UNTANGLING THE WEB OF

ANTIRETROVIRALPRICE REDUCTIONS
18th Edition – July 2016www.msfaccess.org

PREFACE
In this report, we provide an update on the key facets of HIV treatment access. It includes
the latest HIV treatment guidelines from World Health Organization (WHO), an overview on
pricing for first-line, second-line, and salvage regimens, and a summary of the opportunitiesfor – and threats to – expanding access to affordable antiretroviral therapy (ART). There is atable with information on ARVs, including quality assurance, manufacturers and pricing on
pages 19 to 21.

Detailed information on key antiretroviral drugs
and fixed-dose combinations is available at:www.msfaccess.org/utw2016
THE MSF ACCESS CAMPAIGNIn 1999, on the heels of Médecins Sans Frontières (MSF) being awarded the Nobel Peace Prize – andlargely in response to the inequalities surrounding access to HIV/AIDS treatment between rich andpoor countries – MSF launched the Campaign for Access to Essential Medicines. Its sole purpose
has been to push for access to, and the development of, life-saving and life-prolonging medicines,
diagnostics and vaccines for patients in MSF programmes and beyond.

www.msfaccess.org
MSF AND HIV
Médecins Sans Frontières (MSF) began providing antiretroviral therapy to a small number ofpeople living with HIV/AIDS in 2000 in projects in Thailand, South Africa and Cameroon.
At the time, treatment for one person for one year cost more than US$10,000. With increased
availability of low-cost, quality antiretroviral drugs (ARVs), MSF provides antiretroviral treatment
to 247,000 people in 18 countries, implements treatment strategies to reach more people earlier
in their disease progression, and places people living with HIV at the centre of their care.
Over the past 16 years, the MSF Access Campaign has been monitoring the barriers toavailability and affordability of life-saving ARVs and appropriate formulations, including patentmonopolies, prices and lack of generic competition through Untangling the Web and pushingfor the uptake of policies that promote access to affordable quality medicines. Due primarily togeneric competition, the price of ARVs has dropped by more than 99% over the last 15 years,
but the price of the newest drugs, already needed by some people in MSF projects, is prohibitive
and a source of great concern both for MSF and national treatment programmes.

PATENT OPPOSITION DATABASE
The Patent Opposition Database was launched by the MSF Access Campaign in October 2012 as an
online space where civil society can share the resources and tools needed to oppose patents on
medicines. The database gathers contributions from around the world. It allows documents to beshared, arguments to be replicated, and new alliances to be forged, with the aim of successfully
opposing patents and ultimately improving access to medicines in developing countries. To findout more about patents that block access to essential medicines and what you can do to challengethem, or to contribute by sharing resources, visit:www.patentoppositions.org

Médecins Sans Frontières | July 2016

2	STATE OF HIV TREATMENT ACCESS
Speed up treatment scale-up in Western and Central Africa		

TABLE OF CONTENTSTABLE OF CONTENTS

4	OPTIMISING HIV TREATMENT 		
7	PRICINGHigh antiretroviral prices in middle- and high-income countries		
11	REGISTRATION
Lack of access to dolutegravir in India
12	PATENT OPPOSITIONS AND PATENT LAW REFORM
Patent oppositions for hepatitis C		
Evergreening		
14	TRADE AGREEMENTS
LDC exemption from pharmaceutical IP extended		
Colombia: Compulsory licence threat invites US pressure
16	STOCKOUTS
Market shaping institutions – what needs to happen
Update on the Medicines Patent Pool’s new licences		
18

CONCLUSION

19ANNEX: SUMMARY TABLE OF ALL PRICES

22REFERENCES

24

GLOSSARY AND ABBREVIATIONS

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1

STATE OF HIV TREATMENT ACCESSSTATE OF HIV
TREATMENT ACCESSIn 2000, when the International AIDS Conference was last held in Durban, South Africa, a basic
antiretroviral (ARV) regimen cost over US$10,000 per person per year (pppy), multilateral programmes
funding the fight against HIV, TB, and malaria did not exist, and many donors – such as the US
government – had yet to provide a single dollar for antiretroviral treatment in resource-limited countries.

Now, in 2016, 17 million HIV-positive
people are receiving lifesaving
antiretroviral therapy (ART),1 and thelowest price for a generic, World HealthOrganization (WHO)-recommended
first-line regimen is $100 pppy.

At the UN High Level Meeting on
HIV in June 2016, governments
agreed on a global target: reaching
30 million people with treatment
by 2020. Reaching this goal will
require increased and sustained
support from donors.

THE 2020 UNAIDS
TARGET: 90-90-90
By 2020, 90% of all
HIV-positive people will beaware of their status; 90%of all people diagnosed
with HIV will have access tosustained ART; and 90% of
people on ART – or 73% of
all HIV-positive people – willachieve viral suppression.3© Isabel Corthier

In 2015, the number of people starting
HIV treatment surpassed the numberof new infections in Africa for the
first time. Since 2010, the number ofpeople receiving ART has more thandoubled.1,2 The push to continue
ARV scale-up has gained momentum
around the UNAIDS global targets

for 2020, referred to as ‘90-90-90’.3
To meet these targets, the number ofpeople on treatment will need to morethan double again, since nearly 20
million HIV-positive people are newly
eligible for ART under the new ‘treatall’ recommendation.1

Tsandia receives her antiretroviral medicines at the HIV department of the Arua Regional hospital in Uganda.

2

Médecins Sans Frontières | July 2016

Originator products
Generic products

US$ per person per year

12000
10000

10439

8000
6000
4000
2767

2000

549

0

132

June 00

Sept 01

June 02

June 03

Dec 03

Apr 04

June 05

STATE OF HIV TREATMENT ACCESS

GRAPH 1: GENERIC COMPETITION AS A CATALYST FOR PRICE REDUCTION FOR A FIRST-LINE REGIMEN

June 06

Since 2000, MSF has been providing HIV care and treatment
to people in developing countries. Today, MSF provides HIV
treatment for nearly 250,000 people.

SPEED UP TREATMENT SCALE-UP IN WESTERN AND CENTRAL AFRICA
Although HIV prevalence is lower inWestern and Central Africa than inSouthern Africa, over a quarter ofworsened by the Ebola outbreak add to barriers that include limitedaccess to diagnostic and monitoring

tests, drug stockouts, out-of-pocket
fees for healthcare, and lack ofdecentralised treatment.4

all AIDS-related deaths occur in theregion, including 40% of all deaths
among children.4
In Central African Republic, HIV

In 2015, only 1.8 million
people (28%) of the region’s
6.5 million HIV-positive people
were accessing ART.1 Politicalinstability, inadequate funding andweak healthcare systems - some

© Sam Phelps

prevalence is 5%, but HIV accounts
for 84% of hospital-based deaths
where MSF works. In Democratic
Republic of the Congo, three outof four HIV-positive people who
present to the hospital where MSF
works are too sick to save.

Mohamed (left) is tested for HIV at an MSF mobile clinic in Conakry, Guinea.

