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What is it to be mentally healthy? In the ongoing movement to promote mental health, to reduce stigma, and to establish parity between mental and physical health, there is a clear enthusiasm about this concept and a recognition of its value in human life. However, it is often unclear what mental health means in all these efforts and whether there is a single concept underlying them. Sometimes, the initiatives for the sake of mental health are aimed just at reducing mental illness, thus implicitly identifying mental health with the absence of diagnosable psychiatric disease. More ambitiously, there are high-profile proposals to adopt a positive definition, identifying mental health with psychic or even overall well-being. We argue against both: a definition of mental health as mere absence of mental illness is too thin, too undemanding, and too closely linked to psychiatric value judgments, while the definition in terms of well-being is too demanding and potentially oppressive. As a compromise, we sketch out a middle position. On this view, mental health is a primary good, that is, the psychological preconditions of pursuing any conception of the good life, including well-being, without being identical to well-being.

Patients with severe disorders of consciousness are thought to be unaware of themselves or their environment. However, research suggests that a minority of patients diagnosed as having a disorder of consciousness remain aware. These patients, designated as having “cognitive motor dissociation” (CMD), can demonstrate awareness by imagining specific tasks, which generates brain activity detectable via functional neuroimaging. The discovery of consciousness in these patients raises difficult questions about their well-being, and it has been argued that it would be better for these patients if they were allowed to die. Conversely, I argue that CMD patients may have a much higher level of well-being than is generally acknowledged. It is far from clear that their lives are not worth living, because there are still significant gaps in our understanding of how these patients experience the world. I attempt to fill these gaps, by analyzing the neuroscientific research that has taken place with these patients to date. Having generated as comprehensive a picture as possible of the capacities of CMD patients, I examine this picture through the lens of traditional philosophical theories of well-being. I conclude that the presumption that CMD patients do not have lives worth living is not adequately supported.

This essay provides an account of how to distinguish between health and pathology of trait tokens in medical theory. It (1) proposes to distinguish between two health/pathology concepts—health/pathology pertaining to survival and health/pathology pertaining to reproduction. It (2) defines measures for survival-efficiency and reproduction-efficiency of performances of physiological functions. It (3) provides an account of how, using the efficiency measures, to draw the line between health and pathology. The account draws, but seeks to improve, on Christopher Boorse’s biostatistical theory. In relation to that theory, the suggested account has the advantages (1) that it defines efficiency and (2) that it harmonizes with judgments in medical theory in cases of common diseases and “normal aging.” Furthermore, the essay argues against a competing idea of how to improve on the biostatistical theory, advocated by Peter Schwartz and Daniel Hausman.

According to what we propose to call “the competence model,” competence is a necessary condition for valid informed consent. If a person is not competent to make a treatment decision, the decision must be made by a substitute decision-maker on her behalf. Recent reports of various United Nations human rights bodies claim that article 12 of the Convention on the Rights of Persons with Disabilities involves a wholesale rejection of this model, regardless of whether the model is based on a status, outcome, or functional approach to competence. The alleged rationale of this rejection is that denying persons the right to make their own treatment decisions based on an assessment of competence necessarily discriminates against persons with mental disorders. Based on a philosophical account of the nature of discrimination, we argue that a version of the competence model that combines supported decision-making with a functional approach to competence does not discriminate against persons with mental disorders. Furthermore, we argue that status- and outcome-based versions of the competence model are discriminatory.

Robert Card’s “Reasonability View” is a significant contribution to the debate over the place of conscientious objection in health care. In his view, conscientious objections can only be accommodated if the grounds for the objection meet a reasonability standard. I identify inconsistencies in Card’s description of the reasonability standard and argue that each version he specifies is unsatisfactory. The criteria for reasonability that Card sets out most frequently have no clear underpinning principle and are too permissive of immoral objections. Card has also claimed that petitioners must justify their positions with Rawlsian public reason. I argue that, although the resulting reasonability standard is principled, it is overly restrictive. I also show that a reasonability standard built on Rawls’ more lenient conception of reasonableness would be overly permissive of objections at odds with professional healthcare standards. Finally, I argue for my favored solution, which bases the reasonability standard on minimal professional standards.

Recent editions of diagnostic manuals in psychiatry have focused on providing quick and efficient operationalized criteria. Notwithstanding the genuine value of these classifications, many psychiatrists have argued that the operationalization approach does not sufficiently accommodate the rich and complex domain of patients’ experiences that is crucial for clinical reasoning in psychiatry. How can we increase the role of phenomenology in the process of diagnostic reasoning in psychiatry? I argue that this could be done by adopting a clinical staging approach in diagnostic reasoning in psychiatry. The approach has the resources to include the progressive nature of patients’ experiences to a much greater degree than is currently practiced. It can address the recent plea for increasing the role of phenomenology in psychiatric diagnosis by offering a model for clinical reasoning that goes beyond the operationalized, static criteria of diagnostic manuals, without depriving us of their benefits.

Central to the identity of modern medical specialities, including psychiatry, is the notion of hypostatic abstraction: doctors treat conditions or disorders, which are conceived of as “things” that people “have.” Mad activism rejects this notion and hence challenges psychiatry’s identity as a medical specialty. This article elaborates the challenge of Mad activism and develops the hypostatic abstraction as applied to medicine. For psychiatry to maintain its identity as a medical speciality while accommodating the challenge of Mad activism, it must develop an additional conception of the clinical encounter. Toward elaborating this conception, this article raises two basic framing questions: For what kind of understanding of the situation should the clinical encounter aim? What is the therapeutic aim of the encounter as a whole? It proposes that the concepts of “secondary insight” (as the aim of understanding) and of “identity-making” (as a therapeutic aim) can allow the clinical encounter to proceed in a way that accommodates the challenge of Mad activism.

