ELECTRONIC ASSIGNMENT COVERSHEET Student Number31305598

SurnameSUSANTO Given nameRONNY Emailironichorus@yahoo.com

Unit CodeGEN330A
Unit nameGlobalisation, Gender and Power Enrolment modeExternal Date22/02/13 Assignment number Assignment 2 Assignment name Major Essay Tutor Dr Elaine Tay

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In the past few decades, HIV/AIDS has become a pressing economic, social and security concern for many countries around the world. For low- and middle-income countries in the Sub-Saharan Africa and some parts of Asia, the magnitude of the negative impact of this disease is devastating (Berthelsen, 2003). What these nations need is cheap, affordable and yet effective HIV/AIDS medications. The main purpose of this essay is to discuss the complex nature of global attempts to fight HIV/AIDS. This essay will focus its discussion on the impact of the relatively high cost of HIV/AIDS medications, as the result of intellectual property rights and patent protection, and the availability of affordable treatments. It will also analyse the relationship between gender and the accessibility of treatment. For better understanding, this essay will discuss the role of the government, the big pharmaceutical companies and Non-Government Organisations (NGOs), as the major stake-holders in this particular matter. This essay highlights the existence of structural difficulties in the global fight against HIV/AIDS. By putting aside their differences and negotiating a mutual arrangement and understanding, to ensure the availability of affordable HIV/AIDS treatments, medications and services, the global fight against this disease will likely to succeed.

In 2010, there were approximately 34 million people living with HIV/AIDS worldwide with more than 83 percent living in Sub-Saharan Africa and some parts of Asia (World Health Organization [WHO], 2013a). This statistic highlights the fact that the majority of these reported cases are from low- and middle-income countries. Providing basic needs for their citizens, such as food, water, shelter, education, sanitary and health, can be
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challenging for these countries, let alone to provide affordable treatment for HIV/AIDS. Available statistics show that less than 30 percent of HIV/AIDS patients in these countries have received antiretroviral therapy (ARV) (McNeil Jr., 2012, para. 10). The inability to provide and access effective and affordable ARV drugs is likely to be the main challenge in the global attempt to contain and reduce the transmission of the HIV virus.

Although HIV/AIDS treatments have become more widely available and effective, the cost is still relatively high. In the United States, the lifetime cost for treatment is estimated at more than $370,000 per person (Centers for Disease Control and Prevention [CDC], 2012). For low- and middleincome countries, such as Kenya, Nigeria, Cambodia, Thailand and India, the availability of HIV/AIDS medications is largely dependant on foreign aid provided by international donors (Condon & Sinha, 2008, pp. 142-143). The willingness and the commitment of the donors to provide assistance and cheap ARV drugs is one of the possible solutions to ensure the availability of HIV/AIDS treatments as its stands. Without this assistance, it is difficult for low- and middle-income countries to access and provide the recommended HIV/AIDS treatments.

From the 34 million people living with HIV/AIDS worldwide, it was estimated that more than half are women (Joint United Nations Programme on HIV/AIDS [UNAIDS], 2011). In Kenya for example, women account for 58 percent or 928,000 individuals who live with this disease (National AIDS Control Council & National AIDS and STI Programme, 2012). Arguably, gender inequality and vulnerability are two of the driving forces
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behind the spread of this disease in many parts of the world (Waithera, 2011, p. 2). Women are more susceptible and vulnerable to this disease due to various social and security factors including rape, sex slavery, forced marriage, discrimination and the existence of a patriarchal structure in the society (Ashford, 2008, p. 197). Unlike, their male counterparts, there is a greater barrier for women, especially in Africa and Asia, to access and receive treatments. The social stigma surrounding women with HIV/AIDS and the lack of power and the inability of these women to participate in the decision making process have made it difficult for them to seek the necessary support and assistance (Amnesty International, 2008). In recent years, there is an international agreement which place women in the centre of the global attempt to eradicate this disease by ensuring equal access to treatments, medications and support (Seldin, 2012). For this to eventuate, the government of a country must ensure that women are treated with equal and mutual respect and allow women to access treatments without discrimination.

The inability of a country to provide affordable HIV/AIDS treatment is due to a combination of several factors such as poor economic performance, high cost of available treatments and the lack of an alternative to the recommended treatment regimes. In 1994, to ensure a proper and legal treatment, usage and administration of intellectual property, the World Trade Organisation (WTO) introduced the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement (WHO, 2013b). As the result, big pharmaceutical companies have the legal rights and ability to protect their ownership of intellectual property (Miller & Jentz, 2010).
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Under this agreement, a WTO member must ensure that its national patent law is in accordance with TRIPS regulations to avoid possible legal challenge (Dinwoodie & Dreyfuss, 2012, p. 118). In this particular matter, this legal requirement and protection has become a source of conflict of interest between the big pharmaceutical companies, the government, NonGovernment Organisations (NGOs) and HIV/AIDS activists (Seckinelgin, 2008).

