untangling the web (9th edition) - english version
DESCRIPTION
This is the ninth edition of Untangling the web of price reductions: a pricing guide for the purchase of ARVs for developing countries. The report was first published by Médecins Sans Frontières (MSF) in October 2001[1] in response to the lack of transparent and reliable information about prices of pharmaceutical products on the international market – a factor which significantly hampers access to essential medicines in developing countries.TRANSCRIPT
July 2006 (Revised)
a pricing guide for the purchase of ARVs for developing countries
price Untangling the web of price reductions:
9th Edition
countries
reductions
price
eligibility
price countries
reductions
company
2 •M
édecins Sans Frontières • ww
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ed-msf.org •
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eb of Price Reductions
Table of Contents
Single products
Double fixed-dose com
binations
1Table of contents
5Background
11M
ethodology
Product Cards
12How
to read the product cards
13AB
ACAVIR (ABC)
14ATAZAN
AVIR (ATZ)
15DID
ANOSIN
E (ddl)
16EFAVIREN
Z (EFV)
17EM
TRICITABIN
E (FTC)
18LAM
IVUDIN
E (3TC)
19NELFIN
AVIR (NFV
)
20NEVIRAPIN
E (NVP)
21RITO
NAVIR (r or RTV
)
22SAQ
UIN
AVIR (SQV)
23STAVU
DIN
E (d4T)
24TEN
OFO
VIR DISO
PROXIL
FUM
ARATE (TDF)
25ZID
OVU
DIN
E (AZT, ZDV)
26AB
ACAVIR/LAMIVU
DIN
E (ABC/3TC)
27LAM
IVUDIN
E/STAVUDIN
E (3TC/d4T)
28LO
PINAVIR/RITO
NAVIR (LPV/r)
29TEN
OFO
VIR DISO
PROXIL
FUM
ARATE/EMTRICITAB
INE (TD
F/FTC)
29TEN
OFO
VIR DISO
PROXIL
FUM
ARATE/LAMIVU
DIN
E (TDF/3TC)
30ZID
OVU
DIN
E/LAMIVU
DIN
E (AZT/3TC)
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31LAM
IVUDIN
E/STAVUDIN
E/NEVIRAPIN
E(3TC/d4T/N
VP)
32TEN
OFO
VIR DISO
PROXIL
FUM
ARATE/EMTRICITAB
INE/EFAVIREN
Z (TDF/FTC/EFV
)
33ZID
OVU
DIN
E/LAMIVU
DIN
E/ABACAVIR (AZT/3TC/AB
C)
34ZID
OVU
DIN
E/LAMIVU
DIN
E/NEVIRAPIN
E (AZT/3TC/NVP)
35LAM
IVUDIN
E/STAVUDIN
E + EFAVIRENZ (3TC/d4T+EFV
)
35LAM
IVUDIN
E/ZIDOVU
DIN
E + EFAVIRENZ (3TC/AZT+EFV
)
36TTaabbllee 22::
Conditions of offer by company
38TTaabbllee 33::
Summ
ary of prices in US$ quoted by com
panies for eligible developing countries
Annexes
40AAnnnneexx 11::
Least developed countries (LDCs)
40AAnnnneexx 22::
Hum
an Developm
ent Index (HDI)
40AAnnnneexx 33::
Sub-Saharan countries
41AAnnnneexx 44::
World Bank classification of econom
ies
41AAnnnneexx 55::
Global Fund recipient countries
41AAnnnneexx 66::
Bristol-Myers Squibb eligible countries
42AAnnnneexx 77::
Abbott eligible countries
42AAnnnneexx 88::
Gilead eligible countries
42AAnnnneexx 99::
Suggested resources for further information
43AAnnnneexx 1100::
Company contacts
45Notes and References
46Glossary
Triple fixed-dose combinations
Double fixed-dose com
binations
in co-blister
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Box 1: Q
uality issuesThis report is a pricing guide and does not include detailed inform
ationabout the quality of the products listed. H
owever, price should not be the
only factor determining procurem
ent decisions. Readers and purchasersw
ishing to obtain more inform
ation about drug quality are thereforeencouraged to consult “The W
HO Prequalification Project: Access to
HIV
/AID
S Drugs and D
iagnostics of Acceptable Quality” (know
n as theW
HO prequalification list), a project initiated by the W
orld Health
Organization (W
HO) and developed in collaboration w
ith other United
Nations organisations. This project evaluates pharm
aceuticalm
anufacturers and products according to WHO recom
mended standards of
quality and compliance w
ith Good M
anufacturing Practices. It is part of anongoing process that w
ill expand as the participation of suppliersincreases. N
ot all the products listed in this report have beenprequalified by W
HO, and only som
e of them are used by M
SF in its own
projects. Products included in the last edition of the WHO prequalification
list (38th edition, published on 13th July 2006) appear in bold in thetables. Please consult the W
HO w
ebsite (http://mednet3.w
ho.int/prequal/)for the latest inform
ation.
particularly the case for the most
recent ARVs, including thoserecom
mended in the 2006 W
HO
treatment guidelines
[2]for both first-and second-line), (2) that m
ostoriginator com
panies establish acountry prem
ium, thereby excluding
patients in some developing countries,
(3) that even if companies announce
discounted prices for their products insom
e eligible developing countries, theproducts are in fact not alw
aysavailable or affordable, and (4) thatpaediatric H
IV/AIDS is neglected by
most pharm
aceutical companies.
12000US$
10000US$
8000US$
6000US$
4000US$
2000US$0
Low
est Orig
inator $10439
Jun
e 00
Jan
01
Mar
01
O
ct 01
Ju
ne
02
Dec
02
May
03
D
ec 03
A
pr
04
F
eb
05
Ju
ne
05
July
06
Low
est Orig
inator $727
Low
est Orig
inator $556
Cip
la $132
Hetero
$201H
etero $168
Brazil $2767
Auro
bind
o $209
Cip
la $350
■■
■
■■
■■
■■
■
■■
■■
■■
■■
■■
■■
■■
Graph 1: Sam
ple of ARV triple-combination: stavudine (d4T) + lam
ivudine (3TC)+ nevirapine (N
VP). Lowest w
orld prices per patient per year.
The Effects of Generic Com
petition June 2000-June 2006
BACKGRO
UND
This is the ninth edition of Untangling
the web of price reductions: a pricing
guide for the purchase of ARVs fordeveloping countries. The report w
asfirst published by M
édecins SansFrontières (M
SF) in October 2001
[1]inresponse to the lack of transparentand reliable inform
ation about pricesof pharm
aceutical products on theinternational m
arket – a factor which
significantly hampers access to
essential medicines in developing
countries.
The purpose of this document is to
provide information on prices and
suppliers that will help purchasers
make inform
ed decisions when
buying antiretrovirals (ARV
s). Thisreport is a pricing guide and doesnot include detailed inform
ationabout the quality of the productslisted. For further inform
ation onquality, please see box 1.
Since the first edition of “Untangling”,
prices of some first-line ARVs have
fallen significantly due to competition
between m
ultiple producers. How
ever,M
SF finds that there are still comm
onproblem
s affecting the availability ofthe m
ost needed essential medicines:
(1) that in the absence of competition
from m
ultiple producers, companies
may charge prohibitive prices (this is
(1) Absence of competition leads to
prohibitive prices for ARVsCom
petition between m
ultiplem
anufacturers has had a major im
pactin driving prices dow
n. Treating anadult patient for one year w
ith a tripleantiretroviral first-line regim
ens may
now cost as low
as US$ 132.
Graph 1provides a good illustration of
how prices charged by originator
manufacturers fall as generic
competitors enter the m
arket.
Such reduced prices were a necessary
prerequisite for the scaling up of AIDS
treatment to the levels w
e see today.But the picture is about to changeradically. Faced w
ith the emergence of
resistance and the arrival of improved
Jun00
Jun01
Mar
01Oct
01Jun02
Dec
02Dec
03Apr04
Feb05
Jun05
July06
May
03Generic com
petition has shown to be the m
ost effective means of low
ering drug prices.During the last five years, originator com
panies have often responded to generic competition.
6•
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Graph 2: Average weighted prices paid in 2005, reported to W
HO G
PRM for
second-line ARVs in low- and m
iddle-income countries, com
pared with first-line
regimens
Note: the price of U
S$ 132 quoted above is the price advertised by generic companies. In this
graph, US$ 144 is the 2005 average w
eighted price reported to WHO G
PRM as actually paid by
countries.
products on the market, the new
WHO
guidelines include second generationARVs for both first- and second-linetreatm
ent. In the absence ofcom
petition, the price of treatment
based on these second generationARVs is currently extrem
ely high.
Improved first-line treatm
entW
hereas most of the regim
enspreviously recom
mended included
stavudine (d4T) or zidovudine (AZT),the 2006 W
HO treatm
ent guidelineshave added an im
proved first-linetreatm
ent based on combinations
including tenofovir disoproxil fumarate
(TDF). TD
F is to be administered in
combination w
ith two drugs – one
being either lamivudine (3TC) or
emtricitabine (FTC), the other being
either efavirenz (EFV) or nevirapine
(NVP).
The improved first-line regim
en thereforerepresents only a change in one drug –replacing d4T
or AZTwith TD
F. Butusing such an im
proved first-line, basedon TD
F+3TC+NVP, w
ould increase theannual cost of treating an adult for oneyear in a developing country from
US$
132 (with the triple fixed-dose
combination 3TC/d4T/N
VP) to:
■ at the very least, U
S$ 321, which
is two and a half tim
es more. This
assumes that G
ilead's advertised
differential prices for TDF can be
obtained, and that countries chooseto purchase the cheapest W
HO
prequalified generics for 3TC andNVP.
■ up to U
S$ 708, which is alm
ost five and a half tim
es more. This
assumes the originator
manufacturers' advertised differential
prices can be obtained for all threedrugs. If they cannot be obtained,the price w
ould be higher still.
■ Scaling up treatm
ent to one million
people with this im
proved regimen
would therefore im
ply an extrafinancial burden of betw
een US$
189 million and U
S$ 576 million.
Second-line treatment
It is estimated that 5-10%
of a patientcohort in a given year w
ill need tom
ove from first- to second- line
treatment. D
ata from an M
SF project inSouth Africa show
s that 16.7% of
patients were on a second-line
regimen after 48 m
onths[3].
As more and m
ore patients will need
to move to second-line regim
ens, theim
pact of these prices on the financialsustainability of AID
S programm
es isdevastating. Sw
itching one-tenth ofpatients in a given country in Africa tosecond-line treatm
ent would double
the costs of drugs for the nationalbudget.
Graph 2illustrates this change, by
comparing the price paid in low
-incom
e countries for the first-linecom
bination (3TC/d4T/NVP) w
ith theprice paid in low
- and middle-incom
ecountries for one of the W
HO
recomm
ended second-line regimens
(ABC+ddI+LPV/r), according to the
WHO G
lobal Price ReportingM
echanism (G
PRM) database
[4].
Patent barriers Although Least D
eveloped Countries(LD
Cs) are not obliged under theW
orld Trade Organization (W
TO) rules
enshrined in the 2001 Doha
Declaration to grant or enforce
pharmaceutical product patents until at
least 2016, other developing countriessaw
this transition period end inJanuary 2005
[5]. This includes countriesw
ith significant manufacturing capacity,
such as India, a major source of W
HO
prequalified generic antiretrovirals,
1st line (Low Incom
e Countries)2nd line (Low
Income Countries)
2nd line (Middle incom
ecountries)
$1 700
$5 229x36x12
$144
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which w
ere required to introduce newpharm
aceutical patent legislation. It iscrucial to note that changes in patentlaw
s in countries with m
anufacturingcapacity also affect other countriesthat depend on im
ports from these
countries.
India was therefore required to change
its patent legislation in 2005. Thenew
2005 Indian Patents Act does notaffect m
edicines that were invented
before 1995. How
ever, patentapplications could be filed in Indiafrom
1995 onwards. The Indian patent
offices have started to examine the
thousands of pending patentapplications, and patents on key AID
Sm
edicines may subsequently be
granted.
If a patent were granted for a
medicine for w
hich generic versionsw
ere available before January 2005, itw
ould not stop Indian genericm
anufacturers who already produce
from continuing to m
arket them
edicine, provided they have made a
“significant investment”. Indeed, the
2005 India Patents Act stipulates anautom
atic licensing system w
hichallow
s for the continued production ofthe generic version upon paym
ent of a“reasonable” royalty.
If a patent were granted for a
medicine, but no generic version w
as
marketed before 2005, only patent
holders would have the right to
produce this medicine unless India,
and other countries where the drug is
under patent, make use of the
flexibilities enshrined in the Doha
Declaration on the Agreem
ent onTrade-Related Aspects of IntellectualProperty Rights (TRIPS) and PublicHealth. They could, for exam
ple,authorise governm
ental use or issuecom
pulsory licenses, thereby giving athird party the right to produce,m
arket, export and import the
patented product.
These TRIPS flexibilities, however,
remain underused. Least D
evelopedCountries still continue to purchaseunnecessarily expensive originatorproducts, w
hen much cheaper generics
of equivalent quality exist, and areaccessible to them
under the transitionperiod described above. O
therdeveloping countries are not m
akingfull use of the TRIPS and D
ohaflexibilities to purchase generics, andare continuing to pay prohibitive pricesfor originator ARVs or ration access tothese drugs, w
hen cheaper WHO
prequalified generic versions exist.
Some recent exam
ples include:
■ purchases of nevirapine 200 m
g illustrated in the W
HO G
lobal PriceReporting M
echanism (G
PRM)
summ
ary report issued in March
2006[4], w
hich shows how
“low-
income countries paid on average
US$ 219 per patient-year (even m
orethan m
iddle-income countries, at
US$ 112) as 40.5%
of their totaltransaction volum
e was w
ithBoehringer Ingelheim
(BI), at an
average price of US$ 445 per
patient-year, the remainder 59.5%
being with generic com
panies, at anaverage price of U
S$ 64 per patient-year.” In countries such as Kenya,all buyers (including U
NICEF, the
Global Fund, ID
A, MSH
) reportedhaving bought B
I's product at evenUS$ 499 per patient per year.
Nevirapine is still under patent in
Kenya and in other several low-
income countries or regions such as
Malaw
i, Uganda, Zam
bia, Zimbabw
e[6]
and most francophone African
countries[7].
■ purchases of older ARVs such as lam
ivudine/zidovudine, for which
GPRM
data shows that m
anycountries purchased the originatorproduct at prices ranging from
US$
240 in LDCs such as Zam
bia,Ethiopia or Rw
anda to more than
US$ 270 in South Africa or Sudan,
despite the existence of WHO
prequalified generics available at anaverage of U
S$ 131.
Lack of generic competition also
impacts the production of fixed-dose
combinations (FD
Cs), which w
ere a keyfactor for starting ARV treatm
ent inresource-poor settings. FD
Cs increaseadherence, decrease costs, andfacilitate supplies. But w
ith genericproduction under threat, theproduction of appropriate FD
Cs fornew
er ARVs is at risk.
The Doha D
eclaration was a m
ilestonein its affirm
ation of the primacy of
public health interests in theapplication of intellectual propertyrights protection. By confirm
ing theinherent flexibilities w
ithin the TRIPSAgreem
ent, it allows governm
ents totake m
easures to protect public health,and places the responsibility forensuring that patents do not constitutea barrier to access to m
edicines firmly
in the hands of national authorities.
Mem
ber States of the World Trade
Organization classified as “Least
Developed” are authorised, under
paragraph 7 of the Doha D
eclaration,to not recognise, grant or enforcepatents or data exclusivity rights onpharm
aceutical products that havealready been granted until at least 1stJanuary 2016.
Article 31 of the TRIPS Agreement,
confirmed by paragraph 5(b) of the
Doha D
eclaration, authorises WTO
Mem
bers to produce, purchase, import
8•
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and use generic versions of medicines
under patent protection through thegranting of a com
pulsory licence orgovernm
ent use.
Countries should proactively make use
of these provisions and donorcountries and agencies should activelyencourage countries to use the TRIPSsafeguards to ensure that alreadyscarce resources are not w
asted on thepurchase of overpriced products.
(2) Most of the originator com
paniesestablish a country prem
ium thereby
excluding patients in some developing
countriesW
hen originator companies apply
discounted prices on ARVs, each hasdifferent eligibility criteria, w
hich is aconsiderable source of confusion forpurchasers.
Most originator com
panies offer theirm
ost discounted prices only to acertain group of countries, usuallyLeast D
eveloped Countries and sub-Saharan Africa. These prices arereferred in this docum
ent as firstcategory prices. O
ther companies do it
differently: Merck extends first category
prices to countries ranked as 'low' and
'medium
' on the Hum
an Developm
entIndex w
ith HIV prevalence rates greater
than 1%; G
laxoSmithKline offers
differential prices for their products to
all Global Fund grantees; and G
ileadhas established its ow
n list of eligiblecountries w
ith a sort of mixed criteria,
including some m
iddle-income
countries. This means that if a country
qualifies for the discounted pricesoffered by one com
pany, it may not
necessarily be included in the list ofeligible countries of another com
pany.
Certain manufacturers (such as M
erckand Roche) also offer second categoryprices for som
e middle-incom
ecountries. These are alm
ost twice as
high as the first category prices. Also,Bristol-M
yers Squibb (BM
S) places allSouthern African countries in itssecond category prices, includingcountries as poor as M
ozambique and
others with the highest prevalence rate
in all Africa.
Graph 2, and G
raph 3 below both
show how
middle-incom
e countries arepaying extrem
ely high prices for ARVs.W
ithout competition, the price of
second generation ARVs is prohibitive,and lim
itations imposed by com
paniesto accessing the low
est price lead tohuge discrepancies am
ong developing
countries. Middle-incom
e countries arestill paying 1.5 tim
es the price paid inlow
-income countries for first-line ARVs
and even up to nine times m
ore, fornew
ARVs such as LPV/r, according todata published by W
HO
[9].
