Is value-based healthcare a strategy to achieve universal health coverage that includes oral health? An Australian case study.

The 2021 Resolution on Oral Health by the 74th World Health Assembly supports an important health policy direction: inclusion of oral health in universal health coverage. Many healthcare systems worldwide have not yet addressed oral diseases effectively. The adoption of value-based healthcare (VBHC) reorients health services towards outcomes. Evidence indicates that VBHC initiatives are improving health outcomes, client experiences of healthcare, and reducing costs to healthcare systems. No comprehensive VBHC approach has been applied to the oral health context. Dental Health Services Victoria (DHSV), an Australian state government entity, commenced a VBHC agenda in 2016 and is continuing its efforts in oral healthcare reform. This paper explores a VBHC case study showing promise for achieving universal health coverage that includes oral health. DHSV applied the VBHC due to its flexibility in scope, consideration of a health workforce with a mix of skills, and alternative funding models other than fee-for-service.

Ethical analysis examining the prioritisation of living donor transplantation in times of healthcare rationing.

The transplant community has faced unprecedented challenges balancing risks of performing living donor transplants during the COVID-19 pandemic with harms of temporarily suspending these procedures. Decisions regarding postponement of living donation stem from its designation as an elective procedure, this despite that the Centers for Medicare and Medicaid Services categorise transplant procedures as tier 3b (high medical urgency-do not postpone). In times of severe resource constraints, health systems may be operating under crisis or contingency standards of care. In this manuscript, the United Network for Organ Sharing Ethics Workgroup explores prioritisation of living donation where health systems operate under contingency standards of care and provide a framework with recommendations to the transplant community on how to approach living donation in these circumstances.To guide the transplant community in future decisions, this analysis suggests that: (1) living donor transplants represent an important option for individuals with end-stage liver and kidney disease and should not be suspended uniformly under contingency standards, (2) exposure risk to SARS-CoV-2 should be balanced with other risks, such as exposure risks at dialysis centres. Because many of these risks are not quantifiable, donors and recipients should be included in discussions on what constitutes acceptable risk, (3) transplant hospitals should strive to maintain a critical transplant workforce and avoid diverting expertise, which could negatively impact patient preparedness for transplant, (4) transplant hospitals should consider implementing protocols to ensure early detection of SARS-CoV-2 infections and discuss these measures with donors and recipients in a process of shared decision-making.

Sustained ethical analysis of global dilemmas and country-level decision making during and post the COVID-19 pandemic: A systematic review.

The COVID-19 pandemic has highlighted the vulnerability of countries worldwide and their abilities to cope with the fast-paced demands of the research and medical community. A key to promoting ethical decision-making frameworks is by calibrating the sustainability at regional, national, and global levels to incorporate coordinated reforms. We performed a sustained ethical analysis and critically reviewed evidence addressing country-level responses to practices during the COVID-19 pandemic using PubMed (MEDLINE), Scopus, and CINAHL. The World Health Organization's ethical framework proposed for the entire population during the pandemic was applied to thematically delineate findings under equality, best outcomes (utility), prioritizing the worst off, and prioritizing those tasked with helping others. The findings demarcate ethical concerns about the validity of drug and vaccine trials in developing and developed countries, hints of unjust healthcare organizational policies, lack of equal allocation of pertinent resources, miscalculated allocation of resources to essential workers and stratified populations.

Value assessment frameworks: who is valuing the care in healthcare?

Many healthcare agencies are producing evidence-based guidance and policy that may determine the availability of particular healthcare products and procedures, effectively rationing aspects of healthcare. They claim legitimacy for their decisions through reference to evidence-based scientific method and the implementation of just decision-making procedures, often citing the criteria of 'accountability for reasonableness'; publicity, relevance, challenge and revision, and regulation. Central to most decision methods are estimates of gains in quality-adjusted life-years (QALY), a measure that combines the length and quality of survival. However, all agree that the QALY alone is not a sufficient measure of all relevant aspects of potential healthcare benefits, and a number of value assessment frameworks have been suggested. I argue that the practical implementation of these procedures has the potential to lead to a distorted assessment of value. Undue weight may be ascribed to certain attributes, particularly those that favour commercial or political interests, while other attributes that are highly valued by society, particularly those related to care processes, may be omitted or undervalued. This may be compounded by a lack of transparency to relevant stakeholders, resulting in an inability for them to participate in, or challenge, the decisions. The makes it likely that costly new technologies, for which inflated prices can be justified by the current value frameworks, are displacing aspects of healthcare that are highly valued by society.

