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bioethics
Developing World Bioethics ISSN 1471-8731 (print); 1471-8847 (online) Volume 14 Number 2 2014 pp 59–66
doi:10.1111/dewb.12046
ARTICLES ACCESS TO MEDICINES AND DISTRIBUTIVE JUSTICE: BREACHING DOHA’S ETHICAL THRESHOLD RACHEL KIDDELL-MONROE
Keywords distributive justice, pharmaceutical, ethics, developing world bioethics, HIV/AIDS, health, treatment
ABSTRACT The global health crisis in non-communicable diseases (NCDs) reveals a deep global health inequity that lies at the heart of global justice concerns. Mirroring the HIV/AIDS epidemic, NCDs bring into stark relief once more the human consequences of trade policies that reinforce global inequities in treatment access. Recognising distributive justice issues in access to medicines for their populations, World Trade Organisation (WTO) members confirmed the primacy of access to medicines for all in trade and public health in the landmark Doha Declaration on the TRIPS Agreement and Public Health of 2001.
In this article, I argue the Doha Declaration on the TRIPS Agreement and Public Health in 2001 acknowledged that the protection of intellectual property on medicines was subject to considerations of justice and equity. Demonstrating that access to Non-communicable Disease medicines is an issue of global health equality and justice, I show that the negotiated removal of a reference to the Doha Declaration in the 2011 UN Political Declaration on Non-communicable Diseases marked a retreat by UN member states from their commitment to distributive justice in global health. While the consequences of breaching this ethical threshold for treating NCD patients in low and middle income countries remain to be seen, I argue that promoting the ethical principles underpinning the Doha Declaration are central to global strategies to address the NCD crisis facing the world today.
INTRODUCTION Non-communicable diseases (NCDs) are a global health crisis. By 2030, 75% of the world’s deaths will be caused by cancer, diabetes, heart and lung disease. Not only are NCDs a global health crisis, they also reveal a crisis of global health inequality: 80% of the NCD deaths reported worldwide occur in low and middle income countries (WHO, 2008). Such inequity lies at the heart of global justice concerns.
Ensuring equitable access to essential NCD medicines is central to treating millions of people worldwide who are currently ill and dying. Yet millions of NCD patients today living in low and middle income countries (LMICs) are unable to access treatment. It is not news that there is an inequitable distribution of essential medicines globally that disproportionately affects the poor. According to the WHO, in LMICs one in three people do not have access to essential medicines. This figure rises to one in two in sub-Saharan Africa. While the reasons are complex, the HIV/AIDS epidemic has brought into stark relief the human consequences of trade policies that reinforce global inequities in treatment access. Recognising that pharmaceutical patenting was fuelling this global health inequity, the World Trade Organisation (WTO) agreed to clarify and amend the 1995 Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS). Through its focus on the protection of patents on pharmaceuticals, TRIPS had allowed pharmaceutical monopolies. These monopolies prevented market competition for medicines urgently needed to treat patients dying from HIV/AIDS. This kept patented medicines at prices that poor patients and countries could not afford. The focus on prevention strategies only rather than ensuring treatment for those infected has been blamed for the soaring HIV infections and AIDS related deaths. Today we know that treatment is prevention in
Address for correspondence: Rachel Kiddell-Monroe, Law and Bioethics, Chancellor Day Hall, McGill University, 3644, rue Peel, Montreal, Quebec H3A 1X1 Canada. Email: [email protected]. Conflict of interest statement: No conflicts declared © 2014 John Wiley & Sons Ltd
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HIV/AIDS and that access to affordable treatment is the key to dealing with the pandemic. Understanding that prevention alone was not enough to address a global health crisis, LMICs drove the 2001 Doha Declaration on the TRIPS Agreement and Public Health (the Doha Declaration or Doha) through the WTO (World Trade Organisation, 2001a) and thereby confirmed the importance of using TRIPS flexibilities to ensure low-cost generic production of essential medicines. By recognizing that TRIPS should be interpreted and implemented ‘to promote access to medicines for all’ (World Trade Organisation, 2001a), Doha added access to treatment and an ethical rationale to the intellectual property and health debate, an approach so sorely missing in TRIPS. As a result, the Doha Declaration can be seen as a recognition that the protection of intellectual property on medicines was subject to considerations of justice and equity. Despite this important advance in the intellectual property and global health landscape, in 2011 UN members removed reference to this critical document in their strategy to address the scourge of NCDs. This effectively turned back the clock to a pre-Doha landscape, where the focus on prevention overshadows any attempt to ensure those who are already sick receive treatment. This paper looks at the potential reasons for this retreat from Doha and its message of access to medicines for all when addressing the NCD crisis. Presenting access to NCD medicines as an issue of global health equality and justice, I demonstrate that the negotiated removal of a reference to the Doha Declaration in the 2011 UN Political Declaration on Non-communicable Diseases (Political Declaration) marked a retreat by UN member states from their earlier commitment to distributive justice in global health. While the consequences of this ‘ethical retreat’ on the lives and health of NCD patients in LMICs are yet to be seen, the ethical principles underpinning the Doha Declaration will prove central to effective global strategies to address the NCD crisis facing the world today.
THE EPIDEMIC OF NON-COMMUNICABLE DISEASES: A GLOBAL HEALTH CRISIS For every five deaths world wide, three are caused by cancer, heart and lung disease, and diabetes. Translating to 36 million deaths per year in 2008, NCDs account for over 63% of total deaths globally and over 80% of those deaths occur in developing countries (WHO, 2010a). In 2007, the United Nations (UN) recognized the rise of NCDs as one of the major challenges for development in the twenty-first century and an ‘epidemic that threatens many of the development gains made over the last twenty years’ (WHO, 2010b).
NCDs are no longer a disease of the rich and elderly: these diseases are devastating young adult populations in the poorest countries of the world and are ignorant of geographical boundaries. As truly global diseases, they also represent huge inequities between populations. One look at the figures shows why. While mortality due to NCDs has declined by more than half in some high-income countries, this is not the case in LMICs. Here death rates among young adults are increasing at an alarming rate, especially among the poorer populations. If nothing is done, the WHO predicts that by 2015, the rate of NCDs will increase by 20% in LMICs and by 25% on the African continent. NCDs are one of two leading causes of death among women in LMICs and a woman in Africa is twice as likely to die from an NCD as a woman living in a high income country. In the light of these startling figures, it is little wonder that the World Economic Forum has ranked NCDs as the third greatest risk for global economic loss, largely due to escalating costs of care, threats to productivity as a result of young lives lost, and the poverty caused by high treatment costs (World Bank, 2011).
NCDs as health inequity Of course, not all inequalities are bad: some inequalities just are. Global health is principally concerned with identifying, measuring and addressing those health inequalities and understanding when and why those inequalities are bad or unjust. Health inequalities between social groups can be seen as ‘unjust when they result from an unjust distribution of socially controllable factors that affect population health and its distribution’ (Daniels, 2011). This is clearly the case for NCDS where the WHO has demonstrated that there is an ‘unjust distribution of socially controllable factors’ both on an international and a local level (WHO, 2010a). The WHO identifies both local and global social and economic conditions which influence a person’s exposure to NCDs: from the inability of governments to regulate in-country marketing of harmful products or to educate their populations about the associated health risks, through to unfair trade and irresponsible marketing of health-compromising products which target children and women. (WHO, 2008). People of lower social and economic positions fare worse in countries at all levels of development. Academic studies and policy reports from WHO, as well as many of its member governments, point clearly to gross inequities in the way low income, less educated and otherwise socially disadvantaged people are impacted by NCDs. Vulnerable and socially disadvantaged people get sicker and die sooner than people of higher social positions. This story is repeated in country after country as NCDs
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Breaching Doha’s Ethical Threshold are caused by, and are a cause of, poverty. The cycle of poverty is not only a temporal problem: evidence shows that that ‘the poor may begin life with increased vulnerability to NCDs and are then exposed to additional risks throughout life. . .. As a consequence the poor are more likely to die prematurely from NCDs’ (WHO, 2010a).
