400-500 case

Trade, Intellectual Property Rights and HIV/AIDS

Film, “Fire In the Blood” (59 min)
Case Study D (on the film, Fire in the Blood)

111

Redefining the Possible
The Global AIDS Response

l u k e m e s s a c , k r i s h n a P r a b h u

t h e g o l d e n a g e o f g l o b a l h e a lt h

No past effort to combat disease captures the promise of medicine and
global health like the worldwide response to AIDS. Medicine has been
termed the “youngest science”: the great tools of medicine— diagnos-
tics, preventatives, therapeutics— were late twentieth-century innova-
tions. Then came AIDS, and in the space of thirty years scientists iden-
tified the pathogen and developed the necessary tools to turn what
had been a death sentence into a manageable chronic disease. This is
modern medicine at its best. What’s more, there was an equity plan:
led by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR),
the Global Fund to Fight AIDS, Tuberculosis and Malaria, and the Bill
and Melinda Gates Foundation, great strides have been made to ensure
that the world’s poor have access to these fruits of modern medicine.
In November 2011, U.S. Secretary of State Hillary Clinton even spoke
of an “AIDS-free generation.”1 Will this audacious vision come to pass
in the next decade? How might global health practitioners and policy-
makers sustain and strengthen the progress made in the first decade of
the twenty-first century? In addressing these and other similar ques-
tions, this chapter explores some of the major forces underpinning the
golden age of global health.

The first years of this century saw an unprecedented rise in both pub-
lic attention and funding directed to global health. Health researcher

Farmer, P., Kleinman, A., Kim, J., & Basilico, M. (Eds.). (2013). Reimagining global health : An introduction. University of California Press.
Created from ucb on 2022-02-11 08:16:08.

C
o
p
y

ig
h
t
©

1
3
.
U

n
iv

e
rs

ity
o

f
C

a
lif

o
rn

ia
P

re
ss

.
A

ll
ri
g
h
ts

r
e
se

rv
e
d
.

112 | Chapter 5

Nirmala Ravishankar and colleagues estimate that development assis-
tance for health from public and private institutions rose from $8.65
billion in 1998 to $21.79 billion in 2007 (see figure 5.1).2 Between fiscal
years 2000 and 2006, the U.S. government increased funding for inter-
national AIDS prevention and treatment more than tenfold.3 Private
philanthropists also devoted greater sums to research and service pro-
grams. Burgeoning public activism around global health was evidence
of the growing recognition that epidemic scourges such as HIV and
malaria are treatable diseases. International institutions began new ini-
tiatives to galvanize and coordinate state and nonstate actors. The new
funding, transnational activism, and refashioned institutional archi-
tecture of health care delivery around the world triggered some of the
greatest advances toward global health equity in history.

At the turn of the twenty-first century, the U.S. government seemed
an unlikely champion of people living with AIDS in developing coun-
tries. A number of congressional leaders and the newly inaugurated

f i g u r e 5 .1 . Development assistance for health, from public and private institutions,
1990– 2007, by disease. Source: Nirmala Ravishankar, Paul Gubbins, Rebecca J.
Cooley, Katherine Leach-Kemon, Catherine M. Michaud, Dean T. Jamison, and
Christopher J. L. Murray, “Financing of Global Health: Tracking Development
Assistance for Health from 1990 to 2007,” Lancet 373, no. 9681 (2009): 2113– 2124.

20
06

20
05

20
04

20
03

20
02

20
01

20
00

19
99

19
98

19
97

19
96

19
95

19
94

19
93

19
92

19
91

19
90

20
07

D
ev

el
o

pm
en

t
A

ss
is

ta
nc

e
fo

r
H

ea
lth

in
2

00
7

U
S$

(
b

ill
io

ns
)

21.79

18.99

17.90

15.60

13.55

12.44

10.9010.69

9.80

8.658.42
8.108.017.76

6.61
6.11

5.475.59

Unallocable
Other
Health-sector support
Tuberculosis
Malaria
HIV/AIDS

Farmer, P., Kleinman, A., Kim, J., & Basilico, M. (Eds.). (2013). Reimagining global health : An introduction. University of California Press.
Created from ucb on 2022-02-11 08:16:08.

C
o
p
yr

ig
h
t
©

2
0
1
3
.
U

n
iv
e
rs
ity
o
f
C
a
lif
o
rn
ia
P
re
ss
.
A
ll
ri
g
h
ts
r
e
se
rv
e
d
.

Redefining the Possible | 113

president, George W. Bush, had a record of coolness toward foreign
aid.4 In the years following the 1994 “Republican revolution,” when
Republicans gained majorities in both houses of Congress, some con-
servatives decried foreign aid as wasteful. Senator Jesse Helms (R-N.C.),
chair of the Senate Committee on Foreign Relations from 1995 until
2001, boasted that he had “never voted for a foreign aid giveaway.”5
The prospects of global AIDS funding in particular appeared espe-
cially dim, as influential Christian conservative leaders had a history
of opposing federal funding for AIDS treatment and research even in
the United States during the 1980s and 1990s: “AIDS is God’s pun-
ishment” for homosexuality and promiscuity, proclaimed Reverend
Jerry Falwell in 1983.6 Given the skepticism about foreign aid in the
Republican Party, and the stigma and rhetoric of blame associated
with AIDS, few would have predicted that the U.S. government would
launch one of the largest and most successful global health programs
in history— the U.S. President’s Emergency Plan for AIDS Relief— dedi-
cating billions of dollars to combating AIDS around the world.

Nonetheless, it was during an era of Republican control over the
U.S. executive and legislative branches that federal appropriations for
international AIDS prevention, care, and treatment programs increased
from approximately $300 million in fiscal year 2000 to more than $3.4
billion by fiscal year 2006.7 This influx of funds dramatically increased
access to services in many developing countries affected by the pan-
demic. In 2000, the United States funded lifesaving antiretroviral
therapy (ART) for no more than a few hundred patients around the
world; by late September 2009, the U.S. State Department claimed that
PEPFAR supported (in whole or in part) treatment for some 2.5 million
people in twenty-four foreign nations8 and interventions for 509,800
HIV-positive pregnant women that allowed them to avert mother-to-
child HIV transmission.9 It is no exaggeration to credit PEPFAR with
preventing millions of deaths.10

Private foundations also helped to transform common conceptions
of the possible. Established in 1994, the Bill and Melinda Gates Foun-
dation has become the largest private funder of global health research
and implementation. By 2009, the Gates Foundation— its assets nearly
doubled by investor Warren Buffett— had disbursed over $10 billion for
global health.11 Funding priorities of the foundation’s Global Health
Program focus on discovery, delivery, and policy advocacy to fight and
prevent major global health problems, including enteric and diarrheal
diseases; HIV/AIDS; malaria; pneumonia; tuberculosis; neglected dis-

Farmer, P., Kleinman, A., Kim, J., & Basilico, M. (Eds.). (2013). Reimagining global health : An introduction. University of California Press.
Created from ucb on 2022-02-11 08:16:08.
C
o
p
yr
ig
h
t
©
2
0
1
3
.
U
n
iv
e
rs
ity
o
f
C
a
lif
o
rn
ia
P
re
ss
.
A
ll
ri
g
h
ts
r
e
se
rv
e
d
.

114 | Chapter 5

eases; family planning; nutrition; maternal, neonatal, and child health;
tobacco control; and vaccine-preventable diseases.

