To the extent that antibiotic resistance (ABR) is accelerated by antibiotic consumption and that it represents a serious public health emergency, it is imperative to drastically reduce antibiotic consumption, particularly in high‐income countries. I present the problem of ABR as an instance of the collective action problem known as ‘tragedy of the commons’. I propose that there is a strong ethical justification for taxing certain uses of antibiotics, namely when antibiotics are required to treat minor and (...) self‐limiting infections, such as respiratory tract infections, in otherwise healthy individuals. Taxation would allow a reduction in consumption (given certain behavioural economics assumptions) and/or ensure that individuals internalize or compensate for their contribution to the erosion of the common good of antibiotic effectiveness. I suggest that revenue from the tax could be used to fund conservation and innovation strategies. Taxation might be a coercive policy, especially for certain individuals, but the ethical case for coercive policies is very strong when the good to be preserved is important enough and when they force individuals to do something they have a moral obligation to do anyway. I argue that, in the case of mild and self‐limiting infections, individuals have a moral duty of easy rescue and a moral duty of fairness to make their contribution to the preservation of the common good of antibiotic effectiveness by foregoing antibiotics. I also suggest that taxing antibiotics in such cases is an all things considered ethically justified policy even if it would introduce inequalities in access to healthcare. (shrink)

“Antibiotic resistance is usually associated with a fitness cost” is frequently accepted as common knowledge in the field of infectious diseases. However, with the advances in high‐throughput DNA sequencing that allows for a comprehensive analysis of bacterial pathogenesis at the genome scale, including antibiotic resistance genes, it appears that this paradigm might not be as solid as previously thought. Recent studies indicate that antibiotic resistance is able to enhance bacterial fitness in vivo with a (...) concomitant increase in virulence during infections. As a consequence, strategies to minimize antibiotic resistance turn out to be not as simple as initially believed. Indeed, decreased antibiotic use may not be sufficient to let susceptible strains outcompete the resistant ones. Here, we put in perspective these findings and review alternative approaches, such as preventive and therapeutic anti‐bacterial immunotherapies that have the potential to by‐pass the classic antibiotics. (shrink)

Antibiotic resistance presents a classic example of the “tragedy of the commons.” In this eponymous tragedy, the commons — shared, public access lands — are overgrazed because farmers can send their livestock onto the land at a zero price. The “tragedy” occurs because overgrazing destroys the land and reduces its ability to provide fodder. The application to antibiotics is obvious: the use of antibiotics creates selection pressure leading to increased proportions of resistant bacteria in the patient and the (...) environment. The increase in frequency of resistant organisms diminishes the effectiveness of antibiotics in treating future infections; thus, the long-term value of the antimicrobial resource is reduced. (shrink)

Beginning in the 1940s, mass production of antibiotics involved the industrial-scale growth of microorganisms to harvest their metabolic products. Unfortunately, the use of antibiotics selects for resistance at answering scale. The turn to the study of antibiotic resistance in microbiology and medicine is examined, focusing on the realization that individual therapies targeted at single pathogens in individual bodies are environmental events affecting bacterial evolution far beyond bodies. In turning to biological manifestations of antibiotic use, sciences fathom (...) material outcomes of their own previous concepts. Archival work with stored soil and clinical samples produces a record described here as ‘the biology of history’: the physical registration of human history in bacterial life. This account thus foregrounds the importance of understanding both the materiality of history and the historicity of matter in theories and concepts of life today. (shrink)

Antibiotic resistance poses an urgent public health risk. High rates of ABR have been noted in all regions of the globe by the World Health Organization. ABR develops when bacteria are exposed to antibiotics either during treatments in humans or animals or through environmental sources contaminated with antibiotic residues. Spread beyond those administered antibiotics occurs through direct contact with the infected or colonized person or animal, through contact or ingestion of retail meat or agricultural products contaminated with (...) ABR organisms, or through the environment. ABR bacteria spread from individuals to populations and across countries. (shrink)

Most proposals for new international agreements aim to address important global challenges. If the goal is to solve problems, then the value of these agreements depends on their ability to influence the world — to shape norms, constrain behavior, facilitate cooperation, and mobilize action. A recent review of empirical studies has suggested that many international agreements fail to achieve their aspirations. The review indicates that the form in which states make commitments to each other — through an international legal agreement (...) or through other means — may not be as important as commonly thought. It is the content of the commitments and how these are supported by mechanisms to encourage implementation that matter the most. When developing proposals for new international agreements, like the one that has recently been proposed to address antibiotic resistance, attention to implementation mechanisms should therefore be equal to if not greater than the attention paid to its form. (shrink)

1. This paper investigates the viability of the harm principle (HP) to justify restricting consumer freedom regarding the purchase of products, such as meat, that require intense use of antibiotics...