Inequitable access to NCD medicines It seems almost too obvious to point out that medicines are central to any public health and medical system. Yet, 30% of the global population, or between 1.3 and 2.1 billion people, still lack access to essential medicines and those people are largely living in LMICs. In India, between 50–65% of the population, an estimated 499–649 million people, do not have regular access to essential medicines.1 Throughout Africa, a further 267 million people or almost half the population (which is 15% of the world total) also lack access (WHO, 2004). One major barrier to accessing treatment is the cost of medicines in developing countries. Nowhere is this shown more clearly than in the HIV/AIDS crisis that exposed the fatal inequity of access to life saving treatments. Civil society organizations argue that the disproportionate burden of mortality in LMICs is also caused by the lack of access to NCD medicines (MSF et al., 2011). While the health prevention approach to NCDs through regulation and sanction in HICs has been an important aspect of the domestic public health approach, access to effective treatment for current and future NCD patients has also been a critical piece of the puzzle. Numerous treatments for NCDs have been made available to patients in HICs. Furthermore, the majority of these patients are able to access treatment subsidized under their universal health care systems.2 NCDs in highincome countries have therefore been addressed both through recognizing the need to prevent but also the need to treat. Yet, this privileged access to treatment is not shared with the world’s poor on whom the majority burden of NCD morbidity falls. On top of the inequalities in the NCD morbidity and mortality burden, there are inequities in the economic consequences of NCDs. The World Health Report 2010 states that each year 100 million people are pushed into 1
The Indian health ministry has proposed a new initiative called ‘Free medicine for all through Public Health facilities’ as part of its goal of Universal Health Care for all (Singh, 2012). This comes as the Indian government increases its spending on health care, while simultaneously making use of TRIPS flexibilities such as its recent compulsory license on the cancer drug, Nexavar (Ananthakrishnan, 2012). 2 A notable exception is in the US where a significant minority of the population are unable to access health care while the rest of the population depends on workers health insurance to access expensive treatments. The new US health care legislation is intended to rectify this inequality within the US.
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poverty because they have to pay directly for health services: in some countries this may represent 5% of the population being forced into poverty each year. Out of pocket payments still represent more than 50% of total health expenditures in a large number of LMICs (WHO, 2008). In some cases, medicines can cost up to 90% of a family’s budget and represent the largest family expenditure item after food (Cameron, Ewen, Ross-Degnan, Ball, & Laing, 2009). Many poor sick people, often mothers and caregivers, do not seek treatment for their illnesses.
THE SHIFT TO SOCIAL JUSTICE The TRIPS challenge TRIPS introduced medicines as a commodity, finalizing efforts to class medicines as a product with a market utility value just like any other marketable product such as compact discs, DVDs or books that could be measured and distributed according to price. This represented a major shift away from the social justice approach to medicines and health previously adopted by many LMICs and even some HICs (Correa & Matthews, 2011). Countries like Brazil and India had resisted applying certain types of patents to medicines because they considered the public health advantages for their population in keeping the prices down outweighed any perceived negative impacts on innovation for new medicines (E t Hoen, Berger, Calmy, & Moon, 2011). Even as recently as the 1970s, some rich countries such as Sweden, Switzerland and Italy were among the few European countries that resisted patenting medicines for essentially the same reasons, with Spain only offering patent protection in 1992 (La Croix & Liu, 2009). In essence those countries had prioritised health as a public good that should not be adversely affected by trade agreements or activities. With the promise of better access to investment and other developmental advantages, WTO members, rich and poor, adopted TRIPS and created an inextricable link between trade and health that would come to impact fundamentally the ability of countries to provide global public health goods, such as medicines, to their people. As a result of TRIPS and its system of patent monopolies, HIV patients in LMICs, not covered by universal health care, were unable to afford the high prices of treatment. Mortality was rising exponentially with untold millions dying from AIDS each year. As HIV/AIDS developed into a major global public health catastrophe, access to essential medicines to treat HIV/AIDS became a priority. Yet governments could not afford the high prices of patented medicines. In 2000, a one-year course of a single brand name anti-retroviral drug (ARV), d4T, cost between US$10,000 and US$15,000. Médecins sans Frontières (MSF) found that through the promotion of
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competition, the price of medicines could be dramatically reduced. Noting how large-scale treatment of HIV with antiretroviral (ARVs) drugs has become a reality and an international priority, MSF credited the ‘massive price reductions triggered by generic competition for the first generations of ARVs’ (MSF, 2011). This price drop helped initiate of a full scale roll-out of ARV treatment in Africa and finally a dent was made in the HIV/AIDS crisis.3
Doha: A declaration of social justice in health Recognizing the impact of TRIPS on distributive justice in pharmaceuticals, the public health community first raised concerns about the impacts of international trade on health and access to medicines during the World Health Assembly 1996 (E. t Hoen, 2002). At the World Health Assembly in 1998, Member States resolved to ensure that public health interests were paramount in pharmaceutical and health polices (SouthCentre, 2011) and the WHO produced a guide with recommendations to States on how to implement TRIPS while limiting the negative effects of higher levels of patent protection on drug availability (Velasquez & Boulet, 1999). Meanwhile, at the WTO, LMICs spearheaded and drove the debate forward.4 This reflected growing concerns about the implications of the TRIPS Agreement on access to medicines manifested by ‘the HIV crisis in subSaharan African countries, the attempts by the pharmaceutical government, backed by some governments, to block the implementation of TRIPS-compatible measures by the South African government and the complaint by the USA against Brazil’ (Correa, 2002). These LMICs managed to force HICs to negotiate an agreement that would clarify and amend5 the ability of countries to use the flexibilities built into TRIPS to protect public health in their countries. WTO members finally agreed the Doha Declaration on TRIPS and Public Health in 2001 which confirmed that ‘the [TRIPS] Agree3
Treatment was vastly expanded with coverage quadrupling from 400,000 people in December 2003 to 1.6 million at the end of June 2006. This included a ten-fold increase in sub-Saharan Africa (WHO, 2006). 4 Supported by civil society domestically and internationally, it was the African Group of countries, supported by other LMICS, which in 2001 requested that the Council for TRIPS deal specifically with the relationship between TRIPS and public health. As the Africa Group led by Kenya noted at the time ‘Indeed, we are very encouraged by the degree of agreement, as indicated in the Members’ statements, on the need to ensure that the implementation of the TRIPS Agreement does not prevent Members from adopting appropriate measures to protect public health and ensure to affordable medicines’ (Africa Group, 2001). 5 It is important to note the potential to amend TRIPS. Some high income countries only wanted to allow a clarification of TRIPS but in the end such a text was not included. ‘As a result, one could argue that the Declaration actually does go beyond clarifying the already existing rules.’ (E. t Hoen, 2002).
ment can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.’ (World Trade Organisation, 2001b). By doing this, countries had implicitly acknowledged a place for distributive justice in access to medicines. The Doha Declaration was a ground-breaking document for global public health and a ‘concrete success’ to which developing countries and NGOs could point (Drahos, 2002). It was a remarkable victory for LMICs that had had to resist intense resistance from some HICs such as the United States and Canada. Driving that resistance was the powerful pharmaceutical company lobby which was opposed to any amendment to TRIPS, an agreement which they had been key in bringing onto the international agenda.6 As just one example of how far their lobbying efforts went, US pharmaceutical companies even asked the United States Trade Representative to re-open negotiations after an agreement on the text had been reached (E. t Hoen, 2002). Doha and the road to Doha ‘represented the first significant push back to the relentless march to strengthen private intellectual property rights without regard for societal consequences in poor countries’ (E t Hoen et al., 2011). For civil society and many LMICs, Doha was seen as a clarion call for equitable allocation of health resources to ensure medicines were available to all patients, wherever they lived and in whatever socioeconomic, cultural or political context they found themselves. The year Doha was signed marked a year in which a movement for social justice in global health policy began to concretely take shape at international policy making levels and was the culmination of years of LMIC efforts to place social justice at the heart of protecting and promoting health (Nunn, Fonseca, & Gruskin, 2009). Doha was tangible and deeply consequential in the realisation of the steady push to bring policy changes in the discussion of access to medicines for all on the basis of justice rather than trade economics.
Health as a global public good The Doha Declaration ‘unequivocally recognised that access to medicines should have primacy over commercial interests’ (MSF, 2003). Until then, private interests 6 Duncan Matthews remarks that during the Uruguay round of negotiations that led to TRIPS the influence of business interests ‘was undoubtedly crucial to the developed countries’ negotiating positions on intellectual property protection . . . and played an important role in influencing policy decisions’ (Matthews, 2002). He writes that US officials were in constant contact with their national industries which provided ‘technical and legal expertise and advocacy skills based on years of experience’ and how these industries had been openly critical of some of the drafts which they saw as too lenient on developing countries (Matthews, 2002).