In most legal orders, human germline modification is either prohibited or severely restricted. A recurring thought in these legal frameworks is that heritable genome editing would result in practices that are at odds with principles of human rights, such as dignity, justice, and equality. However, now that CRISPR is bringing heritable genome editing within human reach, the question has risen as to whether these human rights bans still make sense. The call is growing louder to lift the ban on heritable genome editing for therapeutic purposes as soon as the technology is safe for introduction in the clinic. This article critically examines these recent proposals from a human rights perspective. First, it examines the question as to how realistic the proposed distinction between the therapeutic and the nontherapeutic uses of human germline modification is in the CRISPR era. Second, it argues that these proposals rely on a one-dimensional understanding of the meaning of human rights for this issue. Finally, it suggests that this one-dimensional understanding paves the way for a regime of self-regulation by the scientific community that leaves little room for public debate on the question as to whether or how human germline modification fits in the long-term aspirations of society.

People of color and the poor die younger than the White and prosperous. And when they are alive, they are sicker. Health inequity is morally tragic. But it is also economically inefficient, raising the nation’s healthcare bill and lowering productivity. The COVID pandemic only, albeit dramatically, highlights these pre-existing inequities. COVID sufferers of color die at twice the rate of Whites. The cause, in large part, is structural inequality and racism. Neither the popular nor the scholarly discussion of healthcare inequity, while robust, has translated into palpable and rapid progress. This article describes why health inequity has so far proven intractable. In the healthcare system, no one actor has both adequate incentive and adequate wherewithal to create progress. The healthcare system cannot solve the problem alone. To jumpstart reform, the article suggests a new regulatory approach, grounded in principles of democratic experimentalism and cooperative federalism. It draws inspiration from the examples that the Health Insurance Portability and Accountability Act (HIPAA) and the Clean Air Act provide. A federal health equity mandate, with funding and penalties for state non-compliance, will spur collaboration between federal, state, local, public, and private entities and start the USA on the path to remediating healthcare’s inequities.

In its judgement of July 25, 2018, the Court of Justice of the European Union (CJEU) in the case C-528/16, Confédération paysanne and Others, held that organisms obtained by techniques of mutagenesis are ‘genetically modified organisms’ (GMOs). It follows from the Court’s reasoning that genome-edited organisms, ie organisms resulting from techniques of directed mutagenesis, are GMOs as well and are fully regulated by Directive 2001/18/EC. However, Directive 2001/18/EC only stipulates rules for the deliberate release and placing on the market of GMOs. By contrast, the European Union (EU) has adopted a separate set of rules laid down in Directive 2009/41/EC, which apply to the so-called ‘contained use’ of ‘genetically modified micro-organisms’ (GMMs). Whether also genome-edited micro-organisms are GMMs and, thus, subject to Directive 2009/41/EC is of crucial importance since contained use activities with genome-edited micro-organisms are currently carried out extensively, eg in laboratories and research facilities. An in-depth legal analysis shows that the CJEU’s interpretation of Directive 2001/18/EC can be extended to Directive 2009/41/EC which means that, in the end, genome-edited micro-organisms are GMMs invariably subject to Directive 2009/41/EC.

COVID-19 transmission among students, faculty, and staff at US institutions of higher education (IHEs) is a pressing concern, especially with the dominance of the highly contagious Delta variant and emergence of the Omicron variant. From the start of the pandemic to May 26, 2021, >700,000 cases were linked to US colleges and universities. To protect their populations and surrounding communities, IHE administrators are increasingly considering COVID-19 vaccine requirements. Roughly one-quarter of the nearly 4,000 college and university campuses across the US have announced COVID-19 vaccine mandates for students or employees. However, deciding to require vaccination is only the first of multiple decisions, as IHEs face complex issues of how to design and refine their mandates, including whether to require boosters. Mandates vary significantly in stringency, implementation, impact on members of the college or university community, and net benefit to the institution. This essay examines 10 key questions that an IHE must face in designing or refining a COVID-19 vaccination mandate. Showing that these 10 questions were carefully considered may be crucial if the institution's mandate is challenged. Ultimately, how an IHE designs its mandate may make the difference between meaningful risk mitigation that advances institutional goals and benefits students, faculty, and staff versus a public health failure that erodes trust, raises equity concerns, threatens to undermine preexisting vaccination requirements, and divides the campus.

The Courts of Justice of the European Union (CJEU) held in its July 2020 Schrems II decision that, in order for entities in other countries to import personal data from the European Economic Area (EEA), the importer must be able to provide data protections ‘essentially equivalent’ to those the EEA offers under its General Data Protection Regulation. The CJEU expressed particular concern that United States’ national security intelligence gathering laws prevent U.S.-based entities from providing such protections. This decision has sharply limited the sharing of clinical research data from the EEA to the United States. After describing the pertinent aspects of the Schrems II decision, this article evaluates U.S. national security intelligence gathering frameworks, including Section 702 of the Foreign Intelligence Surveillance Act and Executive Order 12333. The article then leverages recent draft guidance from the European Data Protection Board to explain how entities may be able to adopt widely used contractual and technical measures, such as data pseudonymization, to provide ‘essentially equivalent’ protections in the clinical research context.

