Journal of Law and the Biosciences最新文献

The HeLa cell line was created in 1951 without consent from Henrietta Lacks, the person whose tissue sample was used. In 2021, the descendants of Henrietta Lacks sued a well-known biotechnology company for the profits it made from the HeLa cell line. In this article, ownership of the cell lines is investigated from a South African legal perspective by considering three possible contemporary scenarios bearing points of similarity to the Henrietta Lacks case. In the first scenario, informed consent is obtained to use a tissue sample for research and to commercialize the products of such research; in the second scenario, informed consent is materially deficient because of an honest mistake on the part of the research institution; and in the third scenario, informed consent is materially deficient due to willful disregard of the law on the part of the research institution. In the first two scenarios, ownership of the cell line created from the tissue sample would vest in the research institution, and the research participant would not have any legal action for financial compensation. However, in the third scenario, ownership of the cell line would vest in the research participant, who would be able to claim all profits made from trading the cell line. Whether the research institution acted in good faith is therefore a crucial determinant of the legal outcome.

Digitization in transplantation is not a new phenomenon. Algorithms are being used, for example, to allocate organs based on medical compatibility and priority criteria. However, digitization is accelerating as computer scientists and physicians increasingly develop and use machine learning (ML) models to obtain better predictions on the chances of a successful transplant. The objective of the article is to shed light on the potential threats to equitable access to organs allocated through algorithms, whether these are the consequence of political choices made upstream of digitization or of the algorithmic design, or are produced by self-learning algorithms. The article shows that achieving equitable access requires an overall vision of the algorithmic development process and that European legal norms only partially contribute to preventing harm and addressing equality in access to organs.

Currently, parties to the Convention on Biological Diversity (CBD) are negotiating a strategic plan to save biodiversity. One crucial element of an agreement is the question of whether and how digital sequence information (DSI) is subject to access and benefit-sharing from the utilization of genetic resources, one main instrument of the CBD. In the EU, the Open Data Directive (ODD) of 2019 and the recently adopted Data Governance Act (DGA) already cover research data and to some extent DSI. An analysis of the ODD and the DGA throws a spotlight on the legal uncertainty of utilizing DSI and reveals systemic tensions between open data principles and benefit-sharing restrictions on non-commercial use. It also suggests that a future benefit-sharing mechanism for DSI should avoid distinguishing between commercial and non-commercial use upstream, but should instead favor a solution, which imposes benefit-sharing obligations further downstream or outside of the DSI life cycle.

The body is precondition of human existence and reference point of many legal norms. But the law only rarely asks what the body is more precisely. Answers might appear evident, but commonsensical conceptions of the body have been cast into doubt by feminists, artists, and disability theorists. Drawing on polyphonic arguments, they suggest social or post-human reconceptualizations with potential legal implications. Civil rights activists call for better protection of cyborg bodies; some legal scholars suggest redefining or even dismissing the right to bodily integrity because of its uncertain foundations. Of particular importance is the question of the boundaries of the body because the legal treatment of prostheses and assistive devices depends on whether they are part of it. This paper analyzes these boundaries with a focus on the right to bodily integrity, in light of the jurisprudence of the European Court of Human Rights and the foundational legal distinction between persons and things. It argues that bodies indeed have multiple boundaries, but none of them qualifies for legal purposes. The law must thus draw normative boundaries. Against the temper of times, it should resort to a naturalistic conception because it accommodates interests of stakeholders in the best way.

This article explores whether 'digital pills' that track medication intake should be used to enhance adherence. We concentrate on psychiatric conditions since these pose unique challenges. We analyze two public policies that potentially encourage the development of systems for remote monitoring of intake, namely the granting of patents and marketing authorization, and identify key stakeholders and their main interests so as to discuss whether these policies provide disproportionate benefits to some. The stakeholders identified are patients, system providers, drug manufacturers, insurers or healthcare systems, physicians, data users, and society at large. We discuss relevant industry reports, regulatory data, patent documents, and academic literature, and argue that there is concern that the drivers for these tracking systems are revenue and the monitoring of 'compliance' rather than 'adherence'. While accepting that the use of these systems can be justified in some circumstances, in our view these systems pose risks to patient autonomy, Shared Decision-Making, and privacy. We also find that policies on granting patents and marketing authorization overly favor the commercial actors and put patients' interests at risk. Accordingly, we propose that additional safeguards are required.