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Breaching Doha’s Ethical Threshold had been supported by TRIPS in maintaining tight control over the supply, cost and delivery of medicines. The intersection of trade and health in the field of pharmaceutical products enshrined in TRIPS promoted a utilitarian approach which foresaw market incentives to incentivize companies to innovate new treatments and medical technologies. Medicines became a commodity like any other and subject to the will of the market economy. Not only has this ‘patent to innovate’ argument been proven unfounded (Commission on Intellectual Property Rights, 2006), distribution according to the market has created ‘two kinds of medicine – one for the rich and one for the poor. And it too often happens that the medicine for the poor is none at all’ (Munson, 2000). If we understand health care to be a public good and access to essential medicines as a core element of that public good, then it is hard to claim that the poor somehow deserve to have a smaller share of the medicines available than the rich (Sen, 1999). While they clearly do not deserve it, the reality today is that this is too often the case. Recognizing that introducing TRIPS and patent monopolies globally had created inequity in the distribution of essential resources for health, Doha clarified the primacy of public health in the application of international patent obligations. As had happened before TRIPS, LMICs were implicitly recognising that medicines are no ordinary product and that the market could not always be left to ensure a just distribution of those goods. As Amartya Sen notes ‘the rationale of the market system is geared to private goods (like apples and shirts), rather than public goods (like the malaria-free environment), and it can be shown that there maybe a good case for the provisioning of public goods, going beyond what the private markets would foster’ (Sen, 1999). Sen argues that the far-reaching powers of the market mechanism have to be supplemented by the creation of basic social opportunities for social equity and justice (Sen, 1999). While TRIPS indicates that countries were willing to treat medicines as just another commodity, Daniels questions whether inequalities in access should be allowed to vary with ‘whatever economic inequalities are permissible according to more general principles of distributive justice’ (Daniels, 2008). Health has a special moral importance (Daniels, 2008) and, since health care cannot function without medicines, medicines become a public good which ‘people should be assured of the possibility of accessing . . . if they are needed to promote their ‘normal functioning’. (Daniels, 2008). In other words, just because some people are richer than others, which may be inequitable but not unjust, it does not mean that as a result they should be able access medicines, which others cannot afford. That would be unjust. Health cannot be isolated from broader social justice. Making health inequalities acceptable ‘must be compat-
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ible with what justice requires in the distribution of a broad range of social goods’ (Daniels, 2008). In other words, if there is distributive justice in allocating social goods, like medicines, then any inequalities in health may be acceptable. However, if the distribution of medicines is unjust and there is consequently no distributive justice, then the inequality in health is unjust and is therefore not simply an inequality but rather an inequity. Adopting Daniels’ ethical perspective, Doha becomes a strategy to acknowledge the primacy of social justice in global health, and more particularly in the distribution of health resources. I would argue that this approach to health as a social justice issue with its roots in distributive justice provides a compelling view of the crisis in access to medicines that Doha set out to address. Through Doha, countries basically were claiming that medicines are not a commodity like any other and, therefore, flexibilities in TRIPS needed to be used to recognise the unique moral importance of medicines as a public good in global health. To restore distributive justice as a basis for ensuring just health, the countries insisted on the special importance of medicines and a rejection of health inequalities to become health inequities because of the commodification of health goods based on economic access to medicines. TRIPS revealed that the market alone did not work to enable people to access medicines equitably. There needed to be specific measures to control the influence of the market in order to enable equitable access to medicines. The Doha Declaration tried to strike a delicate balance between acknowledging the importance of the market-led system to innovate and develop new treatments and the need to supplement this with guarantees of distributive justice to guide global policy making on the provision of specific health goods. By signing Doha countries had not rejected the market based system per se, but rather were addressing what they saw as a problem arising from, as Amartya Sen puts it, ‘the unregulated use of activities that allow the powerful to capitalize on their asymmetrical advantage.’ Sen goes on to say that these have to be dealt with not by suppressing the markets ‘but by allowing them to function better and with greater fairness, and with adequate supplementation. The overall achievement of the market is deeply contingent on political and social arrangements.’ (Sen, 1999). This view is supported by Sigrid Sterckx who viewed Doha as an attempt to reach ‘a fairer balance between the rights and obligations of patent holders and between the interests of patients and those of patent owners’ (Sterckx, 2004). The claim that Doha is a declaration of social justice is an important one given the practical reality of medicines and their distribution. The social justice discourse recognizes that health is inherent to each of us and having health, as broadly conceived, is an issue of justice first and foremost. Recognizing the social justice motivation of
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Doha provides the ethical and moral foundation for distributive justice in health that is able to unite and propel efforts by states and organizations to realize equity in global health.7 It follows that to deny Doha and to ignore it in global health agreements, such as we will see in the recent Political Declaration on NCDs, is to deny the ethical imperative to ensure distributive justice.
PULLING BACK FROM SOCIAL JUSTICE: RETURNING TO THE PRE-DOHA LANDSCAPE8 Countries have continuously reneged on Doha. MSF noted in their 2003 report that ‘[s]ince Doha, some Members have attacked both the spirit and intent of the Declaration, putting the interests of their pharmaceutical industries ahead of the health of the world’s poor.’ (MSF, 2003). To date, attacks on Doha have outweighed the ability of countries to use the TRIPS flexibilities.9 The negotiation process around the UN Political Declaration on NCDs confirms the extent of the drift away from a social justice approach to health and shows how states crossed an ethical threshold. Prior to the negotiation, the issue of access to medicines for NCD patients had first been raised at the WHO Ministerial Meeting in Moscow where the resulting Moscow Declaration included for the first time mention of the need to ensure affordable access to medicines for NCDs (WHO, 2011).10 Based on the discussions that began at that Moscow meeting, delegates from LMICs included clear references to TRIPS and Doha in the draft Political Declaration for the UN High Level Meeting. A comparison of the language of the final text of the Political Declaration as well 7 This reflection is being reflected today in the efforts to acknowledge social determinants of health. Sir Michael Marmot, who chaired the World Health Organization (WHO) Commission on Social Determinants of Health, stated that that public policy needs to be based ‘on a vision of the world where people matter and social justice is paramount’ (Marmot, 2005, p1009 in Labonté and Schrecker p24). 8 Malini Aisoli coined this characterisation of access to medicines after the 2011 UNGA Political Declaration on NCDs. 9 See the case of Thailand to understand how political and economic pressures not to use TRIPS flexibilities has impacted access to medicines (Wibulpolprasert, Chokevivat, Oh, & Yamabhai). See also the case of Thailand’s compulsory licence on Plavix which provoked criticism from the EU and US. As they see it, using TRIPS flexibilities for chronic NCDS like cancer ‘hits right at the heart of the global pharmaceutical industry’s profit model’ (Correa & Matthews, 2011). The same has happened to India in the wake of the 2012 compulsory licence issued for Imatinib. The US Commerce Secretary raised concerns about India’s action stating that ‘Any dilution of the international patent regime is a cause for deep concern for the US’ (Daglian, 2012). 10 That Moscow Declaration stopped short of mentioning intellectual property issues related to access to affordable medicines and simply referred to the need to ensure access to affordable medicines. Experience from the HIV/AIDS crisis has shown that such weak references in documents become mere rhetoric unless they are backed up.
as prior versions clearly shows the evolution of the text from one that sought to include stronger references to TRIPS flexibilities and the Doha Declaration, to one that has dangerously weak safeguards in place. The negotiation process was reportedly fraught, with a clear divide between the G77 (an important grouping of LMICs) and the US and EU. Countries reported that one of the most problematic issues was related to the G77’s proposed language on TRIPS flexibilities and the Doha Declaration. The EU and US had been calling for deletion of references to both to prevent what they saw as establishing a new interpretation of TRIPS to cover drugs for NCDs. The US claimed that Doha did not apply to NCDs, as they were neither an epidemic nor a set of diseases to which TRIPS applied. Both these arguments are deeply flawed. During negotiations on Doha, any efforts to limit Doha to specific diseases or countries were rejected (E. t Hoen, 2002) and there is no language in Doha that limits its applicability to epidemics or emergencies. Indeed, efforts to limit were an important point of negotiation and text was changed to specifically broaden the application to public health.11 Yet, the US maintained that no Political Declaration would be preferable to one with reference to TRIPS flexibilities and the Doha Declaration. In the end, the text adopted by the members at the last minute represented a clear compromise to the advantage of the US position: TRIPS was mentioned but all references to Doha included in the draft text were deleted. Despite the misleading and incorrect polemic in the negotiations around the Political Declaration on NCDs, the LMICs had eventually caved to the US and EU pressure.12 Some commentators have argued that the mention of TRIPS in the Political Declaration is sufficient.13 However, given the intense negotiations over the inclusion of references to Doha up until the last minute, and given that the very same UN members made strong references to the importance of Doha in the second Political Declaration on HIV/AIDS (United Nations General Assembly, 2011) only three months prior to the Political Declaration on NCDs, the deliberate removal of Doha from the Political Declaration becomes even more striking.14 11
As is can be seen in the reference to public health in the title of the Doha Declaration (E. t Hoen, 2002). 12 Interesting the Political Declaration on NCDs was adopted as the first agenda item of the High Level Meeting on NCDs. The completion of the negotiations several weeks before the HLM allowed member states to go on to make unequivocal statements that not only did Doha apply to NCDs but that access to medicines was essential to addressing the NCD crisis. 13 See for example Professor Fred Abbott on the omission of Doha in the Political Declaration (Silverman, 2011). 14 In looking at the ethical impact of Doha and its impact, it is important to put Doha in context. Doha represents an agreed understanding of aspects of TRIPS and clarifies specific provisions, with legal effect in
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Breaching Doha’s Ethical Threshold The attempts by some member states to return to a pre-Doha landscape for NCDs obscures once more the importance of access to medicines in addressing the global health crisis of NCDs and draws political attention and resources only to prevention.15 By specifically negotiating out the text on Doha, countries could be seen as giving the signal that TRIPS as it stands is able to deal with access to NCD medicines issues. History tells us this is not the case.
