Ethical reflections on Covid-19 vaccines.

OBJECTIVES: More than 1 year after the start of the Covid-19 pandemic it is becoming increasingly clear that vaccines will prove to be essential in combating this global pandemic. The demand for such vaccines is great (since nearly everyone is a candidate for vaccination) yet supplies are currently limited. This raises clear ethical questions regarding the current and future Covid-19 vaccines. METHODS: In this paper we highlight the several ethical questions that are raised using a three-fold categorization. We will discuss questions concerning: (1) the design and testing of vaccines; (2) who gets the vaccines; and (3) the tensions between public health and individual interest/autonomy. Each of these three more broad categories encompasses many different and concrete ethical questions. RESULTS: We argue that different ethical frameworks apply both across these three categories, but also within these categories. CONCLUSION: Despite the fact that ethical conflict might not completely disappear, we argue that distinguishing and discussing separate questions from an ethical perspective can help create the necessary clarity and provide an ethical justification in favour of particular vaccination issues.

Ethical issues in managing the COVID-19 pandemic.

The COVID-19 pandemic has had an immense and worldwide impact. In light of future pandemics or subsequent waves of COVID-19 it is crucial to focus on the ethical issues that were and still are raised in this COVID-19 crisis. In this paper, we look at issues that are raised in the testing and tracing of patients with COVID-19. We do this by highlighting and expanding on an approach suggested by Fineberg that could serve as a public health approach. In this way, we highlight several ethical issues. As regards testing, questions are raised such as whether it is ethical to use less reliable tests in order to increase testing capacity or minimize harm for patients. Another issue is how wide testing should be and whether selective testing is in accordance with principles of social justice. Patients who have recovered from COVID-19 might have some degree of immunity but attributing certain 'immunopriviliges' raises ethical questions. The use of various tracing methodologies (mobile apps or databases and trained tracers) raised evident questions of social justice and privacy. We argue why it is key to always uphold a test of proportionality where a fair balance must be sought.

Euthanasia in Belgium: Shortcomings of the Law and Its Application and of the Monitoring of Practice.

In 2002 with the passing of the Euthanasia Law, Belgium became one of the few countries worldwide to legalize euthanasia. In the 18 years since the passing of the law, much has changed. We argue that in Belgium a widening of the use of euthanasia is occurring and that this can be ethically and legally problematic. This is in part related to the fact that several legal requirements intended to operate as safeguards and procedural guarantees in reality often fail to operate as such. We focus on three kinds of safeguards or procedural guarantees: (1) the legally defined due care criteria for eligibility for euthanasia; (2) the consultation of a second (and sometimes third) physician; and (3) the reporting of euthanasia cases to the Federal Control and Evaluation Commission for Euthanasia. We will show how each of these three safeguards can exhibit shortcomings in theory and practice.

Challenges in turning a great idea into great health policy: the case of integrated care.

BACKGROUND: In the organization of health care and health care systems, there is an increasing trend towards integrated care. Policy-makers from different countries are creating policies intended to promote cooperation and collaboration between health care providers, while facilitating the integration of different health care services. Hopes are high, as such collaboration and integration of care are believed to save resources and improve quality. However, policy-makers are likely to encounter various challenges and limitations when attempting to turn these great ideas into effective policies. In this paper, we look into these challenges. MAIN BODY: We argue that the organization of health care and integrated care is of public concern, and should thus be of crucial interest to policy-makers. We highlight three challenges or limitations likely to be encountered by policy-makers in integrated care. These are: (1) conceptual challenges; (2) empirical/methodological challenges; and (3) resource challenges. We will argue that it is still unclear what integrated care means and how we should measure it. 'Integrated care' is a single label that can refer to a great number of different processes. It can describe the integration of care for individual patients, the integration of services aimed at particular patient groups or particular conditions, or it can refer to institution-wide collaborations between different health care providers. We subsequently argue that health reform inevitably possesses a political context that should be taken into account. We also show how evidence supporting integrated care may not guarantee success in every context. Finally, we will discuss how promoting collaboration and integration might actually demand more resources. In the final section, we look at three different paradigmatic examples of integrated care policy: Norway, the UK's NHS, and Belgium. CONCLUSIONS: There seems widespread agreement that collaboration and integration are the way forward for health care and health care systems. Nevertheless, we argue that policy-makers should remain careful; they should carefully consider what they hope to achieve, the amount of resources they are willing to invest, and how they will evaluate the success of their policy.