This article answers two questions from the perspective of United Kingdom law and policy: (i) is health information property? and (ii) should it be? We argue that special features of health information make it unsuitable for conferral of property rights without an extensive system of data-specific rules, like those that govern intellectual property. Additionally, we argue that even if an extensive set of rules were developed, the advantages of a property framework to govern health information would be slight: propertization is unlikely to enhance patient self-determination, increase market efficiency, provide patients a foothold in the data economy, clarify legal uses of information, or encourage data-driven innovation. The better approach is to rely less, not more, on property. We recommend a regulatory model with four signature features: (i) substantial protection for personal health data similar to the GDPR with transparent limits on how, when, and by whom patient data can be accessed, used, and transmitted; (ii) input from relevant stakeholders; (iii) interoperability; and (iv) greater research into a health-data service, rather than goods, model.

Biomedical researchers collect large amounts of personal data about individuals, which are frequently shared with repositories and an array of users. Typically, research data holders implement measures to protect participants’ identities and unique attributes from unauthorized disclosure. These measures, however, can be less effective if people disclose their participation in a research study, which they may do for many reasons. Even so, the people who provide these data for research often understandably expect that their privacy will be protected. We discuss the particular challenges posed by self-disclosure and identify various steps that researchers should take to protect data in these cases to protect both the individuals and the research enterprise.

This research investigates the extent to which financial incentives (conditional cash transfers) would induce Americans to opt for vaccination against coronavirus disease of 2019. We performed a randomized survey experiment with a representative sample of 1000 American adults in December 2020. Respondents were asked whether they would opt for vaccination under one of three incentive conditions ($1000, $1500, or $2000 financial incentive) or a no-incentive condition. We find that—without coupled financial incentives—only 58 per cent of survey respondents would elect for vaccination. A coupled financial incentive yields an 8-percentage-point increase in vaccine uptake relative to this baseline. The size of the cash transfer does not dramatically affect uptake rates. However, incentive responses differ dramatically by demographic group. Republicans were less responsive to financial incentives than the general population. For Black and Latino Americans especially, very large financial incentives may be counter-productive.

This article seeks to bring the invisible child of personalized medicine out from the shadows through legal analysis and empirical data. It uses Denmark as a case to argue that existing policies, laws and practices on personalized medicine neglect the legal and ethical issues specific to children. The article investigates Danish laws and practices in clinical genetics and describes how the law neglects children’s right to self-determination in three ways. Firstly, while child participation is provided for by law, no guidelines have been created to operationalize this norm. Secondly, children’s right not to know is inadequately reflected in current policies. Thirdly, the storage of information from prenatal genetic sequencing raises important issues that are in need of reflection. Several recommendations are made, including for strengthening children’s participation and limiting parents’ access to secondary findings where they relate to untreatable or unpreventable conditions. It furthermore recognizes, however, that children’s self-determination in some circumstances should be viewed relationally due to the interconnected nature of genetics.

I argue that expectations or strong beliefs about what can occur, and the imaginaries they construct, can be shaped by organizations and used by them as techniques for public legitimation of their governance and regulatory activities. I advance this argument by reference to the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The expectations and imaginary flowing from the ICH’s mission and framing, ‘harmonisation for better health’, support a focus on technological development for the production of safe, quality, and effective pharmaceuticals and individual ethical conduct to achieve it. The expectations also marginalize wider systemic issues relating to social justice, particularly those affecting the global South. The central role of scientific-technical knowledge and expertise to harmonization abets the latter by minimizing the value to governance of public knowledges on systemic issues. Instead of ensuring the contribution of these knowledges to governance through public participation, there is an attempt to bolster legitimation through communication of expectations and transparency to show practices are in accordance with them (ie expectations are met).

This article considers two competing types of conceptions of the pre-autonomous child’s right to bodily integrity. The first, which I call encroachment conceptions, holds that any physically serious bodily encroachment infringes on the child’s right to bodily integrity. The second, which I call best-interests conceptions, holds that the child’s right to bodily integrity is infringed just in case the child is subjected to a bodily encroachment that substantially deviates from what is in the child’s best interests. I argue in this article that best-interests conceptions are more plausible than encroachment conceptions. They have more attractive implications regarding the permissibility of interventions in children’s bodies that are beneficial for the child but are not medically necessary. They are better able to explain the moral distinction between cases in which an encroachment on a child’s body is needed to benefit that child and cases in which an encroachment on one child’s body is needed to benefit another. Finally, best-interests conceptions are more consonant than encroachment conceptions with our understanding of adults’ right to bodily integrity.

