Risk communication has been generally categorized as a warning act, which is performed in order to prevent or minimize risk. On the other side, risk analysis has also underscored the role played by information in reducing uncertainty about risk. In both approaches the safety aspects related to the protection of the right to health are on focus. However, it seems that there are cases where a risk cannot possibly be avoided or uncertainty reduced, this is for instance valid for the (...) declaration of side effects associated with pharmaceutical products or when a decision about drug approval or retirement must be delivered on the available evidence. In these cases, risk communication seems to accomplish other tasks than preventing risk or reducing uncertainty. The present paper analyzes the legal instruments which have been developed in order to control and manage the risks related to drugs – such as the notion of “development risk” or “residual risk” – and relates them to different kinds of uncertainty. These are conceptualized as epistemic, ecological, metric, ethical, and stochastic, depending on their nature. By referring to this taxonomy, different functions of pharmaceutical risk communication are identified and connected with the legal tools of uncertainty management. The purpose is to distinguish the different functions of risk communication and make explicit their different legal nature and implications. (shrink)

Pharmaceutical paternalism is the normative stance upheld by pharmaceutical regulatory agencies like the US Food and Drug Administration. These agencies prevent patients from accessing treatments declared safe and ineffective for the patient’s good without their consent. Libertarian critics of the FDA have shown a number of significant flaws in regulatory paternalism. Against these objections, I will argue that, in order to make an informed decision about treatments, a libertarian patient should request full disclosure of the uncertainty about an (...) experimental treatment. But pharmaceutical markets, on their own, are not a reliable source of information about such uncertainty. And companies have the power to capture any independent expert who may assess it. Therefore, the libertarian is better off deferring on an independent regulatory body the assessment of the pharmaceutical risks, constraining access to treatments until tested. (shrink)

The moral justification of intellectual property is often called into question when placed in the context of pharmaceutical patents and global health concerns. The theoretical accounts of both John Rawls and Robert Nozick provide an excellent ethical framework from which such questions can be clarified. While Nozick upholds an individuals right to intellectual property, based upon its conformation with Lockean notions of property and Nozicks ideas of just acquisition and transfer, Rawls emphasizes the importance of basic liberties, such as (...) an individuals right to health, superceding such secondary rights as intellectual property rights. From a policy perspective, patent protection for pharmaceutical products necessarily entails the balancing of corporate intellectual property interests and public interests in healthcare. The moral dilemma that occurs when these two interests clash is not easily resolved. Aside from corporate and public interests, the state maintains an interest in creating and preserving policies that regulate the moral dilemma itself. This paper analyzes the economic and ethical factors surrounding the production and distribution of the anti-HIV medication, AZT. Potential policy implications and recommendations are also discussed. (shrink)

Drug regulation is fraught with inductive risk. Regulators must make a prediction about whether or not an experimental pharmaceutical will be effective and relatively safe when used by typical patients, and such predictions are based on a complex, indeterminate, and incomplete evidential basis. Such inductive risk has important practical consequences. If regulators reject an experimental drug when it in fact has a favourable benefit/harm profile, then a valuable intervention is denied to the public and a company’s material interests are (...) needlessly thwarted. Conversely, if regulators approve an experimental drug when it in fact has an unfavourable benefit/harm profile, then resources are wasted, people are needlessly harmed, and other potentially more effective treatments are underutilized. Given that such regulatory decisions have these practical consequences, non-epistemic values about the relative importance of these consequences impact the way such regulatory decisions are made (similar to the analysis of laboratory studies on the toxic effects of dioxins presented in Douglas [2000]). To balance the competing demands of the pertinent non-epistemic values, regulators must perform what I call an “inductive risk calculus.” At least in the American context this inductive risk calculus is not well-managed. (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)

Abstract: To improve the countries’ pharmaceutical situation and to monitor the progress, the World Health Organization (WHO) and member states developed a system of indicators to measure the respective important aspects as a prerequisite step. Level I indicators to assess the country’s pharmaceutical situation include the national drug policy; legislation and regulations; drug accessibility and affordability; essential drug list; quality control; pharmacovigilance; storage and distribution; information and rational use. This study is aimed to document the professional opinion (...) of 20 pharmacy practice professionals on Libya’s current pharmaceutical situation, utilizing WHO indicator-based approach. The core indicators measure the most important information needed to understand the pharmaceutical situation in a country. A closed-end questionnaire was distributed to ten practicing pharmacists and ten pharmacy teaching staff members who practice pharmacy. The questionnaires were handed over personally and collected on the same day. The responses were analyzed using simple statistics. The results were argued in the light of the first author’s observation and view, being expert in this field, with reference to the other experts’ views, relevant publications’ findings and WHO reports’ conclusions on these indicators. Suggestions and recommendations for a proper situation assessment, planning and action taking are presented. Primarily, government’s commitment towards appropriate restructuring, management and monitoring of the pharmaceutical sector is crucial. That is to enhance the country’s pharmaceutical situation, to provide and sustain efficient pharmaceutical services and to improve the overall health care system’s performance. (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.