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3

OPTIMISING HIV TREATMENT

OPTIMISING HIV TREATMENTCOUNTRIES SHOULD IMPLEMENT WHO GUIDELINES
Immediate treatment and a steadysupply of affordable medicines are
essential to curbing the HIV epidemic.
ART lowers the risk of serious illness
and death, reduces the risk ofdeveloping tuberculosis (TB) by
65%, and reduces HIV transmission
by 96%.5,6,7,8
In light of the individual andcommunity benefits of HIV treatment,

WHO has recommended immediateand lifelong ART for everyone with
HIV: all infants, children, adolescents,
and adults, including pregnant andbreastfeeding women, regardless of
CD4 cell count or disease stage.9
In June 2016, WHO issued new HIV
treatment guidelines, including
recommendations for new ARV
regimens and differentiated models

of care that put the patient at thecentre of their treatment.10
Countries should implement the WHO
recommendations, including ‘test andstart’, routine viral load monitoring[see below], better drugs (newARVs and once-daily, fixed-dose
combinations), adherence support, anddifferentiated models of care to facilitate
rapid scale-up and quality patient care.10

ROUTINE VIRAL LOAD MONITORING
Access to viral load testing – the gold
standard for HIV treatment monitoring– is essential to achieving the 90-90-90
targets. For infants, an early diagnosis
can be life-saving – and requires
viral load testing. In 2016, WHOrecommended point-of-care viral load
testing for HIV-exposed infants.10
Since 2013, WHO has recommended
routine viral load monitoring for
diagnosing HIV treatment failure; the2015 guidelines recommend viral loadmonitoring – now with dried blood spot
testing – at six and 12 months after
starting ART. For stable patients, viralload monitoring is recommended once
every year thereafter instead of CD4 cellcount monitoring.9,10

MSF began implementing viral load
testing in 2012. In Lesotho, Malawi,
Mozambique, Swaziland, Uganda,
and Zimbabwe, risk factors for having
a detectable viral load have been
identified, leading to interventions
including a child-friendly clinic,
community ART groups, and enhanced
adherence counselling. Routine viralload testing has triggered a switch tosecond-line treatment and enhanced
adherence counselling in 10% to 68%
of patients. 12

4

Médecins Sans Frontières | July 2016

© Isabel CorthierAs tests have become more affordable
and rollout less complex, morecountries have adopted routine viralload as part of national policy. However,
implementation still lags far behind;a 2014 WHO study of 122 low- andmiddle-income countries found that
only 22% of people on ART received
viral load monitoring.11

People wait to have their blood tested to measure their viral load at the HIV departmentof Arua Regional Hospital in Uganda.

© Ron Haviv/VII Photo

An MSF outreach worker measures out antiretroviral medication during a home visit
in Dawei, in southeastern Myanmar.

The 2015 WHO HIV treatment
guidelines added recommendations
for two alternative first-line ARVs:
dolutegravir (DTG), a well-tolerated
integrase inhibitor that rapidly lowers
HIV viral load and is robust, with very
few documented cases of resistance,13
and a lower, equally effective dose ofefavirenz (EFV; 400mg vs. 600mg)9
that is better tolerated than the higher
dose.14 Before these ARVs become
part of a preferred first-line regimen,
additional clinical data on their safety
and efficacy during TB treatment,
pregnancy, and breast-feeding areneeded;9,15 these studies are plannedor underway.

OPTIMISING HIV TREATMENT

IMPROVING FIRST-LINE TREATMENT

BETTER SECOND-LINE TREATMENT

DRV is a boosted protease inhibitor(PI) with fewer side effects than theother second-line protease inhibitors(although it cannot be used during
rifampicin-based TB treatment).16,17,18
But access to DRV/r is limited; there
is no quality-assured heat-stable
FDC on the market, and the current
price of generic DRV alone is at least
three times more than other proteaseinhibitors, making it costly for widespread use.

© Julie Remy

As access to viral load monitoring
increases, more people in needof second-line treatment will beidentified. The WHO treatment
guidelines have added two alternative
recommendations for second-line ART:a heat-stable, fixed-dose combination(FDC) of darunavir/ritonavir (DRV/r)
and a two-drug regimen of raltegravir(RAL; an integrase inhibitor) withlopinavir/ritonavir (LPV/r).10

Loved Mupandanana is HIV positive, and her first-line treatment for HIV seems to be
failing. At Gombe clinic, in Manicaland Province in Zimbabwe, she is receiving counselling
about the need to move on to second-line treatment.

In 2015, MSF provided second-line
HIV treatment for 10,200 people.

Continued overleaf
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5

OPTIMISING HIV TREATMENT

Optimising HIV treatment continued

THE ARV PIPELINE FOR ADULTS
The ARV pipeline includes new drug
formulations and classes. Tenofovir
alafenamide (TAF), a new prodrug of
tenofovir disoproxil fumarate (TDF),
is equally effective as the currently
available version, at one-tenth of thedose. TAF is likely to be safer, andshould be significantly less expensive
to produce than TDF,19 but data on
drug interactions between TAF and TB
treatment are needed.

three TAF-based FDCs (in November
2015, March 2016 and April 2016).
Stand-alone TAF has been approvedin Europe (and filed in the US) for
hepatitis B treatment only. If Gilead,the company marketing TAF, does notregister the drug as a single ARV for
use in HIV, generic manufacturers may
face complications and long delays
in registering TAF-containing FDCs inother countries.

The United States Food and Drug
Administration (USFDA) has approved

Long-acting, injectable ARVs withmonthly or bi-monthly dosing could

improve adherence and significantly
reduce the cost of HIV treatment;interim results from a trial of a longacting injectable combination (rilpivirine
and cabotegravir) are promising,although an interaction between
cabotegravir and rifampicin requires
further study.20,21,22,23
New ARV classes include attachment
and maturation inhibitors; there are also
new versions of integrase inhibitors andnon-nucleoside reverse transcriptase
inhibitors (NNRTI) in development.

THE ARV PIPELINE FOR CHILDREN

Research and development of
paediatric ARVs and FDCs has lagged
far behind adult treatment, which has
severely limited treatment options for
HIV-positive infants and children.
There is a new pellet formulationof LPV/r, which is part of the WHOrecommended first-line regimen forchildren under three years old.10
In May 2015, the USFDA granted
tentative approval for LPV/r pellets
for children who weigh >5 kg and areover 14 days old.27,28 This formulationof LPV/r is available to a limited groupof low- and middle-income countries
through a Medicines Patent Pool (MPP)
voluntary licence (VL), although one
year after stringent regulatory authority(SRA) approval, it has not yet been
made commercially available.
Pellets could replace LPV/r syrup, whichcontains 40% alcohol and propylene
glycol, requires refrigeration, and has
been described as tasting “horrible”29 –all of which have made treating young

6

Médecins Sans Frontières | July 2016

children difficult. The price of the pellets
needs to be reduced so it is at leaston par with the syrup, to encouragecountries to adopt them.
The Drugs for Neglected Diseases
initiative (DNDi) LIVING study islooking at the safety, effectivenessand acceptability of LPV/r pellet-based
therapy in infants (>four weeks old)and children, with enrolment having
begun in Kenya.30

In 2015, MSF
supported
treatment for
6,800 HIV-positive
pregnant women,
and post-exposure
treatment for
4,400 babies.

© Sydelle WIllow Smith

Only 49% of the world’s HIV-positive
children had access to treatment in2015.24 Without treatment, over halfof all HIV-positive children die before
their second birthday;25 treating infants
when they are less than 12 weeks oldlowers mortality by 75%.26

Jennipher Mwamvera is a mother of four and a patient in the prevention-of-mother-tochild transmission of HIV (PMTCT) program in Thyolo, Malawi.

PRICING

PRICING
Affordable generic ARVs have made HIV treatment scale-up possible in countries that can access them.
Robust competition between multiple generics producers has dramatically lowered the price of first-line
antiretroviral therapy over the last decade-and-a-half.

FIRST-LINE REGIMENS
Since 2014, there has been a 30%
reduction in the price for genericfirst-line treatment.* If countries areable to import and use generics,
the price for the fixed-dose of the
WHO-recommended combinationof tenofovir/emtricitabine/efavirenz(TDF/FTC/EFV) can be as low as$100 pppy, down from $143 pppy in2014. Prices for first-line treatment
are unlikely to decrease further, since
they are now close to the minimum
sustainable production price,according to experts.31

Aurobindo’s generic version of
dolutegravir will have a price of$44 pppy,32 which is on par withthe price of efavirenz 600mg.
A fixed-dose combination of DTG
with TDF/XTC should be available
by the end of 2017.
Continued overleaf

GRAPH 2: THE PRICES OF DIFFERENT FIRST-LINE REGIMENS TODAY

1200

$1033

US$ per person per year

1000

800

$ 613
600

400

200

0

$94
Lowestgeneric price
AZT/3TC/NVP

$124

$164

LowestLowestgeneric pricegeneric price
TDF/3TC + NVP AZT/3TC + EFV$66
Lowestgeneric price
TDF/3TC + EFV

$106

$100

Lowestgeneric price
TDF/3TC/EFV

Lowestgeneric price
TDF/FTC/EFV

Originator
price forCat.1
TDF/FTC/EFV

Originator
price forCat.2
TDF/FTC/EFV				*	Price reductions may be due in part to currency fluctuations.