The prospect theory of patents views patents as a tool for the development and commercialization of inventions. Prospect patents rely on broad control of technology so that rivalry between competing products is diminished thus avoiding waste of common-pool resources. The theory has been widely criticized but in this article we argue that it does not address the realities of an economy where many innovations are created by universities. Although university patents on inventions such as new gene-editing tools fit squarely in the definition of prospect patents, they may still allow rivalry to resurface at the commercialization stage. This rivalry is not between competing firms; it is between competing visions of the prospect: ‘the university’s vision versus the licensees.’ We use as a case study the CRISPR-Cas9 technology invented by universities and commercialized by licensees. We employ patent landscape analysis showing that CRISPR-Cas9’s prospects comply with the characteristics of prospect patents and, above all, diminish rivalry at the commercialization stage. As the lack of competition leads to excessive treatment prices, tensions arise because the licensee understands CRISPR-Cas9 as a revenue-generating prospect, whereas the university views it as a technology requiring broad distribution. Such discerning visions can breed rivalry between licensor and licensee despite broad patent rights. In addressing this we turn to the literature on semi-commons, which implies an environment where private rights of exclusion such as prospect patents work with ethical licenses and a domain of resources open for reuse to foster innovation. We argue that in this environment, universities can emerge as important actors in the regulatory enterprise through additional ex post licensing. To this end, we propose a market-based solution in the form of a license allowing for patent re-licensing if the licensee fails to address a predefined demand for the final product.

This article explores the social imaginary in the context of data ownership and the (non-)delivery of the data sharing revolution in biomedicine. We contribute to this Special Issue’s broad definition of an imaginary—as the shared (or, here, divergent) stakeholder views on the hopes, promises and expectations to be engendered through technoscientific development—by developing a method and paradigm of ‘competing narratives’. Despite multiple initiatives to encourage health data sharing, and a strong ‘open access’ agenda, the data sharing revolution is not yet delivered. Ownership is persistently (though inconsistently) presented as a barrier to data sharing. However, existing literature does not reveal how far appeals to ownership are part of the problem. This paper reports original, interdisciplinary research asking: in health research, in what ways, if at all, do notions of ownership (broadly conceived) of health-related data impact on sharing practices? Doctrinal and empirical research methods are used to expose evidence of drivers behind appeals to ownership in health data sharing. The findings speak to how funders and data custodians can better tailor existing and potential data sharing initiatives to perspectives and behaviors. The concept of ‘my data’ is important: notions of reward, opportunity, control, and safeguarding establish legitimate, potentially competing ‘ownership’ interests in data. In particular, this research raises questions about the long-term effectiveness of an open access ideology that ignores these subtleties. In conclusion we find power in the social imaginary of ownership with respect to biomedical data; however, that power emerges and is enacted in unexpected ways by multiple actors within the ecosystem, often driven by competing narratives about what is at stake. Importantly, formal legal property-type appeals to ownership appear to have far less power in the narratives about data than the ethical and social concerns that underpin responsible biomedical research.

The first law-led collection of papers on imaginaries. This inaugural special issue advances discussion between law and science and technology studies.

The introduction of behavioral, including psychiatric, genetic information in American courts has gained traction but raises concerns of undue influence on judicial outcomes. We conducted a vignette-based survey of a nationally representative sample of US adults to assess how evidence about a parent’s psychiatric genetic makeup and explicit and implicit stigmatizing beliefs about psychiatric conditions may affect key decisions in child custody proceedings. Psychiatric genetic evidence did not affect public perspectives on custody decisions, but it increased the genetic essentialist understanding of psychiatric conditions (regardless of a diagnosis). Explicit stigma was associated with a preference to deny parents with a (or with an alleged) psychiatric condition joint custody. Our newly created Implicit Association Test identified an association between psychiatric conditions and perceived bad parenting. Research to identify effective interventions and educational programs to address genetic essentialism and to reduce bias against people, including parents, with psychiatric conditions is urgently needed.

Solitary confinement is not cruel and unusual punishment. It is cruel and unusual if one or more of its accompanying material conditions result in a wanton and unnecessary infliction of pain upon an individual. This requirement is met when such conditions involve a “deprivation of basic identifiable human needs” to an extent that they inflict harm or create a “substantial risk of serious harm” and they are enacted with “deliberate indifference” by prison personnel. With limited exceptions, the Supreme Court and lower federal courts have perpetuated a narrow application of these standards. In particular, Courts have often discounted the generalized mental pain caused by extreme isolation. Accordingly, Courts have often neglected the duration of solitary confinement as an autonomous aspect of constitutional scrutiny. Growing neuroscientific research has emphasized that social interaction and environmental stimulation are of vital importance for physiological brain function. It has further highlighted that socio-environmental deprivation can have damaging effects on the brain, many of which may entail irreversible consequences. Drawing on these insights, this article suggests that solitary confinement is in and of itself cruel and unusual punishment even under the current standards. Avenues for a profound rethinking of solitary confinement regimes are presented and discussed.

This essay indicates that Confucian family-based ethics is by no means a stumbling block to organ donation in China. We contend that China should not change to an opt-out consent system in order to enhance donation because a “hard” opt-out system is unethical, and a “soft” opt-out system is unhelpful. We argue that the recently-introduced familist model of motivation for organ donation in mainland China can provide a proper incentive for donation. This model, and the family priority right that this model supports, is ethically justifiable in terms of Confucian family-based ethics.

This paper represents a systematic effort to describe and assess China’s evolving biosafety/biosecurity legislative and regulatory regime. It catalogs and analyzes laws, regulations, and measures, including the newly passed Biosafety/Biosecurity Law. Various reasons are underlying China’s recently accelerating legislative process for such a law, from international attention increasingly turning biosafety/biosecurity governance into a more regular fixture; the emergence of infectious diseases and even pandemics linked with zoonosis; advances in the global frontier of the life sciences and biotechnology and their integration with other technologies, which, while holding great promise for advancements in global health, raises biosafety/biosecurity concerns; to the strengthening of biosafety/biosecurity governance in many countries. Chinese leadership’s ‘holistic view of national security’ encompasses broad areas of concerns of national security with biosafety/biosecurity being an integral part. However, having progressed alongside its development of the life sciences and biotechnology, China’s current biosafety/biosecurity legislative and regulatory regime is far from rising to the challenges and even the newly enacted Biosafety/Biosecurity law still has room for improvement. The paper’s findings have significant policy implications for further enhancing China’s biosafety/biosecurity legislation and governance and making them better serve domestic interests while converging with international norms.

