Journal of Law and the Biosciences最新文献

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.

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.

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.

State militaries have strong interests in developing enhanced warfighters: taking otherwise healthy service personnel (soldiers, marines, pilots, etc.) and pushing their biological, physiological, and cognitive capacities beyond their individual statistical or baseline norm. However, the ethical and regulatory challenges of justifying research into these kinds of interventions to demonstrate the efficacy and safety of enhancements in the military has not been well explored. In this paper, we offer, in the context of the US Common Rule and Institutional Review Board framework, potential justifications for justifying research into enhancing warfighters on the grounds of (i) individual and group risk reduction; (ii) protection of third parties such as civilians; and (iii) military effectiveness.

In July 2023, the United States and the European Union introduced the Data Privacy Framework (DPF), introducing the third generation of cross-border data transfer agreements constituting adequacy with respect to personal data transfers under the General Data Protection Regulation (GDPR) between the European Union (EU) and the US. This framework may be used in cross-border healthcare and research relationships, which are highly desirable and increasingly essential to innovative health technology development and health services deployment. A reliable model meeting EU adequacy requirements could enhance the transfer of patient and research participant data. While the DPF might present a familiar terrain for US organizations, it also brings unique challenges. A notable concern is the ability of individual EU Member States to establish individual and additional requirements for health data that are more restrictive than GDPR requirements, which are not anticipated by the DPF. This article highlights the DPF's potential impact on the healthcare and research sectors, finding that the DPF may not provide the degree of lawful health data transfer desirable for healthcare entities. We examine the DPF against a background of existing Health Insurance Portability and Accountability Act obligations and other GDPR transfer tools to offer alternatives that can improve the likelihood of reliable, lawful health data transfer between the US and EU.

The regulation of neurotechnologies for non-medical purposes such as enhancement, gaming, or well-being is a topic of ongoing controversy. Without much attention, the European Union addressed it by two implementing regulations to the Medical Device Regulation (MDR) for non-invasive brain stimulation devices, passed in December 2022. This paper presents main aspect of these regulations and the conditions for placing non-medical neurodevices on the EU market, especially the risk threshold and the requirement for pre-market certification. It also provides a first critical comment on selected aspects and the unclear situation regarding research only devices which has alarmed the European neurotechnology sector.

Biologics are playing an increasingly important role in health care globally but are placing a substantial burden on payers. The development of biosimilars-drugs that are highly similar to and have no clinically meaningful differences from originator biologics-is critical to improving the affordability and accessibility of these medications. Medicines regulators, however, have had varied success with biosimilars to date. We examined agency guidance documents, peer-reviewed articles, and gray literature related to biosimilars in Australia, Canada, the European Union, the United Kingdom, and the United States to evaluate variations in the approaches to biosimilar approval taken by their respective medicines regulators. We found that the medicines regulators take similar approaches to biosimilar approvals, but that differences in their policies and their jurisdiction's laws regarding testing requirements, indication extrapolation, exclusivities, and substitution may contribute to the varied successes of biosimilars observed. Policies supportive of product-specific guidance, extrapolation, shorter exclusivity periods, and substitution were correlated with greater success in biosimilar approval and uptake. As medicines regulators work to promote biosimilars, understanding the impact of these laws and policies is crucial. Reforms consistent with these policies can create regulatory environments more supportive of biosimilar approvals, promoting access to affordable biologics for patients globally.

The affordability of publicly funded medicines has been a longstanding concern. In 2023, the Biden administration took several steps on this front, including incorporation of a price constraint in an agreement between the US Biomedical Advanced Research and Development Authority (BARDA) and Regeneron Pharmaceuticals, Inc. to develop a new COVID-19 monoclonal antibody. The agreement included a 'Most Favored Nation' (MFN) clause in which Regeneron agreed that the US commercial list price of certain products developed using BARDA funding would not exceed their retail price in comparable global markets. The Administration for Strategic Preparedness and Response (ASPR) included similar language in subsequent agreements, with a promise that this would become a new standard. Even beyond the preparedness context, government funders and purchasers might consider incorporating similar clauses in future contracts, especially given that the Regeneron agreement and its progeny have been praised as 'groundbreaking.' Yet a closer look reveals cause for skepticism. Regeneron's MFN clause includes several loopholes related to covered purchasers and reference countries, prices, and conditions. We describe agreement terms that can make the difference between legally meaningful price constraints and mere window dressing. Our critical analysis offers important lessons for future efforts to improve the affordability of medical technology developed with public funds.