In addition, international institutions have played a critical role.
The Global Fund to Fight AIDS, Tuberculosis and Malaria— an inde-
pendent, multilateral organization established in 2002— receives pub-
lic and private donations, which it allocates to countries with coor-
dinated strategies for combating the three leading infectious killers
on the planet. As of December 2011, the Global Fund had approved
US$22.6 billion for more than a thousand grants in 150 countries.12
Beginning in 1996, the World Bank and the International Monetary
Fund began offering debt relief to heavily indebted poor countries,
writing off more than $76 billion in debt by 2011 and thereby increas-
ing the resources available for public health in the government budgets
of poor countries.13

New international health policy initiatives have also served as cat-
alysts for this unprecedented increase in funding for HIV/AIDS treat-
ment in developing countries. One such effort, the “3 by 5” initiative
launched by the World Health Organization (WHO) and the Joint
United Nations Programme on HIV/AIDS (UNAIDS) in 2003, set a
goal of extending antiretroviral treatment to 3 million people living
with AIDS in low- and middle-income countries by the end of 2005.
By setting an ambitious treatment target, the WHO leveraged its
unique position as the principal standard-setting body in global health
to reimagine worldwide access to antiretroviral treatment. This ini-
tiative was not without its detractors. Many remained unconvinced
that ART could be delivered effectively and at large scale in develop-
ing countries; at the end of 2003, only one hundred thousand people—
2 percent of those in need— were receiving treatment in sub-Saharan
Africa.14 Nonetheless, this clear target helped to coalesce a diverse set
of actors— multilateral and bilateral donors, health practitioners, inter-
national policymakers, governments of AIDS-afflicted countries, AIDS
patients and their advocates throughout the world— around further
ART scale-up initiatives. By measuring success according to the num-
ber of people being treated rather than the amount of money donated,
the 3 by 5 campaign also encouraged accountability among donors. By
the end of 2005, the number of people receiving antiretroviral therapy
in sub-Saharan Africa had increased eightfold, covering 17 percent of
those in need.15 Although the treatment target was reached in 2007,
not 2005, the 3 by 5 initiative helped galvanize the global AIDS effort.

Redefining the Possible | 115

The WHO’s early leadership set an example that would give direction
to many subsequent initiatives. By the end of 2011, UNAIDS estimated
that nearly 6.6 million people were receiving antiretroviral therapy.16

As Ravishankar and colleagues noted in The Lancet in June 2009,
the increase in development assistance for health during the 1990s—
from $5.6 billion in 1990 to $9.8 billion in 1999— pales in compari-
son to the rise during the 2000s: $21.8 billion was disbursed for global
health programs in 2007.17 What factors led to this surge in available
resources? Why did AIDS— a chronic disease that demands a more
expensive and complex treatment regimen than that for many leading
causes of death and disability around the world— spark this surge, at
least in part? Accounting for the golden age of global health demands
biosocial analysis that is geographically deep and historically broad.

How did this bold vision of global health equity enter the public
imagination? How did the conception of the possible shift so dramati-
cally in the space of a decade? One way to answer this question draws
on the concept of institutionalization, as explained by sociologists
Peter Berger and Thomas Luckmann (see chapter 2). Before the 2000s,
low expectations (and paltry resources) for international health were
the norm. Over time, policymakers, donors, and health professionals
had all become socialized for scarcity: they focused on optimizing use
of a tiny resource pie instead of also reimagining and seeking to expand
the size of that pie. Health providers in poor countries became accus-
tomed to targeting the “low-hanging fruit” of public health— vaccines,
handwashing, bed nets, condoms, the GOBI interventions (discussed
in chapter 4), to name a few examples— just as donors became accus-
tomed to disbursing modest sums for global health programs. The high
prices of lifesaving interventions, including antiretroviral therapy and
second-line TB treatment, were accepted as fixed. In other words, con-
straint was institutionalized as the status quo in global health.

This had far-reaching effects on what the “stakeholders” in global
health, including poor people in need of basic medical care, considered
possible. “Habitualization carries with it the important psychological
gain that choices are narrowed,” write Berger and Luckmann.18 For
many years, the only approach deemed possible in global health was
harvesting the low-hanging fruit. But high drug costs, paltry funding,
and low expectations were constructs— institutionalized habits— vul-
nerable to large-scale social change. In the next decade, the bar would
be raised.

116 | Chapter 5

f r o m d e at h s e n t e n c e t o c h r o n i c c o n d i t i o n :
a i d s i n t h e t i m e o f a n t i r e t r o v i r a l t h e r a P y

During the 1980s and into the early 1990s, an HIV diagnosis was a
guarantee of early death. In the first years of the pandemic, physi-
cians in both rich and poor settings lacked therapeutic tools capable
of suppressing the virus and preventing the onset of clinical symptoms.
The best they could do was treat opportunistic infections associated
with HIV, such as pneumonia and herpes. Azidothymidine (AZT), the
first drug found to safely and effectively slow replication of HIV in
the body, won approval from the U.S. Food and Drug Administration
(FDA) for use against AIDS in 1987.19 Until the introduction of didan-
osine in 1991, AZT monotherapy was the only treatment option— and
it was accessible only to patients who could afford its $8,000 annual
cost.20 Although AZT suppressed the virus for a time, HIV replica-
tion remained high enough that AZT-resistant strains soon emerged.21
Without therapy capable of stopping the progression from HIV infec-
tion to full-blown AIDS, mortality rates from the disease increased
steadily in the United States between 1987 and 1995.22

Meanwhile, AIDS was taking an even greater toll in the develop-
ing world. But addressing AIDS on a global scale did not figure high
on the agenda of most policymakers and activists in rich countries.
In The Invisible People, a chronicle of the history of the AIDS pan-
demic from the 1980s to the early 2000s, Greg Behrman notes that
few AIDS activists in the United States understood the magnitude of
the international pandemic; even fewer were willing to expand their
campaigns beyond U.S. borders.23 While thousands formed human
blockades in New York City and protested outside federal buildings
in Washington, D.C., calling for increased access to AZT monother-
apy, greater appropriations for research, more rapid FDA approval of
new therapies, nondiscrimination in the workplace, subsidized hous-
ing, condom distribution, and other measures in care, prevention, and
treatment, only a few concurrently demanded similar interventions for
at-risk populations and people living with AIDS in developing coun-
tries.24 According to Eric Sawyer, co-founder of the activist group
AIDS Coalition to Unleash Power (ACT UP), as late as the mid-1990s
only 10 percent of the domestic activist community paid attention to
the global pandemic.25

The year 1996 marked a turning point in the search for effective
therapeutics against AIDS. In 1995, the FDA had approved saquina-

Redefining the Possible | 117

vir, the first in a new class of antiretrovirals called protease inhibitors.
In 1996, nevirapine, the first in another class of antiretrovirals known
as non-nucleoside reverse transcriptase inhibitors (NNRTIs), received
FDA approval. Later that year, the Eleventh International Confer-
ence on AIDS affirmed the promise of these new therapeutics. At that
meeting, held in Vancouver, David Ho, scientific director and CEO of
the Aaron Diamond AIDS Research Center in New York, announced
study results demonstrating that regimens containing three antiretro-
viral drugs from at least two different classes of antiretrovirals— regi-
mens that came to be known as Highly Active Antiretroviral Therapy,
or HAART— suppressed the virus and restored patients’ immune sys-
tems for sustained periods.26

Evidence of the effectiveness of HAART continued to mount in sci-
entific studies published in the subsequent months.27 For those who
could access the drugs, it began to seem possible that AIDS would be –
come a manageable chronic disease rather than a certain killer. Accord-
ing to the U.S. Centers for Disease Control and Prevention (CDC),
age-adjusted mortality from AIDS-related causes in the United States
declined 28 percent between 1995 and 1996, 46 percent between 1996
and 1997, and 18 percent between 1997 and 1998.28 By 1998, fewer

f i g u r e 5 . 2 . Deaths from HIV/AIDS in the United States, 1987– 2008. (Estimates
based on the age distribution of the U.S. population in 2000.) Source: Centers for
Disease Control and Prevention, HIV Mortality: Trends (1987– 2008), “Slide 5: Trends in
Annual Age-Adjusted Rate of Death Due to HIV Disease: United States, 1987– 2008,”
www.cdc.gov/hiv/pdf/statistics_surveillance_statistics_slides_HIV_mortality .
Courtesy Centers for Disease Control and Prevention.

