Journal of Law and the Biosciences最新文献

Human embryo-like structures (ELSs) are novel entities emulating aspects of embryogenesis to advance understanding of early human life and enable future clinical applications. ELSs frequently fall into a regulatory gap: the laws that govern embryo research do not commonly apply, but nor are there bespoke regulatory schemes. There is international consensus that the gap must be addressed, but disagreement as to when and how this should be achieved. To date ELSs model embryos, mimicking aspects of embryonic development. In 2024 a UK Nuffield Council on Bioethics report recommended that these `stem cell-based embryo models' should be regulated separately to embryos. Building on this report, this paper considers a subset of ELSs that may in future lose their model status because they replicate rather than model embryos. Distinguishing between models and replicas it considers what circumstances, in the UK and internationally, would require regulation as an embryo, the circumstances in which replicas might justifiably be regulated separately to embryos and why maintaining distinct regulatory paths for embryos and ELSs is beneficial.

Genome editing technology is rapidly advancing and has generated significant controversy, particularly in the field of human heritable genome editing, while also presenting vast potential applications. Following the He Jiankui incident in 2018, there was a global call to reinforce the regulatory frameworks governing human germline and heritable genome editing. China's existing regulatory framework for human genome editing has improved with several laws enacted and updated, but there are shortcomings. These include overlapping responsibilities of multiple governing agencies and limited involvement of patient groups and the public in the legislative process. By drawing insights from regulatory agencies, legislation, and multigroup participation from abroad, especially in the United Kingdom and the United States, we can compare the differences between China and foreign countries and help China enhance its regulatory framework based on international practices. This article proposes recommendations for enhancing China's regulatory framework, such as clarifying the responsibilities of agencies, updating policies in a timely manner, strengthening bioethics education and training, and emphasizing the need for a forward-looking, balanced, meticulous, and adaptable regulatory approach.

Federated Learning (FL) promises to enhance data-driven health research by enabling collaborative machine learning across distributed datasets without direct data exchange. However, current FL implementations primarily reflect the data-sharing interests of institutional controllers rather than those of individual patients whose data are at stake. Existing consent mechanisms-like broad consent under HIPAA or explicit consent under the GDPR-fail to provide patients with control over how their data is used. This article explores the integration of smart contracts (SCs) into FL as a mechanism for automating, enforcing, and documenting consent in data transactions. SCs, encoded in decentralized ledger technologies, can ensure that FL processes align with patient preferences by providing an immutable, and dynamically updatable consent architecture. Integrating SCs into FL and swarm learning (SL) frameworks can mitigate ethico-legal concerns related to patient autonomy, data re-identification, and data use. This approach addresses persistent principle-agent asymmetries in biomedical data sharing by ensuring that patients, rather than data controllers alone, can specify the terms of access to insights derived from their health data. We discuss the implications of this model for regulatory compliance, data governance, and patient engagement, emphasizing its potential to foster public trust in health data ecosystems.

The rapid advancements in neuroscience highlight the pressing need to safeguard neural personal information (NPI). China has achieved significant progress in brain-computer interface technology and its clinical applications. Considering the intrinsic vulnerability of NPI and the paucity of legal scrutiny concerning NPI breaches, a thorough assessment of the adequacy of China's personal information protection legislation is essential. This analysis contends that NPI should be classified as sensitive personal information. The absence of bespoke provisions for NPI in current legislation underscores persistent challenges in its protection. To address these gaps, this work proposes the establishment of a concentric-circle hard-soft law continuum to support a hybrid governance model for NPI, rooted in fundamental human rights principles.

Alzheimer's disease (AD) is a neurodegenerative disease with devastating personal and social consequences. In June 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to aducanumab (Aduhelm; Biogen), a first-in-class monoclonal antibody (mAb) for treatment of AD. In July 2021, responding to the significant controversy sparked by aducanumab's approval, the Centers for Medicare and Medicaid Services (CMS) opened a National Coverage Determination (NCD) analysis for mAbs intended for the treatment of AD. CMS received a record number of public comments on the proposed NCD, which included a proposal for coverage with evidence development (CED). We undertook an in-depth qualitative analysis of those comments. Broad themes included: the appropriateness of FDA's approval of aducanumab; the nature of the relationship between CMS and FDA; anticipated downstream effects of CED on innovation and health equity; aducanumab's cost, value, and affordability; and whether aducanumab offered patients hope. The aducanumab controversy occurred at the intersection of multiple contentious issues; in the discussion, we contextualize our findings within these broader debates. Though Biogen pulled aducanumab from the market in early 2024, the effects of the public discourse surrounding its approval and coverage have been long-lasting and far-reaching, affecting health law, policy, and clinical practice.

