 35 mg dispersible tablets

5*

104 (0.057)

40 / 10 / 70 mg dispersible tablets

2.5*

88 (0.096)

150 / 30 / 200 mg tablets

2

139 (0.190)

132 (0.181) 101 (0.138) 119 (0.163)• WHO updated the 2006 guidelines torecommend a reduction in dose of d4T for all
weight categories of patients, from 40 mg to30 mg [43]150 / 40 / 200 mg tablets

2

146 (0.200)

140 (0.192) 104 (0.142) 128 (0.175) 101 (0.139) 125 (0.171)• Included in the WHO Model List of Essential
Medicines (EML) - only the d4T 30 mg
presentation [14]121 (0.166)*WHO has developed recommendations for dosage for different weight categories for the paediatric FDC - see spotlight on access issues for moredetails. [44)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in their consortium. See
Annex 10 for details.
3TC / D4T / NVP 150mg + 40mg + 200mg• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations [14]lowest originator price withseparate products
generic price FDC

US $ ppy• Only generic companies manufacture the
combination; it is not available in Westerncountries because of various patents on 3TC,
d4T and NVP. If these medicines had been
under patent in India, this important FDC may
never have been developed.

99 (0.135)

800
700
600
500
400
300
200
100
0

727
343
295

Oct June
2001 2002

101

Dec May Dec Apr
2002 2003 2003 2004

Feb June June June
2005 2005 2006 2007

Evolution of the lowest price quoted for eligible developing countries since 2001
As of June 2007, there are three WHO prequalified generic sources of 3TC/d4T/NVP. The
lowest available WHO prequalified generic price is therefore given here. As there is no
originator FDC, the price used is the combination of the three single products.
Competition among WHO prequalified sources continues, and has led to a steadydecrease in prices.

Spotlight on access issues:This is still the most commonly prescribed therapy inresource-limited settings for first-line treatment in
adults. With the recent change in WHO
recommendations concerning the dose of d4T,
products using d4T 40 mg should gradually disappear.
Some generic manufacturers have now produced
paediatric triple fixed-dose combinations. This is an
important breakthrough, greatly facilitating thetreatment of children.
Unfortunately, WHO recommendations on an ideal FDC
for children came too late, and none of the products
currently marketed follow the WHO guidelines. In
order to address this problem, dosing tables weredeveloped by an expert committee to give clear
guidance on how to administer the current
formulations.
None of the existing paediatric products areprequalified. The WHO Prequalification project mustprioritise the assessment of these products.

Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions • 33

TENOFOVIR DISOPROXIL
FUMARATE/EMTRICITABINE/EFAVIRENZ (TDF/FTC/EFV)

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily
dose

General information
Eligibility restrictions• Therapeutic class: 1 NtRTI + 1 NRTI + 1
NNRTI in a triple fixed-dose combination, for
HIV-1• Indicated for first-line for adults (WHO 2006
guidelines) [2]

TDF/FTC/EFV 300/200/600 mg tablets

1

Gilead/BMS/Merck
Category 1

Category 2

See table 2

See table 2613 (1.68)

1033 (2.83)

Matrix (CF)None

487(1.333)• First approval by US Food and Drug
Administration (FDA): July 2006
• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations [14]• World sales of the originator: In 2006, US$
205 million. [24]Category 1

Category 2

See table 2

See table 2527 (1.44)

742 (2.033)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in theirconsortium. See Annex 10 for details.

• Originator company, and product brand
name: Gilead and BMS/Merck, Atripla• Included in the WHO Model List of Essential
Medicines (EML) [14]Cipla

Spotlight on access issues:This is the first one-pill-a-day FDC, which makes it well adapted to resource-poor settings.
This combination will probably become one of the most recommended first-line therapies,
as it is well tolerated and delays the emergence of resistance, although it cannot be usedin women of childbearing age.
Some generic manufacturers have started production of this FDC. Gilead patent applications
are currently under examination at the Indian patent office, however. Indian patient groups
opposed the granting of TDF patent in India in May 2006. [46]The Clinton Foundation's HIV/AIDS Initiative, after negotiation with generic manufacturers,
has recently announced a price of US$ 385 for this combination for countries in theirconsortium. This is a positive indication that the price of the generic formulations willcontinue to drop as the market grows. [11]34 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

TENOFOVIR DISOPROXIL
FUMARATE / LAMIVUDINE /EFAVIRENZ (TDF/3TC/EFV)

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily dose

General information
Eligibility restrictions• Therapeutic class: 1 NtRTI + 1 NRTI + 1
NNRTI in a triple fixed-dose combination, for
HIV-1• Indicated for first-line for adults (WHO 2006
guidelines) [2]• Included in the WHO Model List of Essential
Medicines (EML) [14]• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations [14]• The product is developed only by genericmanufacturers and is not available in Westerncountries because of various patents on TDF,
3TC and EFV

Cipla
Category 1

Category 2

See table 2

See table 2

TDF/3TC/EFV 300/150/600mg tablets (FDC) 1
TDF/3TC 300/150 mg +EFV 600mg (Co-Pack) 1 kit (2 tabs)

Matrix (CF)426 (1.167)
493 (1.351)

695 (1.904)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on someformulations for countries in their consortium. See Annex 10 for details.

Spotlight on access issues:This combination is likely to be widely used in developing countries, even more so than theoriginator combination of TDF/FTC/EFV. This is for two reasons. Firstly, the combination contains
3TC instead of FTC. 3TC is equally effective and safe but comes with fewer patent restrictions and isavailable at cheaper prices. Secondly, the fact that this combination is already produced by genericcompanies is likely to have an impact on the price as competition develops. Gilead patentapplications on TDF are however pending in India, threatening the future production of this FDC.
The Clinton Foundation's HIV/AIDS Initiative, after negotiation with generic manufacturers, hasrecently announced a price of US$ 339 for this combination for countries in their consortium. Thisis a positive indication that the price of the generic formulations will continue to drop as themarket grows. [11]Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 35

ZIDOVUDINE/LAMIVUDINE/ABACAVIR (AZT/3TC/ABC)

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily dose

General information• Therapeutic class: three NRTI in triple fixeddose combination, for HIV-1 and -2• Indicated for first-line, for adults,
adolescents and children (WHO 2006
guidelines) [2]• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations [14]• Originator company, and product brand
name: GlaxoSmithKline (GSK), Trizivir• First approval by US Food and Drug
Administration (FDA): November 2000
• World sales of originator product: 2006
US$ 529 million, 2005 US$ 598 million, 2004
US$ 635 million. [26]

Eligibility restrictions
AZT/3TC/ABC 300/150/300 mg (FDC)

GSK

Aurobindo

Cipla

HeteroMatrixRanbaxy

See table 2

None

None

None

None

None

548 (0.750)

730 (1.000)

548 (0.750)

639 (0.875)

852 (1.167)

2

AZT/3TC 300/150 mg +ABC 300mg (Co-Pack) 1 kit (4 tabs)

ABC/3TC/AZ

548 (1.50)

generic pricelowest originator price

3000
2500

2409

2000
1500

1648

852

1000
500

548

0
Oct June Dec May
2001 2002 2002 2003

Dec AprFeb
2003 2004 2005

June June June
2005 2006 2007

Evolution of the lowest price quoted for eligible developing countries since 2001
As of June 2007, there was no WHO prequalified generic source of an FDC containing
AZT/3TC/ABC.
The lowest available generic price is therefore given here.

Spotlight on access issues:This FDC was the first triple formulation developed by an originator company to be made available in Western countries, and is therefore oneof the most commonly prescribed regimens. The market remains very small in developing countries, however. Indeed only three countries
reported transactions to WHO GPRM in 2006 (Madagascar, Côte d'Ivoire and the Central African Republic). [13]The fixed-dose combination is still very expensive compared to other triple first-line FDCs, notably because of the high price of abacavir.

36 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

ZIDOVUDINE/LAMIVUDINE/NEVIRAPINE (AZT/3TC/NVP)

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries
Daily dose

General information• Therapeutic class: two NRTI + one NNRTI in
triple fixed-dose combination, for HIV-1

Eligibility restrictions• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations [14]• Only generic companies manufacture the
combination; it is not available in Westerncountries because of various patent rights on
AZT, 3TC and NVP.