(3) Advertised differential prices arenot alw
ays available in eligibledeveloping countries There are tw
o issues here: them
arketing and registration of products,and com
plexity of companies’‘access
programm
es’.
Box 2: Limiting the scope of patentability
On a m
ore positive note, the 2005 India Patents Act includes key provisionsto ensure that patents are not used to extend m
onopolies on medicines
artificially at the expense of the public. Firstly, the law states that patents
should not be granted on derivatives of known m
olecules, such as salts,polym
orphs or combinations, unless efficacy is im
proved. Secondly, thirdparties can seek to oppose a patent before it is granted, on the basis of suchprovisions, to m
ake sure that patents are not unduly granted[8].
Graph 3: Brand and country premium
: example of prices paid
by developingcountries for ARVs
WHO G
PRMAverage prices paid in 2005
5000
4500
4000
3500
3000
2500
2000
1500
1000
50003TC+d4T(30)+NVP
3TC+AZTEFV
ABC 300mg
ddl EC 400mg
TDFRTV
LPV/rLow icom
e countries
Middle incom
e countries
old 1st line ARVs;com
petition
2nd-generation ARVs; no competition
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■ M
arketing and registrationRegistration of a m
edicine allows it to
be marketed in a country after
evaluation of the product dossier bythe relevant N
ational Drug Regulatory
Authorities (NDRA). In order to
purchase or import a drug into a
country, it must be registered there.
Applications must com
e fromm
anufacturers or their representativesin each country.
Nevertheless, som
e companies are
neglecting to register their productseven in countries for w
hich they haveannounced a discounted price. Even incountries w
ith the greatest needs, suchas M
ozambique or Cam
bodia, some
ARVs manufactured by originator
companies are neither registered nor
marketed, and m
ust be bought inneighbouring countries, w
ith all theadditional expenses and investm
ent inhum
an and administrative resources
that this implies.
In fact, non-registered drugs become
unattainable for all but those who can
obtain a special authorisation forim
port from the M
inistry of Health. In
several countries, including Uganda,
Guatem
ala, Honduras, Laos or
Ethiopia, Médecins Sans Frontières'
experience has shown that obtaining
such authorisations to import non-
registered drugs can be extremely
complex and tim
e-consuming.
The consequences of not registering adrug are obvious in term
s of access.Gilead's TD
F is registered in thirteen ofthe 97 countries deem
ed eligible for adiscounted price according to G
ilead'sow
n policies. The significant time
required to overcome the lack of
registration makes the use of TD
F apractical im
possibility for most care-
providers. For instance, in South Africa,M
SF must apply for special
authorisation to use TDF on a patient-
by-patient basis. Another example
concerns Abbott's new therm
ostablelopinavir/ritonavir (LPV/r), w
hich is notregistered anyw
here but in the UnitedStates and the European Union. O
thercountries are therefore forced to usethe older version that is ill-suited tostorage at high tem
peratures, andtherefore unsuitable for m
uch ofdeveloping countries
[10].
The problem is com
pounded by thefact that N
ational Drug Regulatory
Authorities' procedures for registeringthe products are often slow
, even ifcom
panies do everything necessary toget approval. Fast-track registrationprocedures should be put in place fornew
products of relevant interest forpublic health, based on W
HO
prequalification or on registration inhigh-regulated countries.
The pace of registration of ARVs,including generic form
ulations as theybecom
e available, is of criticalim
portance. It is stronglyrecom
mended for countries to
accelerate registration of needed ARVs,applying fast-track procedures for W
HO
prequalified products, thus avoidingunnecessary delays.
■ Com
plexity of companies’so-called
‘access programm
es’The sheer com
plexity of these schemes
also impacts the availability of
advertised differential prices in eligiblecountries. The channel chosen by thecom
panies to distribute the productsoffered at low
er price is still tooburdensom
e.
Roche's products, for example, have to
be ordered from Basel, Sw
itzerland,and paid for in Sw
iss francs, which is
difficult for procurement centres in
developing countries.
MSF's experience purchasing TD
Fdirectly from
Gilead for patients in
South Africa has revealed how the
procedure involves extensivepaperw
ork, including supplyinginform
ation on the history of thetreatm
ent programm
e, funding sources,catchm
ent areas, the type and number
of employees, protocols initiating
treatment, the first- and second-line
regimens used, laboratory m
onitoringand other program
me details.
(4) Paediatric HIV/AID
S is neglected bym
ost companies:
Today, most sm
all children are treatedw
ith liquid formulations. These syrups
or oral solutions are ill-adapted for usein rem
ote settings, as they are complex
to reconstitute and administer, can
taste foul, and are cumbersom
e totransport and store. They are alsoexpensive. Indeed, treating a childw
eighing 10 kg for one year with
stavudine, nevirapine and lamivudine
(d4T, NVP
and 3TC) syrups can cost upto U
S$ 534, while treating an adult
with the sam
e drugs costs US$ 132, or
five times less. A
major difference is
also that adult treatment exists in
fixed-dose combinations, w
hereasproduction of paediatric FD
Cs isextrem
ely limited. An alternative is to
treat children by opening adultcapsules or breaking adult tablets.How
ever, such non-standard practicepresents significant risks of under- orover-dosing.
Yet most m
anufacturers still producepaediatric versions of their drugs onlyin syrups, suspensions or oralsolutions. Som
e companies such as
Gilead, H
etero and Strides do notm
anufacture any paediatric
10•
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formulations at all. Pharm
aceuticalcom
panies are not investing enoughresources in the developm
ent ofappropriate paediatric form
ulations,since it is a sm
all and risky market
without enough im
portance inw
ealthier countries, where prevention
of mother-to-child transm
ission islargely successful.
Alim
ited number of generic paediatric
triple fixed-dose combinations are
currently reaching the market, how
ever,and pressure should be put on thesem
anufacturers to complete their
dossiers and submit it to the W
HO
prequalification as a priority. These arefor first-line therapies (such as thed4T/3TC/N
VPFD
C manufactured by
both Cipla and Ranbaxy). But nosecond-line form
ulations are in thepipeline for children and m
oreform
ulations are needed to complete
the spectrum of regim
ens needed in anAID
S programm
e.
Donors and international organisations
need to prioritise paediatric AIDS
therapy, and work proactively to
encourage much-needed R&
D for this
neglected group of patients. WHO
must give clear recom
mendations to
manufacturers on dosages for children,
to avoid the current situation where
Cipla and Ranbaxy are developingpaediatric form
ulations for
3TC/d4T/NVP, but at different dosages.
The WHO Prequalification project m
ustprioritise these products, by outliningthe requirem
ents needed for thequalification of the new
formulations.
If necessary, support should beorganised to help m
anufacturers speedup the com
pletion of their productdossiers.
FINAL
CONSID
ERATIONS
According to UNAID
S and WHO, an
estimated 250,000 to 350,000 deaths
were averted in 2005 because of
expanded access to AID
S treatment.
This picture must be balanced w
iththe three m
illion people who died of
AID
S-related illnesses in 2005. Of
these, more than 500,000 w
erechildren
[11]. Proactive efforts must be
taken. These must not only focus on
increasing the number of patients on
treatment, but also on providing
them w
ith the best possibletreatm
ent, which includes ensuring
that those who begin treatm
ent will
receive at affordable prices second-and even third-line treatm
ent, when
they eventually need it.
95% of the people living w
ith HIV live
in developing countries. Research anddevelopm
ent (R&D) for diagnostics,
medicines, preventive therapies, and
vaccines, for children, mothers, and
adults must be conducted to develop
products that are affordable andsuitable for use in rem
oter settings.The need for these specific m
edicaltools is clear. This echoes the recentdecision by the 2006 W
orld Health
Assembly to draw
up a strategy andplan of action to secure an enhancedand sustainable basis for needs-driven,essential health R&
D.
Patents should no longer be a barrierto accessing affordable m
edicines,increasing generic com
petition andassuring that the appropriate FD
Cs,including those for children, aredeveloped. Flexibilities in bothinternational and national patent rulesexist to allow
for this and there is noexcuse for delaying the use of thesesafeguards. H
owever, despite the
medical urgency, it seem
s that thepolitical w
ill to do so is often lacking.
Médecins Sans Frontières • w
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METH
ODOLO
GY
As with previous editions, M
SF sentquestionnaires to both originator andgeneric com
panies asking them to
provide the following inform
ationabout ARV prices for developingcountries: price per unit (or per dailydose), restrictions that apply to each ofthe prices quoted (eligibility criteria),and any additional specificityapplicable to the quoted prices. Thedata w
ere collected up to 18th May
2006.All originator com
panies marketing
ARVs were included in the survey. But
the list of generic producers is by nom
eans exhaustive[12]. Indeed, only
those generic companies having at
least one antiretroviral prequalified byW
HO are included in the survey.
Some im
portant preliminary rem
arkson the data presented in this report:
■ The inform
ation on prices given in this docum
ent only relates to ARVs.It does not include other costslinked to antiretroviral treatm
ent,such as diagnosis, m
onitoring ortreatm
ent of opportunisticinfections. For inform
ation on theprices of these products, pleaseconsult the m
ost recent edition of“Sources and prices of selecteddrugs and diagnostics for peopleliving w
ith HIV/AID
S”, published
yearly by UNICEF, U
NAID
S, WHO,
and MSF
[13].
■ The prices listed here are those quoted as sale prices by them
anufacturers. The prices paid bythe consum
er might be higher
because of add-ons (such as import
taxes and distribution mark-ups), or
may be low
er if subsidised.
■ Com
panies might use different trade
terms (know
n as incoterms
[14]). Pricesquoted by all generic com
panies,plus Roche, Abbott and G
ilead are“FCA” or “FO
B”, m
eaning thattransport, international freight andinsurance costs are not included.Rem
aining companies listed in this
report do include freight andinsurance in their prices. Prices havenevertheless not been adjusted. Asrecently dem
onstrated by US
General Accountability O
ffice, thesedifferences do not underm
ine theiressential com
parability[15].
■ O
riginator companies have different
eligibility criteria for countries andentities, as explained in theintroductory chapter. The differentcategories of prices are detailed inthe product cards. Please refer toTable 2 for explanations on differenteligibility criteria quoted bycom
panies.
■ G
eneric companies norm
ally do not im
pose restrictions on prices, exceptfor Aspen. But occasionally genericcom
panies may negotiate prices
different from those quoted here.
■ The Clinton H
IV/AIDS Initiative
[16]for exam
ple negotiates prices for ARVsand diagnostic tests w
ith genericcom
panies on behalf of nationalAID
S programm
es included in theirconsortium
. To date the ClintonFoundation has reached agreem
entsw
ith five ARVs manufacturers to
lower the prices of 20 ARV
formulations. W
hen these pricesdiffer significantly from
thosequoted in the survey by com
panies,they are m
entioned in the productcard.
■ Inform
ation on patents is only indicative and should be checkedw
ith national authorities. It shouldin no w
ay form the basis of a
procurement decision.
■ Inform
ation on the WHO pre-
qualification status must alw
ays bechecked in the W
HO w
ebsite(http://m
ednet3.who.int/prequal/)
12 •M
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eb of Price Reductions
products according to WHO recom
mended standards of quality and G
oodM
anufacturing Practices.
Chart 1: Evolution of the lowest price quoted by com
panies for eligiblecountries since 2001This chart show
s the price evolution over time, for both originator and generic
products, as quoted to MSF surveys since 2001. W
hen they exist, only genericproducts that are W
HO prequalified are considered for the graph. If no generic
is WHO prequalified yet, the low
est possible price is taken into account.
Chart 2: Transaction prices of ARVs purchased in developing countries ascom
piled by WHO G
PRM 2005-2006
This chart gives examples of transaction prices of ARVs purchased in som
edeveloping countries, as com
piled by WHO/AM
DS G
lobal Price ReportingM
echanism (G
PRM)[9,18], based on inform
ation from U
NICEF, International
Dispensary Association, M
SH/D
eliver, and the Global Fund. This chart does not
represent the price paid by consumers, w
hich might be higher (due to taxes,
transport, and other add-ons along the distribution chain), or lower if
subsidised. Each point in the chart represents one transaction, so one countrycan be represented by several points.
Spotlight on access issuesIn this new
edition we have tried to sum
marise the m
ost salient issues relatedto access to each product, w
ith the aim of facilitating inform
ed decisions atcountry level, taking into account the problem
s and obstacles that may be
encountered when trying to gain access to a product, and at the best price.
How
to read the product cards?
General inform
ation:For each of the ARVs, general inform
ation on the history of the product andrelevant W
HO guidance is provided
[2,17].
Table 1: Prices quoted by companies for eligible developing countries
All prices are quoted in US$. Conversions have been m
ade on the day theprice inform
ation was received using the currency converter site:
ww
w.oanda.com
. Prices are rounded up to the third decimal for unit price and
to the nearest whole num
ber for yearly price per patient.
The annual cost of treatment per patient (ppy) has been calculated according
to WHO dosing schedules, m
ultiplying the unit price (one tablet or capsule) bythe num
ber of units required for the daily dose and by 365. The price ofsm
allest unit is included in brackets.
When no inform
ation was provided, w
e have inserted “n/a” for “not available”.
For paediatric treatments, prices are calculated for a 10 kg child using W
HO
treatment guidelines
[2]. This is an estimate since the w
eight of a child increasesduring any given year. W
hen it was not possible to calculate the dose for a 10
kg child, only the unit price is indicated.
To know w
hether 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 W
HO prequalification list
(38th edition, published 13th July 2006) appear in bold in the tables. Readersand purchasers w
ishing to obtain more inform
ation about the quality of ARVsare encouraged to consult the W
HO Prequalification project w
ebsite(http://m
ednet3.who.int/prequal/) as this list is updated very frequently.
Initiated by WHO in 2001, and developed in collaboration w
ith other UnitedNations agencies, this project evaluates pharm
aceutical manufacturers and
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July 2006 (Revised) •Untangling the W
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ABACAVIR (ABC)
General inform
ation
•Therapeutic class: H
IV-1 and HIV-2
nucleoside reverse transcriptase inhibitor(N
RTI)
•Indicated for first- and second-line, for
adults, adolescents and children (WHO
2006 guidelines[2])
•Originator com
pany, and product brandnam
e: GlaxoSm
ithKline (GSK), Ziagen
•First approval by U
S Food and Drug
Administration (FD
A): 17th Decem
ber1998
•Included in the W
HO M
odel List ofEssential M
edicines (EML)
[17]
•W
orld sales of originator product: US$
290 million in 2004
[19]
3000
2500
2000
1500
1000
5000Oct Jan D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic price
lowest originator price
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries
As of June 2006, there was a W
HO prequalified generic source of Abacavir,
and hence its price is considered here.
Between O
ctober 2001 and June 2006, the lowest price of the originator
product was divided by 2.2. D
uring same period of tim
e, generic prices havebeen divided by 4.5.
Spotlight on access issues:There is a need for greater com
petition between m
anufacturers to reduce prices further. The current lowest price for the originator product, at
US$ 636, is alm
ost five times the price of the triple FD
C used in most first-line regim
ens today.
In addition, because of GSK
's eligibility restrictions, potential non-African buyers of abacavir that are not funded by the G
lobal Fund, have noaccess to the low
est prices for the GSK
product.
Although the abacavir m
olecule was developed in the 1980's, G
SK applied for patents in 1997 on abacavir sulphate. This m
ay hamper generic
competition. If the Indian patent office grants a patent, Indian m
anufacturers may have to w
ithdraw their products from
the market, unless
they can make use of the autom
atic licensing provisions of the 2005 India Patents Act (see introduction). Indian NGOs and m
anufacturers may
however seek to oppose the granting of this patent in India.
Although abacavir w
as included as part of first-line NRTI backbone in m
ost recent WHO recom
mendations for paediatric treatm
ent, no company
has yet developed a child-friendly version.
Eligibility restrictions
ABC 300 m
g tablets
ABC 20 m
g/ml oral solution
Daily dose
2--
GSK
See table 2
636 (0.871)
304 (0.104/ml)
Aurobindo
none
564 (0.780)
Cipla
none
456 (0.625)
336 (0.115/ml)
Hetero
none
727 (0.995)
Ranbaxy
none
511 (0.700)
Note: the Clinton Foundation has agreed w
ith Cipla to sell ABC 300 m
g at US$ 447 per patient per year in countries included in their
consortium[16].
Chart 1: Evolution of the lowest price quoted for eligible developing
countries since 2001
2628
US$ ppy
636
564
1387
ABC 300 m
g
14•
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ATAZANAVIR (ATZ)
General inform
ation
•Therapeutic class: H
IV-1 proteaseinhibitor (PI)
•Indicated for second-line, for adults
and adolescents (WHO 2006 guidelines
[2])
•Originator com
pany, and product brandnam
e: Bristol-Myers Squibb (B
MS),
Reyataz
•First approval by U
S Food and Drug
Administration (FD
A): 20th June 2003
•Not included in the W
HO M
odel List ofEssential M
edicines (EML)
[17]
•W
orld sales of originator product: US$
81 million in 2003, U
S$ 369 million in
2004. ATZ represents 19.6% of all PI
sales in the US
[20].
Spotlight on access issues:Atazanavir is one of the three protease inhibitors recom
mended by W
HO for second-line treatm
ent, and is the most patient-friendly PI as its
administration requires an intake of only tw
o 150mg pills a day. B
ut its price, at more than U
S$ 6,125 per adult patient per year in richm
arkets[21], is prohibitive for developing countries. M
oreover, it must be com
bined with ritonavir as a booster, so the final cost w
hen compared
with other PI regim
ens is prohibitive.