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7

PRICING

Pricing continued

GRAPH 3: THE EVOLUTION IN PRICE OF DIFFERENT FIRST-LINE REGIMENS

TDF/FTC/EFV (1 pill/once a day)TDF/3TC/EFV (1 pill/once a day)AZT/3TC + EFV (1 pill/twice a day + 1 pill/once a day)

US$ per person per year

600
500
400

487
426
410

300
200

164
106
100

100
0
June 07

June 08

Dec 09June 10

June 11

June 12June 13

June 14June 16

HIGH ANTIRETROVIRAL PRICES IN MIDDLE- AND
HIGH-INCOME COUNTRIES
According to UNAIDS, 70% of all
HIV-positive people will be living in
middle-income countries by 2020.33
Several ARVs are still on patent in
middle-income countries. Somelower- and upper-middle-income
countries where patent barriers on
key ARVs remain cannot produce or
buy generic ARVs, because they are

not included in voluntary licensing
agreements, and/or have not used
TRIPS flexibilities such as compulsory
licences.* Instead, they must pay
high prices to originator companies
for patented drugs on a case-bycase basis or under ‘tiered pricing’schemes that are not based on arealistic concept of affordability.34

High-income countries such as the
US are struggling with spiralling
costs of patented medicines,
including ARVs. In the US, thecombination of TDF/FTC/EFV (soldunder the brand name Atripla) costs
nearly $30,000 pppy35 versus $100
pppy for Indian generic versions.

				*	The World Trade Organization’s Trade-Related Aspects of Intellectual Property (TRIPS) Agreement can and should be interpreted in light of the goal “to promote access to medicines”. Legalsafeguards include (but are not limited to) enabling networks of people living with HIV/AIDS to challenge patent claims before and/or after they are granted; the right to examine patentclaims strictly and reject new use and/or new forms of known medicines; the right to register generic versions of patented medicines; the right to issue compulsory licences (CLs; these allow
countries to import or locally produce generic versions of patented medicines without the patent holder’s consent); and the right to import and resell lower-priced medicines from othercountries instead of paying higher prices for them – also without consent from the patent holder (called parallel importing).

8

Médecins Sans Frontières | July 2016

PRICINGSECOND-LINE REGIMENS
Boosted protease inhibitors are thebackbone of second-line regimens.
The lowest-priced generic secondline regimen, zidovudine/lamivudine(AZT/3TC) and atazanavir/r (ATV/r), is
now priced at $286 pppy. Since 2014,
the price has dropped by 11%, from$322 pppy.
Switching to second-line therapy
nearly triples the price of treatment[see graph 5]. Currently, there
are two WHO-preferred boosted
protease inhibitors for secondline regimens, ATV/r and LPV/r;
one alternative boosted proteaseinhibitor, darunavir+r (DRV+r); andan alternative, twice-daily two-ARV
regimen, the integrase inhibitor
raltegravir (RAL) plus LPV/r.10
A generic, fixed-dose, heat-stable
formulation of ATV/r is available. It has
fewer side effects than LPV/r, although
it cannot be used during rifampicinbased TB treatment. Because of supply
problems with LPV/r, an increasein demand for ATV/r is expected,
hopefully leading to lower prices.

Prices for boosted protease inhibitors
are especially high in middle-income
countries, since many of them havepatent barriers and are excluded fromvoluntary licensing agreements. In
its designated Category 2 countries,*
AbbVie charges higher prices for LPV/rthan in least-developed countries(LDCs): $740 pppy (which has notchanged since 2012), compared to$231 pppy in LDCs [see graph 4]. In
Malaysia, prices for LPV/r were quoted
above $3,500 pppy in 2014.36 The
originator price from Bristol-Myers
Squibb (BMS) for atazanavir– whichmust be used with ritonavir (RTV) – is$816 pppy; AbbVie’s originator pricefor RTV is set on a “case-by-case” basis.

Although LPV/r must be taken twice
a day, it can be dose-adjusted for use
with rifampicin-based TB treatment.
LPV/r is still more expensive than
ATV/r, at $243 pppy versus $213
pppy [see graph 4]. The price ofgeneric LPV/r is 5% higher thanthe originator product, because theoriginator company, AbbVie, has been
consistently undercutting genericcompetition with slightly lower prices.
For several of the newer second-line
options, current demand is low. The
price of generic versions has not yet
come down, and only a few
producers have entered the market.
DRV is much more expensive than
ATV/r or LVP/r, and it is not available
as a fixed-dose combination withritonavir (RTV or r). Darunavir isavailable from the originator for$663 pppy; generic versions are$1217 pppy, since the current low
demand prevents companies frombeing motivated to commercialise it
in low- and middle-income countries.

The lowest originator price for RAL is$675 pppy; the lowest-price genericversion is $973 pppy [see graph 6].
Currently, RAL is taken twice daily,
however, Merck plans to submit
data to the USFDA and the European
Medicines Agency (EMA) to seek
approval for once-daily RAL.37 RAL
can be dose-adjusted for use during
rifampicin-based TB treatment.38

GRAPH 4: THE EVOLUTION IN PRICE OF BOOSTED PROTEASE INHIBITORS FOR SECOND-LINE REGIMENS

Lowest generic ATV/r

Originator price for Cat. 1 LPV/r

Lowest generic LPV/r

Originator Price for Cat. 2 LPV/r

US$ per person per year

1200
1000

1034
1000

800

740

600
500

400
243
231
213

304

200
0
2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

				
*	Albania, Armenia, Azerbaijan, Belarus, Bolivia, Bosnia and Herzegovina, China, Colombia, Dominican Republic, Ecuador, El Salvador, Fiji, Georgia, Guatemala, Guyana, Honduras, India,
Indonesia, Jamaica, Jordan, Kazakhstan, Kyrgyzstan, Macedonia, Marshall Islands, Micronesia, Moldova, Mongolia, Montenegro, Nicaragua, Pakistan, Papua New Guinea, Paraguay, Peru,
Philippines, Serbia, Sri Lanka, Suriname, Syria, Tajikistan, Thailand, Tonga, Turkmenistan, Ukraine, Uzbekistan, Viet Nam.

Continued overleaf
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9

PRICING

Pricing continued

SALVAGE REGIMENS+ ETV), in countries that fall into theselect group eligible for access pricing
from originators (but many countries
are paying much more). This represents
nearly an 18-fold increase over the lowest
first-line prices, and nearly a seven-foldincrease over the most affordable
second-line regimen [see graph 5].

There is an urgent need for more
affordable third-line, or salvage regimens
for people that have acquired resistanceto first- and second-line treatment.
Low volume and high prices from bothoriginator and generic companies keepthese medicines out of reach.
The lowest price for a salvage regimen
today is $1,859 pppy, for darunavir+r,
raltegravir and etravirine (DRV+ r + RAL

Since 2014, the price of generic DRV
has increased by 10%, from $1,095 to$1,217; this does not include the ritonavir
it must be used with. At the same time,
the access price from the originator has
dropped by 17%, from $810 to $675.
A quality-assured generic RAL is priced at$973 pppy, but it is still more expensive
than the originator version, which has
stayed at $675 since 2011. The originator
price for ETV has stayed at $438 since2011 [see graph 6].