Cipla (CF)HeteroMatrix (CF) Ranbaxy

Strides

See table 2

None

None

None

None

None

None

231 (0.317) 231 (0.317) 194 (0.266) 199 (0.273) 223 (0.306)
225 (0.616)

xx

XX For prices on this product please contact Aspen directly(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in theirconsortium. See Annex 10 for details.

AZT / 3TC / NVP 300mg/ 150mg/ 200mg

US $ ppy• Included in the WHO Model List of Essential
Medicines (EML) [14]Aurobindo2

AZT/3TC/NVP 150/300/200mg (FDC)

AZT/3TC 150/300mg + NVP 200mg (Co-Pack) 1 kit (4 tabs)• vIndicated for first-line, for adults,
adolescents and children (WHO 2006
guidelines) [2]

Aspen

1600
1400
1200
1000
800
600
400
200
0

lowest originator price withseparate products

Spotlight on access issues:

generic price FDC

The price of this triple FDC is still a barrier for use
and for scaling up purposes, especially whencompared with other triple first-line FDCs.
Today, there are no paediatric formulations available
for this FDC, although it is recommended by WHO for
first-line children treatment.

1356
500
419
231
Oct June Dec May Dec Apr Feb June June June
2001 2002 2002 2003 2003 2004 2005 2005 2006 2007

Evolution of the lowest price quoted for eligible developing countries since2001
As of June 2007, there are two WHO prequalified generic sources of
AZT/3TC/NVP FDC. The lowest available WHO prequalified generic price istherefore given here.
As there is no originator FDC, the price used is the combination of thethree single products.

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 37

LAMIVUDINE/STAVUDINE + EFAVIRENZ(3TC/d4T+EFV)

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries

General information

Daily dose

Cipla

Ranbaxy

None

None

• Therapeutic class: two NRTI + one NNRTI in a co-blister, for HIV-1

Eligibility restrictions• Indicated for first-line, for adults, adolescents and children (WHO 2006
guidelines) [2]

3TC/d4T+EFV
150 / 30 + 600 mg
daily co-blister

1 kit(3 tabs)

274 (0.750)

345 (0.945)

3TC/d4T+EFV
150 / 40 + 600 mg
daily co-blister

1 kit(3 tabs)

280 (0.767)

358 (0.980)• The WHO Expert Committee on the Selection and Use of Essential Medicines
recommends and endorses the use of fixed-dose combinations and thedevelopment of appropriate new fixed-dose combinations [14]• Only generic companies manufacture the combination; it is not available inWestern countries because of various patents rights on 3TC, d4T and EFV.

ZIDOVUDINE/LAMIVUDINE + EFAVIRENZ(AZT/3TC + EFV)

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries

General information• Therapeutic class: two NRTI +one NNRTI in a co-blister, for HIV-1• Indicated for first-line, for adults, adolescents and children (WHO 2006
guidelines [2])Dose
Eligibility restrictions
AZT/3TC +EFV
150/300 + 600 mg daily co-blister• The WHO Expert Committee on the Selection and Use of Essential Medicines
recommends and endorses the use of fixed-dose combinations and thedevelopment of appropriate new fixed-dose combinations [17]• Only generic companies develop this product; it is not available in Westerncountries because of various patents on AZT, 3TC and EFV
38 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

1 kit(3 tabs)

Aurobindo

Cipla

Ranbaxy

Strides

None

None

None

None

410 (1.125)

347 (0.950) 434 (1.190)

420 1.150)

PMTCT: NEVIRAPINE + ZIDOVUDINE(NVP+AZT)

Price information:
Table 1: Prices in US$ quoted by companies for eligible developing countries

General information• Therapeutic class: one NNRTI + one NRTI in a co-blister, for HIV-1• Indicated for prevention of mother to child transmission [47]Dose
Eligibility restrictions
NVP 6 mg granules + AZT 16 mg granules
NVP 6 mg granules + AZT 16 mg granules

StridesNone

1 + 14
1 + 562.50
4.70• Only generic companies manufacture the combination; it is not available inWestern countries because of various patents rights on NVP and AZT.

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 39

Table 2: Conditions of offer by company
Company

Eligibility (countries)

Eligibility (bodies)

AbbottCategory 1 countries
All African countries and all Least Developed
Countries (as defined by UN) outside of Africa
Category 2 countries
All Low income countries (excluding Africancountries and LDC countries) plus all lower
middle income countries
See Annex 6 for more details

Category 1 countries
Organisations providing sound, sustainablecare, including, but not limited togovernments, NGOs, UN organisations,private employers, hospitals and clinics
Category 2 countries
Governments and programs fully-funded bygovernments, UN Systems organisations,
NGOs and other not-for-profit institutional
providers of HIV treatment.

Aspen

Sub-Sahara Africa including Mauritius,
Seychelles, Madagascar for all products except
Viread and Truvada

Governments, NGOs and other partners
including private and such organisations
that are able to run programmes in a
responsible, sustainable and medicallysound manner

Delivery terms: 90-120 days

For Viread and Truvada - entire African
continent

Additional comments

Delivery of goods
FOB

No minimum order unless any special
labelling is required.

Quote ex works. Deliver CIF
as per client request - freightcharges to consignees account.
Payment by telegraphic transfer

Aurobindo

No reported restrictions

NGOs and governmental organisations

Prices available for above 500,000
units for tablet packs and above
10,000 units for oral solutions.
Delivery of goods 4-6 weeks from thedate of confirmed orders.

Payment by letter of credit
FOB Hyderabad (India)

Bristol-Myers Squibb

First category of countries:
Sub-Saharan African countries (except southern
African countries) plus countries classified as
low-income by the World Bank (except Korea,
Kyrgyzstan, Moldova and Uzbekistan).

Both private and public sector
organisations that are able to provide
effective, sustainable and medically soundcare and treatment of HIV/AIDS

Category 1 countries are invoiced in
US $,CIP incoterm

Category 2 countries are invoiced inSouth African Rand

Second category of countries:
Southern African countries
See annex 5 for more details.
For other developing countries, prices arenegotiated on a case-by-case basis with BMS
local representatives
Boehringer-Ingelheim

Category 1. All LDCs, all low income countries
and all Africa
Category 2 All middle income countries notcovered under category 1

Governments, NGOs and other partners
who can guarantee that the programme is
run in a responsible manner

40 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

CIF

Company

Eligibility (countries)

Eligibility (bodies)

Additional comments

Delivery of goods

Cipla

For products with differential pricing
Category 1 Low Human Development Index
countries
Category 2 Medium Human Development Index
countries

No restrictions

No quantity related conditions Prices
for larger quantities are negotiable

FOB Mumbai (India) or CIF Freight charges separately on
actualOrganisations that provide HIV treatmentin the 98 countries covered by the Gilead
Access Program.
For organisations in Africa enquiries should
be directed to Ansie Savrda(asavrda@aspenpharma.com)

Shipping terms vary by local
The programme is managed throughdistributor
Gilead International Access Operationsand Gilead`s local distribution partners.
Please note that local taxes, tariffs,
and limited distributor mark-ups may
be added to the ex-factory prices.

