Cost-Related Non-Adherence to Prescribed Medicines: What Are Physicians' Moral Duties?

As the price of pharmaceuticals and biologicals rises so does the number of patients who cannot afford them. In this article, we argue that physicians have a moral duty to help patients access affordable medicines. We offer three grounds to support our argument: (i) the aim of prescribing is to improve health and well-being which can only be realized with secure access to treatment; (ii) there is no morally significant difference between medicines being unavailable and medicines being unaffordable, so the steps physicians are willing to take in the first case should extend to the second; and (iii) as the primary stakeholder with a duty to put the individual patient's interests first, the medical professional has a duty to address cost-barriers to patient care. In articulating this duty, we take account of important epistemic and control conditions that must be met for the attribution of this duty to be justified.

A study protocol for live and deceased donor uterus transplantation as a treatment for women with uterine factor infertility.

AIM: Uterus transplantation (UTx) is an emerging treatment option for women with uterine factor infertility (UFI) or the absence of a functional uterus. This is the study protocol for the first human UTx clinical trial in Australia. MATERIALS AND METHODS: This protocol outlines the approved training program used to plan, diagnose, screen, and treat patients who may be eligible for UTx using living and deceased donors. This multi-site clinical research study includes three tertiary hospital sites within New South Wales (NSW), Australia - Prince of Wales, Royal Hospital for Women and Westmead Hospitals. Our UTx protocol is based on that used by our collaborative partner, the inaugural UTx team in Gothenburg, Sweden. The Swedish UTx team provides ongoing preceptorship for the Australian UTx team. Ethics approval for six UTx procedures using living or deceased donors (Western Sydney Local Health District Human Research Ethics Committee: 2019/ETH138038) was granted in 2020. RESULTS: Results from surgeries and live births will be published. Data will be prospectively entered into the registry of the International Society of Uterus Transplantation (ISUTx), a sub-section of The Transplantation Society (TTS). TRIAL ID: ACTRN12622000917730. DISCUSSION: A multidisciplinary research team has been formed between three tertiary hospitals in Sydney - The Royal Hospital for Women, Prince of Wales and Westmead Hospitals; and with the Swedish UTx, University of Gothenburg. The Swedish team pioneered animal and human UTx studies since 1998, including publishing the first live birth after UTx. (1) This Australian trial commenced in January 2023. CONCLUSION: Uterus transplantation gives women with UFI the opportunity to be gestational and genetic mothers. It is a complex procedure for both the donor and recipient, with medical and surgical risks. An extensive multidisciplinary approach is required to optimise patient safety and graft outcomes. This protocol outlines our Australian UTx team strategy for screening, recruitment, surgical approach, and clinical management of UTx recipients and donors.

Public funding of uterus transplantation: Deepening the socio-moral critique.

Human uterus transplantation (UTx)-the most radical and experimental of all current forms of assisted reproduction-gives rise to a range of complex ethical questions, including those related to individual safety, risk, and informed consent. I have argued elsewhere that the wider social impacts and implications of UTx provision must form part of a comprehensive ethical analysis. My socio-moral critique of UTx provision has been responded to with a number of defences of possible public funding of UTx. In this paper I examine a select number of those defences. These include: that UTx provision would address harms and needs that already exist and as such have priority; that UTx provision is fully compatible with the needed reform of the procreative context in which it would be offered; that UTx provision would not necessarily involve legitimation or endorsement of what are widely agreed to be problematic pronatalist or geneticist norms; and that UTx provision is required as a matter of justice and consistency with other practices. Importantly, defenders are not proposing a ceteris paribus justification of UTx provision; nor do my responses to their arguments represent a comprehensive opposition to UTx. Rather, my more limited purpose here is to show that whatever other defences may be given of publicly funded UTx provision, those considered here do not ultimately succeed and therefore do not allay the concerns underpinning the original socio-moral critique.

Uterus transplantation as radical reproduction: Taking the adoption alternative more seriously.

