This paper reflects on the relationship between theory and practice in bioethics, by using various concepts drawn from debates on innovation in healthcare research—in particular debates around how best to connect up blue skies ‘basic’ research with practical innovations that can improve human lives. It argues that it is a mistake to assume that the most difficult and important questions in bioethics are the most abstract ones, and also a mistake to assume that getting clear about abstract cases will automatically (...) be of much help in getting clear about more complex cases. It replaces this implicitly linear model with a more complex one that draws on the idea of translational research in healthcare. On the translational model, there is a continuum of cases from the most simple and abstract to the most concrete and complex. Insights need to travel in both directions along this continuum—from the more abstract to the more concrete and from the more concrete to the more abstract. The paper maps out some difficulties in moving from simpler to more complex cases, and in doing so makes recommendations about the future of bioethics. (shrink)

The scope and type of property rights recognized over the effectiveness of antibiotics have a direct effect on how those claiming ownership engage in the exploitation and stewardship of this scarce resource. We examine the different property claims and rights the four major interest groups are asserting on antibiotics: (i) the inventors, (ii) those demanding that the resource be treated like any other transferable commodity, (iii) those advocating usage restrictions based on good stewardship principles and (iv) those considering the resource (...) as common heritage of humankind. (shrink)

Individuals are at risk of acquiring untreatable agents of infection when they travel to countries where antibiotic-resistant agents of infection are prevalent, and particularly when they travel for healthcare. Uncertainty with respect to the overall political and economic consequences seems to underlie the reluctance of public health authorities to issue relevant travel advisories. The conditions of choice, the act of choice and the consequences of choice can each be a primary focus of ethical appraisal of public health policy. The ‘value (...) of choice’ account provided by Scanlon draws attention to the value of the choices that individuals are given, and the potential for reasonable rejection of policies that do not give adequate emphasis to the conditions of individual choice. There is both instrumental and symbolic value in informing people of the risk of acquisition of antibiotic-resistant microbes associated with health tourism. We cannot reasonably reject a principle of actively informing unless there are insurmountable countervailing reasons. These reasons should be explicit and subject to review. If health tourism is a concern then we might also consider how best to facilitate alternative choices. (shrink)

Antibiotic resistance is widely recognized as a major threat to public health and healthcare systems worldwide. Recent research suggests that pollution from antibiotics manufacturing is an important driver of resistance development. Using Sweden as an example, this article considers how industrial antibiotic pollution might be addressed by public actors who are in a position to influence the distribution and use of antibiotics in high-income countries with publicly funded health systems. We identify a number of opportunities for these actors to incentivize (...) industry to increase sustainability in antibiotics production. However, we also show that each alternative would create tensions with other significant policy goals, necessitating trade-offs. Since justifiable trade-offs require ethical consideration, we identify and explore the main underlying normative issues, namely, the weighing of local versus global health interests, the weighing of present versus future health interests, and the role of individualistic constraints on the pursuit of collective goals. Based on this analysis, we conclude that the actors have weighty principled reasons for prioritizing the goal of addressing pollution, but that translating this stance into concrete policy requires accommodating significant pragmatic challenges. (shrink)

In this paper, we provide a state-of-the-art overview of the ethical challenges that arise in the context of antimicrobial resistance, which includes an introduction to the contributions to the symposium in this issue. We begin by discussing why AMR is a distinct ethical issue, and should not be viewed purely as a technical or medical problem. In the second section, we expand on some of these arguments and argue that AMR presents us with a broad range of ethical problems that (...) must be addressed as part of a successful policy response to emerging drug resistance. In the third section, we discuss how some of these ethical challenges should be addressed, and we argue that this requires contributions from citizens, ethicists, policy makers, practitioners and industry. We conclude with an overview of steps that should be taken in moving forward and addressing the ethical problems of AMR. (shrink)

