Untangling the web (9th edition) - English version

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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July 2006 (Revised) •Untangling the W

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


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


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.


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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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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


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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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


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


IV-1 proteaseinhibitor (PI)

•Indicated for second-line, for adults

and adolescents (WHO 2006 guidelines

[2])

•Originator com


e: Bristol-Myers Squibb (B

MS),

Reyataz


S Food and Drug

Administration (FD

A): 20th June 2003

•Not included in the W

HO M


edicines (EML)

[17]

•W


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.


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Price information:


panies for eligible developing countries:DID

ANOSIN

E (ddI)

General inform

ation


IV-1 and HIV-2


RTI)

•Indicated for second-line, for adults,

adolescents and children (WHO 2006

guidelines[2])

•Originator com



MS), Videx


S Food and Drug

Administration (FD

A): October 1991 for

chewable tablets; O

ctober 2000 for enteric-coated tablets


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



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


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EFAVIRENZ (EFV

)

General inform

ation


IV-1 non-nucleosidereverse transcriptase inhibitor (N

NRTI)


adults, adolescents and children (WHO 2006

guidelines[2])

•Originator com

panies, and product brandnam

es: Bristol-Myers Squibb (B

MS), Sustiva,

or Merck, Stocrin


S Food and Drug

Administration (FD

A): 17th September 1998


HO M


edicines (EML)

[17]

•W


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:


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.


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


500

485300 394

767

462

346277

217

697

920821

None

None


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.


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EMTRICITABIN

E (FTC)

General inform

ation


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


S Food and Drug

Administration (FD

A): July 2003


HO M


edicines (EML)

[17]

•W


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


IV-1 and HIV-2


RTI)

•Indicated for first- and second-line for

adults and adolescents, and for first-line onlyfor children (W

HO 2006 guidelines

[2])

•Originator com


e: GlaxoSm

ithKline (GSK), Epivir


S Food and Drug

Administration (FD

A): Novem

ber 1995


HO M


edicines (EML)

[17]

•W


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


Price information:




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.


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


234

91

51 69

US$ ppy


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


IV-1 and HIV-2 protease

inhibitor (PI)

•Indicated only for second-line in adults,


guidelines[2])

•Originator com


e: Roche, Viracept


S Food and Drug

Administration (FD

A): 14th March 1997


HO M


edicines (EML)

[17]

•W


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:



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.


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 .

▲

▲

▲

▲

▲

▲▲

▲▲

▲▲

▲

▲

▲


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


2924 3139

986

683

2361

1543

US$ per unit

20•


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NEVIRAPIN

E (NVP)

General inform

ation


IV-1 non-nucleosidereverse transcriptase inhibitor (N

NRTI)



guidelines[2])

•Originator com


e: Boehringer-Ingelheim

(BI), Viram

une


S Food and Drug

Administration (FD

A): 21st June 1996


HO M


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


Price information:



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


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


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


ith Cipla to sell NVP

50 mg / 5 m


l) in countries included in theirconsortium

[16].


ww.accessm

ed-msf.org •



RITONAVIR (r or RTV

)

General inform

ation



inhibitor (PI)

•Indicated for second-line as a booster, for


guidelines[2])

•Originator com


e: Abbott Laboratories, Norvir


S Food and Drug

Administration (FD

A): March 1996 for the oral

solution and 29th June 1999 for capsules


HO M


edicines (EML)

[17]

•W


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


Price information:




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


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


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•


ww.accessm

ed-msf.org •



SAQUIN

AVIR (SQV)

General inform

ation



inhibitor (PI)

•Indicated for second-line, to be used

boosted by ritonavir, for adults, adolescentsand children. (W

HO 2006 guidelines)

•Originator com


e: Roche, Invirase


S Food and Drug

Administration (FD

A): Decem

ber 1995


HO M


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


Price information:






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


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


ww.accessm

ed-msf.org •



STAVUDIN

E (d4T)

General inform

ation


IV-1 and HIV-2


RTI)

•Indicated for first-line, for adults,


guidelines[2])

•Originator com



MS), Zerit


S Food and Drug

Administration (FD

A): Decem

ber 1994


HO M


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:



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.


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


d4T 40 mg

44

74

36 5555

None

None

None

None

None

▼

▼

US$ ppy


ith Cipla to sell d4T1 m

g / ml at U

S$ 0.017 per unit (ml) in countries included in their consortium

[16].