This paper urges reconsideration of analyses of the alternatives to reproductive uterus transplantation (UTx). I focus here specifically on the adoption alternative. Importantly, my purpose is not to oppose UTx provision. Rather, it is to propose ways in which ethical analysis and provision of UTx can potentially accommodate the concerns discussed here. I argue that the adoption alternative to UTx is too readily dismissed, and that this is a dismissal with significant moral costs. I suggest that the radical nature of UTx as a form of assisted reproduction calls for an equivalently radical socio-moral agenda for reform and transformation of adoption law, policy and practice, as well as of the norms that prevail within our presently strongly bio-normative reproductive context. In doing so I widen the ethical frame of responsible provision of assisted reproduction to encompass not just obligations towards donors and recipient, but also our broader social responsibilities to ensure that we are doing our best to meet the significant needs of some of the most vulnerable members of our society.

Getting Clearer About Surgical Innovation: A New Definition and a New Tool to Support Responsible Practice.

OBJECTIVES: This article presents an original definition of surgical innovation and a practical tool for identifying planned innovations. These will support the responsible introduction of surgical innovations. BACKGROUND: Frameworks developed for the safer introduction of surgical innovations rely upon identifying cases of innovation; oversight cannot occur unless innovations are identified. However, there is no consensus among surgeons about which interventions they consider innovative; existing definitions are vague and impractical. METHODS: Using conceptual analysis, this article synthesizes findings from relevant literature, and from qualitative research with surgeons, to develop an original definition of surgical innovation and a tool for prospectively identifying planned surgical innovations. The tool has been developed in light of feedback from health care professionals, surgeons, and policy makers. RESULTS: This definition of innovation distinguishes between variations, introduction of established interventions, and innovations in surgical techniques or use of devices. It can be applied easily and consistently, is sensitive to the key features of innovation (newness and degree of change), is prospective, and focuses on features relevant to safety and evaluation. The accompanying tool is deliberately broad so that appropriate supports may, if necessary, be provided each time that a surgeon does something "new." CONCLUSIONS: The definition presented in this article overcomes a number of practical challenges. The definition and tool will be of value in supporting responsible surgical innovation, in particular, through the prospective identification of planned innovations.

Identifying surgical innovation: a qualitative study of surgeons' views.

OBJECTIVE: This study explores how surgeons define innovation, critically examines and evaluates these views, and uses the findings to develop practical criteria for identifying surgical innovation for ethical and regulatory purposes. BACKGROUND: Surgical innovation is crucial for progress in surgery, but can be harmful to patients and difficult to identify and therefore support appropriately. Current attempts to define surgical innovation lack precision, and do not give enough guidance to identify innovations in practice. This study is the first to give an account of surgeons' own views about defining innovation. METHODS: This qualitative study involved interviews with 18 Australian surgeons. Participants provided examples of innovation and distinguished innovation from variations in practice and from research. Data were collected using audio-recorded semistructured interviews. The data were coded using a template and analyzed to develop a thematic account of innovative surgery in practice. RESULTS: There was no uniform view about innovation, but participants identified 5 features of surgical innovation that distinguish it from variations: newness or novelty; degree of change; level of risk; impact; and requiring formal processes. There was no agreement on the distinction between innovation and research. CONCLUSIONS: Drawing on surgeons' own views is important for the development of a practical definition of surgical innovation. We have used a critical analysis of surgeons' own views as the basis for defining the core features of innovation. A precise definition of innovation will assist surgeons to identify and manage innovation and thereby enhance patient safety.

The ethics of uterus transplantation.

