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UNTANGLING THE WEB OF ANTIRETROVIRAL PRICE REDUCTIONS 18th Edition – July 2016 www.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 opportunities
for – and threats to – expanding access to affordable antiretroviral therapy (ART). There is a
table 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 CAMPAIGN
In 1999, on the heels of Médecins Sans Frontières (MSF) being awarded the Nobel Peace Prize – and
largely in response to the inequalities surrounding access to HIV/AIDS treatment between rich and
poor 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 of
people 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 to
availability and affordability of life-saving ARVs and appropriate formulations, including patent
monopolies, prices and lack of generic competition through Untangling the Web and pushing
for the uptake of policies that promote access to affordable quality medicines. Due primarily to
generic 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 be
shared, 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 find
out more about patents that block access to essential medicines and what you can do to challenge
them, or to contribute by sharing resources, visit:
www.patentoppositions.org
Médecins Sans Frontières | July 2016
TABLE OF CONTENTS
TABLE OF CONTENTS
2 STATE OF HIV TREATMENT ACCESS
Speed up treatment scale-up in Western and Central Africa
4 OPTIMISING HIV TREATMENT
7 PRICING
High 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
19 ANNEX: SUMMARY TABLE OF ALL PRICES
22 REFERENCES
24 GLOSSARY AND ABBREVIATIONS
Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016 1
STATE OF HIV
STATE OF HIV TREATMENT ACCESS
TREATMENT ACCESS
In 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 for 2020, referred to as ‘90-90-90’.3
people are receiving lifesaving To meet these targets, the number of THE 2020 UNAIDS
antiretroviral therapy (ART),1 and the people on treatment will need to more
lowest price for a generic, World Health than double again, since nearly 20
TARGET: 90-90-90
Organization (WHO)-recommended million HIV-positive people are newly By 2020, 90% of all
first-line regimen is $100 pppy. eligible for ART under the new ‘treat- HIV-positive people will be
all’ recommendation.1 aware of their status; 90%
In 2015, the number of people starting
HIV treatment surpassed the number At the UN High Level Meeting on of all people diagnosed
of new infections in Africa for the HIV in June 2016, governments with HIV will have access to
first time. Since 2010, the number of agreed on a global target: reaching sustained ART; and 90% of
people receiving ART has more than 30 million people with treatment people on ART – or 73% of
doubled.1,2 The push to continue by 2020. Reaching this goal will all HIV-positive people – will
ARV scale-up has gained momentum require increased and sustained achieve viral suppression.3
around the UNAIDS global targets support from donors.
© Isabel Corthier
Tsandia receives her antiretroviral medicines at the HIV department of the Arua Regional hospital in Uganda.
2 Médecins Sans Frontières | July 2016
STATE OF HIV TREATMENT ACCESS
GRAPH 1: GENERIC COMPETITION AS A CATALYST FOR PRICE REDUCTION FOR A FIRST-LINE REGIMEN
Originator products
Generic products
12000
10439
10000
US$ per person per year
8000
6000
4000
2767
2000 549
0 132
June 00 Sept 01 June 02 June 03 Dec 03 Apr 04 June 05 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 in worsened by the Ebola outbreak - tests, drug stockouts, out-of-pocket
Western and Central Africa than in add to barriers that include limited fees for healthcare, and lack of
Southern Africa, over a quarter of access to diagnostic and monitoring decentralised treatment.4
all AIDS-related deaths occur in the
region, including 40% of all deaths
among children.4
In Central African Republic, HIV
prevalence is 5%, but HIV accounts
for 84% of hospital-based deaths
where MSF works. In Democratic
Republic of the Congo, three out
of four HIV-positive people who
present to the hospital where MSF
works are too sick to save.
In 2015, only 1.8 million
© Sam Phelps
people (28%) of the region’s
6.5 million HIV-positive people
were accessing ART.1 Political
instability, inadequate funding and
Mohamed (left) is tested for HIV at an MSF mobile clinic in Conakry, Guinea.
weak healthcare systems - some
Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016 3
OPTIMISING HIV TREATMENT
OPTIMISING HIV TREATMENT
COUNTRIES SHOULD IMPLEMENT WHO GUIDELINES
Immediate treatment and a steady WHO has recommended immediate of care that put the patient at the
supply of affordable medicines are and lifelong ART for everyone with centre of their treatment.10
essential to curbing the HIV epidemic. HIV: all infants, children, adolescents,
Countries should implement the WHO
ART lowers the risk of serious illness and adults, including pregnant and
recommendations, including ‘test and
and death, reduces the risk of breastfeeding women, regardless of
start’, routine viral load monitoring
developing tuberculosis (TB) by CD4 cell count or disease stage.9
[see below], better drugs (new
65%, and reduces HIV transmission
In June 2016, WHO issued new HIV ARVs and once-daily, fixed-dose
by 96%.5,6,7,8
treatment guidelines, including combinations), adherence support, and
In light of the individual and recommendations for new ARV differentiated models of care to facilitate
community benefits of HIV treatment, regimens and differentiated models 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, WHO
recommended 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; the
2015 guidelines recommend viral load
monitoring – now with dried blood spot
testing – at six and 12 months after
starting ART. For stable patients, viral
load monitoring is recommended once
every year thereafter instead of CD4 cell
count monitoring.9,10
As tests have become more affordable
and rollout less complex, more
countries have adopted routine viral
load as part of national policy. However,
implementation still lags far behind;
a 2014 WHO study of 122 low- and
middle-income countries found that
only 22% of people on ART received
viral load monitoring.11
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
© Isabel Corthier
identified, leading to interventions
including a child-friendly clinic,
community ART groups, and enhanced
adherence counselling. Routine viral
load testing has triggered a switch to
second-line treatment and enhanced
People wait to have their blood tested to measure their viral load at the HIV department
adherence counselling in 10% to 68%
of Arua Regional Hospital in Uganda.
