Journal of Law and the Biosciences最新文献

This essay examines how Canadian copyright law treats neurodata generated for neuroprediction and further probes if copyright or similar protections would offer mechanisms to safeguard individuals who produce those data. Using a hypothetical fact pattern, we apply the conditions for subsistence of copyright to neurodata created by a research participant and processed by a researcher. The results of the analysis indicate that both parties can credibly argue that copyright subsists in the neurodata, although such an outcome is neither established nor guaranteed under current law. We then explore the policy significance of this legal analysis from a neuroethics perspective. Drawing together literatures on data justice, political economy, and neurotechnology governance, we argue that when people produce neurodata, legal systems should appropriately honor their contributions. This could be accomplished through protections of the integrity of neurodata from harmful misuse, akin to what moral rightsholders can accomplish under Canadian moral rights doctrine. We further highlight the need to protect individual autonomy over brain data, whether via copyright or another mechanism. We conclude that the Canadian approach to copyright law and moral rights offers a model for policy and governance as neurodata find their way into legally and socially consequential technologies.

Since 2003, US federal funders' scientific data-sharing policies have encouraged open sharing of weakly de-identified medical and genomic data. This sharing fueled important scientific advances but, as this article explains, was of dubious legality, and recent regulations have removed any doubt: open access to medical data is a dying concept if not already dead. The future of medical data sharing lies with controlled access data repositories, which replicate many of the scientific benefits of data sharing but provide stronger privacy and data security protections. The drawback is that meaningful data protections cost money, forcing controlled access repositories to explore new private funding models to sustain data availability over the long haul after federal funding expires. Unless carefully crafted, transactions to finance controlled access repositories (such as charging user fees or receiving discounts on cloud storage from information technology service providers) can violate federal laws this article explores. Going forward, the law of medical privacy boils down to how much privacy those who share and use our data can realistically and lawfully finance. That is how much privacy we, the public, can expect.

In recent decades, neurotechnological cognitive enhancers (NCEs), including neurofeedback systems and neurostimulation devices, have attracted increasing attention due to their potential to enhance human cognition. Developments in this field of technology raise significant ethical challenges that warrant careful reflection from a human rights perspective. Currently, human rights experts and international institutions are actively examining how neurotechnological interventions affecting mental states, capacities, and processes impact human rights and fundamental freedoms. Within these efforts, however, greater attention must be paid to the positive dimension of human rights, examining whether and to what extent human rights frameworks support individuals' freedom to use neurotechnologies to enhance their mental capacities. This article addresses that question by first outlining the concept of cognitive enhancement and assessing the current and anticipated development of NCEs. It then explores the tension between empowerment and constraint, analysing how human rights both support the use of NCEs and potentially justify limitations on that freedom. In doing so, it examines the existence and scope of a right to mental self-determination, the role of human dignity, and the conditions under which restrictions on NCE may be justified.

Lawyers and law professors are increasingly involved in interdisciplinary scientific teams and grant research to answer ethical, legal and policy questions related to biomedical topics. Yet, the methods that lawyers use to conduct legal research and analysis are not always familiar to scientists and social scientists conducting peer review of a proposed project with legal aims or a publication reporting a legal study. To better facilitate interdisciplinary ethical, legal, and social implications collaboration, there is a need to better explain how legal research methodologies can provide robust tools to address a range of nuanced biomedical questions. This paper explores legal research and analysis methodologies relevant to federally funded research and scientific inquiry. It sets out different ways that legal research and analysis can advance and support biomedical, bioethics, and health law research and then demonstrates how these benefits can be realized using case studies from existing literature.

The aim of this article is to provide an overview and analyze the implications of the provisions on dataset quality and bias in the AI Act (AIA). The AIA requires providers of AI systems to take measures to identify, prevent, and mitigate biases as part of the data governance practices. The AIA also explicitly prescribes certain characteristics required of training, validation, and testing datasets. These include notions widely considered as best practice such as representativeness as well as consideration of characteristics particular to the "geographical, contextual, behavioural or functional setting" which might expand the scope of considerations already common among AI developers. The AIA also aims to address the legal limitations on access to sensitive data by introducing the so called "debiasing exception," which under certain conditions permits the processing of sensitive data for debiasing purposes. To ensure enforcement of the data governance provisions, the AIA grants notified bodies and enforcement authorities access to training, validation, and testing datasets; however, further efforts may be needed to reconcile data protection concerns with these enforcement powers. The AIA's requirements will likely help mitigate bias in medical AI systems. Associated soft law instruments should contribute to the effective implementation of these requirements.

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.