2005200019951990 2008

D
ea

th
s

(p
er

1
00

,0
00

p
o

pu
la

tio
n)

1987
0

2
4
6
8
10
12
14
16
18
Farmer, P., Kleinman, A., Kim, J., & Basilico, M. (Eds.). (2013). Reimagining global health : An introduction. University of California Press.
Created from ucb on 2022-02-11 08:16:08.
C
o
p
yr
ig
h
t
©
2
0
1
3
.
U
n
iv
e
rs
ity
o
f
C
a
lif
o
rn
ia
P
re
ss
.
A
ll
ri
g
h
ts
r
e
se
rv
e
d
.

118 | Chapter 5

people in the United States were dying of AIDS-related causes than had
been the case in 1991 (see figure 5.2).

o n e w o r l d , o n e h o P e ? d i f f e r e n t i n c o m e s ,

d i f f e r e n t o u t c o m e s

The theme of the Vancouver Conference was “One World, One Hope.”
Yet even with the reported promise of HAART, not all attendees were
flush with optimism. Initially, pharmaceutical companies set prices
for antiretroviral treatment with a three-drug cocktail at $10,000 to
$15,000 per patient per year— far out of reach for most people liv-
ing with AIDS in developing countries. Speaking at the Vancouver
Conference, Eric Sawyer argued that “drug companies should consider
developing a two-tier pricing system. . . . AIDS treatments must also
be made available to the poor everywhere, at cost or at very minimal
levels of profit.”29

The discovery of effective drug therapy inspired some American
AIDS activists to join with advocacy groups in the developing world.30
But as therapeutic advances and improved public services for affected
individuals made HIV infection less of a mortal crisis for many erst-
while advocates, the activist movement in the developed world dwin-
dled in numbers and militancy. At its peak in 1992, ACT UP had thou-
sands of active members spread across seventy chapters in the United
States and Europe. But by the late 1990s, many of these chapters had
folded, and even the largest surviving chapters— New York City,
Philadelphia, San Francisco, and Washington, D.C.— counted far fewer
members at weekly meetings.31

Meanwhile, prominent voices in international public health and
development circles were arguing against treating AIDS in poor coun-
tries. In 2002, two articles in The Lancet, a highly regarded medi-
cal journal, posited that HAART was not cost-effective in poor coun-
tries. Elliot Marseille and colleagues concluded that “data on the
cost- effectiveness of HIV prevention in sub-Saharan Africa and on
highly active antiretroviral therapy indicate that prevention is at least
28 times more cost effective than HAART.”32 Andrew Creese and col-
leagues reached a similar conclusion: “The most cost-effective inter-
ventions are for prevention of HIV/AIDS and treatment of tubercu-
losis, while HAART for adults, and home based care organized from
health facilities, are the least cost-effective.”33 In both articles, preven-
tion and treatment were deemed mutually exclusive activities; assum-

Redefining the Possible | 119

ing scarce resources for health care delivery in poor countries, invest-
ing in AIDS treatment instead of prevention would, by these accounts,
cost lives. Such claims were echoed among foreign aid officials. “If
we used antiviral drugs in treatment regimens similar to those used
in the U.S.,” argued the chief of the HIV/AIDS division in the U.S.
Agency for International Development (USAID) in 1998, “it would cost
approximately $35 billion per year to treat those infected in the devel-
oping world. We are talking about medical regimens that cost $5,000
to $10,000 a year and require sophisticated health provider and labo-
ratory infrastructure. . . . How can we get involved in care in the face
of such staggering statistics?”34

Others argued that HAART was too complex to deliver in resource-
poor settings. In testimony before the House of Representatives Com-
mittee on International Relations in June 2001, Andrew Natsios, head
of USAID, said, in reference to UN Secretary-General Kofi Annan’s
proposed budget for a possible global fund:

The biggest problem, if you look at Kofi Annan’s budget, half the budget is
for antiretrovirals. If we had them today, we could not distribute them. We
could not administer the program because we do not have the doctors, we
do not have the roads, we do not have the cold chain. This sounds small and
some people, if you have traveled to rural Africa you know this, this is not
a criticism, just a different world. People do not know what watches and
clocks are. They do not use Western means for telling time.35

Natsios’s claim about watches and “Western means for telling time”
cast aspersions on Africans’ ability to adhere to treatment regimens.
Antiretroviral therapy demands strict, lifelong adherence; missing
even a few doses per month increases the risk that resistant strains will
develop, rendering first-line treatment ineffective. Second- and third-
line regimens for resistant strains are expensive. Confident that such
treatments could not be effectively delivered, Natsios argued against the
comprehensive and recalibrated response to the pandemic advocated
by Kofi Annan and others. Natsios and many public health “experts”
instead promoted prevention and palliation, even as the fatality rates of
these diseases dropped in affluent parts of the world. Lack of access to
treatment in the face of explosive epidemics remained the norm across
the developing world.36

As such immodest claims— reflecting a restrictive conception of
the possible— were aired in policy circles and the media, evidence was
mounting about the feasibility (and effectiveness) of treating AIDS
in resource-poor settings. In 2001, the Bulletin of the World Health

120 | Chapter 5

Organization published the results of a Partners In Health study that
followed 150 patients receiving HAART in Haiti’s rural Central Pla-
teau. While Natsios had argued that patients in such settings would
not adhere to therapy, this study found adherence rates above those
documented in many parts of the United States.37 Another study that
followed 288 adults receiving HAART beginning in 2001 in a commu-
nity-based program operated by Médecins Sans Frontières (Doctors
Without Borders) in Khayelitsha township— a poor urban neighbor-
hood outside Cape Town, South Africa— found immune restoration,
viral load suppression, and high adherence rates in the vast majority
of the patient cohort.38 Furthermore, these studies challenged the pre-
sumed dichotomy between prevention and treatment. When HAART
became available, more people began seeking voluntary counseling and
testing— a pillar of HIV prevention. In other words, the possibility of
receiving treatment functioned as an incentive for people to learn their
status. The findings of these studies contradicted immodest claims
about adherence and about the supposed conflict between treatment
and prevention.

Armed with examples of successful HAART delivery in impover-
ished settings, a small coalition of health providers, policymakers,
activists, and academics in rich and poor countries decried the lack of
access to HAART globally. In 2001, 133 Harvard University faculty
members signed a “Consensus Statement on Antiretroviral Treatment
for AIDS in Poor Countries,” declaring that “the objections to HIV
treatment in low-income countries are not persuasive and . . . there are
compelling arguments in favor of a widespread treatment effort.”39 This
statement helped policymakers reimagine the possible in global health:
if delivering HAART— chronic care for a chronic disease— was feasible
in Haiti and South Africa, why not scale it up around the world? Why
not use HAART to usher in a more ambitious agenda of health system
strengthening globally?

The Harvard consensus statement noted two principal barri-
ers to expanding access to HAART: the high price of antiretrovirals
and insufficient funding for implementation. These hurdles were well
known to AIDS activists. U.S. AIDS advocacy organizations such as
ACT UP Philadelphia were, by the early 2000s, made up mostly of low-
income, HIV-positive African American individuals who had personal
experience with a health system that divided patients according to their
ability to pay for lifesaving medications— what they termed “medical
apartheid.”40 These groups had led struggles to expand access to anti-

Redefining the Possible | 121

retroviral drugs, including a successful campaign to get Pennsylvania
Medicaid— government insurance for the poor— to cover antiretroviral
drug costs. Realizing the links between their own campaigns for access
and the growing treatment gap between the rich and poor worlds,
these groups established transnational alliances with AIDS activists in
developing countries.41 For example, the Health Global Action Proj-
ect (Health GAP) and ACT UP joined forces with a South African civil
society group, made up largely of poor people living with HIV/AIDS,
called the Treatment Action Campaign (see figure 5.3). Together, these
organizations led a worldwide campaign to lower the costs of antiret-
roviral drugs in poor countries.

u n Pa c k i n g t h e “ c o s t ” o f a i d s t r e at m e n t:

i n t e l l e c t u a l P r o P e r t y a n d c i v i l s o c i e t y

Intellectual property rights lay at the heart of the first transnational
battle for expanded access to antiretrovirals. In the mid-1990s, pub-
lic laboratories and privately owned companies in Brazil began pro-
ducing generic versions of patented ARV (antiretroviral) medications;
Brazil also imported generic antiretrovirals from suppliers in India.

f i g u r e 5 . 3 . A demonstration organized by the Treatment Action Campaign at the
2000 International AIDS Conference in Durban, South Africa. Courtesy Gideon
Mendel/CORBIS.