of patients. 12
4 Médecins Sans Frontières | July 2016
OPTIMISING HIV TREATMENT
IMPROVING FIRST-LINE TREATMENT
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 of
efavirenz (EFV; 400mg vs. 600mg)9
© Ron Haviv/VII Photo
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 are
An MSF outreach worker measures out antiretroviral medication during a home visit needed;9,15 these studies are planned
in Dawei, in southeastern Myanmar.
or underway.
BETTER SECOND-LINE TREATMENT
As access to viral load monitoring
increases, more people in need
of second-line treatment will be
identified. 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) with
lopinavir/ritonavir (LPV/r).10
DRV is a boosted protease inhibitor
(PI) with fewer side effects than the
© Julie Remy
other 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 Loved Mupandanana is HIV positive, and her first-line treatment for HIV seems to be
FDC on the market, and the current failing. At Gombe clinic, in Manicaland Province in Zimbabwe, she is receiving counselling
about the need to move on to second-line treatment.
price of generic DRV alone is at least
three times more than other protease
inhibitors, making it costly for wide-
spread use.
In 2015, MSF provided second-line
HIV treatment for 10,200 people.
Continued overleaf
Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016 5
OPTIMISING HIV TREATMENT
Optimising HIV treatment continued
THE ARV PIPELINE FOR ADULTS
The ARV pipeline includes new drug three TAF-based FDCs (in November improve adherence and significantly
formulations and classes. Tenofovir 2015, March 2016 and April 2016). reduce the cost of HIV treatment;
alafenamide (TAF), a new prodrug of Stand-alone TAF has been approved interim results from a trial of a long-
tenofovir disoproxil fumarate (TDF), in Europe (and filed in the US) for acting injectable combination (rilpivirine
is equally effective as the currently hepatitis B treatment only. If Gilead, and cabotegravir) are promising,
available version, at one-tenth of the the company marketing TAF, does not although an interaction between
dose. TAF is likely to be safer, and register the drug as a single ARV for cabotegravir and rifampicin requires
should be significantly less expensive use in HIV, generic manufacturers may further study.20,21,22,23
to produce than TDF,19 but data on face complications and long delays
New ARV classes include attachment
drug interactions between TAF and TB in registering TAF-containing FDCs in
and maturation inhibitors; there are also
treatment are needed. other countries.
new versions of integrase inhibitors and
The United States Food and Drug Long-acting, injectable ARVs with non-nucleoside reverse transcriptase
Administration (USFDA) has approved monthly or bi-monthly dosing could inhibitors (NNRTI) in development.
THE ARV PIPELINE FOR CHILDREN
Only 49% of the world’s HIV-positive children difficult. The price of the pellets
children had access to treatment in needs to be reduced so it is at least In 2015, MSF
2015.24 Without treatment, over half on par with the syrup, to encourage
of all HIV-positive children die before countries to adopt them.
supported
their second birthday;25 treating infants treatment for
The Drugs for Neglected Diseases
when they are less than 12 weeks old 6,800 HIV-positive
initiative (DNDi) LIVING study is
lowers mortality by 75%.26
looking at the safety, effectiveness
pregnant women,
Research and development of and acceptability of LPV/r pellet-based and post-exposure
paediatric ARVs and FDCs has lagged therapy in infants (>four weeks old) treatment for
far behind adult treatment, which has and children, with enrolment having 4,400 babies.
severely limited treatment options for begun in Kenya.30
HIV-positive infants and children.
There is a new pellet formulation
of LPV/r, which is part of the WHO-
recommended first-line regimen for
children under three years old.10
In May 2015, the USFDA granted
tentative approval for LPV/r pellets
for children who weigh >5 kg and are
over 14 days old.27,28 This formulation
of LPV/r is available to a limited group
of low- and middle-income countries
through a Medicines Patent Pool (MPP)
voluntary licence (VL), although one
© Sydelle WIllow Smith
year after stringent regulatory authority
(SRA) approval, it has not yet been
made commercially available.
Pellets could replace LPV/r syrup, which
contains 40% alcohol and propylene
glycol, requires refrigeration, and has
been described as tasting “horrible”29 – Jennipher Mwamvera is a mother of four and a patient in the prevention-of-mother-to-
child transmission of HIV (PMTCT) program in Thyolo, Malawi.
all of which have made treating young
6 Médecins Sans Frontières | July 2016
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% (TDF/FTC/EFV) can be as low as Aurobindo’s generic version of
reduction in the price for generic $100 pppy, down from $143 pppy in dolutegravir will have a price of
first-line treatment.* If countries are 2014. Prices for first-line treatment $44 pppy,32 which is on par with
able to import and use generics, are unlikely to decrease further, since the price of efavirenz 600mg.
the price for the fixed-dose of the they are now close to the minimum A fixed-dose combination of DTG
WHO-recommended combination sustainable production price, with TDF/XTC should be available
of tenofovir/emtricitabine/efavirenz according to experts.31 by the end of 2017.
