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This chapter begins with a background note on international human rights law and the right to health — the most commonly mentioned basis for a right to access to medicine — as well as human rights aspects of intellectual property. It then discusses the interpretation of human rights conventions. The rights at issue are closely connected to the notion of economic, social, and cultural rights. Some authors argue that this category of human rights is of doubtful legal relevance, an objection that is treated under the heading of ‘justiciability’. The chapter also examines whether pharmaceutical companies are directly bound by these rights and whether the WTO is bound by human rights law. Finally, the right to access to medicine is discussed in detail, proceeding in the order of the sources recognized by international law as stated in Article 38 of the Statute of the International Court of Justice (ICJ): international conventions, customary international law, and general principles of law.

This chapter begins by discussing the extent to which human rights can be applied in WTO dispute settlement, finding that they can only be used as an aid to interpreting the ‘covered agreements’. It then takes up that approach and interprets the ‘TRIPS flexibilities’ using the right to access to medicine. It demonstrates that the right serves as a helpful argument for a broad interpretation of the flexibilities, but suffers from the defect that it is merely one argument amongst many and cannot provide developing countries with legal security as to the interpretation of the flexibilities. It is this lack of legal security that discourages developing countries from making use of the flexibilities, particularly in the face of pressure for greater intellectual property protection by the developed world. The chapter also describes the action taken within the WTO to remedy the problem of access to medicines, its legal status, and analyzes whether the action is sufficient.

States have an international obligation to cooperate for the purpose of realizing the right to health. This chapter examines the nature of this obligation and concludes that it consists of three discrete obligations — an obligation to take reasonable measures subject to available resources to respect, protect, and fulfil the right to health of individuals in other states. The effect of these obligations is demonstrated via a case study, namely the impact of the TRIPS regime on access to medicines. It is suggested that, on balance, a state's involvement in TRIPS does not necessarily violate the respect and protect elements of its international obligation to secure the right to health. But this regime is not an effective mechanism by which to facilitate access to medicines in developing states, and the international obligation to fulfil the right to health requires that states must make bona fide efforts to develop a complementary system which is more likely to achieve this end.

This chapter provides a broader view of the development of international laws impacting the protection of drugs. Whereas prior chapters focused primarily on how patent-owning companies impact these laws, this chapter shows that such companies do not necessarily always dominate the conversation. In particular, just as companies have utilized tools such as forum shifting and trade pressures to achieve their goals, access to medicine proponents have used forum shifting and public pressure to promote their interests. The chapter demonstrates that the development of laws and policies impacting access to medicine is a dynamic process in which competing patent perspectives (as well as their confluence) play an important role.

This chapter builds upon the basic rules for compulsory licenses under TRIPS (Chapter 5) and also provides a complementary examination of compulsory licenses. It introduces competing patent perspectives; it provides a case study of Thailand's recent compulsory licenses to explain some of the confusion and controversy concerning them. In particular, the lens of competing perspectives is used to provide an enriched understanding of why there has been so much confusion concerning compulsory licensing. In addition, this introduction to competing patent perspectives constructs a framework for subsequent chapters that revisit how such perspectives have played a role in issues involving access to medicine.

This chapter discusses the facts that called attention to the conflict between the TRIPS Agreement and access to medicine. The public discussion was initially triggered by the pricing decision of the patent holder of the first AIDS medicine AZT. It took on global proportions when the pharmaceutical industry sued the South African government that wanted to impose compulsory licences for patents on pharmaceuticals to provide its population with cheap AIDS medication. The chapter also recounts the events surrounding the anthrax attacks in the United States, when the Canadian and US governments threatened to break Bayer's patent on Cipro.

This chapter focuses on possible new approaches to dealing with the longstanding problem of how patents may impact short-term access to medicine. To emphasize why new approaches are necessary, it begins with an overview of current and forthcoming tensions in the global debate concerning access to medicine. It then focuses on a few approaches that have been proposed thus far. Although there are many possible solutions to the problem of providing more low-cost medicines, the chapter focuses on a few that help highlight other themes in the book. In particular, it explains how each proposal reflects a certain perspective that may have an impact not only on its possible adoption, but also to counter-proposals.

