







































   Columbia Social Work Review, Volume V       21

Global Trade Limitations to HIV Medication Access in Developing 
Countries 

Yixuan Wang

International trade and patent laws pose monetary and logistical chal-
lenges to all countries affected by the HIV/AIDS epidemic in their abili-
ties to access the most current and effective treatments. The development 
of international patent law applicable to medications has undergone sig-
nificant changes since the 1990’s under The Agreement on Trade Related 
Aspects of Intellectual Property Rights (TRIPS) established by the World 
Trade Organization (WTO). Case studies of China, India and Brazil’s im-
plementation of pharmaceutical patent protection reveal the limitations 
of TRIPS and its subsequently recognized flexibilities.  Although the goal 
of these flexibilities is to allow for greater access to medications, they fall 
short in reaching the universally accepted goal of a right to health. 

Despite decreasing incidence, in 2012, 35.3 million people were 
living with HIV worldwide, and 2.3 million are newly infected each 
year (UNAIDS, 2013). In order to alleviate the HIV/AIDS epidemic, 
the World Health Organization (WHO) has expanded coverage of HIV 
treatment. Still, in 2012, only 9.7 million out of over 30 million people 
in low- and middle-income countries received antiretroviral therapy 
(UNAIDS, 2013). Meanwhile, in wealthier industrialized countries, even 
more advanced forms of antiretroviral medications are sold that are less 
toxic, are more effective, and require simpler regimens. 

Challenges to expanding HIV treatment in low-income and 
developing countries include the inabilities of these countries to import 
inexpensive pharmaceuticals or manufacture antiretroviral medications 
domestically because of restrictions placed by the World Trade Organiza-
tion (WTO). Global patent protections on pharmaceuticals increase costs 
and constrain developing countries’ attempts to access the most advanced 
forms of antiretroviral medications. The Agreement on Trade Related 
Aspects of Intellectual Property Rights (TRIPS) requires countries within 
the WTO to adopt International Intellectual Property Rules (IPRs) which 
provide strict national protections for competing pharmaceutical com-
panies internationally. Specifically, TRIPS obliges all WTO member 



22       Columbia Social Work Review, Volume V

Global Trade Limitations to HIV Medication

countries to grant at least 20 years of patent protection for new medi-
cations, resulting in costly market prices for new medications (Alikhan 
& Mashelkar, 2004). As corporations in developed countries hold the 
majority of pharmaceutical patents, some advocates maintain that IPRs 
generally reflect the economic interests of those developed countries. 

To improve access to HIV medications in least developed countries, 
in 2001, the WTO developed the concept of TRIPS flexibilities. Initiating 
TRIPS flexibilities to obtain lower cost medications has proven difficult 
at a practical level. The challenges and importance of TRIPS policy, 
its established flexibilities and successes serve to underline inequity in 
healthcare as a human rights issue. With a focus on the conflict between 
patent rights and the right to health, this paper focuses on Brazil, India, 
and China as examples of how TRIPS flexibilities help provide adequate 
access to HIV medications. Then, this paper will advocate that TRIPS 
flexibilities should be unconditionally expanded to all developing coun-
tries experiencing an HIV/AIDS epidemic, not only to those at the lowest 
degree of development. Social workers, particularly those involved in 
the formulation and evaluation of macro-level policy, are bound under 
the National Association of Social Workers (NASW) Code of Ethics to 
advocate for just and equal treatment of all people, which includes access 
to healthcare and treatment. This article serves to inform social workers 
of the complexities involved in accessing HIV/AIDS treatment in order 
to improve their ability to advocate for universal access. 

TRIPS Framework

 The research and development (R&D) of a new HIV medication 
requires the investment of billions of dollars and intense intellectual 
labor over many years (Smelyanskaya, 2013). In order for pharmaceu-
tical manufacturers to recover R&D costs and provide protection for 
their products, companies patent their new medications. Patent registra-
tion grants the manufacturer a certain period of time to exclusively sell 
their medication on the open market. Entities seeking to produce or sell 
formulations must obtain permission from the patent holder. As a result, 
pharmaceutical manufacturers may set high prices for their products to 
maximize profits due to the de facto legalized monopoly that the patent 
registration effetively creates.