For products with no differential pricing there
is no reported restrictions but higher prices
have been negotiated separately for 10 Latin
American countries
Gilead98 countries including all African states and 44
additional countries classified as low-incomeby the World Bank. See Annex 7 for moredetails
For other developing countries, prices arenegotiated on a case by case basis

GlaxoSmithKline

Least Developed Countries (LDCs) plus subSaharan Africa
All Country Coordination Mechanisms (CCM)
projects fully financed by the Global Fund toFight AIDS, TB and Malaria, as well as projects
funded by PEPFAR.
For other low and middle-income countries,
public sector prices are negotiated on a caseby-case basis, either bilaterally or through
GSK's Accelerating Access Initiative

For other countries application instructions
are available at www.gileadaccess.org
Governments, aid organisations, charities,
UN agencies, other not-for-profit
organisations and international
procurement agencies

Supply Agreement required (For NGOs
requiring fewer than ten patient packs
per month, this requirement may be
waived)In sub-Saharan Africa, employers offering
HIV/AIDS care and treatment directly totheir staff through workplace clinics orsimilar arrangements

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

CIP

Hetero Drugs Ltd

No reported restrictions

Private sector, public sector and NGOs

Prices may be negotiated on individual
basis according commercial terms

FOB Mumbai (India)

MatrixNo reported restrictions except
Belarus, Cuba, Democratic Republic of Congo,
Iran, Liberia, Sudan and Syria for which priorapproval from Mylan Labs Inc is required

No restrictions

None

Ex-works Nashik, India or as
specified by customers

Merck & Co. Inc

First category of countries:
Low Human Development Index (HDI) countries
plus medium HDI countries with adult HIV
prevalence of 1% or greater

Governments, international organisations,NGOs, private sector organisations (e.g.
employers, hospitals and insurers)

Merck & Co. Inc may under certain
circumstances supply ARVs to patients
through retail pharmacies

CIP

Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions • 41

Company

Eligibility (counries)

Eligibility (bodies)

Additional comments

Delivery of goods

Second category of countries:
Medium HDI countries with adult HIV prevalence
less than 1%
Ranbaxy

No reported restrictions, but higher prices werenegotiated separately for ten Latin Americancountries

NGOs and governments or programmes
supported by them

Confirmed letter of credit or advancepayment preferred for new customers

FOB Delhi (India)

Roche

First category of countries:
All countries in sub-Saharan Africa and all
countries classified as Least Developed Countries
by the United Nations

Governments, non-profit institutional
providers of HIV care, NGOs

CAD (Cash Against Documents) 30
days at sight. Minimum order anddelivery amount per shipment is CHF
10,000 (US$ 8,179)

FCA Basel airport (Switzerland)or CIP airport of destination

Governments, non-profit institutional
providers of HIV treatment, NGOs

Payment by signed letter of credit

FOB Bangalore (India)

Second category of countries:
Low-income countries and lower middle-income
countries, as classified by the World Bank.
Strides Arcolab Ltd

No reported restrictions

Notes:
The conditions detailed in the table above were those quoted directly by the companies. Definitions of eligibility vary from company to company. Each originator company establishes different restrictions to their offer of reduced
prices, and classifies countries according to different categories. Some companies resort to Least Developed Countries (LDC) criteria developed by the United Nations, others to the UN Development Programme's Human
Development Index (UNDP HDI), and others still to World Bank classifications concerning country income.
This lack of uniformity leads to significant differences in the eligibility of a country for different products. For instance, some countries are considered Least Developed Countries by the United Nations, but are classified as having
medium development by UNDP. These include Bangladesh, Cambodia, Laos and Sudan. Six other LDCs do not appear in the UNDP HDI rankings at all – these include Liberia and Somalia.
Furthermore, many developing countries are left out of the differential pricing scheme altogether. These include Bolivia, Nicaragua, and Ukraine for the UNDP classification, and China, Honduras and Sri Lanka for the World Bank
classification.
For full details please refer to annexes 1-8.

42 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

Table 3: Summary of prices in US$ quoted by companies for eligible developing countries
Prices are quoted as per patient year followed in brackets by the smallest unit price.

ABC
300 mg tablet
20 mg / ml oral solution
ATZ

Daily dose2
10 ml

150 mg
200 mgddl

2

25 mg tablet
50 mg tablet
100 mg tablet
150 mg tablet
200 mg tablet
125 mg EC capsule
250 mg EC capsule
400 mg EC capsule
2g powder for reconstitutionEFV

5

50 mg capsule
100 mg capsule
200 mg capsule
600 mg tablet
30 mg / ml suspension
FTC
200 mg capsule susp
IDV
400mg cap

4

1
1
1
12 ml

3
1

4

Aurobindo
429 (0.587)
310 (0.085)
BMS
Cat 1
353 (0.484). (0.602)
Aurobindo

234 (0.160). (0.235). (0.315)Cipla
456 (0.625)
420 (0.115)
BMS
Cat 2
425 (0.582). (0.732)
BMS
Cat 1
212 (0.116). (0.158)
310 (0.212). (0.308). (0.425)

127 (0.350)
208 (0.570)
47 (2.160/2g)
Aurobindo

223 (0.611)
239 (0.655)
103 (0.283)
288 (0.789)
309 (0.846)
132 (0.363)
138 (6.295/2g) 148 (6.748/2g)
Cipla
HeteroMatrix156 (0.427)
248 (0.679)
Merck
Cat 1
. (0.120)

Merck
Cat 2
. (0.210)

Ranbaxy

Strides226 (0.206)
218 (0.597)

219 (0.200)
201 (0.55)

187 (0.512)

394 (0.360)
237 (0.65). (0.094 / ml)

821 (0.750)
657 (1.80). (0.151 / ml)

210 (0.192)
185 (0.506)

219 (0.200)
219 (0.600)

Aurobindo

Cipla

432 (0.296)

321 (0.220)

Merck
Cat 1
400 (0.274)

Merck
Cat 2
686 (0.470). (0.100). (0.185)
233 (0.267)
201 (0.550). (0.069 / ml)

GSK
636 (0.871)
380 (0.104)

Hetero548 (0.750)

Matrix439 (0.602)

BMS
Cat 2
416 (0.228). (0.288)352 (0.241). (0.334)

Cipla

Ranbaxy. (0.063). (0.079)
171 (0.117). (0.167). (0.232)

321 (0.220)

Ranbaxy
473 (0.648). (0.210)

Ranbaxy
639 (0.292)

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 43

3TC
150 mg tab
300 mg tab
10 mg / ml suspension
25 mg granules
50 mg granules
NFV

Daily dose
2
1
10 ml

200 mg tab
50 mg / g oral powder
NVP

10
24 g

200 mg tab
10 mg / ml suspension
25 mg granules
50 mg granules
RTV
100 mg caps
80 mg / ml oral solution
SQV

2
20 ml

200 mg hard caps
500 mg tabs
d4T

10
4

15 mg caps
20 mg caps
30 mg caps
40 mg caps
1 mg / ml powder for susp
5 mg granules
10 mg granules
TDF
300 mg tab

Aurobindo
47 (0.064)
57 (0.155)
44 (0.012/ml)

Cipla
51 (0.070)
55 (0.150)
66 (0.018/ ml)

GSK
69 (0.095)

Hetero53 (0.073)

Matrix49 (0.067)

Ranbaxy
43 (0.059)
66 (0.180)

Strides46 (0.063)

102 (0.028/ml). (2.20). (2.70)

Aurobindo

Cipla

Hetero

Roche
Roche
Cat 1
Cat 2
1069 (0.293)
2201 (0.603)
1927 (0.220/g)) 2234 (0.255/g)
Cipla
Hetero1379 (0.420)

1496 (0.407)

1011 (0.277)

51 (0.070)
95 (0.013)

Boehringer
Cat 1
219 (0.300)
380 (0.052/ml)

Boehringer
Cat 2
438 (0.600) 55 (0.075)
533 (0.073/ml) 131 (0.018/ml)

48 (0.066)

MatrixRanbaxy

Strides54 (0.074)

52 (0.071)

50 (0.070). (2.50). (3.00)2

Abbot
83 (0.114)
0.093/ml)
Cipla

Aurobindo
336 (0.460)

Cipla
313 (0.429)

Hetero1825 (0.500)

996 (0.270)

Roche
Roche
Cat 2
Cat 1
1051 (0.288) 2201 (0.603)
968 (0.663) 2205 (1.51)
Cipla
HeteroBMS
Cat 2. (0.048). (0.089). (0.050). (0.089)
39 (0.053)
20 (0.027)
65 (0.089)
42 (0.057)
24 (0.033)
65 (0.089)
58 (0.008/ml) 146 (0.020/ml)

Aurobindo

2
2
20 ml

BMS
Cat 1
. (0.032). (0.082). (0.034). (0.094)
28 (0.039)
48 (0.066)
29 (0.040)
55 (0.075)
73 (0.010/ml) 51 (0.007/ml)

Hetero190 (0.260)

Strides365 (0.500)

MatrixRanbaxy

Strides31 (0.042)
34 (0.046)

28 (0.039)
34 (0.047)

31 (0.042)
33 (0.045). (2.00). (2.50)

1

Cipla
Cat 1
195 (0.534)

Cipla
Cat 2
340 (0.932)

