Journal of Law and the Biosciences最新文献

This article offers a thorough analysis of an important public health issue-the lack of regulation of companies selling direct-to-consumer (DTC) microbiome-based tests. These companies invite curious consumers and desperate patients to submit stool and/or vaginal secretion samples to them for analysis. Purchasers receive a report about the composition of their gut and/or vaginal microbiomes with recommendations to change their diet or take certain dietary supplements. The piece is grounded in a study the authors conducted of DTC microbiome testing company websites and their practices, which are often misleading to consumers. Moreover, the tests lack analytical and clinical validity. This means they may have many "false positive" or "false negatives" and can harm consumers who rely on them as a basis for determining their health status The current regulatory framework for these tests has significant gaps. These include the lack of proficiency testing under the Clinical Laboratory Improvement Amendments (CLIA) and the lack of regulation by FDA as a medical device. Although FDA has distinguished DTC tests from other Laboratory Developed Tests and asserted that they may pose unique risks because they are ordered outside of a physician-patient relationship, they have largely ignored this group of tests, likely because they view them as low risk, general wellness tests and exempted from regulation as medical devices under the software exemptions in the 21st Century Cures Act (Cures Act). The authors conclude, however, that many of these tests are not low risk general wellness tests, nor do they meet the exemptions under the Cures Act and as a result should be more stringently regulated.

Heritable human genome editing (HHGE) has emerged as one of the most contested frontiers of bioscience, where law is mobilized as a political instrument. This article uses South Africa as a case study in the politics of law in HHGE governance, showing how even a substantively strong regulatory framework can collapse when procedurally fragile and politically contested. The National Health Research Ethics Council's 2024 guidelines established a regulated pathway for HHGE research and anticipated the eventual possibility of clinical application. The guidelines were aligned with constitutional rights and contained various ethical safeguards. Yet their adoption was procedurally weak: consultation was confined to research ethics committees, excluding broader scientific and public engagement. This lack of participatory legitimacy left the guidelines vulnerable. Critics seized on the fact that the guidelines contemplated children being born with edited genomes, collapsing anticipation into permission. These critiques were amplified by institutional actors, culminating in the repeal of the guidelines in 2025 and their replacement with an indefinite placeholder. The South African case highlights a lesson of global significance: that the governance of HHGE, and of emerging biotechnologies more broadly, depends not only on substantive ethical safeguards but also on inclusive procedures that can withstand political contestation.

Stem cell science lies at the heart of regenerative medicine; it is believed to have the potential to address several otherwise incurable diseases. However, even though stem cell interventions are at the experimental stage, they are advertised as a panacea for various human maladies. India, like other jurisdictions across the globe, has witnessed the mushrooming of 'experts' and 'clinics' selling (unproven) stem cell therapies to vulnerable and desperate patients. The unscrupulous activities in the stem cell industry endanger patients and hinder legitimate scientific progress. In light of the crisis of unproven stem cell therapies, I seek to comprehensively study the Indian regulatory framework on stem cells. The article identifies multiple issues in the framework-the inherent ambiguity in the governing laws, the unscientific functioning of the regulatory institutions, the poor implementation of the existing laws, and the seemingly consequent rise of India as an unregulated stem cell tourism hub. The suggested reforms broadly include streamlined funding, consolidated clinical regulation, and public engagement. The policymakers shall consider redefining their playbook to facilitate a conducive atmosphere for the growth of stem cell science.

As artificial intelligence (AI) transforms drug development, regulatory frameworks are evolving to oversee its implementation, particularly at the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This paper makes three contributions to understanding emerging regulatory approaches. First, we offer a comparative analysis of how these agencies have responded to AI-driven advances, incorporating new US executive orders and the European Union (EU)'s AI Act. Second, we propose a novel analytical framework to understand regulatory divergence: the FDA's flexible, dialog-driven model contrasts with the EMA's structured, risk-tiered approach, reflecting broader institutional and political-economic differences. While the former encourages innovation via individualized assessment, it can create uncertainty about general expectations; by contrast, the EMA's clearer requirements may slow early-stage AI adoption but provide more predictable paths to market. Third, we examine whether AI applications-spanning target identification, generative chemistry, and clinical trial 'digital twins'-are mature enough for standardized regulation, particularly amid shifting US policies and the EU's structured oversight regime. Our analysis reveals patterns of convergence on risk-based principles but persistent transatlantic implementation differences, compounded by diminished US engagement in international cooperation. We conclude that heightened regulatory uncertainty in the USA under a new administration's 'America First' stance and more stable, formalized rules in Europe both pose opportunities and challenges to AI-driven innovation in drug development.

Local vaccine and pharmaceutical production has transitioned from a mere policy option to an essential requirement in the aftermath of the COVID-19 pandemic. Developed countries' vaccine nationalism and hoarding through bilateral agreements with manufacturers left African countries with minimal access to vaccines. As Africa strives for self-sufficiency in vaccine development and pharmaceutical manufacturing by aiming to produce 60 percent of the continent's vaccine doses through indigenous manufacturing by 2040, it is crucial to examine existing initiatives and the roles of foreign players, especially China. In the first section, this article examines and evaluates regional initiatives aimed at promoting local production in Africa, focusing on efforts at global, continental, and regional levels to boost the manufacturing of vaccines and pharmaceuticals on the continent. The second section shifts focus to China's role in Africa's healthcare sector and highlights Chinese-backed pharmaceutical companies involved in vaccine and pharmaceutical production on the continent. The paper concludes by advocating for a harmonized and sustainable approach to local manufacturing. Specifically, the article argues that for these initiatives, whether government-backed or private investment, to succeed, there is a critical need to harmonize regulations, streamline procurement, diversify production, and address the challenge posed by intellectual property rights.

