Udo Schüklenk

The late Robert Veatch, one of the United States’ founders of bioethics, never tired of reminding us that the paradigm-shifting contribution that bioethics made to patient care was to liberate patients out of the hands of doctors, who were traditionally seen to know best, even when they decidedly did not know best. It seems to us that with the advent of COVID-19, health policy has come full-circle on this. COVID-19 gave rise to a large number of purportedly “ethical” guidance documents aiming to assist health care providers and practitioners with responding to the ethical challenges that might arise in their response to the pandemic. Ethics has two primary functions: provide clear action guidance, and provide clear action justification. The documents in question arguably reflect the ultimate policy triumph of bioethical “principlism”, and, perhaps surprisingly, as a corollary, the ultimate triumph of “doctor-knows-best”.

The COVID-19 pandemic has coincided with the proliferation of ethical guidance documents to assist public health authorities, health care providers, practitioners and staff with responding to ethical challenges posed by the pandemic. Like ethical guidelines relating to infectious disease that have preceded them, what unites many COVID-19 guidance documents is their dependency on an under-developed approach to bioethical principlism, a normative framework that attempts to guide actions based on a list of prima facie, unranked ethical principles. By situating them in relation to the key philosophical debates concerning bioethical principlism, we aim to explore the limits and limitations of pandemic ethical guidance documents as, specifically, ethics documents – documents that fulfil the functions of ethics as a fundamentally normative discipline. This means not only determining whether such ethical guidance documents can, in principle, provide adequate action guidance and action justification, but also, more importantly where pandemics are concerned, determining whether they support consistent decision making and transparent processes of justification. Having highlighted the problems with merely furnishing ethical guidelines with substantive ethical content in terms of principles and values, we argue that organizations that develop these documents should, instead, focus on the procedural dimensions of action guidance and action justification, which extend to questions regarding the make-up of the committees, panels and groups that develop such guidelines, the public transparency of justifications for specific pandemic-related advice or interventions and the development of explicit procedures for transparent and consistent decision making.

In an article in this journal, Christopher Cowley argues that we have ‘misunderstood the special nature of medicine, and have misunderstood the motivations of the conscientious objectors’. We have not. It is Cowley who has misunderstood the role of personal values in the profession of medicine. We argue that there should be better protections for patients from doctors' personal values and there should be more severe restrictions on the right to conscientious objection, particularly in relation to assisted dying. We argue that eligible patients could be guaranteed access to medical services that are subject to conscientious objections by: removing a right to conscientious objection; selecting candidates into relevant medical specialities or general practice who do not have objections; demonopolizing the provision of these services away from the medical profession.

Some jurisdictions that have decriminalized assisted dying exclude psychiatric patients on the grounds that their condition cannot be determined to be irremediable, that they are vulnerable and in need of protection, or that they cannot be determined to be competent. We review each of these claims and find that none have been sufficiently well-supported to justify the differential treatment psychiatric patients experience with respect to assisted dying. We find bans on psychiatric patients’ access to this service amount to arbitrary discrimination. Proponents of banning the practice ignore or overlook alternatives to their proposal, like an assisted dying regime with additional safeguards. Some authors have further criticized assisted dying for psychiatric patients by highlighting allegedly problematic practices in those countries which allow it. We address recent evidence from the Netherlands, showing that these problems are either misrepresented or have straightforward solutions. Even if one finds such evidence troubling despite our analysis, other jurisdictions need not adopt every feature of the Dutch system.

In the first part of this article, we considered how Thandi, a 15-year-old girl, was treated when taken by her mother to their GP, Dr Randera. Dr Randera notified them that Thandi was pregnant, HIV positive, and had syphilis and herpes. Dr Randera also informed them that there was a substantial risk that the baby would be born HIV positive. Both Thandi and her mother wanted an abortion. However, Dr Randera, who was morally opposed to abortions, refused to provide the service and did not refer Thandi to another doctor who would perform the abortion.The saga continues:

ABSTRACTThis report on end‐of‐life decision‐making in Canada was produced by an international expert panel and commissioned by the Royal Society of Canada. It consists of five chapters.Chapter 1 reviews what is known about end‐of‐life care and opinions about assisted dying in Canada.Chapter 2 reviews the legal status quo in Canada with regard to various forms of assisted death.Chapter 3 reviews ethical issues pertaining to assisted death. The analysis is grounded in core values central to Canada's constitutional order.Chapter 4 reviews the experiences had in a number of jurisdictions that have decriminalized or recently reviewed assisted dying in some shape or form.Chapter 5 provides recommendations with regard to the provision of palliative care in Canada, as well as recommendations for reform with respect to the various forms of assisted death covered in this document