The draw of the few: the challenge of crisis guidelines for extremely scarce resources.

The COVID-19 pandemic has focused considerable attention on crisis standards of care (CSCs). Most public CSCs at present are effective tools for allocating scarce but not uncommon resources (like ventilators and dialysis machines). However, a different set of challenges arise with regard to extremely scarce resources (ESRs), where the number of patients in need may exceed the availability of the intervention by magnitudes of hundreds or thousands. Using the allocation of extracorporeal membrane oxygenation machines as a case study, this paper argues for a different set of CSCs specifically for ESRs and explores four principles (transparency, uniformity, equity and impact) that should shape such guidelines.

Unweighted lotteries and compounding injustice: reply to Schmidt et al.

I argue that Schmidt et al, while correctly diagnosing the serious racial inequity in current ventilator rationing procedures, misidentify a corresponding racial inequity issue in alternative 'unweighted lottery' procedures. Unweighted lottery procedures do not 'compound' (in the relevant sense) prior structural injustices. However, Schmidt et al do gesture towards a real problem with unweighted lotteries that previous advocates of lottery-based allocation procedures, myself included, have previously overlooked. On the basis that there are independent reasons to prefer lottery-based allocation of scarce lifesaving healthcare resources, I develop this idea, arguing that unweighted lottery procedures fail to satisfy healthcare providers' duty to prevent unjust population-level health outcomes, and thus that lotteries weighted in favour of Black individuals (and others who experience serious health injustice) are to be preferred.

WHO's allocation framework for COVAX: is it fair?

The COVID-19 Vaccines Global Access Facility (COVAX) represents an unprecedented global collaboration facilitating the development and distribution of vaccines for COVID-19. COVAX pools and channels funds from state and non-state actors to promising vaccine candidates, and has started to distribute successful candidates to participating states. The WHO, one of the leaders of COVAX, recognised vaccine doses would initially be scarce, and therefore, prepared a two-staged allocation mechanism they considered fair. In the first stage, vaccine doses are distributed equally among participating countries, while in the second stage vaccine doses will be allocated according to a country's need. Ethicists have questioned whether this is the fairest distribution-they argue a country's need should be taken into account from the start and correspondingly, have proposed a framework that treats individuals with equal moral concern, aims to minimise harm and gives priority to the worst-off. In this paper, we seek to explore these concerns by comparing COVAX's allocation mechanism to a targeted allocation based on need. We consider which distribution would more likely maximise well-being and align with principles of equity. We conclude that although in theory, a targeted distribution in proportion to a country's need would be more morally justifiable, when political realities are taken into account, an equal distribution seems more likely to avert a greater number of deaths and reduce disparities.

A world away and here at home: a prioritisation framework for US international patient programmes.

Programmes serving international patients are increasingly common throughout the USA. These programmes aim to expand access to resources and clinical expertise not readily available in the requesting patients' home country. However, they exist within the US healthcare system where domestic healthcare needs are unmet for many children. Focusing our analysis on US children's hospitals that have a societal mandate to provide medical care to a defined geographic population while simultaneously offering highly specialised healthcare services for the general population, we assume that, given their mandate, priority will be given to patients within their catchment area over other patients. We argue that beyond prioritising patients within their region and addressing inequities within US healthcare, US institutions should also provide care to children from countries where access to vital medical services is unavailable or deficient. In the paper, we raise and attempt to answer the following: (1) Do paediatric healthcare institutions have a duty to care for all children in need irrespective of their place of residence, including international patients? (2) If there is such a duty, how should this general duty be balanced against the special duty to serve children within a defined geographical area to which an institution is committed, when resources are strained? (3) Finally, how are institutional obligations manifest in paradigm cases involving international patients? We start with cases, evaluating clinical and contextual features as they inform the strength of ethical claim and priority for access. We then proceed to develop a general prioritisation framework based on them.

Promoting equity with a multi-principle framework to allocate scarce ICU resources.

