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Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India. From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges. Based on the 2014 O'

Individual and population health in unincorporated U.S. territories – American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands – lag terribly behind those in the 50 U.S. states and D.C. The populations in the territories – with drastically higher rates of poverty – suffer and die from chronic conditions like cancer, diabetes, and heart disease at far higher rates; must find facilities and doctors thousands of miles away for even moderately complex cases; and perpetually struggle to make access to basic services available. While scholars have long pointed to the disparate treatment of these populations by Congress – especially with respect to Medicaid reimbursement – this Essay argues that the disadvantages and health disparities experienced by territorial populations run far deeper. In fact, the entire structure of healthcare access and financing in unincorporated U.S. territories is fundamentally shaped by how the U.S. federal government occupied those territories, restructured healthcare practice and facilities to sustain the U.S. presence, and as those territories were transferred to the Department of the Interior, imposed financing and programming constraints that made dependency perpetual. This Essay argues for two immediate measures: parity in Congressional commitment to healthcare financing as between U.S. states and U.S. territories, and establishment of investigatory committees to identify and restore indigenous health practices destroyed by U.S. occupation modeled on the Native Hawaiian Healthcare Improvement Act.

This Article critically examines calls by scholars, legislators, and regulators advocating the imposition of fiduciary duties upon a broad range of actors including judges, jurors, agencies, parents, friends, and even entire countries. The Article examines the physician-patient relationship—an archetypal and frequently cited relationship in which fiduciary duties, administered by courts, are asserted to work well. It argues that some of the most significant problems fiduciary duties are used to address like asymmetry of information, conflicts of interest, and professional conduct have not only been handled badly by courts, but have actually found more effective resolution through legislative fact-finding, acknowledgment of the complexity of medical practice, and ultimately regulatory solutions aimed at sources of conflicts of interest and specific circumstances in which claims for medical malpractice arise. Behind many of these initiatives are physicians themselves—who experience the sources of potential conflicts and endeavor to create self-regulatory and legislative solutions to them. In contrast, court-administered fiduciary duties are often marginalized as judicially manageable claims related to the duties of loyalty and the duty of care converge, litigants focus on settlement, and the high expectations held for fiduciaries are rarely enforced. The Article concludes that not only may imposing more fiduciary duties on more relationships not generate the benefits many scholars suggest, but that doing so will stymie more targeted and effective solutions to problems that occur in trust relationships.

Introduction: Viral sovereignty, technology transfer, and the changing global system for sharing pathogens for public health research / Sam Halabi and Rebecca Katz -- The history of accessing and sharing human pathogens for public health / Michelle Rourke -- Attitudes towards transfers of human samples across borders : a multi-country perspective / Ben Krohmal -- The scope of global infectious disease research : field capture, quarantine, and sample transfer to detect emerging pathogen threats / Brian Bird -- The ethics of conducting genomic research in low-resource settings / Hayley K. Sullivan and Benjamin E. Berkman -- The ethics of human pathogen research during public health emergencies in low-and middle income countries : lessons from Latin America and the Caribbean / Sam Halabi -- Biosecurity, biosafety and the management of dangerous pathogens for public health research / Joshua Teperowski Monrad and Rebecca Katz -- Human rights implications of pathogen sharing and technology transfer / Alexandra Phelan -- Material transfer agreements and the regulation of the collaborative environment / Sherry Brett-Major -- Sharing of biological samples during public health emergencies : challenges and opportunities for national and international action / Maria Julia Marinissen, Ruvani Chandrasekera, John Maria Julia Marinissen, Ruvani Chandrasekera, John Simpson, Theodore Kuschak, and Simpson, Theodore Kuschak, and Lauren Barna -- Facilitating material transfer agreements from a practitioner's perspective / Michael Mowatt and Mukul Ranjan -- The pandemic influenza preparedness framework as an access and benefit sharing mechanism / Anne Huvos, Steven A. Solomon and Claudia Nannini.

