Responding to Public Health Emergencies

As COVID-19 revealed, pandemics and other public health emergencies raise significant challenges that are best met through a coordinated, international response. The four articles highlighted in this section demonstrate how international collaborations can promote more equitable vaccine development and allocation, improve multi-site ethics review procedures for clinical trials during public health emergencies, and strengthen climate change mitigation efforts by accounting for the harms to human health caused by environmental degradation.

In “The Coalition for Epidemic Preparedness Innovations (CEPI) and the Partnerships of Equitable Vaccine Access, ” Sam Halabi, Lawrence Gostin, Kashish Aneja, Francesca Nardi, Katie Gottschalk, and John Monahan analyse the role and effectiveness of the CEPI in the international collaboration to support the development of COVID-19 vaccine candidates and to facilitate global access to the resulting vaccines, known as COVAX.Reference Halabi, Gostin and Aneja ¹

Initially aiming to distribute two billion doses by the end of 2021, the COVAX effort is now largely seen as having failed to realize much of its initial promise, as national governments in wealthy nations sought to dominate access to vaccines in the early months of the pandemic. As the authors describe, even with its significant portfolio of legal claims upon vaccine doses and platforms, CEPI proved unable to exert sufficient leverage against national governments and on vaccine manufacturers to meaningfully reform global vaccine distribution. By going directly to companies instead of spreading investment and risk through COVAX, wealthy governments were able to re-direct billions of doses to their populations. Nearly 85 percent of the vaccine doses were administered to high-income and upper middle-income countries.

Future pandemic preparedness, prevention, and response will require collaborations of this kind to be sustained and effective going forward. The article analyses CEPI’s unique contribution to international collaborations across the pandemic vaccine supply chain and situates it within the much broader literature on global public health partnerships. The contribution adds to the understanding of how and when these kinds of partnerships can work for public health, especially under emergency circumstances.

In “Increasing Equity in the Transnational Allocation of Vaccines Against Emerging Pathogens: A Multimodal Approach,” Ana Santos Rutschman envisages how a workable corrective procurement framework, like the COVAX facility, might be strengthened to increase equity in the transnational allocation of critically needed medicines and vaccines during large outbreaks of emerging pathogens.Reference Rutschman ² The current “bi-modal” approach, termed “vaccinationalism” or “vaccine nationalism,” relies primarily on unbridled market-based dynamics via bilateral contracts between countries and manufacturers for the former to capture as many doses as possible. The result is prioritization of the needs of populations in politically dominant, wealthy countries, rather than based on public health need.

To address this imbalance, Santos Rutschman, in a highly imaginative exercise in lateral thinking, looks to the eligibility rules for allocation of a coveted place in the New York marathon for inspiration for her proposed “multi-modal” framework. Aimed specifically at infusing greater equity, the allocative framework would utilize ex ante bargaining to incorporate more public health based and equity enhancing levers before the public health crisis occurs and scarcity becomes an acute problem. Realpolitik, however, leads her to advocate for a system that responds at least somewhat to market-driven considerations. In cases where a country funded the R&D of one of the distributed vaccines, Santos Rutschman’s “allocation through funding” criterion would become active. This is clever. In addition to incentivizing participation by wealthy nations, this criterion would also promote maximization of the supply of the scarce resource.

Rutschman then turns her attention to the relationship between these decision modes and the functioning of the system, which would have to be administered through an international structure created before the onset of the next pandemic. While some critical issues are left undetermined, Rutschman’s proposal is promising in that it moves thinking forward about a more flexible and politically viable alternative to the market-based status quo with its perniciously inequitable effects.

In “Enhancing Reciprocity, Equity and Quality of Ethics Review for Multisite Research During Public Health Crises: The Experience of the COVID-19 Clinical Research Coalition,” Vasiliki Rahimzadeh, Jennyfer Ambe, and Jantina de Vries analyse the possibility of using ethics review mutual recognition protocols to streamline international ethics review procedures during public health emergencies.Reference Rahimzadeh, Ambe and de Vries ³ In ethics review mutual recognition, local research ethics committees at different sites review and either choose to accept or reject the research decisions made by a central ethics review committee following a full ethics review by the latter of the proposed multisite project. In their article, the authors explore whether a hypothetical system of ethics review mutual recognition could help communities accelerate approval for rigorously designed research protocols during public health emergencies, when time and resources constraints are most extreme.