24•


ww.accessm

ed-msf.org •



TENOFO

VIR DISO

PROXIL

FUM

ARATE (TDF)

General inform

ation


IV-1 nucleotide reversetranscriptase inhibitor (N

tRTI)


adults and adolescents (WHO 2006

guidelines[2])

•Originator com


e: Gilead, Viread


S Food and Drug

Administration (FD

A): October 2001


HO 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


Price information:



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


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.


ww.accessm

ed-msf.org •



ZIDOVU

DIN

E (AZT, ZDV)

General inform

ation


IV-1 and HIV-2


RTI)



guidelines[2])

•Originator com


e: GlaxoSm

ithKline (GSK), Retrovir


S Food and Drug

Administration (FD

A): March 1987


HO M


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


Price information:


panies for developing countries:


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


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


US$ ppy

684

193

103

212


ith Cipla to sell AZT

50 mg / 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)



guidelines[2])

•Originator com


e: GlaxoSm

ithKline (GSK), Kivexa


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


w.accessm

ed-msf.org •



Price information:



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.


ABC 600 / 3TC 300 m

g

Daily dose

1

GSK

Cipla

None

678 (1.858)255 (0.700)

See table 2


ww.accessm

ed-msf.org •



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



guidelines[2])

•The W

HO Expert Com

mittee on the


recomm




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:


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.


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



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•


ww.accessm

ed-msf.org •



LOPIN

AVIR/RITONAVIR

(LPV/r)

General inform

ation

•Therapeutic class: boosted Protease

Inhibitor (PI) in double fixed-dosecom


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


e: Abbott Laboratories, Kaletra

• Included in the WHO M


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


Price information:



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

▲

▲▲

▲▲▲


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


ww.accessm

ed-msf.org •



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


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:




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


edicinesrecom




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:




TDF/3TC

300 + 300 mg tablets

Daily dose

1

Cipla

1,034 (2.833)

None

30•


ww.accessm

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ZIDOVU

DIN

E/LAMIVU

DIN

E(AZT/3TC)

General inform

ation


RTI in double fixed-dose com


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


e: GlaxoSm

ithKline (GSK), Com

bivir


S Food and Drug

Administration (FD

A): September 1997

•The W

HO Expert Com

mittee on the


recomm




binations.[17]

•W


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:




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)


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


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


ww.accessm

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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


adolescents and children ((WHO 2006

guidelines[2])

•The W

HO Expert Com

mittee on the


recomm




binations.[17]


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


(separate products)


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:




30 / 6 / 50 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•


ww.accessm

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TENOFO

VIR DISO

PROXIL

FUM

ARATE/EMTRICITABIN

E/EFAVIREN

Z (TDF/FTC/EFV

)

General inform

ation


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


e: Gilead and B

MS/M

erck, Atripla


S Food and Drug

Administration (FD

A): July 2006

•The W

HO Expert Com

mittee on the


recomm




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.


ww.accessm

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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



guidelines[2])

•The W

HO Expert Com

mittee on the


recomm




binations.[17]

•Originator com


e: GlaxoSm

ithKline (GSK), Trizivir


S Food and Drug

Administration (FD

A): Novem

ber 2000

•W


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





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:




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


o NRTI + one N

NRTI in

triple fixed-dose combination, for H

IV-1



guidelines[2])

•The W

HO Expert Com

mittee on the


recomm




binations.[17]


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:




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


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


(separate products)



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


ww.accessm

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LAMIVUDIN

E/STAVUDINE +

EFAVIRENZ

(3TC/d4T+EFV)

General inform

ation


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


edicinesrecom




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:




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


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


edicinesrecom




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:




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•


ww.accessm

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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


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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


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.


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•


ww.accessm

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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


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


bination in co-blister


ww.accessm

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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


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


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


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


w.accessm

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Annexes


ww.accessm

ed-msf.org •



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


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;






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


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•


ww.accessm

ed-msf.org •



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;




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



jibouti;Dom

inica; Dom

inican Republic; Egypt;Equatorial 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


ww.accessm

ed-msf.org •



“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


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

[email protected]

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


w.accessm

ed-msf.org •



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


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


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


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


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


ww.accessm

ed-msf.org •



[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


data basehttp://w

ww.w

ho.int/hiv/amds/gprm

/en/index.htm

lThe W

HO G


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


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-

[email protected]

[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


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


1021523&contenttype=

PARA&

Notes &

References

46 •M


w.accessm

ed-msf.org •



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


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


ww.accessm

ed-msf.org •



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


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


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


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@

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w.accessm

ed-msf.org

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