122 | Chapter 5

These actions precipitated a 70 percent drop in Brazil’s domestic price
of HAART by 2001.42 Some countries attempted to emulate Brazil’s
strategy by passing legislation that permitted generic production of cer-
tain patented drug formulations.43 In late 1997, South Africa’s parlia-
ment approved the Medicines Act, which stipulated that in the case of
a national health emergency, the government could allow both compul-
sory licensing (generic production of patented antiretroviral medicines
without the permission of the patent holder, who would, however, be
paid an appropriate royalty) and parallel importation (importation of
these drugs from countries where they are sold at lower prices). These
measures aimed to lower prices for antiretroviral therapy in South
Africa, where, in 2000, only an estimated 1 percent of the half million
South Africans in need of antiretrovirals received them.44

Thirty-nine pharmaceutical companies, alarmed by the prospect of
losing the exclusive rights guaranteed by their patents, filed suit in South
African courts in 1998 to overturn the Medicines Act. These compa-
nies argued that the legislation undermined the notion of intellectual
property, thereby weakening incentives for innovation and decreasing
funds for pharmaceutical research and development. Advocates of the
law, including AIDS activists in the United States and South Africa,
pointed out that brand-name pharmaceutical companies in the United
States derived only 5 to 7 percent of their profits from low- and middle-
income countries.45 They argued further that branded antiretroviral
prices far exceeded outlays for production, research, and development,
contending that companies set ARV prices high to increase profits at
the margins.

Initially, the Clinton administration sided with the pharmaceutical
companies. Vice President Al Gore, who served with Deputy Prime
Minister Thabo Mbeki of South Africa as co-chairs of a bilateral com-
mission to promote democracy in South Africa, used the forum to
express the U.S. government’s opposition to the Medicines Act. When
President Nelson Mandela and the South African legislature remained
unmoved, Charlene Barshefsky, President Clinton’s U.S. trade repre-
sentative, placed South Africa on a “priority watch list”— a diplomatic
precursor to trade sanctions— in March 1999, citing the Medicines Act
as South Africa’s major transgression. In Barshefsky’s words, the pas-
sage of the Medicines Act merited this response because it could “abro-
gate patent rights.”46

American AIDS activists and members of the Congressional Black
Caucus called on the Clinton administration to stop pressuring South

Redefining the Possible | 123

Africa to repeal the Medicines Act. Members of what would become
Health GAP targeted Gore’s presidential campaign rallies (see figure
5.4). As he announced his candidacy on June 16, 1999, in a carefully
choreographed event in Carthage, Tennessee, activists interrupted
his speech with whistles, banners, and chants of “Gore’s greed kills!
AIDS drugs for Africa!”47 In the ensuing days, similarly disruptive pro-
tests took place at other campaign events, lending the bilateral dispute
prominence in the U.S. press.

Soon after these protests, the political winds shifted decidedly
against the pharmaceutical lobby. In September 1999, just three months
after the Carthage demonstration, Barshefsky announced the Clinton
administration’s support for the Medicines Act. In December, Clinton
announced that the United States would not pressure any sub- Saharan
African country into purchasing brand-name AIDS drugs and would
support parallel importation or generic production as a means to
lower prices.48

By April 2001, all thirty-nine pharmaceutical companies had with-
drawn their lawsuits.49 Later that year, the Doha Declaration, adopted

f i g u r e 5 . 4 . Activists interrupted the first three events of Vice President Al Gore’s
presidential campaign in 1999, before the 2000 election. Within a year, President Bill
Clinton issued an executive order meeting the activists’ demands that the United
States not interfere with South Africa’s generic licensing policies for lifesaving
medications. Courtesy Luke Frazza/AFP/Getty Images.

124 | Chapter 5

university students and access to medicines:
yale and d4t

Although deprived of political support after President Clinton pub-
licly backed South Africa’s Medicines Act in 1999, the thirty-nine
pharmaceutical companies continued to sue the South African gov-
ernment in an effort to overturn the Medicines Act and retain their
exclusive patents. In opposition, Amy Kapczynski, a first-year Yale
University law student who had recently returned from the Durban
International AIDS Conference, helped launch a campaign to improve
treatment access by leveraging Yale’s intellectual property rights.1

In the mid-1980s, a team of researchers led by Yale’s William
Prusoff had detected the potency of d4t, an antiretroviral also known
as stavudine, against HIV; and Yale secured a patent for the dis-
covery. In 1988, Yale issued an exclusive license to Bristol-Meyers
Squibb (BMS) to produce and sell d4t. By 1999, this license alone
accounted for approximately $40 million of the $46.12 million that
the university collected in royalties. As it became a mainstay in first-
line HAART regimens, d4t garnered $578 million in sales for BMS
in 2000. In 2001, d4t (sold by BMS under the brand name Zerit) cost
nearly $1,600 per patient per year in South Africa, a nation with a per
capita GDP of approximately $3,000. BMS, one of the parties to the
suit challenging South Africa’s Medicines Act, was strongly opposed
to generic production or importation of d4t in South Africa.2

In 2001, Amy Kapczynski and her classmates, working along-
side Médecins Sans Frontières (MSF), demanded that Yale renegoti-
ate its license for d4t with BMS and that the university “issue a vol-
untary license to allow the importation and use of generic stavudine
in South Africa.”3 Yale initially denied this request, explaining that it
had granted exclusive rights to the company and that only BMS could
renegotiate the license.4 MSF responded that Yale should breach its
contract to ensure that d4t could reach poor patients unable to afford
Zerit’s high price. The students protested and gathered petition signa-
tures (drawing media attention in the process) and convinced Prusoff
to pen a New York Times op-ed arguing that “d4t should be either
cheap or free in sub-Saharan Africa.”5 Within one month of MSF’s
original request, Yale and BMS announced that they would permit
the sale of generic d4t in South Africa.6 In June 2001, BMS signed an
“agreement not to sue” with Aspen Pharmacare, a generic manufac-
turer in South Africa. The price of d4t in South Africa subsequently
dropped by 96 percent.7

Redefining the Possible | 125

at a ministerial meeting of the World Trade Organization (WTO), re –
affirmed that the 1995 international agreement on intellectual prop-
erty protections, known as TRIPs, “does not and should not prevent
Members from taking measures to protect public health.” The agree-
ment recognized the right of each WTO member “to grant compul-
sory licenses and the freedom to determine the grounds upon which
such licenses are granted.”50 In other words, the world’s most power-
ful states had agreed, for the moment at least, that access to medicines
could, in certain instances, trump patent protections.

This nascent international political and legal consensus opened the
door to generic production of patented HIV drugs for poor countries.
Realizing this opportunity, the William J. Clinton Foundation— estab-
lished in 2001 after President Clinton left the White House— and other
institutions sought rapid reductions in treatment costs. Beginning in
2002, the Clinton Foundation’s HIV/AIDS Initiative worked to gen-
erate demand, securing agreements from the governments of develop-
ing countries to place large orders of generic antiretrovirals at specified
prices. Generic producers in India and South Africa, in turn, agreed to
alter their business models, producing higher volumes and improving
production processes to lower unit costs, while seeking smaller mar-

f i g u r e 5 . 5 . Prices of first-line HIV/AIDS drug regimens, branded versus generic,
2002. Sources: Internal Partners In Health data and Médecins Sans Frontières.