Patents on ATZ were applied for in 1997-98 in m
any countries, including India. Oppositions to the patent application m
ay however be filed in
India. Unrestrained generic com
petition from Indian com
panies will only be possible if the patent is rejected by the Indian patent office or if
the Indian government is w
illing to grant compulsory licenses to Indian m
anufacturers or applies for governmental use.
Médecins Sans Frontières • w
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July 2006 (Revised) •Untangling the W
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Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:DID
ANOSIN
E (ddI)
General inform
ation
•Therapeutic class: H
IV-1 and HIV-2
nucleoside reverse transcriptase inhibitor(N
RTI)
•Indicated for second-line, for adults,
adolescents and children (WHO 2006
guidelines[2])
•Originator com
pany, and product brandnam
e: Bristol-Myers Squibb (B
MS), Videx
•First approval by U
S Food and Drug
Administration (FD
A): October 1991 for
chewable tablets; O
ctober 2000 for enteric-coated tablets
•Included in the W
HO M
odel List of EssentialM
edicines (EML)
[17]
•W
orld sales of originator product: US$ 274
million in 2004
[22] (in 1999, the figure was
already US$ 205 m
illion[23])
•Didanosine w
as developed by the National
Institutes of Health (N
IH), a U
S government
research institute, which then licensed the
drug to Bristol-Myers Squibb, in exchange for
a 5 to 6% royalty on sales
[24]. NIH
basicpatents on didanosine are supposed to expirein the U
S in 2006-2007, but BM
S holdspatents on im
proved formulations, w
hich rununtil 2012 and 2018.
Chart 1: Evolution of the lowest price quoted for
developing countries since 2001As of June 2006, there w
as no WHO prequalified
generic source of didanosine 400mg. The low
estavailable generic price is therefore given here.
In the absence of strong competition, originator
prices have not changed in the last five years.
Spotlight on access issues:The B
ristol-Myers Squibb list of eligible countries is too lim
ited, as it only includes 66 countries, and the product is not always available in the countries defined
as eligible. Additionally, BM
S has no pricing policy for middle-incom
e countries. For instance, according to the WHO G
PRM
database in 2005, in El Salvador,w
here there is no competition, purchasers paid U
S$ 1,533 per patient per year for the originator 100 mg form
ulation (five times the price fixed by B
MS in
eligible countries). But in neighbouring H
onduras, where there is com
petition between the originator and generic alternatives, the sam
e report lists the pricecharged by B
MS at U
S$ 429 per patient per year.
Similarly, according to a M
édecins Sans Frontières (MSF) survey com
pleted in September 2005, M
SF paid US$ 3,175 per patient per year for ddI EC 400 in
Guatem
ala (or 1000% m
ore than the lowest B
MS price), U
S$ 1,091 in Thailand (280%), and U
S$ 975 in Ukraine (238%
). The enteric-coated ddI is not yet widely
used, but is recomm
ended in the new W
HO guidelines for second-line treatm
ent, and therefore all steps should be taken to improve access to this product as
scaling up occurs. There is an urgent need to have generic versions prequalified by WHO, and m
ade available in countries. How
ever, it remains to be seen
whether B
MS w
ill obtain patents in India on the enteric-coated formulation of ddI.
350
300
250
200
150
100500
ddl 400 mg EC
Oct Jun D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic price
lowest originator price
Eligibility restrictions
ddI 25 mg tablets
ddI 50 mg tablets
ddI 100 mg tablets
ddI 200 mg tablets
ddI 250 mg enteric-
coated capsules
ddI 400 mg enteric-
coated capsules
ddI 2 g powder for
reconstitution
Daily
dose
----4211--
BM
S
1stcategory
SouthernAfrican
countries
Aspen V
Lfrom
BM
SAurobindo
Cipla
See table 2See table 2
None
None
310 (0.212)
223 (0.611)
288 (0.789)
130 (6.295/2g)
401 (0.275)
273 (0.747)
352 (0.964)
140 (7.697/2g)
(0.191)
(0.192)
307 (0.210)233 (0.160)
127 (0.350)
208 (0.570)
44 (2.160/2g)
(0.063)
(0.075)
195 (0.134)
146 (0.200)
103 (0.283)
134 (0.367)
Hetero
None
280 (0.192)
Ranbaxy
None
321 (0.220)
146 (0.400)
219 (0.600)
278271
134
288
US$ ppy
16 •M
édecins Sans Frontières • ww
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EFAVIRENZ (EFV
)
General inform
ation
•Therapeutic class: H
IV-1 non-nucleosidereverse transcriptase inhibitor (N
NRTI)
•Indicated for first- and second-line, for
adults, adolescents and children (WHO 2006
guidelines[2])
•Originator com
panies, and product brandnam
es: Bristol-Myers Squibb (B
MS), Sustiva,
or Merck, Stocrin
•First approval by U
S Food and Drug
Administration (FD
A): 17th September 1998
•Included in the W
HO M
odel List of EssentialM
edicines (EML)
[17]
•W
orld sales of originator product: US$ 621
million in 2004
[19].. In 2004, EFV was the m
ostprescribed ARV in the U
S, representing 65%of all N
NRTIs prescriptions
•Efavirenz w
as developed by Dupont Pharm
aand is now
marketed by B
MS. M
erck has them
arketing license in several countries.
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Spotlight on access issues:Efavirenz is a key drug for first-line treatm
ent. Although EFV
has been marketed for a considerable period already, its price is still very high.
Alone, it is priced at m
ore than twice the price of the m
ost widely used triple FD
C (stavudine, lamivudine and nevirapine).
The generic products are priced between 2.4 and 3.2 tim
es cheaper than Merck's second category price, but countries are still purchasing the
originator product. Even buyers in some countries such as El Salvador, B
olivia or Tajikistan were reported by the W
HO G
PRM
as paying more
than US$ 800 and as m
uch as US$ 1,128 in 2005. In B
razil, where this product is under patent, in 2005 EFV
alone took up 14% of the
National A
IDS Program
me budget
[25].
There is an urgent need to have fixed-dose combinations including efavirenz that could sim
plify the new W
HO recom
mended treatm
ent.
Eligibility restrictions
EFV 50 m
g capsule
EFV 200 m
g capsule
EFV 600 m
g tablet
EFV 30 m
g/ml
suspension
Daily
dose
--31--
1stcategory
2nd category
AurobindoM
erkCipla
Hetero
Ranbaxy
Strides
See table 2None
None
None
(0.116)
394 (0.360)
277 (0.760)
309 (0.094)
(0.213)
821 (0.750)
697 (1.910)
496 (0.151)
(0.110)
292 (0.267)
299 (0.820)
227 (0.069)
225 (0.206)
217 (0.597)
292 (0.267)
291(0.750)
300 (0.274)
292 (0.800)240 (0.670)
US$ ppy
1000
800
600
400
200
0
US$ ppy
9008007006005004003002001000
EFV 200 m
g
Oct June D
ec May D
ec Apr Feb June June01 02 02 03 03 04 05 05 06
generic pricelow
est originator priceoriginator 2nd price
EFV 600 m
g
Oct Jun D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic pricelow
est originator priceoriginator 2nd price
500
485300 394
767
462
346277
217
697
920821
None
None
Note: the Clinton Foundation has agreed w
ith Aspen, Cipla, R
anbaxy, and Strides to sell EFV 600 m
g at the price of US$ 240 per patient per year,
and with R
anbaxy and Strides to sell EFV 200 m
g at the price of US$ 240 per patient per year, in countries of their consortium
[16].
Chart 1: Evolution of the lowest price quoted for
eligible developing countries since 2001
The price of the lowest W
HO prequalified
generic of EFV is given here.
Médecins Sans Frontières • w
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July 2006 (Revised) •Untangling the W
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EMTRICITABIN
E (FTC)
General inform
ation
•Therapeutic class: H
IV-1 nucleosidereverse transcriptase inhibitor (N
RTI)
•Indicated for first-line, for adults (W
HO
2006 guidelines[2])
•Originator com
pany and product brandnam
e: Gilead, Em
triva
•First approval by U
S Food and Drug
Administration (FD
A): July 2003
•Not included in the W
HO M
odel List ofEssential M
edicines (EML)
[17]
•W
orld sales of originator product: US$
10 million in 2003 (in five m
onths)[26],
US$ 57.6 m
illion in 2004[27].
•Em
tricitabine was developed by Em
oryUniversity in 1996. The University agreedto w
aive their right to a royalty on salesw
ithin the Gilead Access Program
[28].
•Patents on the basic m
olecule are dueto expire in 2010-2011
[28].
Spotlight on access issues:
Emtricitabine is neither registered nor m
arketed in developing countries, but is available co-formulated w
ith TDF. W
hen making the choice, it
should be taken into account that there are potential intellectual property issues that could affect this product in countries in need, while its
older therapeutic equivalent, lamivudine (w
hich has the same indications and profile), could be free of such restrictions.
18•
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LAMIVU
DIN
E (3TC)
General inform
ation
•Therapeutic class: H
IV-1 and HIV-2
nucleoside reverse transcriptase inhibitor(N
RTI)
•Indicated for first- and second-line for
adults and adolescents, and for first-line onlyfor children (W
HO 2006 guidelines
[2])
•Originator com
pany, and product brandnam
e: GlaxoSm
ithKline (GSK), Epivir
•First approval by U
S Food and Drug
Administration (FD
A): Novem
ber 1995
•Included in the W
HO M
odel List of EssentialM
edicines (EML)
[17]
•W
orld sales of originator product: US$ 549
million in 2004
[19]and more than U
S$ 500m
illion each year for last nine years[29].
•Patent status: the patent holder is IAF
Biochem International SA
(Canada). Variouslitigations have taken place w
ith the rights, asresearch w
as undertaken by others includinga Yale University scientist. G
SK pays a 14 %royalty to the Canadian firm
[30].
250
200
150
100500Oct Jan D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic price
lowest originator price
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Chart 1: Evolution of the lowest price quoted for eligible developing
countries since 2001The price of the low
est WHO prequalified generic of 3TC is given here.
Spotlight on access issues:
Lamivudine is a product in high dem
and, whose price has
substantially decreased. There are, as of June 2006, five generic
versions prequalified by WHO. In 2005, m
ost countries reported to
the WHO G
PRM
having paid the lowest price, w
hether for the
generic or the originator product.
Some transactions, how
ever, were reported at double the price, or
more, for exam
ple in Swaziland - w
ith Cipla's product, or in
Thailand - with G
PO's product.
In China, lamivudine is still unaffordable at U
S$ 1,977 per patient
per year, due to GSK
monopoly rights on the drug.
No com
pany produces a child-friendly low dosage pill, and
adapted dosages, for example 75 m
g tablets, are urgently
required. Some fixed-dose com
bination formulations for children
containing 3TC have been developed by generic companies and
should reach the market very soon.
Eligibility restrictions
3TC 150 mg tablet
3TC 300 mg tablet
3TC 10 mg/m
l oral solution and drysyrup
Daily
dose
21--
AurobindoGSK
Aspen under
VL
from G
SKCipla
Hetero
Ranbaxy
Strides
None
None
None
69 (0.095)
n/a
82 (0.028)
69 (0.095)
50 (0.017)
54 (0.075)
56 (0.155)
58 (0.020)
51 (0.070)
54 (0.150)
52 (0.018)
53 (0.073)66 (0.090)
66 (0.18)
58 (0.080)
None
None
See table 2See table 2
234
91
51 69
US$ ppy
Note: the Clinton Foundation has agreed w
ith Cipla to sell abacavir 50 mg / 5 m
l at US$ 0.009 per unit (m
l) in countries included in theirconsortium
[16].
lamivudine 150 m
g
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NELFIN
AVIR (NFV
)
General inform
ation
•Therapeutic class: H
IV-1 and HIV-2 protease
inhibitor (PI)
•Indicated only for second-line in adults,
adolescents and children (WHO 2006
guidelines[2])
•Originator com
pany, and product brandnam
e: Roche, Viracept
•First approval by U
S Food and Drug
Administration (FD
A): 14th March 1997
•Included in the W
HO M
odel List of EssentialM
edicines (EML)
[17]
•W
orld sales of originator product: US$ 259
million in 2004
[19]
•Nelfinavir w
as developed by AgouronPharm
aceuticals Inc. in collaboration with the
pharmaceutical division of Japan Tobacco Inc.
In Europe and a few other countries outside
the United States, Agouron/Pfizer has licensedRoche to m
arket nelfinavir[31]. Patents on
nelfinavir are due to expire in 2014.
0.45
0.4
0.35
0.3
0.25
0.2
0.15
0.1Roche 1st category of countries
Roche 2nd category
of countries
originator price
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries
Chart 2: Transaction prices for NFV as com
piled by WHO GPRM
in 2005-06(see “how
to read the product cards” box)For the treatm
ent of children, procurement prices reported in 2005 to the
WHO G
PRM w
ere always higher than the price announced by the com
pany- m
ore than twice in Guatem
ala, for example.
Chart 1: Evolution of the lowest price quoted for eligible developing
countries since 2001As of June 2006, there w
as no WHO prequalified generic source of
nelfinavir. The lowest available generic price is therefore given here
NFV 50 m
g / g
Spotlight on access issues:The use of nelfinavir in children is extrem
ely complex, due to the significant am
ounts of powder that have to be taken on a daily basis (12
grams of pow
der twice a day for a 10 kg child). N
ot only is this formulation ill-adapted, but its price rem
ains prohibitive, as is the case with
other protease inhibitors. There is no generic production of adapted paediatric formulations .
▲
▲
▲
▲
▲
▲▲
▲▲
▲▲
▲
▲
▲
Eligibility restrictions
NFV
250 mg tablets
NFV
625 mg tablets
NFV
50 mg/g oral
powder
Daily
dose
94--
Roche
1stcategory
2ndcategory
AurobindoCipla
Hetero
See table 2None
None
None
683 (0.208)
n/a
69 (0.174)[32]
1,543 (0.470)
n/a
82 (0.199)[32]
1,379 (0.420)1,337 (0.407)
986 (0.300)
US$ ppy
3500300025002000150010005000
NFV
250 mg
Oct June D
ec May D
ec Apr Feb June June01 02 02 03 03 04 05 05 06
generic pricelow
est originator priceoriginator 2nd price
2924 3139
986
683
2361
1543
US$ per unit
20•
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NEVIRAPIN
E (NVP)
General inform
ation
•Therapeutic class: H
IV-1 non-nucleosidereverse transcriptase inhibitor (N
NRTI)
•Indicated for first- and second-line, for
adults, adolescents and children (WHO 2006
guidelines[2])
•Originator com
pany, and product brandnam
e: Boehringer-Ingelheim
(BI), Viram
une
•First approval by U
S Food and Drug
Administration (FD
A): 21st June 1996
•Included in the W
HO M
odel List of EssentialM
edicines (EML)
[17]
•W
orld sales of originator product in 2004:US$ 282 m
illion[33]
•Patents on the nevirapine m
olecule are dueto expire in 2010 in m
ost countries, but BI
also holds patents on the syrup formulation
of nevirapine, which could run until 2018.
500
400
300
200
1000Oct Jan D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic price
lowest originator price
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Spotlight on access issues:In m
any developing countries, Boehringer-Ingelheim
's nevirapine isstill being bought, although cheaper W
HO prequalified generic
versions exist.The brand prem
ium for N
VP
is prohibitive: in 2005, many buyers
reported to the WHO G
PRM
paying prices five times higher than W
HO
prequalified generics. Countries such as Bulgaria, B
elarus and theRussian Federation are paying betw
een US$ 2,614 and U
S$ 5,213 perpatient per year (or betw
een 500 and 1100% higher than the low
estBI price).
Further, according to WHO G
PRM
Summ
ary report issued in March
2006, “in the case of nevirapine 200 mg, low
-income countries paid
on average US$ 219 per patient-year as 40.5%
of their totaltransaction volum
e was w
ith Boehringer Ingelheim
, at an averageprice of U
S$ 445 per patient-year, the remainder 59.5%
being with
generic companies, at an average price of U
S$ 64 per patient-year.” But these generics need to be registered - this is especially urgent in
the case of paediatric formulations, as the originator product is not
always available.
Some FD
C tablet formulations containing N
VP
for children have beendeveloped by generic com
panies and will be soon on the m
arket. BI
applied for a patent on the syrup formulation of nevirapine, w
hich, ifgranted, could ham
per such developments. P
LWHA
groups in Indiaopposed the grant of this patent before the Indian patent office on9th M
ay 2006. The final decision was still pending at the tim
e ofpublication.
438
150
432
56
Eligibility restrictions
NVP
200 mg tablets
NVP
10 mg / m
l or 50
mg
/5ml suspension
Daily
dose
2--
AurobindoBI
Aspen under
VL
from B
ICipla
Hetero
Ranbaxy
Strides
None
None
None
432 (0.600)
401 (0.073)
97 (0.133)
214 (0.039)
61 (0.083)
135 (0.025)
56 (0.075)
99 (0.018)
73 (0.100)61 (0.083)
60 (0.080)
None
None
See table 2See table 2
Chart 1: Evolution of the lowest price quoted for eligible developing countries
since 2001The low
est WHO prequalified generic price for N
VPis given here. In five years, the
generic price, (which from
the outset was already m
uch lower than the originator
price) has been halved, while the originator price has rem
ained constant. As of June 2006, the originator price w
as eight times m
ore expensive (770%), than
the WHO prequalified generics.
US$ ppy
Nevirapine 200 m
g
Note: the Clinton Foundation has agreed w
ith Cipla to sell NVP
50 mg / 5 m
l at US$ 0.009 per unit (m
l) in countries included in theirconsortium
[16].
