Intellectual Property Rights and Access to Medicines: International Trade Issues

Shayerah Ilias
Analyst in International Trade and Finance

A patent, which is a form of intellectual property right (IPR), is a legal, exclusive right granted for the invention of a new product, process, organism, design, and plant. It allows the right holder to exclude others from making, using, or selling the protected invention for a period of 20 years. Patents constitute the most common method for governments to encourage research and development (R&D) in order to find pharmaceutical treatments and cures for diseases and other illnesses. 

IPR protection and enforcement have evolved from an area primarily of national concern to an area of international trade policy. The World Trade Organization (WTO) Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS) established minimum standards for IPR protection and enforcement. 

The U.S. government considers the protection and enforcement of international IPR standards, including those for patents, to be an important goal of U.S. trade policy for economic, health and safety, and national security reasons. As such, the United States has pursued strong IPR regimes through multilateral, regional, and bilateral free trade agreement (FTA) negotiations and unilateral trade policy tools, namely the Special 301 process and the Generalized System of Preferences (GSP). 

IPR provisions in trade policies are among the range of social, economic, and political factors that may affect public health, including the ability of countries to deliver health services to their populations. Patents, through their possible impact on innovation and drug prices, may affect access to existing medicines and the development of new medicines. According to the World Health Organization (WHO), about one-third of the world's population, primarily those residing in poorer parts of Africa and Asia, lacks regular access to essential medicines. 

While the United States places priority on promoting a strong international IPR regime, some Members of Congress have expressed concern over how to balance the goals of providing longterm incentives for innovation through patents and addressing the short-term need to provide affordable access to medicines. 

This report focuses on the relationship between IPR provisions in international and U.S. trade policy and access to medicines. This issue represents one component of a broader debate about the relationship between trade policy and public health. Possible issues of interest for Congress include incorporating public health concerns into the U.S. trade policy advisory process, developing new U.S. trade policy guidance on public health, considering the implications of the U.S. strategy on IPRs and trade for U.S. access to medicines, and reviewing the range of options utilized for expanding global access to medicines.


Date of Report: June 14, 2010
Number of Pages: 33
Order Number: R40607
Price: $29.95

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