Doha’s ethical value: A conclusion? Not including reference to Doha in the NCD Declaration was not a mere oversight–reaching a global agreement on a Political Declaration on NCDs was uncertain without its removal. So has that removal marked the demise of the ethical value embodied in the Doha Declaration? I have argued that the members of the WTO adopted Doha and created a global moral precedent that was intended to form the basis of a drive for global distributive justice in access to essential medicines. It also demonstrated a step towards a rebalancing, or even a pulling back, from a market driven global health system. Doha represented a rejection of the wholesale commodification of medicines introduced by TRIPS and that led to the creation of profound health inequities. In other words, the supreme global trade body had implicitly recognized that market values as a driver of justice had not provided equitable access to medicines as many had claimed it would. Viewed in this way, we can see just how extraordinary Doha was. favour of WTO members right to protect public health in cases of ambiguity (Correa, 2002). Furthermore, WTO members have to implement Doha and operationalise flexibilities through national legislation. Since the Political Declaration there have been important examples of countries doing just that – India has issued a compulsory licence on an anti-cancer drug, China is amending patent laws to ease provisions for compulsory licensing and South Africa is designing a new intellectual property policy that many hope will raise patentability standards. When questioned countries like India vigorously defend their use of TRIPS flexibilities, invoke Doha and the need for consumer protection. While this shows important ways in which some governments are defending the ethical value of Doha, there are also examples of countries moving in the opposite direction. Kenya recently introduced an anti-counterfeit drug bill will could block the commercialization of affordable generic medicines and negotiations of a Trans Pacific Partnership contains terms which could negatively impact access to medicines as does the European-India Free Trade Agreement. Given this ambiguity in the stance of different countries on access to medicines, the implication of key high-income countries fighting for the removal of references to Doha in the Political Declaration cannot be ignored. 15 This scenario is a throwback to the early days of the HIV/AIDS crisis when political actors were denying the importance, or in some cases the possibility of treating AIDS patients and instead focused on prevention measures. It was not until Doha came into being that countries were able to unequivocally use WTO language to show how TRIPS flexibilities could and should be used given the context of global inequality.
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Doha was pragmatic yet profound in its ambition. It recognized that the market system was dominant and that the members of the WTO had chosen to come together precisely because of that economic model. Yet some member states also recognized that the system created deep inequities in global health due to abuse by vested interests operating at the intersection of trade and health. Doha was arguably an attempt to provide a check and balance for market interests as a system of choice by placing interests in health equity as a preeminent condition of that choice. As an instrument of social justice, Doha therefore made an important mark on the global health scene. Yet those same ground-breaking member states buckled a decade later. While the reasons around the recent retreat from Doha are multi-layered and complex, the practical result is that access to NCD medicines has not been accorded the same status as access to HIV/AIDS drugs. Deliberate misrepresentations, misinformation and ignorance of historical discussions and debates have undermined the social justice ambitions lying at the heart of the Doha Declaration. Removing the mention of Doha from the Political Declaration has the potential to force prevention-only NCD strategies on LMICs when what is needed are prevention and treatment approaches. By pushing back social justice efforts and turning us back once more to a market driven-approach where medicines are a commodity just like any other, we to return to the travesty of justice witnessed in the 1990s. By the end of that decade, 22 million people in LMICs had died of AIDS simply because they were not able to access affordable medicines. The market system had failed millions of HIV/AIDS patients. Doha came to account for, and correct, that grave global injustice. Are we now witnessing the return of that injustice? But, the Doha Declaration has not been revoked. The optimistic view of the Political Declaration is that including TRIPS implies the inclusion of Doha. Access minded actors working on the global NCD crisis have to make sure that the removal of the reference to Doha does not signal that Doha is not applicable to NCDs. Doha’s value lies in its acknowledgement that access to essential medicines for all is a fundamental issue of social justice. Doha marks an ethical threshold and States are challenged to defend those values. By insisting on the relevance of Doha despite the compromises made in the Political Declaration, the reference to TRIPS must be read to include the principles evoked by Doha. While it may be true that the constant attacks on Doha since its passage has tarnished its reputation, its ethical values of justice and equity in global health remain as noble and as essential today as they were over a decade ago. Promoting and defending those ethical values in the wake of the Political Declaration remains a central element of the struggle to support access to medicines for all.
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Acknowledgements Special thanks to my McGill University bioethics professor, Dr Carolyn Ells, whose guidance, encouragement and patience has been invaluable to me in writing this paper. Thanks also to my colleagues Sandeep Kishore, Malini Aisola, Cailin Morrison and Ethan Guillen for their thoughtful and knowledgeable comments and encouragement on the draft. And above all, thank you to all the treatment activists, patients and friends who have taught me all I know about justice and equity in access to medicines over the past 10 years and whose courage and brilliance has been such an inspiration.
Biography Rachel Kiddell-Monroe, LLM Bioethics, member of the United Kingdom Law Society since 1991, has worked on humanitarian and human rights issues since 1989. Working with Médecins sans Frontières between 1992 and 2007, Rachel headed emergency humanitarian missions in Africa and Latin America and then directed MSF’s Access to Essential Medicines Campaign in Canada. Rachel also lectures at McGill University and has consulted for the Drugs for Neglected Diseases Initiative (www.dndi.org) and the Canadian HIV/AIDS Legal Network on the Canadian Access to Medicines Regime (www.aidslaw.ca). Currently a member of the MSF International Board, Rachel is also Senior advisor for Universities Allied for Essential Medicines (www.uaem.org).
APPENDIX Africa Group. 2001. Statement by the Africa Group at TRIPS and Public Health Informal session of the WTO TRIPS Council, July 25, 2001. http://www.twnside.org: Third World Network. G. Ananthakrishnan. 2012, 14 March 2012. A historic move to make drugs affordable, Op-Ed, The Hindu. Retrieved from http://www .thehindu.com/opinion/op-ed/article2991869.ece [Accessed 24 Feb 2014]. A. Cameron, M. Ewen, D. Ross-Degnan, D. Ball & R. Laing. Medicine prices, availability, and affordability in 36 developing and middleincome countries: a secondary analysis. The Lancet 2009; 373(9659): 240–249. Commission on Intellectual Property Rights, I. a. P. H. C. 2006. Public health, innovation and intellectual property rights: Report of the Commission on Intellectual Property Rights Innovation and Public Health. In WHO (Ed.). Geneva. C. Correa. 2002. Implications of the Doha Declaration on The TRIPS Agreement and Public Health WHO (pp. 70): WHO. C. Correa & D. Matthews. 2011. The Doha Declaration Ten Years on and its Impact on Access to Medicines and the Right to Health. In UNDP (Ed.): UNDP. M. Daglian. 2012, 30 March 2012. US protests India’s Compulsory Licence for Nexavar, The Burrill Report. Retrieved from http:// www.burrillreport.com/article-us_protests_india%E2%80%99s _compulsory_license_for_nexavar.html [Accessed 24 Feb 2014]. N. Daniels. 2008. Just Health: Meeting Health Needs Fairly: Cambridge University Press. N. Daniels. (Ed.). 2011. International health inequalities and global justice: toward a middle ground. Toronto: Cambridge. P. Drahos. 2002. Developing Countries and International Intellectual Property Standard Setting (Vol. Study prepared for the UK Commission on Intellectual Property Rights). S. La Croix & M. Liu. The Effect o GDP Growth on Pharmaceutical Patent Protection 1945–2005. Brussels economic review 2009; 52(3/4 Autumn1Winter). D. Matthews. 2002. Globalising intellectual Property Rights: The TRIPs Agreement. London and New York: Routledge.
