Journal of Law and the Biosciences最新文献

Accelerating biosimilar market access: the case for allowing earlier standing.

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2025-01-03 eCollection Date: 2025-01-01 DOI: 10.1093/jlb/lsae030

S Sean Tu, Rachel Goode, Matthew Turner, Victor Van de Wiele

{"title":"Accelerating biosimilar market access: the case for allowing earlier standing.","authors":"S Sean Tu, Rachel Goode, Matthew Turner, Victor Van de Wiele","doi":"10.1093/jlb/lsae030","DOIUrl":"https://doi.org/10.1093/jlb/lsae030","url":null,"abstract":"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.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"12 1","pages":"lsae030"},"PeriodicalIF":2.5,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11697977/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142932472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Forensic genetics in the shadows.

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-12-23 eCollection Date: 2024-07-01 DOI: 10.1093/jlb/lsae028

Teneille Brown, Sarah Duensing, Bob Wong

{"title":"Forensic genetics in the shadows.","authors":"Teneille Brown, Sarah Duensing, Bob Wong","doi":"10.1093/jlb/lsae028","DOIUrl":"10.1093/jlb/lsae028","url":null,"abstract":"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.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"11 2","pages":"lsae028"},"PeriodicalIF":2.5,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11668330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142886334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The law for mini-organ prototypes in a dish. Mapping the legal status options for organoids in Swiss law.

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-12-17 eCollection Date: 2024-07-01 DOI: 10.1093/jlb/lsae025

Inesa Fausch

{"title":"The law for mini-organ prototypes in a dish. Mapping the legal status options for organoids in Swiss law.","authors":"Inesa Fausch","doi":"10.1093/jlb/lsae025","DOIUrl":"https://doi.org/10.1093/jlb/lsae025","url":null,"abstract":"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.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"11 2","pages":"lsae025"},"PeriodicalIF":2.5,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11649945/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142848555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Intellectual property issues for open science practices in genomic-related health research and innovation in Africa.

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-12-17 eCollection Date: 2024-07-01 DOI: 10.1093/jlb/lsae026

Aishatu Eleojo Adaji, Lukman Adebisi Abdulrauf

{"title":"Intellectual property issues for open science practices in genomic-related health research and innovation in Africa.","authors":"Aishatu Eleojo Adaji, Lukman Adebisi Abdulrauf","doi":"10.1093/jlb/lsae026","DOIUrl":"https://doi.org/10.1093/jlb/lsae026","url":null,"abstract":"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.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"11 2","pages":"lsae026"},"PeriodicalIF":2.5,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11649944/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142848560","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Uterus transplants and Mexico's rule of law.

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-12-17 eCollection Date: 2024-07-01 DOI: 10.1093/jlb/lsae027

César Palacios-González, Héctor A Mendoza Cárdenas

引用次数: 0

Data ownership in genomic research consortia.

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-12-06 eCollection Date: 2024-07-01 DOI: 10.1093/jlb/lsae024

Jane Nielsen, Dianne Nicol

引用次数: 0

How do we justify research into enhanced warfighters? 我们如何证明对增强型作战人员的研究是合理的？

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-11-01 eCollection Date: 2024-07-01 DOI: 10.1093/jlb/lsae023

Nicholas G Evans, Blake Hereth, Michael L Gross, Jonathan D Moreno

引用次数: 0

The new EU-US data protection framework's implications for healthcare. 新的欧盟-美国数据保护框架对医疗保健的影响。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-09-27 eCollection Date: 2024-07-01 DOI: 10.1093/jlb/lsae022

Charlotte Tschider, Marcelo Corrales Compagnucci, Timo Minssen

{"title":"The new EU-US data protection framework's implications for healthcare.","authors":"Charlotte Tschider, Marcelo Corrales Compagnucci, Timo Minssen","doi":"10.1093/jlb/lsae022","DOIUrl":"https://doi.org/10.1093/jlb/lsae022","url":null,"abstract":"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.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"11 2","pages":"lsae022"},"PeriodicalIF":2.5,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11427690/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142333294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The new regulation of non-medical neurotechnologies in the European Union: overview and reflection. 欧盟对非医疗神经技术的新规定：概述与思考。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-09-25 eCollection Date: 2024-07-01 DOI: 10.1093/jlb/lsae021

Christoph Bublitz, Sjors Ligthart

引用次数: 0

Implementing the human right to science in the context of health: introduction to the special issue. 在健康领域落实科学人权：特刊导言。

IF 2.5 2区哲学

Journal of Law and the Biosciences Pub Date : 2024-09-15 eCollection Date: 2024-07-01 DOI: 10.1093/jlb/lsae018

Bartha Maria Knoppers, Michael J S Beauvais

引用次数: 0