Uterine transplantation (UTx) is a programme of treatment aimed at providing a unique solution to absolute uterine factor infertility, enabling patients to have children as a result of their own pregnancies. As a transplant procedure performed for fertility purposes it may be thought obvious that the welfare of any children created should be assessed prior to treatment provision. However, major concerns about the breadth and scope of such requirements, and the potential threat they pose to patients' reproductive autonomy, have been raised. In this paper, I analyse novel questions regarding the role of the pre-conception welfare principle in UTx. After outlining traditional critiques of the principle, I focus on the unique issues raised by its application in the two areas of medicine occupied by UTx. As a treatment for a particular form of infertility, I explore whether law and policy regulating traditional assisted reproductive technologies applies equally to the case of UTx, and whether a distinction (in welfare terms) does and should exist between fertility treatment involving gametes and embryos and gynaecological surgery for fertility purposes. As a quality-of-life-enhancing transplant, I consider and reject proposals in favour of using pre-conception welfare considerations to inform patient listing and the allocation of deceased donor uteri on the grounds that such assessments may both compromise patient autonomy and lead to unjust discrimination against particular patients or groups of patients.

With the limited initial availability of COVID-19 vaccines in the first months of 2021, decision-makers had to determine the order in which different groups were prioritized. Our aim was to find out what normative approaches to the allocation of scarce preventive resources were embedded in the national COVID-19 vaccination schedules. We systematically reviewed and compared prioritization regulations in 27 members of the European Union, the United Kingdom, and Israel. We differentiated between two types of priority categories: groups that have increased infection fatality rate (IFR) compared to the average for the general population and groups chosen because their members experience increased risk of being infected (ROI). Our findings show a clear trend: all researched schedules prioritized criteria referring to IFR (being over 65 years old and coexisting health conditions) over the ROI criteria (eg occupation and housing conditions). This is surprising since, in the context of treatment, it is common and justifiable to adopt different allocation principles (eg introducing a saving more life-year approach or prioritizing younger patients). We discuss how utilitarian, prioritarian, and egalitarian principles can be applied to interpret normative differences between the allocation of curative and preventive interventions.

Chimeric Antigen Receptor T cells, or CAR-Ts, are a novel class of gene and cell 'one-shot' therapies based upon collecting, reprogramming, and using patients' own immune cells to treat their cancer. The article discusses the status, prospects, and some relevant legal issues of this frontier of personalized medicine. In particular, it explores the legitimacy of 'in-house' CAR-Ts, ie treatments manufactured and delivered to patients within the same clinical center by relying upon automated cell processing systems, a decentralized model which is very different from the one currently adopted for manufacturing existing commercial CAR-Ts. A few legal routes are envisioned for legitimately developing CAR-Ts within decentralized, non-commercial operational sets. In more detail, the article explores, firstly, the issue of 'academic' CAR-Ts (ie therapies developed and administered to patients as experimental drugs). A focus is then provided on what is known as the 'hospital exception' (HE), a special feature of current EU pharmaceutical regulation for non-routine preparations of custom-made advanced therapy medicinal products. Conclusions support a regulatory convergence on shared models of decentralized manufacturing, also through a broader and clearer application of the HE, to enhance a virtuous complementarity between in-house autologous and commercial allogeneic CAR-Ts, for the benefit of patients, pharmaceutical R&D, and sustainable healthcare systems.

The fast evolution of genetic sequencing techniques led to new applications in forensic genetics, one of these being the prediction of the physical appearance of a possible perpetrator from biological traces found at the crime scene. Some European countries recently changed their legislations, to permit this technique, also known as Forensic DNA Phenotyping (FDP). The phenotypical traits that may be analyzed under those revised domestic laws are usually restricted to include no information about the suspect's health. This article elaborates whether the European legal framework, as set by the Council of Europe and the European Union (EU), defines any boundaries for the analytical scope of FDP. After a brief introduction to FDP and a description of the type of data collected through predictive forensic genetics, this article discusses the relevant European legislation and the case law of the European Court of Human Rights (ECtHR) and the Court of Justice of the European Union (CJEU) around privacy, data protection and the use of genetic data. The article attempts to define possible limits for forensic genetic analysis, by eventually trying to predict the jurisprudence of the two European courts.

The vast majority of women who experience physical intimate partner violence (IPV) will likely suffer a brain injury (BI) as a result of the abuse. Accurate screening of IPV-BI can ensure survivors have access to appropriate health care and other supports, but screening results may also impact them receiving fair and equitable treatment in the legal system, and the justice they deserve. We used semi-structured interviews, combined with a contrastive vignette that described a realistic but hypothetical scenario involving IPV with or without BI, to explore the impact of BI on parenting disputes. Participants were lawyers (n = 12) whose focus is family law. Results highlight the potential adverse consequences of a positive BI screen that are influenced by the legal responsibility of counsel, the legal aid status of the woman, ongoing family dynamics, and the expectations of society while the focus on the best interests of the child is retained. Taken together, the findings reflect the legal vulnerability of women in decision-making about their capacity to parent after a BI. We conclude with recommendations for the future of IPV-BI screening aimed at mitigating risk and equipping women to navigate a legal system that has disadvantaged them, both historically and in the current context.