Recently, dramatic price increases by several pharmaceutical companies have provoked public outrage. These scandals raise questions both about how pharmaceutical firms should be regulated and about how pharmaceutical executives ethically ought to make pricing decisions when drug prices are largely unregulated. Though there is an extensive literature on the regulatory question, the ethical question has been largely unexplored. This article defends a Kantian approach to the ethics of pharmaceutical pricing in an unregulated market. To the extent (...) possible, pharmaceutical companies must price drugs so that those who genuinely need them can get them without financial ruin. This requirement is an ethical side constraint, like the moral prohibitions on deception and theft, that takes precedence over a business’s interest in maximizing profit. That said, the requirement’s application is sensitive to the need to recoup the costs of research and to produce a return that financially justifies the original investment. It may not be either feasible or desirable for government to attempt to enforce the ethical requirements concerning just pharmaceutical pricing. Either price regulation or subsidy could fulfill government’s obligation to protect patients from being objectionably vulnerable to pricing decisions by private companies. (shrink)

Introduction: There is currently no binding, internationally accepted and successful approach to ensure global equitable access to healthcare during a pandemic. The aim of this ethical analysis is to bring into the discussion a legally regulated vaccine allocation as a possible strategy for equitable global access to vaccines. We focus our analysis on COVAX (COVID-19 Vaccines Global Access) and an existing EU regulation that, after adjustment, could promote global vaccine allocation. -/- Methods: The main documents discussing the two strategies are (...) examined with a qualitative content analysis. The ethical values reasonableness, openness and transparency, inclusiveness, responsiveness and accountability serve as categories for our ethical analysis. -/- Results: We observed that the decision-making processes in a legal solution to expand access to vaccines would be more transparent than in COVAX initiative, would be more inclusive, especially of nation states, and the values responsiveness and accountability could be easily incorporated in the development of a new regulation. -/- Discussion: A legal strategy that offers incentives to the pharmaceutical industry in return for global distribution of vaccines according to the Fair Priority Model is an innovative way to achieve global and equitable access to vaccines. However, in the long term, achieving the Sustainable Development Goals will require from all nations to work in solidarity to find durable solutions for global vaccine research and development. Interim solutions, such as our proposed legal strategy for equitable access to vaccines, and efforts to find long-term solutions must be advanced in parallel. (shrink)

Ongoing research in the fields of genetics and biotechnology hold the promise of improved diagnosis and treatment of genetic diseases, and potentially the development of individually tailored pharmaceuticals and gene therapies. Difficulty, however, arises in determining how these services are to be evaluated and integrated equitably into public health care systems such as Canada's. The current context is one of increasing fiscal restraint on the part of governments, limited financial resources being dedicated to health care, and rising costs for new (...) health care services and technologies. This has led to increasing public debate in the last few years about how to reform public health care, and whether we should prohibit, permit or perhaps even encourage private purchase of health care services. ;In Canada, some of these concerns have crystallized around the issue of gene patents and commercial genetic testing, in particular as illustrated by the case of Myriad Genetics' patented BRACAnalysis test for hereditary breast and ovarian cancer. While most Canadians who currently access genetic services do so through the public health care system, for those with the means, private purchase is becoming an option. This situation raises serious concerns---about justice in access to health care; about continued access to safe and reliable genetic testing supported by unbiased patient information; and about the broader effects of commercialization for ongoing research and the Canadian public health care system. Commercial genetic testing presents a challenge to health care professionals, policy analysts, and academics concerned with the social, ethical and policy implications of new genetic technologies. Using the Myriad case as an exemplar, tools from moral philosophy, the social sciences, and health policy and law will be brought to bear on the larger issues of how as a society we should regulate commercial research and product development, and more coherently decide which services to cover under public health insurance and which to leave to private purchase. Generally, the thesis is concerned with the question of "how best to bring capital, morality, and knowledge into a productive and ethical relationship". (shrink)

Promotion of prescription drugs may appear to be severely limited in some jurisdictions due to restrictions on direct-to-consumer advertising. However, in most jurisdictions, strategies exist to raise consumer awareness about prescription drugs, notably through the deployment of direct-to-consumer information campaigns that encourage patients to seek help for particular medical conditions. In Canada, DTCI is presented by industry and regulated by Health Canada as being purely informational activities, but their design and integration in broader promotional campaigns raise very similar ethical concerns (...) as those associated with DTCA. Specifically, DTCI can be an effective means of familiarizing the public with the scope and benefits of a particular prescription drug and so, like DTCA, can promote increased patient-consumer demand and thus a problematic rise in the prescribing and use of medications that may be neither the most appropriate nor the most cost-effective. Yet, with DTCI the industry is playing within the existing rules and regulations set by health regulators. To respond appropriately to this regulatory incoherence, we argue that DTCI should be regulated as a type of direct-to-consumer indirect advertising. Even if the case and specific regulations presented here are Canadian, the implications extend to every country that has a partial or total prohibition on DTCA. (shrink)