Past, present and future of university hospitals.

Objectives: Health care systems worldwide are changing and taking new forms. The old, more hierarchically oriented, model with individual institutional and bilateral interactions between primary, secondary, tertiary and quaternary care is being replaced by an integrated and dynamic network model. We aim to look at what role university hospitals will play in this future organization of health care.Method: In this paper, we look at the relevant literature on the history of academic medicine and university hospitals. Subsequently, we look at the challenges university hospitals are facing according to contemporary literature on the topic.Results: Our current model of academic medicine with its university hospitals finds its origin in the institutionalization of the academic mission in the late 18th century. Currently, the sustainability of the model is under immense pressure. University hospitals are facing economic challenges, teaching challenges and research challenges. However, there is reason to believe that they can continue to play a role of importance in tomorrow's medicine. The organization of health care is undergoing two important changes. The first is the evolution towards a more dynamic and integrated network model. University hospitals can become an important hub within this network. The second change is an evolution towards evidence based medicine and translational research.Conclusion: Due to their unique tripartite mission, we argue that university hospitals can continue to play an important and critical role in promoting evidence-based medicine and speedy translation of new evidence.

'Capacity for Discernment' and Euthanasia on Minors in Belgium.

In 2014, the Belgian Euthanasia Law was amended so as to extend the possibility of obtaining euthanasia to minors who have the capacity for discernment. The amendment led to considerable debate among Belgian legal experts, health care professionals and ethicists, in large part due to concerns about the scope and assessment of the minor's 'capacity for discernment', a concept first introduced in Belgian medical law by the amendment. This article offers a critical legal analysis of the concept of 'capacity for discernment' and its implications for euthanasia practice in Belgium. We do so by focusing on a ruling of the Belgian Constitutional Court of 29 October 2015, where the concept figured prominently in the examination of the constitutionality of the amendment. This approach also allows us to shed light on the interpretation of several core aspects of the original 2002 Euthanasia Law and its 2014 amendment.

Organizing Health Care Networks: Balancing Markets, Government and Civil Society.

Much is changing in health care organization today. A perspective or paradigm that is gaining ever increasing momentum is that of translational, extramural and integrated care. Current research suggests many potential benefits for integrated care and health care networks but the ethical issues are less frequently emphasized. Showing that integrated care can be beneficial, does not mean it is automatically ethically justified. We will argue for three ethical requirements such health care networks should meet. Subsequently we will look at the mechanisms driving the formation of networks and examine how these can cause networks to meet or fail to meet these ethical requirements or obligations. The three mechanisms we will examine are government, civil society and market mechanisms, which, we argue, should be balanced properly. Each mechanism is able to provide a relevant ethical perspective to health care networks. However, when the balance is skewed towards a single mechanism, health care networks might fail to promote one or more of the ethical requirements.

The patient perspective in health care networks.

BACKGROUND: Health care organization is entering a new age. Focus is increasingly shifting from individual health care institutions to interorganizational collaboration and health care networks. Much hope is set on such networks which have been argued to improve economic efficiency and quality of care. However, this does not automatically mean they are always ethically justified. A relevant question that remains is what ethical obligations or duties one can ascribe to these networks especially because networks involve many risks. Due to their often amorphous and complex structure, collective responsibility and accountability may increase while individual responsibility goes down. MAIN BODY: We argue that a business ethics approach to ethical obligations for health care networks, is problematic and we propose to opt for a patient perspective. Using the classic four principles of biomedical ethics (justice, nonmaleficence, beneficence and autonomy) it is possible to identify specific ethical duties. Based on the principle of justice, health care networks have an ethical duty to provide just and fair access for all patients and to be transparent to patients about how access is regulated. The principle of nonmaleficence implies an obligation to guarantee patient safety, whereas the principle of beneficence implies an obligation for health care networks to guarantee continuity of care in all its dimensions. Finally, the principle of autonomy is translated into a specific obligation to promote and respect patient choice. Networks that fail to meet any of these conditions are suspect and cannot be justified ethically. CONCLUSIONS: Faced with daunting challenges, the health care system is changing rapidly. Currently many hopes ride on integrated care and broad health care networks. Such networks are the topic of empirical debate, but more attention should be given to the ethical aspects. Health care networks raise new and pressing ethical issues and we are in need of a framework for assessing how and when such networks are justified.

