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. (shrink)

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. (shrink)

The objective of this module is to cover ground that was not covered in‐depth in any of the other modules, including: scientific misconduct, issues concerning the publication and ownership of research results (authorship guidelines – who is eligible to be considered an author, or contributor to a scientific paper etc.), special problems occurring in social science and epidemiological research, and the problems pertaining to conflicts of interest the various players in biomedical research activities could encounter.

The question of whether problems with the social determinants of health that might impact decision-making justify denying eligibility for assisted dying has recently come to the fore in debates about the legalisation of assisted dying. For example, it was central to critiques of the 2021 amendments made to Canada’s assisted dying law. The question of whether changes to a country’s assisted dying legislation lead to descents down slippery slopes has also come to the fore—as it does any time a jurisdiction (...) changes its laws. We explore these two questions through the lens of Canada’s experience both to inform Canada’s ongoing discussions and because other countries will confront the same questions if they contemplate changing their assisted dying law. Canada’s Medical Assistance in Dying law has evolved through a journey from the courts to Parliament, back to the courts, and then back to Parliament. Along this journey the eligibility criteria, the procedural safeguards, and the monitoring regime have changed. In this article, we focus on the eligibility criteria. First, we explain the evolution of the law and what the eligibility criteria were at the various stops along the way. We then explore the ethical justifications for Canada’s new criteria by looking at two elements of the often-corrosive debate. First, we ask whether problems with the social determinants of health that might impact decision-making justify denying eligibility for assisted dying of decisionally capable people with mental illnesses and people with disabilities as their sole underlying medical conditions. Second, we ask whether Canada’s journey supports slippery slope arguments against permitting assisted dying. All data relevant to the study are included in the article. (shrink)

South Africa has an abortion law which codifies the broad themes of reproductive rights set out in the Constitution of South Africa, other laws and national guidelines. Certain wording of the conditions in the Choice Act for abortion after 20 weeks' gestation, are open to interpretation, being ‘severe malformation of the fetus’ and ‘risk of injury to the fetus’. From 24 weeks onwards, abortion is carried out by feticide/induced fetal cardiac asystole (‘IFCA’) and subsequent induction of labour in South Africa. (...) Some maternal‐fetal units have developed guidelines to assist clinicians and patients in decision‐making around eligibility for abortion after 20 weeks' gestation, given the broad terms in the law. We consider the guideline used by an institution in the Western Cape for abortion after 23 weeks and 6 days gestation, in terms of its alignment with the law on reproductive rights and its compliance with fair and transparent procedures. We also note its effect on respect for patients and on staff professionalism. (shrink)

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. (shrink)

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”. (shrink)

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. (shrink)

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. (shrink)

Conscience-based refusals by health care professionals to provide care to eligible patients are problematic, given the monopoly such professionals hold on the provision of such services. This article reviews standard ethical arguments in support of conscientious refuser accommodation and finds them wanting. It discusses proposed compromise solutions involving efforts aimed at testing the genuineness and reasonability of refusals and rejects those solutions too. A number of jurisdictions have introduced policies requiring conscientious refusers to provide effective referrals. These policies have turned (...) out to be unworkable. They subject patients to a health care delivery lottery, which is incompatible with the fundamental values of medical professionalism. This paper sheds light on transnational efforts aimed at undermining progress made in reproductive health by means of conscientious refusal accommodation claims. The view that the accommodation of conscientious refusers is indefensible on consequentialist ethical grounds, as well as on grounds related to medical professionalism itself, is defended. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

Research into the genetic component of some complex behaviors often causes controversy, depending on the social meaning and significance of the behavior under study. Research into sexual orientation—simplistically referred to as “gay gene” research—is an example of research that provokes intense controversy. This research is worrisome for many reasons, including the fact that it has been used to harm lesbians and gay men. Many homosexual people have been forced to undergo “treatments” to change their sexual orientation. Others chose to undergo (...) them to escape discrimination and social disapprobation. But there are other reasons to worry about such research. The very motivation for seeking an “origin” of homosexuality reveals homophobia. Moreover, such research may lead to prenatal tests that claim to predict for homosexuality. For homosexual people who live in countries with no legal protections these dangers are particularly serious. (shrink)

Developing World Bioethics, Volume 21, Issue 3, Page 99-99, September 2021.

Developing World Bioethics, Volume 21, Issue 3, Page 99-99, September 2021.

In a commentary published in Bioethics I defended Qatar as the location of the 2024 World Congress of Bioethics (Schuklenk 2023). I have since, reluctantly, changed my views on this.This brief resp...