Endocrinologists apply the idea of feedback loops to explain how hormones regulate certain bodily functions such as glucose metabolism. In particular, feedback loops focus on the maintenance of the plasma concentrations of glucose within a narrow range. Here, we put forward a different, organicist perspective on the endocrine regulation of glycaemia, by relying on the pivotal concept of closure of constraints. From this perspective, biological systems are understood as organized ones, which means that they are constituted of a set of (...) mutually dependent functional structures acting as constraints, whose maintenance depends on their reciprocal interactions. Closure refers specifically to the mutual dependence among functional constraints in an organism. We show that, when compared to feedback loops, organizational closure can generate much richer descriptions of the processes and constraints at play in the metabolism and regulation of glycaemia, by making explicit the different hierarchical orders involved. We expect that the proposed theoretical framework will open the way to the construction of original mathematical models, which would provide a better understanding of endocrine regulation from an organicist perspective. (shrink)

In July 2014, the roboticist Ronald Arkin suggested that child sex robots could be used to treat those with paedophilic predilections in the same way that methadone is used to treat heroin addicts. Taking this onboard, it would seem that there is reason to experiment with the regulation of this technology. But most people seem to disagree with this idea, with legal authorities in both the UK and US taking steps to outlaw such devices. In this paper, I subject these (...) different regulatory attitudes to critical scrutiny. In doing so, I make three main contributions to the debate. First, I present a framework for thinking about the regulatory options that we confront when dealing with child sex robots. Second, I argue that there is a prima facie case for restrictive regulation, but that this is contingent on whether Arkin’s hypothesis has a reasonable prospect of being successfully tested. Third, I argue that Arkin’s hypothesis probably does not have a reasonable prospect of being successfully tested. Consequently, we should proceed with utmost caution when it comes to this technology. (shrink)

The International Bill of Rights enshrines a right to health, which includes a right to access essential medicines. This right frequently appears to conflict with the intellectual property regime that governs pharmaceutical patents. However, there is also a human right that protects creative works, including scientific productions. Does this right support intellectual property protections, even when they may negatively affect health? -/- This article examines the recent attempt by the Committee on Economic, Social and Cultural Rights to resolve this (...) issue and argues that it fails. This is problematic because it means defenders of the present patent regime can continue using human rights documents to support their position. I offer a new framework for resolving the problem by examining the values that underlie human rights. (shrink)

Regulation by design (RBD) is a growing research field that explores, develops, and criticises the regulative function of design. In this article, we provide a qualitative thematic synthesis of the existing literature. The aim is to explore and analyse RBD's core features, practices, limitations, and related governance implications. To fulfil this aim, we examine the extant literature on RBD in the context of digital technologies. We start by identifying and structuring the core features of RBD, namely the goals, regulators, regulatees, (...) methods, and technologies. Building on that structure, we distinguish between three types of RBD practices: compliance by design, value creation by design, and optimisation by design. We then explore the challenges and limitations of RBD practices, which stem from risks associated with compliance by design, contextual limitations, or methodological uncertainty. Finally, we examine the governance implications of RBD and outline possible future directions of the research field and its practices. (shrink)

Affective experiences such as pains, pleasures, and emotions have affective phenomenology: they feel pleasant. This type of phenomenology has a loopy regulatory profile: it often motivates us to act a certain way, and these actions typically end up regulating our affective experiences back. For example, the pleasure you get by tasting your morning coffee motivates you to drink more of it, and this in turn results in you obtaining another pleasant gustatory experience. In this article, we argue that reflexive imperativism (...) is the only intentionalist account of affective phenomenology—probably, the only account at all—that is able to make sense of its loopy regulatory profile. (shrink)

Emotion processing is known to be impaired in psychopathy, but less is known about the cognitive mechanisms that drive this. Our study examined experiencing and suppression of emotion processing in psychopathy. Participants, violent offenders with varying levels of psychopathy, viewed positive and negative images under conditions of passive viewing, experiencing and suppressing. Higher scoring psychopathics were more cardiovascularly responsive when processing negative information than positive, possibly reflecting an anomalously rewarding aspect of processing normally unpleasant material. When required to experience emotional (...) response, by ‘getting into the feeling’ of the emotion conveyed by a negative image, higher factor 1 psychopathic individuals showed reduced responsiveness, suggesting that they were less able to do this. These data, together with the absence of corresponding differences in subjective self-report might be used to inform clinical strategies for normalising emotion processing in psychopathic offenders to improve treatment outcome, and reduce risk amongst this client group. (shrink)

A few decades from now, it might become possible to gestate fetuses in artificial wombs. Ectogestation as this is called, raises major legal and ethical issues, especially for abortion rights. In countries allowing abortion, regulation often revolves around the viability threshold—the point in fetal development after which the fetus can survive outside the womb. How should viability be understood—and abortion thus regulated—after ectogestation? Should we ban, allow or require the use of artificial wombs as an alternative to standard abortions? Drawing (...) on Cohen, I evaluate three possible positions for the post-ectogestative abortion laws: restrictive, conservative and liberal. While the restrictive position appears untenable, I argue that the liberal and conservative positions can be combined to form a legally and morally coherent basis for post-ectogestative abortion legislation, offering an improvement from the point of both prolife and prochoice positions. (shrink)