Antibiotic resistance (AR) is a major threat to public health and healthcare worldwide. In this article, we analyse and discuss the claim that taking actions to minimize AR is everyone's responsibility, focusing on individual moral responsibility. This should not be merely interpreted as a function of knowledge of AR and the proper use of antibiotics. Instead, we suggest a circumstantial account of individual responsibility for AR, where individuals do or do not engage in judicious antibiotic behaviour with (...) different degrees of voluntariness. Furthermore, we suggest a notion of responsibility as a virtue, in which individuals have the opportunity to develop a sensitivity towards the AR theme and, consequently, are capable of engaging, actively and voluntarily, in judicious antibiotic behaviour. The development of such sensitivity depends on the creation of adequate circumstances, that is individual capacities and availability of resources. (shrink)

There are substantial inequalities associated with antibiotics and the determinants of their effectiveness, including the risk of exposure to antibiotic‐resistant microbes, access to relevant treatment advice, diagnostic facilities, risk of life‐threatening infectious disease, and access to antibiotics. Current arrangements (social, political, economic) allow inequalities in the distribution of antibiotic benefits and burdens. This article focuses on the justification of relevant inequalities from a contractualist perspective.

The use of subtherapeutic doses of antibiotics in food-producing animals has been linked to antibiotic resistant infections in humans. Although this practice has been banned in Europe, the U.S. regulatory authorities have been slow to act. This paper discusses the regulatory hurdles and ethical dilemmas of banning this practice within the context of the risk analysis model (risk assessment, risk management, and risk communication). Specific issues include unethical use of scientific uncertainty during the risk assessment phase, the rejection of (...) the precautionary principle leading to ineffective risk management, and the criticality of risk communication to build consensus and force action. The underlying root cause is a conflict of values (Type I ethical problem) among key stakeholders, which is examined in depth along with an ethical analysis using public health ethical values. (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)

This article assesses which policies for addressing antibiotic resistance as part of a multi-pronged approach would benefit from legalization through an international legal agreement. Ten candidate policies were identified based on a review of existing literature, especially The Lancet Series on Antimicrobial Resistance, The Lancet Infectious Diseases Commission on AMR, and the World Health Organization Global Action Plan for AMR. These policies were then grouped under the headings of access, conservation, and innovation.Each of the ten policies were (...) assessed using four criteria developed by Hoffman, Røttingen, and Frenk to help consider why their legalization may be helpful, necessary and/or justified. These criteria are: the problem has a significant transnational dimension; the goal justifies the coercive nature of law; the outcome is likely to be beneficial; and legalization represents the best commitment mechanism among competing alternatives. (shrink)

The nature and effectiveness of any international legal agreement is heavily shaped by the forum in which it is negotiated and implemented. This includes both the substantive content that global policymakers agree upon and the subsequent state compliance with those provisions. Forums differ in their institutional characteristics, thereby providing unique opportunities and costs for participating actors. Forums may have different mandates, capacities, cultures, members, and legal processes — all of which ultimately affect distributions of power and influence. These differences then (...) shape how issues are framed, the content of agreements as they are negotiated, and the incentives states have to comply with any obligations. (shrink)

Antibiotic-resistant bacteria pose a serious threat to our health. Our ability to destroy deadly bacteria by using antibiotics have not only improved our lives by curing infections, it also allows us to undertake otherwise dangerous treatments from chemotherapies to invasive surgeries. The emergence of antibiotic resistance, I argue, is a consequence of various iterations of prisoner’s dilemmas. To wit, each participant (from patients to nations) has rational self-interest to pursue a course of action that is suboptimal for (...) all of us. The standard solutions to prisoner’s dilemma look to realign cost-benefit such that individuals’ interests match those of the collective. However, the lack of a global organization to enforce an effective carrot-and-stick system makes it unlikely that we can solve the antibiotic resistance problem this way. I argue that our best chance might be an attempt to teach altruism and convince individuals to act not out of their self-interests. (shrink)