Human uterus transplantation (UTx) is currently under investigation as a treatment for uterine infertility. Without a uterus transplant, the options available to women with uterine infertility are adoption or surrogacy; only the latter has the potential for a genetically related child. UTx will offer recipients the chance of having their own pregnancy. This procedure occurs at the intersection of two ethically contentious areas: assisted reproductive technologies (ART) and organ transplantation. In relation to organ transplantation, UTx lies with composite tissue transplants such as face and limb grafts, and shares some of the ethical concerns raised by these non-life saving procedures. In relation to ART, UTx represents one more avenue by which a woman may seek to meet her reproductive goals, and as with other ART procedures, raises questions about the limits of reproductive autonomy. This paper explores the ethical issues raised by UTx with a focus on the potential gap between women's desires and aspirations about pregnancy and the likely functional outcomes of successful UTx.

Procreative reasons-relevance: on the moral significance of why we have children.

Advances in reproductive technologies - in particular in genetic screening and selection - have occasioned renewed interest in the moral justifiability of the reasons that motivate the decision to have a child. The capacity to select for desired blood and tissue compatibilities has led to the much discussed 'saviour sibling' cases in which parents seek to 'have one child to save another'. Heightened interest in procreative reasons is to be welcomed, since it prompts a more general philosophical interrogation of the grounds for moral appraisal of reasons-to-parent, and of the extent to which such reasons are relevant to the moral assessment of procreation itself. I start by rejecting the idea that we can use a distinction between 'other-regarding' and 'future-child-regarding' reasons as a basis on which to distinguish good from bad procreative reasons. I then offer and evaluate three potential grounds for elucidating and establishing a relationship between procreative motivation and the rightness/wrongness of procreative conduct: the predictiveness, the verdictiveness, and the expressiveness of procreative reasons.

Vulnerability and resilience: a critical nexus.

Not all forms of human fragility or vulnerability are unavoidable. Sometimes we knowingly and intentionally impose conditions of vulnerability on others; and sometimes we knowingly and intentionally enter into and assume conditions of vulnerability for ourselves (for example, when we decide to trust or forgive, enter into intimate relationships with others, become a parent, become a subject of medical or psychotherapeutic treatment, and the like). In this article, I propose a presently overlooked basis on which one might evaluate whether the imposition or assumption of vulnerability is acceptable, and on which one might ground a significant class of vulnerability-related obligations. Distinct from existing accounts of the importance of promoting autonomy in conditions of vulnerability, this article offers a preliminary exploration of the nature, role, and importance of resilience promotion, its relationship to autonomy promotion, and its prospects for improving human wellbeing in autonomy inhibiting conditions.

Surgical innovation as sui generis surgical research.

Successful innovative 'leaps' in surgical technique have the potential to contribute exponentially to surgical advancement, and thereby to improved health outcomes for patients. Such innovative leaps often occur relatively spontaneously, without substantial forethought, planning, or preparation. This feature of surgical innovation raises special challenges for ensuring sufficient evaluation and regulatory oversight of new interventions that have not been the subject of controlled investigatory exploration and review. It is this feature in particular that makes early-stage surgical innovation especially resistant to classification as 'research', with all of the attendant methodological and ethical obligations--of planning, regulation, monitoring, reporting, and publication--associated with such a classification. This paper proposes conceptual and ethical grounds for a restricted definition according to which innovation in surgical technique is classified as a form of sui generis surgical 'research', where the explicit goal of adopting such a definition is to bring about needed improvements in knowledge transfer and thereby benefit current and future patients.

Reproductive cloning and a (kind of) genetic fallacy.

Many people now believe that human reproductive cloning--once sufficiently safe and effective--should be permitted on the grounds that it will allow the otherwise infertile to have children that are biologically closely related to them. However, though it is widely believed that the possession of a close genetic link to our children is morally significant and valuable, we argue that such a view is erroneous. Moreover, the claim that the genetic link is valuable is pernicious; it tends to give rise to highly undesirable consequences, and therefore should be combated rather than pandered to. The emphasis on the genetic is unwarranted and unfortunate; rather than giving us moral reason to support reproductive cloning in the case of infertility, the fact that cloning requests are likely to be motivated by the genetic argument gives us reason to oppose its availability.