Millions of people in developing countries die of diseases for which treatments exist that can relieve suffering and save, or at least prolong, people’s lives. High-profile pandemics like HIV/AIDS understandably attract considerable attention. Millions of people have died of this terrible disease - 2.6 million in 2003 and 2.8 million in 2005, of which Sub-Saharan Africa contributed 1.9 million and 2.0 million respectively. As the above quote makes clear, there are a whole host of diseases that have particularly devastating impacts on the poor.

Improving access to essential medicines in low- and middle-income countries (LMICs) has become a critical health policy issue. Millions more people die each year in poorer countries from diseases that are treated by pharmaceutical agents currently available in higher income nations. Recent medical innovation has tended to focus on problems affecting populations in developed countries and avoid those found exclusively or predominantly in LMICs. The etiology of these disparities is multifactorial, and can include high costs of products, inadequate cooperation between governments and aid agencies, rigid protection of intellectual property rights, and poor local health leadership regarding dissemination of products.

Over the past two decades, there have been growing efforts to reduce global disparities in availability of essential medicines. At the forefront of these efforts have been international agencies such as the World Health Organization, or groups like Médicins Sans Frontières and Partners in Health, which have helped set international health priorities and sought to improve local health care delivery systems.

Increasingly, health is recognized as a major force for economic development; and because economic development is central to political and social stability, health is being looked at as the great hope for the future of the world, as population sizes and disparities among them increase. This perspective has been growing ever since the 1993 World Development Report was released by the World Bank, and it has fueled an intensive scrutiny of health care around the world, focusing on systems and health care delivery on the one hand, and equitable access to the products of research on the other hand. In the middle of all of is this is a concern about how health care (which must include both the training of personnel from the basic low level health care worker to the physician), and research and development (which must include the financing of research in academia and the development of products primarily in the private sector) are organized, and how they do or do not address inequities between and within populations and nations.

Patent rules matter to the structure and evolution of pharmaceutical markets. If they did not, pharmaceutical multinationals would not spend resources on their globalization and content. The role of pharmaceutical multinationals in shaping the patent provisions of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been well documented. The contributions of developing country coalitions and nongovernmental organizations (NGOs) in the World Trade Organization (WTO) on TRIPS and access to medicines have also been studied.

One actor, the patent office, has largely escaped detailed scrutiny in the literature that has grown around intellectual property law and access to medicines. There is an obvious explanation. Patent offices are administrative bodies. They administer patent standards that are decided and defined by others – the courts, legislatures or the executive acting in the context of treaty negotiation. For those interested in the structural reform of pharmaceutical markets, reforming patent office administration has not been a high priority.

In May 2006, at the World Health Assembly, the governments of Kenya and Brazil called on fellow nations to promote the development of the public health tools necessary to build the research capacity of developing countries. That call was again made at the G8 Summit in June 2007, when the national science academies of the G8 nations and Brazil, China, India, Mexico and South Africa signed a statement on the promotion and protection of innovation. Highlighting the need to balance the protection of intellectual property with the need to foster access to knowledge and remove barriers to innovation, the statement calls on world leaders to:

Today's global health programs will attain their objectives only if products appropriate to the health problems in low- and middle-income countries are developed, manufactured and made available when and where they are needed. Achieving this requires mobilizing public and charitable money for more and better products to diagnose, prevent and treat HIV/AIDS, tuberculosis, malaria, reproductive health problems and childhood killers. But more money is only one part of the story. Weak links in the global health value chain—from research and development through service delivery—are constraining on-the-ground access to essential products. The consequences of those weak links are many: supply shortages, inefficient use of scarce funding, reluctance to invest in R&D for developing country needs and, most importantly, the loss of life among those who need essential products.

Recent activity at major intergovernmental organizations reflects a renewed emphasis on making the international intellectual property system work to foster global health in developing countries. The World Intellectual Property Organization (“WIPO”) recently approved a historic “Development Agenda” – a wide-ranging set of reforms that reorients WIPO towards development and reconfigures how the organization makes policy, provides technical assistance, and is administered. Such an initiative may seem natural for the only inter-governmental organization (IGO) that is focused primarily on intellectual property, but such reforms are not restricted to WIPO. The World Health Organization (“WHO”) has launched its own development agenda of sorts – an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (“IGWG”) that is tasked with preparing “a global strategy and plan of action” aimed at “securing an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries, proposing clear objectives and priorities for research and development, and estimating funding needs in this area.”

The health needs of most of the world's population are not well served by patent-based pharmaceutical markets. The poor in low- and medium-income countries (LMICs) lack the financial resources to sustain the attention of global commercial drug companies. After an extensive consultation process, in 2006, the World Health Organization's Commission on Innovation, Intellectual Property and Public Health issued its Report (the WHO CIPIH Report), finding this concern to be significant:

On this issue, the WHO CIPIH Report was preceded by the Access to Medicines movement, an informal coalition of civil society organizations such as Médecins Sans Frontières, Treatment Action Campaign, Health GAP, Oxfam, and Knowledge Ecology International (formerly the Consumer Project on Technology).

The pharmaceutical industry's dependence on intellectual property rights (IPRs), especially patents, to exclude competitors and thereby recoup past expenditures, incentivize future investments in research and development (R&D), and maximize profits is well known. Although initially content to solidify patent rights in the rich-country markets of North America, Europe, and Japan, in the last quarter of the 20th century the industry has increasingly turned its attention to emerging markets in Latin America, Asia, and even Africa as sites of future market expansion. Big middle-income countries like Brazil, India, China, and Indonesia have growing middle classes that increasingly favor allopathic medicine over the more traditional medicines of their elders. Obtaining monopoly rights in these growing markets could help the pharmaceutical industry weather the storm of increased consumer, business, and government blow-back against supra-competitive drug prices charged in rich country markets.

On December 6, 2005, shortly before the World Trade Organization (“WTO”) Ministerial Conference in Hong Kong, WTO member states agreed to accept a protocol of amendment to the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPs Agreement”). This amendment sought to provide a permanent solution to implement paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (“Doha Declaration”). If ratified, the new article 31bis of the TRIPs Agreement will allow countries with insufficient or no manufacturing capacity to import generic versions of on-patent pharmaceuticals.

To facilitate the supply of essential medicines to countries with insufficient or no manufacturing capacity, article 31bis(3) creates a special arrangement not only for the affected countries, but also for those belonging to a regional trade agreement. Such an arrangement allows less developed countries to aggregate their markets to generate the purchasing power needed to make the development of an indigenous pharmaceutical industry attractive.

The goal of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement is to harmonize the intellectual property rights of World Trade Organization (WTO) member countries to a certain minimum standard. As a WTO member, the organization required India to enact legislation that enforces TRIPS by 2005. Part of India's motivation to pass its 2005 Patents Act stemmed from its obligations as a WTO member nation, as well as the government's desire to stimulate greater foreign investment, innovative research and economic growth.

India's implementation of the TRIPS Agreement has generated a great deal of controversy. Disagreement exists about whether the Indian Patents Act overzealously protects intellectual property rights and whether the Patents Act goes beyond the spirit of the TRIPS Agreement. Many health officials and non-governmental organizations (NGOs) are seriously concerned about what the Patents Act implies for people suffering from diseases in less developed countries. Nonprofit and some World Health Organization officials argue that the new law prevents India from producing and supplying generic drugs within its borders and to other developing countries.