Established in 1994 during the Uruguay Round of the General 
Agreement on Tariffs and Trade, TRIPS requires countries within the 



   Columbia Social Work Review, Volume V       23

Wang

WTO to establish domestic minimum protection standards for intellec-
tual property products. In addition to IPRs inherited from predecessor 
agreements, TRIPS introduced patent protection of pharmaceuticals 
into the international trading system. WTO members must internalize 
the IPRs of TRIPS into their domestic laws to gain national jurisdiction 
against international intellectual property rights infringements. Develop-
ing countries not part of the WTO can potentially sell, manufacture, or 
make use of patented HIV pharmaceuticals without permission of patent 
holders. However, “special and differential treatment” as a WTO mem-
ber, exemplified in technology transfer and investments from wealthy 
countries and preferential trading rules, attracts developing countries to 
join the WTO. For example, while WTO members trade amongst one an-
other with relatively low tariffs on goods, non-WTO countries who trade 
with WTO members incur higher tariffs, potentially hindering domestic 
economic growth. 

Historically, developing countries strived to become members 
of the WTO and established or modified domestic patent laws to adopt 
TRIPS IPRs in preparation. Once admitted, if the patent of a new HIV 
medication is filed and international valuations remain constant, pric-
es would likely be unattainable for most national health programs in 
developing countries (Intellectual Property Watch, 2013). Under this 
framework, industrialized countries that export medications achieve legal 
grounds to initiate trade actions against piracy in developing countries. 
These restrictions, while offering intellectual protections, place remark-
able burden on emerging international economies.

While international patent laws may be necessary to drive 
innovation, royalties drastically drive up the price of new HIV medica-
tions and put low-income patients’ lives at risk. Generally speaking, the 
average cost of HIV treatment is $14,000 - $20,000 a year (Vann, 2009), 
which is more than ten years’ income for people living in low-income 
countries (UNDESA, 2013). For instance, Uganda has one of the highest 
HIV/AIDS adult prevalence rates around the world (Central Intelligence 
Agency, 2014), but its gross national income per capita was only $479 a 
year in 2011 (World Bank, 2014). As such, Ugandans living with HIV are 
often unable to access the most effective HIV treatments.

The History of Flexibilities

 With the implementation of TRIPS pharmaceutical IPRs in the 



24       Columbia Social Work Review, Volume V

Global Trade Limitations to HIV Medication

1990’s, the conflict between the right to health and intellectual property 
intensified. In 2010, companies within industrialized countries held more 
than 80% of the pharmaceutical patents (Julian-Arnold & Gianna, 1993), 
while over 80% of people living with HIV were in developing countries 
(AVERT, 2011).

Increasingly, the clash between healthcare and economic de-
velopment began to receive attention internationally, and on August 
17, 2000, the United Nations High Commissioner for Human Rights 
approved a resolution on intellectual property and human rights. The 
resolution claimed that TRIPS did not “adequately reflect the fundamen-
tal nature and indivisibility of all human rights, including…the right to 
health…[t]he apparent conflicts between the intellectual property rights 
regime embodied in the TRIPs Agreement…and international human 
rights law” (United Nations High Commissioner for Human Rights, 
2000). On June 27, 2001, a UN report further discussed the relationship 
between TRIPS and human rights, encouraging governments to take le-
gal and administrative measures to protect human rights under the TRIPS 
framework (United Nations Committee on Economic, Social and Cultur-
al Rights, 2001). 

The TRIPS Agreement was reinterpreted during the WTO 
Doha Round (WTO, 2001) in order to explicitly deliver an international 
consensus that the private interest of patent rights should not go against 
public interest and human rights during a public health crisis. The Doha 
Declaration clarified the scope of TRIPS and detailed the application of 
its flexibilities. One of the most crucial flexibilities is compulsory licens-
ing, which can be applied under a “national emergency or other circum-
stance of extreme urgency” such as “public health crises, including those 
relating to HIV/AIDS” (WTO, 2001). It allows a national government 
to issue licenses to domestic pharmaceutical manufacturers to produce 
generic versions of patent medications without the permission of patent 
holders.

