'Staying in the lane' of public health? Boundary-work in the roles of state health officials and experts in COVID-19 policymaking.

The state-level COVID-19 response in the United States necessitated collaboration between governor' offices, health departments and numerous other departments and outside experts. To gain insight into how health officials and experts contributed to advising on COVID-19 policies, we conducted semi-structured interviews with 25 individuals with a health specialisation who were involved in COVID-19 policymaking, taking place between February and December 2022. We found two diverging understandings of the role of health officials and experts in COVID-19 policymaking: the role of 'staying in the lane' of public health in terms of the information that they collected, their advocacy for policies and their area of expertise and the role of engaging in the balancing of multiple considerations, such as public health, feasibility and competing objectives (such as the economy) in the crafting of pandemic policy. We draw on the concept of boundary-work to examine how these roles were constructed. We conclude by considering the appropriateness as well as the ethical implications of these two approaches to public health policymaking.

The Value of Explicit, Deliberative, and Context-Specified Ethics Analysis for Health Technology Assessment: Evidence From a Novel Approach Piloted in South Africa.

OBJECTIVES: This article explores the perceived value, including associated strengths and challenges, of using a context-specified ethics framework to guide deliberative health technology appraisals. METHODS: The South African Values and Ethics for Universal Health Coverage (SAVE-UHC) approach, piloted in South Africa, consisted of 2 phases: (1) convening a national multistakeholder working group to develop a provisional ethics framework and (2) testing the provisional ethics framework through simulated health technology assessment appraisal committee meetings (SACs). Three SACs each reviewed 2 case studies of sample health interventions using the framework. Participants completed postappraisal questionnaires and engaged in focus group discussions. RESULTS: The SACs involved 27 participants across 3 provinces. Findings from the postappraisal questionnaires demonstrated general support for the SAVE-UHC approach and content of the framework, high levels of satisfaction with the recommendations produced, and general sentiment that participants were able to actively contribute to appraisals. Qualitative data showed participants perceived using a context-specified ethics framework in deliberative decision making: (1) supported wider consideration of and deliberation about morally relevant features of the health coverage decisions, thereby contributing to quality of appraisals; (2) could improve transparency; and (3) offered benefits to those directly involved in the priority-setting process. Participants also identified some challenges and concerns associated with the approach. CONCLUSIONS: The SAVE-UHC approach presents a novel way to develop and pilot a locally contextualized, explicit ethics framework for health priority setting. This work highlights how the combination of a context-specified ethics framework and structured deliberative appraisals can contribute to the quality of health technology appraisals and transparency of health priority setting.

COVID-19 vaccine policy development in a sample of 44 countries - Key findings from a December 2021 survey of National Immunization Technical Advisory Groups (NITAGs).

National Immunization Technical Advisory Committees (NITAGs) are tasked with the responsibility of guiding ministries of health and national immunization programmes in their policy development processes. Many NITAGs rely on evidence reviewed by the World Health Organization's (WHO) Strategic Group of Experts(SAGE) on immunization and aim to adapt WHO's recommendations to their respective contexts. This relationship took on exceptional importance since the onset of the COVID-19 pandemic, during which NITAGs have expressed a notable struggle to craft appropriate policies on population prioritization and vaccine utilization in the face of supply constraints and complex programmatic and delivery logistics. This online survey was conducted to assess the usefulness of the SAGE guidance documents for COVID-19 vaccine policies and to examine the persisting needs and challenges facing NITAGs. Results confirmed that SAGE recommendations concerning COVID-19 vaccines are easy to access, understand, and adapt. They have been found to be comprehensive and timely under the data and time constrained circumstances confronting SAGE. The Global NITAG Network (GNN) appears to be the most popular vehicle for addressing questions among high income countries, in contrast to lower income countries who favour WHO Country or Regional Offices. NITAGs place much value on interaction with other NITAGs, which requires facilitation and could benefit from increased opportunities, especially within regions. It is further noted that some NITAGs have had to tackle issues during the pandemic not typically considered by SAGE, such as supply chain logistics and vaccine demand. Learning from the COVID-19 experience offers opportunities to strengthen NITAGs and the pandemic recovery effort through the development of more concrete procedures and consideration of more varied types of data, including implementation effectiveness and uptake data. There is also an opportunity for an increasing involvement of Country Office WHO personnel to support NITAGs, while ensuring information and evidence needs of countries are adequately reflected in SAGE deliberations.

Ethical and economic implications of the adoption of novel plant-based beef substitutes in the USA: a general equilibrium modelling study.