Recent economic and political advances in developing countries on the African continent and South East Asia are threatened by the rising death and morbidity rates of HIV/AIDS. In the first part of this paper we explain the reasons for the absence of affordable access to essential AIDS medication. In the second part we take a closer look at some of the pivotal frameworks relevant for this situation and undertake an ethical analysis of these frameworks. In the third part we discuss a few of the proposed solutions to the problem and conclude with an argument in support of our preferred course of action. In this article we argue for compulsory licensing of essential AIDS medications in the current conditions of public health emergency. We argue on broadly consequentialist grounds that compulsory licensing is preferable both morally and pragmatically to the alternatives, notably the currently offered price cuts and drug donation schemes.

This paper examines two strategies aimed at demonstrating that moral obligations to improve global health exist. The ‘humanitarian model’ stresses that all human beings, regardless of affluence or global location, are fundamentally the same in terms of moral status. This model argues that affluent global citizens’ moral obligations to assist less fortunate ones follow from the desirability of reducing disease and suffering in the world. The ‘political model’ stresses that the lives of the world's rich and poor are inextricably linked because of harmful state-to-state actions and because of the currently existing transnational institutions. These institutions’ design at once secures the high standard of living of the affluent and reinforces the continued foreseeable—and avoidable—deprivation of many of the global poor; and these give rise to compensatory health-related moral obligations beyond borders. This paper argues that political reasoning is unsuitable for the crucial task of determining priority in the receipt of health aid. We conclude that in the context of global health ethics, political reasoning must be supplemented with, if not replaced by, humanitarian reasoning

We describe a number of conscientious objection cases in a liberal Western democracy. These cases strongly suggest that the typical conscientious objector does not object to unreasonable, controversial professional services—involving torture, for instance—but to the provision of professional services that are both uncontroversially legal and that patients are entitled to receive. We analyse the conflict between these patients' access rights and the conscientious objection accommodation demanded by monopoly providers of such healthcare services. It is implausible that professionals who voluntarily join a profession should be endowed with a legal claim not to provide services that are within the scope of the profession's practice and that society expects them to provide. We discuss common counterarguments to this view and reject all of them.

This response addresses criticisms in this journal of an Editorial written by Willem Landman and Udo Schuklenk. I demonstrate that the UNESCO Declaration on Bioethics and Human Rights is in crucial aspects deficient, despite attempts in this journal to defend the Declaration against its critics. I focus on individual versus societal interests, research ethics, informed consent and the use of “human dignity” to illustrate the weaknesses of the UNESCO Declaration on Bioethics and Human Rights. This article concludes with reflections on what documents such as the UNESCO Declaration on Bioethics and Human Rights ought to be called to avoid the mislabelling of what essentially are policy documents.

Healthcare professionals’ capacity to protect themselves, while caring for infected patients during an infectious disease pandemic, depends on their ability to practise universal precautions. In turn, universal precautions rely on the availability of personal protective equipment (PPE). During the SARS-CoV2 outbreak many healthcare workers across the globe have been reluctant to provide patient care because crucial PPE components are in short supply. The lack of such equipment during the pandemic was not a result of careful resource allocation decisions in the global north, where the short supply could be explained through their high cost. Instead, they were the result of democratically elected governments prioritising low tax regimes over an adequate resourcing of their healthcare delivery systems. Such decisions were made despite global health experts warning about the high probability of pandemics like SARS-CoV2 occurring during our lifetimes. Avoidable allocation decisions by democratically elected political leaders resulted in a lack of sufficient PPE for healthcare professionals. After discussing and discounting various ethical arguments in support of a professional obligation to treat, even without or with suboptimal PPE, I conclude that these policy decisions were sufficiently grave that they provide a sound ethical rationale to justify healthcare workers’ refusal to provide care to infected patients.