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RITONAVIR (r or RTV
)
General inform
ation
•Therapeutic class: H
IV-1 and HIV-2 protease
inhibitor (PI)
•Indicated for second-line as a booster, for
adults, adolescents and children (WHO 2006
guidelines[2])
•Originator com
pany, and product brandnam
e: Abbott Laboratories, Norvir
•First approval by U
S Food and Drug
Administration (FD
A): March 1996 for the oral
solution and 29th June 1999 for capsules
•Included in the W
HO M
odel List of EssentialM
edicines (EML)
[17]
•W
orld sales of originator product: US$ 194
million in 2004, U
S$ 93 million in 2003, and
US$ 122 m
illion in 2002[34].
500
400
300
200
1000Oct Jun D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic price
lowest originator price
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Chart 1: Evolution of the lowest price quoted for eligible developing
countries since 2001
Spotlight on access issues:RTV
is of crucial importance for scaling up and m
anagement
of second-line treatment, as all protease inhibitors m
ust beboosted w
ith this drug.
Abbott has developed a heat-stable fixed-dose combination
of ritonavir combined w
ith lopinavir, but the heat-stableritonavir alone is not com
mercialised yet. M
anufacturing thisform
ulation is crucial, in order to make other PIs, such as
atazanavir, free of refrigeration constraints when used
together.
Generic firm
s are working on the developm
ent of the ritonavirheat-stable tablets. There is a need for W
HO prequalification
of generic versions of RTV, in particular for middle-incom
ecountries w
hich do not have access to Abbott's lowest price.
Abbott has applied for various patents on improved
formulations on ritonavir, w
hich renders the extent of genericcom
petition unclear. Oppositions to these derivative patents
in India will be needed to ensure prices can decrease further,
as demand w
ill increase with scaling up.
ritonavir 100 mg
Eligibility restrictions
100 mg capsule
80 mg/m
l oral solution
Daily dose used
as booster
2--
AurobindoAbbott
CiplaHetero
Strides
None
None
None
83 (0.114)
34 (0.093)
336 (0.460)313 (0.429)
190 (0.260)438 (0.600)
None
See table 2
Note: the daily dose referred to is 100 m
g twice daily, for use as booster m
edication.
3504
650
83 190
US$ ppy
As of June 2006, there w
as no WHO prequalified generic source of
ritonavir. The lowest available generic price is therefore given here.
The price of ritonavir, both originator and generic, fell dramatically in
2001. Today, the low
est originator price is 2.3 times low
er than the genericprices.
22•
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SAQUIN
AVIR (SQV)
General inform
ation
•Therapeutic class: H
IV-1 and HIV-2 protease
inhibitor (PI)
•Indicated for second-line, to be used
boosted by ritonavir, for adults, adolescentsand children. (W
HO 2006 guidelines)
•Originator com
pany, and product brandnam
e: Roche, Invirase
•First approval by U
S Food and Drug
Administration (FD
A): Decem
ber 1995
•Included in the W
HO M
odel List of EssentialM
edicines (EML)
[17]
2800
2400
2000
1600
1200
800
400Oct Jun D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic pricelow
est originator priceoriginator 2nd price
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Chart 1: Evolution of the lowest price quoted for eligible developing
countries since 2001As of June 2006, there w
as no WHO prequalified generic source of
saquinavir. The lowest available generic price is therefore given here.
Spotlight on access issues:Saquinavir is very difficult to adm
inister, due to a high pill burden (ten capsules a day, to be combined w
ith three other products includingthe booster). N
evertheless, the product is still recomm
ended by WHO. Very few
transactions were reported during last year to the W
HO G
PRM
.As w
ith other protease inhibitors, its high price continues to be a barrier. Solid competition and econom
ies of scale among producers are
severely limited, as its use is very reduced.
Since 2004, Roche has been marketing in the U
S a new version of saquinavir, in a tablet of 500 m
g. This formulation reduces the pill burden
from ten to four tablets, but is not m
arketed in developing countries.
saquinavir 200 mg
Eligibility restrictions
SQV 200 m
g hard capsules
SQV 500 m
g tablets
Daily dose
10 (boosted by ritonavir)
4 (boosted by ritonavir)
RocheCipla
1st category
Hetero
None
989 (0.271)
n/a
2212 (0.606)
n/a
1825 (0.500)986 (0.270)
See table 2 2nd category
1342
2362
2212
986
989
US$ ppy
None
Médecins Sans Frontières • w
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STAVUDIN
E (d4T)
General inform
ation
•Therapeutic class: H
IV-1 and HIV-2
nucleoside reverse transcriptase inhibitor(N
RTI)
•Indicated for first-line, for adults,
adolescents and children (WHO 2006
guidelines[2])
•Originator com
pany, and product brandnam
e: Bristol-Myers Squibb (B
MS), Zerit
•First approval by U
S Food and Drug
Administration (FD
A): Decem
ber 1994
•Included in the W
HO M
odel List of EssentialM
edicines (EML)
[17]
•W
orld sales of originator product: $272m
illion in 2004[19], U
S$354 million in 2003
[24]
•Stavudine w
as the result of US public sector
research. It was originally synthesised by the
Michigan Cancer Foundation in 1966 on a
grant from the N
ational Cancer Institute.Researchers from
Yale University firstdiscovered its activity against H
IV/AIDS and
hold the key use patent filed in the US in
Decem
ber 1986. Yale licensed its marketing
and distribution rights to BM
S in 1988[24].
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Spotlight on access issues:Bristol-M
yers Squibb has no policy for middle-incom
ecountries, and prices are negotiated on a case-by-case basis.The new
criteria chosen by BM
S to establish eligibility fordiscounted prices aim
s to protect certain markets, and
imposes a prem
ium (34%
more expensive) that applies even
to countries as poor as Mozam
bique.
Nevertheless, m
any WHO prequalified generics exist as
alternatives to this ARV
and have already been on the market
for a considerable time.
In any case, d4Tis m
ostly used today in double or triplefixed-dose com
binations.
The price of BM
S's paediatric formulation has decreased
significantly since last year (divided by 6.33).Chart 1: Evolution of the low
est price quoted for eligible developingcountries since 2001:The low
est WHO prequalified generic price for d4T
is given here.
Eligibility restrictions
15 mg capsule
20 mg capsule
30 mg capsule
40 mg capsule
1 mg / m
l powder for
syrup
Daily
dose
----22--
BM
SAspen under
VL
from B
MS
AurobindoCipla
Hetero
Ranbaxy
Strides
1st category
See table 2
(0.082)
(0.094)
48 (0.066)
55 (0.075)
51 (0.007)
---(0.101)
74 (0.101)
74 (0.101)
66 (0.009)
(0.054)
(0.056)
41 (0.056)
41 (0.057)
44 (0.060)
42 (0.058)
146 (0.020)
(0.048)
(0.050)
39 (0.053)
41 (0.057)
146 (0.020)
20(0.027)
24 (0.033)
36 (0.049)
45 (0.062)
29 (0.040)
36 (0.050)
See table 2
Southern African
countries
806040200Oct Jun D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic pricelow
est originator priceoriginator 2nd price
d4T 40 mg
44
74
36 5555
None
None
None
None
None
▼
▼
US$ ppy
Note: the Clinton Foundation has agreed w
ith Cipla to sell d4T1 m
g / ml at U
S$ 0.017 per unit (ml) in countries included in their consortium
[16].
24•
Médecins Sans Frontières • w
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eb of Price Reductions
TENOFO
VIR DISO
PROXIL
FUM
ARATE (TDF)
General inform
ation
•Therapeutic class: H
IV-1 nucleotide reversetranscriptase inhibitor (N
tRTI)
•Indicated for first- and second-line, for
adults and adolescents (WHO 2006
guidelines[2])
•Originator com
pany, and product brandnam
e: Gilead, Viread
•First approval by U
S Food and Drug
Administration (FD
A): October 2001
•Not included in the W
HO M
odel List ofEssential M
edicines (EML)
[17]
•W
orld sales of originator product: today,TD
F is the most com
monly prescribed
branded ARV in the US, w
ith sales climbing to
US$ 783 m
illion in 2004, representing a 38%increase over the previous year
[27]
•Although tenofovir w
as discovered andpatented in the U
SAin 1985, G
ilead laterapplied for additional patents on a new
formof the drug, tenofovir disoproxil fum
arate.These later patents are due to expire in2018
[26].
180016001400120010008006004002000
1st category of countries Others
originator price▲
500
400
300
200
1000Oct Jun D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic price
lowest originator price
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Chart 2: Transaction prices for NFV as com
piled by WHO
GPRM
in 2005-06 (see “how to read the product cards”
box)Countries deem
ed ineligible by Gilead for the discounted
price (see list in annex 8) are paying up to five times the
price paid by eligible countries. El Salvador, for example,
reported to the WHO G
PRM paying U
S$ 1,700 per patientper year in August 2005.
Chart 1: Evolution of the lowest price quoted for eligible
developing countries since 2001As of June 2006, there w
as no WHO prequalified generic
source of TDF. The low
est available generic price is thereforegiven here.▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲▲
▲
▲
▲
▲▲
▲▲
▲
TDF 300 m
g
TDF 300 m
g
Eligibility restrictions
TDF 300 m
g tablets
Daily dose
1
Gilead
CiplaHetero
None
None
207 (0.567)973 (2.667)
365 (1.000)
See table 2
475
207
365
US$ ppy
US$ ppy
Spotlight on access issues:The use of tenofovir disoproxil fum
arate is likely to increase, as it is now part of the
WHO recom
mended first-line treatm
ent. The addition of TDF to these regim
ens will
have a substantial impact on the budgets of A
IDS program
mes. First-line regim
ens nowcosts as low
as US$ 132 per patient per year (triple FD
C 3TC/d4T/NVP), but unless
important reductions are seen w
ith the entry of generics in the market in the near
future, the use of TDF w
ill raise the cost from a m
inimum
of 2.5 up to 5.5 times m
oreper patient per year in Sub-Saharan A
frican and other countries eligible for lowest
prices. The impact w
ill be even more dram
atic in countries that are excluded from the
lowest prices. Further price reductions can be expected in the near future w
ith theentry of generic versions on the m
arket. Som
e middle-incom
e countries, such as Brazil, possess negotiating capacity through
the threat of local production or importation through com
pulsory licenses. As a result,
Gilead recently agreed to halve the price from
US$ 2,766 to U
S$ 1,380 per patient peryear in B
razil. Nevertheless, this product is barely available in developing countries. A
s of June 2006,Gilead's TD
F was registered in only 13 of the 97 countries G
ilead deems eligible
[35]. Forinstance, TD
F is not registered in either Zimbabw
e or South Africa, w
here HIV
/AID
Sprevalence exceeds 25%
, and there are to date no distributors to import the product in
these countries. Com
petition between generics and originators for TD
F is now underw
ay, as genericproducts have already been m
arketed in India for several months. B
ut such genericcom
petition will depend on the patent status of TD
F in India. Gilead patent
applications are currently under examination at the Indian patent office. P
LWHA
groupsopposed the grant of this patent on 9th M
ay 2006[36]. If the Indian patent office grants
patents on TDF, generic com
petition from Indian m
anufacturers will be very lim
ited andprices of TD
F will likely rem
ain high. Fixed-dose combinations are also being
developed, but their availability will also necessarily depend on the patent status of
TDF in India.
TDF is not included in the 2005 revision of the W
HO M
odel List of Essential Medicines
(EML) because G
ilead opposed the publication of certain data by WHO
[37]. Inclusion ofa drug on the EM
Lfacilitates fast-track registration approval and encourages countries
to ensure that the drug is available.Crucially, TD
F has not yet been tested in children, despite urgent needs.
Médecins Sans Frontières • w
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eb of Price Reductions •25
ZIDOVU
DIN
E (AZT, ZDV)
General inform
ation
•Therapeutic class: H
IV-1 and HIV-2
nucleoside reverse transcriptase inhibitor(N
RTI)
•Indicated for first- and second-line, for
adults, adolescents and children (WHO 2006
guidelines[2])
•Originator com
pany, and product brandnam
e: GlaxoSm
ithKline (GSK), Retrovir
•First approval by U
S Food and Drug
Administration (FD
A): March 1987
•Included in the W
HO M
odel List of EssentialM
edicines (EML)
[17]
•W
orld sales of originator product: GB£ 43
million in 2004; dow
n from U
S$ 476 million
in 1997
•Zidovudine w
as first discovered in 1964 asan anti-cancer m
edicine. Most of the research
that showed the drug's effectiveness as an
antiretroviral was done by the U
S National
Institutes of Health. N
evertheless, Glaxo
Wellcom
e, having obtained the patent forzidovudine for the treatm
ent of AIDS, brought
the drug onto the market in 1987 as one of
the most expensive ever sold
[38].GlaxoSm
ithKline's patents on AZTexpired in
September 2005 in the U
SAand several
generic versions of the drug are thereforeavailable on the U
S market. Patents in other
countries are due to expire in 2006.
8007006005004003002001000
Oct Jan D
ec May D
ec Apr Feb Jun Feb01 02 02 03 03 04 05 05 06
generic price
lowest originator price
Price information:
Table 1: Prices in US$ quoted by com
panies for developing countries:
Chart 1: Evolution of the lowest price quoted for eligible developing
countries since 2001The low
est WHO prequalified generic price for zidovudine is given here.
Spotlight on access issues:In 2005, despite the existence of generic com
petition and theavailability of W
HO prequalified products, m
any countries,including Least D
eveloped Countries such as Haiti or Ethiopia,
were still purchasing the originator version of zidovudine.
Countries have reported to the WHO G
PRM
that they were
purchasing GSK
products at prices between U
S$ 212 and US$ 241
(almost double the generic price).
In January 2006, GSK
announced a shortage of AZT.
zidovudine 300 mg
Eligibility restrictions
AZT
300 mg tabs
AZT
100 mg caps**
AZT
250 mg caps**
AZT
50 mg/5m
l oral sol and 10 m
g/ml
syrop
Daily
dose
2------
AurobindoGSK
Aspen under
VL
from G
SKCipla
Hetero
Ranbaxy
None
None
None
212 (0.290)
(0.158)
(0.332)
259 (0.036)
158 (0.216)
(0.201)
(0.205)
202 (0.028)
134 (0.183)
108 (0.015)
103 (0.142)
(0.075)
101 (0.014)
133 (0.181)139 (0.190)
None
See table 2See table 2
US$ ppy
684
193
103
212
Note: the Clinton Foundation has agreed w
ith Cipla to sell AZT
50 mg / m
l at US$ 0.011 per unit (m
l) in countries included in their consortium[16].
ABACAVIR/LAMIVU
DIN
E(ABC/3TC)
General inform
ation
•Therapeutic class: double fixed-dose
combination, for H
IV-1 and HIV-2 (N
RTIs)
•Indicated for first-line, for adults,
adolescents and children (WHO 2006
guidelines[2])
•Originator com
pany, and product brandnam
e: GlaxoSm
ithKline (GSK), Kivexa
•First approval by U
S Food and Drug
Administration (FD
A): August 2004
•The W
HO Expert Com
mittee on the
Selection and Use of Essential Medicines
recomm
ends and endorses the use of fixed-dose com
binations and the development of
appropriate new fixed-dose com
binations[17]
•W
orld sales of originator product: GSK
estimates that sales w
ill reach $490 million in
2009[39].
26 •M
édecins Sans Frontières • ww
w.accessm
ed-msf.org •
July 2006 (Revised) •Untangling the W
eb of Price Reductions
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Spotlight on access issues:To date, no transactions have been reported in the W
HO G
PRM
database. GSK
only very recently quoted a specific price for thisdouble fixed-dose com
bination for developing countries.
Generic production is very recent.
Eligibility restrictions
ABC 600 / 3TC 300 m
g
Daily dose
1
GSK
Cipla
None
678 (1.858)255 (0.700)
See table 2
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LAMIVU
DIN
E/STAVUDIN
E(3TC/d4T)
General inform
ation
•Therapeutic class: 2 N
RTIs in double fixed-dose com
bination, for HIV-1 and H
IV-2
•Indicated for first-line, for adults,
adolescents and children (WHO 2006
guidelines[2])
•The W
HO Expert Com
mittee on the
Selection and Use of Essential Medicines
recomm
ends and endorses the use of fixed-dose com
binations and the development of
appropriate new fixed-dose com
binations[17]
•The product is developed only by generic
manufacturers and is not available in W
esterncountries because of various patents on 3TCand d4T.
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:Spotlight on access issues:Although included in the W
HO recom
mendations for children, to
date there are no adapted formulations available.
Eligibility restrictions
3TC 150 mg / d4T
30 m
g tablet
3TC 150 mg / d4T
40 m
g tablet
Daily
dose
22
Hetero
AurobindoCipla
Ranbaxy
Strides
None
None
80 (0.110)
87 (0.120)
64 (0.088)
67 (0.092)
143 (0.195)
146 (0.200)
74 (0.101)
80 (0.109)
73 (0.100)
80 (0.110)
None
None
None
Chart 1: Evolution of the lowest price quoted for eligible developing
countries since 2001The low
est WHO prequalified generic price for 3TC/d4T
is given here.
The first generic to be WHO prequalified w
as from Strides in February
2005. Prices of generic drugs have been decreasing since that date.
Combined, the low
est price of originator products, only availableseparately instead of FD
Cs, reaches US$ 124.