Continued overleaf
GRAPH 2: THE PRICES OF DIFFERENT FIRST-LINE REGIMENS TODAY
1200
$1033
1000
US$ per person per year
800
$ 613
600
400
200 $164 $106 $100
$94 $124 $66
0
Lowest Lowest Lowest Lowest Lowest Lowest Originator Originator
generic price generic price generic price generic price generic price generic price price for price for
AZT/3TC/NVP TDF/3TC + NVP AZT/3TC + EFV TDF/3TC + EFV TDF/3TC/EFV TDF/FTC/EFV Cat.1 Cat.2
TDF/FTC/EFV TDF/FTC/EFV
* Price reductions may be due in part to currency fluctuations.
Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016 7
PRICING
Pricing continued
GRAPH 3: THE EVOLUTION IN PRICE OF DIFFERENT FIRST-LINE REGIMENS
TDF/FTC/EFV (1 pill/once a day)
TDF/3TC/EFV (1 pill/once a day)
AZT/3TC + EFV (1 pill/twice a day + 1 pill/once a day)
600
500
487
US$ per person per year
426
400 410
300
200
164
106
100 100
0
June 07 June 08 Dec 09 June 10 June 11 June 12 June 13 June 14 June 16
HIGH ANTIRETROVIRAL PRICES IN MIDDLE- AND
HIGH-INCOME COUNTRIES
According to UNAIDS, 70% of all not included in voluntary licensing High-income countries such as the
HIV-positive people will be living in agreements, and/or have not used US are struggling with spiralling
middle-income countries by 2020.33 TRIPS flexibilities such as compulsory costs of patented medicines,
licences.* Instead, they must pay including ARVs. In the US, the
Several ARVs are still on patent in
high prices to originator companies combination of TDF/FTC/EFV (sold
middle-income countries. Some
for patented drugs on a case-by- under the brand name Atripla) costs
lower- and upper-middle-income
case basis or under ‘tiered pricing’ nearly $30,000 pppy35 versus $100
countries where patent barriers on
schemes that are not based on a pppy for Indian generic versions.
key ARVs remain cannot produce or
buy generic ARVs, because they are realistic concept of affordability.34
* 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”. Legal
safeguards 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 patent
claims 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 other
countries instead of paying higher prices for them – also without consent from the patent holder (called parallel importing).
8 Médecins Sans Frontières | July 2016PRICING
SECOND-LINE REGIMENS
Boosted protease inhibitors are the Although LPV/r must be taken twice Prices for boosted protease inhibitors
backbone of second-line regimens. a day, it can be dose-adjusted for use are especially high in middle-income
The lowest-priced generic second- with rifampicin-based TB treatment. countries, since many of them have
line regimen, zidovudine/lamivudine LPV/r is still more expensive than patent barriers and are excluded from
(AZT/3TC) and atazanavir/r (ATV/r), is ATV/r, at $243 pppy versus $213 voluntary licensing agreements. In
now priced at $286 pppy. Since 2014, its designated Category 2 countries,*
pppy [see graph 4]. The price of
the price has dropped by 11%, from AbbVie charges higher prices for LPV/r
generic LPV/r is 5% higher than
$322 pppy. than in least-developed countries
the originator product, because the (LDCs): $740 pppy (which has not
Switching to second-line therapy originator company, AbbVie, has been changed since 2012), compared to
nearly triples the price of treatment consistently undercutting generic $231 pppy in LDCs [see graph 4]. In
[see graph 5]. Currently, there competition with slightly lower prices. Malaysia, prices for LPV/r were quoted
are two WHO-preferred boosted above $3,500 pppy in 2014.36 The
protease inhibitors for second- For several of the newer second-line
originator price from Bristol-Myers
line regimens, ATV/r and LPV/r; options, current demand is low. The
Squibb (BMS) for atazanavir– which
one alternative boosted protease price of generic versions has not yet must be used with ritonavir (RTV) – is
inhibitor, darunavir+r (DRV+r); and come down, and only a few $816 pppy; AbbVie’s originator price
an alternative, twice-daily two-ARV producers have entered the market. for RTV is set on a “case-by-case” basis.
regimen, the integrase inhibitor DRV is much more expensive than
raltegravir (RAL) plus LPV/r.10 The lowest originator price for RAL is
ATV/r or LVP/r, and it is not available
$675 pppy; the lowest-price generic
as a fixed-dose combination with
A generic, fixed-dose, heat-stable version is $973 pppy [see graph 6].
ritonavir (RTV or r). Darunavir is
formulation of ATV/r is available. It has Currently, RAL is taken twice daily,
fewer side effects than LPV/r, although available from the originator for
however, Merck plans to submit
it cannot be used during rifampicin- $663 pppy; generic versions are data to the USFDA and the European
based TB treatment. Because of supply $1217 pppy, since the current low Medicines Agency (EMA) to seek
problems with LPV/r, an increase demand prevents companies from approval for once-daily RAL.37 RAL
in demand for ATV/r is expected, being motivated to commercialise it can be dose-adjusted for use during
hopefully leading to lower prices. in low- and middle-income countries. rifampicin-based TB treatment.38
GRAPH 4: THE EVOLUTION IN PRICE OF BOOSTED PROTEASE INHIBITORS FOR SECOND-LINE REGIMENS
Lowest generic ATV/r Originator price for Cat. 1 LPV/r
Lowest generic LPV/r Originator Price for Cat. 2 LPV/r
1200
1034
1000 1000
US$ per person per year
800
740
600
500
400
304 243
231
200 213
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
Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016 9PRICING
Pricing continued
SALVAGE REGIMENS
There is an urgent need for more + ETV), in countries that fall into the $1,217; this does not include the ritonavir
affordable third-line, or salvage regimens select group eligible for access pricing it must be used with. At the same time,
for people that have acquired resistance from originators (but many countries the access price from the originator has
to first- and second-line treatment. are paying much more). This represents dropped by 17%, from $810 to $675.