U
S$

p
er

P
at

ie
nt

p
er

Y
ea

Average Wholesale
Prices in the United States

(branded drugs)

International Development Association
Prices for Developing Countries

(generic drugs)

10,000

8,000

6,000

4,000

2,000

12,000

Drug regimens

d4t, 3TC, NVP

AZT, 3TC, NVP

10,220

412300

10,622

126 | Chapter 5

gins per pill sold. By harnessing newfound economies of scale, generic
producers of antiretrovirals realized higher profits (after suffering some
anticipated losses in the short term), while purchasers secured substan-
tial price reductions.51 The lowest available annual per-patient price of
the most common first-line HAART regimen in the developing world
fell from $10,000– $15,000 in the late 1990s to $300 in 2002 and to
$87 in 2007. Figure 5.5 contrasts the 2002 costs of branded drugs in the
United States with the costs of generic drugs in developing countries.52

This precipitous decrease in drug prices created new opportuni-
ties to scale up AIDS treatment programs globally. Yet another hurdle
remained— the lack of dedicated funding for implementation in poor
countries.

s t r a n g e b e d f e l l o w s i n t h e f i g h t f o r f u n d i n g

With growing consensus that antiretroviral therapy could be delivered
effectively and affordably in resource-poor settings, advocates contin-
ued calling for increased funding for global AIDS treatment programs.
The World Health Organization’s Commission on Macroeconomics
and Health, chaired by economist Jeffrey Sachs, published a report in
2001 providing evidence that improved health outcomes could boost
economic growth. (The economic effects of health programs are diffi-
cult to capture in metrics used to formulate development policy.) The
report also suggested that donor dollars had an important role to play
in fostering the virtuous cycle of growth and health improvements in
poor countries.53

Earlier that year, Sachs and Harvard colleague Amir Attaran had
published an article in The Lancet proposing a practical application
of these findings: a new funding stream dedicated to controlling the
world’s greatest infectious killers. Funded by increased foreign aid com-
mitments from rich nations, this new body would use a competitive and
transparent process to distribute grants, rather than loans, to health
projects in developing countries. Grants would be “directed toward
funding projects which are proposed and desired by the affected coun-
tries themselves, and which are judged as having epidemiological merit
against the pandemic by a panel of independent scientific experts.”54
UN Secretary-General Kofi Annan vocally endorsed the plan, and lead-
ers of the developed world launched the Global Fund to Fight AIDS,
Tuberculosis and Malaria at the G8 Summit in Genoa, Italy, in 2001.
In 2002, the fund made its first disbursements.55

Redefining the Possible | 127

In rich countries, the political capital of global health increased rap-
idly in the early 2000s. In 2001, students at Harvard’s undergradu-
ate campus and the Kennedy School of Government jointly founded
the Student Global AIDS Campaign, an advocacy group that by 2004
boasted more than eighty chapters at colleges and universities across
the country.56 A number of global AIDS advocacy organizations soon
established a presence in Washington, including the Health Global
Access Project (June 1999), the Global AIDS Alliance (March 2001),
Prescription for Hope (2002), and DATA (Debt, AIDS, Trade, Africa)
(2002). Once established, the AIDS lobby— made up of conservative
evangelical Christians, college students, gay rights activists, African
Americans, and people living with AIDS— began exerting significant
pressure on the federal appropriations process.

The AIDS movement also drew considerable support from opin-
ion leaders and celebrities. Franklin Graham, founder of the Chris-
tian charity Samaritan’s Purse and son of the renowned evangelist Billy
Graham, helped convince Senator Jesse Helms that AIDS afflicted the
“blameless” just as often as it afflicted homosexuals, whom Helms
judged to be immoral.57 Helms, chair of the Senate Committee on For-
eign Relations, noted that Graham was the first to explain to him the
toll taken on “innocent victims of this sexually transmitted disease”—
the millions of children who had either contracted the infection from
their mothers or been orphaned by the death of a parent.58 Bono, lead
singer of the Irish rock band U2, who had already played a key role in
the Jubilee 2000 campaign advocating debt forgiveness for poor coun-
tries, emerged as a champion of worldwide AIDS efforts. In a meeting
with Helms, he pointed out that the Bible mentions poverty in 2,103
verses, while it mentions sexual behavior in only a few.59 Helms would
repeat this observation in a press conference, and soon thereafter he
would publicly apologize for not supporting AIDS care and treatment
efforts in the past.60 In late 2001, Helms joined his colleague William
Frist (R-Tenn.) in sponsoring a $500 million initiative— which came to
be known as the Helms Legacy Amendment— to prevent mother-to-
child transmission of HIV in poor countries.

The most important convert was, in some ways, the least likely:
President George W. Bush. During Bush’s tenure as governor of Texas,
his senior health advisor had observed that “the one thing Bush is really
uncomfortable dealing with is AIDS” because of supposed links (much-
discussed in conservative media) between the disease, homosexuality,
and promiscuity.61 During his 2000 presidential campaign, Bush told

128 | Chapter 5

journalist Jim Lehrer that Africa “doesn’t fit into the national strategic
interests” of the United States and would therefore not figure promi-
nently in his foreign policy agenda.62

But in January 2003, Bush reinvented himself as one of the great
champions of global AIDS relief. During his State of the Union Address
that year (see figure 5.6), he proposed a sweeping new international
AIDS initiative:

AIDS can be prevented. Antiretroviral drugs can extend life for many
years. . . . Seldom has history offered a greater opportunity to do so much
for so many. . . . To meet a severe and urgent crisis abroad, tonight I pro-
pose the Emergency Plan for AIDS Relief— a work of mercy beyond all cur-
rent international efforts to help the people of Africa. . . . I ask the Congress
to commit $15 billion over the next five years, including nearly $10 billion
in new money, to turn the tide against AIDS in the most afflicted nations of
Africa and the Caribbean.63

No one in Congress— Democrat or Republican— had formally pro-
posed $3 billion in annual spending on global AIDS programs. Prodded
by Bush’s powerful proposal, both houses of Congress passed legisla-

f i g u r e 5 . 6 . Ugandan physician and AIDS expert Peter Mugyenyi attends President
George W. Bush’s 2003 State of the Union address as a special guest of First Lady
Laura Bush. Dr. Mugyenyi’s efforts to provide AIDS treatment and prevention
services at the Joint Clinical Research Centre in Uganda helped convince President
Bush to launch PEPFAR. Courtesy George W. Bush Presidential Library.

Redefining the Possible | 129

tion in May 2003 authorizing the five-year $15 billion U.S. President’s
Emergency Plan for AIDS Relief.64

Spurred by the same forces— lower drug prices, growing evidence of
treatment efficacy in resource-poor settings, grassroots activism, and
advocacy by elites— other rich nations also increased their allocations
to global AIDS programs. At the G8 summit in Gleneagles, Scotland,
in 2005, leaders of rich countries pledged to double aid to Africa and to
ensure “as close as possible to universal access to treatment for AIDS”
by 2010.65 UNAIDS reported that disbursements by the G8 and the

the Politics of global aids funding in
the american heartland

The nascent global AIDS lobby proved its clout in 2004, convinc-
ing a congressional committee chair to reverse a budgetary deci-
sion that could have decreased U.S. AIDS appropriations. In April
2004, as the House considered the fiscal year 2005 budget resolu-
tion, Representative Jim Nussle (R-Ind.), then chair of the House
Budget Committee, proposed $3.6 billion less for the international
affairs account than had been proposed by either the Senate Budget
Committee or the president’s budget.1 Because the majority of global
AIDS spending came from that account, AIDS activists worried that
Nussle’s proposal would lower the U.S. contribution to treatment
and prevention programs abroad. In response, Student Global AIDS
Campaign members at Luther College— Nussle’s alma mater— peti-
tioned the college president to revoke Nussle’s forthcoming public
service award and staged a protest at one of his town hall events.
Meanwhile, advocacy groups such as DATA and the Global AIDS
Alliance convinced sympathetic religious leaders in Nussle’s district
to express public disapproval of this funding shortfall. Lutheran
bishop Phillip Hougen, one such leader, emphasized his congrega-
tion’s ties to Tanzania, telling a reporter from Roll Call: “Iowans are
somewhat more globally aware than people give them credit for.”2

Faced with a surge of political pressure during an election year,
Nussle relented.3 In late May, he announced that he would request
an additional $2.8 billion for the international affairs account when
the budget resolution was negotiated in conference committee. Nussle
spokesperson Sean Spicer acknowledged the influence of constituent
activists: “He wanted to make sure they understood that he truly was
supportive” of AIDS funding.4 Global AIDS once again proved to be a
political issue that could unite people across the ideological spectrum.

