In this paper, I discuss the politics of access to essential medicines and identify ‘space’ in the current system where change can be made. I would like to start by stating the obvious problem: the current state of access to essential medicines among the global poor is unacceptable. Every year there are over 18 million preventable deaths and tens of millions more cases of increased morbidity due to poverty-related causes and arguably the unavailability of essential medicines. Why in a world of plenty do we still have so much suffering? This leads us to a moral question: what are our moral duties to those who are suffering from preventable and treatable illnesses due to the unavailability of pharmaceuticals, or, when they do exist, a lack of access to them? The current situation constitutes a violation of the human rights of millions of the world's poorest people.

At a global level, there is a systematic weakness of health concerns relative to trade and tensions between the governance of trade and health (Lee et al., 2008). For example, human rights and health activists have argued that patent protection prevents access to essential medicines, resulting in unnecessary, excessive and unjust mortality and morbidity. However, this argument has been dismissed by pharmaceutical industry representatives and their host countries, who have argued that patent protection, such as that afforded by the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS),¹ is necessary to incentivize research and thus save lives in the long term. In terms of patent protection barring access to drugs, they point to research such as Attaran's (2004) article, which argues that patent protection for AIDS medications has little effect on the distribution of drugs, to argue that it is other factors in developing countries that result in limited access to essential medicines.

The patent regime notwithstanding, there are structural and wider societal factors in developing countries that impede access to medicines. Morbidity and mortality are often the result of underlying social inequality, poverty, gender inequality, caste/class discrimination and lack of access to clean water and adequate sanitary facilities. Thus there is an argument to be made for paying attention to the forces that produce and aggravate the social conditions that impede access to essential medicines. Indeed, this line of argument has been used by pharmaceutical companies, lobbyists and the US government to stall action on generic drug production and uphold patent protection, such as that afforded by TRIPS.

There is no question that structural factors are important. Most developing countries do need better health systems and infrastructure, more health workers, clean water and proper sanitation and better institutions. They do need equitable economic growth, job creation and poverty reduction. Few would question this. But the importance of these factors does not reduce the significance of the barriers to access to essential medicines at reasonable prices that are created through patent laws. The focus on structural factors in developing countries is often an excuse for the lack of progress in trade negotiations. In addition, when access to essential medicines is blocked by two barriers (patent protection and structural factors in developing countries), we cannot absolve one of responsibility on the basis that the other exists. This would provide perverse incentives for those who would block attempts to address structural factors to ensure that there is a second barrier to patent protection also in place. And it would provide no moral incentives to remove either barrier (as each is innocent of the harm they together produce).

Why did developing countries, which had the most to lose, agree to TRIPS? Some have explained the agreement of developing countries to TRIPS by pointing to the elites that govern them, who do not always represent the needs of the poorest citizens. While I recognize the validity of this argument in some cases, I argue that government should nonetheless be the key actor in development if its legitimacy is derived from democracy and an electoral process. Thus I take the perspective that developing country governments with democratic legitimacy should have the authority and capacity to represent their countries’ interests in trade negotiations, and should be able to do so on fair terms with wealthy countries. In brief, ownership and control of trade negotiations by developing country governments are important for three distinct reasons: effectiveness and sustainability, democracy and self-determination and the alignment of accountability with effectiveness (such that those who make the key decisions also bear the risk if policies have detrimental effects).

Pogge (2007) offers an alternative explanation. He argues that most poor countries lacked the bargaining power to resist the conditions of TRIPS that were imposed by rich countries. This situation raises the question of how relatively weak developing countries can negotiate on a fair basis with the powerful, developed states within the WTO. Using a political-economic perspective, we can choose a country that has achieved a certain level of success in pharmaceutical trade negotiations, such as India, and try to understand what factors facilitated the process. Drawing on interviews with Indian government officials involved in the negotiations, I identify four main factors: financial independence from wealthier states, a clear plan, strong leadership and technical expertise in intellectual property law.²

Countries that enter trade negotiations without these four elements face a significant disadvantage. This can be overcome through developing countries organising and forming a coalition and pushing forward their collective agenda. Developing country coalitions have built and used coalitions to improve their bargaining power.³ As Patel (2007) describes, this pooling of bargaining resources has improved the technical and lobbying capacity by which developing countries engage in the WTO. These coalitions are highly visible, formalized and coordinated and focus on working within the WTO and existing trading structures to proactively engage in the negotiation process with the purpose of improving outcomes for developing countries.