400
300
200
1000Oct Jun D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic pricelow
est originator price(separate products)
3TC/d4T 40 mg
139124
80
289
US$ ppy
28•
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LOPIN
AVIR/RITONAVIR
(LPV/r)
General inform
ation
•Therapeutic class: boosted Protease
Inhibitor (PI) in double fixed-dosecom
bination, for HIV-1 and H
IV-2
• Indicated for second-line, for adults,adolescents and children (W
HO 2006
guidelines[2])
• First approval by US Food and D
rugAdm
inistration (FDA): soft gel capsules w
ereapproved in Septem
ber 2000. Heat-stable
tablets were approved in O
ctober 2005.
• Originator com
pany, and product brandnam
e: Abbott Laboratories, Kaletra
• Included in the WHO M
odel List of EssentialM
edicines (EML)
[17]
• World sales of originator product: LPV/r is
the most com
monly used PI in the U
S,representing 34%
of total PI prescriptions. Infour years, from
2001 to 2004, salesam
ounted to US$ 2.5 billion (U
S$ 292 million
in 2001, US$ 551 m
illion in 2002, US$ 754
million in 2003 and U
S$ 897 million in
2004)[34]. Cum
ulative sales are estimated to
reach US$ 7 billion over the years 2001 to
2008[34].
• Abbott patents on soft gel capsules are dueto expire in the U
SAin 2018. Patents w
erealso filed to protect the heat-stable tablets,w
hich are to run until 2024.
7000
6000
5000
4000
3000
2000
100001st category of countries
Others
originator price▲
5000
4000
3000
2000
10000Oct Jun D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic price
lowest originator price
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Chart 1: Evolution of the lowest quoted price for eligible
developing countries since 2001 As of June 2006, there was no
WHO prequalified generic source of lopinavir/ritonavir. The low
estavailable generic price is therefore considered for the graph.
Only originator sales w
erereported to the W
HO G
PRM in
2005. In countries excluded fromAbbott's list of eligible countries,such as som
e low-incom
e(Tajikistan), and low
er middle-
income countries (Jordan,
Belarus, Georgia, Guyana,
Ukraine), transactions w
erereported up to U
S$ 6,300 perpatient per year. Inform
ation on add-ons(transportation, taxes, m
argins ofprivate distributors) in the localm
arket are not included here.
Spotlight on access issues:Abbott developed a new
formulation of the LP
V/r FD
C, but it is not made available in developing countries. Crucially, the new
formulation has great advantages
for these resource-poor settings: it has a lower pill count (reducing the burden from
six to four pills per day), there is no need for refrigeration, and there are nodietary restrictions. N
evertheless, Abbott has not filed for registration in developing countries, except for South Africa. It is only after M
édecins Sans Frontières(M
SF) publicly placed an order, supported by a petition letter signed by more than 300 scientists and organisations, that Abbott allow
ed the drug to bedelivered to M
SF programm
es in African countries w
here it is not registered. But as of July 2006, the com
pany declined to fill orders placed for Guatem
ala orThailand. Further, there are still problem
s of availability of the old formulation. In China, for exam
ple, negotiations between Abbott and the Chinese authorities have been
ongoing for two years. In June 2004, Abbott told M
SF that the product would be m
arketed there by October 2004, but as of June 2006, it w
as still not available.M
oreover, current generic competition, w
hich would be expected to drive prices dow
n as demand increases, is under threat. Abbott has applied for patents on
both combinations in India (soft gel capsules and m
ore recent heat-stable tablets). Opposition to the grant of Indian patents on the com
bination is needed. In B
razil, where this product is under patent, the cost of it alone used to take up 27%
of the National A
IDS Program
me budget. A
fter strong negotiations with
the company, the price w
as recently further reduced to US$ 1,518 for the heat-stable tablets
[25]. Adapted paediatric formulations and FD
Cs to facilitate theadm
inistration of the recomm
ended WHO com
bination therapy are urgently needed.
▲▲ ▲
▲▲▲▲ ▲▲▲▲▲ ▲
▲▲▲▲▲▲▲▲▲▲▲▲
▲▲
▲▲▲▲▲
▲▲
▲▲▲▲▲▲ ▲
▲
▲▲
LPV/r 133 / 33 mg
LPV/r 133 / 33 mg
▲
▲▲
▲▲▲
Eligibility restrictions
LPV/r 133 / 33 m
g Soft gel capsule
LPV/r 200 / 50 m
gTablet (heat-stable)
LPV/r 80 + 20 m
g / ml
Oral solution
Daily dose
64--
AbbottCipla
Hetero
None
None
500 (0.228)
n/a
152 (0.139)
1338 (0.611)1,898 (0.867)
See table 2
500500
1338
US$ ppy
3833
Chart 2: Transaction prices of LPV/r as compiled by W
HO
GPRM in 2005-06 (see “how
to read the product cards”box)
US$ ppy
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TENOFO
VIR DISO
PROXIL
FUM
ARATE/EM
TRICITABINE (TD
F/FTC)
General inform
ation
•Therapeutic class: one N
tRTI + one NRTI in double fixed-dose com
bination,for H
IV-1
•Indicated for first-line, for adults and adolescents (W
HO 2006 guidelines
[2])
•Originator com
pany, and product brand name: G
ilead, Truvada
•First approval by U
S Food and Drug Adm
inistration (FDA): August 2004
•The W
HO Expert Com
mittee on the Selection and Use of Essential M
edicinesrecom
mends and endorses the use of fixed-dose com
binations and thedevelopm
ent of appropriate new fixed-dose com
binations[17]
•W
orld sales of originator product: TDF/FTC w
as launched in August 2004 andw
ithin six months sales already accounted for U
S$ 70 million
[27]. In 2005, salesreached U
S$ 568 million
[26], meaning an increase of sales of 735%
.
•Patent holders of both TD
F and FTC have agreed to waive their right to the
royalties for sales within G
ilead's Access Program[28].
Spotlight on access issues:As of February 2006, this com
binationw
as registered in only four developingcountries. The publicised offered price istherefore m
eaningless.
Purchases reported to the WHO G
PRM
areso far extrem
ely limited, and can be found
only among countries eligible for the
lowest G
ilead price (only threetransactions reported).
The final patent status of TDF in India w
illhave im
plications on the availability ofgeneric versions of this FD
C (see TDF
product card).
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Eligibility restrictions
TDF/FTC
300 + 200 mg tablets
Daily dose
1
Gilead
319 (0.875)
See table 2
TENOFO
VIR DISO
PROXIL
FUM
ARATE/LAM
IVUDIN
E (TDF/3TC)
General inform
ation
•Therapeutic class: N
tRTI + NRTI in double fixed-dose com
bination, HIV-1
•Indicated for first-line, for adults and adolescents (2006 W
HO guidelines
[2])
•The W
HO Expert Com
mittee on the Selection and Use of Essential M
edicinesrecom
mends and endorses the use of fixed-dose com
binations and thedevelopm
ent of appropriate new fixed-dose com
binations[17]
•The product is developed only by generic com
panies but its final availabilityw
ill depend on the patent status of TDF in India. It is not available in W
esterncountries because of various patents on TD
F and 3TC.
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Eligibility restrictions
TDF/3TC
300 + 300 mg tablets
Daily dose
1
Cipla
1,034 (2.833)
None
30•
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ZIDOVU
DIN
E/LAMIVU
DIN
E(AZT/3TC)
General inform
ation
•Therapeutic class: 2 N
RTI in double fixed-dose com
bination, for HIV-1 and H
IV-2
•Indicated for first- and second-line for
adults and adolescents, and only for first-linein children (W
HO 2006 guidelines
[2])
•Originator com
pany, and product brandnam
e: GlaxoSm
ithKline (GSK), Com
bivir
•First approval by U
S Food and Drug
Administration (FD
A): September 1997
•The W
HO Expert Com
mittee on the
Selection and Use of Essential Medicines
recomm
ends and endorses the use of fixed-dose com
binations and the development of
appropriate new fixed-dose com
binations.[17]
•W
orld sales of originator product: US$ 914
million in 2004
[39], US$ 1,045 m
illion in 2005 -of w
hich 89% com
es from Europe and the
US
[40]
•Patent status: G
SK holds a patent for thiscom
bination in tablet form in m
ost countriesof the w
orld, which is due to expire in 2017.
Spotlight on access issues:Com
petition between originator and generics exist for adult form
ulationsbut Indian generic versions of the m
edicine are under threat. GSK
appliedfor a patent on the com
bination, which is currently under exam
ination bythe Indian patent office. P
LWHA
opposed the grant of this patent in Indiaon 30th M
arch 2006[41]. If the Indian patent office grants the patent, Indian
generic manufacturers w
ill only be able to continue producing the medicine
under the “automatic licensing” provisions of the 2005 India Patents Act,
but will have to pay a “reasonable royalty” to G
SK, w
hich may increase the
price of the combination (see introduction).
In some countries, generic versions of the FD
C are not available because ofGSK
patent rights. In China, only the originator product is available at US$
593 because of GSK
exclusive rights on 3TC alone.
In Honduras, the governm
ent only decided to procure from a generic source
after GSK
's shortage of AZT
in January 2006.
WHO G
PRM
2005 data show that m
any countries, including LeastDeveloped Countries, such as Zam
bia, Ethiopia, Sudan or Rw
anda,purchased the originator product at prices around U
S$ 250, despite theexistence of W
HO prequalified generics available at an average of U
S$ 131.
To date, no formulation adapted for children is m
arketed and it is urgentlyneeded.
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Eligibility restrictions
AZT
300 / 3TC 150 mg
Daily
dose
2
GSK
Aspen under
VL
from B
MS
AurobindoCipla
Hetero
Ranbaxy
Strides
See table 2
237 (0.325)220 (0.302)
197 (0.270)134 (0.183)
161 (0.220)168 (0.230)
182 (0.250)
See table 2See table 2
None
None
None
None
800
600
400
2000Oct Jun D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic price
lowest originator price
Chart 1: Evolution of the lowest price quoted for eligible
developing countries since 2001The low
est WHO prequalified generic price for AZT/3TC is given
here.Com
petition among W
HO prequalified sources continues, and
has led to a steady decrease in prices.
AZT/3TC
270
134
237
US$ ppy
730
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3TC/d4T/NVP
150 / 40 / 200 mg
LAMIVU
DIN
E/STAVUDIN
E/NEVIRAPIN
E (3TC/d4T/NVP)
General inform
ation
•Therapeutic class: tw
o NRTI + one N
NRTI in
triple fixed-dose combination, for H
IV-1
•Indicated for first-line, for adults,
adolescents and children ((WHO 2006
guidelines[2])
•The W
HO Expert Com
mittee on the
Selection and Use of Essential Medicines
recomm
ends and endorses the use of fixed-dose com
binations and the development of
appropriate new fixed-dose com
binations.[17]
•The product is developed only by generic
companies; it is not available in W
esterncountries because of various patents on 3TC,d4T
and NVP. If these m
edicines had beenunder patent in India, this im
portant FDC m
aynever have been developed.
8007006005004003002001000
Oct Jun D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic price
lowest originator price
(separate products)
Chart 1: Evolution of the lowest price quoted for eligible developing
countries since 2001Over the last five years, generic com
petition has shown to be the m
osteffective m
eans of lowering drug prices. Prices are still decreasing, w
ith aW
HO prequalified product being currently available at U
S$ 132.Com
bined, the price of originator products marketed separately, and not in
FDCs, reaches U
S$ 556.
Spotlight on access issues:This is still the m
ost comm
only prescribed therapy inresource-lim
ited settings for first-line treatment in adults.
Unfortunately, as equivalent paediatric form
ulations havenot existed until recently, and separate syrups areexpensive and ill-adapted to resource-poor settings, careproviders have been forced to use adult tablets forchildren, by breaking or crushing them
, which is a sub-
optimal practice.
Alim
ited number of generic paediatric triple fixed-dose
combinations are currently reaching the m
arket. But W
HO
must urgently give clear guidance on the best dosages for
children. The WHO Prequalification project m
ust alsoprioritise these products, by outlining the requirem
entsneeded for the qualification of the new
formulations to be
developed, and facilitating the speedy completion of
product dossiers.
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Eligibility restrictions
30 / 6 / 50 mg dispersible tablets
60 / 12 / 100 mg dispersible tablets
20 / 5 / 35 mg dispersible tablets
40 / 10 / 70 mg dispersible tablets
150 / 30 / 200 mg tablets
150 / 40 / 200 mg tablets
Daily
dose
--------22
AurobindoCipla
Hetero
Ranbaxy
Strides
None
138 (0.190)
146 (0.200)
(0.108)
91 (0.125)
132 (0.181)
140 (0.192)
143 (0.195)
146 (0.200)
80 (0.055)
79 (0.108)
146 (0.200)
153 (0.210)
146 (0.200)
153 (0.210)
None
None
None
None
US$ ppy
727
295
140
556
32•
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TENOFO
VIR DISO
PROXIL
FUM
ARATE/EMTRICITABIN
E/EFAVIREN
Z (TDF/FTC/EFV
)
General inform
ation
•Therapeutic class: 1 N
tRTI + 1 NRTI + 1
NNRTI in a triple fixed-dose com
bination, forHIV-1
•Indicated for first-line for adults (W
HO
2006 guidelines[2])
•Originator com
pany, and product brandnam
e: Gilead and B
MS/M
erck, Atripla
•First approval by U
S Food and Drug
Administration (FD
A): July 2006
•The W
HO Expert Com
mittee on the
Selection and Use of Essential Medicines
recomm
ends and endorses the use of fixed-dose com
binations and the development of
appropriate new fixed-dose com
binations.[17]
Spotlight on access issues:This is the first one-pill-a-day FD
C, which m
akes it well adapted to resource-poor settings.
This combination w
ill probably become one of the m
ost recomm
ended first-line therapies,as it is w
ell tolerated and delays the emergence of resistance, but it cannot be used in
wom
en of childbearing age.
To date, there has been no announcement as to w
hat the price for this FDC w
ill be or anyindication of a registration tim
eline.
Generic versions are being developed in India and the approxim
ate market launch could be
expected before the end of 2006 in India. How
ever, Gilead patent applications are
currently under examination at the Indian patent office, and P
LWHA
groups opposed thegrant of TD
F patent in May 2006
[36].
If the patent is granted on TDF, any generic production could be blocked, or severely
restricted, until the patent expires, which could be as late as 2018.
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ZIDOVU
DIN
E/LAMIVU
DIN
E/ABACAVIR (AZT/3TC/ABC)
General inform
ation
•Therapeutic class: three N
RTI in triple fixed-dose com
bination, for HIV-1 and -2
•Indicated for first-line, for adults,
adolescents and children (WHO 2006
guidelines[2])
•The W
HO Expert Com
mittee on the
Selection and Use of Essential Medicines
recomm
ends and endorses the use of fixed-dose com
binations and the development of
appropriate new fixed-dose com
binations.[17]
•Originator com
pany, and product brandnam
e: GlaxoSm
ithKline (GSK), Trizivir
•First approval by U
S Food and Drug
Administration (FD
A): Novem
ber 2000
•W
orld sales of originator product: US$ 602
million in 2004
[19].
3000
2500
1500
1000
5000Oct Jun D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic price
lowest originator price
Chart 1: Evolution of the lowest price quoted for eligible developing
countries since 2001As of June 2006, there w
as no WHO prequalified generic source of
AZT/3TC/ABC. The lowest available generic price is therefore given here.
Spotlight on access issues:This FD
C is the only triple formulation available in W
estern countries. It is hence one of the most com
monly prescribed regim
ens, but them
arket is very small in developing countries.
The FDC is still very expensive com
pared to other triple first-line FDCs, notably because of the high price of abacavir.
AZT/3TC/ABC
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Eligibility restrictions
300 /150 /300 mg tablet
Daily
dose
2
GSK
CiplaHetero
Ranbaxy
See table 2
852 (1.167)548 (0.750)
950 (1.300)745 (1.020)
None
None
None
2409
US$ ppy
1648
852
548
34•
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ZIDOVU
DIN
E/LAMIVU
DIN
E/NEVIRAPIN
E (AZT/3TC/NVP)
General inform
ation
•Therapeutic class: tw
o NRTI + one N
NRTI in
triple fixed-dose combination, for H
IV-1
•Indicated for first-line, for adults,
adolescents and children (WHO 2006
guidelines[2])
•The W
HO Expert Com
mittee on the
Selection and Use of Essential Medicines
recomm
ends and endorses the use of fixed-dose com
binations and the development of
appropriate new fixed-dose com
binations.[17]
•The product is developed only by generic
companies; it is not available in W
esterncountries because of various patent rights onAZT, 3TC and N
VP.
Spotlight on access issues:The price of this triple FD
C is still a barrier for use andfor scaling up program
mes, especially w
hen compared
with other triple first-line FD
Cs.
Today, there are no paediatric formulations available for
this FDC, although it is recom
mended by W
HO for first-
line children treatment.
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Eligibility restrictions
300 / 150 / 200 mg tablet
Daily
dose
2
Aspen under V
Lfrom
GSK
and BI
CiplaAurobindo
Hetero
Ranbaxy
See table 2
308 (0.422)
co-blister, not FDC
257 (0.352)231 (0.317)
263 (0.360)255 (0.350)
None
None
None
None
Note: the Clinton Foundation has agreed w
ith Cipla, Hetero and R
anbaxy for a price of US$ 239 per patient per year, in countries of their
consortium.