We wholeheartedly agree with Schmidt and colleagues' efforts to promote equity in intensive care unit (ICU) triage. We also take issue with their characterisation of the New Jersey (NJ) allocation framework for ICU beds and ventilators, which is modelled after the multi-principle allocation framework we developed early in the pandemic. They characterise it as a two-criterion allocation framework and claim-without evidence-that it will 'compound disadvantage for black patients'. However, the NJ triage framework-like the model allocation policy we developed-actually contains four allocation criteria: the two criteria that the authors mentioned (chances for survival and near-term prognosis) and two criteria that they failed to mention which we included to promote equity: giving priority to frontline essential workers and giving priority to younger patients. These omissions are problematic both for reasons of factual accuracy and because the two criteria they failed to acknowledge would likely mitigate rather than exacerbate racial disparities during triage.

Rare diseases in healthcare priority setting: should rarity matter?

Rare diseases pose a particular priority setting problem. The UK gives rare diseases special priority in healthcare priority setting. Effectively, the National Health Service is willing to pay much more to gain a quality-adjusted life-year related to a very rare disease than one related to a more common condition. But should rare diseases receive priority in the allocation of scarce healthcare resources? This article develops and evaluates four arguments in favour of such a priority. These pertain to public values, luck egalitarian distributive justice the epistemic difficulties of obtaining knowledge about rare diseases and the incentives created by a higher willingness to pay. The first is at odds with our knowledge regarding popular opinion. The three other arguments may provide a reason to fund rare diseases generously. However, they are either overinclusive because they would also justify funding for many non-rare diseases or underinclusive in the sense of justifying priority for only some rare diseases. The arguments thus fail to provide a justification that tracks rareness as such.

Fallacy of the last bed dilemma.

The COVID-19 pandemic highlights the relevance of adequate decision making at both public health and healthcare levels. A bioethical response to the demand for medical care, supplies and access to critical care is needed. Ethically sound strategies are required for the allocation of increasingly scarce resources, such as rationing critical care beds. In this regard, it is worth mentioning the so-called 'last bed dilemma'. In this paper, we examine this dilemma, pointing out the main criteria used to solve it and argue that we cannot face these ethical issues as though they are only a dilemma. A more complex ethical view regarding the care of COVID-19 patients that is focused on proportional and ordinary treatments is required. Furthermore, discussions and forward planning are essential because deliberation becomes extremely complex during an emergency and the physicians' sense of responsibility may be increased if it is faced only as a moral dilemma.

Ethical decision making during a healthcare crisis: a resource allocation framework and tool.

The COVID-19 pandemic has strained healthcare resources the world over, requiring healthcare providers to make resource allocation decisions under extraordinary pressures. A year later, our understanding of COVID-19 has advanced, but our process for making ethical decisions surrounding resource allocation has not. During the first wave of the pandemic, our institution uniformly ramped-down clinical activity to accommodate the anticipated demands of COVID-19, resulting in resource waste and inefficiency. In preparation for the second wave, we sought to make such ramp down decisions more prudently and ethically. We report the development of a tool that can be used to make fair and ethical decisions in times of resource scarcity. We formed an interprofessional team to develop and use this tool to ensure that a diverse range of stakeholder perspectives were represented in this development process. This team, called the clinical activity recovery team, established institutional objectives that were combined with well-established procedural values, substantive ethical principles and decision-making criteria by using a variation on the well-known accountability for reasonableness ethical framework. The result of this is a stepwise, semiquantitative, ethical decision tool that can be applied to resource allocation challenges in order to reach fair and ethically defensible decisions. This ethical decision tool can be applied in various contexts and may prove useful at both the institutional and the departmental level; indeed this is how it is applied at our centre. As the second wave of COVID-19 strains healthcare resources, this tool can help clinical leaders to make fair decisions.

What is common and what is different: recommendations from European scientific societies for triage in the first outbreak of COVID-19.

A public health emergency, as the COVID-19 pandemic, may lead to shortages of potentially life-saving treatments. In this situation, it is necessary, justifiable and proportionate to have decision tools in place to enable healthcare professionals to triage and prioritise access to those resources. An ethically sound framework should consider the principles of beneficence and fair allocation. Scientific Societies across Europe were concerned with this problem early in the pandemic and published guidelines to support their professionals and institutions. This article aims to compare triage policies from medical bodies across Europe, to characterise the process of triage and the ethical values, principles and theories that were proposed in different countries during the first outbreak of COVID-19.

Pandemic prioritarianism.