GileadHeteroMatrix207 (0.567)

268 (0.733)

199 (0.546)

44 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

AZT
300 mg tab
100 mg caps
250 mg caps
10 mg / ml suspension
25 mg granules
50 mg granules
ABC/3TC
300 mg / 600 mg tab
3TC/d4T
150 mg / 30 mg tab
150 mg / 40 mg tab
LPV/rDaily dose2

Aurobindo
120 (0.165). (0.110)Cipla
104 (0.142). (0.075)

20ml

95 (0.013/ml)

102 (0.014/ml)

133 mg / 33 mg soft gel caps
200 mg / 50 mg tab
80 mg / 20 mg / ml solution
TDF/FTC

644ml

300 mg/ 200 mg tab
TDF/3TC1

300 mg / 300 mg tab
AZT/3TC
300 mg / 150 mg tab
3Tc/d4T/NVP
30mg/ 6mg/ 50mg disp tab
60mg/ 12mg/ 100mg disp tab
20mg/ 5mg/ 35mg disp tab
40mg/ 10mg/ 70mg disp tab
150mg/ 30mg/ 200mg tab
150mg/ 40mg/ 200mg tab
TDF/FTC/EFV

1300mg/ 200mg/ 600mg tab

1

HeteroGSK
110 (0.150)
212 (0.290. (0.158). (0.332)
263(0.036/ml)

Matrix110 (0.150)

Ranbaxy
115 (0.157)

Strides. (2.85). (3.36)
1
2
2

2
4
2
5
2.5
2
2

Cipla
256 (0.700)
Aurobindo
72 (0.099)
74 (0.101)
AbbottCat 1
500 (0.228)
500 (0.342)
200 (0.137/ml)
Cipla
Cat 1
300 (0.822)
Cipla
Cat 1
265 (0.726)
Aurobindo
140 (0.192)
Aurobindo

139 (0.190)
146 (0.200)
Cipla
Cat 1
526 (1.44)

GSK
678 (1.858)
Cipla
64 (0.088)
67 (0.092)
AbbottCat 21000 (0.457)
1000 (0.457)
400 (0.274/ml)
Cipla
Cat 2
503 (1.379)
Cipla
Cat 2
475 (1.301)
Cipla
134 (0.183)
Cipla
158 (0.108)
91 (0.125)

132 (0.181)
140 (0.192)
Cipla
Cat 2
742 (2.033)

Hetero91 (0.125)
93 (0.127)
Cipla

Matrix73 (0.100)
79 (0.108)
Hetero1338 (0.611)

1140 (0.520)

Ranbaxy
61 (0.083)
64 (0.088)
MatrixStrides61 (0.083)
63 (0.087)

1034 (0.708)
GileadMatrix319 (0.875)
Matrix274 (0.750)

237 (0.650)
GSK
237 (0.325)
HeteroHetero161 (0.220)
MatrixMatrix152 (0.208)
Ranbaxy

Ranbaxy
140 (0.192)
Strides101 (0.138)
104 (0.142)
Matrix119 (0.163)
128 (0.175)

104 (0.057)
88 (0.096)
99 (0.135)
101 (0.139)

121 (0.166)
125 (0.171)

Gilead/BMS/Merck

Gilead/BMS/Merck

487 (1.333)

613 (1.68)

1033 (2.83)

Strides170 (0.233)

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 45

TDF/3TC/EFV

Daily dose

300mg/300mg/600mg tab (FDC) 1
300mg/300mg+600mg Co-pack 1 kit (2 tabs)
AZT/3TC/ABC
300mg/150mg/300mg tab (FDC) 2
300mg/150mg + 300mg Co-pack 1 kit (4 tabs)
AZT/3TC/NVP
300mg/150mg/200mg tab (FDC) 2
300mg/150mg+200mg Co-pack 1 kit (4 tabs)
3TC/d4T + EFV (Co-blister)
150mg/ 30mg + 600mg
1 kit (3 tabs)
150mg/ 40mg + 600mg
1 kit (3 tabs)
AZT/3TC + EFV (Co-blister)
150mg/ 300mg + 600mg
1 kit (3 tabs)
NVP + AZT (Co-pack)
6mg + 16mg granules
1 + 146mg + 16mg granules
1 + 56

Cipla
Cat 1

Cipla
Cat 2

493 (1.351)
Aurobindo

695 (1.904)
Cipla
548 (0.750)

GSK
852 (1.167)

Hetero730 (1.000)

Matrix548 (0.750)

Ranbaxy
639 (0.875)

Cipla
231 (0.317)

Hetero194 (0.296)

Matrix199 (0.273)

Ranbaxy
223 (0.306)

Strides

Matrix426 (1.167)

548 (1.500)
Aurobindo
231 (0.317)

225 (0.616)
Cipla
274 (0.750)
280 (0.767)
Aurobindo
410 (1.125)
Strides. (2.50). (4.70)

Ranbaxy
345 (0.945)
358 (0.980)
Cipla
347 (0.950)

Ranbaxy
434 (1.190)

Strides420 (1.15)

46 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

Annexes

Annex 1: Least Developed
Countries (LDCs)

Annex 2: Human Development
Index (HDI)

Source: United Nations
http://www.un.org/specialrep/ohrlls/ldc/list.htm

Source: United Nations Development
Programme (UNDP)
http://hdr.undp.org/hdr2006/statistics/d
ocuments/hdi2004.pdf

Fifty countries are currently designatedby the United Nations as least
developed countries (LDCs).

The Human Development Index is
published annually as a part of
UNDP's annual Human Development
Report.

Afghanistan; Angola; Bangladesh;
Benin; Bhutan; Burkina Faso; Burundi;
Cambodia; Cape Verde; Central African
Republic; Chad; Comoros; Congo(Democratic Republic); Djibouti;
Equatorial Guinea; Eritrea; Ethiopia;
Gambia; Guinea; Guinea-Bissau; Haiti;
Kiribati; Lao PDR; Lesotho; Liberia;
Madagascar; Malawi; Maldives; Mali;
Mauritania; Mozambique; Myanmar;
Nepal; Niger; Rwanda; Samoa; São
Tomé and Principe; Senegal; Sierra
Leone; Solomon Islands; Somalia;
Sudan; Timor-Leste; Togo; Tuvalu;
Uganda; Tanzania; Vanuatu; Yemen;Zambia.

Low human development:
Angola; Benin; Burkina Faso; Burundi;,
Central African Republic; Chad; Congo(Democratic Republic); Côte d'Ivoire;
Djibouti; Eritrea; Ethiopia; Gambia;
Guinea; Guinea-Bissau; Haiti; Kenya;
Lesotho; Malawi; Mali; Mauritania;
Mozambique; Niger; Nigeria; Rwanda;
Senegal; Sierra Leone; Tanzania;
Togo;Yemen; Zambia; Zimbabwe..
Medium human development:
Albania; Algeria; Armenia; Azerbaijan;
Bangladesh; Belarus; Belize; Bhutan;
Bolivia; Botswana; Brazil; Cambodia;
Cameroon; Cape Verde; China;
Colombia; Comoros; Congo; Dominica;
Dominican Republic; Ecuador; Egypt;
El Salvador; Equatorial Guinea; Fiji;
Gabon; Georgia; Ghana; Grenada;
Guatemala; Guyana; Honduras; India;
Indonesia; Iran; Jamaica; Jordan;
Kazakhstan; Kyrgyzstan; Lao PDR;
Lebanon; Libya; Macedonia;
Madagascar; Maldives; Moldova;

Mongolia; Morocco; Myanmar;
Namibia; Nepal; Nicaragua; Pakistan;
Palestinian Territories; Papua New
Guinea; Paraguay; Peru; Philippines;
Russian Federation; St. Lucia; St.
Vincent and the Grenadines; Samoa;
São Tomé and Principe; Saudi Arabia;
Solomon Islands; South Africa; Sri
Lanka; Sudan; Suriname; Swaziland;
Syrian Arab Republic; Tajikistan;Thailand; Timor-Leste; Tunisia; Turkey;
Turkmenistan; Uganda; Ukraine;
Uzbekistan; Vanuatu; Venezuela; Viet
Nam;

Annex 3: Sub-Saharan countries
Source: World Bank country
classification
http://web.worldbank.org/WBSITE/EXTE
RNAL/DATASTATISTICS/0,,contentMDK:
20421402~pagePK:64133150~piPK:64
133175~theSitePK:239419,00.html#Su
b_Saharan_Africa
Angola; Benin; Botswana; Burkina
Faso; Burundi; Cameroon; Cape Verde;Central African Republic; Chad;
Comoros; Congo; Congo (Democratic
Republic); Côte d'Ivoire; Equatorial
Guinea; Eritrea; Ethiopia; Gabon;
Gambia; Ghana; Guinea; GuineaBissau; Kenya; Lesotho; Liberia;
Madagascar; Malawi; Mali; Mauritania;
Mauritius; Mayotte; Mozambique;
Namibia; Niger; Nigeria; Rwanda; São
Tomé and Principe; Senegal;
Seychelles; Sierra Leone; Somalia;

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 47

South Africa; Sudan; Swaziland;
Tanzania; Togo; Uganda; Zambia;
Zimbabwe.

