Hepatitis B and C cause most cases of hepatitis in the United States and the world. The two diseases account for about a million deaths a year and 78 percent of world's hepatocellular carcinoma and more than half of all fatal cirrhosis. In 2013 viral hepatitis, of which hepatitis B virus (HBV) and hepatitis C virus (HCV) are the most common types, surpassed HIV and AIDS to become the seventh leading cause of death worldwide. The world now has the tools to prevent hepatitis B and cure hepatitis C. Perfect vaccination could eradicate HBV, but it would take two generations at least. In the meantime, there is no cure for the millions of people already infected. Conversely, there is no vaccine for HCV, but new direct-acting antivirals can cure 95 percent of chronic infections, though these drugs are unlikely to reach all chronically-infected people anytime soon. This report, the first of two, examines the feasibility of hepatitis B and C elimination in the United States and identifies critical success factors. The phase two report will outline a strategy for meeting the elimination goals discussed in this report. Table of Contents Front Matter Summary 1 Introduction 2 The Elimination of Hepatitis B 3 The Elimination of Hepatitis C 4 Conclusion Appendix A: Committee Meeting 1 Agenda Appendix B: Committee Meeting 2 Agenda Appendix C: Committee Biographies Appendix D: Glossary

Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone. The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress. The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape. Table of Contents Front Matter Summary 1 Introduction 2 Regulatory Systems, Global Health, and Development 3 Global Efforts to Strengthen Regulatory Systems 4 The Role of the National Government 5 The Role of the Regulatory Agency Appendix A: Committee Member Biographies Appendix B: Public Meeting Agendas Appendix C: Call for Comments Appendix D: Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond the three hardest-hit countries and beyond the health sector. Education, child protection, commerce, transportation, and human rights have all suffered. The consequences and lethality of Ebola have increased interest in coordinated global response to infectious threats, many of which could disrupt global health and commerce far more than the recent outbreak. In order to explore the potential for improving international management and response to outbreaks the National Academy of Medicine agreed to manage an international, independent, evidence-based, authoritative, multistakeholder expert commission. As part of this effort, the Institute of Medicine convened four workshops in summer of 2015 to inform the commission report. The presentations and discussions from the Pandemic Financing Workshop are summarized in this report. Table of Contents Front Matter 1 Introduction 2 International Cooperative Action on Pandemics 3 Pandemic Emergency Funds 4 Adapting Insurance Products for Pandemic Risk 5 Innovative Financing Mechanisms for Preparedness and Response 6 Identifying Triggers and Modeling Risk 7 Financing Challenges In-Country 8 Donor Considerations and Crowding-In 9 The Role of the Private Sector 10 Incentives and Preparedness Appendix A: References Appendix B: Workshop Agenda Appendix C: Participant Biographies

The United States has been a generous sponsor of global health programs for the past 25 years or more. This investment has contributed to meaningful changes, especially for women and children, who suffer the brunt of the world's disease and disability. Development experts have long debated the relative merits of vertical health programming, targeted to a specific service or patient group, and horizontal programming, supporting more comprehensive care. The U.S. government has invested heavily in vertical programs, most notably through the President's Emergency Plan for AIDS Relief (PEPFAR), its flagship initiative for HIV and AIDS. PEPFAR and programs like it have met with good success. Protecting these successes and continuing progress in the future depends on the judicious integration of vertical programs with local health systems. A strong health system is the best insurance developing countries can have against a disease burden that is shifting rapidly and in ways that history has not prepared us for. Reaching the poor with development assistance is an increasingly complicated task. The majority of the roughly 1 billion people living in dire poverty are in middle-income countries, where foreign assistance is not necessarily needed or welcome. Many of the rest live in fragile states, where political volatility and weak infrastructure make it difficult to use aid effectively. The poorest people in the world are also the sickest; they are most exposed to disease vectors and infection. Nevertheless, they are less likely to access health services. Improving their lot means removing the systemic barriers that keep the most vulnerable people from gaining such access. Investing in Global Health Systems discusses the past and future of global health. First, the report gives context by laying out broad trends in global health. Next, it discusses the timeliness of American investment in health systems abroad and explains how functional health systems support health, encourage prosperity, and advance global security. Lastly, it lays out, in broad terms, an effective donor strategy for health, suggesting directions for both the manner and substance of foreign aid given. The challenge of the future of aid programming is to sustain the successes of the past 25 years, while reducing dependence on foreign aid. Investing in Global Health Systems aims to help government decision makers assess the rapidly changing social and economic situation in developing countries and its implications for effective development assistance. This report explains how health systems improvements can lead to better health, reduce poverty, and make donor investment in health sustainable.