In Defence of Moral Pluralism and Compromise in Health Care Networks.

The organisation of health care is rapidly changing. There is a trend to move away from individual health care institutions towards transmural integrated care and interorganizational collaboration in networks. However, within such collaboration and network there is often likely to be a pluralism of values as different health care institutions often have very different values. For this paper, we examine three different models of how we believe institutions can come to collaborate in networks, and thus reap the potential benefits of such collaboration, despite having different moral beliefs or values. A first way is the pragmatic way in which the different health care institutions avoid ethical reflection and focus on solutions. A second possible route is that of consensus where health care institutions base their collaboration on values that they all share. The third, and final, approach is that of compromise. Although moral compromise is often seen in a negative light, we argue that in many cases compromise might be necessary and ethically justified. In a final section, we will shift our focus from discussing various theoretical methods to allow collaboration to the potential content of consensus or compromise.

Euthanasia embedded in palliative care. Responses to essentialistic criticisms of the Belgian model of integral end-of-life care.

The Belgian model of 'integral' end-of-life care consists of universal access to palliative care (PC) and legally regulated euthanasia. As a first worldwide, the Flemish PC organisation has embedded euthanasia in its practice. However, some critics have declared the Belgian-model concepts of 'integral PC' and 'palliative futility' to fundamentally contradict the essence of PC. This article analyses the various essentialistic arguments for the incompatibility of euthanasia and PC. The empirical evidence from the euthanasia-permissive Benelux countries shows that since legalisation, carefulness (of decision making) at the end of life has improved and there have been no significant adverse 'slippery slope' effects. It is problematic that some critics disregard the empirical evidence as epistemologically irrelevant in a normative ethical debate. Next, rejecting euthanasia because its prevention was a founding principle of PC ignores historical developments. Further, critics' ethical positions depart from the PC tenet of patient centeredness by prioritising caregivers' values over patients' values. Also, many critics' canonical adherence to the WHO definition of PC, which has intention as the ethical criterion is objectionable. A rejection of the Belgian model on doctrinal grounds also has nefarious practical consequences such as the marginalisation of PC in euthanasia-permissive countries, the continuation of clandestine practices and problematic palliative sedation until death. In conclusion, major flaws of essentialistic arguments against the Belgian model include the disregard of empirical evidence, appeals to canonical and questionable definitions, prioritisation of caregiver perspectives over those of patients and rejection of a plurality of respectable views on decision making at the end of life.

An analysis of common ethical justifications for compassionate use programs for experimental drugs.

BACKGROUND: When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years. This raises an issue for drugs which could benefit terminally ill patients. These patients might set their hopes on the experimental drug but are unable to wait since they are likely to pass away before the drug is available. As a means of nevertheless getting access to experimental drug, many seriously ill and terminally ill patients are therefore very willing to participate in randomised controlled trials. However, only very few terminally ill patients are able to actually participate, and those that do participate are at risk of participating solely as a way of getting experimental drugs. Currently, there are, however, ways of getting access to drugs that have not (yet) gained market approval. One such mean is via expanded access or compassionate use programs where terminally ill patients receive experimental new drugs that are not yet market approved. In this paper, I examine some of the common justifications for such programs. MAIN BODY: The most frequently voiced justifications for compassionate use or expanded access programs could be put in one of three categories. First, there are justifications of justice, where compassionate use programs could be seen as a just or fair way to distribute experimental new drugs to patients who are denied access to RCT's through no fault of their own. Second, such programs could be justified by reference to the ethical principle of beneficence where it could be claimed that terminally ill patients stand to benefit greatly at very little risk (as they are already dying). Third, there are considerations of autonomy where, it is claimed, patients should be able to exercise their autonomy and have access to such drugs if that is there free choice and they are fully aware of the risks associated with that choice. SHORT CONCLUSION: In this paper, I argue currently all justifications are potentially problematic. If they truly form the basis for justification, compassionate use programs should be designed to maximize justice, beneficence and autonomy.

