	Introduction

This report focuses on the relationship between intellectual property rights (IPRs) provisions pursued through international and U.S. trade policy and access to medicines. Patents, a form of IPR, constitute the most common method by which governments encourage research and development (R&D) in order to find treatments and cures for diseases and other illnesses. A patent is a legal, exclusive right granted for the invention of a new product, process, organism, design, or plant that allows the right holder to exclude others from making, using, or selling the protected invention for a period of 20 years. 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. Some policymakers also have expressed concern about the health and safety implications of counterfeit goods, including pharmaceutical drugs. The Office of the U.S. Trade Representative (USTR) considers the protection and enforcement of international IPR standards to be a high priority for U.S. trade policy. As such, the USTR has pursued strong IPR regimes by participating in multilateral, regional and bilateral FTAs, as well as through 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. Through their possible impact on innovation and drug prices, patents may affect the ability of countries to provide medicines to their populations and for populations in general to access medicines. According to the World Health Organization (WHO), about one-third of the world's population, primarily residing in poorer parts of Africa and Asia, lacks regular access to essential medicines. At the center of the debate is the question of how to balance providing long-term incentives for innovation through patents and addressing the short-term need to provide affordable access to medicines. The debate over IPRs and access to medicines represents one component of a broader debate over the relationship between international trade policy and global public health. Issues for Congressional Consideration

Possible issues of interest for Congress include incorporating public health input 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.
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 long-term 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.