MSF. 2003. Doha Derailed: A Progress Report on TRIPS and Access to Medicines. MSF Briefing for the 5th WTO Ministerial Conference, Cancun 2003. MSF, UAEM, KEI, Oxfam, TWN, HAI & YPCDN. 2011. NonCommunicable Diseases & Access to Medicines: Recommendations for Member States to Control NCDs in Low and Middle-Income Countries Ensuring. New York: UAEM, YPCDN. R. Munson. 2000. Interventon and Reflection: Basic Issues in Medical Ethics (7th ed.). Belmont, CA: Thomson Wadsworth. A. Nunn, E.D. Fonseca & S. Gruskin. Changing global essential medicines norms to improve access to AIDS treatment: lessons from Brazil. Global public health 2009; 4(2): 131–149. doi: 10.1080/ 17441690802684067 A. Sen. 1999. Development as Freedom: Anchor Books. E. Silverman. 2011, 9 December 2011. Essential Meds, Patents & NCDs: Abbott Explains. Retrieved from http://www.pharmalot.com/ 2011/09/essential-meds-patents-ncds-abbott-explains/ [Accessed 24 Feb 2014]. D.M. Singh. 2012. “Health Outlay to be increased to 2.5% of GDP. New Delhi: PMIO Retrieved from http://pmindia.nic.in/press-details .php?nodeid=1378. [Accessed 24 Feb 2014]. SouthCentre. 2011. The Doha Declaration on TRIPS and Public Health Ten Years Later: The State of Implementation. In S. Centre (Ed.), Policy Brief. S. Sterckx. Patents and access to drugs in developing countries: an ethical analysis. Developing world bioethics 2004; 4(1): 58–75. doi: 10.1111/j.1471-8731.2004.00067.x. E. t Hoen. TRIPS, pharmaceutical patents, and access to essential medicines: a long way from Seattle to Doha. Chicago journal of international law 2002; 3(1): 27–46. E. t Hoen, J. Berger, A. Calmy & S. Moon. Driving a decade of change: HIV/AIDS, patents and access to medicines for all. [Review]. Journal of the International AIDS Society 2011; 14: 15. doi: 10.1186/17582652-14-15. United Nations General Assembly. 2011. Political Declaration on HIV/ AIDS: Intensifying our Efforts to Eliminate HIV/AIDS. New York: United Nations. G. Velasquez & P. Boulet. 1999. Globalization and Access to Drugs: Perspectives on the WTO/TRIPS Agreement. In WHO (Ed.), (2nd ed.). Geneva. WHO. 2004. The World Medicines Situation In WHO (Ed.), (pp. 151). Geneva: WHO. WHO. 2006. HIV treatment reaches over 1 million people in subSaharan Africa, WHO Reports. Toronto: WHO. WHO. 2008. 2008–2013 Action Plan for the Global Strategy for the Prevention and Control of Noncommunicable Diseases. In WHO (Ed.). Geneva: WHO. WHO. 2010a. Global Status Report on Noncommunicable Diseases. In WHO (Ed.) WHO. WHO. 2010b. WHO Discussion Paper for Informal Dialogue with the NGO Sector in the preparation of the UN High Level Meeting of the General Assembly on Noncommunicable Diseases. New York: WHO. WHO. 2011. Moscow Declaration First Global Ministerial Conference on Healthy Lifestyles and Noncommunicable Disease Control, Moscow. Moscow: WHO. S. Wibulpolprasert, V. Chokevivat, C. Oh & I. Yamabhai. Government use licenses in Thailand: The power of evidence, civil movement and political leadership. Globalization and Health 7(32). doi: 10.1186/ 1744-8603-7-32. World Bank. 2011. The Growing Danger of Non-Communicable Diseases: Acting Now to Reverse the Course: The World Bank. World Trade Organisation. 2001a. Declaration on TRIPS and Public Health, WT/MIN(01)/DEC/2. [WTO ministerial declaration]. World Trade Organisation. 2001b. Ministerial Declaration WT/ MIN(01)/DEC/1.
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bioethics
Developing World Bioethics ISSN 1471-8731 (print); 1471-8847 (online) Volume 14 Number 2 2014 pp 59–66
doi:10.1111/dewb.12046
ARTICLES ACCESS TO MEDICINES AND DISTRIBUTIVE JUSTICE: BREACHING DOHA’S ETHICAL THRESHOLD RACHEL KIDDELL-MONROE
Keywords distributive justice, pharmaceutical, ethics, developing world bioethics, HIV/AIDS, health, treatment
ABSTRACT The global health crisis in non-communicable diseases (NCDs) reveals a deep global health inequity that lies at the heart of global justice concerns. Mirroring the HIV/AIDS epidemic, NCDs bring into stark relief once more the human consequences of trade policies that reinforce global inequities in treatment access. Recognising distributive justice issues in access to medicines for their populations, World Trade Organisation (WTO) members confirmed the primacy of access to medicines for all in trade and public health in the landmark Doha Declaration on the TRIPS Agreement and Public Health of 2001.
In this article, I argue the Doha Declaration on the TRIPS Agreement and Public Health in 2001 acknowledged that the protection of intellectual property on medicines was subject to considerations of justice and equity. Demonstrating that access to Non-communicable Disease medicines is an issue of global health equality and justice, I show that the negotiated removal of a reference to the Doha Declaration in the 2011 UN Political Declaration on Non-communicable Diseases marked a retreat by UN member states from their commitment to distributive justice in global health. While the consequences of breaching this ethical threshold for treating NCD patients in low and middle income countries remain to be seen, I argue that promoting the ethical principles underpinning the Doha Declaration are central to global strategies to address the NCD crisis facing the world today.
INTRODUCTION Non-communicable diseases (NCDs) are a global health crisis. By 2030, 75% of the world’s deaths will be caused by cancer, diabetes, heart and lung disease. Not only are NCDs a global health crisis, they also reveal a crisis of global health inequality: 80% of the NCD deaths reported worldwide occur in low and middle income countries (WHO, 2008). Such inequity lies at the heart of global justice concerns.
Ensuring equitable access to essential NCD medicines is central to treating millions of people worldwide who are currently ill and dying. Yet millions of NCD patients today living in low and middle income countries (LMICs) are unable to access treatment. It is not news that there is an inequitable distribution of essential medicines globally that disproportionately affects the poor. According to the WHO, in LMICs one in three people do not have access to essential medicines. This figure rises to one in two in sub-Saharan Africa. While the reasons are complex, the HIV/AIDS epidemic has brought into stark relief the human consequences of trade policies that reinforce global inequities in treatment access. Recognising that pharmaceutical patenting was fuelling this global health inequity, the World Trade Organisation (WTO) agreed to clarify and amend the 1995 Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS). Through its focus on the protection of patents on pharmaceuticals, TRIPS had allowed pharmaceutical monopolies. These monopolies prevented market competition for medicines urgently needed to treat patients dying from HIV/AIDS. This kept patented medicines at prices that poor patients and countries could not afford. The focus on prevention strategies only rather than ensuring treatment for those infected has been blamed for the soaring HIV infections and AIDS related deaths. Today we know that treatment is prevention in
Address for correspondence: Rachel Kiddell-Monroe, Law and Bioethics, Chancellor Day Hall, McGill University, 3644, rue Peel, Montreal, Quebec H3A 1X1 Canada. Email: [email protected]. Conflict of interest statement: No conflicts declared © 2014 John Wiley & Sons Ltd
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HIV/AIDS and that access to affordable treatment is the key to dealing with the pandemic. Understanding that prevention alone was not enough to address a global health crisis, LMICs drove the 2001 Doha Declaration on the TRIPS Agreement and Public Health (the Doha Declaration or Doha) through the WTO (World Trade Organisation, 2001a) and thereby confirmed the importance of using TRIPS flexibilities to ensure low-cost generic production of essential medicines. By recognizing that TRIPS should be interpreted and implemented ‘to promote access to medicines for all’ (World Trade Organisation, 2001a), Doha added access to treatment and an ethical rationale to the intellectual property and health debate, an approach so sorely missing in TRIPS. As a result, the Doha Declaration can be seen as a recognition that the protection of intellectual property on medicines was subject to considerations of justice and equity. Despite this important advance in the intellectual property and global health landscape, in 2011 UN members removed reference to this critical document in their strategy to address the scourge of NCDs. This effectively turned back the clock to a pre-Doha landscape, where the focus on prevention overshadows any attempt to ensure those who are already sick receive treatment. This paper looks at the potential reasons for this retreat from Doha and its message of access to medicines for all when addressing the NCD crisis. Presenting access to NCD medicines as an issue of global health equality and justice, I demonstrate that the negotiated removal of a reference to the Doha Declaration in the 2011 UN Political Declaration on Non-communicable Diseases (Political Declaration) marked a retreat by UN member states from their earlier commitment to distributive justice in global health. While the consequences of this ‘ethical retreat’ on the lives and health of NCD patients in LMICs are yet to be seen, the ethical principles underpinning the Doha Declaration will prove central to effective global strategies to address the NCD crisis facing the world today.
THE EPIDEMIC OF NON-COMMUNICABLE DISEASES: A GLOBAL HEALTH CRISIS For every five deaths world wide, three are caused by cancer, heart and lung disease, and diabetes. Translating to 36 million deaths per year in 2008, NCDs account for over 63% of total deaths globally and over 80% of those deaths occur in developing countries (WHO, 2010a). In 2007, the United Nations (UN) recognized the rise of NCDs as one of the major challenges for development in the twenty-first century and an ‘epidemic that threatens many of the development gains made over the last twenty years’ (WHO, 2010b).