It is necessary to complement next‐generation sequencing data on the soil resistome with theoretical knowledge provided by ecological studies regarding the spread of antibiotic resistant bacteria (ARB) in the abiotic and, especially, biotic fraction of the soil ecosystem. Particularly, when ARB enter agricultural soils as a consequence of the application of animal manure as fertilizer, from a microbial ecology perspective, it is important to know their fate along the soil food web, that is, throughout that complex network of feeding (...) interactions among members of the soil biota that has crucial effects on species richness and ecosystem productivity and stability. It is critical to study how the ARB that enter the soil through the application of manure can reach other taxonomical groups (e.g., fungi, protists, nematodes, arthropods, earthworms), paying special attention to their presence in the gut microbiomes of mesofauna‐macrofauna and to the possibilities for horizontal gene transfer of antibiotic resistant genes. (shrink)

Antibiotic development and usage, and antibiotic resistance in particular, are today considered global concerns, simultaneously mandating local and global perspectives and actions. Yet such global considerations have not always been part of antibiotic policy formation, and those who attempt to formulate a globally coordinated response to antibiotic resistance will need to confront a history of heterogeneous, often uncoordinated, and at times conflicting reform efforts, whose legacies remain apparent today. Historical analysis permits us to highlight (...) such entrenched trends and processes, helping to frame contemporary efforts to improve access, conservation and innovation. (shrink)

In March 2015, the Dag Hammarskjöld Foundation convened a workshop in Uppsala, Sweden to address questions about antibiotic resistance, in partnership with the Global Strategy Lab, the Journal of Law, Medicine & Ethics, the Norwegian Institute of Public Health, and ReAct – Action on Antibiotic Resistance. Eleven concise articles were commissioned to explore whether ABR depended on global collective action, and if so, what tools could help states and non-state actors to achieve it. This article introduces (...) that collection, which is found in an online-only symposium at aslme.org. (shrink)

Antibiotic use in animal farming is one of the main drivers of antibiotic resistance both in animals and in humans. In this paper we propose that one feasible and fair way to address this problem is to tax animal products obtained with the use of antibiotics. We argue that such tax is supported both by deontological arguments, which are based on the duty individuals have to compensate society for the antibiotic resistance to which they are (...) contributing through consumption of animal products obtained with the use of antibiotics; and a cost-benefit analysis of taxing such animal products and of using revenue from the tax to fund alternatives to use of antibiotics in animal farming. Finally, we argue that such a tax would be fair because individuals who consume animal products obtained with the use of antibiotics can be held morally responsible, i.e. blameworthy, for their contribution to antibiotic resistance, in spite of the fact that each individual contribution is imperceptible. (shrink)

We consider the implications for the ethical evaluation of research programs of two fundamental changes in the revised research ethical guideline of the Council for International Organizations of Medical Sciences. The first is the extension of scope that follows from exchanging “biomedical” for “health‐related” research, and the second is the new evaluative basis of “social value,” which implies new ethical requirements of research. We use the example of antibiotic resistance interventions to explore the need to consider the instances (...) of what we term the pragmatic risks of such interventions to evaluate the social value of certain kinds of health‐related research. These (pragmatic) risks severely threaten the social value of interventions in every area where human and social responses significantly impact on their effectiveness. Thus, the social value of health‐related research needed to demonstrate its effectiveness depends on the extent and successful management of such risks. Research designed to take into account the management of pragmatic risks also gives rise to similar types of risks, and the potential for social value in light of those risks needs to be considered in ethical reviews based on the new guidelines. We argue that, to handle this new expanded task, the international system of research ethical review addressed by the guidelines needs institutional development. (shrink)