The authors’ findings, informed by discussions with the members of the Ethics Working group of the COVID-19 Clinical Research Coalition, suggest that that operationalizing a system of ethics review mutual recognition would be premature at present. They consider indigenous populations, colonialism, and power dynamics between the global north and south in research ethics protocols and propose practical recommendations to support local ethics committee trust-building, as well as building their capacity, in an effort to build the foundation necessary for ethics review mutual recognition.

In “In This Together: International Collaborations for Environmental and Human Health,” we, the issue’s editors, along with our co-author Alistair Woodward call for a reframing and broadening of the traditional approach to tackling the existential threat of climate change.Reference King, Manning and Woodward ⁴ The evidence is undeniable that climate change is currently exacting a terrifying price in human lives and health, one disproportionately experienced by poorer nations and vulnerable populations. This loss of human health and well-being, the associated eye-watering economic costs, and the co-benefits for population health of mitigating climate change all provide essential support for aggressive climate action.

Our article highlights the potential for collaborative approaches between and among states to advance progress on climate change. These range from relatively low-stakes activities, like information-sharing of best practices e.g. on model transportation policies and practices, to voluntary agreements to share resources and personnel in disaster relief and, better still, for green technologies, to exciting developments which could make a substantial difference in reducing emissions, such as binding international trade agreements with environmental conditions and strong financial incentives, like green tariffs. Yet international collaboration need not be restricted to the public sector. Private investors, especially ones with economic heft, can exert their financial muscle as shareholders of multi-national corporate emitters to hold their boards to account to ensure their emissions reduction commitments are honored and not merely “greenwashing.” Since we are truly all in this together, international collaboration on climate change and health, as befits a globalized world, offers another fruitful avenue for climate action.

Each of these articles proposes new methods of international collaborations to respond to public health emergencies and address global crises that impact health. In doing so, each also calls for greater attention to the most vulnerable among us to promote broader health equity.

Addressing International Challenges in Health Information Storage and Use

The second grouping of papers examines opportunities and challenges arising from the storage and use of health information in international contexts. These include offering telehealth in the metaverse, genomic nationalism and its impact on the genomic commons, and the development of an international, patient-controlled, research subject data platform.

In “Telehealth in the Metaverse: Legal and Ethical Challenges for Cross-Border Care in Virtual Worlds,” Barry Solamain explores the exciting possibilities of using the metaverse to expand and improve telehealth, as well as many of the ethical and legal challenges that will arise.Reference Solamain ⁵ The author cautions that the technology is at a very early stage — meta-medicine may never take off. Much will depend on whether the technology can provide a consistently viable alternative to in-person care. But the article is a useful step in attempting to pre-empt what the author considers to be the most critical ethical and legal concerns that could arise should meta-medicine become more embedded in clinical practice.

The article analyzes the potential for meta-medicine to harness the power of AI, making more attainable the much-championed goal of shifting the focus from treatment to prevention and patient education, as well as improving diagnosis and care. In some cases, the legal issues that arose from the sudden, exponential growth in telemedicine during COVID-19 are merely replicated in the metaverse context, but the metaverse also poses new legal challenges. Solamain emphasizes that cross-border collaborations will be required to address the concerns that will have to be contended with, relating to jurisdiction and liability, standard of care, privacy and data security, and the quality of information and informed consent.

In “Genomic Data as a National Strategic Resource,” Kyle McKibbin and Mahsa Shabani consider the benefits of the worldwide collection of publicly accessible human genomic data and the supporting information technology infrastructure, known as “the information commons of human genomic data.”Reference McKibbin and Shabani ⁶ Although the need for widespread data sharing and international collaboration in the field of genomics has never been greater, the authors point to a growing impediment to the commons arising in the national policies of China, the United States, and the European Union, in particular. Policymakers in these jurisdictions increasingly categorize collections of human genomic data and the supporting infrastructure as a “national strategic resource,” for which states compete and which they see as necessary to effectuate national strategic goals, such as national security, economic security, and national autonomy. As a result, these jurisdictions may seek to exclude or restrict access to the commons by foreign governments to prevent its misuse as a weapon or surveillance tool, or by foreign researchers and commercial entities to secure a competitive advantage. They thus elevate their own national strategic interests over the collective interest in cooperative biomedical advancement and innovation, thereby derailing the policies of openness, objectivity, fairness, reciprocity, and transparency that underpin the commons.