NCDs are no longer a disease of the rich and elderly: these diseases are devastating young adult populations in the poorest countries of the world and are ignorant of geographical boundaries. As truly global diseases, they also represent huge inequities between populations. One look at the figures shows why. While mortality due to NCDs has declined by more than half in some high-income countries, this is not the case in LMICs. Here death rates among young adults are increasing at an alarming rate, especially among the poorer populations. If nothing is done, the WHO predicts that by 2015, the rate of NCDs will increase by 20% in LMICs and by 25% on the African continent. NCDs are one of two leading causes of death among women in LMICs and a woman in Africa is twice as likely to die from an NCD as a woman living in a high income country. In the light of these startling figures, it is little wonder that the World Economic Forum has ranked NCDs as the third greatest risk for global economic loss, largely due to escalating costs of care, threats to productivity as a result of young lives lost, and the poverty caused by high treatment costs (World Bank, 2011).
NCDs as health inequity Of course, not all inequalities are bad: some inequalities just are. Global health is principally concerned with identifying, measuring and addressing those health inequalities and understanding when and why those inequalities are bad or unjust. Health inequalities between social groups can be seen as ‘unjust when they result from an unjust distribution of socially controllable factors that affect population health and its distribution’ (Daniels, 2011). This is clearly the case for NCDS where the WHO has demonstrated that there is an ‘unjust distribution of socially controllable factors’ both on an international and a local level (WHO, 2010a). The WHO identifies both local and global social and economic conditions which influence a person’s exposure to NCDs: from the inability of governments to regulate in-country marketing of harmful products or to educate their populations about the associated health risks, through to unfair trade and irresponsible marketing of health-compromising products which target children and women. (WHO, 2008). People of lower social and economic positions fare worse in countries at all levels of development. Academic studies and policy reports from WHO, as well as many of its member governments, point clearly to gross inequities in the way low income, less educated and otherwise socially disadvantaged people are impacted by NCDs. Vulnerable and socially disadvantaged people get sicker and die sooner than people of higher social positions. This story is repeated in country after country as NCDs
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Breaching Doha’s Ethical Threshold are caused by, and are a cause of, poverty. The cycle of poverty is not only a temporal problem: evidence shows that that ‘the poor may begin life with increased vulnerability to NCDs and are then exposed to additional risks throughout life. . .. As a consequence the poor are more likely to die prematurely from NCDs’ (WHO, 2010a).
Inequitable access to NCD medicines It seems almost too obvious to point out that medicines are central to any public health and medical system. Yet, 30% of the global population, or between 1.3 and 2.1 billion people, still lack access to essential medicines and those people are largely living in LMICs. In India, between 50–65% of the population, an estimated 499–649 million people, do not have regular access to essential medicines.1 Throughout Africa, a further 267 million people or almost half the population (which is 15% of the world total) also lack access (WHO, 2004). One major barrier to accessing treatment is the cost of medicines in developing countries. Nowhere is this shown more clearly than in the HIV/AIDS crisis that exposed the fatal inequity of access to life saving treatments. Civil society organizations argue that the disproportionate burden of mortality in LMICs is also caused by the lack of access to NCD medicines (MSF et al., 2011). While the health prevention approach to NCDs through regulation and sanction in HICs has been an important aspect of the domestic public health approach, access to effective treatment for current and future NCD patients has also been a critical piece of the puzzle. Numerous treatments for NCDs have been made available to patients in HICs. Furthermore, the majority of these patients are able to access treatment subsidized under their universal health care systems.2 NCDs in highincome countries have therefore been addressed both through recognizing the need to prevent but also the need to treat. Yet, this privileged access to treatment is not shared with the world’s poor on whom the majority burden of NCD morbidity falls. On top of the inequalities in the NCD morbidity and mortality burden, there are inequities in the economic consequences of NCDs. The World Health Report 2010 states that each year 100 million people are pushed into 1
The Indian health ministry has proposed a new initiative called ‘Free medicine for all through Public Health facilities’ as part of its goal of Universal Health Care for all (Singh, 2012). This comes as the Indian government increases its spending on health care, while simultaneously making use of TRIPS flexibilities such as its recent compulsory license on the cancer drug, Nexavar (Ananthakrishnan, 2012). 2 A notable exception is in the US where a significant minority of the population are unable to access health care while the rest of the population depends on workers health insurance to access expensive treatments. The new US health care legislation is intended to rectify this inequality within the US.
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poverty because they have to pay directly for health services: in some countries this may represent 5% of the population being forced into poverty each year. Out of pocket payments still represent more than 50% of total health expenditures in a large number of LMICs (WHO, 2008). In some cases, medicines can cost up to 90% of a family’s budget and represent the largest family expenditure item after food (Cameron, Ewen, Ross-Degnan, Ball, & Laing, 2009). Many poor sick people, often mothers and caregivers, do not seek treatment for their illnesses.
THE SHIFT TO SOCIAL JUSTICE The TRIPS challenge TRIPS introduced medicines as a commodity, finalizing efforts to class medicines as a product with a market utility value just like any other marketable product such as compact discs, DVDs or books that could be measured and distributed according to price. This represented a major shift away from the social justice approach to medicines and health previously adopted by many LMICs and even some HICs (Correa & Matthews, 2011). Countries like Brazil and India had resisted applying certain types of patents to medicines because they considered the public health advantages for their population in keeping the prices down outweighed any perceived negative impacts on innovation for new medicines (E t Hoen, Berger, Calmy, & Moon, 2011). Even as recently as the 1970s, some rich countries such as Sweden, Switzerland and Italy were among the few European countries that resisted patenting medicines for essentially the same reasons, with Spain only offering patent protection in 1992 (La Croix & Liu, 2009). In essence those countries had prioritised health as a public good that should not be adversely affected by trade agreements or activities. With the promise of better access to investment and other developmental advantages, WTO members, rich and poor, adopted TRIPS and created an inextricable link between trade and health that would come to impact fundamentally the ability of countries to provide global public health goods, such as medicines, to their people. As a result of TRIPS and its system of patent monopolies, HIV patients in LMICs, not covered by universal health care, were unable to afford the high prices of treatment. Mortality was rising exponentially with untold millions dying from AIDS each year. As HIV/AIDS developed into a major global public health catastrophe, access to essential medicines to treat HIV/AIDS became a priority. Yet governments could not afford the high prices of patented medicines. In 2000, a one-year course of a single brand name anti-retroviral drug (ARV), d4T, cost between US$10,000 and US$15,000. Médecins sans Frontières (MSF) found that through the promotion of
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competition, the price of medicines could be dramatically reduced. Noting how large-scale treatment of HIV with antiretroviral (ARVs) drugs has become a reality and an international priority, MSF credited the ‘massive price reductions triggered by generic competition for the first generations of ARVs’ (MSF, 2011). This price drop helped initiate of a full scale roll-out of ARV treatment in Africa and finally a dent was made in the HIV/AIDS crisis.3
Doha: A declaration of social justice in health Recognizing the impact of TRIPS on distributive justice in pharmaceuticals, the public health community first raised concerns about the impacts of international trade on health and access to medicines during the World Health Assembly 1996 (E. t Hoen, 2002). At the World Health Assembly in 1998, Member States resolved to ensure that public health interests were paramount in pharmaceutical and health polices (SouthCentre, 2011) and the WHO produced a guide with recommendations to States on how to implement TRIPS while limiting the negative effects of higher levels of patent protection on drug availability (Velasquez & Boulet, 1999). Meanwhile, at the WTO, LMICs spearheaded and drove the debate forward.4 This reflected growing concerns about the implications of the TRIPS Agreement on access to medicines manifested by ‘the HIV crisis in subSaharan African countries, the attempts by the pharmaceutical government, backed by some governments, to block the implementation of TRIPS-compatible measures by the South African government and the complaint by the USA against Brazil’ (Correa, 2002). These LMICs managed to force HICs to negotiate an agreement that would clarify and amend5 the ability of countries to use the flexibilities built into TRIPS to protect public health in their countries. WTO members finally agreed the Doha Declaration on TRIPS and Public Health in 2001 which confirmed that ‘the [TRIPS] Agree3
Treatment was vastly expanded with coverage quadrupling from 400,000 people in December 2003 to 1.6 million at the end of June 2006. This included a ten-fold increase in sub-Saharan Africa (WHO, 2006). 4 Supported by civil society domestically and internationally, it was the African Group of countries, supported by other LMICS, which in 2001 requested that the Council for TRIPS deal specifically with the relationship between TRIPS and public health. As the Africa Group led by Kenya noted at the time ‘Indeed, we are very encouraged by the degree of agreement, as indicated in the Members’ statements, on the need to ensure that the implementation of the TRIPS Agreement does not prevent Members from adopting appropriate measures to protect public health and ensure to affordable medicines’ (Africa Group, 2001). 5 It is important to note the potential to amend TRIPS. Some high income countries only wanted to allow a clarification of TRIPS but in the end such a text was not included. ‘As a result, one could argue that the Declaration actually does go beyond clarifying the already existing rules.’ (E. t Hoen, 2002).