Organisms are complex biological entities that are less easily defined by specific structures or sequences than molecules, nucleic acids, and antibodies. Nor are they necessarily fixed in time or reproducible by repeatable methods, given their capacity for replication and mutation. Like organisms themselves, names and classifications also change over time as scientists better understand extant biodiversity. Taxonomy is the field of evolutionary biology concerned with classifying, naming, and identifying organisms, while phylogenetics concerns organisms' evolutionary history and relatedness. Here, I review the challenges evolution poses for patentees, using the examples of evolving influenza viruses and bacterial classifications, and Federal Circuit decisions relevant each issue. I conclude that careful consideration of organisms' evolutionary histories and the systematics underlying their classification in specification drafting allows patentees to: (i) mitigate the impact of scientific disagreement (such as the 'species problem' in microbiology) in claim construction; (ii) limit the effects of changing classifications on infringement analysis; (iii) describe generic categories of related organisms to encompass later-arising ones; and (iv) bolster compliance with the written description and enablement requirements of 35 U.S.C. § 112(a). Accordingly, patentees might address the challenges that evolutionary uncertainty poses for organism-centered patents by embracing these areas of evolutionary biology.

Research in biomedical and health sciences using data-intensive methods increasingly involve multi-party cross-border institutional collaborations. Regulatory complexities governing international data flow remain challenging to navigate, particularly where differing legal standards in relation to data and privacy protections exist in the respective jurisdictions. In this paper, we use the example of a use case from a joint health research program between Singapore and Switzerland to illustrate the possibility of cross-border data flow for these two jurisdictions with no reciprocal adequacy recognition standards. We have therefore compared data privacy and biomedical research ethics laws in both jurisdictions to help determine when cross-border data sharing could occur that are compliant with data privacy laws. Our comparison makes reference to when technical and organizational measures including privacy enhancing technologies are appropriate to support data sharing. This paper has the potential to inform researchers collaborating with international institutions in navigating similar privacy regulatory considerations in their research and in developing their collaborative agreements.

Recent advances in microbiome science and omics technologies are reshaping our understanding of human behavior, suggesting that microbial communities significantly influence cognition, impulse control, and aggression. Emerging studies in neuromicrobiology, including fecal transplant studies, are pointing toward a causal role for gut microbes and their metabolites in human cognition and behavior. This essay introduces the legalome-a framework integrating microbial perspectives, including microbiome and omics sciences, into the courts and larger criminal justice system. We argue that the legalome is on a trajectory that will move the field of neurolaw forward, and challenge traditional doctrines of mens rea and culpability. Drawing on recent court decisions related to auto-brewery syndrome, and neuro-microbiological research, we examine how subtle biological processes influence behavior in ways overlooked by current legal standards. Recent findings raise questions about criminal intent, biological determinism, and equitable access to scientific defenses. At the same time, emergent research also suggests potential for microbiome-based rehabilitative interventions. Despite methodological challenges, we advocate for interdisciplinary collaboration to harmonize biological research with legal principles, creating a more nuanced framework for justice in the twenty-first century. The legalome provides concrete implementation protocols and assessment tools that demonstrate practical utility for courts, practitioners, and policymakers.

Partial ectogestation is being developed in a bid to improve the survival rates and health outcomes associated with prematurity, but limited empirical research has been conducted on the views of key stakeholders, particularly healthcare professionals, in relation to this technology. This paper explores healthcare professionals' perspectives in England on the use and implementation of partial ectogestation, within the medicalized context of pregnancy and childbirth. Following an online survey, qualitative interviews were undertaken with 22 healthcare professionals who work closely with pregnant individuals and fetuses. Using a formula of the precautionary principle from environmental studies, the analysis presented illustrates healthcare professionals' apprehension toward partial ectogestation. With the fetus who may come to be transferred to an artificial placenta device at the centre of their concerns, participants were cautious of the technology producing poor outcomes and pushing the boundaries of nature. In response to these threats, they encourage strict criteria and clear parameters around the use of the technology. While healthcare professionals appear to endorse a social model of pregnancy when it comes to partial ectogestation, echoes of medicalization persist through medical determinations of poor outcomes and the continued centralization of the fetus as a patient.

Access and benefit sharing (ABS) regulates the collection and use of genetic resources, associated traditional knowledge and in some cases digital sequence information for research and development (R&D) purposes and the equitable sharing of monetary and non-monetary benefits from their use. Global examples of benefit sharing have fallen short of expectations under this framework and there is little empirical data about the effects of regulation on bio-innovation. This article argues that the limited ABS tools of authorization and contracts are not effectively delivering benefit sharing aspirations because of the disconnect between linear assumptions underlying genetic resource R&D. Through a critical legal analysis of ABS, circular economy principles and legal mechanisms, it rethinks ABS governance to propose a new circular bio-economy system for more efficient benefit sharing. It proposes a pathway for transforming the linear 'single use' regulatory model toward a generative value chain model, supported by a range of legal tools that facilitate long-term benefit sharing for the planet and its people.