The distinction between the regulative (‘practical’, ‘subjective’, ‘decision-procedural’) and the theoretical (‘objective’, ‘absolute’) pertains to the aims (the desiderata) of an account of justification. This distinction began in ethics and spread to epistemology. Each of internalism, externalism, is separately forced to draw this distinction to avoid a stock, otherwise fatal, argument levelled against them by the other. Given this situation however, we may finesse much partisan conflict in epistemology by simply seeing differing accounts of justification as answering to radically distinct (...) desiderata of adequacy. We should see knowledge as answering to the theoretical desideratum of adequacy alone; and rationality as answering to the regulative desideratum of adequacy alone. Objections to this ‘Gordian’ [knot] approach to epistemology (from virtues theorists and others) are rejected. Such an approach may make for accounts that violate our ordinary language intuitions; but in developing an epistemological axiology, any such intuitions are not to the point. (shrink)

In debates over the regulation of communication related to dual-use research, the risks that such communication creates must be weighed against against the value of scientific autonomy. The censorship of such communication seems justifiable in certain cases, given the potentially catastrophic applications of some dual-use research. This conclusion however, gives rise to another kind of danger: that regulators will use overly simplistic cost-benefit analysis to rationalize excessive regulation of scientific research. In response to this, we show how institutional design principles (...) and normative frameworks from free speech theory can be used to help extend the argument for regulating dangerous dual-use research beyond overly simplistic cost-benefit reasoning, but without reverting to an implausibly absolutist view of scientific autonomy. (shrink)

As a result of the doctoral research developed by the main author (Vargas-Chaves, 2017), it was identified the evolution and perspectives of the pharmaceutical patent in the international trade system, as well as it future legal research needs in this topic, both immediate and long-term. Furthermore, a number of problems of public health were highlighted in which the patent-term-extension mechanisms have produced a lack of access to medicines.

Philosophical work exploring the relation between cognition and the Internet is now an active area of research. Some adopt an externalist framework, arguing that the Internet should be seen as environmental scaffolding that drives and shapes cognition. However, despite growing interest in this topic, little attention has been paid to how the Internet influences our affective life — our moods, emotions, and our ability to regulate these and other feeling states. We argue that the Internet scaffolds not only cognition but (...) also affect. Using various case studies, we consider some ways that we are increasingly dependent on our Internet-enabled “techno-social niches” to regulate the contours of our own affective life and participate in the affective lives of others. We argue further that, unlike many of the other environmental resources we use to regulate affect, the Internet has distinct properties that introduce new dimensions of complexity to these regulative processes. First, it is radically social in a way many of these other resources are not. Second, it is a radically distributed and decentralized resource; no one individual or agent is responsible for the Internet’s content or its affective impact on users. Accordingly, while the Internet can profoundly augment and enrich our affective life and deepen our connection with others, there is also a distinctive kind of affective precarity built into our online endeavors as well. (shrink)

Status of the national currency of Ukraine exchange rate has been characterized as unstable in recent years. Herewith, the Government has not implemented decisive measures on its stabilization, as a rule, underestimating the importance of the Hryvnia exchange rate stability for the successful economic growth in terms of socio-economic transformations. It should also be noted that in modern conditions among scientific and methodical approaches to the State exchange rate formation mechanisms some uncertainty regarding basic and additional tools for such regulatory (...) activities allocation is still persist. The problem relevance is exacerbated by the lack of effective policy (coordination between the NBU and the Government actions) regarding the national currency stabilization as an indispensable prerequisite for an effective macroeconomic development. These circumstances determine the importance of factors influencing the national currency exchange rate and its regulation tools research, as well as new organizational and economic mechanisms for the national currency exchange rate in Ukraine stabilization identification. In the emerging market economy conditions formation of the efficient State currency exchange-rate regulation system provides an opportunity not only to stabilize its exchange rate in different socio-economic conditions, but to create the basis for improvement the country economic development as a whole. Given this, the issue of effective tools for the national currency exchange-rate regulation by the state determination is of theoretical, practical and methodological significance. This emphasizes the relevance of further scientific-methodological and practical principles in-depth development for the national currency exchange-rate regulation. (shrink)

In 2000 Bill Joy proposed that the best way to prevent technological apocalypse was to "relinquish" emerging bio-, info- and nanotechnologies. His essay introduced many watchdog groups to the dangers that futurists had been warning of for decades. One such group, ETC, has called for a moratorium on all nanotechnological research until all safety issues can be investigated and social impacts ameliorated. In this essay I discuss the differences and similarities of regulating bio- and nanotechnological innovation to the efforts to (...) regulate nuclear and biological weapons of mass destruction. I then suggest the creation of a global technology regulatory regime to ensure the safe and equitable diffusion of genetic, molecular and information technologies, and point out the principal political obstacles to implementing such a regime. (shrink)

The objective of the paper is to analyze whether that the pharmaceutical companies producing HIV drugs have moral obligation(s) towards the HIV victims in developing countries who don‟t have access to get drug to reduce their risks. The primary assessment is that the pharmaceutical companies have minimum moral obligation(s) to the HIV patients especially in developing countries. It is because they are human beings and hence they are the subject of moral considerations. The paper argues that from the (...) sense of benevolence, there may be an obligation that will tend pharmaceutical companies to make an opportunity of the concerned HIV patients of developing countries to get drugs. The discussion will be made from the utilitarian point of view. Though it is assumed that, utilitarianism is too demanding, I will show that the too demanding ness of utilitarianism can be minimized and it will not be contradictory with the main theme of utilitarian morality. In this respect the counter examples and arguments will also be analyzed to make the claim stronger. The paper also argues that though the primary aim of the pharmaceutical companies is to make money, the actions that might be taken by the pharmaceutical companies for the welfare of HIV victims will not hamper them in making money for which they are deployed. (shrink)

