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Competition Law and Ethics of Innovation as Catalysts for Fairness: Reimagining the EU's COVID-19 Vaccine Strategy. 竞争法和创新伦理作为公平的催化剂：重新构想欧盟的COVID-19疫苗战略。
IF 1.7 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 DOI: 10.1017/jme.2025.10141
Mina Hosseini
{"title":"Competition Law and Ethics of Innovation as Catalysts for Fairness: Reimagining the EU's COVID-19 Vaccine Strategy.","authors":"Mina Hosseini","doi":"10.1017/jme.2025.10141","DOIUrl":"10.1017/jme.2025.10141","url":null,"abstract":"<p><p>The \"EU Vaccines Strategy\" launched by the European Commission in June 2020 aimed to ensure vaccine safety, equitable access, affordability, swift distribution, and global solidarity for COVID-19 vaccines. This study critiques the Commission's centralized procurement approach, focusing on Advance Purchase Agreements (APAs) through a literature review, policy analysis, and a case study of the EU-AstraZeneca's APA. It identifies critical challenges, including transparency deficits, accountability gaps, and anticompetitive practices by vaccine producers that undermine equitable access. Drawing on these insights, the study proposes the FACER Framework - Fairness, Accountability, Competition Law, Ethics of Innovation, and Resilience - a novel model integrating the Treaty on the European Union (TEU) and the Treaty on the Functioning of the European Union (TFEU) oversight with ethical principles. By embedding legal and moral accountability, FACER offers EU policymakers a robust tool to enhance vaccine strategy and equity in future health crises.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"388-397"},"PeriodicalIF":1.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144683455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
An Analysis of Anti-Bullying Laws in the United States. 美国反欺凌法律分析。
IF 1.7 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 DOI: 10.1017/jme.2025.10115
Dane Alexander White, Gabrielle F Miller, Kyle Rosenblum, Christopher Dunphy, Riley Wagner, Molly Merrill-Francis
{"title":"An Analysis of Anti-Bullying Laws in the United States.","authors":"Dane Alexander White, Gabrielle F Miller, Kyle Rosenblum, Christopher Dunphy, Riley Wagner, Molly Merrill-Francis","doi":"10.1017/jme.2025.10115","DOIUrl":"10.1017/jme.2025.10115","url":null,"abstract":"<p><p>Bullying is a public health concern that results in diminished well-being for children and adolescents. One approach that lawmakers have taken to address bullying is enacting anti-bullying laws, which require school districts to establish bullying prevention policies. In this study, researchers used standard legal epidemiology methods to systematically retrieve and analyze anti-bullying laws in the United States (US). While they found that every US state and the District of Columbia has a school anti-bullying law, there is wide variation in their scope and requirements. Some jurisdictions specified requirements that school districts must implement in their anti-bullying policies, while others deferred policy enactment entirely to school districts. Given the differences in requirements and scoping afforded in anti-bullying laws, understanding the important components included in such policies can help provide policymakers and practitioners with information about bullying prevention strategies across jurisdictions.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"467-472"},"PeriodicalIF":1.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144976641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Intellectual Property Rights and Global Access to Health Technologies During Pandemics: Reflecting on Vaccine Nationalism, COVID-19 & the WHO Pandemic Agreement Negotiations - The Need for Collective Action and Institutional Change. 大流行期间的知识产权和全球获得卫生技术：反思疫苗民族主义、COVID-19和世卫组织大流行协议谈判——集体行动和制度变革的必要性。
IF 1.7 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 DOI: 10.1017/jme.2025.10149
Aisling M McMahon
{"title":"Intellectual Property Rights and Global Access to Health Technologies During Pandemics: Reflecting on Vaccine Nationalism, COVID-19 & the WHO Pandemic Agreement Negotiations - The Need for Collective Action and Institutional Change.","authors":"Aisling M McMahon","doi":"10.1017/jme.2025.10149","DOIUrl":"10.1017/jme.2025.10149","url":null,"abstract":"<p><p>Focusing on intellectual property rights (IPRs) and their role in global access to vaccines during the COVID-19 pandemic, this article argues that key aspects of the current institutional system align towards delivering individualistic state/regional/rightsholders priorities in the use of IPRs over pandemic health technologies. This played a key role in the vaccine nationalism and global vaccine inequity that emerged during the pandemic. It critically analyzes the IPR provisions within the World Health Organisation's Pandemic Agreement and negotiation process. It argues that nationalistic/individualistic approaches toward the use of IPRs over health technologies also permeate such contexts. The final text of the Agreement leaves considerable discretion to states around IPRs, and much will depend on how it is implemented in practice. For effective future pandemic preparedness around how IPRs are used over health technologies, this article argues that a deeper bottom-up institutional change is needed - one which offers nuanced strategies to balance the potential incentivization role of IPRs with the implications certain uses of IPRs can have on access to downstream health technologies. A key element of this change is embedding a greater recognition of the range of resources provided by entities (e.g. funders, biobanks, and universities) necessary in the successful development of health technologies, including in pandemic contexts. Such entities should leverage these resources, including by attaching contractual conditions to access these, which mandate avenues for downstream access to pandemic health technologies. In the longer term such approaches could be part of a broader institutional change, which prioritises global collective health needs in pandemics.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"398-414"},"PeriodicalIF":1.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144976842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Standing in the Light of Dr. King. 站在金博士的光辉下。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 Epub Date: 2025-06-06 DOI: 10.1017/jme.2025.13