The Biosecurity Law has laid down a regulatory framework on bioethics in China, from raising awareness through education, requiring researchers to conform to ethical principles and conduct ethical reviews on biomedical research, to giving special attention to human genetic resources. The law constructively leaves a wide range of discretion to medical institutions and professionals in ethical decision-making, adaptive to the biotechnology-ethics-regulation dynamics. This regulatory strategy poses crucial institutional challenges in its implementation, particularly on how to safeguard institutional review boards (IRB), a core mechanism in the governance, to effectively protect human subjects but not unnecessarily hinder the progress of biomedical research. Further measures need to clarify important issues on the IRB-based governance, including legal status of the IRB review decision, potential liabilities, and protections of the IRB members.

Consumers suffer from high drug prices, which stem in large part from pharmaceutical companies’ anticompetitive games. This essay discusses the crucial role antitrust enforcement agencies can play in addressing pay-for-delay settlements and product hopping and draws lessons from this enforcement. In particular, it explains how, learning from the experience with U.S. pay-for-delay settlements, the Chilean National Economic Prosecutor’s Office (FNE) should consider the potential downsides from exclusivity periods that make it easier for brand firms to keep generics off the market. And it explains how the Federal Trade Commission and FNE can target product hopping that makes no sense other than by harming the generic.

A recent article by Giubilini, Savulescu, and Wilkinson1 exposes an ethical issue that deserves careful analysis: should we vaccinate children to save the old? The answer provided by the authors is ‘yes’ under the condition that some circumstances apply, namely: (i) the vaccines provide better results in children than in old people; (ii) children are a vector for the contagion of the elderly, who are not adequately protected by the vaccine; (iii) there is only a small harm to the children; and (iv) this demonstrates to be the most effective strategy to save the greatest number of people. If all of these conditions apply, then we should target children for vaccination instead of the elderly, even though this might be considered as using children as mere means. In this comment, I would like to address some of the statements made by the authors, clarify some misconceptions and provide reasons to support that vaccinating children instead of the elderly is not a good idea in the case of COVID-19. European Commission (H2020 SWAFS Programme, PANELFIT Project, research grant number 788039), Eusko Jaurlaritza (Ayudas a Grupos de Investigación IT-1066-16), and La Caixa Foundation (LCF/BQ/ DR20/11790005).

Although the principle of respect for personal autonomy has been the subject of debate for almost 40 years, the conversation has often suffered from lack of clarity regarding the philosophical traditions underlying this principle. In this article, I trace a genealogy of autonomy, first contrasting Kant’s autonomy as moral obligation and Mill’s teleological political liberty. I then show development from Mill’s concept to Beauchamp and Childress’ principle and to Julian Savulescu’s non-teleological autonomy sketch. I argue that, although the reach for a new principle to guide choices in physician–patient relationships can rightfully be seen as important, the notion that is now called autonomy within bioethics has corollaries that undermine critical aspects of medical care. As such, there is need for a richer account of the interplay between the free choice of patients and the informed recommendations of doctors.

‘Artificial womb’ technology is highly anticipated for the benefits it might have as an alternative to neonatal intensive care and for pregnant people. In the bioethical literature, it has been suggested that such technology will force us to rethink the ethics of abortion. Some scholars have suggested that a pregnant person may be entitled to end a pregnancy but, with the advent of ectogestation, they may not be unilaterally entitled to opt for an abortion where the other genetic progenitor does not agree. Following two high-profile cases in England and Wales in the late 70s and 80s, English law is clear that genetic progenitors who do not gestate have no say in abortion decisions. It might be argued, however, that ectogestation casts doubt on the exclusion of all claims by genetic progenitors. In this article, I assess what a legal challenge to a decision to opt for abortion might look like with the advent of this technology, by examining whether genetic progenitors have the locus standi or grounds to seek an injunction to prevent abortion. I argue that such a challenge is unlikely to be successful.

Several large clinical trials are underway to discover therapies to delay or prevent the onset of dementia caused by Alzheimer’s disease (AD). A common feature of these trials is that they are testing therapies in people who do not yet have changes in memory or thinking—that is, who are cognitively unimpaired—but who have a biologically defined risk of developing dementia caused by AD. When these trials eventually succeed, it is reasonable to expect the widespread adoption of biomarker and genetic testing of cognitively unimpaired individuals into clinical practice, as well as treatment prescribed to individuals at heightened risk. Here, we report results from two qualitative studies that sought to understand with whom, why, and how individuals share their AD biomarker and genetic testing results, respectively. We found that sharing is common within the confines of close relationships. However, when sharing outside such relationships, people have multiple concerns, including stigma and discrimination. These concerns highlight the need for additional legal protections and policy changes in anticipation of the coming transformation of AD clinical care.

