Infectious diseases kill over 10 million people each year, more than 90 percent of whom are in the developing world.1 The leading causes of illness and death in Africa, Asia, and South America-regions that account for four-fifths of the world's population-are HIV/AIDS, respiratory infections, malaria, and tuberculosis.
In particular, the magnitude of the AIDS crisis has drawn attention to the fact that millions of people in the developing world do not have access to the medicines that are needed to treat disease or alleviate suffering. Each day, close to eight thousand people die of AIDS in the developing world.2 The reasons for the lack of access to essential medicines are manifold, but in many cases the high prices of drugs are a barrier to needed treatments. Prohibitive drug prices are often the result of strong intellectual property protection. Governments in developing countries that attempt to bring the price of medicines down have come under pressure from industrialized countries and the multinational pharmaceutical industry.
The World Trade Organization ("WTO") Trade-Related Aspects of Intellectual Property Rights Agreement ("TRIPS" or "Agreement"), which sets out the minimum standards for the protection of intellectual property, including patents for pharmaceuticals, has come under fierce criticism because of the effects that increased levels of patent protection will have on drug prices. While TRIPS does offer safeguards to remedy negative effects of patent protection or patent abuse, in practice it is unclear whether and how countries can make use of these safeguards when patents increasingly present barriers to medicine access.
The Fourth WTO Ministerial Conference, held in 2001 in Doha, Qatar, adopted a Declaration on TRIPS and Public Health ("Doha Declaration" or "Declaration") which affirmed the sovereign right of governments to take measures to protect public health. Public health advocates welcomed the Doha Declaration as an important achievement because it gave primacy to public health over private intellectual property, and clarified WTO Members' rights to use TRIPS safeguards. Although the Doha Declaration broke new ground in guaranteeing Members' access to medical products, it did not solve all of the problems associated with intellectual property protection and public health.
II. THE ACCESS PROBLEM AND INTELLECTUAL PROPERTY
A number of new medicines that are vital for the survival of millions are already too costly for the vast majority of people in poor countries. In addition, investment in research and development ("R&D") towards the health needs of people in developing countries has almost come to a standstill. Developing countries, where three-quarters of the world population lives, account for less than 10 percent of the global pharmaceutical market. The implementation of TRIPS is expected to have a further upward effect on drug prices, while increased R&D investment, despite higher levels of intellectual property protection, is not expected.3 One-third of the world population lacks access to the most basic essential drugs and, in the poorest parts of Africa and Asia, this figure climbs to one-half Access to treatment for diseases in developing countries is problematic either because the medicines are unaffordable, have become ineffective due to resistance, or are not sufficiently adapted to specific local conditions and constraints.
Many factors contribute to the problem of limited access to essential medicines. Unavailability can be caused by logistical supply and storage problems, substandard drug quality, inappropriate selection of drugs, wasteful prescription and inappropriate use, inadequate production, and prohibitive prices. Despite the enormous burden of disease, drug discovery and development targeted at infectious and parasitic diseases in poor countries has virtually ground to a standstill because drug companies in developed and developing nations simply cannot recoup the cost of R&D for products to treat diseases that abound in developing countries. …