GRAPH 5: PRICE COMPARISONS OF FIRST-LINE, SECOND-LINE AND POSSIBLE THIRD-LINE
TREATMENT REGIMENS2000

US$ per person per year

$1,8591500

x 17.4
x 6.5

1000

x 2.7
500

$106
0

$286

Lowest generic price
TDF/3TC/EFVFirst-line regimen

Lowest generic price
AZT/3TC+ATV/rSecond-line regimen

RAL+DRV+r+ETV
Third-line regimen

GRAPH 6: PRICES FOR THIRD-LINE ARVSDRV 600 mg originator priceDRV 600 mg generic priceETV 100 mg originator priceRAL 400 mg originator priceRAL 400 mg generic price2000

US$ per person per year

1750

1752

1500
1250
1000
750

1217
1095
973

913
810

675
663

675

500

438

250
0

10

June 11

Médecins Sans Frontières | July 2016

June 12June 13

June 14June 15

June 16

In many countries, marketing authorisation for promising new ARVs can take several years; this typeof regulatory lag forces people living with HIV/AIDS to wait for life-saving medicines. National Drug
Regulatory Authorities (NDRAs) do not always have the resources to ensure timely registration of more
affordable generic versions of new ARVs, and/or fail to prioritise them.39

Pharmaceutical companies don’t
often prioritise registration in lowand middle-income countries. Someoriginator companies shift the
responsibility for filing registration
dossiers in high-burden developing
countries to generics companies thathave signed voluntary licences.
In some countries, generics companies
are able to register generic versionsof medicines, but in others, when
originators don’t register their ARVs
before generics companies do, it may
cause significant delays, or become an
absolute barrier to treatment access.
Countries have different regulatory
pathways, priorities, rules,
requirements, legal frameworks,
capacities, and timelines, and some
do not have NDRAs. There is no‘essential documentation package’to streamline the registration processacross all NDRAs in developing
countries, and country-levelbureaucracy can delay registration.

Collaborative or regional registration
processes have reduced the time toregistration for some products insome participating countries. These
collaborations should be consideredby national regulatory authorities toreduce the considerable workload
associated with reviewing registration
dossiers. For example, in East Africa,a pilot of the African Medicines
Registration Harmonisation Initiative
has reduced the time to registration
by 50% in Burundi, Kenya, Rwanda,
Uganda, and Zanzibar.39
India’s lack of intellectual property(IP) barriers and historically efficientregulatory pathway made it possible
for generics companies to produce andregister more affordable medicines fordeveloping countries. But availabilityof new quality-assured generic ARVs
and FDCs from India is starting to bedelayed. This is partly because India’s
criteria to waive phase III clinical trials
are restrictive in certain cases. These
criteria need to be expanded to include

REGISTRATIONREGISTRATION

new drugs for neglected diseases, ARVs
for paediatrics, and salvage regimens.
In addition, the Indian NDRA should
prioritise new ARVs, FDCs, and childfriendly formulations, taking note of,and relying on WHO guidelines and/or
Expression of Interest from the
WHO prequalification programme.*
Another delay is the WHO
prequalification programme, which has
been essential for reviewing the quality,
safety, and efficacy of generic ARVs thataren’t always reviewed or approved bya stringent regulatory authority (SRA).
In 2013, the median wait for WHO
prequalification was 15.1 months.39

97% of the
medicines MSF uses
to treat people withHIV are generics
made in India.

BARRIERS TO UNIVERSAL ACCESS TO GENERIC
DOLUTEGRAVIR FROM INDIA
The pharmaceutical company ViiV has granted voluntary
licences (VLs) for the integrase inhibitor dolutegravir(DTG) to several Indian generic companies throughthe Medicines Patent Pool (MPP). The VLs will not
result in universal access to the drug, since a number ofhigh-burden countries are excluded from the territories
that can import the generic version from India.
In India, generic DTG will only be available on the
public market or to non-governmental providers,leaving a number of patients with drug resistance
who need immediate access without any sourcefrom Indian pharmacies.
Although DTG has been registered in many othercountries, ViiV, the originator company, has not filed

for registration in India. As a result, the responsibility
for registration is now with Indian producers that havedeveloped generic dolutegravir. They will need to do
local clinical trials, as per the Indian NDRA requirements
for new drugs, which will lead to a significant delayin the availability of affordable generics across thedeveloping world. In the meantime, patients in India
who have exhausted other treatment options are left
without access to DTG, since ViiV has been dragging its
feet to provide the medicine via compassionate use.
To ensure open generic competition in the future,a patent opposition for DTG has been filed in India,
by and on behalf of people living with HIV, andsupported by MSF.

				*	These include: dolutegravir (DTG) singles and FDCs, including tenofovir/lamivudine/dolutegravir; a low-dose (400mg) efavirenz FDC and heat-stable darunavir/ritonavir Priority pediatricformulations for HIV include: lopinavir/ritonavir pellets or sachets; abacavir/lamivudine/lopinavir/ritonavir (ABC/3TC/LPV/r) zidovudine/lamivudine/lopinavir/r (AZT/3TC/LPV/r) pellets orsachets for children over three years old and lamivudine/abacavir/efavirenz (3TC/ABC/EFV 75/150/150mg) dispersible tablets for children ages 3-10 years.

Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016

11

PATENT OPPOSITIONS AND PATENT LAW REFORM

PATENT OPPOSITIONSAND PATENT LAW REFORM
INDIA, THE ‘PHARMACY OF THE DEVELOPING WORLD’, IS UNDERPRESSURE TO DROP ITS PUBLIC HEALTH SAFEGUARDS
Indian generics comprise 76% of
the ARVs used in low- and middleincome countries and more than
97% of those used by MSF in its
treatment programmes.31,44 India
encouraged generic competition for
decades, since it did not introduce
patents for pharmaceuticals until
2005 (when it had to comply withinternational trade rules under theWorld Trade Organization [WTO]
Agreement on Trade-related Aspectsof Intellectual Property Rights [TRIPS]).
India’s national patent laws include
public health safeguards such as
stringent patentability criteria, and theopportunity to file legal challenges topatents before and/or after they are
granted (called pre-and post-grant
patent oppositions).

pressure – led by the multinational

India has fought off numerous
challenges to its public healthsafeguards, but it has been underexcessive external and domestic

demands to grant patents more easily,

pharmaceutical lobby – to change its
national intellectual property laws andpolicies, or sign free trade agreementsthat will dismantle them. Over the last
two years, pharmaceutical industryled pressure from the US has been
escalating. India must reject theas well as TRIPS-plus rules that theUnited States is trying to force upon
India’s Ministry of Commerce.

PATENT OPPOSITIONS FOR HEPATITIS C

12Patent oppositions have been used when patentclaims do not meet national patentability criteria,
and when a patent directly blocks or delays accessto essential medicines.

has applied for WHO prequalification for their genericWorldwide, an estimated 150 million people
have chronic hepatitis C virus infection; without
treatment, they are at risk of developing liver
failure and liver cancer.45

This decision is now under appeal. If upheld, theHepatitis C can be cured with a few months’ treatmentusing oral drugs, called direct-acting antivirals (DAAs).
In 2013, the price of the first DAA on the market,
sofosbuvir, sent shock waves throughout the world.
Although it can be mass-produced for less than
$1 per pill,46 sofosbuvir’s launch price was $1,000
per pill in the US.

to supply sofosbuvir to millions of people in India

Gilead’s patent on sofosbuvir has been opposed –and rejected – in some countries. The patent on the
pro-drug form of sofosbuvir was rejected in China andUkraine. In Egypt, where the primary patent application
for sofosbuvir was rejected, a company called Pharco

producing sofosbuvir without a patent in force – andMédecins Sans Frontières | July 2016

version of the drug.
In India, one critical sofosbuvir patent has been
recently granted, reversing its prior rejection in 2015.
patent will block additional competition from theIndian generics companies that do not want to signa voluntary licence with Gilead, leaving them unable
and other middle-income countries. In addition, thisdecision would allow Gilead to disrupt or stop exportsof the raw materials from India that are used to makesofosbuvir’s key active pharmaceutical ingredient (API).
This will make it difficult for the generics companies in
Egypt, Bangladesh, Pakistan and Latin America that arewithout a licence agreement with Gilead – to continue
production. More patent oppositions on sofosbuvir
have been filed in Argentina, Brazil, Russia, Thailand,
France and India.