Low volume and high prices from both nearly an 18-fold increase over the lowest A quality-assured generic RAL is priced at
originator and generic companies keep first-line prices, and nearly a seven-fold $973 pppy, but it is still more expensive
these medicines out of reach. increase over the most affordable
than the originator version, which has
second-line regimen [see graph 5].
The lowest price for a salvage regimen stayed at $675 since 2011. The originator
today is $1,859 pppy, for darunavir+r, Since 2014, the price of generic DRV price for ETV has stayed at $438 since
raltegravir and etravirine (DRV+ r + RAL has increased by 10%, from $1,095 to 2011 [see graph 6].
GRAPH 5: PRICE COMPARISONS OF FIRST-LINE, SECOND-LINE AND POSSIBLE THIRD-LINE
TREATMENT REGIMENS
2000
$1,859
1500
x 17.4
US$ per person per year
x 6.5
1000
x 2.7
500
$106
$286
0
Lowest generic price Lowest generic price RAL+DRV+r+ETV
TDF/3TC/EFV AZT/3TC+ATV/r
First-line regimen Second-line regimen Third-line regimen
GRAPH 6: PRICES FOR THIRD-LINE ARVS
DRV 600 mg originator price RAL 400 mg originator price
DRV 600 mg generic price RAL 400 mg generic price
ETV 100 mg originator price
2000
1750 1752
US$ per person per year
1500
1250 1217
1095
1000 973
913
810
750 675
675 663
500
438
250
0
June 11 June 12 June 13 June 14 June 15 June 16
10 Médecins Sans Frontières | July 2016REGISTRATION
REGISTRATION
In many countries, marketing authorisation for promising new ARVs can take several years; this type
of 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 Collaborative or regional registration new drugs for neglected diseases, ARVs
often prioritise registration in low- processes have reduced the time to for paediatrics, and salvage regimens.
and middle-income countries. Some registration for some products in In addition, the Indian NDRA should
originator companies shift the some participating countries. These prioritise new ARVs, FDCs, and child-
responsibility for filing registration collaborations should be considered friendly formulations, taking note of,
dossiers in high-burden developing by national regulatory authorities to and relying on WHO guidelines and/or
countries to generics companies that reduce the considerable workload Expression of Interest from the
have signed voluntary licences. associated with reviewing registration WHO prequalification programme.*
dossiers. For example, in East Africa,
In some countries, generics companies Another delay is the WHO
a pilot of the African Medicines
are able to register generic versions prequalification programme, which has
Registration Harmonisation Initiative
of medicines, but in others, when been essential for reviewing the quality,
has reduced the time to registration
originators don’t register their ARVs safety, and efficacy of generic ARVs that
by 50% in Burundi, Kenya, Rwanda,
before generics companies do, it may aren’t always reviewed or approved by
Uganda, and Zanzibar.39
cause significant delays, or become an a stringent regulatory authority (SRA).
absolute barrier to treatment access. India’s lack of intellectual property In 2013, the median wait for WHO
(IP) barriers and historically efficient prequalification was 15.1 months.39
Countries have different regulatory regulatory pathway made it possible
pathways, priorities, rules, for generics companies to produce and
requirements, legal frameworks, register more affordable medicines for
capacities, and timelines, and some developing countries. But availability 97% of the
do not have NDRAs. There is no of new quality-assured generic ARVs medicines MSF uses
‘essential documentation package’
to streamline the registration process
and FDCs from India is starting to be to treat people with
delayed. This is partly because India’s
across all NDRAs in developing criteria to waive phase III clinical trials HIV are generics
countries, and country-level are restrictive in certain cases. These made in India.
bureaucracy can delay registration. criteria need to be expanded to include
BARRIERS TO UNIVERSAL ACCESS TO GENERIC
DOLUTEGRAVIR FROM INDIA
The pharmaceutical company ViiV has granted voluntary for registration in India. As a result, the responsibility
licences (VLs) for the integrase inhibitor dolutegravir for registration is now with Indian producers that have
(DTG) to several Indian generic companies through developed generic dolutegravir. They will need to do
the Medicines Patent Pool (MPP). The VLs will not local clinical trials, as per the Indian NDRA requirements
result in universal access to the drug, since a number of for new drugs, which will lead to a significant delay
high-burden countries are excluded from the territories in the availability of affordable generics across the
that can import the generic version from India. developing world. In the meantime, patients in India
In India, generic DTG will only be available on the who have exhausted other treatment options are left
public market or to non-governmental providers, without access to DTG, since ViiV has been dragging its
leaving a number of patients with drug resistance feet to provide the medicine via compassionate use.
who need immediate access without any source To ensure open generic competition in the future,
from Indian pharmacies.