This chapter illustrates how individual nations may promote access to medicine while still complying with TRIPS, using India's patent laws as an example. As noted earlier, TRIPS requirements are not only skeletal, but undefined. Accordingly, under TRIPS nations have freedom and flexibility to define important terms and requirements. In particular, the chapter discusses various aspects of India's patent laws that are intended to promote access to medicine in a post-TRIPS world where patents must be granted. Although TRIPS flexibility may sometimes be constrained by international agreements or pressures, the chapter first explores what flexibilities countries should have under TRIPS. Understanding existing flexibilities under TRIPS is important because it provides a foundation to better understand how subsequent obligations may limit these flexibilities.

The campaign for access to HIV/AIDS medicines was history’s most successful health rights campaign, and a model for modern-day advocacy for access to essential medicines. A growing access to medicines movement is profiled, and suggestions for action—and talking points to buttress arguments—are provided.

This chapter provides an overview of international developments since TRIPS that further impact access to medicine. In particular, some countries are now required to adopt higher standards than those required by TRIPS. These “TRIPS-Plus” standards are predominantly implemented as a result of bilateral or regional trade agreements instigated by wealthy countries since the conclusion of TRIPS. Although they are dubbed “TRIPS-Plus,” they have no formal relation to TRIPS. Rather, the term is used to indicate that these requirements go beyond the minimum obligations imposed under TRIPS. The chapter explains common themes among TRIPS-Plus requirements that impact upon the cost of drugs. This thematic approach aims to highlight how drug costs may be impacted, as well as how and why countries adopt such requirements; however, it is not intended to provide a comprehensive review of every enacted or pending TRIPS-Plus requirement.

This chapter takes a look at the problems associated with patent development within developing countries, specifically Brazil and India. The first half of the chapter discusses the patent regime in India, including the Ayyangar Report, which analyzes the adaptability of foreign patent regimes and policy options to address the national issues of the country, and the process patent regime of the 1970s, where the processes and methods of producing food, medical, and chemical invention products were protected. The second half of the chapter focuses on Brazil's constitutional commitment to access to medicines and its patent law. A section on the similarities between these two countries concludes the chapter.

This chapter traces how a new critique of differential access to therapeutics developed in American domestic health policy and approaches to international development over the course of the 1960s and 1970s. This is not a comprehensive global history of pharmaceutical disparities. Rather, it is an attempt to read the globalizing narrative of American pharmaceutical policy and international relations in close relation to one another in the old War era. It focuses on a few key episodes in which the voices of several stakeholders present in debates over the role of pharmaceuticals in health and development—physicians, patients, lawmakers, regulators, researchers, and manufacturers—became audible. All of these parties agreed that a veritable therapeutic revolution had taken place in the mid-twentieth century. All believed furthermore that the problem of uneven access to new and lifesaving drugs was an urgent and pressing issue for their times. They differed significantly, however, in their understanding of what kind of objects pharmaceuticals were, and how and why they moved or did not move across domestic and global scales.

This Chapter analyzes the decisions of the Dispute Settlement Body (DSB) in intellectual property cases to assess whether national laws can be adapted to reflect diversity, balance and historical contingency. It does so by considering three initiatives: (1) raising the height of the inventive step (2) creating new statutory defenses to liability for patent infringement; and (3) refusing to award injunctions automatically to prevailing plaintiffs. These initiatives implicate a nation’s ability: to ensure access to medicines, a value highlighted in the amendment of TRIPS arising out of the Doha Declaration; to offer gene-based diagnostic testing without permission of patentees; and to deal with the costs of patent trolls. In some respects the DSB has promoted the values underlying neo-federalism. However, panels often pursue a formalistic reading of the Agreement and one that is largely devoid of normative content. Instead, if TRIPS is to be resilient, panels must have regard to the normative underpinnings of intellectual property law, including the Objectives and Principles of the TRIPS Agreement. And panels will need to establish benchmarks against which to measure claimed deviations, requiring regard to national practices.