Oct Jun D
ec May D
ec Apr Feb Jun Jun01 02 02 03 03 04 05 05 06
generic price
lowest originator price
(separate products)
Chart 1: Evolution of the lowest price quoted for eligible developing
countries since 2001The low
est WHO prequalified generic price for AZT/3TC/N
VPis considered
here. Generic products have led to a decrease in prices, especially w
hencom
pared with originator products m
arketed separately and not in FDCs,
whose com
bined price reaches US$ 713
AZT/3TC/NVP1356
US$ ppy
419
713
257
1600
1200
800
4000
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LAMIVUDIN
E/STAVUDINE +
EFAVIRENZ
(3TC/d4T+EFV)
General inform
ation
•Therapeutic class: tw
o NRTI +one N
NRTI in a co-blister, for H
IV-1
•Indicated for first-line, for adults, adolescents and children (W
HO 2006
guidelines[2])
•The W
HO Expert Com
mittee on the Selection and Use of Essential M
edicinesrecom
mends and endorses the use of fixed-dose com
binations and thedevelopm
ent of appropriate new fixed-dose com
binations[17]
•The product is developed only by generic com
panies; it is not available inW
estern countries because of various patents rights on 3TC, d4Tand EFV.
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Eligibility restrictions
3TC/d4T+EFV150 / 30 + 600 m
gdaily co-blister
3TC/d4T+EFV150 / 40 + 600 m
gdaily co-blister
Daily dose
1 kit(3 tabs)
1 kit(3 tabs)
Cipla
274 (0.750)
280 (0.767)
None
Ranbaxy
365 (1.000)
372 (1.020)
None
ZIDOVU
DIN
E/LAMIVU
DIN
E + EFAVIREN
Z(AZT/3TC+
EFV)
General inform
ation
•Therapeutic class: tw
o NRTI +one N
NRTI in a co-blister, for H
IV-1
•Indicated for first-line, for adults, adolescents and children (W
HO 2006
guidelines[2])
• The WHO Expert Com
mittee on the Selection and Use of Essential M
edicinesrecom
mends and endorses the use of fixed-dose com
binations and thedevelopm
ent of appropriate new fixed-dose com
binations[17]
• This product is developed only by generic companies; it is not available in
Western countries because of various patents on AZT, 3TC and EFV.
Price information:
Table 1: Prices in US$ quoted by com
panies for eligible developing countries:
Eligibility restrictions
AZT/3TC+EFV
150 / 300 + 600 mg
daily co-blister
Daily dose
1 kit(3 tabs)
Aurobindo
451 (1.237)
None
Cipla
347 (0.950)
None
Ranbaxy
457 (1.250)
None
36•
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Table 2: Conditions of offer by company
Company
Abbott
Aspen
Aurobindo
Bristol-M
yers Squibb
Boehringer-Ingelheim
Cipla
Gilead
Eligibility (countries)
All A
frican countries and LDCs outside of A
fricaFor other developing countries, prices arenegotiated on a case-by-case basis
Sub-Sahara Africa including M
auritius,Seychelles, M
adagascar
No reported restrictions
First category of countries:Sub-Saharan A
frican countries (except SouthernAfrican countries) plus countries classified as
low-incom
e by the World B
ank (except Korea,Kyrgyzstan, M
oldova and Uzbekistan).
Second category of countries:Southern A
frican countriesSee annex 6 for m
ore details.For other developing countries, prices arenegotiated on a case-by-case basis w
ith BM
Slocal representatives
All countries classified by the W
orld Bank as
low-incom
e, and sub-Saharan Africa
Other countries on a case-by-case basis
No reported restrictions, but higher prices
were negotiated separately for ten Latin
Am
erican countries
97 countries including all African states and 44
additional countries classified as low-incom
e bythe W
orld Bank.
For other developing countries, prices arenegotiated on a case by case basis
Delivery of goods
FOB
Quote ex w
orks. Deliver CIF as
per client request - freightcharges to consignees account.Paym
ent by telegraphic transfer
Payment by letter of credit
FOB H
yderabad (India)
DDU to French-speaking A
fricaand CIP
incoterm for English-
speaking Africa (Kenya,
Uganda, Tanzania, Ethiopia,
Nigeria, G
hana, Eritrea, Zambia)
CIF
FOB M
umbai (India) or CIF -
Freight charges separately onactual
FOB O
rigin
Additional comm
ents
Delivery term
s: 90-120 days
No m
inimum
order unless any speciallabelling is required.
Prices available for at least 1,000,000units for each product per singleshipm
ent
For southern African countries, invoices
will be only in South A
frican Rand.
No quantity related conditions Prices
for larger quantities are negotiable
The programm
e is managed through
Gilead Access Program
(GAP) In A
fricancountries w
here the drugs areapproved, they can be obtainedthrough distributors. In the course of2006, G
ilead's new m
anufacturing anddistribution partner, A
spen Pharmacare,
will begin m
anufacturing Gilead A
RVs
in South Africa
Eligibility (bodies)
Governm
ents, NGOs, U
N organisations and
other national and international healthinstitutions
Governm
ents, NGOs and other partners
including private and such organisationsthat are able to run program
mes in a
responsible, sustainable and medically
sound manner
NGOs and governm
ental organisations
Both private and public sector
organisations that are able to provideeffective, sustainable and m
edically soundcare and treatm
ent of HIV
/AID
S
Governm
ents, NGOs and other partners
who can guarantee that the program
me is
run in a responsible manner
No restrictions
Organisations that provide H
IV treatm
ent inthe 97 countries covered by the G
ileadAccess Program
.
Application instructions atw
ww.gileadaccess.org
Médecins Sans Frontières • w
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July 2006 (Revised) •Untangling the W
eb of Price Reductions •37
Company
GlaxoSm
ithKline
Hetero D
rugs Ltd
Merck &
Co. Inc
Ranbaxy
Roche
Strides Arcolab Ltd
Eligibility (bodies)
Governm
ents, aid organisations, charities,UN agencies, other not-for-profit
organisations and internationalprocurem
ent agencies
In sub-Saharan Africa, em
ployers offeringHIV
/AID
S care and treatment directly to
their staff through workplace clinics or
similar arrangem
ents
Private sector, public sector and NGOs
Governm
ents, international organisations,NGOs, private sector organisations (e.g.
employers, hospitals and insurers)
NGOs and governm
ents or programm
essupported by them
Governm
ents, non-profit institutionalproviders of H
IV care, N
GOs
Governm
ents, non-profit institutionalproviders of H
IV treatm
ent, NGOs
Additional comm
ents
Supply Agreem
ent required (For NGOs
requiring fewer than ten patient packs
per month, this requirem
ent may be
waived)
All organisations m
ust supply thepreferentially priced products on a not-for-profit basis.
Prices may be negotiated on individual
basis according comm
ercial terms
Merck &
Co. Inc does not rule outsupplying A
RVs to patients through
retail pharmacies
Confirmed letter of credit or advance
payment preferred for new
customers
CAD (Cash A
gainst Docum
ents) 30 daysat sight. M
inimum
order and deliveryam
ount per shipment is CH
F 10,000(U
S$ 8,179)
Payment by signed letter of credit
Delivery of goods
CIP
FOB M
umbai (India)
CIP
FOB D
elhi (India)
FCABasel (Sw
itzerland)
FOB B
angalore (India)
Eligibility (countries)
Least Developed Countries (LD
Cs) plus sub-Saharan A
frica
All Country Coordination M
echanisms (CCM
)projects fully financed by the G
lobal Fund toFight A
IDS, TB
and Malaria, as w
ell as projectsfunded by PEP
FAR.
For other low and m
iddle-income countries,
public sector prices are negotiated on a case-by-case basis, either bilaterally or throughGSK
's Accelerating Access Initiative
No reported restrictions
First category of countries:Low
Hum
an Developm
ent Index (HDI) countries
plus medium
HDI countries w
ith adult HIV
prevalence of 1% or greater
Second category of countries:M
edium H
DI countries w
ith adult HIV
prevalence less than 1%
Although Rom
ania does not fall under thesecategories, it also benefits from
these pricesdue to a governm
ent comm
itment to a
programm
e of universal access
No reported restrictions, but higher prices w
erenegotiated separately for ten Latin A
merican
countries
First category of countries:All countries in sub-Saharan A
frica and allcountries classified as Least D
evelopedCountries by the U
nited Nations
Second category of countries:Low
-income countries and low
er middle-incom
ecountries, as classified by the W
orld Bank.
No reported restrictions
Notes: The conditions detailed in the table above w
ere those quoted directly by the companies. D
efinitions of eligibility vary from com
pany to company. Each originator com
pany establishes different restrictions to their offer of reduced prices, and classifies countries according todifferent categories. Som
e companies resort to Least D
eveloped Countries (LDC) criteria developed by the United N
ations, others to the UN D
evelopment Program
me's H
uman D
evelopment Index (U
NDP
HDI), and others still to W
orld Bank classifications concerning country income.
This lack of uniformity leads to significant differences in the eligibility of a country for different products. For instance, som
e countries are considered Least Developed Countries by the United N
ations, but are classified as having medium
development by U
NDP. These include
Bangladesh, Cambodia, Laos and Sudan. Six other LD
Cs do not appear in the UNDP
HDI rankings at all - these include Liberia and Som
alia.
Furthermore, m
any developing countries are left out of the differential pricing scheme altogether. These include B
olivia, Nicaragua, and U
kraine for the UNDP
classification, and China, Honduras and Sri Lanka for the W
orld Bank classification.For full details please refer to annexes 1-8.
38•
Médecins Sans Frontières • w
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eb of Price Reductions
Table 3: Summ
ary of prices in US$ quoted by com
panies for eligible developing countriesThe price for adult form
ulations is the yearly price per patient. The price for paediatric formulations is the price for the sm
allest unit available. Products that were W
HO
prequalified as of July 2006 are listed in bold.
abacavir300 m
g tablet20 m
g / ml oral solution
atazanavir150 m
gdidanosine25 m
g tablet50 m
g tablet100 m
g tablet200 m
g tablet250 m
g enteric-coated capsule400 m
g enteric-coated capsule2 g pow
der for reconstitutionefavirenz50 m
g capsule200 m
g capsule600 m
g tablet30 m
g / ml suspension
emtricitabine
200 mg capsule
lamivudine
150 mg tablet
300 mg tablet
10 mg / m
l oral solution and syrup and dry syrupnelfinavir250 m
g tablet50 m
g / g oral powder
nevirapine200 m
g tablet10 m
g / ml or 50 m
g / 5 ml suspension
ritonavir100 m
g capsule80 m
g / ml oral solution
saquinavir200 m
g hard capsulestavudine15 m
g capsule20 m
g capsule30 m
g capsule40 m
g capsule1 m
g / ml pow
der for syrup
Originator low
est offer /originator second price
when specified
Strides
Strides
Strides
Strides
240
Strides
Strides58Strides
Strides60Strides438
Strides
Strides
2936
Ranbaxy
511
Ranbaxy
Ranbaxy
321
146219
Ranbaxy
300292
Ranbaxy
Ranbaxy
6666Ranbaxy
Ranbaxy
61Ranbaxy
Ranbaxy
Ranbaxy
3645
Hetero
727
Hetero
Hetero
280
Hetero
292291
Hetero
Hetero
53Hetero
986
Hetero
73Hetero
190
Hetero
986Hetero
2024
Cipla4560.115 / m
lCipla
Cipla0.063 / tab0.075 / tab195146103134
Cipla
225217
Cipla
Cipla51270.018 / m
lCipla1,337
Cipla560.018 / m
lCipla313
Cipla1825Cipla0.048 / cap0.050 / cap39410.020 / m
l
Aurobindo564
Aurobindo
Aurobindo
233
1272082.160 / 2 gAurobindo0.110 / cap2922990.069 / m
lAurobindo
Aurobindo54560.020 / m
lAurobindo1,379
Aurobindo610.025 / m
lAurobindo336
Aurobindo
Aurobindo
44420.020 / ml
Aspen
Aspen
Aspen
0.191 / tab0.192 / tab307
Aspen
Aspen
Aspen
690.017 / ml
Aspen
Aspen
970.039 / ml
Aspen
Aspen
Aspen
0.054 / cap0.056 / cap4141
Generic offers
Single formulations
Product
GSK
6360.104 / m
lBM
Sn/aBM
S
310 / 401
223 / 273288 / 3526.295 / 7.697 / 2 gM
erck0.116 / 0.213 / cap394 / 821277 / 6970.094 / 0.151 / m
lGilead
n/aGSK
690.028 / ml
Roche683 / 1.5430.174 / 0.199 / gBoehringer
4320.073 / m
lAbbott830.093 / m
lRoche989 / 2,212BM
S0.082 / cap 0.094 / 0.101 / cap48 / 7455 / 740.007 / 0.009 / m
l
Double fixed-dose com
bination in co-blister
Médecins Sans Frontières • w
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eb of Price Reductions •39
ProductOriginator low
est offer /originator second price
when specified
Strides
Strides
Strides
Strides7380Strides
Strides
Strides
Strides182
Strides
146153Strides
Strides
Strides
Strides
Ranbaxy
Ranbaxy
139
Ranbaxy
Ranbaxy
7480Ranbaxy
Ranbaxy
Ranbaxy
Ranbaxy
168
Ranbaxy
0.055 / tab0.108 / tab146153Ranbaxy
255Ranbaxy
745
Ranbaxy
365
372
Ranbaxy
457
Hetero
365Hetero
139
Hetero
Hetero
143146Hetero
1,898
Hetero
Hetero
Hetero
161
Hetero
143146Hetero
263Hetero
950
Hetero
Hetero
Cipla973Cipla0,075 / cap
1030.014 / m
l
Cipla255Cipla6467Cipla1,338
Cipla
Cipla1,034Cipla134
Cipla0.108 / tab0.125 / tab
132140Cipla231Cipla548
Cipla274
280
Cipla347
Aurobindo
Aurobindo
1340.015 / m
l
Aurobindo
Aurobindo8087Aurobindo
Aurobindo
Aurobindo
Aurobindo197
Aurobindo
138146Aurobindo257Aurobindo
Aurobindo
Aurobindo451
Aspen
Aspen
0,201 / cap0,205 / cap1580,028 / m
l
Aspen
Aspen
Aspen
Aspen
Aspen
Aspen
220
Aspen
Aspen
308 c0-blisterAspen
Aspen
Aspen
Generic offers
Single formulations
tenofovir300 m
g tabletzidovudine100 m
g capsule250 m
g capsule300 m
g tablet50 m
g / 5 ml oral solution and 10 m
g/ml syrup
abacavir / lamivudine
600 + 300 mg tablet
lamivudine / stavudine
150 + 30 mg tablet
150 + 40 mg tablet
lopinavir / ritonavir133 + 33 m
g soft gel capsule200 + 50 m
g tablet80 + 20 m
g / ml oral solution
tenofovir / emtricitabine
300 + 200 mg tablet
tenofovir / lamivudine
300 + 300 mg tablet
zidovudine / lamivudine
300 + 150 mg tablet
lamivudine / stavudine / nevirapine
30 + 6 + 50 mg tablet
60 + 12 + 100 mg tablet
20 + 5 + 35 mg tablet
40 + 10 + 70 mg tablet
150 + 30 + 200 mg tablet
150 + 40 + 200 mg tablet
lamivudine / zidovudine / nevirapine
150 + 300 + 200 mg tablet
zidovudine / lamivudine / abacavir
300 + 150 + 300 mg tablet
tenofovir / emtricitabine / efavirenz
300 + 200 + 600 mg tablet
lamivudine / stavudine + efavirenz
150 / 30 + 600 mg
co-blister (daily kit), tablet150 / 40 + 600 m
g co-blister (daily kit) tabletzidovudine / lam
ivudine + efavirenz300 / 150 + 600 m
g co-blister (daily kit) tablet
Gilead
207GSK
0.158 / cap0.332 / cap2120.036 / m
l
GSK
678
Abbott500n.a. 0.139 / m
lGilead
319
GSK
237
GSK
852Gilead / B
MS / M
erckn/a
Double fixed-dose com
bination
Triple fixed-dose combination
Annex 2: Hum
an Developm
entIndex (H
DI)
Source: United Nations D
evelopment
Programm
e (UNDP)
http://hdr.undp.org/reports/global/2005/pdf/H
DR05_H
DI.pdf
The Hum
an Developm
ent Index ispublished annually as a part ofUNDP's annual H
uman D
evelopment
Report.
Low hum
an development:
Angola; Benin; B
urkina Faso; Burundi;
Cameroon, Central African Republic;
Chad; Congo (Dem
ocratic Republic);Côte d'Ivoire; D
jibouti; Eritrea;Ethiopia; G
ambia; G
uinea; Guinea-
Bissau; H
aiti; Kenya; Lesotho;M
adagascar; Malaw
i; Mali; M
auritania;M
ozambique; N
iger; Nigeria; Rw
anda;Senegal; Sierra Leone; Sw
aziland,Tanzania; Yem
en; Zambia.
Medium
human developm
ent:Albania; Algeria; Antigua and B
arbuda,Arm
enia; Azerbaijan; Bangladesh;
Belarus; B
elize; Bhutan; B
olivia;Bosnia and H
erzegovina; Botsw
ana;Brazil; Cam
bodia; Cape Verde; China;Colom
bia; Comoros; Congo; D
ominica;
Dom
inican Republic; Ecuador; Egypt;El Salvador; Equatorial G
uinea; Fiji;Gabon; G
eorgia; Ghana; G
renada;Guatem
ala; Guyana; H
onduras; India;Indonesia; Iran; Jam
aica; Jordan;Kazakhstan; Kyrgyzstan; Lao PD
R;
Annex 1: Least Developed
Countries (LDCs)
Source: United Nations
http://ww
w.un.org/specialrep/ohrlls/ldc/l
ist.htm
Fifty countries are currently designatedby the United N
ations as leastdeveloped countries (LD
Cs). The list isscheduled for review
in 2006.