a patent opposition for DTG has been filed in India,
Although DTG has been registered in many other by and on behalf of people living with HIV, and
countries, ViiV, the originator company, has not filed supported 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 pediatric
formulations 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 or
sachets 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 11PATENT OPPOSITIONS
PATENT OPPOSITIONS AND PATENT LAW REFORM
AND PATENT LAW REFORM
INDIA, THE ‘PHARMACY OF THE DEVELOPING WORLD’, IS UNDER
PRESSURE TO DROP ITS PUBLIC HEALTH SAFEGUARDS
Indian generics comprise 76% of of Intellectual Property Rights [TRIPS]). pressure – led by the multinational
the ARVs used in low- and middle- India’s national patent laws include pharmaceutical lobby – to change its
income countries and more than public health safeguards such as national intellectual property laws and
97% of those used by MSF in its stringent patentability criteria, and the policies, or sign free trade agreements
treatment programmes.31,44 India opportunity to file legal challenges to that will dismantle them. Over the last
encouraged generic competition for patents before and/or after they are two years, pharmaceutical industry-
decades, since it did not introduce granted (called pre-and post-grant led pressure from the US has been
patent oppositions).
patents for pharmaceuticals until escalating. India must reject the
2005 (when it had to comply with India has fought off numerous demands to grant patents more easily,
international trade rules under the challenges to its public health as well as TRIPS-plus rules that the
World Trade Organization [WTO] safeguards, but it has been under United States is trying to force upon
Agreement on Trade-related Aspects excessive external and domestic India’s Ministry of Commerce.
PATENT OPPOSITIONS FOR HEPATITIS C
Patent oppositions have been used when patent has applied for WHO prequalification for their generic
claims do not meet national patentability criteria, version of the drug.
and when a patent directly blocks or delays access
In India, one critical sofosbuvir patent has been
to essential medicines.
recently granted, reversing its prior rejection in 2015.
Worldwide, an estimated 150 million people This decision is now under appeal. If upheld, the
have chronic hepatitis C virus infection; without patent will block additional competition from the
treatment, they are at risk of developing liver Indian generics companies that do not want to sign
failure and liver cancer.45 a voluntary licence with Gilead, leaving them unable
Hepatitis C can be cured with a few months’ treatment to supply sofosbuvir to millions of people in India
using oral drugs, called direct-acting antivirals (DAAs). and other middle-income countries. In addition, this
In 2013, the price of the first DAA on the market, decision would allow Gilead to disrupt or stop exports
sofosbuvir, sent shock waves throughout the world. of the raw materials from India that are used to make
Although it can be mass-produced for less than sofosbuvir’s key active pharmaceutical ingredient (API).
$1 per pill,46 sofosbuvir’s launch price was $1,000 This will make it difficult for the generics companies in
per pill in the US. Egypt, Bangladesh, Pakistan and Latin America that are
Gilead’s patent on sofosbuvir has been opposed – producing sofosbuvir without a patent in force – and
and rejected – in some countries. The patent on the without a licence agreement with Gilead – to continue
pro-drug form of sofosbuvir was rejected in China and production. More patent oppositions on sofosbuvir
Ukraine. In Egypt, where the primary patent application have been filed in Argentina, Brazil, Russia, Thailand,
for sofosbuvir was rejected, a company called Pharco France and India.
12 Médecins Sans Frontières | July 2016PATENT OPPOSITIONS AND PATENT LAW REFORM
PATENT LAW REFORM IN BRAZIL, SOUTH AFRICA AND ARGENTINA
South Africa and Brazil are in the pharmaceutical companies involved that charge unaffordable prices.
process of reforming their patent laws, in the ‘Pharmagate’ scandal (a In order to overcome IP barriers to
in part to more effectively manage covert, $600,000 campaign funded generic competition, a coalition of
prices for medicines, and to encourage by large pharmaceutical companies civil society groups has recently filed a
competition (and local production). and medical device producers to patent opposition in Brazil on the main
There is a lot at stake: South Africa has delay - and influence - South African patent related to TAF. In addition, in
the largest number of people living with patent reforms). South African Health November 2015, GTPI (Working Group
HIV in the world, and Brazil guarantees Minister Aaron Motsoaledi has accused on Intellectual Property), a civil society
HIV treatment for all, with many people the multinational pharmaceutical coalition, filed a patent opposition to
on salvage therapy, as well as first- and companies in South Africa of conspiring deny a patent to BMS (for atazanavir;
second-line treatment. But delays in against the state and the people of ATV) that could extend the patent
patent law reform will undermine access South Africa, and called on all South holder’s monopoly until 2024. Brazil
to affordable medicines, including ARVs. Africans to fight back “…to the last currently pays $496.40 pppy for
drop of their blood.”50 the 300mg version of ATV; a Health
SOUTH AFRICA Ministry-approved licence between
In 2015, 3.1 million people living BRAZIL BMS and the Brazilian government-
with HIV were accessing antiretroviral Brazil is consistently excluded from linked pharmaceutical laboratory
therapy through South Africa’s public voluntary licensing programmes, and Farmanguinhos forbids production of
sector,47 and the government recently therefore forced into tiered pricing atazanavir in newer formulations and
announced a ‘test and start’ policy.48 schemes from originator companies combinations, such as ATV/r.51
As more people are treated, the need
for second-line and salvage regimens
will increase. Many of these ARVs
are patented and are too expensive
for the government to procure for
the public sector. But South Africa
has not introduced or implemented
key measures to safeguard public
health, 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
© Stefan Heunis
In 2009, South Africa’s Department
of Trade and Industry (DTI) initiated a
process 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 MSF and the Treatment Action Campaign launched the ‘Fix the Patent Laws’ campaign
other non-governmental organisations. to demand patient-focused reforms to South Africa’s patent laws.