Introduction: Viral sovereignty, technology transfer, and the changing global system for sharing pathogens for public health research / Sam Halabi and Rebecca Katz -- The history of accessing and sharing human pathogens for public health / Michelle Rourke -- Attitudes towards transfers of human samples across borders : a multi-country perspective / Ben Krohmal -- The scope of global infectious disease research : field capture, quarantine, and sample transfer to detect emerging pathogen threats / Brian Bird -- The ethics of conducting genomic research in low-resource settings / Hayley K. Sullivan and Benjamin E. Berkman -- The ethics of human pathogen research during public health emergencies in low-and middle income countries : lessons from Latin America and the Caribbean / Sam Halabi -- Biosecurity, biosafety and the management of dangerous pathogens for public health research / Joshua Teperowski Monrad and Rebecca Katz -- Human rights implications of pathogen sharing and technology transfer / Alexandra Phelan -- Material transfer agreements and the regulation of the collaborative environment / Sherry Brett-Major -- Sharing of biological samples during public health emergencies : challenges and opportunities for national and international action / Maria Julia Marinissen, Ruvani Chandrasekera, John Maria Julia Marinissen, Ruvani Chandrasekera, John Simpson, Theodore Kuschak, and Simpson, Theodore Kuschak, and Lauren Barna -- Facilitating material transfer agreements from a practitioner's perspective / Michael Mowatt and Mukul Ranjan -- The pandemic influenza preparedness framework as an access and benefit sharing mechanism / Anne Huvos, Steven A. Solomon and Claudia Nannini.

The ebola epidemic of 2014-2015 : a perfect storm / Anthony S. Fauci -- Treating, containing, mobilizing : the role of Médecins sans frontières in the West Africa ebola epidemic response / Heather Pagano and Marc Poncin -- The effect of ebola virus disease on health outcomes and systems in Guinea, Liberia, and Sierra Leone / John D. Kraemer and Mark J. Siedner -- Infectious disease threats in high-resource settings : the MERS-CoV Outbreak in Korea / Sugy Choi, Jong Koo-Lee, and Daniel R. Lucey -- Antibiotic resistance / Gail Hansen -- The international health regulations : the governing framework for global health security / Lawrence O. Gostin and Rebecca Katz -- Global health diplomacy and the ebola outbreak / David P. Fidler -- The future of global financing for infectious diseases / Jen Kates and Adam Wexler -- International public-private partnerships as part of the solution to infectious disease threats : operational, legal, and governance considerations / Kevin A. Klock -- Global vaccine access as a critical intervention to fight infectious disease, antibiotic resistance, and poverty / Seth Berkley -- Bridging the gap between biomedical innovation and access to treatments to fight infectious disease / Veronica Miller -- Ethical challenges in the development and deployment of medical therapies and vaccines in the context of public health emergencies / Annick Antierens -- Evidence, strategies, and challenges for assuring vaccine availability, efficacy, and safety / Saad Omer and Sam Halabi -- An HIV vaccine / Mary Marovich -- Isolation, quarantine and infectious disease threats arising from global migration / Martin Cetron -- Epilogue / Renee Fox

BACKGROUND: The 2005 International Health Regulations (IHR (2005)) require States Parties to establish National Focal Points (NFPs) responsible for notifying the World Health Organization (WHO) of potential events that might constitute public health emergencies of international concern (PHEICs), such as outbreaks of novel infectious diseases. Given the critical role of NFPs in the global surveillance and response system supported by the IHR, we sought to assess their experiences in carrying out their functions. METHODS: In collaboration with WHO officials, we administered a voluntary online survey to all 196 States Parties to the IHR (2005) in Africa, Asia, Europe, and South and North America, from October to November 2019. The survey was available in six languages via a secure internet-based system. RESULTS: In total, 121 NFP representatives answered the 56-question survey; 105 in full, and an additional 16 in part, resulting in a response rate of 62% (121 responses to 196 invitations to participate). The majority of NFPs knew how to notify the WHO of a potential PHEIC, and believed they have the content expertise to carry out their functions. Respondents found training workshops organized by WHO Regional Offices helpful on how to report PHEICs. NFPs experienced challenges in four critical areas: 1) insufficient intersectoral collaboration within their countries, including limited access to, or a lack of cooperation from, key relevant ministries; 2) inadequate communications, such as deficient information technology systems in place to carry out their functions in a timely fashion; 3) lack of authority to report potential PHEICs; and 4) inadequacies in some resources made available by the WHO, including a key tool – the NFP Guide. Finally, many NFP representatives expressed concern about how WHO uses the information they receive from NFPs. CONCLUSION: Our study, conducted just prior to the COVID-19 pandemic, illustrates key challenges experienced by NFPs that can affect States Parties and WHO performance when ...