Some of the most promising recent advances in health research offer opportunities to improve diagnosis and therapy for millions of patients. They also require access to massive collections of health data and specimens. This need has generated an aggressive and lucrative push toward amassing troves of human data and biospecimens within academia and private industry. But the differences between the strict regulations that govern federally funded researchers in academic medical centers (AMCs) versus those that apply to the collection of health data and specimens by industry can entrench disparities. This article will discuss the value of secondary research with data and specimens and analyze why AMCs have been put at a disadvantage as compared to industry in amassing the large datasets that enable this work. It will explore the limitations of this current governance structure and propose that, moving forward, AMCs should set their own standards for commercialization of the data and specimens they generate in-house, the ability of their researchers to use industry data for their own work, and baseline informed consent standards for their own patients in order to ensure future data accessibility.

Legal contexts frequently impose steep communication barriers, but because the law’s ontological framework of communication views it as an atomized, transaction phenomenon, the law lacks the ability to conceptualize and describe the way in which it itself imposes systemic communication burden. To overcome this shortcoming, this article presents a model for a systemic analysis of communication within the law. Part One operationalizes a set of cognitive-communication resources necessary to navigate communication in legal contexts. Part Two uses the operational model to illustrate how systemic elements of the law pressure the cognitive resources that underlie communication. Finally, Part Three uses the model to predict how possible systemic interventions might improve communication outcomes by alleviating or reducing systemic communication burdens. Not only does this article provide a conceptual tool to articulate the law’s systemic impacts on communication, the subsequent analysis offers a framework for exploring interventions that could ultimately lead to better outcomes for persons, particularly vulnerable or at-risk persons, who must navigate legal contexts. By changing how it conceptualizes communication and working to modify the communication dynamics that it itself perpetuates, the law can reduce the weight of the communication burdens that it imposes on the people within it.

Deemed consent for organ donation has long been discussed as a potential solution to the shortage of organs for transplantation, with several countries having implemented it. In Great Britain, Wales was the first nation to introduce such a system, having done so in 2015. Now, the other two nations are following suit. In this paper, I compare the approaches of England and Scotland in moving to systems of deemed consent for organ donation. After outlining both sets of legislation, I focus on three points on which the two nations differ. First, the role of those close to the deceased in the consent process and the extent to which clinicians are required to consult them ahead of consent being deemed. Second, the role of government ministers in ensuring widespread public awareness. Third, the ways in which the two nations responded to the challenge of the COVID-19 pandemic in relation to the implementation of deemed consent. I conclude that on all three points, the Scottish approach is preferable.

Gene-editing technologies, ie those able to make changes in the DNA of an organism, are the object of global competition and a regulatory race between countries and regions. There is an attempt to craft legal frameworks protective enough for users, but flexible enough for developers of gene-editing technologies. This article examines the imaginary built into the framing of EU-level legal regulation of human gene-editing technologies and identifies its three key related facets: the tension around naturalness; safeguarding morality and ethics; and the pursuit of medical objectives for the protection of human health. Concerns around the use of gene-editing technologies in relation to eugenics and human enhancement have produced a multifaceted imaginary. We argue that this imaginary not only places a limit on EU-level regulation, despite a strong EU competence in respect of the internal market, but also seeks to ensure its legitimation.

The Chinese regulatory framework on access to assisted reproduction technologies (hereafter ART) is relatively restrictive, limiting ART exclusively to heterosexual married couples as a medical treatment for infertility. ART clinics across China are prohibited from providing ART services for single women. This creates significant regulatory barrier for single women to exercise their procreative rights. The restriction finds its root in the population and family planning law under which reproduction is tied to marriage and childbirth outside marriage are deemed as illegitimate with punishing consequences. It essentially denies the procreative rights of single women which are recognized by Chinese law. A welcoming development is that in seven out of 10 cases the court is willing to grant exceptions by allowing posthumous implantation procedure for widowed women after the sudden and unexpected death of the husband.

ImportanceDiscovery of effective vaccines and increased confidence that infection confers extended protection against COVID-19 have renewed discussion of using immunity certificates or “passports” to selectively reduce ongoing public health restrictions.ObjectiveTo determine public views regarding government and private conferral of immunity privileges.Design and SettingNational on-line survey fielded in June 2020. Participants were randomly asked about either government “passports” or private “certificates” for COVID-19 immunity.ParticipantsAdults from a standing panel maintained for academic research, selected to approximate national demographics.Main Outcomes/MeasuresLevel of support/opposition to immunity privileges, and whether views vary based on: government vs. private adoption; demographics; political affiliation or views; or various COVID19-related attitudes and experiences.ResultsOf 1315 respondents, 45.2% supported immunity privileges, with slightly more favoring private certificates than government passports (48.1% vs 42.6%, p=0.04). Support was greater for using passports or certificates to enable returns to high-risk jobs or attendance at large recreational events than for returning to work generally. Levels of support did not vary significantly according to age groups, socioeconomic or employment status, urbanicity, political affiliation or views, or whether the respondent had chronic disease(s). However, estimates from adjusted analyses showed less support among women (Odds Ratio, 0.64; 95% Confidence Interval, 0.51 to 0.80), and among Hispanics (0.56; 0.40 to 0.78) and other minorities (0.58; 0.40 to 0.85) compared with whites, but not among blacks (0.83; 0.60 to 1.15). Support was much higher among those who personally wanted a passport or certificate (75.6% vs 24.4%) and much lower among those who believed this would harm the social fabric of their community (22.9% vs 77.1%).Conclusions and RelevancePublic views are divided on either government or private use of immunity certificates, but, prior to any efforts to politicize the issues, these views do not vary along usual political lines, nor by characteristics that indicate individual vulnerability to infection. Social consensus on the desirability of an immunity privileges programs may be difficult to achieve.Key PointsQuestionWhat are the public’s views on government or private use of immunity “passports” to selectively lift COVID-19 restrictions?FindingsViews are divided and do not vary substantially according to political affiliation or many demographic factors. Support is greater among men but lower among Hispanics and those who believe that immunity privileges would harm the social fabric of society.MeaningSocial consensus will be difficult to achieve on the appropriateness of immunity privileges.