ment can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.’ (World Trade Organisation, 2001b). By doing this, countries had implicitly acknowledged a place for distributive justice in access to medicines. The Doha Declaration was a ground-breaking document for global public health and a ‘concrete success’ to which developing countries and NGOs could point (Drahos, 2002). It was a remarkable victory for LMICs that had had to resist intense resistance from some HICs such as the United States and Canada. Driving that resistance was the powerful pharmaceutical company lobby which was opposed to any amendment to TRIPS, an agreement which they had been key in bringing onto the international agenda.6 As just one example of how far their lobbying efforts went, US pharmaceutical companies even asked the United States Trade Representative to re-open negotiations after an agreement on the text had been reached (E. t Hoen, 2002). Doha and the road to Doha ‘represented the first significant push back to the relentless march to strengthen private intellectual property rights without regard for societal consequences in poor countries’ (E t Hoen et al., 2011). For civil society and many LMICs, Doha was seen as a clarion call for equitable allocation of health resources to ensure medicines were available to all patients, wherever they lived and in whatever socioeconomic, cultural or political context they found themselves. The year Doha was signed marked a year in which a movement for social justice in global health policy began to concretely take shape at international policy making levels and was the culmination of years of LMIC efforts to place social justice at the heart of protecting and promoting health (Nunn, Fonseca, & Gruskin, 2009). Doha was tangible and deeply consequential in the realisation of the steady push to bring policy changes in the discussion of access to medicines for all on the basis of justice rather than trade economics.
Health as a global public good The Doha Declaration ‘unequivocally recognised that access to medicines should have primacy over commercial interests’ (MSF, 2003). Until then, private interests 6 Duncan Matthews remarks that during the Uruguay round of negotiations that led to TRIPS the influence of business interests ‘was undoubtedly crucial to the developed countries’ negotiating positions on intellectual property protection . . . and played an important role in influencing policy decisions’ (Matthews, 2002). He writes that US officials were in constant contact with their national industries which provided ‘technical and legal expertise and advocacy skills based on years of experience’ and how these industries had been openly critical of some of the drafts which they saw as too lenient on developing countries (Matthews, 2002).
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Breaching Doha’s Ethical Threshold had been supported by TRIPS in maintaining tight control over the supply, cost and delivery of medicines. The intersection of trade and health in the field of pharmaceutical products enshrined in TRIPS promoted a utilitarian approach which foresaw market incentives to incentivize companies to innovate new treatments and medical technologies. Medicines became a commodity like any other and subject to the will of the market economy. Not only has this ‘patent to innovate’ argument been proven unfounded (Commission on Intellectual Property Rights, 2006), distribution according to the market has created ‘two kinds of medicine – one for the rich and one for the poor. And it too often happens that the medicine for the poor is none at all’ (Munson, 2000). If we understand health care to be a public good and access to essential medicines as a core element of that public good, then it is hard to claim that the poor somehow deserve to have a smaller share of the medicines available than the rich (Sen, 1999). While they clearly do not deserve it, the reality today is that this is too often the case. Recognizing that introducing TRIPS and patent monopolies globally had created inequity in the distribution of essential resources for health, Doha clarified the primacy of public health in the application of international patent obligations. As had happened before TRIPS, LMICs were implicitly recognising that medicines are no ordinary product and that the market could not always be left to ensure a just distribution of those goods. As Amartya Sen notes ‘the rationale of the market system is geared to private goods (like apples and shirts), rather than public goods (like the malaria-free environment), and it can be shown that there maybe a good case for the provisioning of public goods, going beyond what the private markets would foster’ (Sen, 1999). Sen argues that the far-reaching powers of the market mechanism have to be supplemented by the creation of basic social opportunities for social equity and justice (Sen, 1999). While TRIPS indicates that countries were willing to treat medicines as just another commodity, Daniels questions whether inequalities in access should be allowed to vary with ‘whatever economic inequalities are permissible according to more general principles of distributive justice’ (Daniels, 2008). Health has a special moral importance (Daniels, 2008) and, since health care cannot function without medicines, medicines become a public good which ‘people should be assured of the possibility of accessing . . . if they are needed to promote their ‘normal functioning’. (Daniels, 2008). In other words, just because some people are richer than others, which may be inequitable but not unjust, it does not mean that as a result they should be able access medicines, which others cannot afford. That would be unjust. Health cannot be isolated from broader social justice. Making health inequalities acceptable ‘must be compat-
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ible with what justice requires in the distribution of a broad range of social goods’ (Daniels, 2008). In other words, if there is distributive justice in allocating social goods, like medicines, then any inequalities in health may be acceptable. However, if the distribution of medicines is unjust and there is consequently no distributive justice, then the inequality in health is unjust and is therefore not simply an inequality but rather an inequity. Adopting Daniels’ ethical perspective, Doha becomes a strategy to acknowledge the primacy of social justice in global health, and more particularly in the distribution of health resources. I would argue that this approach to health as a social justice issue with its roots in distributive justice provides a compelling view of the crisis in access to medicines that Doha set out to address. Through Doha, countries basically were claiming that medicines are not a commodity like any other and, therefore, flexibilities in TRIPS needed to be used to recognise the unique moral importance of medicines as a public good in global health. To restore distributive justice as a basis for ensuring just health, the countries insisted on the special importance of medicines and a rejection of health inequalities to become health inequities because of the commodification of health goods based on economic access to medicines. TRIPS revealed that the market alone did not work to enable people to access medicines equitably. There needed to be specific measures to control the influence of the market in order to enable equitable access to medicines. The Doha Declaration tried to strike a delicate balance between acknowledging the importance of the market-led system to innovate and develop new treatments and the need to supplement this with guarantees of distributive justice to guide global policy making on the provision of specific health goods. By signing Doha countries had not rejected the market based system per se, but rather were addressing what they saw as a problem arising from, as Amartya Sen puts it, ‘the unregulated use of activities that allow the powerful to capitalize on their asymmetrical advantage.’ Sen goes on to say that these have to be dealt with not by suppressing the markets ‘but by allowing them to function better and with greater fairness, and with adequate supplementation. The overall achievement of the market is deeply contingent on political and social arrangements.’ (Sen, 1999). This view is supported by Sigrid Sterckx who viewed Doha as an attempt to reach ‘a fairer balance between the rights and obligations of patent holders and between the interests of patients and those of patent owners’ (Sterckx, 2004). The claim that Doha is a declaration of social justice is an important one given the practical reality of medicines and their distribution. The social justice discourse recognizes that health is inherent to each of us and having health, as broadly conceived, is an issue of justice first and foremost. Recognizing the social justice motivation of
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Doha provides the ethical and moral foundation for distributive justice in health that is able to unite and propel efforts by states and organizations to realize equity in global health.7 It follows that to deny Doha and to ignore it in global health agreements, such as we will see in the recent Political Declaration on NCDs, is to deny the ethical imperative to ensure distributive justice.
PULLING BACK FROM SOCIAL JUSTICE: RETURNING TO THE PRE-DOHA LANDSCAPE8 Countries have continuously reneged on Doha. MSF noted in their 2003 report that ‘[s]ince Doha, some Members have attacked both the spirit and intent of the Declaration, putting the interests of their pharmaceutical industries ahead of the health of the world’s poor.’ (MSF, 2003). To date, attacks on Doha have outweighed the ability of countries to use the TRIPS flexibilities.9 The negotiation process around the UN Political Declaration on NCDs confirms the extent of the drift away from a social justice approach to health and shows how states crossed an ethical threshold. Prior to the negotiation, the issue of access to medicines for NCD patients had first been raised at the WHO Ministerial Meeting in Moscow where the resulting Moscow Declaration included for the first time mention of the need to ensure affordable access to medicines for NCDs (WHO, 2011).10 Based on the discussions that began at that Moscow meeting, delegates from LMICs included clear references to TRIPS and Doha in the draft Political Declaration for the UN High Level Meeting. A comparison of the language of the final text of the Political Declaration as well 7 This reflection is being reflected today in the efforts to acknowledge social determinants of health. Sir Michael Marmot, who chaired the World Health Organization (WHO) Commission on Social Determinants of Health, stated that that public policy needs to be based ‘on a vision of the world where people matter and social justice is paramount’ (Marmot, 2005, p1009 in Labonté and Schrecker p24). 8 Malini Aisoli coined this characterisation of access to medicines after the 2011 UNGA Political Declaration on NCDs. 9 See the case of Thailand to understand how political and economic pressures not to use TRIPS flexibilities has impacted access to medicines (Wibulpolprasert, Chokevivat, Oh, & Yamabhai). See also the case of Thailand’s compulsory licence on Plavix which provoked criticism from the EU and US. As they see it, using TRIPS flexibilities for chronic NCDS like cancer ‘hits right at the heart of the global pharmaceutical industry’s profit model’ (Correa & Matthews, 2011). The same has happened to India in the wake of the 2012 compulsory licence issued for Imatinib. The US Commerce Secretary raised concerns about India’s action stating that ‘Any dilution of the international patent regime is a cause for deep concern for the US’ (Daglian, 2012). 10 That Moscow Declaration stopped short of mentioning intellectual property issues related to access to affordable medicines and simply referred to the need to ensure access to affordable medicines. Experience from the HIV/AIDS crisis has shown that such weak references in documents become mere rhetoric unless they are backed up.
