This collection addresses two different audiences: 1) historians and philosophers of the life sciences reflecting on collaborations across disciplines, especially as regards defining and addressing Grand Challenges; 2) researchers and other stakeholders involved in cross-disciplinary collaborations aimed at tackling Grand Challenges in the life and medical sciences. The essays collected here offer ideas and resources both for the study and for the practice of goal-driven cross-disciplinary research in the life and medical sciences. We organise this introduction in three sections. The (...) first section provides some background and context. The second motivates our take on this topic and then outlines the central ideas of each paper. The third section highlights the specificity and significance of this approach by considering: a) how this collection departs from existing literature on inter- and trans-disciplinarity, b) what is characteristic about this approach, and c) what role this suggests for the history and philosophy of the life sciences in addressing Grand Challenges. (shrink)

The idea of personalised medicine (PM) has gathered momentum recently, attracting funding and generating hopes as well as scepticism. As PM gives rise to differing interpretations, there have been several attempts to clarify the concept. In an influential paper published in this journal, Schleidgen and colleagues have proposed a precise and narrow definition of PM on the basis of a systematic literature review. Given that their conclusion is at odds with those of other recent attempts to understand PM, we consider (...) whether their systematic review gives them an edge over competing interpretations. We have found some methodological weaknesses and questionable assumptions in Schleidgen and colleagues’ attempt to provide a more specific definition of PM. Our perplexities concern the lack of criteria for assessing the epistemic strength of the definitions that they consider, as well as the logical principles used to extract a more precise definition, the narrowness of the pool from which they have drawn their empirical data, and finally their overlooking the fact that definitions depend on the context of use. We are also worried that their ethical assumption that only patients’ interests are legitimate is too simplistic and drives all other stakeholders’ interests—including those that are justifiable—underground, thus compromising any hope of a transparent and fair negotiation among a plurality of actors and interests. As an alternative to the shortcomings of attempting a semantic disciplining of the concept we propose a pragmatic approach. Rather than considering PM to be a scientific concept in need of precise demarcation, we look at it as an open and negotiable concept used in a variety of contexts including at the level of orienting research goals and policy objectives. We believe that since PM is still more an ideal than an achieved reality, a plurality of visions is to be expected and we need to pay attention to the people, reasons and interests behind these alternative conceptions. In other words, the logic and politics of PM cannot be disentangled and disagreements need to be tackled addressing the normative and strategic conflicts behind them. (shrink)

Climate change is an existential risk reinforced by ordinary actions in afuent societies—often silently present in comfortable and enjoyable habits. This silence is sometimes broken, presenting itself as a nagging reminder of how our habits fuel a catastrophe. As a case in point, global warming has created a state of urgency among wine makers in Spain, as the alcohol level has risen to a point where it jeopardises wine quality and thereby Spanish viticulture. Eforts are currently being made to solve (...) this problem technologically by developing (non-GMO) strains of yeast that produce less alcohol. If successful, this could help save Spanish viticulture. This kind of technological solution is routinely criticised for ofering simplistic “techno-fx” solutions to solve complex societal problems. However, it is not clear what features are criticised by the notion of techno-fx and hence how to avoid this criticism. In our interpretation, the techno-fx notion is not exclusively used as a dismissive term. The notion points to a general virtue of engineering: to create technological solutions that work silently in the background. This asset of technological solutions might sometimes be problematic and sometimes not. Hence, it needs to be analysed case-by-case by paying attention to the moral relevance of the hidden implications of the technology and of the unrefective actions and habits that they facilitate. Such moral analysis will in turn inform strategies for foregrounding this technology to counteract silencing. We discuss what this means in the case of modifying yeast as a viticultural climate resilience strategy. (shrink)