In 2003, a permanent amendment was inserted in TRIPS allow-
ing WTO members of least developed countries (LDCs) to import inex-
pensive generics made under compulsory licensing provisions (WTO, 
2003). Therefore, even LDCs lacking production capacity could continue 
to access inexpensive medications. Kenya, an LDC, currently has 1.6 
million people living with HIV out of a population of about 40 million 
(UNAIDS, 2014), but in 2003 only 5% of the people who needed antiret-
roviral treatment received it (WHO/UNAIDS/UNICEF, 2007). Following 



   Columbia Social Work Review, Volume V       25

Wang

the TRIPS amendment, the government of Kenya passed a bill to legal-
ize the purchase of generics from other countries (AVERT, 2013). The 
impact was significant – in 2010, 540,000 people living in Kenya could 
access antiretroviral drugs (NACC and NASCOP, 2012), more than 30% 
of the total population living with HIV. 

Implementation of Flexibilities

While LDCs enjoy unconditional application of flexibilities and 
are granted a transition period to defer the implementation of TRIPS 
on pharmaceuticals until January 2016, the transition period for other 
developing countries ended in January 2005. Since then, many develop-
ing countries have been urged under TRIPS guidelines to issue or protect 
patents for new HIV medications. China, India and Brazil are three active 
WTO member countries with high HIV prevalence rates. Owing to their 
rapidly growing national economies, the international community ex-
pects these countries to take steps to combat their HIV epidemics while 
adhering to TRIPS IPRs. The divergence of these countries’ domestic 
social practices reveals how TRIPS flexibilities fail to adequately provide 
access to medication for people living with HIV in many developing 
countries. 

China 

In 2000, China modified its Patent Law to comply with TRIPS in 
preparation for joining the WTO. The Patent Law was last amended in 
2008 when China fully internalized TRIPS flexibilities and exhaustively 
listed the grounds for initiating compulsory licensing. According to the 
Law, China can grant compulsory licenses to domestic pharmaceutical 
manufacturers or import lower cost HIV generic medications from other 
countries to combat the HIV crisis. In spite of a well-developed legal 
basis, China has not yet issued any compulsory licenses for HIV medica-
tions in practice because the country has been categorized as having low 
HIV prevalence (Ministry of Health of the People’s Republic of China, 
2012) and thereby does not qualify for compulsory licensing according to 
international standards. However, China’s HIV epidemic is quite severe. 
China ranks 13th in the world in number of people living with HIV with 
more than half of this population living in poorer provinces (Index Mun-
di, 2014). 



26       Columbia Social Work Review, Volume V

Global Trade Limitations to HIV Medication

In order to provide treatment to its 780,000 people living with 
HIV (UNGASS, 2012), China began to provide free HIV medications to 
low-income communities in 2003 (Yardley, 2003). However, as TRIPS 
obliges all WTO member countries to grant at least 20 years of patent 
protection for new medications (Alikhan & Mashelkar, 2004), the Chi-
nese government provided patients with an older generation of antiret-
roviral therapies. One study found that half of the patients who received 
these older forms of therapy did not benefit from the treatment after 
five years, most often due to regimen ineffectiveness or medication side 
effects (Zhang et al., 2009). Although the Chinese government started to 
provide newer medications in 2009, as of 2011 only 18,703 adults and 
216 children had received them (UNGASS, 2012).

India

India has the 85th greatest HIV incidence rate yet ranks third in 
the world in terms of prevalence, with 2.4 million people living with HIV 
(Central Intelligence Agency, 2014). Having established its own gener-
ic drug industry, India exports inexpensive HIV medications to other 
developing countries while also selling them domestically. In 1995, when 
India the joined WTO and internalized TRIPS IPRs into its domestic 
patent laws, the Indian government chose to continue to allow generic 
medication production by domestic companies. While HIV medications 
cost $14,000-$20,000 per year in industrialized countries, Cipla, an 
Indian drug manufacturer, offers the medications for as low as $80 per 
year (Harris, 2008). As Indian patent laws support robust generic medica-
tion manufacturing to the detriment of patent protections, an abundance 
of pharmaceutical patent disputes initiated by foreign pharmaceutical 
manufacturers have arisen in Indian courts. As a result, the United States 
placed India on its trade blacklist (Carter & Siddiqui, 2013). Internation-
ally, TRIPS IPRs have challenged India’s efforts to promote universal 
access to HIV medications. Utilizing international legalities and trade 
agreements, the governments of pharmaceutical exporting countries 
have filed complaints against India within the WTO dispute settlement 
body. However, for a government providing universal healthcare and free 
HIV medication for 2.4 million people since 2004 (NACO, 2013), India 
should retain its proactive position of applying TRIPS flexibilities and 
challenging the tolerance of international patent holders.