For sometime now, big pharmaceutical companies have argued that legal protection of their intellectual property is essential in ensuring the continuity of future Research and Development (R&D) program (Resnik, 2012, p. 399). They argue that without a properly funded budget, it will be difficult for them to continue and maintain their R&D. It has been reported that the estimated cost of R&D for a new medication is $1.9 billion (Mestre-Ferrandiz, Sussex & Towse, 2012). This number shows the cost burden for pharmaceutical companies in conducting their program. Hence the argument that, in this particular field, well-funded R&D program is required to find a better and a more effective treatment to fight the severity of HIV/AIDS. Although there have been many promising results and

findings, to achieve the ultimate goal to find the cure for HIV/AIDS and an effective vaccine to prevent the spread of this disease, more R&D is still needed (Medecins Sans Frontieres, 2012).

In the past, big pharmaceutical companies have done everything they could to protect and secure their intellectual property ownership. Patent law has allowed big pharmaceutical companies to limit the availability of affordable
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HIV/AIDS medications and other generic medications (Boulet, Perriens & Renaud-Thery, 2000, pp. 4-5). Under TRIPS, patent protection guarantees exclusive rights for a product from being made, used, sold or imported by other companies without permission from the owner. This measure has allowed big pharmaceutical companies to monopolise and control the price of HIV/AIDS medications and treatments in the global market (Osewe, Nkrumah & Sackey, 2008). Although patent for HIV/AIDS medications is usually granted for a limited period of 20 years, during this period, other companies will not be able to produce a generic alternative to these medications (Elliott & Bonin, 2002, p. 1). The inability to produce a cheaper generic alternative has, as a consequence, resulted in the high cost of treatments. For many developing countries, this situation makes it difficult for them to provide access to affordable medications to the people who need it the most. For HIV/AIDS patients, to wait for 20 years to access affordable treatments is not an option.

Economically speaking, the reluctance of big pharmaceutical companies to share their wealth of knowledge is perhaps understandable. Although they have done much in advancing the treatments for HIV/AIDS, it is important to remember that these companies are for-profit organisations with a corporate and financial responsibility to their share holders (Peng, 2009, p. 91). Like others, big pharmaceutical companies are in operation to make profit and to improve their capital reserve. It has been reported that in 2011, the estimated sales of HIV/AIDS medications in the United States and in five European markets accounted at $13.3 billion (Decision Resources, 2012). From the financial perspective of these companies, it is clear to see
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that this figure represents a vastly profitable and

lucrative business.

Understandably, these companies want to maintain their position in the market for HIV/AIDS medications.

Unlike big pharmaceutical companies, the government sees the high cost of HIV/AIDS medications as a problem. The high cost of ARV drugs has prevented and restricted a nation's ability to care for HIV/AIDS patients. The impact of this condition is not only burdensome for the domestic financial and economic stability but it is likely to have a global implication. As the top donor, the United States of America has donated more than $4.5 billion in its attempt to provide treatment and care to prevent the spread of HIV/AIDS in more than 80 countries (Piccio, 2012). For many receiver countries, this foreign aid is very much needed to provide not only

treatments and medications but also to ensure the availability of other basic needs and services such as the initial HIV testing, the distribution of condoms and the promotion of sexual health education (Leon, 2011; International Monetary of Fund [IMF], 2008). However, due to the recent Global Financial Crisis (GFC), it has been predicted that the amount of available foreign aid, allocated to fight this disease, will likely fall short (Dunlevy, 2012). Without this international aid, it will be difficult and challenging for many low- and middle-income countries to provide the required treatments for HIV/AIDS. This situation will pose a threat to the overall global stability.

In recent years, some developing nations such as India, Indonesia and Thailand have overruled and rejected Pharmaceutical companies claims to
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their intellectual property and patent rights (Canadian HIV/AIDS Legal Network, 2009;; Head, 2007). In 2012, the Indonesian President Susilo Bambag Yudhoyono over-rode patents on seven HIV/AIDS and Hepatitis B medications in Indonesia (Bigg, 2012). This decision allowed other pharmaceutical companies to access information required to manufacture generic alternative to ARV drugs. This move allowed the production of medication with the same function, purpose and composition but at much lower cost. Although big pharmaceutical companies opposed this decision, the government has been able to exploit some ambiguities within the TRIPS agreement to defend and justify its decision. Should the government be able to argue that there is a 'national emergency' which threatens the stability of a nation, then it is legally justifiable to reject and override patent rights (Ford, 2000, 959). Due to the ambiguous nature of the TRIPS agreement in this particular matter and since there is no specific regulation which set the standard on this matter, it is somehow difficult to determine what can be classified as a 'national emergency'. This ambiguity is likely to create confusion of what can and cannot be legally done and is likely to be a source of conflict between all respective stake-holders.

