Journal of Law and the Biosciences最新文献

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.

Advances in generating human mini-organ prototypes will further improve fundamental research, disease modeling, drug screening and the development of personalized medicine. Currently, there is no legal definition, identified legal status, or existing regulatory framework for organoids. Ethical discussions regarding brain and embryo-like mini-organ models leave researchers uncertain about the extent to which work on any organoids is legally permissible. The legal protection of human embryos, many other separated human body parts as well as organoids is more complex than the application of the traditional rules of rights in rem or of the law of personality alone. The paper's focus is to examine whether the legal status of organoids or lack thereof, could influence their concrete regulatory framework, or whether a legal status in private law is necessary for their regulation. This paper deliberately chooses not to attempt a unifying theory of law but rather to argue for a possible regulation of organoids using the example of Swiss law. While, at present, there is no comprehensive research addressing either the status or the regulation of organoids, we believe that the argumentation presented could improve the overall understanding of how a potential organoid regulation could be set out within national legal frameworks.

This paper considers the applicability and implications of intellectual property rights (IPRs) for open science practices in the context of genomic-related health research and innovation in Africa. The first part provides a brief background of the gaps in genomics and health research in Africa, highlighting the possible role of open science in facilitating collaborative research to address the peculiar health needs of the continent. The second part examines intellectual property protection in genomic-related health research and innovation in Africa, outlining some of the existing legal instruments and policies guiding the application of IPRs, focusing on patents and copyrights. Thereafter, the paper examined how intellectual property standards could impact the adoption of open science in genomics health research in Africa. In doing this, the paper considers the role they could play as enablers of open science practices in genomics health research and innovation and the potential challenges they pose. The paper concludes with recommendations regarding aspects of the intellectual property policies and legal frameworks in Africa that could be calibrated to overcome potential challenges and, thereby, stimulate the adoption of an open science model and promote open, collaborative genomics health research and innovation in the continent.

Uterus transplantation is a new fertility treatment for some women who lack a functioning uterus. The number of countries where these transplants are performed has steadily increased, and in Mexico, there is a growing interest in this procedure among patients, researchers, and clinicians. In this paper we look at Mexico and its legal system in order to determine what is the legal status of uterus transplants, and whether there is a right to them according to Mexican legislation. To achieve this objective, we have organized this paper into four sections. First, we present a brief synopsis of what uterus transplants entail. Second, we carry out a historical overview of uterus transplants in Mexico. Third, we present the federal laws and regulations that apply to uterus transplants in Mexico. Finally, we defend that under Mexican legislation there is a positive right to uterus transplants. We substantiate the former by focusing on the right to the protection of health and the right to family making.

Discourse around ownership of genomic sequence data has proliferated over recent years. There are likely to be few people who don't feel a degree of connectedness to their genomic data. The inclusion of individuals' genomic data in genomic datasets is critical to genomic research, and these datasets are most effective if shared widely. Genomic research consortia are an integral part of the genomic data sharing ecosystem, critical in facilitating data sharing among research groups. This article considers the property status of genomic data at various stages of the research life cycle, and the potential 'ownership' claims that may be made by various actors in data sharing networks. It does so by comparing the legal position with the findings of a study that examined policy documents and guidelines produced by international research consortia. This analysis enabled us to assess whether consideration of property interests is at the forefront of data sharing efforts, and if so, where such property interests are likely to reside.