BACKGROUND: Slowing climate change is crucial to the future wellbeing of human societies and the greater environment. Current beef production systems in the USA are a major source of negative environmental impacts and raise various animal welfare concerns. Nevertheless, beef production provides a food source high in protein and many nutrients as well as providing employment and income to millions of people. Cattle farming also contributes to individual and community identities and regional food cultures. Novel plant-based meat alternatives have been promoted as technologies that could transform the food system by reducing negative environmental, animal welfare, and health effects of meat production and consumption. Recent studies have conducted static analyses of shifts in diets globally and in the USA, but have not considered how the whole food system would respond to these changes, nor the ethical implications of these responses. We aimed to better explore these dynamics within the US food system and contribute a multiple perspective ethical assessment of plant-based alternatives to beef. METHODS: In this national modelling analysis, we explored multiple ethical perspectives and the implications of the adoption of plant-based alternatives to beef in the USA. We developed USAGE-Food, a modified version of USAGE (a detailed computable general equilibrium model of the US economy), by improving the representation of sector interactions and dependencies, and consumer behaviour to better reflect resource use across the food system and the substitutability of foods within households. We further extended USAGE, by linking estimates of the environmental footprint of US agriculture, to estimate how changes across the agriculture sector could alter the environmental impact of primary food production across the whole sector, not only the beef sector. Using USAGE-Food, we simulated four beef replacement scenarios against a baseline of current beef demand in the USA: BEEF10, in which beef expenditure is replaced by other foods and three scenarios wherein 10%, 30%, or 60% of beef expenditure is replaced by plant-based alternatives. FINDINGS: The adoption of plant-based beef alternatives is likely to reduce the carbon footprint of US food production by 2·5-13·5%, by reducing the number of animals needed for beef production by 2-12 million. Impacts on other dimensions are more ambiguous, as the agricultural workforce and natural resources, such as water and cropland, are reallocated across the food system. The shifting allocation of resources should lead to a more efficient food system, but could facilitate the expansion of other animal value chains (eg, pork and poultry) and increased exports of agricultural products. In aggregate, these changes across the food system would have a small, potentially positive, impact on national gross domestic product. However, they would lead to substantial disruptions within the agricultural economy, with the cattle and beef processing sectors decreasing by 7-45%, challenging the livelihoods of the more than 1·5 million people currently employed in beef value chains (primary production and animal processing) in the USA. INTERPRETATION: Economic modelling suggests that the adoption of plant-based beef alternatives can contribute to reducing greenhouse gas emissions from the food system. Relocation of resources across the food system, simulated by our dynamic modelling approach, might mitigate gains across other environmental dimensions (ie, water or chemical use) and might facilitate the growth of other animal value chains. Although economic consequences at the country level are small, there would be concentrated losses within the beef value chain. Reduced carbon footprint and increased resource use efficiency of the food system are reasons for policy makers to encourage the continued development of these technologies. Despite this positive outcome, policy makers should recognise the ethical assessment of these transitions will be complex, and should remain vigilant to negative outcomes and be prepared to target policies to minimise the worst effects. FUNDING: The Stavros Niarchos Foundation, the Bill & Melinda Gates Foundation, Johns Hopkins University, the Commonwealth Scientific and Industrial Research Organisation, Cornell University, and Victoria University.

Developing and piloting a context-specified ethics framework for health technology assessment: the South African Values and Ethics for Universal Health Coverage approach.

OBJECTIVES: While ethics has been identified as a core component of health technology assessment (HTA), there are few examples of practical, systematic inclusion of ethics analysis in HTA. Some attribute the scarcity of ethics analysis in HTA to debates about appropriate methodology and the need for ethics frameworks that are relevant to local social values. The "South African Values and Ethics for Universal Health Coverage" (SAVE-UHC) project models an approach that countries can use to develop HTA ethics frameworks that are specific to their national contexts. METHODS: The SAVE-UHC approach consisted of two phases. In Phase I, the research team convened and facilitated a national multistakeholder working group to develop a provisional ethics framework through a collaborative, engagement-driven process. In Phase II, the research team refined the model framework by piloting it through three simulated HTA appraisal committee meetings. Each simulated committee reviewed two case studies of sample health interventions: opioid substitution therapy and either a novel contraceptive implant or seasonal influenza immunization for children under five. RESULTS: The methodology was fit-for-purpose, resulting in a context-specified ethics framework and producing relevant findings to inform application of the framework for the given HTA context. CONCLUSIONS: The SAVE-UHC approach provides a model for developing, piloting, and refining an ethics framework for health priority-setting that is responsive to national social values. This approach also helps identify key facilitators and challenges for integrating ethics analysis into HTA processes.