Universal forensic DNA databases are controversial privacy-wise given their omnibus scope of incorporating DNA profile data of the entire population into the system. Following the landmark decision of the European Court of Human Rights on the retention of DNA profiles in S. and Marper v. the United Kingdom, two differing opinions emerged on its application to universal databases: their acceptability and illegality. This paper makes use of the elements of the right to respect for private life (Article 8 ECHR), distilled from the Court’s jurisprudence involving collection and retention of DNA profile data, in the form of tests—preliminary interference, legality, legitimate purpose, and proportionality—in assessing the feasibility of establishing population-wide DNA databases in Europe.

Prescription pharmaceuticals are frequently used consumer products whose manufacturing location is commonly held as a trade secret by firms and US regulatory agencies. Here we use previously non-publicly available data to describe levels and trends in the manufacturing locations of the most commonly used prescription pharmaceuticals, off-patent generic drugs, intended to be consumed by Americans. We find that the base ingredients required for the manufacturing of these prescription drugs are overwhelmingly and increasingly manufactured in non-domestic locations, specifically India and China. The manufacturing of finished prescription drugs for the American market is more equally split between domestic and foreign locations, but is increasingly foreign as well. The American reliance on non-domestic manufacturing of prescription drugs is important for stakeholders to appreciate, given current quality and pricing concerns and their potential susceptibility to interruptions in supply due to natural disasters, pandemics, and international trade negotiations. We discuss implications of these levels and trends for current domestic and international policy discussions.

It has been variously claimed that alterations to the human genome for reproductive purposes ought to be prohibited on the basis that doing so is contrary to human dignity. This claim leads to the conclusion that germline genome editing (GGE) ought to be categorically banned in all states committed to upholding human dignity as a right recognized in international human rights documents, and which has been entrenched in the constitutions of many liberal democracies. But is it the case that the right to human dignity is necessarily opposed to GGE? This paper explores this question through critical examination of the concept of human dignity in international human rights, and how it has been interpreted by individual states. Recognizing that the interpretation of human dignity is shaped by cultural context, the paper explores an African perspective on this issue, using South African constitutional jurisprudence on human dignity as an example. It concludes that when viewed through the lens of the African ethic of Ubuntu, there is no justification for a categorical prohibition on GGE, on the grounds that it is contrary to human dignity. This illustrates the need for a global discourse on the regulation on genome editing to be sensitive to varying perspectives—specifically on value-laden questions such as the interpretation of human rights.

Investigative genetic genealogy (IGG) is a new technique for identifying criminal suspects that has sparked controversy. The technique involves uploading a crime scene DNA profile to one or more genetic genealogy databases with the intention of identifying a criminal offender’s genetic relatives and, eventually, locating the offender within the family tree. IGG was used to identify the Golden State Killer in 2018 and it is now being used in connection with hundreds of cases in the USA. Yet, as more law enforcement agencies conduct IGG, the privacy implications of the technique have come under scrutiny. While these issues deserve careful attention, we are concerned that their discussion is, at times, based on misunderstandings related to how IGG is used in criminal investigations and how IGG departs from traditional investigative techniques. Here, we aim to clarify and sharpen the public debate by addressing four misconceptions about IGG. We begin with a detailed description of IGG as it is currently practiced: what it is and—just as important—what it is not. We then examine misunderstood or not widely known aspects of IGG that are potentially confusing efforts to have constructive discussions about its future. We conclude with recommendations intended to support the productivity of those discussions.

The implementation of social distancing measures through legal regulations to contain an epidemiologic outbreak has received little research attention. We reviewed and synthesized data on epidemiology, mobility trends and enforcement activities in the first 5 months of the COVID-19 epidemic in Hong Kong to examine the effectiveness of the newly enacted social distancing regulations. Data collected showed reduced patronage of retail and recreational activities during the epidemic. The regulations’ enforcement could be inferred from the increase in the number of inspections, verbal warnings given to operators of scheduled premises and to people in public gatherings, but which rarely led to prosecutions. In parallel, the number of reported COVID-19 cases became stabilized. Our analyses suggested that public compliance with social distancing regulations could be maintained through promotional efforts without enforcement by prosecution. The adverse impacts of prolonged social distancing on the economy and citizens’ social and psychological well-being were, however, of concern.

In this article, I argue that the social imaginaries that inform biomedical regulation circulate not only in technical spheres populated by experts but that they are equally articulated (and vehemently contested) in national public spheres in more popular forms of communication. I examine the relation between a national healthcare imaginary and the regulation of therapeutics through a public controversy about access to an innovative therapeutic indicated for spinal muscular atrophy. The establishment of the Danish Medicines Council, a new health technology assessment institution, and its decision to restrict access to an innovative therapeutic sparked controversy in 2017 involving political proponents, adversaries, and patients, among others. In a variety of ways, they rhetorically mobilized or contested the Danish universalist welfare imaginary which contains promises and prospects of solidarity, security, and absence of market forces in universal healthcare, including access to therapeutics. I use a combination of media content analysis and rhetorical close reading methods to analyze how the imaginary was drawn upon in arguments for and against the new regulatory institution.