The Adverse Outcome Pathway (AOP) concept is a knowledge assembly and communication tool to facilitate the transparent translation of mechanistic information into outcomes meaningful to the regulatory assessment of chemicals. The AOP framework and associated knowledgebases (KBs) have received significant attention and use in the regulatory toxicology community. However, it is increasingly apparent that the potential stakeholder community for the AOP concept and AOP KBs is broader than scientists and regulators directly involved in chemical safety assessment. In this paper we (...) identify and describe those stakeholders who currently—or in the future—could benefit from the application of the AOP framework and knowledge to specific problems. We also summarize the challenges faced in implementing pathway-based approaches such as the AOP framework in biological sciences, and provide a series of recommendations to meet critical needs to ensure further progression of the framework as a useful, sustainable and dependable tool supporting assessments of both human health and the environment. Although the AOP concept has the potential to significantly impact the organization and interpretation of biological information in a variety of disciplines/applications, this promise can only be fully realized through the active engagement of, and input from multiple stakeholders, requiring multi-pronged substantive long-term planning and strategies. (shrink)

Both a significant body of literature and the case study presented here show that digital knowledge repositories struggle to attract the needed level of data and knowledge contribution that they need to be successful. This happens also to high profile and prestigious initiatives. The paper argues that the reluctance of researchers to contribute can only be understood in light of the highly competitive context in which research careers need to be built nowadays and how this affects researchers’ quality of life. (...) Competition and managerialism limit the discretion of researchers in sharing their results and in donating their working time. A growing corpus of research shows that academic researchers are increasingly overworked and highly stressed. This corroborates the point that the room for undertaking additional tasks with future and uncertain benefits is very limited. The paper thus recommends that promoters of digital knowledge repositories focus on the needs of the researchers who are expected to contribute their knowledge. In order to treat them fairly and to ensure the success of the repositories, knowledge sharing needs to be rewarded so as to improve the working conditions of contributors. In order to help implementing this researcher-centred approach, the paper proposes the idea of expediential trust: rewards for contributing should be such that rational, self-interested researchers would freely decide to contribute their knowledge and effort trusting that this would make them better off. (shrink)

The paper uses two historical examples, public health (1840-1880) and town planning (1945-1975) in Britain, to analyse the challenges faced by goal-driven research, an increasingly important trend in science policy, as exemplified by the prominence of calls for addressing Grand Challenges. Two key points are argued. (1) Given that the aim of research addressing social or global problems is to contribute to improving things, this research should include all the steps necessary to bring science and technology to fruition. This need (...) is captured by the idea of practical integration, which brings this type of research under the umbrella of collective practical reason rather than under the aegis of science. Achieving practical integration is difficult for many reasons: the complexity of social needs, the plurality of values at stake, the limitation of our knowledge, the elusive nature of the skills needed to deal with uncertainty, incomplete information and asymmetries of power. Nevertheless, drawing from the lessons of the case studies, it is argued that (2) practical integration needs a proper balance between values, institutions and knowledge: i.e. a combination of mutual support and mutual limitation. Pursuing such a balance provides a flexible strategy for approximating practical integration. (shrink)

The paper discusses the possibility that the benefits of pharmacogenomics will not be distributed equally and will create orphan populations. I argue that since these inequalities are not substantially different from those produced by ‘traditional’ drugs and are not generated with the intention to discriminate, their production needs not be unethical. Still, the final result is going against deep-seated moral feelings and intuitions, as well as broadly accepted principles of just distribution of health outcomes and healthcare. I thus propose two (...) provisos that would prevent the most offensive outcomes and moderate the scope of the produced inequalities. The first proviso rejects pharmacogenomics innovations that worsen existing group inequalities and aggravate the disadvantage of communities with a history of discrimination. The second proviso requires that there is a strategy in place to even out as much as possible the distribution of benefits in the future and that a system of compensations is in place for pharmacogenomic orphans. Given that only one moral problem generated by pharmacogenomics has been tackled, the list of provisos might be expanded when other issues are considered. (shrink)

The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article investigates the regulation (...) of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in-depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis-à-vis their stated goals and objectives. (shrink)

The background paper provides an introduction to the concept of pandemics and to the ethical and political issues related with pandemic preparedness.