The campaign highlights how
pharmaceutical companies have used
evergreening tactics to exploit South
Africa’s patent system. In September
EVERGREENING
2013, the DTI released a draft policy Many countries often do not expired, but they are not because
document for public comment. But the examine patent claims strictly, of evergreening.
new policy is still not finalised, and is not leaving them vulnerable to
In Ukraine, home to nearly
expected until mid-2017. ‘evergreening’, whereby
265,000 people living with HIV,40
pharmaceutical companies make
The longer DTI delays, the longer it GSK extended its abacavir (ABC)
minor changes to medicines that
will take for South Africa to introduce patent monopoly by eight years
are already on the market to extend
short- and long-term reforms that with its secondary patent on the
their patents. Several ARVs should
can accelerate and promote generic hemisulfate salt.41 Ukraine’s price
now be free from patent barriers
competition, and to drive down prices for originator ABC is $277.40
(including ABC, DRV, EFV and
for patented drugs. The delay also raises pppy42 versus $123.42 pppy for
RTV) since their basic patents have
concern about undue political and the generic version.43
commercial pressure from multinational
Continued overleaf
Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016 13PATENT OPPOSITIONS AND PATENT LAW REFORM/ TRADE AGREEMENTS
Patent oppositions and patent law reform continued
At the same time, multinational In November 2014, a multinational Argentina adopted new patentability
drug companies are using lawsuits group of pharmaceutical companies examination guidelines for the
to challenge measures that promote (INTERFAMA, the Pharmaceutical pharmaceutical sector to prevent the
generic competition in Brazil, including Research Industry Association) filed granting of numerous patents that
the country’s patent examination a Collective Action against ANVISA, do not meet specific criteria such as
process. Since 2001, ANVISA, Brazil’s questioning the legitimacy of ANVISA’s novelty, inventive step, and industrial
national drug regulatory agency, has participation in the patent granting application. Since Argentina’s new
participated in analysing pharmaceutical process. Local civil society groups have guidelines were enacted, 95% of
patent applications, instead of leaving strongly reacted to these setbacks. ARV patent applications have been
this task exclusively to patent office rejected, an increase from the 51%
Patent law reform that would improve
examiners, and ANVISA has rejected rejection rate in 2012.54
affordability of new medicines has
more than 400 of them. ANVISA’s role
been delayed for more than two years. In 2015, CAEME – the association
in pharmaceutical patent examination
In 2013, a ‘package’ of bills to amend of multinational pharmaceutical
has been considered an important
Brazil’s patent law was introduced. If companies in Argentina – filed a
safeguard to public health and access to
approved, it will ensure that Brazil has court case questioning the validity of
medicines.52 Multinational companies
clearer criteria for patent examination, the patent guidelines. In response,
have frequently contested ANVISA’s
and introduce important flexibilities civil society groups from Brazil
rejections in court. In 2011, the Attorney
into its national laws.53 and Argentina launched the ‘Big
General’s Office (AGU) issued a legal
opinion strengthening the position of Pharma Drop the Case’ campaign at
pharmaceutical companies – although it ARGENTINA the 31st session of the UN Human
proved unenforceable, the AGU has not Argentina has taken steps to Rights Council, to push CAEME and
formally withdrawn its legal opinion. improve its patent laws. In 2012, INTERFARMA to abandon their actions.
TRADE AGREEMENTS
Governments, civil society and generics producers should use TRIPS flexibilities to improve affordability
of, 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 under
World Trade Organization (WTO) trade rules.
EU-INDIA FTA TRANS PACIFIC access to generic medicines due to
the proposed inclusion of TPP-like
Negotiations on the EU-India FTA PARTNERSHIP intellectual property rules by Japan
began in 2007. They have been stalled AGREEMENT (TPP) and South Korea.
since 2012, in part due to public The TPP is a far-reaching trade agreement
across the Asia-Pacific region. If ratified, Countries that did not join the TPP –
pressure, but may resume this year.
the TPP will be the worst-ever trade particularly India and key members
The EU-India FTA could jeopardise
agreement for access to medicines: it will of the Association of Southeast
access to India’s affordable generic Asian Nations – will be pushed to
lengthen, deepen and expand intellectual
medicines for millions of people, by property and patent monopolies, and adopt similar standards in the RCEP
limiting production, sale and export of prevent or delay access to affordable, negotiations, which would represent a
medicines in the future. life-saving generic medicines for millions rollback of protections against extended
of people.56 While the TPP agreement has patent terms and data exclusivity that
In the past, the EU has demanded been signed by governments, it has yet to are part of past agreements.
a range of intellectual property be ratified by any country.
provisions that exceed India’s The RCEP negotiations will have
REGIONAL serious repercussions globally, since
obligations under TRIPS, including
both India, the ‘pharmacy of the
measures that would allow companies COMPREHENSIVE developing world’, and China, the
to prevent legitimate export of ECONOMIC world’s largest producer of the active
medicines to developing countries or PARTNERSHIP (RCEP) pharmaceutical ingredients (API) used
bring legal action against people who The RCEP trade negotiations among to make medicines, are among the 16
buy or distribute generics.55 16 Asia-Pacific countries could threaten countries included in the negotiations.