Too Many Patients A Framework to Guide Statewide Allocation of Scarce Mechanical Ventilation During Disasters.

The threat of a catastrophic public health emergency causing life-threatening illness or injury on a massive scale has prompted extensive federal, state, and local preparedness efforts. Modeling studies suggest that an influenza pandemic similar to that of 1918 would require ICU and mechanical ventilation capacity that is significantly greater than what is available. Several groups have published recommendations for allocating life-support measures during a public health emergency. Because there are multiple ethically permissible approaches to allocating scarce life-sustaining resources and because the public will bear the consequences of these decisions, knowledge of public perspectives and moral points of reference on these issues is critical. Here we describe a critical care disaster resource allocation framework developed following a statewide community engagement process in Maryland. It is intended to assist hospitals and public health agencies in their independent and coordinated response to an officially declared catastrophic health emergency in which demand for mechanical ventilators exceeds the capabilities of all surge response efforts and in which there has been an executive order to implement scarce resource allocation procedures. The framework, built on a basic scoring system with modifications for specific considerations, also creates an opportunity for the legal community to review existing laws and liability protections in light of a specific disaster response process.

Scarce Resource Allocation During Disasters: A Mixed-Method Community Engagement Study.

BACKGROUND: During a catastrophe, health-care providers may face difficult questions regarding who will receive limited life-saving resources. The ethical principles that should guide decision-making have been considered by expert panels but have not been well explored with the public or front-line clinicians. The objective of this study was to characterize the public's values regarding how scarce mechanical ventilators should be allocated during an influenza pandemic, with the ultimate goal of informing a statewide scare resource allocation framework. METHODS: Adopting deliberative democracy practices, we conducted 15 half-day community engagement forums with the general public and health-related professionals. Small group discussions of six potential guiding ethical principles were led by trained facilitators. The forums consisted exclusively of either members of the general public or health-related or disaster response professionals and were convened in a variety of meeting places across the state of Maryland. Primary data sources were predeliberation and postdeliberation surveys and the notes from small group deliberations compiled by trained note takers. RESULTS: Three hundred twenty-four individuals participated in 15 forums. Participants indicated a preference for prioritizing short-term and long-term survival, but they indicated that these should not be the only factors driving decision-making during a crisis. Qualitative analysis identified 10 major themes that emerged. Many, but not all, themes were consistent with previously issued recommendations. The most important difference related to withholding vs withdrawing ventilator support. CONCLUSIONS: The values expressed by the public and front-line clinicians sometimes diverge from expert guidance in important ways. Awareness of these differences should inform policy making.

Research with Pregnant Women: New Insights on Legal Decision-Making.

U.S. researchers and scholars often point to two legal factors as significant obstacles to the inclusion of pregnant women in clinical research: the Department of Health and Human Services' regulatory limitations specific to pregnant women's research participation and the fear of liability for potential harm to children born following a pregnant woman's research participation. This article offers a more nuanced view of the potential legal complexities that can impede research with pregnant women than has previously been reflected in the literature. It reveals new insights into the role of legal professionals throughout the research pathway, from product conception to market, and it highlights a variety of legal factors influencing decision-making that may slow or halt research involving pregnant women. Our conclusion is that closing the evidence gap created by the underrepresentation and exclusion of pregnant women in research will require targeted attention to the role of legal professionals and the legal factors that influence their decisions.

The community speaks: understanding ethical values in allocation of scarce lifesaving resources during disasters.

INTRODUCTION: Pandemic influenza or other crises causing mass respiratory failure could easily overwhelm current North American critical care capacity. This threat has generated large-scale federal, state, and local efforts to prepare for a public health disaster. Few, however, have systematically engaged the public regarding which values are most important in guiding decisions about how to allocate scarce healthcare resources during such crises. METHODS: The aims of this pilot study were (1) to test whether deliberative democratic methods could be used to promote engaged discussion about complex, ethically challenging healthcare-related policy issues and (2) to develop specific deliberative democratic procedures that could ultimately be used in a statewide process to inform a Maryland framework for allocating scarce healthcare resources during disasters. Using collaboratively developed focus group materials and multiple metrics for assessing outcomes, we held 5-hour pilot community meetings with a combined total of 68 community members in two locations in Maryland. The key outcomes used to assess the project were (1) the comprehensibility of the background materials and ethical principles, (2) the salience of the ethical principles, (3) the perceived usefulness of the discussions, (4) the degree to which participants' opinions evolved as a result of the discussions, and (5) the quality of participant engagement. RESULTS: Most participants were thoughtful, reflective, and invested in this pilot policy-informing process. Throughout the pilot process, changes were made to background materials, the verbal introduction, and pre- and post-surveys. Importantly, by holding pilot meetings in two distinct communities (an affluent suburb and inner city neighborhood), we discerned that participants' ethical reflections were framed in large part by their place-based life experiences. CONCLUSION: This pilot process, coupled with extensive feedback from participants, yielded a refined methodology suitable for wider-scale use and underscored the need for involvement of diverse communities in a statewide engagement process on this critical policy issue.