130 | Chapter 5

European Community for HIV/AIDS prevention, care, and treatment
programs in the developing world rose from $1.2 billion in 2002 to $7.6
billion in 2009, though this figure fell to $6.9 billion in 2010. Leading
public donors to global AIDS programs in 2010 were the United States
($3.7 billion), the United Kingdom ($0.9 billion), and the Netherlands,
Germany, and France (each about $0.4 billion).66

In some cases, AIDS funding increases proved to be a beachhead
for new resources for other global health priorities. For instance, the
WHO estimates that international funding disbursements for malaria
increased from $249 million in 2004 to $1.25 billion in 2008.67 The
second five-year iteration of PEPFAR, authorized by the U.S. govern-
ment in mid-2008, established new goals to strengthen health infra-
structure— recruiting and training (and retaining) 140,000 health care
professionals and paraprofessionals in partner countries by 2013, for
example— in addition to expanding AIDS treatment and prevention
services.68

a f t e r t h e g o l d e n a g e

The first decade of the twenty-first century raised the bar in global
health. The failures of imagination that had long been the status quo
fell prey to evidence of effective health care delivery in resource-poor
settings matched with bold visions of global health equity. Although
some public health “experts” had declared lifesaving interventions such
as antiretroviral treatment too complex or too expensive for resource-
poor settings, pioneering programs proved otherwise. The costs of
numerous preventatives, therapeutics, and diagnostics decreased sig-
nificantly after transnational activism and innovative market coordi-
nation opened the door to generic production as well as new strategies
for financing and procurement. Funding for global health increased
to unprecedented levels; long socialized for scarcity, health practi-
tioners and policymakers around the world were able to reimagine
global health equity. By 2010, drug prices were lower and international
funding levels were higher than almost anyone had thought possible a
decade earlier.

Yet it is still a long road to “health for all.” Although getting 6.6 mil-
lion people on antiretroviral treatment is a feat that affirms the promise
of global health and modern medicine, such progress must be sustained
and expanded. Millions more are in need of antiretroviral treatment

Redefining the Possible | 131

around the world. In the wake of the worldwide economic downturn
in 2008, many countries, including the United States, faltered on their
foreign aid pledges.69 Across the developing world, hospitals and clin-
ics have had to turn away new AIDS patients.

This slowdown was especially poignant because it came on the
heels of breakthrough evidence about AIDS treatment and preven-
tion. In May 2011, a study funded by the National Institutes of
Health found that antiretroviral treatment reduces the rate of trans-
mission by 96 percent.70 Put another way, treatment is prevention.
For the first time in three decades, it became possible to imagine the
“end of AIDS.” Redoubled commitment to HIV-control initiatives
around the world could slow (or even stop) the pandemic. Such an
effort would demand not only increased funding but also better use
of the dollars available. Much of PEPFAR’s funding is distributed to
contractors, including universities and NGOs, which are tasked with
implementing PEPFAR programs. In 2008, journalist Laurie Garrett
reported that although PEPFAR did not provide details on contractor
“overhead” rates—that is, the percentage of funding going toward
expenses such as NGO salaries and office expenses rather than treat-
ment, prevention, and education—reports indicated that rates of 30
to 60 percent were the norm.71 If fewer dollars were siphoned off en
route to poor patients, many more would have access to life-saving
treatment.

Beyond AIDS, the golden age of global health ushered in signifi-
cant advances against other leading causes of suffering and premature
death around the world. Some health providers learned to use “verti-
cal” AIDS programs to simultaneously provide “horizontal” primary
health care services and strengthen health systems. Delivering services
for complex chronic conditions like AIDS requires a full-time salaried
staff; modern facilities; trained community health workers, supported
by stipends; and a robust referral network. It can therefore have pow-
erful spillover effects on other health priorities. Health practitioners,
including community health workers, who are focusing on HIV con-
trol can be trained to simultaneously address other pathologies of pov-
erty: HIV patients infected with tuberculosis, children with pneumo-
nia or diarrheal disease, families without sufficient food or access to
clean water. In other words, AIDS treatment can be used as a wedge
to strengthen health systems.72 The next chapter explores one model of
care based on this approach.

132 | Chapter 5

s u g g e s t e d r e a d i n g a n d o t h e r m e d i a

Behrman, Greg. The Invisible People: How the U.S. Has Slept through the
Global AIDS Pandemic, the Greatest Humanitarian Catastrophe of Our
Time. New York: Free Press, 2004.

“Consensus Statement on Antiretroviral Treatment for AIDS in Poor Coun-
tries, by Individual Members of the Faculty of Harvard University.” March
2001. www.cid.harvard.edu/cidinthenews/pr/consensus_aids_therapy .

d’Adesky, Anne-Christine. Moving Mountains: The Race to Treat Global
AIDS. London: Verso, 2004.

Epstein, Steven. Impure Science: AIDS, Activism, and the Politics of Knowl-
edge. Berkeley: University of California Press, 1996.

Farmer, Paul, Fernet Léandre, Joia Mukherjee, Rajesh Gupta, Laura Tarter,
and Jim Yong Kim. “Community-Based Treatment of Advanced HIV Dis-
ease: Introducing DOT-HAART (Directly Observed Therapy with Highly
Active Antiretroviral Therapy).” Bulletin of the World Health Organization
79, no. 12 (2001): 1145– 1151.

Gupta, Rajesh, Jim Y. Kim, Marcos A. Espinal, Jean-Michel Caudron, Bernard
Pecoul, Paul E. Farmer, and Mario C. Raviglione. “Responding to Market
Failures in Tuberculosis Control.” Science 293, no. 5532 (2001): 1049– 1051.

Kapczynski, Amy, Samantha Chaifetz, Zachary Katz, and Yochai Benkler.
“Addressing Global Health Inequities: An Open Licensing Approach for
University Innovations.” Berkeley Technology Law Journal 20, no. 2
(2005): 1031– 1114.

PBS. The Age of AIDS. Frontline documentary series directed by William Cran
and Greg Barker. 2006. www.pbs.org/wgbh/pages/frontline/aids/.

Public Square Films. How to Survive a Plague. Documentary directed by
David France. 2012.

Siplon, Patricia D. AIDS and the Policy Struggle in the United States. Wash-
ington, D.C.: Georgetown University Press, 2002.

Smith, Raymond A., and Patricia D. Siplon. Drugs into Bodies: Global AIDS
Treatment Activism. London: Praeger, 2006.

8.2: The Pharmaceutical Industry, TRIPS and Hepatitis C

Exam Study Guide (1/2)
What are essential medicines, and the main barriers to accessing them in developing countries?
Main characteristics of “Big Pharma”
The main elements of TRIPS, Doha Declaration and TRIPS+ — including how they affect access to medicines
Why some argue TRIPS are good for developing countries’ economies, and what the counter-arguments are (including evidence cited)
Explain the practice of Evergreening
Provide examples of how some countries are pushing back against Big Pharma and Intellectual Property (IP)

Exam Study Guide (2/2)
About Hepatitis C know:
Method of transmission and statistics on disease progressoin.
History of Hep C in the US and Egypt.
Why the new medications are so much better.
How Gilead is changing it’s approach to selling essential drugs outside high-income countries, and some critiques of their approach
Understand what role India is playing in access to essential medicines, and why India, in particular, is playing that role.

“Big Pharma”
Refers to the top 20-25 multinational pharmaceutical companies
Pharmaceutical companies have some of the biggest profit margins of any industry:
Largest 25 drug companies, 20.1% profit margin in 2015
All other drug companies, 8.6%
E.g. roughly the same as software industry
Influences:
Doctor’s prescribing habits (e.g. Opioid epidemic)
Government policies
International legislation and patent law
Little research in “neglected diseases” that disproportionately affect low-income countries
1/3 of world lacks regular access to essential drugs

See: https
://law.stanford.edu/2018/01/10/new-gao-report-on-drug-industry-profits/
And, https
://www.gao.gov/products/GAO-18-40

From: https://www.gao.gov/assets/690/688472

The WHO’s Essential Medicines list
Mentioned in one of the 10 points of the Alma Ata Declaration
WHO publishes first list in 1977, now updated every 2 years
A guide; not a permanent list of must-have medicines
Each country determines their own list
Essential medicines must:
Satisfy the priority health care needs of the population.
Be selected with regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness.
Intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford.

