American Journal of Law & Medicine

This Article explores the connections between emerging infectious diseases, domestic disease panics, global health, and the law by comparing the American response to Ebola to the initial American response to the AIDS epidemic. We demonstrate that in both cases the arrival of a new deadly disease was initially met with fear, stigma and the use of law to “other” those associated with the disease. We begin by reviewing the initial responses to the AIDS epidemic. We then offer a brief history of emerging infectious disease scares over the past few decades, highlighting the problematic rhetoric that paved the way for the Ebola panic. We then review the 2014 Ebola outbreak, noting its similarities and distinctions from the early AIDS epidemic. Finally, we examine United States policies regarding HIV and Ebola in Africa. We conclude with some tentative observations about the relationship between germ panics, law, and public health.

As Jacobson v. Massachusetts recognized in 1905, the basis of public health law, and its ability to limit constitutional rights, is the use of scientific data and empirical evidence. Far too often, this important fact is lost. Fear, misinformation, and politics frequently take center stage and drive the implementation of public health law. In the recent Ebola scare, political leaders passed unnecessary and unconstitutional quarantine measures that defied scientific understanding of the disease and caused many to have their rights needlessly constrained. Looking at HIV criminalization and exemptions to childhood vaccine requirements, it becomes clear that the blame cannot be placed on the hysteria that accompanies emergencies. Indeed, these examples merely illustrate an unfortunate array of examples where empirical evidence is ignored in the hopes of quelling paranoia. These policy approaches are not only constitutionally questionable, they generate their own risk to public health. The ability of the law to jeopardize public health approaches to infectious disease control can, and should, be limited through a renewed emphasis on science as the foundation of public health, coordination through all levels and branches of government, and through a serious commitment by the judiciary to provide oversight. Infectious disease creates public anxiety, but this cannot justify unwarranted dogmatic approaches as a response. If we as a society hope to ensure efficient, constitutional control over the spread of disease, it is imperative that science take its rightful place at the forefront of governmental decision-making and judicial review. Otherwise, the law becomes its own public health threat.

Non-communicable and chronic diseases have overtaken infectious diseases as the major causes of death and disability around the world. Despite recognition that reduction in the chronic disease burden will require governance systems to address the social determinants of health, most public health recommendations emphasize individual behavior as the primary cause of illness and the target of intervention. This Article argues that focusing on lifestyle can backfire, by increasing health inequities and inviting human rights violations. If States fail to take meaningful steps to alter the social and economic structures that create health risks and encourage unhealthy behavior, health at the population level is unlikely to improve significantly. Viewing the global health challenge from the perspective of human rights, however, reveals opportunities for positive change in all sectors of governance. Explicit recognition of human rights can help refocus attention on the fundamental causes of health and protect individuals from unnecessary harm.

In the absence of capable government services, a railroad company in Texas and multiple cotton mills in North Carolina successfully prevented malaria in the early twentieth century. This Article looks through the lens of economics to understand how and why people had the incentive to privately coordinate malaria prevention during this time, but not after. These firms, motivated by increases in productivity and profit, implemented extensive anti-malaria programs and used their hierarchical organizational structures to monitor performance. The factors underlying the decline of private prevention include a fall in the overall rate of malaria, the increasing presence of the federal government, and technological innovations that lowered exposure to mosquitoes. Understanding how, why, and when firms can prevent diseases has important implications for current disease policy, especially where governments, international organizations, and technologies are not enough.

In public health practice, the concepts of health and safety are often conflated. However, protecting and promoting health is radically different from protecting and promoting safety. Since 9/11, the distinctions between health and safety have changed and are in the process of merging. In our terrorism-obsessed world, public health has been increasingly militarized and enlisted, often without protest, into the service of protecting the safety of the public and the security of the nation. But safety and security are the proper purposes of law enforcement and the military, not of public health. More importantly, using public health to combat terrorism is often counterproductive to the population's health, and undermines human rights. Using the Ebola epidemic of 2014, this Article suggests how the post-9/11 reframing of public health goals as including disaster preparedness and counterterrorism, and the new military metaphors we have adopted to describe public health, have deformed our public health agencies, and have made them less trusted by the public. In turn, these agencies are therefore less able to prevent and respond to new infectious diseases. The United States' response to Ebola gives us an opportunity to reconsider the merger of public health and public safety domestically and globally. This Article suggests that a deeper commitment to human rights, especially to the right to health, has the theoretical and practical strength to act as a countervailing force and refocus public health on the health of populations rather than on safety and national security.

