The United States\u27 Engagement in Global Tobacco Control: Proposals for Comprehensive Funding and Strategies

Tobacco use kills more people annually than HIV/AIDS, tuberculosis, and malaria combined. Unless action is taken, tobacco-related diseases will kill hundreds of millions more in coming decades, mostly in low- and middle-income countries. Beyond its effects on morbidity and mortality, tobacco use has dramatic social and economic consequences, consuming healthcare budgets, robbing families of their primary wage earners, and hindering economic development. Tobacco consumption is shifting from industrialized to developing countries, spurred by rising incomes, trade liberalization, and intensive marketing. Although Congress empowered the U.S. Food and Drug Administration to regulate tobacco domestically, the United States has failed to lead globally. The United States is among a small minority of countries that has signed, but not ratified, the World Health Organization (WHO) Framework Convention on Tobacco Control. A tiny percentage of U.S. funding for global health is dedicated to international tobacco control. U.S. trade policy has supported and enabled the industry to expand tobacco use overseas. In this Commentary, we argue for robust U.S. engagement in global tobacco control, first explaining why it is in the national interest of the United States and then suggesting a comprehensive strategy for supporting tobacco control in low- and middle-income countries

Trade, social preferences and regulatory cooperation : the new WTO-think

This paper advocates changes in the corporate governance of the World Trade Organization (WTO) to reflect the decline in tariffs and other border restraints to commerce and the emerging challenges of advancing freer trade and better regulation cooperation in a world economy dominated by global value chains. Together, these changes form an integration strategy that we refer to as the new WTO Think. This strategy remains rooted in the original rationale of the General Agreement on Trade and Tariffs (GATT) of reducing the negative externalities of unilateral action and solving important international coordination challenges, but is more inclusive of regulators and non-state actors and more flexible and positive in its means. In particular, we advocate that the WTO should embrace the confluence of shared social preferences and trade, where it exists, as a motivation for advancing international regulatory cooperation. The WTO should also multilateralize the important regulatory cooperation occurring in smaller clubs of like-minded countries and better facilitate the use of plurilateral agreements where consensus across all WTO members is not yet possible

Trade, Social Preferences, and Regulatory Cooperation: The New WTO-Think

This paper advocates changes in the corporate governance of the World Trade Organization (WTO) to reflect the decline in tariffs and other border restraints to commerce and the emerging challenges of advancing freer trade and better regulation cooperation in a world economy dominated by global value chains. Together, these changes form an integration strategy that we refer to as the new WTO Think. This strategy remains rooted in the original rationale of the General Agreement on Trade and Tariffs (GATT) of reducing the negative externalities of unilateral action and solving important international coordination challenges, but is more inclusive of regulators and non-state actors and more flexible and positive in its means. In particular, we advocate that the WTO should embrace the confluence of shared social preferences and trade, where it exists, as a motivation for advancing international regulatory cooperation. The WTO should also multilateralize the important regulatory cooperation occurring in smaller clubs of like-minded countries and better facilitate the use of plurilateral agreements where consensus across all WTO members is not yet possible

Global susceptibility and response to noncommunicable diseases.

Globalization and human interdependence have created immeasurable value for humanity. These forces, however, also provide channels for health risks to spread throughout the world. Global functions for health, such as international partnerships or research and development, are a rational response to global health risks like pandemics or globalized supply chains. Self-interest compels governments – or donors – to provide global functions even though their benefits are widely shared the world over

Oral Rehydration Salts, Cholera, and the Unfinished Urban Health Agenda

Cholera has played an outsized role in the history of how cities have transformed from the victims of disease into great disease conquerors. Yet the current burden of cholera and diarrheal diseases in the fast-urbanizing areas of low-income nations shows the many ways in which the urban health agenda remains unfinished and must continue to evolve

Bridging the Gap: Improving Clinical Development and the Regulatory Pathways for Health Products for Neglected Diseases

There has been tremendous progress over the last decade in the development of health products for neglected diseases. These include drugs, vaccines, and diagnostics for malaria and tuberculosis, which kill millions of people annually, plus other diseases like changes and dengue fever, which may less familiar, but nonetheless exact a large and often lethal toll in the world’s poorest communities. Led by product development public- private partnerships (PDPs) and fueled by the support of the Bill & Melinda Gates Foundation, the National Institutes of Health, and other donors, there are now dozens of candidate products in the pipeline. [Working Paper No. 217]health products, drugs, vaccines, malaria, tuberculosis, dengue fever, development public- private partnerships, Bill & Melinda Gates Foundation, National Institutes of Health

Reputation and Authority: The FDA and the Fight over U.S. Prescription Drug Importation