Patel (2007) outlines three benefits of developing country coalitions. First, countries can share the costs of negotiating in the WTO. Developed countries have many negotiators based in Geneva, while developing countries have much fewer. For example, Carolyn Deere has noted that the USA, Canada, Japan, and the EU have roughly two Geneva negotiators per 10 million citizens while developing countries have just one. These numbers do not capture the fact that many of the delegates from developing countries are also responsible for covering other international organisations that are based in Geneva (e.g. World Intellectual Property Organisation, International Labour Organisation). Second, coalitions enable collaboration among countries so that they are able to compensate for their individual capacity limitations by sharing the tasks of technical and legal analysis. Third, coalitions can increase representation of developing countries. In 2004, 33 developing countries that were WTO members had no permanent representatives to the WTO based in Geneva, and so were unable to be present at a number of trade negotiations. More negotiations can be monitored when formal delegates are elected to represent groups of developing countries (e.g. African Group; African, Caribbean and Pacific Group of States (ACP); Least Developed Countries Group (LDC)).

I would add a fourth benefit of developing country coalitions. By aligning with emerging countries such as China, India and Brazil, less powerful countries can better handle the bullying tactics of certain developed states. I would like to elaborate on the final point, as it is critical to understanding the implementation of TRIPS. While most parties involved have seen TRIPS as a maximum standard of compliance, the USA has viewed it as a minimum. The USA has used its power to enforce TRIPS and bully countries into complying. Beyond this, the USA has used bilateral free trade agreements to extend the reach of TRIPS and increase patent protection beyond the provisions of TRIPS; these agreements are referred to as TRIPS-plus. Caroline Thomas (2002: 255) quotes an NGO staff member in Washington, DC:

The problem for developing countries is not whether the compulsory licensing of pharmaceuticals is legal, because it clearly is legal. It is the political problem of whether they will face sanctions from the U.S. government, for doing things that they have a legal right to do, but which the U.S. government does not like.

In addition, in 2006, India rejected Novartis’ patent application for the cancer drug Gleevec. Under Indian law, patents are only given for medicines invented after 1995, or for new and more efficacious versions of older drugs. The law in effect upholds scope for the production of generic medicines. India rejected the patent application because the drug that Novartis wanted to patent was not more efficacious than older versions. Novartis challenged the decision in a court in Chennai as the company argued that the decision, and the criteria used to make the decision, violated WTO law and could set a precedent that would make it very difficult to patent new drugs. In 2007, the court ruled against Novartis and in favour of Indian law, and more importantly for those concerned with public health, in favour of public health interests over intellectual property law. The Novartis case has set an important precedent. GlaxoSmithKline recently withdrew patent applications for its antiretroviral drugs Abacavir and Trizivir in India due to concerns about Novartis’ patent rejection and about challenges to its patent applications by CSOs MSF and I-MAK. GlaxoSmithKline thought it better to withdraw the applications rather than receive a rejection because a rejection could weaken the country's chances of receiving patents in other developing countries.

What is the way forward? To improve access to essential medicines, six C's are needed: coalitions, civil society, citizenship, compromise, communication and collaboration. All six elements came together when the 2001 Doha Declaration was agreed upon. First, developing countries must form a coalition that comes together to achieve a very specific objective and does not fragment. Second, CSOs committed to health issues must continue to push the issue onto the political agenda. Third, citizens in developed countries need to pressure their governments to prioritise health concerns through lobbying, protesting and supporting CSOs. Fourth, the various stakeholders must compromise to a certain extent so that progress can be made. Fifth, health activists must communicate to the media, so that the media can frame the issue of access to essential medicines in an appealing manner. Finally, developing countries, CSOs and citizens in developed countries must collaborate to ensure that the barriers to access to essential medicines are overcome.