In “Challenges and Opportunities in Modernizing Clinical Trial Recruitment,” Amirala Pasha and Richard Silbert argue in favor of the development of peer-to-peer communities that patients can enroll their own health data into and investigators can search for clinical trial use.Reference Pasha and Silbert ⁷ This paradigm shift would disrupt clinical trial recruitment norms that favor large academic institutions in wealthy countries and instead allow participation from a much more diverse group of patients. The authors argue that recent technological advances, such as blockchain, AI, Web 3.0 and the Internet of Things, can significantly aid the development of such communities, which would promote greater inclusion and equity in clinical trial recruitment. These opportunities would, however, create many unique legal and ethical challenges on a global stage. Their article aims to describe this new disruptive model, and identify, analyze, and address some of these challenges and benefits.

Addressing Health Inequities

The third grouping of articles considers ways that international collaborations can elevate marginalized voices and promote global inclusion in decisions made in both health care and health policy. These articles explore ways to do this starting at the patient-provider level through use of shared decision-making in providing care to indigenous populations, moves to discuss the ways law and social justice initiatives can promote health equity through health justice partnerships, and concludes with a broad examination of the importance of democratizing health policy decision-making to include voices beyond those of just “the experts.”

In “Delivering Culturally-Appropriate, Technology-Enabled Health Care in Indigenous Communities,” Laszlo Sajtos, Nataly Martini, Shane Scahill, Hemi Edwards, Potaua Biasiny-Tule, and Hiria Te Rangi propose a culturally-adapted shared decision-making model for delivering health services to Indigenous peoples.Reference Satjos ⁸ The model draws on two research streams for its design and implementation. In the design phase it highlights the relevance of two particular components (cultural knowledge and community, and shared decision-making). A key “success factor” in the design of health interventions in an Indigenous context is the integration of patients’ cultural knowledge and belief systems and life history into care. For the implementation phase, they draw on the motivation-opportunity-ability (MOA) framework from management research to outline factors that they suggest can contribute to positive behavioral change by Indigenous peoples. Somewhat bravely and acknowledging its significant challenges, the authors promote investigating the acceptance and acceptability of digital technologies to develop a single framework for designing and implementing healthcare initiatives by, for and with Indigenous peoples worldwide. They propose that for AI tools to provide personalized and culturally-appropriate and -relevant responses, it is crucial to integrate Indigenous knowledge, language and terminology into AI technologies.

The theme of health inequities arises also in the contribution by Elizabeth Tobin-Tyler, Tessa Boyd-Caine, Hazel Genn, and Nola Ries, “Health Justice Partnership: An International Comparison of Approaches to Employing Law to Promote Prevention and Health Equity.”Reference Tobin-Tyler ⁹ These authors undertake an international comparison of the role and effectiveness of “health justice partnerships” (HJPs) in addressing health inequities. An exciting development, HJPs train and partner health, social, and legal service providers to explicitly identify, prevent, and respond to violations of legal rights that harm health and well-being. Through collaboration across otherwise-siloed health and legal assistance services, HJPs support common cohorts of clients, who are typically low-income and marginalized populations. Through collaboration, these providers can overcome access to justice barriers and promote health equity. The article focuses on US, Australian and UK HJPs which share a commitment to national coordination and support, as well as international collaboration to share lessons and promote innovation. The article traces their different origins in each country and compares their priorities, practices, approaches, and challenges to identify lessons learned and propose areas for future research.

Lastly, in “Malleable Morality: Reshaping Moral Judgments in Health Policymaking,” Shelly Simana questions whether the advice of “moral experts” on health-related moral dilemmas results from rational and deliberate processes, as might be assumed by the governments who frequently rely on such advice.Reference Simana ¹⁰ Using acclaimed social psychologist Jonathan Haidt’s Social Intuitionist Model, Simana claims that the moral judgments of experts, like those of all of us, may be primarily a product of emotions and intuitions, which precede deliberative reasoning and reflection, and which are then rationalized afterwards with publicly acceptable reasons. Further, Simana emphasizes the malleability of one’s intuitions and moral judgments, which are profoundly socially and culturally constructed and easily influenced by others. This suggests that experts’ moral intuitions and judgments might shift if they were exposed to individuals from various backgrounds and points of view. As a result, Simana argues for a more democratic approach to health policymaking, established through vigorous engagement with experts, members of the public, and other stakeholders, particularly diverse and marginalized groups, who may have different moral intuitions and judgments.

Overall, what these articles reveal is that by coming together to collaborate, problem-solve, and listen to each other, we can create pathways to address the even the most “daunting challenges.” We hope that this Special Issue serves as inspiration to keep working across borders, disciplines, cultures, and communities to promote health, equity, justice, and environmental protection.