Annex 4: World Bank classificationof economies
Source: World Bank
http://web.worldbank.org/WBSITE/EXTE
RNAL/DATASTATISTICS/0,,contentMDK:2
0421402~pagePK:64133150~piPK:641
33175~theSitePK:239419,00.html
The list is updated every year on 1st
July. This version is from 2006.
Low-income economies:
Afghanistan; Bangladesh; Benin;
Bhutan; Burkina Faso; Burundi;
Cambodia; Central African Republic;
Chad; Comoros; Congo (Democratic
Republic); Côte d'Ivoire; Eritrea;
Ethiopia; Gambia; Ghana; Guinea;
Guinea-Bissau; Haiti; India; Kenya;
Korea (Democratic Republic);
Kyrgyzstan; Lao PDR; Liberia;
Madagascar; Malawi; Mali; Mauritania;
Mongolia; Mozambique; Myanmar;
Nepal; Niger; Nigeria; Pakistan; Papua
New Guinea; Rwanda; São Tomé andPrincipe; Senegal; Sierra Leone;
Solomon Islands; Somalia; Sudan;
Tajikistan; Tanzania; Timor-Leste; Togo;
Uganda; Uzbekistan; Viet Nam; Yemen;Zambia; Zimbabwe.

Lower middle-income economies:
Albania; Algeria; Angola; Armenia;
Azerbaijan; Belarus; Bolivia; Bosnia
and Herzegovina; Brazil; Bulgaria;
Cameroon; Cape Verde; China;
Colombia; Congo; Cuba; Djibouti;
Dominican Republic; Ecuador; Egypt;
El Salvador; Fiji; Georgia; Guatemala;
Guyana; Honduras; Indonesia; Iran;
Iraq; Jamaica; Jordan; Kazakhstan;
Kiribati; Lesotho; Macedonia;
Maldives; Marshall Islands;
Micronesia; Moldova; Morocco;
Namibia; Nicaragua; Paraguay; Peru;
Philippines; Samoa; Serbia andMontenegro; Sri Lanka; Suriname;
Swaziland; Syria; Thailand; Tonga;
Tunisia; Turkmenistan; Ukraine;
Vanuatu; West Bank and Gaza.
Upper middle-income economies:
American Samoa; Argentina;
Barbados; Belize; Botswana; Chile;
Costa Rica; Croatia; Czech Republic;
Dominica; Equatorial Guinea; Estonia;
Gabon; Grenada; Hungary; Latvia;
Lebanon; Libya; Lithuania; Malaysia;
Mauritius; Mayotte; Mexico; Northern
Mariana Islands; Oman; Palau;
Panama; Poland; Romania; RussianFederation; Seychelles; Slovakia;
South Africa; St. Kitts and Nevis; St.
Lucia; St. Vincent and the Grenadines;
Trinidad and Tobago; Turkey; Uruguay;
Venezuela.

Annex 5: Bristol-Myers Squibb
eligible countries
Countries eligible for 1st pricecategory:
Afghanistan; Angola; Bangladesh;
Benin; Bhutan; Burkina Faso; Burundi;
Cambodia; Cameroon; Cape Verde;Central African Republic; Chad;
Comoros; Congo; Congo (Democratic
Republic); Côte d'Ivoire; Djibouti;
Equatorial Guinea; Eritrea; Ethiopia;
Gabon; Gambia; Ghana; Guinea;
Guinea-Bissau; Haiti; India; Kenya; Lao
PDR; Liberia; Madagascar; Mali;
Mauritania; Mauritius; Mongolia;
Myanmar; Nepal; Nicaragua; Niger;
Nigeria; Pakistan; Papua New Guinea;
Rwanda; São Tomé and Principe;
Senegal; Seychelles; Sierra Leone;
Solomon Islands; Somalia; Sudan;
Tanzania; Timor-Leste; Togo; Tuvalu;
Uganda; Viet Nam; Yemen.
Countries eligible for 2nd pricecategory (Southern African countries):
Botswana; Lesotho; Malawi;
Mozambique; Namibia; South Africa;
Swaziland; Zambia; Zimbabwe.

48 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

Annex 6: Abbott eligible countries
Source: Abbott's Access to HIV Care
Program
http://www.abbott.com/static/content/document/aids_care.pdf
1st Category countries: Africa and LDC(as defined by UN)
Afghanistan; Algeria; Angola;
Bangladesh; Benin; Bhutan;
Botswana; Burkina Faso; Burundi;
Cambodia; Cameroon; Cape Verde;Central African Republic; Chad;
Comoros; Congo-Brazzaville; Côte
d'Ivoire; Dem Rep of Congo; Djibouti;
East Timor; Egypt; Equatorial Guinea;
Eritrea; Ethiopia; Gabon; Gambia;
Ghana; Guinea; Guinea-Bissau; Haiti;
Kiribati; Kenya; Laos; Lesotho;
Liberia; Libya; Madagascar; Malawi;
Maldives; Mali; Mauritania; Mauritius;
Morocco; Mozambique; Myanmar;
Namibia; Nepal; Niger; Nigeria;
Rwanda; Samoa; São Tomé andPrincipe; Senegal; Seychelles; Sierra
Leone; Solomon Islands; Somalia;
South Africa; Sudan; Swaziland;
Tanzania;; Togo; Tunisia; Tuvalu;
Uganda; Vanuatu; Yemen; Zambia;
Zimbabwe.
2nd category countries Low Income
economies (excluding Africa and the
LDC as defined by the UN)
India, Kyrgyzstan, Mongolia, Pakistan,
Papua New Guinea, Tajikistan,
Uzbekistan, Vietnam

Lower Middle Income economies(excluding Africa and the LDC as
defined by the UN)
Albania, Armenia, Azerbaijan, Belarus,
Bolivia, Bosnia and Herzegovina,
Brazil, China, Colombia, Dominican
Republic, Ecuador, El Salvador, Fiji,
Georgia, Guatemala, Guyana,
Honduras, Indonesia, Jamaica, Jordan,
Kazakhstan, Marshall Islands,
Micronesia, Moldova, Nicaragua,Paraguay, Peru, Philippines, Serbia
and Montenegro, Sri Lanka, Suriname,
Syria, Thailand, The FYR-Macedonia,
Tonga, Turkmenistan, Ukraine

Annex 7: Gilead eligible countries
Source: Gilead Access Program
http://www.gileadaccess.org/wt/page/co
untriesAfghanistan; Algeria; Angola; Antigua
and Barbuda; Bahamas; Bangladesh;
Barbados; Belize; Benin; Bhutan;
Bolivia; Botswana; Burkina Faso;
Burundi; Cambodia; Cameroon; Cape
Verde; Central African Republic; Chad;
Comoros; Congo; Congo (Democratic
Republic); Côte d'Ivoire; Djibouti;
Dominica; Dominican Republic; Egypt;
Equatorial Guinea; Eritrea; Ethiopia;
Gabon; Gambia; Ghana; Grenada;
Guatemala; Guinea; Guinea-Bissau;
Guyana; Haiti; Honduras; Indonesia;
Jamaica; Kenya; Kiribati; Kyrgyzstan;
Laos; Lesotho; Liberia; Libya;
Madagascar; Malawi; Maldives; Mali;
Mauritania; Mauritius; Moldova;
Mongolia; Morocco; Mozambique;
Myanmar; Namibia; Nepal; Nicaragua;
Niger; Nigeria; Pakistan; Papua; New
Guinea; Rwanda; St. Kitts and Nevis;
St. Lucia ; St. Vincent and the
Grenadines; Samoa; São Tomé andPrincipe; Senegal; Seychelles; Sierra
Leone; Solomon Islands; Somalia;
South Africa; Sudan; Suriname;
Swaziland; Syria; Tajikistan; Tanzania;
Timor-Leste; Togo; Trinidad andTobago; Tunisia; Tuvalu; Uganda;
Ukraine; Uzbekistan; Vanuatu; Viet
Nam; Yemen; Zambia; Zimbabwe.