Chemotherapy drug shortages in pediatric oncology: a consensus statement.

Shortages of essential drugs, including critical chemotherapy drugs, have become commonplace. Drug shortages cost significant time and financial resources, lead to adverse patient outcomes, delay clinical trials, and pose significant ethical challenges. Pediatric oncology is particularly susceptible to drug shortages, presenting an opportunity to examine these ethical issues and provide recommendations for preventing and alleviating shortages. We convened the Working Group on Chemotherapy Drug Shortages in Pediatric Oncology (WG) and developed consensus on the core ethical values and practical actions necessary for a coordinated response to the problem of shortages by institutions, agencies, and other stakeholders. The interdisciplinary and multiinstitutional WG included practicing pediatric hematologist-oncologists, nurses, hospital pharmacists, bioethicists, experts in emergency management and public policy, legal scholars, patient/family advocates, and leaders of relevant professional societies and organizations. The WG endorsed 2 core ethical values: maximizing the potential benefits of effective drugs and ensuring equitable access. From these, we developed 6 recommendations: (1) supporting national polices to prevent shortages, (2) optimizing use of drug supplies, (3) giving equal priority to evidence-based uses of drugs whether they occur within or outside clinical trials, (4) developing an improved clearinghouse for sharing drug shortage information, (5) exploring the sharing of drug supplies among institutions, and (6) developing proactive stakeholder engagement strategies to facilitate prevention and management of shortages. Each recommendation includes an ethical rationale, action items, and barriers that must be overcome. Implemented together, they provide a blueprint for effective and ethical management of drug shortages in pediatric oncology and beyond.

Social values and health policy: a new international research programme.

PURPOSE: This editorial aims to outline the context of healthcare priority-setting, and summarise each of the other ten papers in this special edition. It introduces a new multidisciplinary research programme drawing on ethics, philosophy, health economics, political science and health technology assessment, out of which the papers in this edition have arisen. DESIGN/METHODOLOGY/APPROACH: Key normative concepts are introduced and policy and research context provided to frame subsequent papers in the edition. FINDINGS: Common challenges of health priority-setting are faced by many countries across the world, and a range of social value judgments is in play as resource allocation decisions are made. Although the challenges faced by different countries are in many ways similar, the way in which social values affect the processes and content of priority-setting decisions means that those challenges are resolved very differently in a variety of social, political, cultural and institutional settings, as subsequent papers in this edition demonstrate. How social values affect decision making in this way is the subject of a new multi-disciplinary research programme. ORIGINALITY/VALUE: Technical analyses of health priority setting are commonplace, but approaching the issues from the perspective of social values and conducting comparative analyses across countries with very different cultural, social and institutional contexts provides the content for a new research agenda.

Eliminating drug price differentials across government programmes in the USA.

Federal agencies in the USA pay significantly different prices for the same prescription drugs because each agency uses a different approach to derive the payment rate. Because we do not identify any economic rationale or socially accepted moral reasoning that would justify the current level of price variation, we suggest that the federal government should pay a uniform price for each drug. Laws and regulations that give certain federal agencies the ability to earn rebates, use formularies, or permit other special arrangements would need to be eliminated in order to have a single payment rate. This could make some government agencies worse off than others; however, a uniform payment rate would not need to affect beneficiaries' current financial contributions, access to drugs, benefits or overall public expenditures. At the same time, having a single rate would permit the government to adopt a more effective approach to purchasing drugs and send a consistent message to pharmaceutical companies concerning which types of drugs the government wants them to develop for government beneficiaries. How this single price would be derived and how it would compare with the lowest or highest prices currently achieved by government agencies would depend on a variety of policy issues including the government's desire to encourage pharmaceutical research and development and the need to control health care spending.

Alternatives to national average income data as eligibility criteria for international subsidies: a social justice perspective.

Current strategies to address global inequities in access to life-saving vaccines use averaged national income data to determine eligibility. While largely successful in the lowest income countries, we argue that this approach could lead to significant inefficiencies from the standpoint of justice if applied to middle-income countries, where income inequalities are large and lead to national averages that obscure truly needy populations. Instead, we suggest alternative indicators more sensitive to social justice concerns that merit consideration by policy-makers developing new initiatives to redress health inequities in middle-income countries.