SOUTH AFRICA
In 2015, 3.1 million people livingwith HIV were accessing antiretroviraltherapy through South Africa’s public
sector,47 and the government recently
announced a ‘test and start’ policy.48
As more people are treated, the needfor second-line and salvage regimens
will increase. Many of these ARVs
are patented and are too expensive
for the government to procure forthe public sector. But South Africa
has not introduced or implemented
key measures to safeguard publichealth, including fully adopting TRIPS
flexibilities, and especially substantive
examination of patent claims. In 2008
alone, South Africa granted 2,442
patents, while Brazil granted only 272
patents between 2003 and 2008.49
In 2009, South Africa’s Departmentof Trade and Industry (DTI) initiated aprocess to reform the country’s IP law
and policy. In 2011, TAC, Section 27
and MSF co-launched the ‘Fix the Patent
Laws’ campaign, which now includes 18
other non-governmental organisations.
The campaign highlights how
pharmaceutical companies have usedevergreening tactics to exploit South
Africa’s patent system. In September
2013, the DTI released a draft policy
document for public comment. But the
new policy is still not finalised, and is notexpected until mid-2017.
The longer DTI delays, the longer itwill take for South Africa to introduce
short- and long-term reforms that
can accelerate and promote genericcompetition, and to drive down prices
for patented drugs. The delay also raises
concern about undue political andcommercial pressure from multinational

pharmaceutical companies involvedin the ‘Pharmagate’ scandal (acovert, $600,000 campaign fundedby large pharmaceutical companies
and medical device producers todelay - and influence - South African
patent reforms). South African Health
Minister Aaron Motsoaledi has accused
the multinational pharmaceuticalcompanies in South Africa of conspiring
against the state and the people ofSouth Africa, and called on all South
Africans to fight back “…to the lastdrop of their blood.”50

BRAZIL
Brazil is consistently excluded fromvoluntary licensing programmes, andtherefore forced into tiered pricing
schemes from originator companies

that charge unaffordable prices.
In order to overcome IP barriers togeneric competition, a coalition ofcivil society groups has recently filed apatent opposition in Brazil on the main
patent related to TAF. In addition, in
November 2015, GTPI (Working Groupon Intellectual Property), a civil society
coalition, filed a patent opposition todeny a patent to BMS (for atazanavir;
ATV) that could extend the patent
holder’s monopoly until 2024. Brazil
currently pays $496.40 pppy forthe 300mg version of ATV; a Health
Ministry-approved licence between
BMS and the Brazilian governmentlinked pharmaceutical laboratory
Farmanguinhos forbids production of
atazanavir in newer formulations andcombinations, such as ATV/r.51© Stefan Heunis

South Africa and Brazil are in theprocess of reforming their patent laws,
in part to more effectively manage
prices for medicines, and to encourage
competition (and local production).
There is a lot at stake: South Africa has
the largest number of people living with
HIV in the world, and Brazil guarantees
HIV treatment for all, with many peopleon salvage therapy, as well as first- andsecond-line treatment. But delays inpatent law reform will undermine accessto affordable medicines, including ARVs.

PATENT OPPOSITIONS AND PATENT LAW REFORM

PATENT LAW REFORM IN BRAZIL, SOUTH AFRICA AND ARGENTINAMSF and the Treatment Action Campaign launched the ‘Fix the Patent Laws’ campaign
to demand patient-focused reforms to South Africa’s patent laws.

EVERGREENING
Many countries often do not
examine patent claims strictly,
leaving them vulnerable to‘evergreening’, whereby
pharmaceutical companies makeminor changes to medicines thatare already on the market to extend
their patents. Several ARVs should
now be free from patent barriers(including ABC, DRV, EFV and
RTV) since their basic patents have

expired, but they are not becauseof evergreening.
In Ukraine, home to nearly
265,000 people living with HIV,40
GSK extended its abacavir (ABC)patent monopoly by eight years
with its secondary patent on thehemisulfate salt.41 Ukraine’s pricefor originator ABC is $277.40
pppy42 versus $123.42 pppy forthe generic version.43

Continued overleaf
Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016

13

PATENT OPPOSITIONS AND PATENT LAW REFORM/ TRADE AGREEMENTS

Patent oppositions and patent law reform continued

At the same time, multinational
drug companies are using lawsuits
to challenge measures that promote
generic competition in Brazil, including
the country’s patent examination
process. Since 2001, ANVISA, Brazil’s
national drug regulatory agency, hasparticipated in analysing pharmaceuticalpatent applications, instead of leaving
this task exclusively to patent officeexaminers, and ANVISA has rejected
more than 400 of them. ANVISA’s rolein pharmaceutical patent examination
has been considered an importantsafeguard to public health and access to
medicines.52 Multinational companies
have frequently contested ANVISA’s
rejections in court. In 2011, the Attorney
General’s Office (AGU) issued a legal
opinion strengthening the position ofpharmaceutical companies – although itproved unenforceable, the AGU has notformally withdrawn its legal opinion.

Patent law reform that would improveaffordability of new medicines has
been delayed for more than two years.
In 2013, a ‘package’ of bills to amend
Brazil’s patent law was introduced. If
approved, it will ensure that Brazil has
clearer criteria for patent examination,and introduce important flexibilities
into its national laws.53

ARGENTINA
Argentina has taken steps toimprove its patent laws. In 2012,

Argentina adopted new patentability
examination guidelines for thepharmaceutical sector to prevent the
granting of numerous patents that
do not meet specific criteria such asnovelty, inventive step, and industrial
application. Since Argentina’s new
guidelines were enacted, 95% of
ARV patent applications have been
rejected, an increase from the 51%
rejection rate in 2012.54
In 2015, CAEME – the associationof multinational pharmaceuticalcompanies in Argentina – filed acourt case questioning the validity ofthe patent guidelines. In response,
civil society groups from Brazil
and Argentina launched the ‘Big
Pharma Drop the Case’ campaign atthe 31st session of the UN Human
Rights Council, to push CAEME and
INTERFARMA to abandon their actions.

TRADE AGREEMENTS
Governments, civil society and generics producers should use TRIPS flexibilities to improve affordabilityof, and access to, needed medicines. But TRIPS flexibilities are endangered by free trade agreements(FTAs) that pose serious threats to access to affordable medicines. These FTAs include intellectual
property provisions – so-called ‘TRIPS-plus’ provisions – that exceed countries’ obligations underWorld Trade Organization (WTO) trade rules.

EU-INDIA FTA
Negotiations on the EU-India FTA
began in 2007. They have been stalledsince 2012, in part due to publicpressure, but may resume this year.
The EU-India FTA could jeopardise
access to India’s affordable generic
medicines for millions of people, bylimiting production, sale and export of
medicines in the future.
In the past, the EU has demanded
a range of intellectual property
provisions that exceed India’s
obligations under TRIPS, including
measures that would allow companies
to prevent legitimate export of
medicines to developing countries orbring legal action against people who
buy or distribute generics.55

14

In November 2014, a multinationalgroup of pharmaceutical companies(INTERFAMA, the Pharmaceutical
Research Industry Association) fileda Collective Action against ANVISA,
questioning the legitimacy of ANVISA’s
participation in the patent granting
process. Local civil society groups havestrongly reacted to these setbacks.

Médecins Sans Frontières | July 2016

TRANS PACIFICPARTNERSHIP
AGREEMENT (TPP)The TPP is a far-reaching trade agreement
across the Asia-Pacific region. If ratified,
the TPP will be the worst-ever trade
agreement for access to medicines: it will
lengthen, deepen and expand intellectual
property and patent monopolies, andprevent or delay access to affordable,
life-saving generic medicines for millions
of people.56 While the TPP agreement has
been signed by governments, it has yet to
be ratified by any country.

REGIONAL
COMPREHENSIVEECONOMICPARTNERSHIP (RCEP)The RCEP trade negotiations among
16 Asia-Pacific countries could threaten

access to generic medicines due tothe proposed inclusion of TPP-like
intellectual property rules by Japanand South Korea.
Countries that did not join the TPP –particularly India and key membersof the Association of Southeast
Asian Nations – will be pushed toadopt similar standards in the RCEP
negotiations, which would represent arollback of protections against extended
patent terms and data exclusivity thatare part of past agreements.
The RCEP negotiations will haveserious repercussions globally, sinceboth India, the ‘pharmacy of thedeveloping world’, and China, theworld’s largest producer of the active
pharmaceutical ingredients (API) used
to make medicines, are among the 16
countries included in the negotiations.