What are rules? In this paper I develop a view of regulative rules which takes them to be a distinctive normative kind occupying a middle ground between orders and normative truths. The paradigmatic cases of regulative rules that I’m interested in are social rules like rules of etiquette and legal rules like traffic rules. On the view I’ll propose, a rule is a general normative content that is in force due to human activity: enactment by an authority or acceptance by (...) a community. Rules are unlike orders in being not necessarily communicative, not an expression’s of the giver’s will, not evaluable for sincerity, and in that they have propositional content. And they’re unlike normative truths in that they’re themselves not even truth-evaluable (though their contents are). This is because rules qua things that are in force are not like constatives which have a mind to world direction of fit, but more like performatives. Furthermore, they differ from normative truths in that their normativity is isolated from their background justification and is therefore not dependent on contributory notions like reasons coming together in a weighing explanation. As such, they occupy a middle ground between orders and normative truths, much like in H. L. A. Hart’s opinion law occupies a middle ground between “coercion” and “morality” (Hart 1961/1994). I also illustrate the virtues of this understanding of rules by showing how proper appreciation of how they differ from normative truths helps us defuse a common objection to Hart’s practice theory of rules. (shrink)

This paper argues that there is an urgent need for an international doctrine for cyberspace skirmishes before they escalate into conventional warfare.

On an account of virtue as skill, virtues are acquired in the ways that skills are acquired. In this paper I focus on one implication of that account that is deserving of greater attention, which is that becoming more skillful requires learning from one’s failures, but that turns out to be especially challenging when dealing with moral failures. In skill acquisition, skills are improved by deliberate practice, where you strive to correct past mistakes and learn how to overcome your current (...) limitations. A similar story applies to virtue acquisition, as moral failures will be a part of anyone’s life, and we will all have to learn from these experiences. However, despite the importance of being able to learn from our mistakes, this is very difficult in practice, given that failure of any kind can be distressing, and especially so for moral failure. The distress created by a recognition of moral failure often prompts responses of anger, avoidance, or defensiveness; rather than attempts to make amends and when necessary to work on self-improvement. The most potentially distressing response to moral failure is shame, as it is often associated with defensiveness. It is here where emotion regulation will be important to manage that distress, and I focus on the skill of emotion differentiation. I argue that emotion differentiation is a promising strategy for distinguishing the emotions we may experience in the wake of failure, including shame, and to encourage those emotions that motivate self-improvement. Thus, emotion regulation is important for virtue acquisition. (shrink)

This paper argues that regulatory agencies have a responsibility to further the public interest when they determine the conditions under which new technological products may be commercialized. As a case study, this paper analyzes the US 9th Circuit Court’s ruling on the efforts of the US Environmental Protection Agency to regulate an herbicide meant for use with seed that are genetically modified to be tolerant of the chemical. Using that case, it is argued that when regulatory agencies evaluate new technological (...) products, they have an obligation to draw on data, analyses, and evaluations from a variety of credible epistemic sources, and not rely solely or even primarily on the technology developer. Otherwise, they create conditions for their own domination and that of the polity by the technology developer. Moreover, in the interest of advancing the public interest, regulatory agencies must evaluate new technologies in a substantively and procedurally unbiased manner. (shrink)

A number of concerns have been raised about the possible future use of pharmaceuticals designed to enhance cognitive, affective, and motivational processes, particularly where the aim is to produce morally better decisions or behavior. In this article, we draw attention to what is arguably a more worrying possibility: that pharmaceuticals currently in widespread therapeutic use are already having unintended effects on these processes, and thus on moral decision making and morally significant behavior. We review current evidence on the moral effects (...) of three widely used drugs or drug types: propranolol, selective serotonin reuptake inhibitors, and drugs that effect oxytocin physiology. This evidence suggests that the alterations to moral decision making and behavior caused by these agents may have important and difficult-to-evaluate consequences, at least at the population level. We argue that the moral effects of these and other widely used pharmaceuticals warrant further empirical research and ethical analysis. (shrink)

Theorists and activists favor empowering government agencies to regulate technology; but an examination of such regulation by the US government exposes the inadequacy of any such regimen. Vested interests routinely interfere, e.g., keeping administration of polio vaccine in the hands of physicians, political infighting with regard to cancer research funding, advantages gained from noncompliance with military technology-constraining treaties. Public/private salary differences limit availability of the best talents for government positions, nor are truly appropriate regulatory policies easily arrived at in the (...) absence of meaningful funding. Solutions such as a Science Court are unreliable given the influences that would undermine neutrality as well as competence. (shrink)