Annex 8: Suggested resources for further information:
For documentation on prices quoted by companies:- Untangling the web of price reductions: a pricing guide for the purchase of
ARVs for developing countries, 8th edition, June 2005, Médecins Sans Frontières
http://www.accessmed-msf.org/documents/untanglingtheweb%208.pdf- Sources and prices of selected medicines and diagnostics for people living with
HIV/AIDS (June 2005)
http://www.who.int/medicines/areas/access/med_prices_hiv_aids/en/index.htmlGlobal HIV/Aids Epidemic Selection of Antiretroviral Medications Provided under
U.S. Emergency Plan Is Limited, January 2005:
http://pdf.dec.org/pdf_docs/Pcaab266.pdf
For documentation on prices reported by countries:- WHO, AMDS, Global Price Reporting Mechanism for ARVs in Developing
Countries
http://www.who.int/3by5/amds/price/hdd/- The Global Fund Price Reporting Mechanism
http://www.theglobalfund.org/en/funds_raised/price_reporting/default.asp and- Management Sciences for Health (MSH) International Drug Price Indicator Guide
http://erc.msh.org/mainpage.cfm?file=1.0.htm&id=1&temptitle=Introduction&modu
le=DMP&language=English#top- WHO AFRO region Essential Medicines Price Indicator
http://www.who.int/medicines/publications/afroessential_med_price_indicator_nocover.pdf
For documentation on patents:- “Determining the patent status of essential medicines in developing countries”,
Health Economies and Drugs, EDM Series No. 17, UNAIDS/WHO/MSF, 2004
- HIV/AIDS medicines and related supplies: Contemporary context andprocurement. Technical guide. Chapter 2 and Annex B. World Bank, Washington,
DC, 2004
http://siteresources.worldbank.org/INTPROCUREMENT/Resources/Technical-GuideHIV-AIDS.pdf“Drug patents under the spotlight. Sharing practical knowledge aboutpharmaceutical patents” MSF, June 2004

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 49

For documentation on quality:- Prequalification project managed by the World Health Organization (WHO)http://mednet3.who.int/prequal/- US Food and Drug Administration (FDA) tentative approval
http://www.fda.gov/cder/ogd/approvals/

Annex 9: Company contacts

Other useful websites referenced in this document:- International Dispensary Association (IDA) price indicator
http://www.idafoundation.org- US Food and Drug Administration orange book
http://www.fda.gov/cder/ob/- Catalogue of US Food and Drug Administration approved products, products
documentation
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/- WHO registration
http://ftp.who.int/htm/AMDS/drugsdatabase.pdf- WHO HIV treatment guidelines for adults and adolescents
WHO Antiretroviral Therapy for HIV Infection in Adults and Adolescentsin Resource-Limited Settings: Towards Universal Access: Recommendations for a
public health approach 2006 version (in press). WHO Geneva 2006.
- WHO HIV treatment guidelines for Children
Antiretroviral therapy of HIV infection in infants and children in resource-limited
settings: towards universal access: Recommendations for a public healthapproach 2006 (in press) WHO Geneva 2006.
- UNICEF website for procurement- Biotechnology/Pharmaceuticals HIV/AIDS Industry Report - April 2005
http://www.aethlonmedical.com/pdfs/IndustryReport.pdf- Clinton Foundation
http://www.clintonfoundation.org/
http://www.clintonfoundation.org/pdf/chai-arv-price-list-050807.pdf- Access Campaign web site
http://www.accessmed-msf.org/

HIV /Access Department
Abbott Laboratories
Abbott Place
219 Golf Club Terrace
Constantia Kloof 1719,
Johannesburg
South Africa
Tel: +27 11 858 2000

Abbott:Rob Dintruff
E-mail: rob.dintruff@abbott.com

Aspen:
Sheldon Purdy - Divisional HeadExportTel: + 27 11 2393311
Mobile: + 27 83 4526537
E-mail: Spurdy@aspenpharma..com
Ansie Savrda - Export Pharmaceutical
Affairs Manager
Tel: + 27 11 2396725
Mobile: + 27 82 4428557
Fax: + 27 11 2396001
Email: savrdaa@aspenpharma.com
Aspen Pharmacare
P O Box 1593
Gallo Manor
2052 South Africa
Tel: +27 11 239 6551
Fax: +27 11 239 6573
website :www.aspenpharma.com

Aurobindo Pharma Ltd:
Sharadd Jain
GM International Sales (Formulation)
Aurobindo Pharma Limited
Survey # 313, Bachupally
Qutubullapur Mandal
Hyderabad-500072, India
Tel: +91 40 23044060 Ext 515 (Office)
Email: jainsharadd@aurobindo.com
Website: www.aurobindo.com
Bristol-Myers Squibb:
All countries with the exception ofSouthern Africa:
Mrs Marie-Astrid Mercier,
Coordinator, Global access program,
BMS office: Paris
E-mail: marie-astrid.mercier@bms.com
Southern Africa:
BMS office: Johannesburg
Miss Melinda Scoones
Tel: +27 11 456 65 03
Email: melinda.scones@bms.com
Miss Michelle ClaaseTel + 27 11 456 65 97
Email: michelle.claase@bms.com
Boehringer-Ingelheim:
Philip BaumCD Communications
Tel: +49 6132 77-2459
Fax: +49 6132 77-3829
E-mail: philipp.baum@ing.boehringeringelheim.com
Michael Rabbow
HIV Policy and Public Affairs

50 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

CD Communications
Tel: + 49 6132 77- 92701
Fax: + 49 6132 77-38 29
E-mail:michael.rabbow@ing.boehringeringelheim.com
Cipla Ltd:Mr. Sanjeev Gupte, General ManagerExports
Mr. Shailesh Pednekar
Executive-Exports, Cipla Limited
Tel: +91 22 23021397 (Direct)
23095521 23092891
Fax: +91 2223070013/23070393/23070385
E-mail: exports@cipla.com,
ciplaexp@cipla.com
Gilead:Jennifer Watt
International Access Operations
Gilead Sciences Europe Ltd
2 Roundwood Avenue
Stockley Park
Uxbridge UB11 1AZ
United Kingdom
E-mail: jwatt@gilead.com
Tel: +44 20 8587 2228
GlaxoSmithKline:
Isabelle Girault
Director, Government Affairs
HIV & AIDS
Tel: + 44 (0) 20 8047 5488
Fax: + 44 (0) 20 8047 6957
E-mail: isabelle.s.girault@gsk.com

Hetero Drugs Limited:
Bhavesh ShahHetero Drugs Limited
607/608 Matharu Arcard
Plot No.32, Subhash Road,
Vile Parle (E),
Mumbai – 400 057
India
Tel : +91 22 6691 0809 (office)Tel : +91 22 6692 2829 (direct)
Fax : +91 22 2684 5709
Mobile : +91 98210 44912
Email :bhavesh@heterodrugs.com
Web : www.heterodrugs.com
MatrixAvrind Kanda
DGM, Global Alliances
Matrix Laboratories Limited
1-1-151/1, V Floor, Sairam Towers
Alexander Road, Secunderabad 500003
Andhra Pradesh
India
Tel: +91 40 27700363
Fax: + 91 99482 20256
Sunir GaurBusiness Development
Matrix Laboratories Limited
1-1-151/1, VI Floor. Sairam Towers
Alexander Road Secunderabad 500003
Andhra Pradesh
India
Tel: +91 40 27700363 or + 91 40
55327722
Cell: +91 9948092653
Fax: +91 40 66336401