as prior versions clearly shows the evolution of the text from one that sought to include stronger references to TRIPS flexibilities and the Doha Declaration, to one that has dangerously weak safeguards in place. The negotiation process was reportedly fraught, with a clear divide between the G77 (an important grouping of LMICs) and the US and EU. Countries reported that one of the most problematic issues was related to the G77’s proposed language on TRIPS flexibilities and the Doha Declaration. The EU and US had been calling for deletion of references to both to prevent what they saw as establishing a new interpretation of TRIPS to cover drugs for NCDs. The US claimed that Doha did not apply to NCDs, as they were neither an epidemic nor a set of diseases to which TRIPS applied. Both these arguments are deeply flawed. During negotiations on Doha, any efforts to limit Doha to specific diseases or countries were rejected (E. t Hoen, 2002) and there is no language in Doha that limits its applicability to epidemics or emergencies. Indeed, efforts to limit were an important point of negotiation and text was changed to specifically broaden the application to public health.11 Yet, the US maintained that no Political Declaration would be preferable to one with reference to TRIPS flexibilities and the Doha Declaration. In the end, the text adopted by the members at the last minute represented a clear compromise to the advantage of the US position: TRIPS was mentioned but all references to Doha included in the draft text were deleted. Despite the misleading and incorrect polemic in the negotiations around the Political Declaration on NCDs, the LMICs had eventually caved to the US and EU pressure.12 Some commentators have argued that the mention of TRIPS in the Political Declaration is sufficient.13 However, given the intense negotiations over the inclusion of references to Doha up until the last minute, and given that the very same UN members made strong references to the importance of Doha in the second Political Declaration on HIV/AIDS (United Nations General Assembly, 2011) only three months prior to the Political Declaration on NCDs, the deliberate removal of Doha from the Political Declaration becomes even more striking.14 11
As is can be seen in the reference to public health in the title of the Doha Declaration (E. t Hoen, 2002). 12 Interesting the Political Declaration on NCDs was adopted as the first agenda item of the High Level Meeting on NCDs. The completion of the negotiations several weeks before the HLM allowed member states to go on to make unequivocal statements that not only did Doha apply to NCDs but that access to medicines was essential to addressing the NCD crisis. 13 See for example Professor Fred Abbott on the omission of Doha in the Political Declaration (Silverman, 2011). 14 In looking at the ethical impact of Doha and its impact, it is important to put Doha in context. Doha represents an agreed understanding of aspects of TRIPS and clarifies specific provisions, with legal effect in
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Breaching Doha’s Ethical Threshold The attempts by some member states to return to a pre-Doha landscape for NCDs obscures once more the importance of access to medicines in addressing the global health crisis of NCDs and draws political attention and resources only to prevention.15 By specifically negotiating out the text on Doha, countries could be seen as giving the signal that TRIPS as it stands is able to deal with access to NCD medicines issues. History tells us this is not the case.
Doha’s ethical value: A conclusion? Not including reference to Doha in the NCD Declaration was not a mere oversight–reaching a global agreement on a Political Declaration on NCDs was uncertain without its removal. So has that removal marked the demise of the ethical value embodied in the Doha Declaration? I have argued that the members of the WTO adopted Doha and created a global moral precedent that was intended to form the basis of a drive for global distributive justice in access to essential medicines. It also demonstrated a step towards a rebalancing, or even a pulling back, from a market driven global health system. Doha represented a rejection of the wholesale commodification of medicines introduced by TRIPS and that led to the creation of profound health inequities. In other words, the supreme global trade body had implicitly recognized that market values as a driver of justice had not provided equitable access to medicines as many had claimed it would. Viewed in this way, we can see just how extraordinary Doha was. favour of WTO members right to protect public health in cases of ambiguity (Correa, 2002). Furthermore, WTO members have to implement Doha and operationalise flexibilities through national legislation. Since the Political Declaration there have been important examples of countries doing just that – India has issued a compulsory licence on an anti-cancer drug, China is amending patent laws to ease provisions for compulsory licensing and South Africa is designing a new intellectual property policy that many hope will raise patentability standards. When questioned countries like India vigorously defend their use of TRIPS flexibilities, invoke Doha and the need for consumer protection. While this shows important ways in which some governments are defending the ethical value of Doha, there are also examples of countries moving in the opposite direction. Kenya recently introduced an anti-counterfeit drug bill will could block the commercialization of affordable generic medicines and negotiations of a Trans Pacific Partnership contains terms which could negatively impact access to medicines as does the European-India Free Trade Agreement. Given this ambiguity in the stance of different countries on access to medicines, the implication of key high-income countries fighting for the removal of references to Doha in the Political Declaration cannot be ignored. 15 This scenario is a throwback to the early days of the HIV/AIDS crisis when political actors were denying the importance, or in some cases the possibility of treating AIDS patients and instead focused on prevention measures. It was not until Doha came into being that countries were able to unequivocally use WTO language to show how TRIPS flexibilities could and should be used given the context of global inequality.
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Doha was pragmatic yet profound in its ambition. It recognized that the market system was dominant and that the members of the WTO had chosen to come together precisely because of that economic model. Yet some member states also recognized that the system created deep inequities in global health due to abuse by vested interests operating at the intersection of trade and health. Doha was arguably an attempt to provide a check and balance for market interests as a system of choice by placing interests in health equity as a preeminent condition of that choice. As an instrument of social justice, Doha therefore made an important mark on the global health scene. Yet those same ground-breaking member states buckled a decade later. While the reasons around the recent retreat from Doha are multi-layered and complex, the practical result is that access to NCD medicines has not been accorded the same status as access to HIV/AIDS drugs. Deliberate misrepresentations, misinformation and ignorance of historical discussions and debates have undermined the social justice ambitions lying at the heart of the Doha Declaration. Removing the mention of Doha from the Political Declaration has the potential to force prevention-only NCD strategies on LMICs when what is needed are prevention and treatment approaches. By pushing back social justice efforts and turning us back once more to a market driven-approach where medicines are a commodity just like any other, we to return to the travesty of justice witnessed in the 1990s. By the end of that decade, 22 million people in LMICs had died of AIDS simply because they were not able to access affordable medicines. The market system had failed millions of HIV/AIDS patients. Doha came to account for, and correct, that grave global injustice. Are we now witnessing the return of that injustice? But, the Doha Declaration has not been revoked. The optimistic view of the Political Declaration is that including TRIPS implies the inclusion of Doha. Access minded actors working on the global NCD crisis have to make sure that the removal of the reference to Doha does not signal that Doha is not applicable to NCDs. Doha’s value lies in its acknowledgement that access to essential medicines for all is a fundamental issue of social justice. Doha marks an ethical threshold and States are challenged to defend those values. By insisting on the relevance of Doha despite the compromises made in the Political Declaration, the reference to TRIPS must be read to include the principles evoked by Doha. While it may be true that the constant attacks on Doha since its passage has tarnished its reputation, its ethical values of justice and equity in global health remain as noble and as essential today as they were over a decade ago. Promoting and defending those ethical values in the wake of the Political Declaration remains a central element of the struggle to support access to medicines for all.
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Rachel Kiddell-Monroe
Acknowledgements Special thanks to my McGill University bioethics professor, Dr Carolyn Ells, whose guidance, encouragement and patience has been invaluable to me in writing this paper. Thanks also to my colleagues Sandeep Kishore, Malini Aisola, Cailin Morrison and Ethan Guillen for their thoughtful and knowledgeable comments and encouragement on the draft. And above all, thank you to all the treatment activists, patients and friends who have taught me all I know about justice and equity in access to medicines over the past 10 years and whose courage and brilliance has been such an inspiration.
Biography Rachel Kiddell-Monroe, LLM Bioethics, member of the United Kingdom Law Society since 1991, has worked on humanitarian and human rights issues since 1989. Working with Médecins sans Frontières between 1992 and 2007, Rachel headed emergency humanitarian missions in Africa and Latin America and then directed MSF’s Access to Essential Medicines Campaign in Canada. Rachel also lectures at McGill University and has consulted for the Drugs for Neglected Diseases Initiative (www.dndi.org) and the Canadian HIV/AIDS Legal Network on the Canadian Access to Medicines Regime (www.aidslaw.ca). Currently a member of the MSF International Board, Rachel is also Senior advisor for Universities Allied for Essential Medicines (www.uaem.org).
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