A narrative review of the major evidence concerning the relationship between emotional regulation and depression was conducted. The literature demonstrates a mediating role of emotional regulation in the development of depression and physical illness. Literature suggests in fact that the employment of adaptive emotional regulation strategies (e.g., reappraisal) causes a reduction of stress-elicited emotions leading to physical disorders. Conversely, dysfunctional emotional regulation strategies and, in particular, rumination and emotion suppression appear to be influential in the pathogenesis of depression and physiological (...) disease. More specifically, the evidence suggests that depression and rumination affect both cognitive (e.g., impaired ability to process negative information) and neurobiological mechanisms (e.g., hypothalamic pituitary adrenal axis overactivation and higher rates of cortisol production). Understanding the factors that govern the variety of health outcomes that different people experience following exposure to stress has important implications for the development of effective emotion-regulation interventional approaches (e.g., mindfulness-based therapy, emotion-focused therapy, and emotion regulation therapy). (shrink)

The history of the regulation of animal research is essentially the history of the emergence of meaningful social ethics for animals in society. Initially, animal ethics concerned itself solely with cruelty, but this was seen as inadequate to late 20th-century concerns about animal use. The new social ethic for animals was quite different, and its conceptual bases are explored in this paper. The Animal Welfare Act of 1966 represented a very minimal and in many ways incoherent attempt to regulate animal (...) research, and is far from morally adequate. The 1985 amendments did much to render coherent the ethic for laboratory animals, but these standards were still inadequate in many ways, as enumerated here. The philosophy underlying these laws is explained, their main provisions are explored, and future directions that could move the ethic forward and further rationalize the laws are sketched. (shrink)

This essay focuses on the interrelationship of regulation and private life in human rights. It argues three main points. Article 8 connects the question of protection of private lives and privacies with the question of their management. Thus, Article 8 orients regulatory practices to private lives and privacies. Article 8’s holders are autonomous to the extent that laws respect their private lives and privacies. They are not autonomous in a ‘pre-political’ sense, where we might expect legal rules to protect an (...) already autonomous private life or privacy. Article 8 does not simply prohibit or permit acts. In certain cases, it also ‘enables’ acts. Then, this essay introduces the idea of oikopolitics. This idea allows us to capture these three points in a useful manner. By this idea, this essay means the context where the interpretation of privacy reaches out to broader social practices and norms and where the status of rights-holders living their private lives makes them objects of attention. (shrink)

Mary Kate McGowan’s Just Words offers an interesting account of exercitives. On McGowan’s view, one of the things we do with words is change what’s permitted, and we do this ubiquitously, without any special authority or specific intention. McGowan’s account of exercitives is meant to identify a mechanism by which ordinary speech is harmful, and which justifies the regulation of such speech. It is here that I part ways. I make three main arguments. First, McGowan’s focus on harm is misguided; (...) that ordinary speech is harmful is harder to support, and in turn does not less to support conclusions about whether it is wrong and warrants regulation, than Just Words suggests. Second, if the speech is harmful, McGowan’s account of exercitives is ill-suited to explain why; the relevant instances of ordinary speech seem to express speakers’ views about moral norms, not change social norms. Third, McGowan’s argument for why ordinary speech should be regulated because it is a form of discrimination presupposes a great deal that is controversial about what makes discrimination wrong and legally actionable, and even if it is right it may license the regulation of more speech than many, including McGowan, would deem acceptable. (shrink)

Understanding the autonomic nervous system and homeostatic changes associated with emotions remains a major challenge for neuroscientists and a fundamental prerequisite to treat anxiety, stress, and emotional disorders. Based on recent publications, the inter-relationship between respiration and emotions and the influence of respiration on autonomic changes, and subsequent widespread membrane potential changes resulting from changes in homeostasis are discussed. We hypothesize that reversing homeostatic alterations with meditation and breathing techniques rather than targeting neurotransmitters with medication may be a superior method (...) to address the whole body changes that occur in stress, anxiety, and depression. Detrimental effects of stress, negative emotions, and sympathetic dominance of the autonomic nervous system have been shown to be counteracted by different forms of meditation, relaxation, and breathing techniques. We propose that these breathing techniques could be used as firstline and supplemental treatments for stress, anxiety, depression, and some emotional disorders. (shrink)

Abstract: This study was aiming to determine the effect of the Vitamin A on paracetamol-induced hepatotoxicity. Fifteen rats were randomly divided into five groups; (three rats each) control group, paracetamol (1000 mg/kg body weight) was used to induce hepatotoxicity in albino rats. Vitamin A (Retinyl palmtate) administered at the dose levels of 100, 500 and1000 IU/kg body weights orally for 7 days prior to paracetamol dose. Hepatic toxicity was observed in paracetamol group; aspartate aminotransaminase (AST) level was high as compared (...) with control group (p = 0.003). The significant hepatoprotective effect of Vitamin A was observed at doses 500 and 1000 IU/kg body weight, as there was significant reduction of serum AST when compared to paracetamol group (p = 0.01 and 0.003 respectivly), where 100 IU/Kg vitamin A not significantly decrease AST. Liver trace element determined by X-ray fluorescence (XRF) (K, Ca, Fe, Cu, Zn and Rb) in paracetamol-treated group were found to be higher than that of the control group, although the only significant increase was observed with Cu. Br shows slight decrease compared to the control group. There were no significant differences between Vitamin A groups (100 mg/kg 500mg/kg and 1000mg/kg) and PCM-treated group in the liver tissue content of Ca, K, Zn, Cu, Rb and Br where Fe concentrations were significantly decrease at doses 500 and 1000IU/l (P value 0.05 and 0.045 respectively). Vitamin A shows protective effect by regulating liver tissue Fe. We recommend to perform further investigation on the mechanisms of Vitamin A hepatoprotective mechanisms of action. (shrink)