Merck & Co. Inc:David Greeley
Sr. Director, Global HIV/Aids programs
Merck & Co., Inc.
One Merck Drive
PO Box 100
Whitehouse Station,
NJ 08889-0100
USA
Tel: +1-908-423-4827
Fax: +1-908-735-1192
E-mail: david_greeley@merck.com

Strides Arcolab Ltd:
Mrs. Aloka Sengupta
Vice President AIDS/Tubrculosis/Malaria
Strides House, Bilekahalli
Bannerghatta Road
Bangalore 560 076,
India
Tel: +91-80-66580748
Mobile : +91 98450 24470
Fax: +91-80-66580800
E-mail:aloka.sengupta@stridesarco.com

Ranbaxy:
Mr Atul Chhabra
Manager-HIV Project
Ranbaxy Laboratories Limited
Plot No.-90, Sector-32, NH-8
Gurgaon -122 001
Haryana
India
Tel: + 91-124 -4185917
Fax : + 91-124 -4166035
Email : atul.chhabra@ranbaxy.com
Roche:
Sandra Torriani
Demand Manager
PTGS-O
F.Hoffmann-La Roche Ltd.
Basel
Building 237/2.17
CH 4303 Switzerland
Tel + 41 61 688 9390
Fax: + 41 61 687 1815
Email:
Sandra.torriani_caccato@roche.com
Website:http://ptb.roche.com/ptb/ptbs/

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Annex 10: The Clinton Foundation ARV list

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54 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

Notes &References[1] To consult previous editions, please see
www.accessmed-msf.org[2] Antiretroviral therapy for HIV infection in adults
and adolescents: Recommendations for a publichealth approach, 2006 revision, WHO, Geneva(http://www.who.int/hiv/pub/guidelines/artadultguidel
ines.pdf ); and Antiretroviral therapy of HIV infection
in infants and children: towards universal access:Recommendations for a public health approach,
WHO Geneva 2006
(http://www.who.int/hiv/pub/guidelines/paediatric020
907.pdf )[3] Pharmaceutical patents and the TRIPS
agreement
http://www.wto.org/english/tratop_e/trips_e/pharma_
ato186_e.htm[4] See Section 3(d) and 25 of the 2005 Patents Act
at
http://www.patentoffice.nic.in/ipr/patent/patent_2005.pdf[5] Outcomes of children, stratified by immune
status, receiving anti-retroviral therapy in Médecins
Sans Frontières supported projects in resourcelimited settings. Dr Daniel O'Brien for the MSF HIV/working group, ICASA Conference[6] UNAIDS/WHO AIDS Epidemic Update 2005.
http://www.who.int/hiv/epi-update2005_en.pdf[7] Examples of other generic manufacturers known
to be producing one or more ARVs, but notincluded in this survey are: Richmond Laboratorios,
Panalab, Filaxis (Argentina); Pharmaquick (Benin);
Far Manguinhos, FURP, Lapefe, Laob, Iquego, IVB(Brazil); Apotex, Novopharm (Canada); Shanghai
Desano Biopharmaceutical Co., Northeast General
Pharmaceutical Factory (China); Biogen (Colombia);
Stein (Costa Rica); Zydus Cadila Healthcare,
SunPharma, EAS-SURG, Mac Leods, IPCA, Emcure(India); Cosmos (Kenya); LG Chemicals, Samchully,
Korea United Pharm Inc. (Korea); Protein, Pisa

(Mexico); Andromaco, CombinoPharm (Spain);
Aspen (South Africa); The Government
Pharmaceutical Organization-GPO, T.O. Chemecal(Thailand); Laboratorio Dosa S.A. (USA), Varichem(Zimbabwe).
[8] Sources and Prices of selected medicines anddiagnostics for people living with HIV/AIDS, June2005
http://www.who.int/hiv/amds/sourcesAug05.pdf[9] Incoterms definitions, International Chamber ofcommerce, see
http://www.iccwbo.org/index_incoterms.asap[10] Global HIV/AIDS Epidemic: Selection of
Antiretroviral Medications Provided Under US
Emergency Plan is Limited. Report to Congressional
Requesters. United States Government
Accountability Office. January 2005.
[11] http://www.clintonfoundation.org,
http://www.clintonfoundation.org/pdf/chai-arv-pricelist-050807.pdf[12] WHO Model List of Essential Medicines
http://www.who.int/medicines/publications/essential
medicines/en/[13] WHO Global Price Reporting Mechanism (GPRM)
database (http://www.who.int/hiv/amds/price/hdd/).
The WHO Global Price Reporting Mechanism database contains prices paid by UNICEF, IDA,
MSH/Deliver, and the Global Fund[14] WHO Model list of Essential Medicines 15th list
March 2007(http://www.who.int/medicines/publications/EssMedLi
st15.pdf )[15] GSK Annual Business Report 2006.
(http://www.gsk.com/investors/reps06/annual-report2006.pdf )[16] Major developments in the treatment of
HIV/AIDS, Biotechnology/pharmaceuticals HIV/AIDS
industry report, April 2005
http://www.aethlonmedical.com/pdfs/IndustryReport.
pdf[17] Bristol Myers Squibb company reports Financial
results for the 4th quarter and 12 months of 2006
and announces EPS guidance for 2007(http://www.bms.com/irdocs/4q06earn.pdf )[18] Will once-daily Kaletra be enough to see off
the threat of Reyataz? Pharmaceutical business
review, http://www.pharmaceutical-businessreview.com/article_feature.asp?guid=19B35C8A-0C614E9B-AA08-B8BF93550BDB[21] Bristol Myers Squibb Annual report 2005
(http://library.corporateir.net/library/10/106/106664/ite

ms/189260/BMY_AR_05.pdf )[22] Pérez-Casas C.: HIV/AIDS medicines pricing
report; 6th July 2000 http://www.accessmedmsf.org/prod/publications.asp?scntid=492001113146&contenttype=PARA&[23] Brazilian government's website
www.aids.gov.br[24] Form 10-K Gilead sciences Annual report which
provides a comprehensive overview of the company
for the past year
(http://www.gilead.com/pdf/GILEADSCIENCESI10K.pdf)[25] Gilead press release:
http://www.gilead.com/wt/sec/pr_678072[26] GSK annual Business Report 2006
(http://www.gsk.com/investors/reps06/annual-report2006.pdf )[27] Love J. CIPLA's lamivudine cheaper than Glaxo,
Ip-health 10-06-99, ip-health@essential.org[28] AIDS map treatment and care, nelfinavir
overview www.aidsmap.com[29] Walmsley S, Bernstein B, King M, et al, andthe M98-863 Study Team. Lopinavir-ritonavir versus
nelfinavir for initial treatment of HIV infection. N
Engl J Med 2002;346(26):2039-46.
[30] BI Annual Report 2004 http://www.boehringeringelheim.com/corporate/download/ar/BI_AR2006_en.pdf[31] BI Annual Report 2005 http://www.boehringeringelheim.com/corporate/home/download/BI_AR2005.pdf[32] BI Annual Report 2006 http://www.boehringeringelheim.com/corporate/home/download/BI_AR2004.pdf[33] Healthcare BiotechnologyGilead Sciences(GILD), 20th April 2006
www.som.yale.edu/AnalystReports/dyn/download.php?reportid=269[34] The Regulatory status of Antiretroviral Drugs
Database
http://ftp.who.int/htm/AMDS/drugsdatabase.pdf[35] See MSF press release at
http://www.accessmedmsf.org/prod/publications.asp?scntid=105200611280
2&contenttype=PARA&[36] Abbott Laboratories Highlights from Recent
Management Meetings, North America Equity
Research, 6th July 2005.
[37]
http://www.abbott.com/static/content/document/hivA
ccess_registration.pdf[38] MSF denounces Abbott's move to withhold
medicines from people in Thailand
http://accessmedmsf.org/prod/publications.asp?scntid=1532007142411
4&contenttype=PARA&[39] Patent Application for Aids drug opposed forfirst time in India: MSF press release
http://www.accessmedmsf.org/prod/publications.asp?scntid=303200610215
23&contenttype=PARA&[40] PBS Australia March 2007.
http://www.pbs.gov.au/html/healthpro/publication/vie
w?date=20070301&type=FlashPaper&name=generalschedule[41] BMS Economic Performance
http://www.bms.com/static/ehs/report/data/eco_06.pd
f[42] http://mednet3.who.int/prequal/,
http://www.emea.europa.eu/pdfs/general/direct/pr/27
536707en.pdf,
http://www.emea.europa.eu/pdfs/human/opinion/277
07307en.pdf[43]
http://www.who.int/hiv/art/ARTadultsaddendum.pdf[44]
http://www.who.int/hiv/events/paediatricmeetingreport.pdf[45] Background: Novartis files case in India
challenging patent office order and Patent Law.
http://www.accessmedmsf.org/prod/publications.asp?scntid=269200610341
09&contenttype=PARA&[46]
http://www.lawyerscollective.org/%5Eamtc/%5EPatent_Oppositions/introduction.asp[47]
http://www.who.int/hiv/pub/guidelines/pmtctguideline
s3.pdf[48] Global Summary of the Aids epidemic Dec 2006
http://data.unaids.org/pub/EpiReport/2006/02Global_Summary_2006_EpiUpdate_eng.pdf[49] EFV: Questions about Compulsory Licensing
Brazil Ministry of Health
http://www.aids.gov.br/main.asp?View={E77B47C83436-41E0-AC19E1B215447EB9}&Team=&params=itemID={74BBB44
9-C364-42B9-B92D6ACC1D9DFC21};&UIPartUID={D90F22DB-05D4-4644A8F2-FAD4803C8898}[50] See 2006 GSK press releses archives at http://
www.gsk.com/media/archive.htm#nolink