Controversies surrounding continuous deep sedation at the end of life: the parliamentary and societal debates in France.

BACKGROUND: Continuous deep sedation at the end of life is a practice that has been the topic of considerable ethical debate, for example surrounding its perceived similarity or dissimilarity with physician-assisted dying. The practice is generally considered to be legal as a form of symptom control, although this is mostly only assumed. France has passed an amendment to the Public Health Act that would grant certain terminally ill patients an explicit right to continuous deep sedation until they pass away. Such a framework would be unique in the world. DISCUSSION: In this paper we will highlight and reflect on four relevant aspects and shortcomings of the proposed bill. First, that the bill suggests that continuous deeps sedation should be considered as a sui generis practice. Second, that it requires that sedation should always be accompanied by the withholding of all artificial nutrition and hydration. In the most recently amended version of the legal proposal it is stated that life sustaining treatments are withheld unless the patient objects. Third, that the French bill would not require that the suffering for which continuous deep sedation is initiated is unbearable. Fourth, the question as to whether the proposal should be considered as a way to avoid having to decriminalise euthanasia and/or PAS or, on the contrary, as a veiled way to decriminalise these practices. The French proposal to amend the Public Health Act to include a right to continuous deep sedation for some patients is a unique opportunity to clarify the legality of continuous deep sedation as an end-of-life practice. Moreover, it would recognize that the practice of continuous deep sedation raises ethical and legal issues that are different from those raised by symptom control on the one hand and assisted dying on the other hand. Nevertheless, there are still various issues of significant ethical concern in the French legislative proposal.

The Extension of Belgium's Euthanasia Law to Include Competent Minors.

Following considerable debate, the practice of euthanasia was legalized in Belgium in 2002, thereby making Belgium one of the few places in the world where this practice is legal. In 2014 the law was amended for the first time. The 2014 amendment makes euthanasia legally possible for all minors who repeatedly and voluntarily request euthanasia and who are judged to possess "capacity of discernment" (regardless of their biological age), as well as fulfil a number of other criteria of due care. This extension of the 2002 euthanasia law generated a lot of national and international debate and has been applauded by many and heavily criticized by others. This evolution is clearly of interest to end-of-life debates in the entire world. This paper will therefore describe how this amendment came to get passed using official documents from Belgium's Senate and Chamber of Representatives where this amendment was discussed and subsequently passed. Next, some of the most commonly given arguments in favour of the law are identified, as well as the arguments most often voiced against the amendment. All these arguments will be expanded upon and it will be examined whether they hold up to ethical scrutiny. Analysing the official documents and identifying the most commonly voiced arguments gives valuable insight into how Belgium came to amend its euthanasia law and why it did so in 2014. It also becomes clear that although the current amendment is often seen as far-reaching, more radical ideas were proposed during the drafting of the law. Also, in analysing those arguments in favour of the amendment and those against, it is clear that the validity of some of these is questionable.

How defining clinical practices may influence their evaluation: the case of continuous sedation at the end of life.