Prioritarianism pertains to the generic idea that it matters more to benefit people, the worse off they are, and while prioritarianism is not uncontroversial, it is considered a generally plausible and widely shared distributive principle often applied to healthcare prioritisation. In this paper, I identify social justice prioritarianism, severity prioritarianism and age-weighted prioritarianism as three different interpretations of the general prioritarian idea and discuss them in light of the effect of pandemic consequences on healthcare priority setting. On this analysis, the paper arrives at the following three conclusions: (1) that we have strong prioritarian reasons for special concern about the vulnerable and socially disadvantaged in reference to pandemic effects, (2) that severity of illness is an important factor in identifying the worse off in priority setting but that this must not over-ride the special priority to the socially disadvantaged and (3) that the maximisation rationale of the age-weighted view runs against the core prioritarian idea, and the age-weighted prioritarianism is thus unfitting as a prioritarian response to the COVID-19 case.

Operating room time as a limited resource: ethical considerations for allocation.

Scheduling surgical procedures among operating rooms (ORs) is mistakenly regarded as merely a tedious administrative task. However, the growing demand for surgical care and finite hours in a day qualify OR time as a limited resource. Accordingly, the objective of this manuscript is to reframe the process of OR scheduling as an ethical dilemma of allocating scarce medical resources. Recommendations for ethical allocation of OR time-based on both familiar and novel ethical values-are provided for healthcare institutions and individual surgeons.

Does NICE apply the rule of rescue in its approach to highly specialised technologies?

The National Institute for Health and Care Excellence (NICE), the UK's main healthcare priority-setting body, recently reaffirmed a longstanding claim that in recommending technologies to the National Health Service it cannot apply the 'rule of rescue'. This paper explores this claim by identifying key characteristics of the rule and establishing to what extent these are also features of NICE's approach to evaluating ultra-orphan drugs through its highly specialised technologies (HST) programme. It argues that although NICE in all likelihood does not act because of the rule in prioritising these drugs, its actions in relation to HSTs are nevertheless in accordance with the rule and are not explained by the full articulation of any alternative set of rationales. That is, though NICE implies that its approach to HSTs is not motivated by the rule of rescue, it is not explicit about what else might justify this approach given NICE's general concern with overall population need and value for money. As such, given NICE's reliance on notions of procedural justice and its commitment to making the reasons for its priority-setting decisions public, the paper concludes that NICE's claim to reject the rule is unhelpful and that NICE does not currently meet its own definition of a fair and transparent decision-maker.

What's yours is ours: waiving intellectual property protections for COVID-19 vaccines.

This paper gives an ethical argument for temporarily waiving intellectual property (IP) protections for COVID-19 vaccines. It examines two proposals under discussion at the World Trade Organization (WTO): the India/South Africa proposal and the WTO Director General proposal. Section I explains the background leading up to the WTO debate. Section II rebuts ethical arguments for retaining current IP protections, which appeal to benefiting society by spurring innovation and protecting rightful ownership. It sets forth positive ethical arguments for a temporary waiver that appeal to standing in solidarity and holding companies accountable. After examining built-in exceptions to existing agreements and finding them inadequate, the paper replies to objections to a temporary waiver and concludes, in section III, that the ethical argument for temporarily waiving IP protection for COVID-19 vaccines is strong.

Who will receive the last ventilator: why COVID-19 policies should not prioritise healthcare workers.

Policies promoted and adopted for allocating ventilators during the COVID-19 pandemic have often prioritised healthcare workers or other essential workers. While the need for such policies has so far been largely averted, renewed stress on health systems from continuing surges, as well as the experience of allocating another scarce resource-vaccination-counsel revisiting the justifications for such prioritisation. Prioritising healthcare workers may have intuitive appeal, but the ethical justifications for doing so and the potential harms that could follow require careful analysis. Ethical justifications commonly offered for healthcare worker prioritisation for ventilators rest on two social value criteria: (1) instrumental value, also known as the 'multiplier effect', which may preserve the ability of healthcare workers to help others, and (2) reciprocity, which rewards past usefulness or sacrifice. We argue that these justifications are insufficient to over-ride the common moral commitment to value each person's life equally. Institutional policies prioritising healthcare workers over other patients also violate other ethical norms of the healthcare professions, including the commitment to put patients first. Furthermore, policy decisions to prioritise healthcare workers for ventilators could engender or deepen existing distrust of the clinicians, hospitals and health systems where those policies exist, even if they are never invoked.