Biobanks are repositories that collect, store and distribute large quantities of biological samples and associated data (collectively called biobank `material'). Although biobanks have different modes of operation, all face a variety of similar challenges. Some of these challenges, such as donor consent and privacy, have been rigorously debated, but comparatively less attention has been paid to biobanks' intellectual property (IP) practices. IP rights (particularly patents) are integral to the translation of research into clinically relevant outcomes and, therefore, are key features in the business models of many biobanks. As a foundation for such research, commentators have identified five IP clauses of interest: (i) non-obstruction clauses; (ii) march-in clauses; (iii) grant-back clauses; (iv) return-of-results clauses and (v) reach-through clauses (also commonly called `reach-through rights'). In the limited literature that discusses the five clauses, commentators have largely debated their advantages and disadvantages in the abstract. The IP terms that biobanks actually use have not been empirically examined, apart from some small case studies. In particular, no industry-wide evidence exists on three points of biobanks' IP practice: (i) if and how biobanks implement these five types of IP clauses, (ii) whether any norms or standards have emerged, and (iii) whether the norms and standards align with commentators' recommendations for using the five IP clauses. To address these three gaps, the authors conducted a systematic, global survey of the IP clauses used by large, human biobanks. The results indicate that biobanks draft bespoke policies to meet their own needs, and probably do so without knowledge of the gamut of IP terms available. This study also revealed that, in general, biobanks are using IP terms differently from the advice of the commentators. On reviewing the differences, we encourage the use of march-in and grant-back clauses, discourage biobanks from using redundant non-obstruction clauses, and call for more research on return-of-results clauses. We also encourage the use of reach-through clauses to claim royalties (not IP), but only in limited circumstances; for example, where user access fees do not cover a biobanks' operational costs.

If, as is alleged, challenge trials of vaccines against COVID-19 are likely to save thousands of lives and vastly diminish the economic and social harms of the pandemic while subjecting volunteers to risks that are comparable to kidney donation, then it would seem that the only sensible objection to such trials would be to deny that they have low risks or can be expected to have immense benefits. This essay searches for a philosophical rationale for rejecting challenge trials while supposing that they have huge benefits and relatively low risks. Although it finds some force in objections to challenge trials grounded in the obligations of researchers to limit the harms imposed on some individuals for the benefit of others, it argues that there is no compelling objection to challenge trials of vaccines for COVID-19—if they have the benefits and risks that have been claimed.

Standard contractual clauses (SCCs) have long been considered the most accessible method to transfer personal data legally across borders. In July 2020, the Court of Justice of the European Union (CJEU) in Data Protection Commissioner v Facebook Ireland Limited, Maximillian Schrems (Schrems II) placed heavy conditions on their use. The Schrems II Court found that SCCs were valid as ‘appropriate safeguards’ for data transfers from EU entities to others outside the EU/EEA as long as unspecified ‘supplementary measures’ were in place to compensate for the lack of data protection in the third country. Data protection officers are under intense pressure to explain these measures and allow routine transfers to continue. Some authorities interpret the decision as preventing the use of SCCs to transfer personal data outside of the EU because private contracts cannot comprehensively redress gaps in national law. This article argues that these authorities are mistaken and that notwithstanding Schrems II SCCs can still be useful instruments for cross-border transfers. This is especially true in highly regulated contexts such as medical research. This paper traces the history of SCCs under the General Data Protection Regulation (GDPR) and shows how the CJEU in Schrems II misunderstood the purpose of SCCs and other Article 46 GDPR ‘appropriate safeguards’. The CJEU mistakenly approached Article 46 safeguards such as SCCs as being similar to country-specific adequacy rulings under Article 45 GDPR. But unlike Article 45 adequacy rulings, SCCs were not intended to provide a stand-alone mechanism for transfer reliant on the law of the importing country. Rather SCCs provide an alternative, multi-layered standard for data protection that encompasses law, technology and organizational commitments. Their purpose is to be used in situations where legislation alone is insufficient to protect data subject rights. The European Commission’s new draft SCCs support this analysis.

Suicide remains a problem of public health importance worldwide. Cognizant of the emerging links between social media use and suicide, social media platforms, such as Facebook, have developed automated algorithms to detect suicidal behavior. While seemingly a well-intentioned adjunct to public health, there are several ethical and legal concerns to this approach. For example, the role of consent to use individual data in this manner has only been given cursory attention. Social media users may not even be aware that their social media posts, movements, and Internet searches are being analyzed by non-health professionals, who have the decision-making ability to involve law enforcement upon suspicion of potential self-harm. Failure to obtain such consent presents privacy risks and can lead to exposure and wider potential harms. We argue that Facebook’s practices in this area should be subject to well-established protocols. 1 These should resemble those utilized in the field of human subjects research, which upholds standardized, agreed-upon, and well-recognized ethical practices based on generations of precedent. Prior to collecting sensitive data from social media users, an ethical review process should be carried out. The fiduciary framework seems to resonate with the emergent roles and obligations of social media platforms to accept more responsibility for the content being shared.