Think globally, prescribe locally: how rational pharmaceutical policy in the U.S. can improve global access to essential medicines.

I. INTRODUCTION 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.1 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,2 inadequate cooperation between governments and aid agencies,3 rigid protection of intellectual property rights,4 and poor local health leadership regarding dissemination of products.5 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,6 or groups like Medicins Sans Frontieres7 and Partners in Health,8 which have helped set international health priorities and sought to improve local health care delivery systems. Other non-profit organizations have also emerged, such as the Institute for OneWorld Health, a pharmaceutical company that produces drugs for neglected diseases in LMICs.9 Some commentators have also suggested changing the incentive system for pharmaceutical research and development by creating prizes for research into so-called "neglected diseases"10 or establishing Advance Market Commitments to promote demand for development of certain products.11 Most such efforts are based in LMIC environments or focus on the operation of LMIC markets. However, recent developments have begun to alter the global pharmaceutical market. The past few years have been dominated by the growth of multinational pharmaceutical companies and international efforts to coordinate intellectual property and other laws affecting health care costs and pharmaceutical research and development. Pharmaceutical manufacturers based in LMICs such as India, Brazil, and South Korea have witnessed substantial growth, including unprecedented penetration into pharmaceutical markets in wealthier countries like the U.S.12 In addition, the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement), began a process of international standardization of intellectual property laws related to pharmaceutical products.13 Patent laws and other aspects of intellectual property and government pharmaceutical regulatory policy play an integral role in the cost and availability of pharmaceutical products.14 There is now a high level of connection between pharmaceutical-related patent laws and regulations, as well as pharmaceutical markets, in LMICs and wealthier nations. Manufacturers participating in the global pharmaceutical market, and the laws regulating these markets, are becoming characterized by less rigid dichotomization between wealthier nations and LMICs. This presents a new opportunity for policies aimed at promoting international equality of access to essential medicines. In this paper, I will address how pharmaceutical policy in wealthier nations will more directly affect access to essential medicines in LMICs because of the increased interdependence of pharmaceutical markets. The U.S. serves as the paradigmatic example of the new "Think Globally, Prescribe Locally" perspective, because the consumer prescription drug market provides pharmaceutical manufacturers with the most substantial portion of their revenues. However, lessons from the U.S. experience can apply to other wealthier nations struggling with the same issues surrounding improving appropriate availability and use of generic drugs. II. GENERIC DRUG AVAILABILITY AND USE IN WEALTHIER COUNTRIES In the U.S. and other wealthier countries, patents have long been used to provide market exclusivity for novel pharmaceutical products developed by innovative manufacturers. …