Epidemics are among the greatest threats to humanity, and the International Health Regulations are the world's key legal instrument for addressing this threat. Since their revision in 2005, the IHR have faced two big tests: the 2009 H1N1 influenza pandemic and the 2014 Ebola epidemic in West Africa. Both exposed major shortcomings of the IHR, and both offered profound lessons for the future.

The objective of this Article is twofold. First, we seek to compare the lessons learned from H1N1 and Ebola for reforming the IHR in order to test the hypothesis that they are similar. Second, we seek to examine the barriers to implementing these lessons and to identify strategies for overcoming those barriers.

We find that the lessons from H1N1 and Ebola are indeed similar, and that opportunities to act on lessons from H1N1 were woefully missed. We identify many political barriers to global collective action and implementation of lessons for the IHR. On that basis, we describe strategies to overcome these barriers, which will hopefully be deployed now to reform the IHR before the policy window following Ebola closes, and before the inevitable next epidemic comes. The emerging threat of the Zika virus underscores that we have no time to waste.

The narrative of Ebola's arrival in the United States has been overwhelmed by our fear of a West African-style epidemic. The real story of Ebola's arrival is about our healthcare system's failure to identify, treat, and contain healthcare associated infections. Having long been willfully ignorant of the path of fatal infectious diseases through our healthcare facilities, this paper considers why our reimbursement and quality reporting systems made it easy for this to be so. West Africa's challenges in controlling Ebola resonate with our own struggles to standardize, centralize, and enforce infection control procedures in American healthcare facilities.

Accelerating the development and approval of novel therapeutics has emerged as a key public health priority given the mortality, morbidity, and economic costs associated with infections caused by drug-resistant bacteria. However, there is limited empirical evidence to guide policymaking, such as the factors that may disadvantage antibiotics compared to other classes of drugs. In this Article, we empirically examine characteristics of the key clinical trials underpinning FDA's approval of antibiotics and other drugs over the past decade. Despite perceptions that antibiotic trials are larger and more difficult to conduct, we find that antibiotic trials are no larger than those conducted for drugs approved in other disease areas with high unmet medical needs, suggesting that policymakers may need to target other levers to meaningfully stimulate innovation. We discuss the risks and benefits of harnessing new and existing regulatory pathways to speed the approval of new drugs, particularly those intended to treat patients with serious and life-threatening infections, and we evaluate ways that proposals for new regulatory pathways could be improved to better prioritize and expedite the approval of therapies with the greatest potential for patient health benefits.

This Article examines the potential stakeholder-related obstacles hindering the implementation of mechanisms to re-ignite the development of novel antibiotics. Proposed economic models and incentives to drive such development include: Public Funding of Research and Development (“R&D”), Tax Incentives, Milestone Prizes, End Payments, Intellectual Property (“IP”) and Exclusivity Extensions, Pricing and Reimbursement Incentives, Product Development Partnerships (“PDPs”), and the Options Market for Antibiotics model. Drawing on personal experience and understanding of the antibiotic field, as well as stakeholder consultation and numerous expert meetings within the DRIVE-AB project and Uppsala Health Summit 2015, the Authors identify obstacles attributable to the following actors: Universities and Research Institutes, Small and Medium-sized Enterprises (“SMEs”), Large Pharmaceutical Companies, Marketing Approval Regulators, Payors, Healthcare Providers, National Healthcare Authorities, Patients, and Supranational Institutions.

The analysis also proposes a characterization and ranking of the difficulty associated with implementing the reviewed mechanisms. Public Funding of R&D, Pricing and Reimbursement Incentives, and PDPs are mechanisms expected to meet highly systemic barriers (i.e., obstacles across the entire antibiotic value chain), imposing greater implementation challenges in that they require convincing and involving several motivationally diverse actors in order to have much effect.

Antibiotics have prevented countless deaths from common infections and have made possible many modern medical procedures. Over the past few decades, antibiotic-resistant bacteria have become a global threat, spreading between healthcare facilities and throughout communities worldwide at an alarming pace. Antibiotic overuse and misuse in humans, animals, and the environment accelerate resistance by selecting for bacteria with antibiotic-resistant traits, which then become predominant and infect others. Meanwhile, few antibiotics remain active against the most resistant bacteria. There is an urgent need for new antibiotics and other antibacterial products to replace second-line and last resort therapies when they no longer work. This Article proposes a new U.S.-based, non-governmental, not-for-profit product development partnership (PDP) model specifically designed for antibacterial development. This new model should both supplement and complement existing government-led efforts and should be built with mechanisms in place to balance the values of innovation, access, and conservation.