In this article we raise a problem, and we offer two practical contributions to its solution. The problem is that academic communities interested in digital publishing do not have adequate tools to help them in choosing a publishing model that suits their needs. We believe that excessive focus on Open Access (OA) has obscured some important issues; moreover exclusive emphasis on increasing openness has contributed to an agenda and to policies that show clear practical shortcomings. We believe that academic communities (...) have different needs and priorities; therefore there cannot be a ranking of publishing models that fits all and is based on only one criterion or value. We thus believe that two things are needed. First, communities need help in working out what they want from their digital publications. Their needs and desiderata should be made explicit and their relative importance estimated. This exercise leads to the formulation and ordering of their objectives. Second, available publishing models should be assessed on the basis of these objectives, so as to choose one that satisfies them well. Accordingly we have developed a framework that assists communities in going through these two steps. The framework can be used informally, as a guide to the collection and systematic organization of the information needed to make an informed choice of publishing model. In order to do so it maps the values that should be weighed and the technical features that embed them. Building on our framework, we also offer a method to produce ordinal and cardinal scores of publishing models. When these techniques are applied the framework becomes a formal decision–making tool. Finally, the framework stresses that, while the OA movement tackles important issues in digital publishing, it cannot incorporate the whole range of values and interests that are at the core of academic publishing. Therefore the framework suggests a broader agenda that is relevant in making better policy decisions around academic publishing and OA. (shrink)

The paper discusses some of the implications of regulatory innovation in the area of advanced biological therapies and personalised medicine. Benefits, risks and trade-offs are highlighted.

The paper points out three serious problems in Ruud ter Meulen’s view of solidarity and of its role in healthcare ethics. First, it is not clear whether and to what extent ter Meulen expects normative concepts to be rooted in existing social practices: his criticism of liberal theories of justice seems to imply a different view on this issue than his implicit assumption that normative concepts are independent from social and historical trends. Second, it is not clear at which level (...) his notion of solidarity is meant to be applied: does it provide principles for individuals or for institutions? Nor is it clear at what level of generality it should work: is it meant for healthcare institutions or for states, for citizens or for healthcare practitioners? Third, it is not at all clear how the communitarian and the universalist aspirations in his conception of solidarity can be reconciled. In light of such difficulties it is argued that within philosophical discourse solidarity can be a useful notion only if it can be clearly distinguished from existing and commonly used ethical concepts. Three examples of such narrow and specific uses of solidarity are presented. Finally, a sceptical view of confining the work of applied philosophers to articulating normative concepts is put forward and an alternative view of blending empirical and philosophical analysis is proposed. This vision of field philosophy requires serious attention and careful understanding of the circumstances and constraints within which normative recommendations operate. It is suggested that such a modest and empirically grounded understanding of normative work is a better way of honouring the belief that philosophy is rooted in social institutions and in complex webs of relations. (shrink)

In this article an attempt is made of presenting the deontological feature of A Theory of Justice under a new light. Through an exploration of the meaning of the priority of the good over the right and of the significance and function of the argument of the congruence between justice and individual good, the differences between teleology and deontology are displayed. Deontology seems to have several advantages: a) it allows for pluralism of values and a richer and deeper understanding of (...) practical reason, b) is rooted in a very compelling account of agency, c) points towards an attractive conception of value. Besides, once it is properly understood that the normative content of justice as fairness is to be applied strictly only to an ideal situation and cannot be taken as straightforwardly action-guiding in the real world, we are led to an understanding of deontology that parts from ethical absolutism, makes room for a proper consideration of consequences and avoids the stiffness often imputed to deontological theories. Finally it is suggested that the development of a normative conception of character along Rawlsian lines offers promising prospects towards a proper balancing between an ethic of conviction and an ethic of responsibility. (shrink)

History, Ethics and Politics in Thucydides - The paper analyses Thucydides’s views on history, ethics and politics trying to highlight how they affect each other. Thucydides has a tragic conception of history, according to which, notwithstanding the presence of some constants, human vicissitudes are open to unpredictability and chance. This view is closely related to Thucydides moral outlook, which is interpreted as a version of moral pluralism that recognises two mutually incompatible families of values: those related with greatness and success, (...) and those stemming from compassion and pity. Coming to politics, it is argued that Thucydides’s most valuable contribution lies in his penetrating analysis of the dynamics of power and in particular in his understanding of the fundamental importance of the dialectic between stabilizing and chaotic factors. Political thought should take account of those factors and that means that historical and empirical considerations should enter political theory no later than moral ideals and normative standards. (shrink)