RATIONALE, AIMS AND OBJECTIVES: Continuous sedation at the end of life is an end-of-life practice that has gained considerable attention in the international literature. Nevertheless, significant confusion persists, even on how to label or define the practice. Several different terms and definitions exist, and these are often non-neutral and indicative of one's normative position on sedation at the end of life. This is problematic for two reasons. First, the use of such value-laden terms or definitions of continuous sedation may make it difficult, if not impossible, to agree on the facts surrounding continuous sedation. Second, including normative criteria in a definition can lead one to make disguised circular or tautological statements. METHODS: This paper identifies commonly used terms and definitions and demonstrates how particular elements present in these are value-laden and can influence the ethical evaluation of continuous sedation at the end of life. RESULTS: Two commonly used terms, 'palliative sedation' and 'terminal sedation', have been strongly criticized. We propose to use another, more descriptive term, namely 'continuous sedation at the end of life'. As regards the different definitions of sedation, some are general, but most contain very specific elements, thereby clearly limiting the number of cases that are covered by the definition. Some definitions of sedation include the intention one should (not) have, the possible indications for the practice, and the type of patients the practice should be reserved for. CONCLUSION: Including value-laden elements in the very definition of a clinical practice runs the risk of pre-empting a proper normative debate about the practice. We explain why this is the case and why it is problematic, and we propose an alternative, descriptive, definition that seeks to avoid these problems.

The language of sedation in end-of-life care: The ethical reasoning of care providers in three countries.

The application of ethically controversial medical procedures may differ from one place to another. Drawing on a keyword and text-mining analysis of 156 interviews with doctors and nurses involved in end-of-life care ('care providers'), differences between countries in care providers' ethical rationales for the use of sedation are reported. In the United Kingdom, an emphasis on titrating doses proportionately against symptoms is more likely, maintaining consciousness where possible. The potential harms of sedation are perceived to be the potential hastening of social as well as biological death. In Belgium and the Netherlands, although there is concern to distinguish the practice from euthanasia, rapid inducement of deep unconsciousness is more acceptable to care providers. This is often perceived to be a proportionate response to unbearable suffering in a context where there is also greater pressure to hasten dying from relatives and others. This means that sedation is more likely to be organised like euthanasia, as the end 'moment' is reached, and family farewells are organised before the patient is made unconscious for ever. Medical and nursing practices are partly responses to factors outside the place of care, such as legislation and public sentiment. Dutch guidelines for sedation largely tally with the practices prevalent in the Netherlands and Belgium, in contrast with those produced by the more international European Association for Palliative Care whose authors describe an ethical framework closer to that reportedly used by UK care providers.

The ethical desirability of moral bioenhancement: a review of reasons.

BACKGROUND: The debate on the ethical aspects of moral bioenhancement focuses on the desirability of using biomedical as opposed to traditional means to achieve moral betterment. The aim of this paper is to systematically review the ethical reasons presented in the literature for and against moral bioenhancement. DISCUSSION: A review was performed and resulted in the inclusion of 85 articles. We classified the arguments used in those articles in the following six clusters: (1) why we (don't) need moral bioenhancement, (2) it will (not) be possible to reach consensus on what moral bioenhancement should involve, (3) the feasibility of moral bioenhancement and the status of current scientific research, (4) means and processes of arriving at moral improvement matter ethically, (5) arguments related to the freedom, identity and autonomy of the individual, and (6) arguments related to social/group effects and dynamics. We discuss each argument separately, and assess the debate as a whole. First, there is little discussion on what distinguishes moral bioenhancement from treatment of pathological deficiencies in morality. Furthermore, remarkably little attention has been paid so far to the safety, risks and side-effects of moral enhancement, including the risk of identity changes. Finally, many authors overestimate the scientific as well as the practical feasibility of the interventions they discuss, rendering the debate too speculative. SUMMARY: Based on our discussion of the arguments used in the debate on moral enhancement, and our assessment of this debate, we advocate a shift in focus. Instead of speculating about non-realistic hypothetical scenarios such as the genetic engineering of morality, or morally enhancing 'the whole of humanity', we call for a more focused debate on realistic options of biomedical treatment of moral pathologies and the concrete moral questions these treatments raise.

Continuous sedation until death: the everyday moral reasoning of physicians, nurses and family caregivers in the UK, The Netherlands and Belgium.