There is popular and bipartisan support for legalizing the importation of lower-cost medicines from Canada to help reduce the high prescription drug costs that Americans pay. Despite the wide interest in this policy, attempts over the last sixteen years to create a formal system for large-scale prescription drug importation in the United States have failed. The Trump Administration recently issued a final rule to enable the legal importation of prescription drugs from Canada, but the rule has important design flaws and seems destined to suffer a similar fate as previous efforts. In this Article, we argue that prescription drug importation is a form of international regulatory engagement that can work, but not in the manner that recent congressional legislation or the Trump Administration has proposed. Importation of prescription drugs, even foreign versions of already-approved drugs, requires the importing nation to accept the marketing approval standards, processes, and product-specific decisions of the exporting nation as equivalent to domestic regulation. The FDA, however, has made far fewer determinations of foreign regulatory equivalence than its counterpart regulators. As a result, the statutory requirements for the FDA maintaining direct oversight over prescription drug imports from Canada are onerous and unlikely ever to be fulfilled. Examining U.S. prescription drug importation as a form of reliance on the equivalence of foreign regulation is, as far as we can determine, a novel inquiry, and it offers useful insights. Foreign equivalence determinations have been successfully used in pharmaceutical regulation in two contexts: (1) trade initiatives and (2) circumstances in which regulatory agencies were unable to fulfill their core institutional mandates without relying on the decisionmaking of their foreign counterparts. The FDA has not fit neatly into either of these contexts. In contrast to many of its foreign counterparts, the FDA has consolidated authority over pharmaceutical regulation, which it sustains through its reputation among its constituents—appropriators, consumers, pharmaceutical product sponsors, and the relevant medical and scientific communities—for overseeing the safety, efficacy, and quality of medicines. The FDA has resisted risking any harm to that gatekeeper reputation that might follow from its pursuit of other policy objectives, such as lowering drug prices or facilitating trade. Furthermore, FDA officials describe themselves as “the gold standard” for drug review—more thorough and rigorous about regulation than their counterparts—and, until recently, as able to fulfill their core institutional mandates without the cooperation of foreign counterparts. Based on this analysis of the political economy of pharmaceutical regulation and international regulatory cooperation at the FDA, we propose that U.S. prescription drug importation could be successfully used to reduce generic drug shortages, a persistent public health problem that the FDA has struggled to solve independently. We argue that the same analysis can help identify other circumstances when the FDA might usefully engage foreign counterparts, such as foreign manufacturer inspections for the rapidly increasing volume of U.S. drug imports, the growing complexity of global pharmaceutical supply chains, and the technological advances in personalized medicines

Trade, Social Preferences, and Regulatory Cooperation: The New WTO-Think

This paper advocates changes in the corporate governance of the World Trade Organization (WTO) to reflect the decline in tariffs and other border restraints to commerce and the emerging challenges of advancing freer trade and better regulation cooperation in a world economy dominated by global value chains. Together, these changes form an integration strategy that we refer to as the new WTO Think. This strategy remains rooted in the original rationale of the General Agreement on Trade and Tariffs (GATT) of reducing the negative externalities of unilateral action and solving important international coordination challenges, but is more inclusive of regulators and non-state actors and more flexible and positive in its means. In particular, we advocate that the WTO should embrace the confluence of shared social preferences and trade, where it exists, as a motivation for advancing international regulatory cooperation. The WTO should also multilateralize the important regulatory cooperation occurring in smaller clubs of like-minded countries and better facilitate the use of plurilateral agreements where consensus across all WTO members is not yet possible

The Equitable Distribution of COVID-19 Therapeutics and Vaccines

Scientists from across the globe are racing to develop effective vaccines and therapeutics for coronavirus disease 2019 (COVID-19). Plans are beginning to emerge for ensuring the equitable worldwide distribution of vaccines and therapeutics resulting from biomedical innovations. Absent broad agreement and buy-in on those plans, governments may prioritize their own populations, resulting in inequitable distribution of medical products both within and among countries. During the 2009 influenza A(H1N1) pandemic, wealthy nations bought virtually all vaccine supplies. Even after the WHO appealed for donations, supplies for low- and middle-income countries (LMICs) were limited. The White House may have already sought exclusive access to a COVID-19 vaccine candidate. European and Asian countries have imposed export controls on personal protective equipment and ventilators, with similar export controls likely to extend to COVID-19 vaccine and therapeutic stocks.The development and widespread distribution of COVID-19 medical treatments are a common global interest. Here we offer a proposal for global cooperation to ensure equitable distribution of vaccines and therapies for COViD-19

The Role of International Organizations in Global Health Governance

Why did the global public health community fail to respond adequately to COVID-19, and what changes are needed for this network to better address future pandemics