The authors present climate change and antibiotic resistance as emergent biosocial phenomena—ongoing products of massively multiple interactions among human lifestyles and broader life processes. They argue that response to climate change and antibiotic resistance is often framed by two varieties of biosocial imagination. Anthropocentric imaginations privilege the question of human distinctiveness. Anthropomorphic imaginations privilege the question of whether biosocial processes can be modeled in terms of centers of moral and causal responsibility. Together, these frame the matter (...) of response in terms of deliberate human action. The authors argue that, considered as emergent biosocial phenomena, climate change and antibiotic resistance “diffract” deliberate human action and thus limit the value of this frame by rendering the human/nonhuman and intended/nonintended distinctions that are crucial to its practical operation locally irrelevant. Alternative biosocial imaginations currently developing around climate change and antibiotic resistance that allow for “diffraction” and therefore frame response differently are considered. (shrink)

Definition of the problem Using the example of the emergence of antibiotic resistance, we show in the first part of our article that there are specific sustainability problems in medicine, which can ultimately lead to an impairment of the ability of future patients to satisfy their basic health needs and realize a flourishing life. Methods After clarification of the concept of sustainability in the second part, we explain why the possibility of satisfying basic health needs, for example, is (...) considered a condition for a good life within the framework of a capability approach. The concept of sustainability, as promoted by the United Nations, requires one to adequately consider the demands for a good life of future patients. Conclusion In the last part of the paper, we show that the orientation towards an idea of sustainability can lead to “sustainability dilemma” and we discuss how this can be dealt with. (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)

The right to health is enshrined in the constitution of the World Health Organization and numerous other international agreements. Yet today, an estimated 5.7 million people die each year from treatable infectious diseases, most of which are susceptible to existing antimicrobials if they were accessible. These deaths occur predominantly among populations living in poverty in low- and middle-income countries, and they greatly exceed the estimated 700,000 annual deaths worldwide currently attributed to antimicrobial resistance. Ensuring universal appropriate access to antimicrobials (...) is not only a critical part of realizing the right to health, it is necessary for mobilizing effective collective action against the development and spread of AMR. (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)

The development of bacterial resistance to antibiotics is one of the best documented examples of contemporary biological evolution. Variability in the mechanisms of resistance depends on the diversity of genotypes in the huge bacterial populations, and also on the diversity of selective pressures that are produced along the antibiotic concentration gradients formed in the highly compartmentalized human body during therapy. These antibiotic gradients can be conceived as comprising selective compartments, each one of them defined as the (...) concentration able to select a particular genetic variant. In vitro experimental models confirm that some antibiotic resistant variants are selected only at certain selective concentrations of antibiotics. The correspondence between selective compartments and selectable variants could offer a way of describing more accurately the antibiotic selective landscapes and for taking measures to prevent the development of a major threat to the future of modern medicine. (shrink)

The development of bacterial resistance to antibiotics is one of the best documented examples of contemporary biological evolution. Variability in the mechanisms of resistance depends on the diversity of genotypes in the huge bacterial populations, and also on the diversity of selective pressures that are produced along the antibiotic concentration gradients formed in the highly compartmentalized human body during therapy. These antibiotic gradients can be conceived as comprising selective compartments, each one of them defined as the (...) concentration able to select a particular genetic variant. In vitro experimental models confirm that some antibiotic resistant variants are selected only at certain selective concentrations of antibiotics. The correspondence between selective compartments and selectable variants could offer a way of describing more accurately the antibiotic selective landscapes and for taking measures to prevent the development of a major threat to the future of modern medicine. (shrink)

Bacterial resistance mechanisms to the antibiotics known as β‐lactams, which include the penicillins and cephalosporins, can take several forms but frequently involve the production of β‐lactamases from either plasmid‐ or chromosomally‐encoded loci. Gram negative bacteria express a β‐lactamase from evolutionarily related chromosomal ampC genes. Genetic analysis of both inducible and constitutively expressed AmpC β‐lactamases provide insights into the mechanisms regulating production of the enzyme. Evolutionary relationships between the genes of different species are discussed, as well as the regulatory mechanisms (...) that in both laboratory mutants and clinical isolates lead to overproduction of β‐lactamase. (shrink)