   Columbia Social Work Review, Volume V       27

Wang

Brazil
As a result of rapid economic growth, the international com-

munity has expected Brazil to fight HIV independently while adhering 
to TRIPS IPRs. Brazil provides free HIV medications for its 530,000 to 
660,000 people living with HIV (UNAIDS, 2012). The Brazilian govern-
ment has found it increasingly difficult to manage its budget for free HIV 
medications since 1997, when they became a WTO member and internal-
ized TRIPS into intellectual property laws. To overcome challenges, in 
2007, Brazil issued its first compulsory license to bypass Merck’s patent 
on Efavirenz, a modern antiretroviral drug. This action would offer 
treatment to 75,000 people living with HIV and was celebrated by human 
rights activists, but regarded as a step backward by the U.S.-Brazil Busi-
ness Council (Janeiro, 2007). The U.S.-Brazil Business Council did not 
support compulsory licensing for Brazil because the country is neither an 
LDC nor under conditions of “extreme urgency” with regard to the HIV 
epidemic. As there are no quantifiable definitions of “extreme urgency” 
or “public health crisis,” Brazil used “extreme urgency” to justify its 
actions. Former President Luiz Inacio Lula da Silva responded to censure 
from international trade partners by defending the action under the name 
of public health, saying, “between our trade and our health, we have 
chosen to look after our health” (Janeiro, 2008).

Conclusion

Intellectual property rights and licensing laws stem from the 
ownership of ideas for profit–an appropriate concept in a generally cap-
italistic world. International organizations that monitor trade and offer 
individuals, companies, and countries protections for their intellectual 
and physical properties are essential in ensuring this system. Pharma-
ceutical patent law offers a method to protect intellectual and market 
interests. TRIPS flexibilities bridge international law and medical need, 
however, unregulated infringement would undermine incentives for new 
R&D projects.

Facing a public health crisis, many poor and developing econo-
mies are unable to offer their citizens available treatments and alleviate 
human suffering. These countries lack resources, making them vulnera-
ble to trade systems driven purely by profit. The technicalities of poli-
cies and securing profits, however, have superseded universal access to 
treatment for HIV–one of the most devastating public health crises in 



28       Columbia Social Work Review, Volume V

Global Trade Limitations to HIV Medication

modern times.  
Brazil’s use of TRIPS flexibilities contrasts with China’s inaction 

and, what some consider, India’s patent infringements. The diversity of 
responses these countries have chosen demonstrates how technicalities 
and profit margins inhibit countries from ensuring the wellbeing of their 
citizens. Each exemplifies challenges faced by developing countries to 
apply TRIPS flexibilities under accepted WTO guidelines. The strict, 
yet poorly defined, TRIPS flexibilities make it difficult for many devel-
oping countries to initiate compulsory license mechanisms to address 
public health crises. The improbability of pharmaceutical companies 
foregoing their profitable patent rights on new HIV medications creates 
significant delays in access to inexpensive generics. Historically in WTO 
pharmaceutical disputes, wealthier countries, which have a dispropor-
tionate number of companies with pharmaceutical patents, resist TRIPS 
flexibilities to appease companies and foster economic growth. Strict 
TRIPS IPRs have become weapons to hinder access to HIV medicines in 
developing countries. 
 If we choose to live in a world where human rights are valued 
above profit, the WTO should work to encourage its member countries to 
protect human rights by expanding the application of TRIPS flexibilities 
for HIV medications unconditionally.  

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Global Trade Limitations to HIV Medication

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