This is the short version, in French translation by Anne Querrien, of the originally jointly authored paper: Müller, Vincent C., ‘Autonomous killer robots are probably good news’, in Ezio Di Nucci and Filippo Santoni de Sio, Drones and responsibility: Legal, philosophical and socio-technical perspectives on the use of remotely controlled weapons. - - - L’article qui suit présente un nouveau système d’armes fondé sur des robots qui risque d’être prochainement utilisé. À la différence des drones qui sont manoeuvrés à distance (...) mais comportent une part importante de discernement humain, il s’agit de machines programmées pour défendre, attaquer, ou tuer de manière autonome. Les auteurs, philosophes, préfèrent prévenir de leur prochaine diffusion et obtenir des Nations Unies leur régulation. Une campagne internationale propose plutôt leur interdiction. (shrink)

Whilst India has been debating how to regulate 'surrogacy' the UK has undergone a major consultation on increasing the amount of 'expenses'paid to egg 'donors', while France has recently finished debating its entire package of bioethics regulation and the role of its Biomedicine Agency. Although it is often claimed that there is no alternative to the neo-liberal, market-based approach in regulating (or not) reproductive medicine--the ideology prevalent in both India and the UK--advocates of that position ignore the alternative model offered (...) by France's tighter regulation, as well as its overarching concern with protecting the vulnerable and ensuring social justice. Whilst the concepts underpinning the French model of regulation also have their provenance in Western political philosophy and not in the developed world, they embody a very different attitude and suggest that there is indeed an alternative to letting the market decide. However, even in France that alternative is highly contested. (shrink)

Many artificial intelligence (AI) systems currently used for decision-making are opaque, i.e., the internal factors that determine their decisions are not fully known to people due to the systems’ computational complexity. In response to this problem, several researchers have argued that human decision-making is equally opaque and since simplifying, reason-giving explanations (rather than exhaustive causal accounts) of a decision are typically viewed as sufficient in the human case, the same should hold for algorithmic decision-making. Here, I contend that this argument (...) overlooks that human decision-making is sometimes significantly more transparent and trustworthy than algorithmic decision-making. This is because when people explain their decisions by giving reasons for them, this frequently prompts those giving the reasons to govern or regulate themselves so as to think and act in ways that confirm their reason reports. AI explanation systems lack this self-regulative feature. Overlooking it when comparing algorithmic and human decision-making can result in underestimations of the transparency of human decision-making and in the development of explainable AI that may mislead people by activating generally warranted beliefs about the regulative dimension of reason-giving. (shrink)

This paper puts forward an account of imaginative immersion. Elaborating on Kendall Walton’s thesis that imagining aims at the fictional truth, it first argues that imaginings are inherently rule- or norm-governed: they are ‘regulated’ by that which is presented as fictionally true. It then shows that an imaginer can follow the rule or norm mandating her to imagine the propositions presented as fictional truths either by acquiring explicit beliefs about how the rule (norm) is to be followed, or directly, without (...) acquiring such beliefs. It proceeds to argue that to the extent that an imaginer follows this rule (norm) without holding such beliefs, she is more immersed in her imaginings. The general idea is that immersion in an activity is a matter of following rules or norms that apply to that activity without explicitly thinking about how to follow them, that is, without ‘doxastic mediation.’ Lastly, the paper shows that this thesis can explain various features associated with imaginative immersion, such as the sort of attentiveness it involves, the emotional response it generates, and its relation to spoilers. (shrink)

This study presented the policy of functional integration of the product planning team as a strategy for the development of the pharmaceutical industry in Palestine. The study population consists of all the workers in companies operating in the field of medicine in Palestine, which are (5) companies producing in the West Bank only for pharmaceuticals used by these companies, which are (296) employees, and was used a simple random sample to choose the sample and size (87) employees of the (...) study population, and to achieve the objectives of the study (87) questionnaires were distributed. The descriptive analytical method was used, and SPSS was used to answer and discuss the study's questions. The results showed that there is a significant relationship between the effectiveness of the policy of product development and the competitiveness of pharmaceutical companies in Palestine (West Bank), where the policy of product development efficiency accounts for 56.6% of the total change in the competitiveness of companies. The product quality component was most influential at all levels of product development effectiveness policy, followed by product identification, product cost reduction, packaging and product deletion. The weakest areas of strategic direction in pharmaceutical companies in Palestine (West Bank) are 67%. The weakest aspects of job integration are: non-regular meetings of representatives of different positions to participate in any project related to product development, to achieve spatial convergence of members of the product planning policy team in offices, laboratories and workplaces. (shrink)