ZusammenfassungDieser Artikel beschreibt die ethischen Herausforderungen, die sich durch das Problem der Antibiotikaresistenz ergeben. Wir legen die Ursachen für ABR dar und argumentieren, dass eine effektive Bekämpfung der ABR es erforderlich macht, den derzeitigen Antibiotikagebrauch drastisch zu reduzieren. Allerdings müssen hierbei auch die ethischen Probleme, die durch ABR entstehen, berücksichtigt werden. ABR führt zum einen zur Verstärkung bereits bestehender Herausforderungen im Infektionsschutz, zum anderen wirft sie neue ethische Probleme auf. Wir argumentieren, dass sich diese Probleme vor allem in Bezug auf (...) kollektive Handlungsentscheidungen und gerechte Ressourcenverteilung ergeben. Um den Konsum von Antibiotika fair zu reduzieren, entwickeln wir anschließend sowohl ein kontraktualistisches Prinzip für die Rationierung, als auch erste Vorschläge zu dessen Implementierung. Hierbei skizzieren wir Risikogrenzen für die Patienten, bei denen ein Verzicht auf Antibiotikatherapie gerechtfertigt werden kann. (shrink)

Many hold that the so-called golden era of antibiotic discovery has passed, leaving only a limited clinical pipeline for new antibiotics. A logical conclusion of such arguments is that we need to reform the current system of antibiotic drug research—including clinical trials and regulatory requirements—to spur activity in discovery and development. The United States Congress in the past few years has debated a number of bills to address this crisis, including the 2012 Generating Antibiotic Incentives Now Act and the 2016 (...) 21st Century Cures Act. Experts have also sought to advance antibiotic development by encouraging greater use of trials with noninferiority hypotheses, which are thought to be easier to conduct. The goal underlying these proposals is to stave off the post-antibiotic era by expanding the pharmaceutical armamentarium as quickly as possible. But although new antibiotic agents are necessary to combat the long-term threat of drug-resistant disease, we argue that these research policies, which effectively lower the bar for antibiotic approval, are ethically problematic. Rather, given broader public health considerations related to the full lifecycle of antibiotic use—including development of resistance—we should reject an overly permissive approach to new antibiotic approval and instead set the bar for regulatory approval at a point that will naturally direct research resources toward the most transformative chemical or social interventions. (shrink)

The One Health approach to antimicrobial resistance (AMR) requires stakeholders to contribute to cross-sectoral efforts to improve antimicrobial stewardship (AMS). One Health AMR policy implementation is challenging in livestock farming because of the infrastructural role of antibiotics in production systems. Mitigating AMR may require the development of more stringent stewardship obligations and the future limitation of established entitlements. Drawing on Amatai Etzioni’s compliance theory, regulatory analyses and qualitative studies with stakeholder groups we examine the structural and socio-cultural dimension of antibiotic (...) use and AMS compliance in Australian beef and dairy production. We found a disconnect between how antibiotic use is conceptualised by farmers and the way in which AMS policies construe agricultural AMR risks. Under the umbrella of food safety standards and national-level prescribing restrictions, farmers and veterinarians interact around antibiotic use with different operating logics and compliance mechanisms. These parallel regimes service distinct and sometimes competing common goods of food security and antibiotic preservation. Further reforms to mitigate AMR need to account for the value orientations of different groups and the embeddedness of the constraints imposed by existing systems. Advocacy for greater AMR precaution in agriculture should acknowledge and compensate for erosions in competing common goods and the cost of proposed interventions. (shrink)

Due to the alarming rise of antibiotic resistance, medically unwarranted use of antibiotics has assumed new moral significance. In this paper, a thematic content analysis of focus group discussions was conducted to explore lay people’s views on the moral challenges posed by antibiotic resistance. The most important finding is that lay people are morally sensitive to the problems entailed by antibiotic resistance. Participants saw the decreasing availability of effective antibiotics as a problem of justice. This involves individual as well as (...) collective moral responsibility. Yet, holding agents responsible for their use of antibiotics involves varying degrees of demandingness. In our discussion, these findings are related to the contemporary ethical debate on antibiotic resistance and two proposals for the preservation of antibiotic effectiveness are compared to and evaluated against participants’ views. (shrink)