Although the government, the big pharmaceutical companies and the NGOs act on compassionate grounds, there is arguably a different motive in their respective action. NGOs such as the Clinton Foundation have become an important independent lobbyist and donor which ensure the availability and access to cheap ARV drugs. In the past decade, the Clinton Health Access Initiative has helped to reduce the cost of HIV/AIDS medications in the low- and middle-income countries from over $10,000 per person per year to
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around $100 to $200 (Clinton Foundation, 2013). The government's decision to override intellectual property and patent on HIV/AIDS medication has often resulted in a stand-off between the two sides. In Thailand for example, in 2006, the Thai government issued a compulsory licensing for ARV efavirenz, patented by Merck & Co Inc., which has enabled the government to offer this drug at half the original price of 1,400 Baht per month. The Thai government has argued that this move will provide affordable medication to up to 100,000 patients, almost six times more people than being treated now (Schuettler, 2006; Kuanpoth, 2010, p. 182). This number stands as a reminder of the existing cost-based challenge in ensuring the availability and easy access to affordable HIV/AIDS medications. Although this action is lawful and legal under international trade law, big pharmaceutical companies have strongly opposed this move. Abbott, a major supplier ARV drugs, has decided to withdraw and not to introduce any new products in the Thai market in the future as a retaliation to the government's decision (Head, 2007). This action is clearly to protect the companies' intellectual property right and patent. What is difficult to comprehend is the fact that at the end of the day, many patients with HIV/AIDS will not be able to receive the best possible treatments due to this conflict of interest.

The decision of a pharmaceutical company, like Abbott, to stop the introduction of a new treatment in a country, based on patent violation, has raised the serious question of a company's corporate social responsibility (CSR). Some have queried the scope of big pharmaceutical companies' social and moral responsibility in ensuring universal access to their
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products (Macklin, 2012, pp. 117-118). Universal access means that anyone living with HIV/AIDS, regardless of their gender, race, nationality and age, should be able to access and receive the necessary services and treatments without discrimination, prejudice or cost restraint (Gibson, 2009, 99. 117118). While some companies have distributed ARV at not-for-profit price, the cost is still relatively high in comparison to the price of its generic alternative. While some real attempts to fight this disease have been made, more actions to bring down the cost of HIV/AIDS medication are still needed. The conflicting nature of the big pharmaceutical companies in balancing their social responsibility and their financial profitability should not be a barrier in the global fight against HIV/AIDS.

To ensure the continuity of R&D program and to keep the cost of ARV drugs low, some forms of assistance should be made available for the big pharmaceutical companies to access. Bernie Sanders, a United States Senator recently argued that it is important to find a way to break the link between drug pricing and funding for medical R&D. He argues that as an alternative to intellectual property rights, an innovation prize should be given as a compensation (Sanders, 2012). This will ensure the continuity of R&D program without putting a hefty price tag on the discovery and innovation. In the past twenty years, government organisations such as amfAR have invested more than $240 million in research grant and funding of more than 2,000 teams around the world (amfAR, 2012). Recently in Australia, the federal Minister for Health Tanya Plibersek announced the allocation of $12.6 million for the ongoing research to find cures, treatments and more effective cares for HIV/AIDS (Australia. National
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Health and Medical Research Council, 2012). Meanwhile, to assist this global effort, the Bill and Melinda Gates Foundation has donated more than $1.4 billion to The Global Fund (The Global Fund, 2013). These global efforts highlight the available resource for R&D and the willingness of the international community to fund this program. To argue that the future of R&D program is dependant solely on the financial performance and profitability of the big pharmaceutical companies is not necessarily correct.

While ensuring the availability of cheap HIV/AIDS medications is important, to find the balance between the need to provide access to treatment and to respect the intellectual property rights of the big pharmaceutical companies is needed to find a long term solution to this cost-related problem. A proper licensing of Pharmaceutical companies' intellectual property and a medical patent pool should be available in order to honour ownership and patent rights (World Intellectual Property Organization [WIPO], 2011). Although, a nation is allowed to override patent rights, it needs to ensure that big pharmaceutical companies are consulted in the decision making process and rewarded for their ongoing efforts. While pharmaceutical companies are warming to the idea of a medication patent pool in HIV/AIDS medication, there is a hesitation of some companies to join this collective action (Boseley, 2011). If agreed, an HIV/AIDS medication patent pool would enable big pharmaceutical companies to share their intellectual property, while at the same time guarantee appropriate rewards and payments. This move might be the solution to balance the need for cheap generic ARV drugs and the protection of patent rights.
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As a conclusion, to combat HIV/AIDS, universal access to effective HIV/AIDS medications, care and treatment is essential. The fact that more than half the world's population living with HIV/AIDS are women highlights the underlining difficulty for women to access treatments and services. More than men, women with HIV/AIDS are likely to face some form of discrimination and prejudice due to their gender. This particular issue has been addressed by the international community and it has been one of the main focuses in the global fight against HIV/AIDS to date. However, the high cost of medications has prevented many patients from receiving the necessary treatment and care. Without affordable ARV, it will be difficult for the world to halt the spread of this disease. The big pharmaceutical companies hesitation in sharing their intellectual property has resulted in the high cost of treatment and medication. Although legal under international law, the government's decision to override patent rights to ensure the availability of generic HIV/AIDS medication has created ongoing conflict of interest between all major stake-holders. To halt the spread of this incurable disease, a new approach, such as prize allocation and medication patent pool, must be supported and agreed by all parties involved. Until the day when the cure and vaccine for HIV/AIDS is found, big Pharmaceutical companies and governments must put their differences, agendas and motives aside and place the interests of the people who live with the reality of HIV/AIDS first and foremost.

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