Michele Bratcher Goodwin
{"title":"Standing in the Light of Dr. King.","authors":"Michele Bratcher Goodwin","doi":"10.1017/jme.2025.13","DOIUrl":"10.1017/jme.2025.13","url":null,"abstract":"<p><p>It has been ten years since the publication of Professor Larry Gostin's pathbreaking contribution to law, medicine, and public health, Global Health Law (Harvard University Press, 2014). As Professor Sofia Gruskin's review in The Lancet noted, the book \"brings attention to critical aspects of law that anyone interested in global health needs to be concerned about…\" This sentiment was echoed throughout the academy, civil society, among non-governmental organizations, legislative bodies, and even courts.Professor Gostin's legacy fits among those who harnessed their wisdom, expertise, and voices for the betterment of others and who recognized that chief among the worst harms for any people to endure is the denial of healthcare. This year, one decade after the publication of this of Global Health Law and numerous articles, commentaries, and books, it is clear that Professor Lawrence O. Gostin refuses to be silent on matters that concern the health of the most vulnerable in our world. Our planet is better for his very presence and commitment to what is just, kind, and compassionate.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"53 S1","pages":"79-80"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144235760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Introduction: Ten Years of Global Health Law. 导言：全球卫生法十年。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 Epub Date: 2025-04-14 DOI: 10.1017/jme.2025.20
Benjamin Mason Meier, Michele Bratcher Goodwin, Katie Gottschalk
{"title":"Introduction: Ten Years of Global Health Law.","authors":"Benjamin Mason Meier, Michele Bratcher Goodwin, Katie Gottschalk","doi":"10.1017/jme.2025.20","DOIUrl":"10.1017/jme.2025.20","url":null,"abstract":"<p><p>The field of global health law has evolved over the past decade to describe new legal and policy instruments that apply to a changing set of public health threats, non-state actors, and regulatory norms that structure the global response to public health challenges. This special issue-bringing together the O'Neill Institute for National & Global Health Law and the Global Health Law Consortium-examines the expansive evolution of the field of global health law and its continuing development to face new health threats.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"2-4"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144054422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Proposed Pandemic Agreement: A Pivotal Moment for Global Health Law. 拟议的大流行病协定：全球卫生法的关键时刻。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 Epub Date: 2025-03-21 DOI: 10.1017/jme.2025.22
Pedro A Villarreal, Aeyal Gross, Alexandra Phelan
{"title":"The Proposed Pandemic Agreement: A Pivotal Moment for Global Health Law.","authors":"Pedro A Villarreal, Aeyal Gross, Alexandra Phelan","doi":"10.1017/jme.2025.22","DOIUrl":"10.1017/jme.2025.22","url":null,"abstract":"<p><p>This article discusses the prospects and pitfalls of a legally binding pandemic agreement under the auspices of the World Health Organization, currently under negotiation in Geneva. Such an agreement could foster a rules-based pandemic prevention, preparedness and response as a reaction to the failures by states during the COVID-19 pandemic, including a lack of effective coordination for sharing all kinds of data and the global inequity in the distribution of medical goods fueled by vaccine nationalism. Achieving these goals, however, will depend upon a meaningful engagement by delegations negotiating the agreement, a legally sound formulation of its provisions, and overcoming the currently pervasive emergency-bias in this field of global health law. Thus, as advocated by Lawrence Gostin in his seminal treatise on Global Health Law ten years ago, the pandemic agreement could help realize the transformative potential of law for facing one of the greatest health threats to humanity.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"55-58"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143674535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Law and Global Governance of Infectious Disease: Access to Medicines on COVID-19, AIDS, and Beyond. 传染病的法律和全球治理：COVID-19、艾滋病和其他疾病的药物获取。
IF 1.6 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 Epub Date: 2025-04-14 DOI: 10.1017/jme.2025.27
Matthew M Kavanagh, Luis Gil Abinader, Fatima Hassan, Eric Friedman
{"title":"Law and Global Governance of Infectious Disease: Access to Medicines on COVID-19, AIDS, and Beyond.","authors":"Matthew M Kavanagh, Luis Gil Abinader, Fatima Hassan, Eric Friedman","doi":"10.1017/jme.2025.27","DOIUrl":"10.1017/jme.2025.27","url":null,"abstract":"<p><p>Scientific advances to fight infectious diseases have been remarkable. International law and global governance have sought, and often failed, to keep pace, secure equity, and stop outbreaks. We trace the law and governance model emerging from early failure in the AIDS response and identify four elements: use of law by national governments to compel sharing; decentralized generic manufacturing; mechanisms for voluntary sharing of patents and technology transfer; international funding. In combination, these created a remarkable new ecosystem. We find that when COVID-19 hit and mRNA vaccines were rapidly developed, global North governments opposed mobilizing this synergistic model. Instead, equity efforts focused on financing purchase of vaccines from originator companies with little use of law. Amidst monopolies and scarcity of doses, vaccine nationalism fatally undermined this effort. Whether more synergistic law and governance emerges from rapidly changing global health law will likely dictate the efficacy of future global infectious disease response.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"23-28"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144048398","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Trust Beyond Borders: European External Regulatory Influence on Access to Medicines. 超越国界的信任：欧洲对药品获取的外部监管影响。