Effective scientific research relies heavily on data sharing, particularly in collaborative projects spanning multiple African countries. Researchers must be cognisant of data protection laws, especially regarding secondary data use and cross-border data sharing. In this article, we examine how the terms 'anonymisation', 'de-identification', and 'pseudonymisation' are employed in data protection legislation across 12 African nations and compare them with two prominent regulatory frameworks-the Health Insurance Portability and Accountability Act of the United States of America and the General Data Protection Regulation of the European Union. While 10 of the selected African countries have enacted data protection laws, only six explicitly incorporate these terms, often without clear definitions. Despite this, our analysis reveals that the terms 'de-identification' and 'anonymisation' are distinct legal concepts in the selected jurisdictions, underscoring that researchers must employ these terms carefully and not assume they are interchangeable. Our study highlights the necessity for researchers to use terminology which is consistent with an individual African country's choice to ensure internal consistency, legal compliance, and respect for legislative preferences. It is imperative for researchers involved in international health projects to be acutely aware of how terms are interpreted within each jurisdiction and the possible legal ramifications for data sharing.

Background: In recent years, there has been a notable uptake in genomic and health-related research activities across the African continent. Similarly, there has been increased introduction of data protection legislation that affects the sharing of personal data, such as health data and genomic data, including for research. Many of these statutes have stricter requirements when sharing personal data across borders. Consequently, the cross-border sharing of health data, that includes genetic data, requires careful navigation of the pertinent data protection legislation, in particular concerning the sharing of such data for research purposes. To help researchers navigate these legal frameworks, 12 African countries were analysed to develop country guides on cross-border data sharing.

Results: Of the 12 African countries that were analysed, 10 have data protection laws in place (Botswana, Ghana, Kenya, Malawi, Nigeria, Rwanda, South Africa, Tanzania, Uganda, and Zimbabwe), while two countries (Cameroon and The Gambia) do not. (At the time of the study, Cameroon did not have a data protection regulation in place. Law No. 2024/017 on the Protection of Personal Data is now in force.) With the exception of Ghana, all countries with data protection statutes had additional requirements to be met when sharing personal data across borders. Consent and adequacy are the most common grounds for justifying the sharing of personal data across borders.

Conclusion: Given the limitations of the current models of consent, consent is not a suitable basis to transfer large quantities of data for research. Adequacy is a common ground, but there are national differences in the implementation of this ground. Researchers must therefore analyse each national legal framework and make decisions on a case-by-case and country-by-country basis.

The potential uses-and misuses-of psychiatric genetic evidence in litigation concerning defendants' responsibility for behavior has, to date, mostly focused on criminal justice. Yet the introduction of psychiatric genetic evidence in tort litigation raises old and new legal and social questions that merit consideration. We conducted a vignette-based survey of state trial court judges (n = 465) and potential jurors (n = 2131) to assess how psychiatric genetic evidence may affect views on civil responsibility and related decisions. Psychiatric genetic evidence had limited impact on judicial decisions, but increased perceptions of the subject's contractual incapabilities. Differences in judges' and jurors' views are highlighted, indicating tension between public sentiments and existing legal doctrine that disallows consideration of a person's psychiatric condition in assessing civil liability. Unexpectedly, jurors' gender impacted all case-related questions-the implications thereof are discussed. Future research can assess the role of education, legal training, and gender differences in judicial decision-making.

Biosimilars, which are affordable alternatives to biologic medicines, face delays in market entry due to the current patent litigation framework under the Biologic Price Competition and Innovation Act. Currently, biosimilar manufacturers can only initiate patent litigation to attempt to clear weak and invalid patents after submitting their Biologic License Application to the Food and Drug Administration (FDA), which happens after completing extensive, and costly clinical trials. By contrast, generic drug manufacturers can start litigation earlier due to shorter development times and less stringent clinical requirements, allowing them to launch immediately after the primary patent expires. We propose allowing biosimilars to begin patent litigation at the start of phase 3 clinical trials, the final stage of biosimilar development, where the product and manufacturing process and product profile are largely finalized. This change would enable biosimilar firms to resolve patent issues well before the brand biologic's primary patent expiration date, potentially reducing market entry delays by about 1.8 years. This article examines the issues surrounding initiation of biosimilar litigation and suggests litigation reforms to expedite biosimilar market availability.

This article examines the controversial practice of law enforcement agencies searching genetic samples obtained in health care settings, without a warrant or consent. While police have previously used public genealogy databases for this purpose, our article describes how they are now secretly accessing genetic information from newborn screening programs and medical tests. This raises ethical and legal concerns, blurring the line between health care and law enforcement. This, in turn, may discourage people from seeking important medical care due to distrust in the police and privacy concerns. To explore public attitudes on this issue, the authors conducted a study examining how lay people view the forensic use of clinical genetic data for different types of crimes. Our findings suggest that people take a utilitarian perspective, where they are more likely to support warrantless searches for serious and ongoing crimes but more likely to oppose these searches for more minor offenses like theft. However, regardless of public support, the little-known practice undermines trust in health care institutions and violates patient privacy. We recommend three legal reforms to restrict law enforcement access to clinical and public health genetic databases and to require explicit consent to forensic uses.