Background: The advent of AIDS brought about a group of patients unwilling to accept crucial aspects of the methodological standards for clinical research investigating Phase 1 drugs, surgeries or devices. Their arguments against placebo controls in trials, which depended-at the time-on the terminal status of patient volunteers led to a renewed discussion of the ethics of denying patients with catastrophic illnesses access to last-chance experimental drugs, surgeries or devices. Sources of data: Existing ethics and health policy literature on the topic of access to experimental drugs. Areas of agreement: The positions of those arguing for or against free access to experimental drugs for terminally ill patients are irreconcilable. Areas of controversy: At stake are questions about the kinds of personal sacrifices society can reasonably expect patients in clinical trials to make to ensure statistically predictive results. These would benefit by necessity a much larger number of current and future patients-the conflict is about individual versus public interests. It is also about the question of whether or not the state can legitimately prevent patients with terminal illnesses from unfettered access to experimental drugs, surgeries or devices in order to motivate them to participate in clinical trials. We review the ethical arguments for and against the provision of access to Phase 1 agents for terminally ill patients. Growing points: Finding a compromise between providing free or no access to Phase 1 drugs for terminally ill patients. Areas timely for developing research: We ought to investigate means to increase access to experimental drugs for terminally ill patients without sacrificing necessary clinical trials' sounds scientific methods.

ABSTRACT Most pharmaceutical research carried out today is focused on the treatment and management of the lifestyle diseases of the developed world. Diseases that affect mainly poor people are neglected in research advancements in treatment because they cannot generate large financial returns on research and development costs. Benefit sharing arrangements for the use of indigenous resources and genetic research could only marginally address this gap in research and development in diseases that affect the poor. Benefit sharing as a strategy is conceptually problematic, even if one, as we do, agrees that impoverished indigenous communities should not be exploited and that they should be assisted in improving their living conditions. The accepted concept of intellectual property protection envisages clearly defined originators and owners of knowledge, whereas the concept of community membership is fluid and indigenous knowledge is, by its very nature, open, with the originator(s) lost in the mists of time. The delineation of ‘community’ presents serious conceptual and practical difficulties as few communities form discrete, easily discernable groups, and most have problematic leadership structures. Benefit sharing is no substitute for governments’ responsibility to uplift impoverished communities. Benefit sharing arrangements may be fraught with difficulties but considerations of respect and equity demand that prior informed consent and consultation around commercialisation of knowledge take place with the source community and their government.1.

Hughes offers a consequentialist response to our rejection of accommodation of conscientious objection in medicine. We argue here that his compromise proposition has been tried in many jurisdictions and has failed to deliver unimpeded access to care for eligible patients. The compromise position, entailing an accommodation of conscientious objection provided there is unimpeded access, fails to grasp that the objectors are both determined not to provide services they object to as well as to subvert patient access to the objected to services. Unpredictable future developments in drug R&D and resulting treatment and prevention options in medicine make the compromise position unrealistic.

In recent years policy makers and public health professionals have described obesity and its associated diseases as a major global public health problem. Bioethicists have tried to address the normative implications of proposed public health interventions by developing guidelines or proposing ethical principles that ethically grounded health policy responses should take into consideration. We are reviewing here relevant literature and conclude that while there are clearly health implications resulting from the increasing number of seriously obese people across the globe, there appear to be legitimate questions about the scope of the problem as well as questions about whether particular demonstrable correlations are indicative of causations. These empirical questions require further clinical and epidemiological research. We then review currently discussed public health ethics guidance documents and proposals. Suffering from the same conceptual problems that are known features of principle-based bioethics, insofar as their capacity to ground ethically justifiable policies is concerned, they are unsuitable for actual policy development. Even if the empirical questions were resolved, health policy makers could not rely on currently existing prominent public health ethics guidance documents to develop ethically defensible policies. Further empirical and ethics research is necessary to develop ethically defensible public health policies targeting obesity.

Today's clinical AIDS research is in trouble. Principal investigators are confronted with young and frequently highly knowledgeable patients. Many of these people with AIDS are often unwilling to adhere to the trial protocols. These PWAs believe they are ethically justified in breaching trial protocols because they do not consider themselves true volunteers in such trials. PWAs argue that they do not really volunteer because existing legislation prevents them from buying and using experimental drugs or from testing alternative treatment strategies. Their only access to such agents is participation in clinical trials

We respond in this paper to various counter arguments advanced against our stance on conscientious objection accommodation. Contra Maclure and Dumont, we show that it is impossible to develop reliable tests for conscientious objectors' claims with regard to the reasonableness of the ideological basis of their convictions, and, indeed, with regard to whether they actually hold they views they claim to hold. We demonstrate furthermore that, within the Canadian legal context, the refusal to accommodate conscientious objectors would not constitute undue hardship for such objectors. We reject concerns that refusing to accommodate conscientious objectors would limit the equality of opportunity for budding professionals holding particular ideological positions. We also clarify various misrepresentations of our views by respondents Symons, Glick and Jotkowitz, and Lyus.