IF 1.7 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 DOI: 10.1017/jme.2025.10140
Pramiti Parwani, Katrina Perehudoff, Anniek de Ruijter
{"title":"Trust Beyond Borders: European External Regulatory Influence on Access to Medicines.","authors":"Pramiti Parwani, Katrina Perehudoff, Anniek de Ruijter","doi":"10.1017/jme.2025.10140","DOIUrl":"10.1017/jme.2025.10140","url":null,"abstract":"<p><p>European institutions are widely recognized as wielding regulatory power in a globalized market, exporting its standards across borders and between sectors. This paper asks what institutional dynamics catalyze European external regulatory impact on pharmaceutical governance in low- and middle-income countries (LMICs). The research focuses on two European regulatory bodies, the European Medicines Agency (EMA) and the European Patent Office (EPO), and explores the dynamics of their technocratic outreach beyond European borders. We find that trust is a key underlying institutional dynamic facilitating some forms of European external relations. The agencies extend their influence through technical assistance, collaboration, and work-sharing with LMIC regulators, fostering a one-sided relationship of \"technocratic trust.\" This trust, reinforced by international regulatory frameworks that position the EMA and EPO as \"trustworthy\" regulators, enables these agencies to expand their regulatory influence beyond Europe. By critically examining the impact of this trust-building on LMICs' regulatory autonomy, this research contributes to the broader discourse on European regulatory power in global health governance and highlights potential implications for pharmaceutical markets and access in LMICs.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"365-378"},"PeriodicalIF":1.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144838438","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
EU's Extraterritorial Obligations for Global Medicine Access Under the Convention on the Rights of Persons with Disability (CPRD). 欧盟在《残疾人权利公约》（CPRD）下对全球药品获取的域外义务。
IF 1.7 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 DOI: 10.1017/jme.2025.10144
Katrina Perehudoff
{"title":"EU's Extraterritorial Obligations for Global Medicine Access Under the Convention on the Rights of Persons with Disability (CPRD).","authors":"Katrina Perehudoff","doi":"10.1017/jme.2025.10144","DOIUrl":"10.1017/jme.2025.10144","url":null,"abstract":"<p><p>Equitable access to medicines is vital for people with disabilities to receive effective, affordable, and quality treatment, helping preserve functionality, prevent further disability, and promote social and economic inclusion. This paper explores the specific medicine needs of people with disabilities in low- and middle-income countries (LMICs), focusing on the European Union's (EU) extraterritorial legal obligations under the Convention on the Rights of Persons with Disabilities (CRPD). As the first regional international organization to accede to a UN human rights treaty, the EU offers a unique case for examining how international legal commitments extend beyond its borders. The paper outlines a legal framework based on the CRPD to assess the EU's responsibilities for ensuring access to medicines globally. This framework is applied to two case studies: the EU's internal joint COVID-19 vaccine procurement strategy and its external BioNTainer initiative for vaccine production in Africa under Team Europe. The analysis finds that the EU falls short of its CRPD obligations, particularly in areas of technology transfer and intellectual property sharing, which are essential for equitable global vaccine access. The paper concludes that the EU's current actions do not fulfill its human rights commitments to people with disabilities in LMICs.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":" ","pages":"356-364"},"PeriodicalIF":1.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144976796","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Do Specialized Medical LLMs Demand a Radically New Approach Under the EU's Medical Device Regulation? 在欧盟医疗器械法规下，专业医学法学硕士是否需要全新的方法？
IF 1.7 4区 哲学
Journal of Law Medicine & Ethics Pub Date : 2025-01-01 Epub Date: 2025-09-15 DOI: 10.1017/jme.2025.10136
Hannah Louise Smith, W Nicholson Price
{"title":"Do Specialized Medical LLMs Demand a Radically New Approach Under the EU's Medical Device Regulation?","authors":"Hannah Louise Smith, W Nicholson Price","doi":"10.1017/jme.2025.10136","DOIUrl":"10.1017/jme.2025.10136","url":null,"abstract":"<p><p>We examine the arguments made by Onitiu and colleagues concerning the need to adopt a \"backward-walking logic\" to manage the risks arising from the use of Large Language Models (LLMs) adapted for a medical purpose. We examine what lessons can be learned from existing multi-use technologies and applied to specialized LLMs, notwithstanding their novelty, and explore the appropriate respective roles of device providers and regulators within the ecosystem of technological oversight.</p>","PeriodicalId":50165,"journal":{"name":"Journal of Law Medicine & Ethics","volume":"53 3","pages":"465-466"},"PeriodicalIF":1.7,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145066297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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