BACKGROUND: Continuous sedation is increasingly used as a way to relieve symptoms at the end of life. Current research indicates that some physicians, nurses, and relatives involved in this practice experience emotional and/or moral distress. This study aims to provide insight into what may influence how professional and/or family carers cope with such distress. METHODS: This study is an international qualitative interview study involving interviews with physicians, nurses, and relatives of deceased patients in the UK, The Netherlands and Belgium (the UNBIASED study) about a case of continuous sedation at the end of life they were recently involved in. All interviews were transcribed verbatim and analysed by staying close to the data using open coding. Next, codes were combined into larger themes and categories of codes resulting in a four point scheme that captured all of the data. Finally, our findings were compared with others and explored in relation to theories in ethics and sociology. RESULTS: The participants' responses can be captured as different dimensions of 'closeness', i.e. the degree to which one feels connected or 'close' to a certain decision or event. We distinguished four types of 'closeness', namely emotional, physical, decisional, and causal. Using these four dimensions of 'closeness' it became possible to describe how physicians, nurses, and relatives experience their involvement in cases of continuous sedation until death. More specifically, it shined a light on the everyday moral reasoning employed by care providers and relatives in the context of continuous sedation, and how this affected the emotional impact of being involved in sedation, as well as the perception of their own moral responsibility. CONCLUSION: Findings from this study demonstrate that various factors are reported to influence the degree of closeness to continuous sedation (and thus the extent to which carers feel morally responsible), and that some of these factors help care providers and relatives to distinguish continuous sedation from euthanasia.

Factors that facilitate or constrain the use of continuous sedation at the end of life by physicians and nurses in Belgium: results from a focus group study.

Continuous sedation at the end of life (CS) is the practice whereby a physician uses sedatives to reduce or take away a patient's consciousness until death. Although the incidence of CS is rising, as of yet little research has been conducted on how the administration of CS is experienced by medical practitioners. Existing research shows that many differences exist between medical practitioners regarding how and how often they perform CS. We conducted a focus group study to find out which factors may facilitate or constrain the use of continuous sedation by physicians and nurses. The participants often had clear ideas on what could affect the likelihood that sedation would be used. The physicians and nurses in the focus groups testified that the use of continuous sedation was facilitated in cases where a patient has a very limited life expectancy, suffers intensely, makes an explicit request and has family members who can cope with the stress that accompanies sedation. However, this 'paradigm case' was considered to occur only rarely. Furthermore, deviations from the paradigm case were said to be sometimes due to physicians initiating the discussion on CS too late or not initiating it at all for fear of inducing the patient. Deviations from the paradigm case may also occur when sedation proves to be too difficult for family members who are said to sometimes pressure the medical practitioners to increase dosages and speed up the sedation.

Similarities and differences between continuous sedation until death and euthanasia - professional caregivers' attitudes and experiences: a focus group study.

BACKGROUND: According to various guidelines about continuous sedation until death, this practice can and should be clearly distinguished from euthanasia, which is legalized in Belgium. AIM: To explore professional caregivers' perceptions of the similarities and differences between continuous sedation until death and euthanasia. DESIGN: Qualitative data were gathered through focus groups. Questions pertained to participants' perceptions of continuous sedation. The focus groups were recorded and transcribed verbatim. Analyses were conducted by a multidisciplinary research team using constant comparison analyses. SETTING/PARTICIPANTS: We did four focus groups at Ghent University Hospital: two with physicians (n = 4 and n = 4) and two with nurses (n = 4 and n = 9). The participants could participate if they were ever involved in the use of continuous sedation until death. RESULTS: Although the differences and similarities between continuous sedation until death and euthanasia were not specifically addressed in the questions addressed in the focus groups, it emerged as an important theme in the participants' accounts. Many caregivers elaborated on the differences between both practices, particularly with regard to patients' preferences and requests, decision-making and physicians' intentions. However, some stated that the distinction between the two sometimes becomes blurred, especially when the sedating medication is increased disproportionally or when sedation is used for patients with a longer life expectancy. CONCLUSIONS: The differences and similarities between continuous sedation until death and euthanasia is an issue for several Flemish professional caregivers in their care for unbearably suffering patients at the end of life. Although guidelines strictly distinguish both practices, this may not always be the case in Flemish clinical practice.