This chapter examines the regulation of patents and access to medicines in Brazil. It demonstrates the incoherence of Brazil's approach, that is, national legislative and political choices do not coherently reflect the country's stance on the promotion of access to health and medicines. On the contrary, many of the decisions taken seem to be dissociated from reality and from one another. The chapter first describes the importance of the right to health for the construction of the current Brazilian public health system and how the issue of access to medicines fits into that frame. It then considers the main actors and events that have helped define health and patent rules and policies.

This chapter provides an overview of the rights-based approach to access to medicines, focusing on the work of international human rights bodies, mechanisms, and procedures on the question of balancing intellectual property and human rights. It first outlines both the broad and specific parameters of the rights-based approach to intellectual property and access to medicine. It then considers the impediments and obstacles to implementing such an approach in practice. These obstacles arise in connection to key interrelated deficits in international human rights law around the issues of legitimacy, accountability, and domestic capacity. It concludes that the full and equitable realization of the right to adequate health depends on the capacity and political inclination of domestic actors to enforce international norms.

The ability of governments to protect and promote health-related human rights can be constrained by international trade rules, including those of the World Trade Organization (WTO). The WTO rules can increase medicine prices, challenge tobacco control measures, restrict national food safety policies, and facilitate brain drain from public health services. This chapter offers a brief history of the WTO’s origins, a high-level overview of the health implications of various WTO agreements, and a closer look at how two key issues—access to medicines and tobacco control—have created greater policy space for health within the WTO. It then identifies the institutional factors that promote or hinder human rights protection and offers conclusions on the prospects for institutionalization of health-related human rights. This chapter concludes that protecting health within the WTO and broader global trade regime is possible, but remains a significant challenge due to major power asymmetries.

This chapter refigures narratives of the mid-twentieth century “therapeutic revolution” as a geographically uneven process and explores how an equity platform—that is, an actionable plan by which chemotherapeutics, preventives, and other tools of “the youngest science” (i.e., medicine)—has begun taking shape in the past two decades as a result of social and political processes that escaped Thomas McKeown’s analysis. Though realized unevenly, this platform has demonstrated that the delivery of medical and public health interventions can contribute to significant population-level declines in mortality. First, McKeown’s thesis is sketched, examining the intellectual and political circumstances of its production and picking out those portions of the argument with special salience for global public health in the following decades. Second, the chapter interrogates the continued relevance of McKeown’s claims about the contribution of medicine to population-level health outcomes. It reviews a survey of recent data demonstrating that medicine has, in fact, contributed to mortality decline particularly in the nations of the Global South. The chapter concludes with a discussion of the continuing need for a biosocial “science of delivery” to help ensure that the sizable and growing armamentarium for health (including but not limited to diagnostics, chemotherapeutics, and preventives) reaches the global poor.

Global inequality impacts global health. The rich can, but the poor cannot, access many of the existing medicines they need. This paper considers the prospects for rating pharmaceutical companies' efforts to extend access on essential medicines to the poor. It argues that it is possible to design a good rating system – one that rewards highly rated companies for doing things that actually promote global health. It also suggests that practical work on promoting global health can yield interesting philosophical questions and conclusions by highlighting some of the normative choices that are important to address in developing a good rating system.

This chapter explores what makes iThemba Pharmaceuticals’s mission of finding new drugs for TB, HIV, and malaria in South Africa distinctive. The chapter contrasts iThemba’s approach with that of the three most prominent discourses of pharmaceuticals and the Global South: access to medicines campaigns that aim to increase distribution of generic drugs; pharmaceutical research based on bioprospecting and traditional knowledges; and clinical trial research. Putting iThemba into comparative relief with these disparate sets of global health discourses reveals a common element among them: all three have an implicit reliance on a problematic conceptual bifurcation between Global North and South. They rely on an assumption that the most prestigious forms of pharmaceutical knowledge will be made in the North, while the South will be relegated to more circumscribed roles: recipients of generic drugs, providers of raw materials, and providers of test subjects. Whether these endeavors operate under a rubric of philanthropy or of science as usual, power inequalities are maintained and reinforced. South Africa itself is in many ways betwixt and between Global North and South, and this small drug discovery company’s mission helps to illuminate some of the limitations of pharmaceutical knowledge-making projects that take global bifurcation for granted.