The primary aim of this interpretive essay is to reconstruct some of the most important features of Rawls’s theory of justice, and to offer a hypothesis about how its assumptions and arguments are tied together in a highly structured construction. An almost philological approach is adopted to highlight Rawlsian ideas. First, I consider in what sense Rawls is an individualist and in what sense he is not. Fromthis I conclude that he ought not be charged of psychological egoism or atomism. (...) Then I consider the role of rational choice, the contract and the relation of the latter to the criterion of reflective equilibrium. Here, pride of place is given to the reflexive method, while the role of contract and rational choice, though not denied, is downgraded. Finally, I enquire whether Rawls can be considered a universalist, and suggest that this category, owing to the theory’s practical aim and pragmatic method, is of little use. If successful, my reconstruction should offer a better insight into the theory and dispel some possible misunderstandings. But my presentation should not be read as either an assessment or a defense. (shrink)

Concerns about emerging and re-emerging infectious diseases have given a new lease of life to quarantinist measures: a series of time-honoured techniques for controlling the spread of infectious diseases through breaking the chain of human contagion. Since such measures typically infringe individual rights or privacy their use is subject to legal regulations and gives rise to ethical and political worries and suspicions. Yet in some circumstances they can be very effective. After considering some case studies that show how epidemics are (...) unique, fluid and affected by a multitude of contingent factors, it is argued that the legal and ethical guidelines may not always be the best approach to discipline the use of quarantinist measures. An alternative model based on ex-post political accountability for reasonableness is proposed. This model restores the centrality of political decision and expert judgement in situations characterized by high risk, uncertainty and contingency. It is argued that such alternative model affords quicker and more flexible responses to serious outbreaks of infections, while providing adequate protection against abuses. (shrink)

The paper is a critical discussion of Susan Fainstein's "The Just City". The review points out some weaknesses of Fainstein's three-dimensional account of justice, because the dimension of equity dominates over those of democracy and diversity. Moreover, the reasons for focusing on the just city instead of the good city are questioned. The review discusses two further important issues emerging from Fainstein's book: 1) the ethos of planners and, more generally, the role of experts in policy making; 2) the use (...) of case studies in applied ethics. (shrink)

Sergio Cremaschi’s L’etica del Novecento offers a clear and careful account of the development of ethical theory in English-language and German Philosophy. The focus on meta-ethics and normative concerns allows the author to offer a very concise, reliable and comprehensive overview of philosophical ethics. In this respect the book effectively fills the gap left by the lack of a good, updated history of ethics. Although those qualities establish Cremaschi’s work as a valuable reference book, a few doubts are raised about (...) the highly theoretical approach adopted. On the one hand this choice proves not to be very hospitable to some traditions and overlooks the connections between ethics and the socio-historical world, with the effect of giving a picture of moral philosophy as a very abstract and academic discipline. On the other hand it is not clear whether the emergence of applied ethics is to be greeted as the culmination of the resurgence of normative ethics, or whether it is conspiring with other trends to undermine the whole enterprise of constructing normative theories. If, as I suspect, the latter is the case, the moral of Cremaschi’s narrative may be different from the one he suggests. (shrink)

In this review of Rawls’ last publication two aims are pursued. First, an attempt is made to clarify how this new work makes the deep structure of the theory emerge, thus indicating the way the different arguments, assumptions and conceptions are strictly intertwined. The main point is to show that the overlapping consensus does not bear a foundational role, since justification rests on the combined work of reflective equilibrium and of the original position. The possibility of an overlapping consensus simply (...) shows that the theory is neither utopian nor pointless. Second, an assessment is made about the supposed new features of the book. It is argued that, rather than real novelties, improvements and clarifications are to be found. Moreover, some interesting topics never thoroughly explored before are not satisfyingly developed. The conclusion is that the book may be of some help to the interpretation of the scope and frame of Rawls’ political liberalism, but however it does not add any particularly significant development or novelty to his theory. (shrink)