In April 2016, a leaked letterfrom the Colombian Embassy
described how the US Senate
Finance Committee and theUnited States Trade Representative
were pressuring the Colombian
government not to issue acompulsory licence* for the anticancer cancer drug imatinib.58

Thailand, Ecuador), which has

As of mid-June 2016, the Colombian

discouraged other governments

Minister of Health announced thatfrom issuing compulsory licences

they had issued a ‘public interest

to ensure affordable medicines.

declaration’ regarding imatinib,

As WHO states in its letter towithout public information about

Colombia’s Minister of Health,whether the government will issue“unaffordable high prices ofa compulsory licence to allow

essential medicines, including for

manufacturing and import of price-

non-communicable diseases, arelowering generic versions of the

A number of countries have also
faced similar pressure (Brazil,

a legitimate reason for issuing adrug, or simply reduce the price ofcompulsory licence”.59

the Novartis product.60

TRADE AGREEMENTS

COLOMBIA: COMPULSORY LICENCE THREAT INVITES US PRESSURE

LDC EXEMPTION FROM PHARMACEUTICAL IP EXTENDED
Least-developed countries

section 7) for pharmaceutical(LDCs) have been granted an

products until 1 January 2033.

exemption from certain obligations

But the free-trade agreements

under TRIPS, in recognition ofthat are being negotiated in many

their economic, financial andcountries across the Asia-Pacificadministrative constraints andregion, in particular RCEP [seetheir need to make or procure low

Trade Agreements, page 14],

cost generic medicines. Under this

could undermine the LDC transitiontransition period, LDCs do not haveperiod, unless UN agencies andto apply or enforce TRIPS provisions

civil society provide technical andconcerning patents (TRIPS section

political support to negotiating5) or test data protection (TRIPS

countries, particularly LDCs, toprotect their TRIPS flexibilities incomplex FTA negotiations.
LDCs in Asia, including Laos,
Bangladesh, Cambodia and Myanmar,
as well as countries in sub-SaharanAfrica, should continue to use thewaiver to the fullest extent possible
to improve access to medicines
and should resist any pressure toprematurely introduce intellectual
property rules that would undermine
access to generic medicines.

© Aye Pyae Sone

57

Regular check-up session for HIV positive patients at Muse clinic in Myanmar.

				*	A compulsory licence (CL) is an effective option for increasing access to ARVs and other medicines in countries where they are patented. It is a legal mechanism to allow producers otherthan the originator company to make the drug or to import generic versions into a given country.

Untangling the Web of ARV Price Reductions | msfaccess.org/utw201615

For years, many countries have faced shortages and stockouts of essential medicines. Stockouts canbe caused by logistical and administrative challenges in procurement, supply chain management,or ‘last mile delivery’, and by medicines having only a single source (which may lead to shortages:
these are generally those under patent, without compulsory or voluntary licences thatallow generic manufacturers to supply them).

Because of stockouts, people may
receive smaller amounts of the
medicine they need, which means
extra time-consuming trips to theclinic. They may also be switched
to different, less-optimal doses orregimens, or be told to buy the
medicines they need from theprivate market with the promise ofreimbursement (which is usually not
fulfilled), or go without medicine
altogether - which can lead to drug
resistance and illness.

governments should make plansneeded to ensure sufficient availability,

for treatment transitions, ensure

while achieving economies of scale.

As countries upgrade their protocols
to reflect WHO’s new ARV guidelines,

appropriate buffer stocks and give
clear clinical guidance on making

In South Africa, the Stop Stockouts

switches correctly.

Project has empowered patients andpushed for accountability in the supply

Generic manufacturers must workof medicines. The Project receives andquickly to avoid shortages andpublishes daily reports about drug

stockouts, using information about

stockouts from people living with HIV

current and pipeline ARVs, doseand health care workers, conducts

optimisation, changes in treatment

comprehensive national surveys toguidelines and eligibility, national andmonitor the locations and extent of

global targets for treatment scale-up,

stockouts, and works with Nationaland HIV epidemiology to anticipate

and Provincial Departments of Healththe quantity of API and final productto identify and implement solutions.61© Mariska Van den Brink

STOCKOUTSSTOCKOUTSIn South Africa, the Stop Stockouts Project – a consortium bringing together six civil society organisations – is pushing for moreaccountability on stockouts of medicines that impact people’s access to regular treatment.

16

Médecins Sans Frontières | July 2016

The Global Fund to Fight AIDS,
Tuberculosis and Malaria (GFATM),UNITAID and the Medicines Patent
Pool have played a central role in
the provision of affordable ARVsaround the world, including use ofquality-assured generic drugs by the
GFATM, PEPFAR and other funders.
The GFATM’s market-shaping
actions go beyond its ability toprovide treatment for millions ofpeople, and have an important
impact on worldwide ARV access.
After years of contributing towards
collective efforts to reduce medicine
prices, the scope and remit of the
GFATM is increasingly less ambitious
and potentially counter-productive.
Progress has stalled, especially for
middle-income countries, where
pharmaceutical companies seek
to charge high prices. Some ofthese countries have a high disease
burden, limited ability to pay for
ARVs, and decreasing support fromthe GFATM and other donors.
The GFATM may not be able toguarantee that these countries will
be able to access the lowest prices
for new medicines, including thoseunder patent, and it may evenfacilitate problematic tiered
pricing strategies used by drug
companies in lieu of promoting
robust generic competition.
There are clear warning signs that
the GFATM is unwilling or unable todefend generic competition for thecountries it supports. The GFATM
did not signal support for the LDC
extension, and has been silent
about the Trans-Pacific Partnershiptrade agreement. It has not
explicitly supported the use of TRIPS
flexibilities, although this principle
has been endorsed since the GFATM
started. Instead, the GFATM has beenchampioning an ‘e-marketplace’(currently known as wambo.org) to
make procurement more efficient.
But the e-marketplace is not expected

to overcome any access barriers toaffordable medicines.

STOCKOUTSMARKET SHAPING INSTITUTIONS – WHAT NEEDS TO HAPPEN

Recent GFATM correspondence
indicates that it may seek to optimise
tiered pricing policies from drug
companies, instead of overcomingcommercial pricing strategies. The
e-marketplace has been recently
criticised by the GFATM’s Office of
the Inspector General for failingto implement competitive bidding
processes for the first products
offered over the website.62
At best, if the e-marketplace canovercome the challenges it is facing,it could provide minimal technicalfixes as to how governmentspurchase medicines, without
dealing with the underlying barriers
that make them unaffordable in thefirst place. At worst, prices offeredunder the e-marketplace will be
insulated from the demands ofgovernment and civil society if suchproducts remain unaffordable.

UPDATE ON THE MEDICINES PATENT POOL’S NEW LICENCES
The MPP voluntary licences(VLs) offer some countries theopportunity to gain access toaffordable generic versions of new
ARVs, although many middleincome and upper-middle-income
countries, such as China and Brazil,
continue to be left out of these VLs
and are therefore prevented frombuying the generic drugs produced
through manufacturers based intheir countries.
On one hand, the MPP has added
new VLs, and increased thegeographic scope or added new
formulations to other licences. In
2014, the MPP announced a new
agreement with AbbVie, for two
specific paediatric formulationsof LPV/r covering 102 low- andmiddle-income countries.63
In late 2015, a separate agreement
was signed between MPP and AbbVieon the adult formulation of LPV/rwhich only covers African countries.64

The VL for tenofovir now includes
tenofovir alafenamide (TAF) andhas an expanded geographic scopethat allows generic producers fromSouth Africa and China to join.
The VL for elvitegravir (EVT) was
amended to include production in
China and South Africa, provided
that products are made from
Gilead-licenced producers of active
pharmaceutical ingredients (API).
In March 2016, GlaxoSmithKline (with
ViiV) announced that it would increase
the geographic scope of its voluntary
licensing agreements to include all
lower-middle-income countries. The
MPP’s VL for DTG has been expanded
to include Ukraine, Morocco,
Moldova, Armenia and 14 otherlow- and middle-income countries.
Although this is a welcome first step,
excluded upper-middle-income
countries will still be forced into tiered
pricing schemes, and price-lowering
competition will be prevented.

Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016

Some MPP licences have been
disappointing. AbbVie’s new MPP
adult licence for LPV/r has a limited
geographic scope and may force
specific generics companies that sign
the licence agreement to forego theright to supply specific countries
that they currently have the rightto supply. Furthermore, a new MPP
licence with Bristol-Myers Squibb for
daclatasvir, a hepatitis C medicine,
introduces a worrying precedent:
it allows BMS to sign sub-licenceagreements with generics companies
together with the MPP (the normal
practice is to not allow branded
companies to be involved in signinga sub-licence agreement). MSF
is concerned that such a practice
could allow branded companies toinfluence the practices of generics
companies, including for unrelated
products, and undermine theneutrality of the MPP in managing
the sub-licence agreements.

17

CONCLUSIONCONCLUSION
The global response to HIV/AIDS has reached a turning point. Ensuring sustainable access to affordable
generic ARVs will save millions of lives. Scaling up to 90-90-90 is projected to save over 1.1 million
lives and prevent 873,000 new HIV infections in the next five years; keeping up the pace for 10 years
will save more than 2.4 million lives (including the mothers of 1.7 million children), and prevent over2 million new infections.65

Market-shaping institutions must
keep their focus on securing andensuring a sustainable supply of
diagnostics and adult and paediatric
ARVs in low- and middle-income
countries, and the pharmaceuticalindustry should commit to registering
ARVs in all countries, and expanding
the scope of their voluntary licensing
agreements to include all low- andmiddle-income countries.

All governments and donors must
do their part to accelerate the global
HIV response and meet the challengeof the 90-90-90 goals, including
fully implementing the latest WHO
guidelines, putting in place effective
policies at the national level, andensuring all people living with HIV
have access to the most effective
drugs, diagnostics, and models of care.

© N’gadi Ikram

To accomplish this, governments
must commit to scaling-up,
optimising, and maintaining access toaffordable generic ARVs in the longrun, as HIV is a disease that requires
people to have constant access to arange of treatment options. This will
require governments to use TRIPS
flexibilities, reform patent laws, andreject harmful TRIPS-plus provisions
proposed in various FTA negotiations.

18

Médecins Sans Frontières | July 2016

Developing country prices in US$ per patient per year, as quoted by companies.
This table contains comprehensive information about ARV pricing in developing countries. It includes adult and paediatricformulations and doses, suppliers and WHO pre-qualification status/ US FDA SRA approval. The prices for developing
countries are in US $, per person, per year, based on WHO dosing recommendations, as quoted by companies. Currency
conversions were made when the pricing information was received, using the currency converter from www.oanda.com.
Each originator company applies its own eligibility criteria for discounting ARVs. Countries that are eligible for a discountfrom one company may not be eligible for discounts from other companies. Usually, companies create two groups of
discount-eligible countries, often called ‘Category 1’ (countries that are eligible for the deepest discounts) and ‘Category 2’(countries that are offered a lesser discount).
Paediatric formulations are highlighted in pink. Prices for paediatric products are estimated, based on WHO-recommended
dosing, for the 10 to 10.9 kg weight band. When it was not possible to calculate dosing for the 10 kg weight band, the unit
price was used.

ANNEX: SUMMARY TABLE OF ALL PRICESANNEX: SUMMARYTABLE OF ALL PRICESThe ARVs that are included in the WHO list of Prequalified Medicinal Products or that have tentative or full US FDA approval(as of May 2016) are in bold.
ARVs inalphabetical order

Daily
dose

Abacavir (ABC)
20mg/ml oral
solution

12 ml

60mg tablet

4

Originator company

Generic companies

ViiV

Aspen

Aurobindo289(0.066)249(0.057)228(0.052)

Cipla

Hetero123(0.028)97(0.067)
BMS

Atazanavir (ATV)

100mg capsule

Cipla

412
(0.564)380(0.520)207(0.283)(0.677)(0.670)(0.433)(0.267)xx

150mg capsule2200mg capsulexx(0.677)300mg capsule1

Atazanavir/
ritonavir (ATV/r)
1

Darunavir (DRV)

EmcureCategory 2
countries

412(0.564)300/100mg tablet

Aspen

Category 1
countries

Janssen

75mg tablet

xx(0.114)150mg tablet

xx(0.227)400mg tablet

2

438(0.600)600mg tablet

2663(0.908)170(0.467)219(0.600)

Cipla

EmcureHetero213(0.583)213(0.583)219(0.600)

Aspen

Hetero973(1.333)658(0.901)1,217(1.667)

Aspen

Aurobindo

Merck
Efavirenz (EFV)

30mg/ml suspensionxx

50mg capsulexx

Category 1
countries

Category 2
countries(0.094)Case-bycase(0.114)Case-bycase

50mg tabletxx

200mg capsule3

200mg tablet

3394(0.360)Case-bycase

600mg tablet

1

237(0.650)Case-bycase

Cipla

EmcureHeteroMacleods

Microlabs(0.058)(0.057)81(0.074)57(0.052)

Quality
Chemicals

StridesSun
Pharma113(0.103)84(0.231)37(0.100)20(0.055)

Untangling the Web of ARV Price Reductions | msfaccess.org/utw201647(0.129)45(0.123)38(0.105)35(0.095)70(0.192)38(0.105)38(0.103)19

ANNEX: SUMMARY TABLE OF ALL PRICES

ARVs inalphabetical order

Daily
dose

Etravirine (ETV)

Originator companies

JanssenGeneric companies

Aspen

25mg tablet

xx(0.075)100mg tablet

4438(0.300)438(0.300)

ViiV

Aspen

Lamivudine (3TC)
10mg/ml oralsuspension

10ml

216
(0.059)150mg tablet

275(0.102)

300mg tablet

175(0.204)55(0.075)Microlabs

StridesSun
Pharma23(0.031)23(0.031)27(0.037)26(0.035)23(0.063)18(0.049)67(0.183)

Aurobindo

Cipla

HeteroMacleods

23(0.006)46(0.013)32(0.009)26(0.007)27(0.037)28(0.038)29(0.040)33(0.092)32(0.087)HeteroMacleods

AbbvieLopinavir/
ritonavir (LPV/r)

Aurobindo
Category 1
countries

Category 2
countries

150(0.103)296(0.203)Cipla

80/20mg/ml
oral solution

4ml

40mg/10mg capsuleheat-stable pellets

8

100/25mg
heat-stable tablet

3

108(0.099)278(0.254)151(0.138)155(0.142)200/50mg
heat-stable tablet

4231(0.158)740(0.507)243(0.167)268(0.183)280(0.192)

293(0.201)

Aspen

Aurobindo

Cipla

EmcureHeteroMacleods Microlabs

Quality
Strides
Chemicals

Sun
Pharma27(0.037)37(0.051)26(0.035)467(0.160)

Nevirapine (NVP)

143(0.131)10mg/mlsuspension

20ml

61
(0.008)91(0.013)50mg tablet fororal suspension

473(0.050)30(0.021)

200mg capsule2200mg tablet

2

28(0.038)28(0.038)28(0.038)29(0.040)

Aurobindo

Cipla

HeteroMacleods

Quality
Strides
Chemicals

57(0.155)46 (0.127)

39(0.107)40(0.110)67(0.183)63(0.087)24(0.033)Merck
Raltegravir (RAL)

HeteroCategory 1
countries

Category 2
countries

25mg chewable
tabletxx(0.300)Case-bycase

100mg chewable
tabletxx(0.600)Case-bycase

400mg tablet

2675 (0.925)

Case-bycase

973(1.333)

AbbvieRitonavir (RTV)
Category 1
countries

Category 2
countries

80mg/ml oral
solutionxx(0.091)Case-bycase

100mg heat-stable
tablet2

83(0.114)Case-bycase
GileadTenofovir (TDF)

300mg tablet

20

1Category 1
countries

Category 2
countries

207(0.567)365(1.000)

Médecins Sans Frontières | July 201645
(0.123)Sun
Pharma43(0.117)27(0.037)

Dailydose

Zidovudine (AZT)