TRIPS: Trade-Related aspects of Intellectual Property Rights
TRIPS (1995) = a World Trade Organization (WTO) trade agreement that sets minimum standards for protection of intellectual property rights (IPR) in the world today
More than 150 WTO members today
Sectors covered include: health; agriculture and genetic resources; traditional knowledge, access and benefit sharing; geographical indications; software and the Internet
Minimum standards include:
Patents must be given for a minimum of 20 years
Patents may be given both for products and processes
Pharmaceutical test data must be protected against ‘unfair commercial use’
What, exactly, should be patented left up to individual countries (can lead to practice of evergreening)

Is TRIPS good for developing countries?
Arguments for TRIPS:
Strong IPR legislation will enable developing countries to attract more investments because foreign companies won’t have to worry that their technologies will be copied
Based on the fact that a strong IPR system was essential for the industrial revolution in the 19th c. in Europe, US and Japan
Arguments against TRIPS:
Developing countries today have radically different social and economic conditions than did Europe, US and Japan when they were developing in the 19th century.
Studies suggest that during recent periods of economic development, many countries have had weak IPR regimes.
Protecting IP in advanced industrial fields (e.g. biotechnology, information and communications technology) will only benefit foreign businesses, since poor countries’ domestic firms lack the capacity to innovate in high-tech fields.
For more, see: http://www.scidev.net/global/policy-brief/trips-and-its-impact-on-developing-
countries.html

TRIPS and essential medicines in developing countries
Vagueness in what can be patented allows “Evergreening” – extending a patent for minor improvements or changes
Vagueness is a problem when countries are weak vis-à-vis a drug company or the country where they are based.
Brazil, Thailand and India have all pushed back against Evergreening
Prevents generic drugs from entering the market, so artificially keeps prices high. Limits competition and local manufacturing of drugs.
ARVs once cost 10,000/year, now they are roughly 100/year
No difference is made between life-saving medicines, consumer goods and “lifestyle” drugs
The danger is that TRIPS extends high drug prices for a longer period of time, and worsens the crisis of access to medicines

Doha Declaration (2001)
“The public health clause” allows countries to determine their own public health crisis and make exceptions to patents held by other countries/companies
“TRIPS does not and should not prevent [WTO] Members from taking measures to protect public health”
The Doha Declaration reinforced the legality of all WTO members to issue “compulsory licenses” to produce medicines even when another country’s patent covered that medicine

but… “TRIPS-plus” in practice
Because TRIPS are only minimum standards, countries are free to negotiate higher standards among themselves (that’s where the “plus” comes in)
In these bilateral trade agreements, developing countries might not be able to protect their right to uphold the public health clause
Developing countries are under pressure to enact tougher or more restrictive conditions in their patent laws – as part of bilateral trade negotiations with the US and the EU
Examples:
Extending the term of a patent longer than the twenty-year minimum
Introducing provisions that limit the use of compulsory licenses or that restrict generic competition.
Data exclusivity: Clinical trial results for a patented drug cannot be used when producing a generic (so the trial has to be conducted again!)
MSF: “Disastrous impact on access to medicines”

Reviewing TRIPS
TRIPS (1995) introduces minimum standards to protect IPR that all countries agree to
But this is bad for developing countries! Especially their public health
“Flexibilities” in TRIPS allow developing countries some leeway, in theory
Can issue “compulsory licenses” to manufacture essential medicines
Can deny patent claims that represent “evergreening”
Doha declaration (2001) reinforced developing countries’ rights to these flexibilities but…
TRIPS plus provisions are becoming more widespread — bilateral agreements that go beyond the minimum standards outlined in TRIPS, e.g.
Extending patents beyond 20-year minimum
New provisions that limit the use of compulsory licenses and restrict generic competition
Allow exclusive rights over test data, preventing generic manufacturers from relying on previous studies/clinical trials (which are expensive!)
https://msfaccess.org/spotlight-trips-trips-plus-and-
doha

Hans Rosling at Global Health Beyond 2015:
https
://www.youtube.com/watch?v=8gY5BSFPlME
(Start at 18:30, watch for 3-4 min)
Pirates or Monopolists?

Start video at 18:30. Turn off after he says government can’t afford it…it’s really a problem. (a couple of minutes).
13

Hepatitis C 101
Viral infection with no known vaccine for prevention
Transmission via blood:
most commonly by sharing needles
needlestick injuries by healthcare workers
moms transmit to their babies (6 per 100)
low risk for sexual transmission
75-80% of those with acute Hep C develop chronic Hep C, which can lead to liver cancer, liver failure, death.
1/3 of injection drug users age 18-30 are Hep C positive
Much higher among older injection drug users

What’s it like to have Hep C?
One person’s voice (watch min. 1-9)

Hep C globally

Hep C & HIV Prevention in the US
In the United States, 3.5 million with chronic Hepatitis C
In the 1980s, US banned funding for needle exchange programs out of a fear that they increased illegal drug use.
WHO research over 2 decades indicates needle exchange programs are effective to prevent HIV and Hepatitis, and do not increase rates of drug use.
In Dec. 2015 the ban was essentially lifted (on all expenses except the actual syringes, which don’t cost much)
Volunteer opportunity: Boulder County Public Health Department has a needle exchange program and they accept volunteers

Egypt: 10% with chronic Hep C

http://www.nytimes.com/2015/12/16/health/hepatitis-c-treatment-
egypt.html

Hepatitis C treatment
Until recently, treatment was interferon plus other drugs (ribavirin, with possible addition of 2 protease inhibitors)
Side effects often severe
60-80% success rate
Sofosbuvir– discovered 2007– a direct-acting antiviral drug
Once daily pill; can cure the disease in 8-12 weeks
Manufactured by Gilead and patented in US 2013. Known as “Solvadi” in US.
In its 1st year on the US market, Solvadi earned Gilead > $10 billion!
2016, WHO puts Sofosbuvir on its essential medicines list
2015 US cost: $84,000 ($1,000 per pill)

India: the battleground for drug patent law and access to essential medicines
After the fight over HIV drug access, the fight is turning to other essential drugs
India recently rejected Gilead’s application for a patent for Sofosbuvir
Gilead response:
Tiered pricing based on country’s economic status and volume of medicine
Allows 11 manufacturers in India to produce generic versions, for sale in 101 developing countries
Program with Egypt
BUT this does not reduce cost of Hep C medicines in middle-income countries
See: http
://www.nature.com/news/hepatitis-c-drugs-re-energize-global-fight-over-patents-
1.21558

Tiered pricing
e.g. 12-week course of Sofosbuvir:
US: $84,000
Turkey and Canada: $50,000
Brazil: $6,000
Egypt: $900
Generic manufacturing:
Manufacturers set prices, pay 7% royalties to Gilead
Retail is $300-900/treatment
E.g. Poland: to treat every infected person would cost 1.6 times annual expenditures on all medicines – costs 6x average annual income in Poland
See here: http://www.nature.com/news/hepatitis-c-drugs-re-energize-global-fight-over-patents-1.21558
20

Gilead in Egypt
2014: Gilead introduces Sofosbuvir to Egypt at cheaper rates
$10/pill to government
Distributed free to patients
Strict rules:
All pills dispensed by government pharmacies
Patients must turn in an old bottle to get a new one
New bottles must be opened, unsealed and first pill taken in front of pharmacist