In December 2014, the United States government expanded the Priority Review Voucher (“PRV” or “voucher”) program to include Ebola and other related Filoviruses. By doing so, lawmakers provided a potentially powerful incentive for drug companies to invest time and money in the development of novel medicines for terrifying diseases. This expansion is one of several additions made to the PRV programs since 2012. Many companies rely on voucher resale to recoup research and development (“R&D”) costs; however, it is unclear whether the PRV program could be overextended, thereby diluting the value of the incentives. In this paper, I use historical approval data from the Food and Drug Administration (“FDA”) and United States drug revenue data to better understand the secondary market value of a PRV. The data suggests that that purchase prices of a PRV could continue to climb; despite this, the market size for these vouchers is limited. The implications of these findings are discussed further.

This Article explores two ways in which airline travel is an important vector for the spread of infectious disease, and argues that airlines have market-based and liability-based reasons to require that passengers be vaccinated. Going further, the Article explores whether the federal government has the legal and constitutional authority—especially under the Commerce Clause—to encourage or mandate that airlines implement such a vaccine screen. By disrupting the spread of disease at key network nodes where individuals interact and then connect with other geographic regions, and by creating another incentive for adult vaccination, an airline vaccine screen could be an effective and legally viable tool for the protection of public health.

The creation of new vaccines is one of the key challenges in the battle against global infectious diseases. Therefore, creating the optimal conditions for innovation in vaccines is one of the most important roles law may undertake in this battle. In relation to pharmaceuticals, the economic theory of patent protection is commonly cited by industry and in the academic literature to justify the patenting of life-saving medicines and vaccines. The economic theory of patent protection holds that innovation occurs due to patents protecting the research and development investment made by the innovator. Proponents of this theory claim that without patents such innovation in medicines and vaccines would occur at a significantly reduced rate. This Article considers the applicability of the economic theory of patent protection to pandemic influenza vaccines. This Article examines a number of factors relevant to patent law, theory, and innovation including: the patent landscape for pandemic influenza vaccines; the market dominance enjoyed by manufacturers; the actual risk posed by imitators making generic vaccines if patent protection were not in place; and, the licensing and regulatory provisions for creating generic vaccines.

According to the economic theory of patent protection, a patent incentivizes innovation by providing an innovator with a temporary monopoly regarding their innovation, and by protecting them from the threat posed by imitators who wish to make a cheap replica of the product. However, even without a patent, pandemic influenza vaccine manufacturers are in this position. Due to economies of scale and the complicated regulatory and licensing frameworks relevant to bringing a pandemic influenza vaccine to market, manufacturers are at little to no risk from generic imitators. Moreover, there is a very strong incentive to innovate because pandemic influenza vaccine manufacturers are selling a product for which demand exceeds supply to a captive market of nations and organizations, each of which is hoping to secure as much vaccine as possible. The unique conditions associated with pandemic influenza vaccines appear to provide more of an incentive to innovate and research in this field than the fact that the innovations can be patented.

A recent measles outbreak in the United States was linked to a single source, yet it spanned eighteen jurisdictions and infected 121 people. ¹ Forty-seven states currently allow legal exemption from vaccination on religious grounds, eighteen of which also allow it on philosophical grounds. ² Recent research usually accepts a fundamental right to vaccine exemption and primarily seeks ways to protect herd immunity while also respecting that right, for example, by keeping the exemption available yet harder to procure or by imposing torts for infection-related injury. ³ We argue that when herd immunity is at risk, any moral claim to exemption from vaccination on conscientious, philosophical, or religious grounds is overridden.

Our argument rests on an analogy to a series of situations in which a person puts others at risk through philosophically or religiously motivated choices. In these situations, intuitively, there is no claim-right to compromise the safety of others. Similarly, we propose, there is no claim-right to refuse vaccination, regardless of one's conscience, when refusal is sufficiently likely to seriously affect herd immunity and the safety of others. We also address several counterarguments. The lack of a claim-right to exemption when herd immunity is at risk does not mean, however, that it is always prudent for the state to force vaccination, or even that forcing vaccinations must be legal. Alternatives to forced vaccination may prove wiser and more conducive to high vaccination rates.