14 Médecins Sans Frontières | July 2016TRADE AGREEMENTS
COLOMBIA: COMPULSORY LICENCE THREAT INVITES US PRESSURE
In April 2016, a leaked letter Thailand, Ecuador), which has As of mid-June 2016, the Colombian
from the Colombian Embassy discouraged other governments Minister of Health announced that
described how the US Senate from issuing compulsory licences they had issued a ‘public interest
Finance Committee and the to ensure affordable medicines. declaration’ regarding imatinib,
United States Trade Representative As WHO states in its letter to without public information about
were pressuring the Colombian Colombia’s Minister of Health, whether the government will issue
government not to issue a “unaffordable high prices of a compulsory licence to allow
compulsory licence* for the anti- essential medicines, including for manufacturing and import of price-
cancer cancer drug imatinib.58
non-communicable diseases, are lowering generic versions of the
A number of countries have also a legitimate reason for issuing a drug, or simply reduce the price of
faced similar pressure (Brazil, compulsory licence”.59 the Novartis product.60
LDC EXEMPTION FROM PHARMACEUTICAL IP EXTENDED
Least-developed countries section 7) for pharmaceutical protect their TRIPS flexibilities in
(LDCs) have been granted an products until 1 January 2033. 57 complex FTA negotiations.
exemption from certain obligations But the free-trade agreements
LDCs in Asia, including Laos,
under TRIPS, in recognition of that are being negotiated in many Bangladesh, Cambodia and Myanmar,
their economic, financial and countries across the Asia-Pacific as well as countries in sub-Saharan
administrative constraints and region, in particular RCEP [see Africa, should continue to use the
their need to make or procure low Trade Agreements, page 14], waiver to the fullest extent possible
cost generic medicines. Under this could undermine the LDC transition to improve access to medicines
transition period, LDCs do not have period, unless UN agencies and and should resist any pressure to
to apply or enforce TRIPS provisions civil society provide technical and prematurely introduce intellectual
concerning patents (TRIPS section political support to negotiating property rules that would undermine
5) or test data protection (TRIPS countries, particularly LDCs, to access to generic medicines.
© Aye Pyae Sone
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 other
than 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/utw2016 15STOCKOUTS
STOCKOUTS
For years, many countries have faced shortages and stockouts of essential medicines. Stockouts can
be 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 that
allow generic manufacturers to supply them).
Because of stockouts, people may governments should make plans needed to ensure sufficient availability,
receive smaller amounts of the for treatment transitions, ensure while achieving economies of scale.
medicine they need, which means appropriate buffer stocks and give
extra time-consuming trips to the clear clinical guidance on making In South Africa, the Stop Stockouts
clinic. They may also be switched switches correctly. Project has empowered patients and
to different, less-optimal doses or pushed for accountability in the supply
regimens, or be told to buy the Generic manufacturers must work of medicines. The Project receives and
medicines they need from the quickly to avoid shortages and publishes daily reports about drug
private market with the promise of
stockouts, using information about stockouts from people living with HIV
reimbursement (which is usually not
current and pipeline ARVs, dose and health care workers, conducts
fulfilled), or go without medicine
optimisation, changes in treatment comprehensive national surveys to
altogether - which can lead to drug
guidelines and eligibility, national and monitor the locations and extent of
resistance and illness.
global targets for treatment scale-up, stockouts, and works with National
As countries upgrade their protocols and HIV epidemiology to anticipate and Provincial Departments of Health
to reflect WHO’s new ARV guidelines, the quantity of API and final product to identify and implement solutions.61
© Mariska Van den Brink
In South Africa, the Stop Stockouts Project – a consortium bringing together six civil society organisations – is pushing for more
accountability on stockouts of medicines that impact people’s access to regular treatment.
16 Médecins Sans Frontières | July 2016STOCKOUTS
MARKET SHAPING INSTITUTIONS – WHAT NEEDS TO HAPPEN
The Global Fund to Fight AIDS, the GFATM and other donors. to overcome any access barriers to
Tuberculosis and Malaria (GFATM), The GFATM may not be able to affordable medicines.
UNITAID and the Medicines Patent guarantee that these countries will
Recent GFATM correspondence
Pool have played a central role in be able to access the lowest prices
indicates that it may seek to optimise
the provision of affordable ARVs for new medicines, including those
tiered pricing policies from drug
around the world, including use of under patent, and it may even
companies, instead of overcoming
quality-assured generic drugs by the facilitate problematic tiered
commercial pricing strategies. The
GFATM, PEPFAR and other funders. pricing strategies used by drug
e-marketplace has been recently
companies in lieu of promoting
The GFATM’s market-shaping criticised by the GFATM’s Office of
robust generic competition.
actions go beyond its ability to the Inspector General for failing
provide treatment for millions of There are clear warning signs that to implement competitive bidding
people, and have an important the GFATM is unwilling or unable to processes for the first products
impact on worldwide ARV access. defend generic competition for the offered over the website.62
countries it supports. The GFATM
After years of contributing towards did not signal support for the LDC At best, if the e-marketplace can
collective efforts to reduce medicine extension, and has been silent overcome the challenges it is facing,
prices, the scope and remit of the about the Trans-Pacific Partnership it could provide minimal technical
GFATM is increasingly less ambitious trade agreement. It has not fixes as to how governments
and potentially counter-productive. explicitly supported the use of TRIPS purchase medicines, without
Progress has stalled, especially for flexibilities, although this principle dealing with the underlying barriers
middle-income countries, where has been endorsed since the GFATM that make them unaffordable in the
pharmaceutical companies seek started. Instead, the GFATM has been first place. At worst, prices offered
to charge high prices. Some of championing an ‘e-marketplace’ under the e-marketplace will be
these countries have a high disease (currently known as wambo.org) to insulated from the demands of
burden, limited ability to pay for make procurement more efficient. government and civil society if such
ARVs, and decreasing support from But the e-marketplace is not expected products remain unaffordable.