Confucianism demands that individuals comport themselves according to the strictures of ritual propriety—specific forms of speech, clothing, and demeanor attached to a vast array of life circumstances. This requires self-regulation, a cognitive resource of limited supply. When this resource is depleted, a person can experience undesirable consequences such as social isolation and alienation. However, one’s cultural background may be an important mediator of such costs; East Asians, in particular, seem to have comparatively greater self-regulatory strength. I offer some considerations as (...) to why this may be so, and what insights it may afford to theories of virtue generally. (shrink)

Limitless is a movie (released in 2011) as well as a novel (published in 2001) about a tormented author who (plagued by a writer’s block) becomes an early user of an experimental designer drug. The wonder drug makes him highly productive overnight and even allows him to make a fortune on the stock market. At the height of his career, however, the detrimental side-effects become increasingly noticeable. In this article, Limitless is analysed from two perspectives. First of all, building on (...) the views of the French novelist Emile Zola, the novel is seen as the report of a closely monitored experiment. Subsequently, building on the phenomenology of Ludwig Binswanger, I will show how the cognitive enhancement drug not only boosts the protagonist’s information processing capacities, but also modifies his experience of space and time, his sense of spatiality, his way of being-in-the-world. On the basis of these (complementary) analyses I will indicate how genres of the imagination (such as movies and novels) may play a significant role in assessing the societal implications of emerging technological developments such as neuro-enhancement, especially during the preparatory or anticipatory stage. (shrink)

What should be a police department's policies and regulations on the use of deadly force? What is the relevance for this of the state law on capital punishment?

Purpose: The research explored empirical evidence to assess the impact of cyber security and supply chain risk on digital operations in the UAE pharmaceutical industry. Methodology/Design/Approach: Based on responses from 243 personnel working at 14 pharmaceutical manufacturing companies in Dubai, data were examined for normality, instrument validity and regression analysis. Cyber security and SC risk on digital operations were explored by applying convenient sampling and descriptive and analytical research design. Findings: The findings validated the significant positive association between (...) cyber security and supply chain risk with digital operations. Research implications and Limitations: The research model was developed with three variables evaluated only on the pharmaceutical industry in Dubai. Future research should focus on multiple manufacturing industries by covering a larger geographic area. Practical implications: When suppliers are highly concentrated, customer-focused organisations with uncertain levels of digital transformation could improve their ability to manage supply chain risk by diversifying their clients. Pharmaceutical firms may require a greater focus on technology-based manufacturing firms to build and maintain customer trust. Originality Value: To illustrate how the pharmaceutical industry has explored the relationship between cyber security, supply chain risk and digital operations, the research highlights the significant and convoluted consequences of the relationship model that have not been previously considered. (shrink)

All parties involved in researching, developing, manufacturing, and distributing COVID-19 vaccines need guidance on their ethical obligations. We focus on pharmaceutical companies' obligations because their capacities to research, develop, manufacture, and distribute vaccines make them uniquely placed for stemming the pandemic. We argue that an ethical approach to COVID-19 vaccine production and distribution should satisfy four uncontroversial principles: optimising vaccine production, including development, testing, and manufacturing; fair distribution; sustainability; and accountability. All parties' obligations should be coordinated and mutually consistent. (...) For instance, companies should not be obligated to provide host countries with additional booster shots at the expense of fulfilling bilateral contracts with countries in which there are surges. Finally, any satisfactory approach should include mechanisms for assurance that all parties are honouring their obligations. This assurance enables countries, pharmaceutical companies, global organisations, and others to verify compliance with the chosen approach and protect ethically compliant stakeholders from being unfairly exploited by unethical behaviour of others. (shrink)

Joel Feinberg’s Offense to Others is the most comprehensive contemporary work on the significance of offense in a liberal legal system. Feinberg argues that being offended can impair a person’s liberty, much like a nuisance, and that it is therefore legitimate in principle to regulate conduct because of its offensiveness. In this article, I discuss some overlooked considerations that give us reason to resist Feinberg’s conclusion, even while granting this premise. My key claim is that the regulation of offense can (...) inadvertently increase the incidence of offense, by nurturing offense-taking sensibilities. In the course of defending this claim and spelling out its implications, I explain why concerns about the inadvertent nurturing of offense are now more pressing, given the identity–political character of contemporary offense-based social conflicts, and I discuss why a reluctance to legally regulate offensive conduct need not be insensitive to the identity–political issues that animate those conflicts. (shrink)

In the ‘Appendix to the Transcendental Dialectic’ of the Critique of Pure Reason, Kant contends that the idea of God has a positive regulative role in the systematization of empirical knowledge. But why is this regulative role assigned to this specific idea? Kant’s account is rather opaque and this question has also not received much attention in the literature. In this paper I argue that an adequate understanding of the regulative role of the idea of God depends on the specific (...) metaphysical content Kant attributes to it in the Critique and other writings. I show that neither a heuristic principle of conceptual systematicity, nor conceiving God as a hypothesis of an intelligent designer, can satisfy the demands of reason to make the unity and necessity of the laws of nature intelligible. Regarding the positive account about the metaphysical content of the idea of God, I support my argument by referring to Kant’s pre-critical discussion of the usefulness of the conception of God for the project of science, and by expounding Kant’s critical account of the necessity of the laws of nature. Thus my account sheds light on the continuity of Kant’s conception of God and his appropriation of his own rationalistic metaphysics. (shrink)