Originator companies
Aurobindo

Cipla

450
(0.051)73(0.008)110(0.013)24ml

60mg tablet

4

100mg capsulexx(0.093)250mg capsulexx(0.187)300mg tablet

2

ABC/3TC4

600/300mg tablet

1

HeteroMacleods

Microlabs

Sun
Pharma91(0.010)40(0.027)(0.055)ViiV

60/30mg tablet

Generic companies

ViiV

10mg/ml oral solution

ANNEX: SUMMARY TABLE OF ALL PRICES

ARVs inalphabetical order

225(0.617)69(0.094)67(0.092)75(0.103)63(0.086)50(0.068)

Aurobindo

Cipla

Hetero110(0.075)110(0.075)220(0.602)164(0.450)161(0.442)

Aurobindo

Cipla

HeteroMacleods

Strides72(0.197)70(0.192)64(0.175)77(0.210)67(0.183)

Aspen

Aurobindo

Cipla

HeteroMacleods

StridesSun
Pharma251(0.689)112(0.307)122(0.333)110(0.300)120(0.328)103(0.283)100(0.273)

Aurobindo

Cipla

HeteroMacleods

Microlabs

Quality
Chemicals

Sun
Pharma57(0.155)58(0.158)46(0.125)50(0.138)47(0.130)84(0.230)52(0.143)

Aurobindo

Cipla

HeteroMacleods

Quality
Chemicals

Microlabs

Quality
Strides
Chemicals

Sun Pharma

74(0.102)

GileadTDF/FTC

300/200mg tablet

1

Category 1
countries

Category 2
countries319(0.875)548(1.500)Merck

TDF/FTC/EFV

300/200/600mg tablet

1

Category 1
countries

Category 2
countries613(1.680)1033(2.830)

TDF/3TC
300/300mg tablet

1

TDF/3TC/EFV
300/300/400mg tablet

1

300/300/600mg tablet

1

97(0.265)110(0.300)

TDF/3TC + NVP(co-pack)
300/300 + 200mg
co-pack

106(0.292)161(0.440)

Aurobindo

Cipla

EmcureHeteroMacleods

54(0.037)46(0.032)82(0.113)82(0.113)127(0.173)84(0.115)84(0.113)73(0.100)116(0.159)

Cipla

HeteroMacleods

Quality
Chemicals

StridesSun
Pharma124(0.340)

1 kit(3 tabs)
ViiV

60/30mg tablet

4

300/150mg tablet

2

AZT/3TC/ABC

161(0.221)46(0.032)76(0.104)

Sun Pharma3

AZT/3TC/NVP

420(0.383)
Aurobindo

60/30/60mg tablet

4

300/150/200mg tablet

2

AZT/3TC + EFV(co-pack)
300/150 + 600mg
tablets (co-packs)

106(0.292)

HeteroAZT/3TC

60/30/50mg tablet

110(0.300)

1 kit(3 tabs)88(0.060)97(0.133)96(0.132)

Aurobindo

Strides164(0.450)170(0.467)80(0.055)95(0.130)Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016

102(0.139)126(0.173)94(0.129)96(0.131)21

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Untangling the Web of ARV Price Reductions | msfaccess.org/utw201623

GLOSSARY AND ABBREVIATIONSGLOSSARY AND
ABBREVIATIONS
3TC: Lamivudine, a nucleosideanalogue reverse transcriptase inhibitor.

DTG: Dolutegravir, an HIV
integrase inhibitor.

NDRA: National Drug Regulatory
Authority.

ABC: Abacavir, a nucleoside analogue
reverse transcriptase inhibitor.

DTI: Department of Trade and Industry.

PEPFAR: The President’s Emergency
Plan for AIDS Relief.

AIDS: Acquired Immune
Deficiency Syndrome.
ANVISA: Brazil’s national healthsurveillance agency, responsible
for approval and oversight ofpharmaceutical products, medical
devices, health services, food,cosmetics, and tobacco.
ARV: Antiretroviral; medicines thattreat HIV/AIDS.
ART: Antiretroviral therapy; acombination of ARVs used to treat
HIV/AIDS.
ATV, ATV/r: Atazanavir, an HIV
protease inhibitor; atazanavir/ritonavir,
a boosted HIV protease inhibitor.
AZT: Zidovudine, a nucleosideanalogue reverse transcriptase inhibitor.
BMS: Bristol Myers-Squibb.
CAEME: Association of multinational
pharmaceutical companies in Argentina.
Category 1: In this document,‘Category 1’ refers to the countries
that are eligible to receive the deepest
discount on a company’s ARV price.
Category 2: In this document,“Category 2’ refers to countries that are
not eligible for a company’s deepest
discount on ARV pricing, but arenevertheless offered a lesser discount.
DAAs: Direct-acting antivirals, oral
drugs used to treat hepatitis C virus.
DRV, DRV/r: Darunavir, an HIV
protease inhibitor; darunavir/ritonavir,
a boosted HIV protease inhibitor.

24

Médecins Sans Frontières | July 2016

EFV: Efavirenz, an HIV non-nucleosidereverse transcriptase inhibitor.

PI: Protease inhibitor.

EMA: European Medicines Agency.

PPPY: Per person, per year.

ETV: Etravirine, an HIV non-nucleosidereverse transcriptase inhibitor.

RAL: Raltegravir, an HIV integrase
inhibitor.

EU: European Union.

RCEP: Regional Comprehensive
Economic Partnership.

Evergreening: Making minor changes
to medicines that are already on themarket, to extend patents.
FTAs: Free trade agreements.
FTC: Emtricitabine; a nucleosideanalogue reverse transcriptase inhibitor.
Generic drug: According to WHO,a generic drug is a pharmaceuticalproduct that is usually intended to beinterchangeable with the originatorproduct.

RTV or /r: Ritonavir, an HIV
protease inhibitor used only at alow dose to boost levels of otherHIV protease inhibitors.
SRA: Stringent regulatory authority.
TAF: Tenofovir alafenamide, a pro-drugof tenofovir.
TB: Tuberculosis.
TDF: Tenofovir; a nucleotide analogue
reverse transcriptase inhibitor.

GFATM: The Global Fund to Fight
AIDS, Tuberculosis and Malaria.

TPP: Trans-Pacific Partnership.

GSK: GlaxoSmithKline.

TRIPS: Trade-Related Aspects ofIntellectual Property Rights.

HCV: Hepatitis C virus.
HIV: Human Immunodeficiency Virus.
INTERFARMA: The Pharmaceutical
Research Industry Association; amultinational group of pharmaceuticalcompanies located in Brazil.
IP: Intellectual property.
LDCs: Least-developed countries.
LPV/r: Lopinavir/ritonavir, a boosted
HIV protease inhibitor.
MPP: Medicines Patent Pool.
MSF: Médecins Sans Frontières;Doctors Without Borders.

UNAIDS: Joint United Nations
Programme on HIV/AIDS.
UNITAID: a market-shaping institutionthat facilitates and accelerates
availability of medicines and diagnostics
for HIV/AIDS, tuberculosis, malaria andhepatitis C.
US: United States.
US FDA: United States Food andDrug Administration.
VL: Voluntary licence.
WHO: World Health Organization.
WTO: World Trade Organization.

ACKNOWLEDGEMENTS:
Front cover photo:© Peter Casaer/MSF
Back cover photo:© Aye Pyae Sone/MSF

Design/artwork/print:
ACW Ltd+44 (0)20 8392 4330
www.acw.uk.com

DISCLAIMER:“Untangling the Web of Antiretroviral Price Reductions” is a pricing guide andcannot be regarded as a company price list nor as a clinical guideline. It is crucial
that any purchaser verify prices and availability as well as quality status directlywith the supplier before procurement. Médecins Sans Frontières has made every
effort to ensure the accuracy of prices and other information presented in thisreport, but MSF makes no representations or warranties, either expressed or
implied, as to their accuracy, completeness or fitness for a particular purpose.
Inclusion of a product in this document does not indicate MSF purchases or uses
the product. Information on patent status of the products mentioned in this guide
is indicative only and not exhaustive, and should be verified with relevant national
patent of prices when used for other than reasons of general information. Clinicaldecisions should not be made based on this document.

Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016

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