India’s importance in the fight for fair drug patent laws
India’s domestic drugs market is the 14th-largest globally, but with growth of 13-14%
In US and Europe, law allows patents for updated versions of drugs (“evergreening”)
India limited patents on drugs with “previously known active ingredients,” unless the change shows clear therapeutic benefit (e.g. prevention of Evergreening)
Denied a patent to Novartis AG (Swiss company) for Glivec, a leukemia/cancer drug, on this basis
Novartis took the case all the way to the Indian Supreme Court, saying they defined innovation too narrowly; ultimately Novartis lost (2013)
Big Pharma then lobbied the US to impose trade sanctions against India

http://in.reuters.com/article/india-drugs-patent-novartis-glivec-
idINDEE93000920130401

Big Pharma’s response to the Glivec decision
The U.S. industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, said the decision reflected a deteriorating environment for innovation in India:
“Protecting intellectual property is fundamental to the discovery of new medicines,” the group said in a statement. “To solve the real health challenges of India’s patients, it is critically important that India promote a policy environment that supports continued research and development of new medicines.”
Source: http
://in.reuters.com/article/india-drugs-patent-novartis-glivec-
idINDEE93000920130401

Cost effectiveness and socialization for scarcity
Cost effectiveness was used as a rationale for not treating people in poor countries with antiretrovirals (ARVs)
That paradigm changed due to:
Influx of money for HIV (PEPFAR & the Global Fund)
The development of generics (allowed under Doha Declaration.)
The study demonstrating that treating a person with HIV reduced the likelihood of transmission by 96% (so treatment = prevention)
In what other aspects of global health do we assume scarce resources and then limit care to the poor?

Film, “Fire In the Blood” (59 min)

https://www.imdb.com/title/tt1787067/?ref_=vp_back

after reading the assigned text, compose a 400-500 word reflection and submit it to the Canvas discussion board.

The lowest case study discussion score will be converted to 10/10 during final grade calculations if you complete the anonymous midterm course survey. Only case studies that are completed are eligible for this conversion (e.g. you can’t apply this incentive to a case study that you didn’t complete).

Content and Grading

In your reflections, address the following 3 questions.

1. What are the author’s main messages/arguments? What is the main takeaway of this case study? What is the essential background information that we need to understand it? (2.5 points)

How does the case study relate to concepts from the course (including lectures, readings and videos)? Connect themes in the case study to at least 2 concepts from the course. Put these concepts in bold so that we can easily find them when grading, and be sure to explain or elaborate on HOW the case study illustrates, complicates or is connected to that topic. (4 points)

3. Share your personal reaction or stance on the issues developed in the case study. Has it changed your opinion on the topic? Does it relate to your own personal experiences? Does it connect to things you have studied in other courses, or articles you’ve been reading in the news lately? (2.5 points)

4. Proper citations (1 point)

Citations

You must include proper academic citation in your case study reflections. This is a good habit to get into generally. Visit this page for the

general course citation guidelines.

· When referring to required course material, use a shortened version of the APA’s author-date, in-text parenthetical citation system, e.g. (Marmot 2010). You can abbreviate our course textbooks to RGH and PIH, or use the case study author’s last name. Be sure to spell the author’s name correctly! Lectures can be cited by the number, e.g. (Ryan lecture 4.2). Videos can be cited by the primary speaker or a shortened version of the title, e.g. (Bad Sugar) or (Rosling).

· When referring to outside articles or sources, use the APA’s author-date, in-text parenthetical citation system, e.g., (Washington Post 2021) and include a hyperlink or full citation to your original source at the end of your submission. Connecting the case studies to outside sources is always welcome, but be sure you are also

· You do not need to write a full bibliography for case study reflections.

8.1: HIV 101

GEOG 3692: Introduction to Global Public Health

Caitlin M. Ryan, PhD

University of Colorado Boulder

Exam study guide topics
Describe the difference between HIV and AIDS, and how HIV progresses
Know the 3 ways HIV is transmitted
Understand the main treatment options for HIV and the expected outcomes with and without treatment
Does the McKeown hypothesis hold true for HIV as it did for tuberculosis in the past? Why or why not?

T / CD4 cells

HIV vs AIDS?
HIV: Human Immunodeficiency Virus detected in blood
AIDS:
having 200 or less CD4 cells/liter
OR having an opportunistic infection and being HIV positive.

CD4 (T4) cells and
Opportunistic Infections

Latent Infection
Initially people are asymptomatic
Lasts 8 years on average (range 4-20 yrs)
Toward end of this period, people start developing symptoms like weight loss and fever
About 5% are long term non-progressors

Outcomes of treatment
Average survival Without treatment:
9-11 yrs after infection of HIV
6-19 months after development of AIDS
Half of infants born with HIV die by age 2

With treatment:
Prospect of a normal lifespan

New prevention tools: Prep and Pep
Prep: taken daily by people at high risk for acquiring HIV
Pep: Taken ASAP after a possible exposure (within 72 hours)
No FDA approved vaccine at this time. Trials under way.

Remember the McKeown Hypothesis? —that determinants of health (ie living conditions, sanitation), other than medications are primarily responsible for improvement over time? Is this true for HIV?

In the film,

Fire In the Blood, the producer’s main points that were pushed across were the effectiveness the United States government and large pharmaceutical companies have on the health of others in the world. This film especially looked into the harm of patents on anti-retroviral medicines large pharmaceutical companies hold on the world. Due to this hundreds of thousands of people were dying because they couldn’t afford/access the medications they needed. Furthermore, until the year of 1996, the first effective treatment was available in curing HIV around the world. When taking a combination of these three medications, within two weeks the person’s strength comes back. It was estimated that around per patient it would be $15,000 for the medication alone. This caused complications to developing countries as the majority of their people could not afford this. There was then a push to create generic versions of these drugs. It would be the same compounds in curing aids, but at a fraction of the cost. However, the patents on these specific drugs would not allow this. Some reasons many activists and the United States government would not allow this is because: if there were cheaper drugs in Africa it would discourage R&D, there was the belief of treating people in developing countries would cause the virus to mutate and could then pass off into the west, and lastly cause a miss use of the medicines provided. Many of these developing country governments were then forced to back off of challenging drug patents in fear of severe consequences. When a leading chemist of India created a generic version of these drugs, at a fraction of the cost, the people’s lives were projected to change. However, as patent laws were still in effect these drugs were highly illegal. Many people were getting these drugs by luck, not choice. Everything changed when the health scare of Anthrax hit the west. This Cited a public health emergency, a valid and legal cause on suspending a patent on a drug called Cipro. The United States government forced these big pharmaceutical companies to push the prices of Cipro down, threatening the ending of the patent on drugs in Africa. Numerous other African countries made use of the “public health emergency” exemptions to allow the importation of generic ARVs. The Bush administration agreed to spend their money on generic made medicines, then the TRIPS agreement denied them access to affordable medication causing a relapse in the affordability of these antiretrovirals.

This film relates to concepts in class because of the legacies of “health is a commodity that should be delivered within a market context.” (Ryan, Lecture 5.3). This is shown how the western pharmaceutical corporations are marking up the prices of these antiretrovirals to get as much money as possible. Another example this film relates to is course concepts is the statement the World Bank speaks about health care. “Health care has to be affordable and effective.” (Ryan, Lecture 5.3). This raises the question of why the World Bank didn’t have more of involvement during these times, including in the creation of the policy TRIPS.

As a personal reaction, this film was extremely frustrating. I thought it was completely disgusting how western pharmaceutical companies have completely monopolized these types of drugs. As a result, there has been an extreme amount of blood on their hands. This is completely their fault, as I believe the health of a person is a human right. When watching this, it completely changed my view on patents of medications. Who should tell another country what they can and can’t do if it’s best for their people. This aspect is disgusting to me as people are still struggling in these very similar situations with other diseases.

Order your essay today and save 25% with the discount code: STUDYSAVE

Order Now

Turn in your highest-quality paper
Get a qualified writer to help you with

“ 400-500 case ”

Get high-quality paper

NEW! AI matching with writer

Order a unique copy of this paper

Type of paper needed:

Pages:

600 words

Academic level:

We'll send you the first draft for approval by September 11, 2018 at 10:52 AM

Total price:

$26

Our Services

400-500 case

Order a unique copy of this paper