Although the COVID-19 pandemic is a serious public health and economic emergency, and although effective vaccines are the best weapon we have against it, there are groups and individuals who oppose certain kinds of vaccines because of personal moral or religious reasons. The most widely discussed case has been that of certain religious groups that oppose research on COVID-19 vaccines that use cell lines linked to abortions and that object to receiving those vaccine because of their moral opposition to abortion. (...) However, moral opposition to COVID-19 vaccine research can be based on other considerations, both secular and religious. We argue that religious or personal moral objections to vaccine research are unethical and irresponsible, and in an important sense often irrational. They are unethical because of the risk of causing serious harm to other people for no valid reason; irresponsible because they run counter to individual and collective responsibilities to contribute to important public health goals; and in the case of certain kinds of religious opposition, they might be irrational because they are internally inconsistent. All in all, our argument translates into the rather uncontroversial claim that we should prioritize people’s lives over religious freedom in vaccine research and vaccination roll out. (shrink)

This paper discusses a number of critical ethical problems that arise in interactions between queer patients and health care professionals attending them. Using real-world examples, we discuss the very practical problems queer patients often face in the clinic. Health care professionals face conflicts in societies that criminalise same sex relationships. We also analyse the question of what ought to be done to confront health care professionals who propagate falsehoods about homosexuality in the public domain. These health care professionals are more (...) often than not motivated by strong religious convictions that conflict with mainstream medical opinion on homosexuality. We argue that they ought to be held accountable for their conduct by their professional statutory bodies, given that they abuse their professional standing to propagate sectarian views not representative of their profession. Lastly, we propose that medical schools have special responsibilities in training future health care professionals that will enable them to respond professionally to queer patients seeking health care. (shrink)

Developing World Bioethics, Accepted Article.

It is interesting, that with the notable exception of the Cologne-based geneticist Benno Müller-Hill, German historians of medicine have not bothered a great deal with looking into German medical history during the Third Reich. We owe Pennsylvania State University's Robert N Proctor a great deal of gratitude for uncovering more and more of this history, and for making it accessible in a highly readable format. Proctor has established himself rapidly as the pre-eminent US American historian of science on all aspects (...) of Nazi medical research and health policy. In this most recent book Proctor looks at Nazism's pioneering contributions in public health research and policy, as well as in environmental health, occupational health, and preventive medicine. This book holds some disturbing lessons for those who hold the view that basically good people will undertake ethical research, and support good health …. (shrink)

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. (shrink)

We will also learn what the issues are that people involved in research on research ethics are concerned with. Ethics without an unde.

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. (shrink)

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. (shrink)

We argue that, in certain circumstances, doctors might beprofessionallyjustified to provide abortions even in those jurisdictions where abortion is illegal. That it is at least professionally permissible does not mean that they have an all-things-considered ethical justification or obligation to provide illegal abortions or that professional obligations or professional permissibility trump legal obligations. It rather means that professional organisations should respect and indeed protect doctors’ positive claims of conscience to provide abortions if they plausibly track what is in the best (...) medical interests of their patients. It is the responsibility of state authorities to enforce the law, but it is the responsibility of professional organisations to uphold the highest standards of medical ethics, even when they conflict with the law. Whatever the legal sanctions in place, healthcare professionals should not be sanctioned by the professional bodies for providing abortions according to professional standards, even if illegally. Indeed, professional organisation should lobby to offer protection to such professionals. Our arguments have practical implications for what healthcare professionals and healthcare professional organisations may or should do in those jurisdictions that legally prohibit abortion, such as some US States after the reversal ofRoe v Wade. (shrink)

The proper role, if any, for religion-based arguments is a live and sometimes heated issue within the field of bioethics. The issue attracts heat primarily because bioethical analyses influence the outcomes of controversial court cases and help shape legislation in sensitive biopolicy areas. A problem for religious bioethicists who seek to influence biopolicy is that there is now widespread academic and public acceptance, at least within liberal democracies, that the state should not base its policies on any particular religion’s metaphysical (...) claims or esoteric moral system. In response, bioethicists motivated by religious concerns have adopted two identifiable strategies. Sometimes they rely on slippery-slope arguments that, sometimes at least, have empirically testable premises. A more questionable response is the manipulation and misuse of secular-sounding moral language, such as references to “human dignity,” and the plights of groups of people labeled “vulnerable.”. (shrink)

This article describes how a small but vocal group of biomedical scientists propagates the views that either HIV is not the cause of AIDS, or that it does not exist at all. When these views were rejected by mainstream science, this group took its views and arguments into the public domain, actively campaigning via newspapers, radio, and television to make its views known to the lay public. I describe some of the harmful consequences of the group's activities, and ask two (...) distinct ethical questions: what moral obligations do scientists who hold such minority views have with regard to a scientifically untrained lay audience, and what moral obligations do mainstream newspapers and government politicians have when it comes to such views. The latter question will be asked because the 'dissidents' succeeded for a number of years in convincing the South African government of the soundness of their views. The consequences of their stance affected millions of HIV infected South Africans severely. (shrink)

This chapter contains sections titled: HIV Testing HIV Infection: Harm to Self or Harm to Others Access to Experimental Drugs and the Ethics of Research Clinical Trials Developing Preventive Vaccines Affordable Access to Life‐preserving Medication HIV Infection in Health‐care Professionals and Patients Final Remarks References Further reading.

This chapter contains sections titled: Introduction Medical Migration and Moral Responsibility Lending Money to Developing Countries Culture and Religion Health Research and Resources Conclusions References.