Antibiotic resistance has become a problem of global scale. Resistance arises through mutation or through the acquisition of resistance gene(s) from other bacteria in a process called horizontal gene transfer (HGT). While HGT is recognized as an important factor in the dissemination of resistance genes in clinical pathogens, its role in the environment has been called into question by a recent study published in Nature. The authors found little evidence of HGT in soil using a (...) culture‐independent functional metagenomics approach, which is in contrast to previous work from the same lab showing HGT between the environment and human microbiome. While surprising at face value, these results may be explained by the lack of selective pressure in the environment studied. Importantly, this work suggests the need for careful monitoring of environmental antibiotic pollution and stringent antibiotic stewardship in the fight against resistance. (shrink)

Existing ethical frameworks for public health provide insufficient guidance on how to evaluate the risks of public health programs that compromise the best clinical interests of present patients for the benefit of others. Given the relevant similarity of such programs to clinical research, we suggest that insights from the long‐standing debate about acceptable risk in clinical research can helpfully inform and guide the evaluation of risks posed by public health programs that compromise patients’ best clinical interests. We discuss how lessons (...) learned regarding the ethics of risk in one context can be fruitfully transferred to the other, using the example of a so‐called ‘rational antibiotic use’ guideline that limits antimicrobial prescribing in order to curb antimicrobial resistance. (shrink)

Horizontal gene transfer (HGT) is a major mechanism responsible for the spread of antibiotic resistance. Conversely, it is often assumed that antibiotics promote HGT. Careful dissection of the literature, however, suggests a lack of conclusive evidence supporting this notion in general. This is largely due to the lack of well‐defined quantitative experiments to address this question in an unambiguous manner. In this review, we discuss the extent to which HGT is responsible for the spread of antibiotic (...) class='Hi'>resistance and examine what is known about the effect of antibiotics on the HGT dynamics. We focus on conjugation, which is the dominant mode of HGT responsible for spreading antibiotic resistance on the global scale. Our analysis reveals a need to design experiments to quantify HGT in such a way to facilitate rigorous data interpretation. Such measurements are critical for developing novel strategies to combat resistance spread through HGT. -/- . (shrink)

The World Health Organization has published a global priority list of antibiotic-resistant bacteria to guide research and development of new antibiotics. Every pathogen on this list requires R&D activity, but some are more attractive for private sector investments, as evidenced by the current antibacterial pipeline. A “pipeline coordinator” is a governmental/non-profit organization that closely tracks the antibacterial pipeline and actively supports R&D across all priority pathogens employing new financing tools.

Antibiotic resistance threatens the capacity to treat life-threatening infections. If it is accepted that it will be many years until the production of new antibiotics overcomes current concerns with antibiotic resistance then ways to conserve the effectiveness of current antibiotics will have to be found. For many bacterial agents of infection levels of antibiotic resistance are directly dependent on the quantity of antibiotic prescribed. Antibiotics are currently underutilised in many parts of the world. (...) If a just distribution of access to antibiotics requires equal access for individuals with equal need irrespective of wealth then responding to this requirement of justice has the potential to shorten the effective life of currently available antibiotics. Increasing the range and numbers of individuals treated with antibiotics would seem to threaten sustainability and also potentially undermine the access of future generations to cost-effective treatments for bacterial infection. The control of antibiotic resistance requires that the determinants of infectious disease transmission are addressed, such as poor housing, education and nutrition as well as the provision of antibiotics. The apparent tension between intragenerational justice and sustainability diminishes when the account of distributive justice extends beyond access to antibiotics and includes plural entitlements. Controlling antibiotic resistance requires more than the redistribution or reduction of antibiotics. (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)

To combat the OneHealth threat of antimicrobial resistance (AMR), the use of antibiotics in agriculture is subject to significant governance-led initiatives to change food system behaviours, including promoting more responsible use of antibiotics on farms through market-level interventions. To combat knowledge gaps about how consumers perceive risks associated with antibiotic use and AMR in farming, the current study carried out an in-depth qualitative focus group study incorporating a risk information exposure exercise with food consumers on the island of (...) Ireland (_n_ = 36). Using a theoretical lens of social representation theory, a thematic analysis of the collected data identified how participants made sense of, often new, information on agricultural antibiotic use and AMR. Participants displayed high awareness and concern for AMR but low understanding and misconceptions around AMR transmission from the agri-food sector. Social representations about antibiotics and food and farming systems shaped preferences for a movement away from antibiotics in farming, and in particular, prophylactic use. However, participants acknowledged the role of antibiotics to protect animal health and the integrity of the food supply chain. They debated the lack of a simple fix to antibiotics in the agri-food system and revealed preferences for preventive actions at farm level and supporting actions at market level. The study highlights the need to first tackle low levels of public understanding through effective risk communication including strategies such as targeted message framing and proactive, cross-sector OneHealth awareness campaigns, followed by the introduction of a trusted antibiotic use food labelling system. (shrink)