Antimicrobial resistance is a health problem that threatens to undermine almost a century of medical progress. Moreover, it is a global problem that requires action both in the United States and internationally. Combating Antimicrobial Resistance and Protecting the Miracle of Modern Medicine discusses ways to improve detection of resistant infections in the United States and abroad, including monitoring environmental reservoirs of resistance. This report sets out a strategy for improving stewardship and preventing infections in humans and animals. The report also discusses the strength of the pipeline for new antimicrobial medicines and steps that could be taken to bring a range of preventive and therapeutic products for humans and animals to the market. Table of Contents Front Matter Summary 1 Introduction 2 The Scope of the Problem 3 The Health and Economic Burden of Resistance 4 Strengthening Surveillance 5 Stewardship and Infection Prevention 6 Bringing New Products to Market and Ensuring Their Reach 7 The National Action Plan for Combating Antibiotic-Resistant Bacteria 8 A Role for the United States in Coordinated Global Action Appendix A: Committee Member Biographies Appendix B: Disclosure of Unavoidable Conflict of Interest Appendix C: Open Session Agendas

A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world. Table of Contents Front Matter Summary 1 Introduction 2 Core Elements of Regulatory Systems 3 Critical Issues 4 A Strategy to Building Food and Medical Product Regulatory Systems 5 International Action 6 Domestic Action 7 Conclusions and Priorities Appendix A: Glossary Appendix B: A Review of Tort Liability's Role in Food and Medical Product Regulation Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China Appendix D: Chinese Food Regulatory System Appendix E: Meeting Agendas Appendix F: Committee Member Biographies Appendix G: Analyzing Food Safety Alerts in European Union Rapid Alerts Systems for Food and Feed Appendix H: Strengthening Core Elements of Regulatory Systems in Developing Countries: Identifying Priorities and an Appropriate Role for the U.S. Food and Drug Administration

Hepatitis B and C cause most cases of hepatitis in the United States and the world. The two diseases account for about a million deaths a year and 78 percent of world's hepatocellular carcinoma and more than half of all fatal cirrhosis. In 2013 viral hepatitis, of which hepatitis B virus (HBV) and hepatitis C virus (HCV) are the most common types, surpassed HIV and AIDS to become the seventh leading cause of death worldwide. The world now has the tools to prevent hepatitis B and cure hepatitis C. Perfect vaccination could eradicate HBV, but it would take two generations at least. In the meantime, there is no cure for the millions of people already infected. Conversely, there is no vaccine for HCV, but new direct-acting antivirals can cure 95 percent of chronic infections, though these drugs are unlikely to reach all chronically-infected people anytime soon. This report, the second of two, builds off the conclusions of the first report and outlines a strategy for hepatitis reduction over time and specific actions to achieve them. Table of Contents Front Matter Summary 1 Introduction 2 Targets for Elimination 3 Public Health Information 4 Essential Interventions 5 Service Delivery 6 Financing Elimination 7 Research Appendix A: Population Health Impact and Cost-Effectiveness of Chronic Hepatitis B Diagnosis, Care, and Treatment in the United States Appendix B: Modeling the Elimination of Hepatitis C in the United States Appendix C: Public Meeting Agenda Appendix D: Committee Biographies

Quality of care is a priority for U.S. Agency for International Development (USAID). The agency's missions abroad and their host country partners work in quality improvement, but a lack of evidence about the best ways to facilitate such improvements has constrained their informed selection of interventions. Six different methods - accreditation, COPE, improvement collaborative, standards-based management and recognitions (SBM-R), supervision, and clinical in-service training - currently make up the majority of this investment for USAID missions. As their already substantial investment in quality grows, there is demand for more scientific evidence on how to reliably improve quality of care in poor countries. USAID missions, and many other organizations spending on quality improvement, would welcome more information about how different strategies work to improve quality, when and where certain tools are most effective, and the best ways to measure success and shortcomings. To gain a better understanding of the evidence supporting different quality improvement tools and clarity on how they would help advance the global quality improvement agenda, the Institute of Medicine convened a 2-day workshop in January 2015. The workshop's goal was to illuminate these different methods, discussing their pros and cons. This workshop summary is a description of the presentations and discussions. Table of Contents Front Matter 1 Introduction 2 An Overview of Quality of Care in Low- and Middle-Income Countries 3 Six Widely Used Methods to Improve Quality 4 Reviewing the Evidence for Different Quality Improvement Methods 5 Synthesizing Evidence, Identifying Gaps 6 Cross-Cutting Approaches to Improve Quality References Appendix A: Workshop Agenda Appendix B: Participant Biographies

The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.