Genetic testing has become a vehicle through which basic constitutional relationships between citizens and the state are revisited, reaffirmed, or rearticulated. The interplay between the is of genetic knowledge and the ought of government unfolds in the context of diverse imaginaries of the forms of human well-being, freedom, and flourishing that states have a duty to support. This article examines how the United Kingdom, Germany, and the United States governed testing for Alzheimer’s disease, and how they diverged in defining potential (...) harms, benefits, and objects of regulation. Comparison before and after the arrival of direct-to-consumer genetic tests reveals differences in national understandings of what it means to protect life and citizenship: in the United Kingdom, ensuring physical wellness through clinical utility; in the United States, protecting both citizens’ physical well-being and freedom to choose through a framework of consumer protection; and in Germany, emphasizing individual flourishing and an unburdened sense of human development that is expressed in genetic testing law and policy as a commitment to the stewardship of personhood. Operating with their own visions of what it means to protect life and citizenship, these three states arrived at settlements that coproduced substantially different bioconstitutional regimes around Alzheimer’s testing. (shrink)

In Italy, during the first wave of the Covid-19 pandemic, the Italian Society of Resuscitators and Pain Therapists (SIAARTI) and the Italian National Bioethics Committee (CNB) published ethical guidance on the allocation of scarce intensive care resources. In this paper, we outline and compare these documents in detail, highlighting differences and similarities. In particular, we argue that major differences exist with respect to the principles and values underpinning the documents and the normative allocation criteria proposed. Conversely, similarities can be traced (...) with respect to a functional rather than substantial endorsement of the age criterion, the importance of transparency, and the consideration over healthcare professionals’ responsibility regarding allocative decisions. In conclusion, we argue that Italy has lacked a comprehensive and publicly-accountable policy articulating principles and operational criteria geared to strengthen the “ethical preparedness” of the country in dealing with current and possible future public health emergencies. (shrink)

The emergence of a global industry of digital health platforms operated by Big Tech corporations, and its growing entanglements with academic and pharmaceutical research networks, raise pressing questions on the capacity of current data governance models, regulatory and legal frameworks to safeguard the sustainability of the health research ecosystem. In this article, we direct our attention toward the challenges faced by the European General Data Protection Regulation in regulating the potentially disruptive engagement of Big Tech platforms in health research. The (...) General Data Protection Regulation upholds a rather flexible regime for scientific research through a number of derogations to otherwise stricter data protection requirements, while providing a very broad interpretation of the notion of “scientific research”. Precisely the breadth of these exemptions combined with the ample scope of this notion could provide unintended leeway to the health data processing activities of Big Tech platforms, which have not been immune from carrying out privacy-infringing and socially disruptive practices in the health domain. We thus discuss further finer-grained demarcations to be traced within the broadly construed notion of scientific research, geared to implementing use-based data governance frameworks that distinguish health research activities that should benefit from a facilitated data protection regime from those that should not. We conclude that a “re-purposing” of big data governance approaches in health research is needed if European nations are to promote research activities within a framework of high safeguards for both individual citizens and society. (shrink)

The rapid spread of SARS‐CoV‐2 worldwide has triggered intense activity in the field of biotechnology, leading to the development and regulatory approval of multiple COVID‐19 vaccines in less than 1 year while raising sustained scrutiny as to the ethical issues associated with this process. This article pursues a twofold objective. First, it reconstructs and provides a thorough overview of the different steps, from clinical trial design to regulatory procedures, underpinning the “fast‐tracking” of COVID‐19 vaccine R&D and approval. Second, drawing on (...) a review of published literature, the article identifies, outlines, and analyzes the most ethically challenging aspects related to such process, including concerns around vaccine safety, issues in study design, the enrollment of study participants, and the challenges in obtaining valid informed consent. By scrutinizing relevant aspects of COVID‐19 vaccine development and regulatory processes leading to market authorization, this article ultimately aims to provide a comprehensive overview of the regulatory and ethical issues underpinning the roll‐out of this key pandemic‐containment technology worldwide. (shrink)