Afghanistan; Angola; Bangladesh;
Benin; B
hutan; Burkina Faso; B
urundi;Cam
bodia; Cape Verde; Central AfricanRepublic; Chad; Com
oros; Congo(D
emocratic Republic); D
jibouti;Equatorial G
uinea; Eritrea; Ethiopia;Gam
bia; Guinea; G
uinea-Bissau; H
aiti;Kiribati; Lao PD
R; Lesotho; Liberia;M
adagascar; Malaw
i; Maldives; M
ali;M
auritania; Mozam
bique; Myanm
ar;Nepal; N
iger; Rwanda; Sam
oa; SãoTom
é and Principe; Senegal; SierraLeone; Solom
on Islands; Somalia;
Sudan; Timor-Leste; Togo; Tuvalu;
Uganda; Tanzania; Vanuatu; Yem
en;Zam
bia.
Lebanon; Libya; Macedonia; M
alaysia;M
aldives; Mauritius; M
oldova;M
ongolia; Morocco; M
yanmar;
Nam
ibia; Nepal; N
icaragua; Om
an;Pakistan; Palestinian Territories;Papua N
ew G
uinea; Paraguay; Peru;Philippines; Rom
ania; RussianFederation; St. Lucia; St. Vincent andthe G
renadines; Samoa; São Tom
éand Principe; Saudi Arabia; Solom
onIslands; South Africa; Sri Lanka;Sudan; Surinam
e; Syrian ArabRepublic; Tajikistan; Thailand; Tim
or-Leste; Togo; Tunisia; Turkey;Turkm
enistan; Uganda; U
kraine;Uzbekistan; Vanuatu; Venezuela; Viet
Nam
; Zimbabw
e.
Annex 3: Sub-Saharan countries
Source: United Nations Secretariat,
Departm
ent of Economic and Social
Affairshttp://esa.un.org/unpp/index.asp?panel=
5
Angola; Benin; B
otswana; B
urkinaFaso; B
urundi; Cameroon; Cape Verde;
Central African Republic; Chad;Com
oros; Congo; Congo (Dem
ocraticRepublic); Côte d'Ivoire; D
jibouti;Equatorial G
uinea; Eritrea; Ethiopia;Gabon; G
ambia; G
hana; Guinea;
Guinea-B
issau; Kenya; Lesotho;Liberia; M
adagascar; Malaw
i; Mali;
Mauritania; M
auritius; Mozam
bique;Nam
ibia; Niger; N
igeria; Rwanda; São
Tomé and Principe; Senegal;
40 •M
édecins Sans Frontières • ww
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eb of Price Reductions
Annexes
Médecins Sans Frontières • w
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July 2006 (Revised) •Untangling the W
eb of Price Reductions •41
Annex 5: Global Fund recipient
countries
Source: The Global Fund to Fight Aids,
Tuberculosis and Malaria
http://ww
w.theglobalfund.org
Albania; Algeria; Angola; Argentina;Arm
enia; Azerbaijan; Bangladesh;
Belarus; B
elize; Benin; B
olivia; Bosnia
and Herzegovina; B
otswana; B
razil;Bulgaria; B
urkina Faso; Burundi;
Cambodia; Cam
eroon; Central AfricanRepublic; Chad; Chile; China;Colom
bia; Comoros; Congo; Congo
(Dem
ocratic Republic); Costa Rica;Côte d'Ivoire; Croatia; Cuba; D
jibouti;Dom
inican Republic; Ecuador; ElSalvador; Equatorial G
uinea; Eritrea;Estonia; Ethiopia; G
abon; Gam
bia;Georgia; G
hana; Guatem
ala; Guinea;
Guinea-B
issau; Guyana; H
aiti;Honduras; India; Indonesia; Iran;
Jamaica; Jordan; Kazakhstan; Kenya;
Kyrgyzstan; Lao PDR; Lesotho; Liberia;
Macedonia; M
adagascar; Malaw
i; Mali;
Mauritania; M
ongolia; Morocco;
Mozam
bique; Myanm
ar; Nam
ibia;Nepal; N
icaragua; Niger; N
igeria;Pakistan; Papua N
ew G
uinea; Peru;Philippines; Rom
ania; RussianFederation; Rw
anda; São Tomé and
Principe; Senegal; Serbia andM
ontenegro; Sierra Leone; Somalia;
South Africa; Sudan; Suriname;
Swaziland; Tajikistan; Tanzania;
Thailand; Timor-Leste; Togo; Turkey;
Uganda; U
zbekistan; Viet Nam
; Yemen;
Zambia; Zim
babwe.
Annex 6: Bristol-Myers Squibb
eligible countries
Countries eligible for 1st pricecategory: Afghanistan; Angola; B
angladesh;Benin; B
hutan; Burkina Faso; B
urundi;Cam
bodia; Cameroon; Cape Verde;
Central African Republic; Chad;Com
oros; Congo; Congo (Dem
ocraticRepublic); Côte d'Ivoire; D
jibouti;Equatorial G
uinea; Eritrea; Ethiopia;Gabon; G
ambia; G
hana; Guinea;
Guinea-B
issau; Haiti; India; Kenya;
Lao PDR; Liberia; M
adagascar; Mali;
Mauritania; M
auritius; Mongolia;
Myanm
ar; Nepal; N
icaragua; Niger;
Nigeria; Pakistan; Papua N
ew G
uinea;Rw
anda; São Tomé and Principe;
Senegal; Seychelles; Sierra Leone;Solom
on Islands; Somalia; Sudan;
Tanzania; Timor-Leste; Togo; Tuvalu;
Uganda; Viet N
am; Yem
en.
Countries eligible for Southern Africanprices: Botsw
ana; Lesotho; Malaw
i;M
ozambique; N
amibia; South Africa;
Swaziland; Zam
bia; Zimbabw
e.
Seychelles; Sierra Leone; Somalia;
South Africa; Sudan; Swaziland;
Tanzania; Togo; Uganda; Zam
bia;Zim
babwe.
Annex 4: World Bank classification
of economies
Source: World B
ankhttp://w
eb.worldbank.org/W
BSITE/EXTE
RNAL/D
ATASTATISTICS/0,,contentMDK:2
0421402~pagePK:64133150~
piPK:64133175~
theSitePK:239419,00.html
The list is updated every year on 1stJuly. This version is from
2006.
Low-incom
e economies:
Afghanistan; Bangladesh; B
enin;Bhutan; B
urkina Faso; Burundi;
Cambodia; Central African Republic;
Chad; Comoros; Congo (D
emocratic
Republic); Côte d'Ivoire; Eritrea;Ethiopia; G
ambia; G
hana; Guinea;
Guinea-B
issau; Haiti; India; Kenya;
Korea (Dem
ocratic Republic);Kyrgyzstan; Lao PD
R; Liberia;M
adagascar; Malaw
i; Mali; M
auritania;M
ongolia; Mozam
bique; Myanm
ar;Nepal; N
iger; Nigeria; Pakistan; Papua
New
Guinea; Rw
anda; São Tomé and
Principe; Senegal; Sierra Leone;Solom
on Islands; Somalia; Sudan;
Tajikistan; Tanzania; Timor-Leste; Togo;
Uganda; U
zbekistan; Viet Nam
; Yemen;
Zambia; Zim
babwe.
Lower m
iddle-income econom
ies:Albania; Algeria; Angola; Arm
enia;Azerbaijan; B
elarus; Bolivia; B
osniaand H
erzegovina; Brazil; B
ulgaria;Cam
eroon; Cape Verde; China;Colom
bia; Congo; Cuba; Djibouti;
Dom
inican Republic; Ecuador; Egypt;El Salvador; Fiji; G
eorgia; Guatem
ala;Guyana; H
onduras; Indonesia; Iran;Iraq; Jam
aica; Jordan; Kazakhstan;Kiribati; Lesotho; M
acedonia;M
aldives; Marshall Islands;
Micronesia; M
oldova; Morocco;
Nam
ibia; Nicaragua; Palestinian
Territories; Paraguay; Peru;Philippines; Sam
oa; Serbia andM
ontenegro; Sri Lanka; Suriname;
Swaziland; Syria; Thailand; Tonga;
Tunisia; Turkmenistan; U
kraine;Vanuatu.
Upper middle-incom
e economies:
American Sam
oa; Argentina;Barbados; B
elize; Botsw
ana; Chile;Costa Rica; Croatia; Czech Republic;Dom
inica; Equatorial Guinea; Estonia;
Gabon; G
renada; Hungary; Latvia;
Lebanon; Libya; Lithuania; Malaysia;
Mauritius; M
ayotte; Mexico; N
orthernM
ariana Islands; Om
an; Palau;Panam
a; Poland; Romania; Russian
Federation; Seychelles; Slovakia;South Africa; St. Kitts and N
evis; St.Lucia; St. Vincent and the G
renadines;Trinidad and Tobago; Turkey; Uruguay;Venezuela.
42•
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eb of Price Reductions
Annex 7: Abbott eligible countriesSource: Abbott's Access to H
IV CareProgramhttp://w
ww.accesstohivcare.org/en/part
ners/countries.aspx
Afghanistan; Algeria; Angola;Bangladesh; B
enin; Bhutan;
Botsw
ana; Burkina Faso; B
urundi;Cam
bodia; Cameroon; Cape Verde;
Central African Republic; Chad;Com
oros; Congo; Congo (Dem
ocraticRepublic); Côte d'Ivoire; D
jibouti;Egypt; Equatorial G
uinea; Eritrea;Ethiopia; G
abon; Gam
bia; Ghana;
Guinea; G
uinea-Bissau; H
aiti; Kiribati;Kenya; Laos; Lesotho; Liberia; Libya;M
adagascar; Malaw
i; Maldives; M
ali;M
auritania; Mauritius; M
orocco;M
ozambique; M
yanmar; N
amibia;
Nepal; N
iger; Nigeria; Rw
anda; Samoa;
São Tomé and Principe; Senegal;
Seychelles; Sierra Leone; Solomon
Islands; Somalia; South Africa; Sudan;
Swaziland; Tanzania; Tim
or-Leste;Togo; Tunisia; Tuvalu; U
ganda;Vanuatu; Yem
en; Zambia; Zim
babwe.
Annex 8: Gilead eligible countries
Source: Gilead Access Program
http://ww
w.gileadaccess.org
Afghanistan; Algeria; Angola; Antiguaand B
arbuda; Baham
as; Bangladesh;
Barbados; B
elize; Benin; B
hutan;Bolivia; B
otswana; B
urkina Faso;Burundi; Cam
bodia; Cameroon; Cape
Verde; Central African Republic; Chad;Com
oros; Congo; Congo (Dem
ocraticRepublic); Côte d'Ivoire; D
jibouti;Dom
inica; Dom
inican Republic; Egypt;Equatorial G
uinea; Eritrea; Ethiopia;Gabon; G
ambia; G
hana; Grenada;
Guatem
ala; Guinea; G
uinea-Bissau;
Guyana; H
aiti; Honduras; Indonesia;
Jamaica; Kenya; Kiribati; Kyrgyzstan;
Lesotho; Liberia; Libya; Madagascar;
Malaw
i; Maldives; M
ali; Mauritania;
Mauritius; M
oldova; Mongolia;
Morocco; M
ozambique; M
yanmar;
Nam
ibia; Nepal; N
icaragua; Niger;
Nigeria; Pakistan; Papua; N
ew G
uinea;Rw
anda; St. Kitts and Nevis; St. Lucia;
St. Vincent and the Grenadines;
Samoa; São Tom
é and Principe;Senegal; Seychelles; Sierra Leone;Solom
on Islands; Somalia; South
Africa; Sudan; Suriname; Sw
aziland;Syria; Tajikistan; Tanzania; Tim
or-Leste; Togo; Trinidad and Tobago;Tunisia; Tuvalu; U
ganda; Uzbekistan;
Vanuatu; Viet Nam
; Yemen; Zam
bia;Zim
babwe.
Annex 9: Suggested resources for further information:
For documentation on prices quoted by com
panies:
- 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://ww
w.accessm
ed-msf.org/docum
ents/untanglingtheweb%
208.pdf- Sources and prices of selected m
edicines and diagnostics for people living with
HIV/AID
S (June 2005) http://mednet2.w
ho.int/sourcesprices/sources.pdf - G
lobal HIV/Aids Epidem
ic Selection of Antiretroviral Medications Provided under
U.S. Em
ergency Plan Is Limited, January 2005:
http://pdf.dec.org/pdf_docs/Pcaab266.pdf
For documentation on prices reported by countries:
- WHO, AM
DS, G
lobal Price Reporting Mechanism
for ARVs in Developing
Countries http://ww
w.w
ho.int/3by5/amds/price/hdd/
- The Global Fund Price Reporting M
echanismhttp://w
ww
.theglobalfund.org/en/funds_raised/price_reporting/default.aspand
http://web.theglobalfund.org/prm
/rc?sessionid=1126169666669_1&
comm
and[PrincipleRecipients_report]=
show- M
anagement Sciences for H
ealth (MSH
) International Drug Price Indicator G
uidehttp://erc.m
sh.org/mainpage.cfm
?file=1.0.htm
&id=
1&tem
ptitle=Introduction&
modu
le=DM
P&language=
English#top- W
HO AFRO
region Essential Medicines Price Indicator
http://ww
w.w
ho.int/medicines/areas/access/ecofin/en/index.htm
lor
http://ww
w.w
ho.int/medicines/publications/afroessential_m
ed_price_indicator_nocover.pdf
For documentation on patents:
- “Determ
ining the patent status of essential medicines in developing countries”,
Health Econom
ies and Drugs, ED
M Series N
o. 17, UNAID
S/WHO/M
SF, 2004- H
IV/AIDS m
edicines and related supplies: Contemporary context and
procurement. Technical guide. Chapter 2 and Annex B
. World B
ank, Washington,
DC, 2004
http://siteresources.worldbank.org/IN
TPROCU
REMEN
T/Resources/Technical-Guide-
HIV-AID
S.pdf
Médecins Sans Frontières • w
ww.accessm
ed-msf.org •
July 2006 (Revised) •Untangling the W
eb of Price Reductions •43
“Drug patents under the spotlight. Sharing practical know
ledge aboutpharm
aceutical patents” MSF, June 2004
For documentation on quality:
- Prequalification project managed by the W
orld Health O
rganization (WHO)
http://mednet3.w
ho.int/prequal/- U
S Food and Drug Adm
inistration (FDA) tentative approval
http://ww
w.fda.gov/cder/ogd/approvals/
Other useful w
ebsites referenced in this document:
- White List for ARV Procurem
ent, 5th June 2005, Clinton Foundationhttp://w
ww
.clintonfoundation.org/pdf/060505-white-list-for-arv-procurem
ent.pdf- W
HO AFRO
region Essential Medicines Price Indicator
http://ww
w.w
ho.int/medicines/publications/afroessential_m
ed_price_indicator_nocover.pdf- International D
ispensary Association (IDA) price indicator
http://ww
w.idafoundation.org
- US Food and D
rug Administration orange book
http://ww
w.fda.gov/cder/ob/
- Catalogue of US Food and D
rug Administration approved products, products
documentation http://w
ww
.accessdata.fda.gov/scripts/cder/drugsatfda/- W
HO registration http://ftp.w
ho.int/htm/AM
DS/drugsdatabase.pdf
- WHO H
IV treatment guidelines for adults and adolescents
WHO Antiretroviral Therapy for H
IV Infection in Adults and Adolescents in Resource-Lim
ited Settings: Towards Universal Access: Recom
mendations for a
public health approach 2006 version (in press). WHO G
eneva 2006.- W
HO H
IV treatment guidelines for Children
Antiretroviral therapy of HIV infection in infants and children in resource-lim
itedsettings: tow
ards universal access: Recomm
endations for a public healthapproach 2006 (in press) W
HO G
eneva 2006.- B
iotechnology/Pharmaceuticals H
IV/AIDS Industry Report - April 2005
http://ww
w.aethlonm
edical.com/pdfs/IndustryReport.pdf
- Clinton Foundation http://ww
w.clintonfoundation.org/
- Access Campaign w
eb site http://ww
w.accessm
ed-msf.org/
Annex 10: Company contacts
Abbott:Rob D
intruff E-m
ail: [email protected]
AXIOS International m
anages therequest process: The Program
me M
anager Access to H
IV Care Programm
e AXIO
S International P.O
. Box 6924
Kampala, U
ganda Tel: +256 75 693 756 Fax:+256 41 543 021 E-m
ail: AccesstoHIVCare@
axiosint.com
Website : w
ww
.accesstohivcare.org
Aspen:Vivian Victor Viljoen - Senior ExecutiveE-m
ail: viljoenv@aspenpharm
a.com
Aspen Pharmacare
PO B
ox 1593Gallo M
anor2052 South AfricaTel: +27 11 239 6551Fax: +27 11 239 6573w
ebsite : ww
w.aspenpharm
a.com
Aurobindo Pharma Ltd:
Mr. A. Vijaykum
ar Head - Anti Retrovirals Project
Tel: +91 40 2304 4070 Or +91 98481 10877 (M
obile)Fax: +91 40 23044058E-m
ail: [email protected]
Bristol-Myers Squibb:
All countries with the exception of
Southern Africa:M
rs Marie-Astrid M
ercier,Coordinator, G
lobal access program,
BM
S Paris office E-m
ail: marie-astrid.m
ercier@bm
s.com
Southern Africa: Gustav Schellack
Project Manager
BM
S offices in Johannesburg Tel: +27 11 456 64 44
Boehringer-Ingelheim
: Helm
ut LeuchtenCD
Marketing Prescription M
edicinesHead of CD
ept. CG H
IV-Specialist/VirologistsPhone: + 49 6132 77-8486Fax: +49 6132 77-3829E-m
ail:helm
ingelheim.com
Michael Rabbow
CD
Marketing Prescription M
edicinesCD
ept. HIV-Specialists/Virologists
Tel: + 49 6132 77- 92701Fax: + 49 6132 77-38 29 E-m
ail: rabbow@
ing.boehringer-ingelheim
.com
44 •M
édecins Sans Frontières • ww
w.accessm
ed-msf.org •
July 2006 (Revised) •Untangling the W
eb of Price Reductions
Cipla Ltd:M
r. Sanjeev Gupte, G
eneral Manager-
Exports
Mr. Shailesh Pednekar
Executive-Exports, Cipla Limited
Tel: +91 22 23021397 (Direct)
23095521 23092891Fax: +91 2223070013/23070393/23070385E-m
ail: [email protected]
andciplaexp@
cipla.com
Gilead:
Gilead Access Program
: Deborah O
vadiaGilead Access Program
Manager
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, California 94404 USA
Tel: +1-650-574-3000, Option #1
Fax: +1-650-522-5870E-m
ail: [email protected]
W
ebsite: ww
w.gileadaccess.org
Corporate Contact:Sheryl M
eredithInternational O
perationsGilead Sciences
333 Lakeside Drive
Foster City, California 94404 USA
Tel: +1-650-522-5505E-m
ail: smeredith@
gilead.com
GlaxoSm
ithKline:
Isabelle Girault
Director, G
overnment Affairs
HIV &
AIDS
Tel: + 44 (0) 20 8047 5488Fax: + 44 (0) 20 8047 6957E-m
ail: [email protected]
Hetero D
rugs Limited:
"Hetero H
ouse", H.N
o.:8-3-166/7/1,Erragadda, H
yderabad - 500 018,India
Tel: +91-40-23704923 / 24Tel (D
irect):+91-40-23818029E-m
ail: msreddy@
heterodrugs.com
Merck &
Co. Inc:Brenda D
. ColatrellaExecutive D
irector, HIV Policy &
External AffairsHum
an Health Intercontinental
Merck &
Co., Inc.One M
erck Drive (W
S2A-56)W
hitehouse Station, NJ 08889-0100
USA
Tel: +1-908-423-2047Fax: +1-908-735-1839E-m
ail: brenda_colatrella@m
erck.com
Ranbaxy:M
r. Sandeep JunejaRanbaxy Laboratories Lim
itedTel: + 91 124 518 59 06 (D
irect)or + 91 124 513 50 00Fax: + 91 124 516 60 35E-m
ail: [email protected]
w
ww
.aidonaids.comw
ww
.ranbaxy.com
Roche: For inform
ation regarding quotationsand deliveries to custom
ers contact: Hanspeter W
älchli Logistics Sales InternationalCustom
ers Dept. PTG
S-I 4303 Kaiseraugst Sw
itzerlandTel: +41 61 688 1060Fax: +41 61 687 1815 E-m
ail: hanspeter.waelchli@
roche.com
Strides Arcolab Ltd:M
rs. Aloka SenguptaAsst. Vice President -AID
S/Tubrculosis/Malaria
Strides House, B
ilekahalliBannerghatta Road
Bangalore 560 076,
IndiaTel: +91-80-57580748M
obile : +91 98450 24470Fax: +91-80-57580800 E-m
ail:aloka.sengupta@
stridesarco.com
Médecins Sans Frontières • w
ww.accessm
ed-msf.org •
July 2006 (Revised) •Untangling the W
eb of Price Reductions •45
[1] To consult previous editions, please seew
ww.accessm
ed-msf.org
[2] WHO A
ntiretroviral Therapy for HIV
Infection in Adults and Adolescents inResource-Lim
ited Settings: Towards U
niversalAccess: Recom
mendations for a Public H
ealthApproach 2006 version (in press), W
HO
Geneva 2006; and A
ntiretroviral Therapy ofHIV
Infection in Infants and Children inResource-Lim
ited Settings: Towards U
niversalAccess: Recom
mendations for a Public H
ealthApproach 2006 (in press), W
HO G
eneva 2006.[3] The K
hayelitsha cohort: survival andchallenges at 48 m
onths; MSF satellite
meeting, ICA
SAconference, D
ecember 2005
[4] WHO G
lobal Price Reporting Mechanism
data basehttp://w
ww.w
ho.int/hiv/amds/gprm
/en/index.htm
lThe W
HO G
lobal Price ReportingM
echanism data base contains prices paid by
UNICEF, ID
A, M
SH/D
eliver, and the Global
Fund[5] Pharm
aceutical patents and the TRIP
Sagreem
enthttp://w
ww.w
to.org/english/tratop_e/trips_e/pharm
a_ato186_e.htm
[6] Determ
ining the Patent status of EssentialM
edicines in Developing Countries”
WHO/U
NAID
S/MSF 2004
[7] Where a regional O
API patent has also
been granted.[8] See Section 3(d) and 25 of the 2005Patents Act athttp://w
ww.patentoffice.nic.in/ipr/patent/patent
_2005.pdf [9] W
HO G
lobal Price Reporting Mechanism
data base
http://ww
w.w
ho.int/hiv/amds/gprm
/en/index.htm
l[10] M
ore empty prom
ises: Abbott fails tosupply critical new
aids drug formulation to
developing countries, 27 April 2006.http://w
ww.accessm
ed-msf.org
[11] UNAID
S/WHO A
IDS Epidem
ic Update 2005.
