Practical Applications of the Flexibilities of the Agreement on Trade-Related Aspects of Intellectual Property Rights: Lessons beyond HIV for access to new essential medicines

Access to expensive medicines is becoming a growing problem worldwide. The manufacturers of medicines demand a high price for their products even if the cost of production is low. The HIV/AIDS crisis of the late 1990s showed how high drug prices posed major problems, especially for developing countries. 8000 people a day died of AIDS in developing countries for lack of treatment while life-saving AIDS medicines had become available in high-income countries. Manufacturers asked 15,000 euros per one-year HIV/AIDS treatment. This price was disproportionate to the production costs of the medicines which was around 50 euros. How is this possible? The answer lies in the monopoly position that the manufacturer has as a result of a patent. A patent gives the holder the right to exclude competitors from the market and can, therefore, determine the price. International organizations such as the World Health Organization and the World Trade Organization have taken measures to ensure access to affordable, quality HIV medicines, even when the medicines were patented. As a consequence, the price of HIV-treatment dropped to 80 Euro per patient per year. The result was impressive: millions of people were given access to life-saving treatment of their disease. This dissertation describes the international processes that led to important policy and legal changes in the area of intellectual property to improve access to medicines. The study maps how national governments have made use of flexibilities in patent law and shows what lessons we be drawn from the HIV/AIDS experience for dealing with high drug prices today.