Securing equitable antibiotic access as an essential component for health system resilience and pandemic preparedness requires a systems perspective. This article discusses key components that need to be coordinated and paired with adequate financing and resources to ensure antibiotic effectiveness as a global public good, which should be central while discussing a new global agreement.

Antibiotic resistance is a serious public health problem on a global scale. In both developed and developing countries, the unpleasant consequences of the phenomenon are being felt. This paper discusses wild-card patent extensions as a means to incentivize research and development of new antibiotics. The thesis defended in the paper is that the implementation of such patent extensions is an appropriate legislative response to the problem of antibiotic resistance. The general idea of wild-card patent extensions is (...) presented in the first part of the paper. A number of objections to the idea are thereafter discussed and rejected. (shrink)

Decisions to use antibiotics require that patient interests are balanced against the public good, that is, control of antibiotic resistance. Patients carry the risks of suboptimal antibiotic treatment and many physicians are reluctant to impose even small avoidable risks on patients. At the same time, antibiotics are overused and antibiotic-resistant microbes are contributing an increasing burden of adverse patient outcomes. It is the criteria that we can use to reject the use of antibiotics that is the (...) focus of this paper. Scanlon's contractualism explains why antibiotics should not be used to gain small benefits, even when the direct costs of antibiotics are low. We know that some individuals now (and probably more in the future will) carry a burden of irretrievable harm as a consequence of treatment- (antibiotic-) resistant infection. If we accept that the dominant justification for use of antibiotics is to prevent irretrievable harm to an individual or contact, then the use of antibiotics for self-limiting conditions, or for the treatment of individuals with conditions for which antibiotics do not substantially impact on outcomes (eg, in the latter stages of terminal illness), or for access based on preference or willingness to pay (internet or over-the-counter access), or the use of antibiotics as animal growth promoters can be rejected. Scanlon's approach also suggests that, with few new antibiotics in the pipeline and an increasing burden of disease attributable to resistant microbes, control of the spread of antibiotic-resistant microbes should be given increasing priority. (shrink)

Antibiotic resistance, arising when bacteria develop defences against antibiotics, is creating a public health threat of massive proportions. This raises challenging questions for standard notions in bioethics when suitable policy is to be characterized and justified. We examine the particular proposal of expediting innovation of new antibiotics by cutting various forms of regulatory ‘red tape’ in the standard system for the clinical introduction of new drugs. We find strong principled reasons in favour of such a lowering of the (...) ethical standards of research and the clinical introduction of new antibiotic formulas. However, this support is undermined by pragmatic challenges owing to expected responses from stakeholders, creating uncertainty about which policies could actually be effectively implemented. We describe an underlying dilemma on how to rationally justify compromises between ideal ethical justification and pragmatic risks that needs to be further addressed in this light. We suggest a solution to this dilemma related to proposals of expediting antibiotic drug innovation. (shrink)

The issue of regularly feeding low levels of antibiotics to farm animals in order to increase productivity is often portrayed as a dilemma. On the one hand, such antibiotic use is depicted as a necessary condition for producing cheap and plentiful food, such that were such use to stop, food prices would rise significantly and our ability to feed people in developing nations would decrease. On the other hand, such antibiotic use seems to breed antibiotic resistance (...) into pathogens affecting human health. Resolving this dilemma, it is alleged, will require great amounts of research into risk/benefit assessment. Contrary to this claim, we will argue that society has all the data it needs to make a reasonable ethical decision, which would be curtailing such use. Such curtailment will not harm consumers significantly, will not harm developing nations'' evolving agriculture, and could produce hitherto unnoticed benefits, namely restoring the possibility of a more husbandry-based, sustainable agriculture to replace the high-tech agriculture that has hurt animals, the environment, small farms, and sustainability. (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)