http://ww
w.w
ho.int/hiv/epi-update2005_en.pdf[12] Exam
ples of other generic manufacturers
known to be producing one or m
ore ARV
s,but not included in this survey are: R
ichmond
Laboratorios, Panalab, Filaxis (Argentina);
Pharmaquick (B
enin); Far Manguinhos, FU
RP,
Lapefe, Laob, Iquego, IVB (B
razil); Apotex,Novopharm
(Canada); Shanghai Desano
Biopharm
aceutical Co., Northeast G
eneralPharm
aceutical Factory (China); Biogen
(Colombia); Stein (Costa R
ica); Zydus CadilaHealthcare, SunPharm
a, EAS-SU
RG, M
acLeods, IP
CA, Em
cure (India); Cosmos (Kenya);
LG Chem
icals, Samchully, Korea U
nited PharmInc. (Korea); Protein, Pisa (M
exico);Androm
aco, CombinoPharm
(Spain); Aspen
(South Africa); The G
overnment
Pharmaceutical O
rganization-GPO, T.O
.Chem
ecal (Thailand); Laboratorio Dosa S.A
.(U
SA), Varichem
(Zimbabw
e).[13] Sources and Prices of selected m
edicinesand diagnostics for people living w
ithHIV
/AID
S, June 2005http://m
ednet2.who.int/sourcesprices/sources.p
df[14] Incoterms definitions, International
Chamber of com
merce, see
http://ww
w.iccw
bo.org/index_incoterms.asap
[15] Global H
IV/A
IDS Epidem
ic: Selection ofAntiretroviral M
edications Provided Under U
SEm
ergency Plan is Limited. Report to
Congressional Requesters. United States
Governm
ent Accountability Office. January
2005.[16] http://w
ww.clintonfoundation.org
[17] WHO M
odel List of Essential Medicines
http://ww
w.w
ho.int/medicines/publications/ess
entialmedicines/en/
[18] Prices collected from January 2005 to
March 2006.
[19] Major developm
ents in the treatment of
HIV
/AID
S, Biotechnology/pharm
aceuticalsHIV
/AID
S industry report, April 2005http://w
ww.aethlonm
edical.com/pdfs/IndustryR
eport.pdf [20] W
ill once-daily Kaletra be enough to see
off the threat of Reyataz? Pharmaceutical
business review, http://w
ww.pharm
aceutical-business-review
.com/article_feature.asp?
guid=19B
35C8A-0C61-4E9B
-AA08-
B8B
F93550BDB
[21] Australian Ex Works price
http://ww
w1.health.gov.au/pbs/
scripts/search.cfm[22] 2004 B
ristol-Myers Squibb's A
nnualReport. http://library.corporate-ir.net/library/10/106/106664/item
s/163922/bms_
ar_04.pdf [23] 1999 B
ristol-Myers Squibb's A
nnualReport. [24] P
érez-Casas C.: HIV
/AID
S medicines
pricing report; 6th July 2000 http://w
ww.accessm
ed-m
sf.org/prod/publications.asp?scntid=4920011
13146&contenttype=
PARA&
[25] B
razilian government's w
ebsitew
ww.aids.gov.br
[26] Healthcare B
iotechnologyGilead Sciences
(GILD
), 20th April 2006w
ww.som
.yale.edu/AnalystReports/dyn/dow
nload.php?reportid=
269 [27] 2004 annual report, p.19,w
ww.gilead.com
[28] Gilead press release:
http://ww
w.gilead.com
/wt/sec/pr_678072
[29] Pharma B
usiness, pp.38-40, July/August1998[30] Love J. CIP
LA's lam
ivudine cheaper thanGlaxo, Ip-health 10-06-99, ip-
[31] AID
S map treatm
ent and care, nelfinaviroverview
ww
w.aidsm
ap.com[32] Please, note that there w
as an error incalculations of this price in the 8th edition of“U
ntangling the web of price reductions”,
MSF, June 2005, w
ww.accessm
ed-msf.org
[33] 2004 annual report p.25,w
ww.boehringer-ingelheim
.com[34] Abbott Laboratories H
ighlights fromRecent M
anagement M
eetings, North A
merica
Equity Research, 6th July 2005. [35] The Regulatory status of A
ntiretroviralDrugs D
atabase http://ftp.who.int/htm
/AM
DS/
drugsdatabase.pdf[36] See M
SF press release athttp://w
ww.accessm
ed-m
sf.org/prod/publications.asp?scntid=10520061
12802&contenttype=
PARA&
[37] W
HO puts abortifacients on it's essential
drug listhttp://bm
j.bmjjournals.com
/cgi/content/full/331/7508/68-c [38] http://w
ww.gsk.fr/gsk/gsk_m
onde/pdf/resultat2004.pdf [39] http://w
ww.pharm
afield.co.uk/asp/article.asp?id=
320&source=
1[40] CN
N M
oney article, 7th June 2005[41] See M
SF press release athttp://w
ww.accessm
ed-m
sf.org/prod/publications.asp?scntid=3032006
1021523&contenttype=
PARA&
Notes &
References
46 •M
édecins Sans Frontières • ww
w.accessm
ed-msf.org •
July 2006 (Revised) •Untangling the W
eb of Price Reductions
Glossary
bears all the risks and any additionalcosts occurring after the goods havebeen delivered. H
owever, in CIP
theseller also has to procure insuranceagainst the buyer's risk of loss of ordam
age to the goods during carriage.Consequently, the seller contracts forinsurance and pays the insuranceprem
ium.
dd44TT stavudine; nucleoside analoguereverse transcriptase inhibitor
ddddIIdidanosine; nucleoside analogue
reverse transcriptase inhibitor
DDU
“Delivered duty unpaid”. A
comm
ercial term (incoterm
) meaning
that the seller delivers the goods tothe buyer, not cleared for im
port, andnot unloaded from
any arriving means
of transport at the named place of
destination. The seller has to bear thecosts and risks involved in shippingthe goods, other than, w
hereapplicable, any 'duty' (w
hich includesthe responsibility for the risks of thecarrying out of the custom
s formalities,
and the payment of form
alities,custom
s duties, taxes and othercharges) for im
port in the country ofdestination. Such 'duty' has to beborne by the buyer as w
ell as anycosts and risks caused by his failure toclear the goods for the im
port time.
EECCenteric-coated
EEMMLL
Essential Medicines List. First
published by WHO in 1977, it serves
to identify a list of medicines, w
hichprovide safe and effective treatm
entfor infectious and chronic diseasesaffecting the vast m
ajority of thew
orld's population. The 12th UpdatedList w
as published in April 2002 andincludes tw
elve antiretrovirals.
EEFFVV orEEFFZZ
efavirenz; non-nucleosideanalogue reverse transcriptaseinhibitor
EEXXWW“Ex-w
orks”. Acom
mercial term
(incoterm) m
eaning that the sellerdelivers w
hen he places the goods atthe disposal of the buyer at theseller's prem
ises or another named
place (i.e. works, factory, w
arehouseetc.) not cleared for export and notloaded on any collecting vehicle.
FFOOBB
“Free on board”. Acom
mercial
(incoterm) term
meaning that the
seller delivers when the goods pass
the ship's rail at the named port of
shipment. This m
eans that the buyerhas to bear all costs and risks of lossor dam
age to the goods from that
point. The FOB term
requires the sellerto clear the goods for export.
FFDDCC
fixed-dose combination - several
drugs combined in a single pill
FFTTCCem
tricitabine; nucleoside analoguereverse transcriptase inhibitor
3TClam
ivudine; nucleoside analoguereverse transcriptase inhibitor
ABCabacavir; nucleoside analogue
reverse transcriptase inhibitor
AIDS
Acquired Imm
une Deficiency
Syndrome
AARRVVAntiretroviral drug
AATTZZatazanavir; protease inhibitor
BBIIBoehringer-Ingelheim
BBMMSS
Bristol-Myers Squibb
CCIIFF“Cost Insurance and Freight”. A
comm
ercial term (incoterm
) meaning
that the seller delivers once the goodspass the ship's rail in the port ofshipm
ent. The seller must pay the
costs and freight necessary to bringthe goods to the nam
ed port ofdestination BU
Tthe risk of loss or
damage to the goods, as w
ell as anyadditional costs due to eventsoccurring after the tim
e of delivery, aretransferred from
the seller to thebuyer.
CCIIPP“Carriage and Insurance paid
to...”. Acom
mercial term
(incoterm)
meaning that the seller delivers the
goods to the carrier nominated by
him, but the seller m
ust in additionpay the cost of carriage necessary tobring the goods to the nam
eddestination. This m
eans that the buyer
Médecins Sans Frontières • w
ww.accessm
ed-msf.org •
July 2006 (Revised) •Untangling the W
eb of Price Reductions •47
GGeenneerriicc ddrruugg
According to WHO, a
pharmaceutical product usually
intended to be interchangeable with
the originator product, which is usually
manufactured w
ithout a license fromthe originator com
pany.
GGPPRRMM
WHO G
lobal Price ReportingM
echanism is a database containing
prices paid by UNICEF, the
International Dispensary Association
(IDA), M
anagement Sciences for H
ealth(M
SH)/D
eliver, and the Global Fund to
Fight AIDS, Tuberculosis and M
alaria.
GGSSKK
GlaxoSm
ithKline
HHDDII H
uman D
evelopment Index. A
summ
ary composite index, com
pile byUNDP, that m
easures a country'saverage achievem
ents in three basicaspects of hum
an development:
longevity (or life expectancy at birth),know
ledge (or adult literacy rate andenrolm
ent in education), and a decentstandard of living (gross dom
esticproduct per capita).
HHIIVV
Hum
an Imm
unodeficiency Virus
LLDDCCss
Least Developed Countries,
according to United Nations
classification
LLPPVV//rrLopinavir/ritonavir; boosted
protease inhibitor
MMSSDD
Merck Sharp &
Dom
e (Merck &
Co., Inc.)
PPLLWWHHAA
People Living With H
IV/AIDS
PPMMTTCCTT
Prevention of Mother-to-Child
Transmission
ppyper patient per year
RR&&DD
Research and Developm
ent
RRTTVVritonavir, protease inhibitor
rrlow
-dose ritonavir, used as a booster
SSQQVV
saquinavir; protease inhibitor
TTDDFF
tenofovir disoproxil fumarate;
nucleotide reverse transcriptaseinhibitor
TTRRIIPPSSTrade-Related aspects of
Intellectual Property Rights
UUNNAAIIDD
SSUnited N
ations JointCosponsored Program
me on H
IV/AIDS,
created in 1996, to lead, strengthenand support an expanded response tothe H
IV/AIDS epidem
ic. The six originalcosponsors are U
NICEF, U
NDP, U
NFPA,
UNESCO
, WHO and the W
orld Bank. UNDCP
joined in April 1999.
UUNNDDPP
United Nations D
evelopment
Programm
e
UUSS FFDD
AAUnited States Food and D
rugAdm
inistration
VVLLVoluntary license
MMSSFF
Médecins Sans Frontières
NNDDRRAA N
ational Drug Regulatory
Authority
NNGGOO
Non-G
overnmental O
rganisation
NNFFVV nelfinavir; protease inhibitor
NNNNRRTTII
Non-N
ucleoside ReverseTranscriptase Inhibitor
NNRRTTII
Nucleoside Analogue Reverse
Transcriptase Inhibitor
NNttRRTTII
Nucleotide Reverse Transcriptase
Inhibitor
NNVVPP
nevirapine; non-nucleosideanalogue reverse transcriptaseinhibitor
OOAAPPII
Organisation Africaine de la
Propriété Intellectuelle, AfricanIntellectual Property O
rganisation,w
hose mem
ber states are Benin,
Burkina Faso, Cameroon, Central
African Republic, Chad, Congo, Côted'Ivoire, G
abon, Guinea, G
uinea-Bissau, Equatorial G
uinea, Mali,
Mauritania, N
iger, Senegal, Togo.
PPEEPPFFAARRPresident's Em
ergency Planfor AID
S Relief, a United Statesprogram
me to fight H
IV/AIDS in
developing countries
PPIIprotease inhibitor
WWHHOO
World H
ealth Organization
WWHHOO GG
PPRRMM W
HO G
lobal PriceReporting M
echanism
WWTTOO
World Trade O
rganization
ZZDDVV zidovudine; nucleoside analogue
reverse transcriptase inhibitor
Campaign for Access to
Essential Medicines
Médecins Sans Frontières
Rue de Lausanne 78, CP116
CH-1211 G
eneva 21, Switzerland
Tel: + 41 (0) 22 849 84 05Fax:+ 41 (0) 22 849 84 04
email: access@
geneva.msf.org
http://ww
w.accessm
ed-msf.org
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ork:Tw
enty 3 Crows Ltd +44 (0) 1848 200401