UPDATE ON THE MEDICINES PATENT POOL’S NEW LICENCES
The MPP voluntary licences The VL for tenofovir now includes Some MPP licences have been
(VLs) offer some countries the tenofovir alafenamide (TAF) and disappointing. AbbVie’s new MPP
opportunity to gain access to has an expanded geographic scope adult licence for LPV/r has a limited
affordable generic versions of new that allows generic producers from geographic scope and may force
ARVs, although many middle- South Africa and China to join. specific generics companies that sign
income and upper-middle-income The VL for elvitegravir (EVT) was the licence agreement to forego the
countries, such as China and Brazil, amended to include production in right to supply specific countries
continue to be left out of these VLs China and South Africa, provided that they currently have the right
and are therefore prevented from that products are made from to supply. Furthermore, a new MPP
buying the generic drugs produced Gilead-licenced producers of active licence with Bristol-Myers Squibb for
through manufacturers based in pharmaceutical ingredients (API). daclatasvir, a hepatitis C medicine,
their countries.
In March 2016, GlaxoSmithKline (with introduces a worrying precedent:
On one hand, the MPP has added ViiV) announced that it would increase it allows BMS to sign sub-licence
new VLs, and increased the the geographic scope of its voluntary agreements with generics companies
geographic scope or added new licensing agreements to include all together with the MPP (the normal
formulations to other licences. In lower-middle-income countries. The practice is to not allow branded
2014, the MPP announced a new MPP’s VL for DTG has been expanded companies to be involved in signing
agreement with AbbVie, for two to include Ukraine, Morocco, a sub-licence agreement). MSF
specific paediatric formulations Moldova, Armenia and 14 other is concerned that such a practice
of LPV/r covering 102 low- and low- and middle-income countries. could allow branded companies to
middle-income countries.63 influence the practices of generics
Although this is a welcome first step,
In late 2015, a separate agreement excluded upper-middle-income companies, including for unrelated
was signed between MPP and AbbVie countries will still be forced into tiered products, and undermine the
on the adult formulation of LPV/r pricing schemes, and price-lowering neutrality of the MPP in managing
which only covers African countries.64 competition will be prevented. the sub-licence agreements.
Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016 17CONCLUSION
CONCLUSION
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 over
2 million new infections.65
To accomplish this, governments Market-shaping institutions must All governments and donors must
must commit to scaling-up, keep their focus on securing and do their part to accelerate the global
optimising, and maintaining access to ensuring a sustainable supply of HIV response and meet the challenge
affordable generic ARVs in the long diagnostics and adult and paediatric of the 90-90-90 goals, including
run, as HIV is a disease that requires ARVs in low- and middle-income fully implementing the latest WHO
people to have constant access to a countries, and the pharmaceutical guidelines, putting in place effective
range of treatment options. This will industry should commit to registering policies at the national level, and
require governments to use TRIPS ARVs in all countries, and expanding ensuring all people living with HIV
flexibilities, reform patent laws, and the scope of their voluntary licensing have access to the most effective
reject harmful TRIPS-plus provisions agreements to include all low- and drugs, diagnostics, and models of care.
proposed in various FTA negotiations. middle-income countries.
© N’gadi Ikram
18 Médecins Sans Frontières | July 2016ANNEX: SUMMARY
ANNEX: SUMMARY TABLE OF ALL PRICES
TABLE OF ALL PRICES
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 paediatric
formulations 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 discount
from 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.
The 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 in Daily
Originator company Generic companies
alphabetical order dose
Abacavir (ABC) ViiV Aspen Aurobindo Cipla Hetero
20mg/ml oral 289 249 228 123
12 ml
solution (0.066) (0.057) (0.052) (0.028)
97
60mg tablet 4
(0.067)
BMS
Atazanavir (ATV) Aspen Cipla Emcure
Category 1 Category 2
countries countries
100mg capsule xx (0.267)
412 412 380 207
150mg capsule 2
(0.564) (0.564) (0.520) (0.283)
200mg capsule xx (0.677) (0.677) (0.670) (0.433)
170 219
300mg capsule 1
(0.467) (0.600)
Atazanavir/
Cipla Emcure Hetero
ritonavir (ATV/r)
213 213 219
300/100mg tablet 1
(0.583) (0.583) (0.600)
Darunavir (DRV) Janssen Aspen Hetero
75mg tablet xx (0.114)
150mg tablet xx (0.227)
438 973
400mg tablet 2
(0.600) (1.333)
663 658 1,217
600mg tablet 2
(0.908) (0.901) (1.667)
Merck
Quality Sun
Efavirenz (EFV) Aspen Aurobindo Cipla Emcure Hetero Macleods Microlabs Strides
Category 1 Category 2 Chemicals Pharma
countries countries
Case-by-
30mg/ml suspension xx (0.094)
case
50mg capsule xx (0.058) (0.057)
Case-by-
50mg tablet xx (0.114)
case
81 57
200mg capsule 3
(0.074) (0.052)
394 Case-by- 113
200mg tablet 3
(0.360) case (0.103)
237 Case-by- 84 37 20 47 45 38 35 70 38 38
600mg tablet 1
(0.650) case (0.231) (0.100) (0.055) (0.129) (0.123) (0.105) (0.095) (0.192) (0.105) (0.103)
Untangling the Web of ARV Price Reductions | msfaccess.org/utw2016 19You can also read