Médecins Sans Frontières • www.accessmed-msf.org • July 2006 • Untangling the Web of Price Reductions • 55

Glossary

3TC lamivudine; nucleoside analogue
reverse transcriptase inhibitor
ABC abacavir; nucleoside analogue
reverse transcriptase inhibitor
AIDS Acquired Immune Deficiency
Syndrome
ARV Antiretroviral drug
ATZ atazanavir; protease inhibitor
BI Boehringer-Ingelheim
BMS Bristol-Myers Squibb
CIF “Cost Insurance and Freight”. A
commercial term (incoterm) meaningthat the seller delivers once the goods
pass the ship's rail in the port of
shipment. The seller must pay thecosts and freight necessary to bring
the goods to the named port ofdestination BUT the risk of loss ordamage to the goods, as well as any
additional costs due to eventsoccurring after the time of delivery, aretransferred from the seller to thebuyer.
CIP “Carriage and Insurance paid
to...”. A commercial term (incoterm)
meaning that the seller delivers the
goods to the carrier nominated byhim, but the seller must in addition
pay the cost of carriage necessary tobring the goods to the named
destination. This means that the buyer

bears all the risks and any additionalcosts occurring after the goods havebeen delivered. However, in CIP theseller also has to procure insurance
against the buyer's risk of loss of ordamage to the goods during carriage.
Consequently, the seller contracts for
insurance and pays the insurance
premium.

EML Essential Medicines List. First
published by WHO in 1977, it serves
to identify a list of medicines, which
provide safe and effective treatment
for infectious and chronic diseases
affecting the vast majority of theworld's population. The 12th Updated
List was published in April 2002 andincludes twelve antiretrovirals.

d4T stavudine; nucleoside analogue
reverse transcriptase inhibitor

EFV or EFZ efavirenz; non-nucleosideanalogue reverse transcriptase
inhibitor

ddI didanosine; nucleoside analogue
reverse transcriptase inhibitor
DDU “Delivered duty unpaid”. A
commercial term (incoterm) meaningthat the seller delivers the goods tothe buyer, not cleared for import, andnot unloaded from any arriving meansof transport at the named place ofdestination. The seller has to bear thecosts and risks involved in shipping
the goods, other than, whereapplicable, any 'duty' (which includes
the responsibility for the risks of thecarrying out of the customs formalities,
and the payment of formalities,
customs duties, taxes and othercharges) for import in the country ofdestination. Such 'duty' has to beborne by the buyer as well as any
costs and risks caused by his failure toclear the goods for the import time.
EC enteric-coated56 • Médecins Sans Frontières • www.accessmed-msf.org • July 2007 • Untangling the Web of Price Reductions

EXW “Ex-works”. A commercial term(incoterm) meaning that the seller
delivers when he places the goods atthe disposal of the buyer at theseller's premises or another named
place (i.e. works, factory, warehouseetc.) not cleared for export and notloaded on any collecting vehicle.
FOB “Free on board”. A commercial(incoterm) term meaning that theseller delivers when the goods pass
the ship's rail at the named port of
shipment. This means that the buyer
has to bear all costs and risks of loss
or damage to the goods from thatpoint. The FOB term requires the seller
to clear the goods for export.
FDC fixed-dose combination - several
drugs combined in a single pill
FTC emtricitabine; nucleoside analogue
reverse transcriptase inhibitor

Generic drug According to WHO, apharmaceutical product usuallyintended to be interchangeable withthe originator product, which is usually
manufactured without a license fromthe originator company.
GPRM WHO Global Price Reporting
Mechanism is a database containing
prices paid by UNICEF, theInternational Dispensary Association(IDA), Management Sciences for Health(MSH)/Deliver, and the Global Fund toFight AIDS, Tuberculosis and Malaria.
GSK GlaxoSmithKline
HDI Human Development Index. A
summary composite index, compile by
UNDP, that measures a country's
average achievements in three basic
aspects of human development:
longevity (or life expectancy at birth),knowledge (or adult literacy rate andenrolment in education), and a decent
standard of living (gross domestic
product per capita).
HIV Human Immunodeficiency Virus
IDV indinavir; protease inhibitor
LDCs Least Developed Countries,
according to United Nationsclassification
LPV/r Lopinavir/ritonavir; boosted
protease inhibitor

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

PI protease inhibitor

VL Voluntary license

PLWHA People Living With HIV/AIDS

WHO World Health Organization

PMTCT Prevention of Mother-to-Child
Transmission

WHO GPRM WHO Global Price
Reporting Mechanism

ppy per patient per year

WTO World Trade Organization

R&D Research and Development

ZDV zidovudine; nucleoside analogue
reverse transcriptase inhibitor

MSF Médecins Sans Frontières
NDRA National Drug Regulatory
Authority
NGO Non-Governmental Organisation
NFV nelfinavir; protease inhibitor
RTV ritonavir, protease inhibitor
NNRTI Non-Nucleoside Reverse
Transcriptase Inhibitorr low-dose ritonavir, used as a booster

NRTI Nucleoside Analogue Reverse
Transcriptase Inhibitor
NtRTI Nucleotide Reverse Transcriptase
Inhibitor

SQV saquinavir; protease inhibitor
TDF tenofovir disoproxil fumarate;
nucleotide reverse transcriptase
inhibitor
TRIPS Trade-Related aspects ofIntellectual Property Rights

NVP nevirapine; non-nucleosideanalogue reverse transcriptase
inhibitor
OAPI Organisation Africaine de la
Propriété Intellectuelle, African
Intellectual Property Organisation,
whose member states are Benin,
Burkina Faso, Cameroon, Central
African Republic, Chad, Congo, Côte
d'Ivoire, Gabon, Guinea, GuineaBissau, Equatorial Guinea, Mali,
Mauritania, Niger, Senegal, Togo.
PEPFAR President's Emergency Plan
for AIDS Relief, a United States
programme to fight HIV/AIDS indeveloping countries

UNAIDS United Nations Joint
Cosponsored Programme on HIV/AIDS,
created in 1996, to lead, strengthenand support an expanded response to
the HIV/AIDS epidemic. The six original
cosponsors are UNICEF, UNDP, UNFPA,UNESCO, WHO and the World Bank.
UNDCP joined in April 1999.
UNDP United Nations Development
Programme
US FDA United States Food and Drug
Administration

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Campaign for Access toEssential Medicines
Médecins Sans Frontières
Rue de Lausanne 78, CP 116
CH-1211 Geneva 21, Switzerland
Tel: + 41 (0) 22 849 84 05
Fax: + 41 (0) 22 849 84 04
http://www.accessmed-msf.org
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