Journal of Law and the Biosciences最新文献

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.

A recent increase in the amount and availability of neuroscience data within and outside of research and clinical contexts will enhance reproducibility of neuroscience research leading to new discoveries on the mechanisms of brain function in healthy and disease states. However, the uniquely sensitive nature of neuroscience data raises critical concerns regarding data privacy. In response to these concerns, various policy and regulatory approaches have been proposed to control access to and disclosure of neuroscience data, but excessive restriction may hamper open science practice in the field. This article argues that it may now be time to expand the scope of regulatory discourse beyond protection of neuroscience data and to begin contemplating how to prevent potential harm. Legal prohibition of harmful use of neuroscience data could provide an ultimate safeguard against privacy risks and would help us chart a path toward protecting data subjects without unduly limiting the benefits of open science practice. Here we take the Genetic Information Non-Discrimination Act (GINA) as a reference for this new legislation and search for answers to the core regulatory questions based on what we have learned from the enactment of the GINA and the merits and weaknesses of the protection it provides.

Our study seeks to determine whether patent thickets covering biologic drugs are responsible for delayed biosimilar market entry. We compare patent assertions against the same biosimilar drugs across three countries. On average nine to twelve times more patents were asserted against biosimilars in the United States than in Canada and the United Kingdom. Biosimilars also enter the Canadian and UK markets more quickly than they do in the United States following regulatory approval. Later market entry is not a problem when the brand name drug company is asserting high quality patents (i.e. patents covering significant advances). Consequently, we drilled down into the U.S. patent portfolio of one major biologic, Abbvie's Humira drug, and found that it was made up of roughly 80% non-patentably distinct (duplicative) patents linked together by terminal disclaimers, which is permitted under United States Patent and Trademark Office (USPTO) rules. In contrast, there were far less non-duplicative European patents that covered Humira. Patent thickets can allow brand name drug companies to delay biosimilar entry by relying on the high cost of challenging many duplicative patents instead of the quality of their underlying patents. Accordingly, we suggest several policy interventions that may thin these biologic patent thickets.

The development of autonomous artificial intelligence (A-AI) products in health care raises novel regulatory challenges, including how to ensure their safety and efficacy in real-world settings. Supplementing a device-centered regulatory scheme with a regulatory scheme that considers A-AI products as a 'physician extender' may improve the real-world monitoring of these technologies and produce other benefits, such as increased access to the services offered by these products. In this article, we review the three approaches to the oversight of nurse practitioners, one type of physician extender, in the USA and extrapolate these approaches to produce a framework for the oversight of A-AI products. Under the framework, the US Food and Drug Administration would evaluate A-AI products and determine whether they are allowed to operate independently of physician oversight; required to operate under some physician oversight via a 'collaborative protocol' model; or required to operate under direct physician oversight via a 'supervisory protocol' model.

Health technology is advancing at a rapid clip, with many of these technologies appearing on consumer products like smartphones and tablets. Federal regulators have responded to these changes with a flexible approach that allows firms to manufacture a 'general wellness product' ('GWP') without being subject to regulation typically applied to 'devices' that diagnose or treat a disease or condition. Using currently available medical products and devices from across a spectrum of diseases, we describe how firms can use this existing regulatory framework to develop innovative products by 'skating the line' between mostly unregulated GWPs and regulated devices. On the one hand, we find that skating the line offers a variety of benefits, including potential improvements to product development, innovation, and patient access to medical technologies. On the other hand, we show that this technique has potential costs to patient safety, competition, and data sharing. Skating the regulatory line between GWP and devices, in other words, offers important benefits but is not without risks. Any further regulatory action to address such risks should be careful to leave significant unregulated space for product development.