Journal of Law and the Biosciences最新文献_第10页

An ethico-legal assessment of intellectual property rights and their effect on COVID-19 vaccine distribution: an Australian case study. 知识产权的伦理-法律评估及其对COVID-19疫苗分发的影响:澳大利亚案例研究。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-12 eCollection Date: 2022-07-01 DOI: 10.1093/jlb/lsac020

James Scheibner, Jane Nielsen, Dianne Nicol

{"title":"An ethico-legal assessment of intellectual property rights and their effect on COVID-19 vaccine distribution: an Australian case study.","authors":"James Scheibner, Jane Nielsen, Dianne Nicol","doi":"10.1093/jlb/lsac020","DOIUrl":"https://doi.org/10.1093/jlb/lsac020","url":null,"abstract":"This article posits that Australia, as an affluent country with increasing capacity to manufacture vaccines, has an obligation to assist its regional (and global) counterparts in implementing vaccination programs that protect their populations. First, the article explores the capacity of high-income nations to meet their obligations, assist their neighbours and refrain from vaccine nationalism. This inquiry involves an analysis of the optimal ethical strategy for distributing vaccines globally, and the role that Australia might play in this distribution strategy. Secondly, the article examines the intellectual property landscape for vaccines in Australia, focusing on the patents that cover vaccine compositions and manufacturing techniques (recognizing the potential for know-how and access to materials as well as patents to affect manufacturing capacity). This article then discusses the strategies the Australian Government has at its disposal to counter potential intellectual property impediments whilst complying with existing obligations under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), as an ethically appropriate response to the pandemic. This article also considers whether a so-called TRIPS waiver could provide better options and concludes that the challenge of compelling disclosure of know-how remains.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsac020"},"PeriodicalIF":3.4,"publicationDate":"2022-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f5/05/lsac020.PMC9278044.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40608442","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: 2

The death of Roe and the future of ex vivo embryos. Roe的死亡和体外胚胎的未来。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-03 eCollection Date: 2022-07-01 DOI: 10.1093/jlb/lsac019

Henry T Greely

引用次数: 4

Vaccination of individuals lacking decision-making capacity during a public health emergency. 在突发公共卫生事件中为缺乏决策能力的个人接种疫苗。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac030

G Owen Schaefer, Tess Johnson, Ryan Friets, Sumytra Menon, Julian Savulescu

{"title":"Vaccination of individuals lacking decision-making capacity during a public health emergency.","authors":"G Owen Schaefer, Tess Johnson, Ryan Friets, Sumytra Menon, Julian Savulescu","doi":"10.1093/jlb/lsac030","DOIUrl":"https://doi.org/10.1093/jlb/lsac030","url":null,"abstract":"This paper explores the ethical challenges in deciding whether to vaccinate individuals lacking the decision-making capacity needed to provide informed consent during a public health emergency like COVID-19. The best interests standard ordinarily governs such decisions, which under the law in jurisdictions like England, Wales and Singapore takes into account the individual's past wishes and present preferences. However, in a public health emergency, the interests of third parties become more salient: those whom the unvaccinated individual might expose to infection have an interest in the individual's being vaccinated. While current mental capacity law has not been interpreted to take such public health considerations into account, we argue that such considerations are nevertheless ethically relevant, and can legitimately be weighed up alongside other considerations such as the preferences of the individual and impacts on their health. This is most relevant for individuals lacking decision-making capacity who have previously declined or presently resist vaccination. The public health impact of vaccination may in some instances be enough to outweigh preferences of the individual and justify providing vaccination against their past or present wishes.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"9 2","pages":"lsac030"},"PeriodicalIF":3.4,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/17/e9/lsac030.PMC9584342.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9082201","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: 1

Prescribing unproven cancer drugs: physician perspectives on expanded access and right to try. 处方未经证实的抗癌药物:医生对扩大获取和试用权的看法。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac031

Haley Manley, Bryan A Sisk, Zubin Master, Christopher Thomas Scott

{"title":"Prescribing unproven cancer drugs: physician perspectives on expanded access and right to try.","authors":"Haley Manley, Bryan A Sisk, Zubin Master, Christopher Thomas Scott","doi":"10.1093/jlb/lsac031","DOIUrl":"https://doi.org/10.1093/jlb/lsac031","url":null,"abstract":"Background: For gravely ill patients who have no treatment options and who are ineligible for clinical trials, the US Food and Drug Administration (FDA) established the Expanded Access Program (EAP). Motivated by efforts to weaken FDA regulation and sold as providing greater access to experimental drugs, the federal Right to Try Act (RTT) was passed in 2017. It reduces FDA oversight by not requiring physicians to report safety data and foregoes approval of protocols by local institutional review boards.Methods: This study explored the views of 17 neuro-oncologists from 15 different academic medical centers with varying experience with EAP and RTT using convenience sampling. We conducted semi-structured interviews and qualitative analysis to identify emerging themes.Results: Most oncologists were confused between the two pathways, had little familiarity with RTT, and had little knowledge about experimental medicine available through either pathway. Oncologists reported a preference of enrolling patients in clinical trials over off-trial preapproval pathways with scant data. As a result, oncologists revealed concerns over properly evaluating risks for their patients.Conclusion: Our findings suggest that neuro-oncologists need better resources and clearer mechanisms at their institutions to help navigate EAP and RTT in order to counsel patients interested in experimental medicine.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"9 2","pages":"lsac031"},"PeriodicalIF":3.4,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/03/17/lsac031.PMC9596169.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9146699","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

Exploring access to genomic risk information and the contours of the HIPAA public health exception. 探索获得基因组风险信息和HIPAA公共卫生例外的轮廓。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac034

Jennifer K Wagner, Juhi K Tanniru, Courtney A Chane, Michelle N Meyer

{"title":"Exploring access to genomic risk information and the contours of the HIPAA public health exception.","authors":"Jennifer K Wagner, Juhi K Tanniru, Courtney A Chane, Michelle N Meyer","doi":"10.1093/jlb/lsac034","DOIUrl":"https://doi.org/10.1093/jlb/lsac034","url":null,"abstract":"Considerable resources have been invested in research to identify pathogenic and likely pathogenic variants that cause morbidity and mortality and also in returning these results to patients. The public health impact and cost-effectiveness of these efforts are maximized when probands' relatives are informed of their risk and offered testing. However, such 'Traceback' cascade testing programs face multiple obstacles, including perceived or actual legal and regulatory hurdles. Here, using genetic cancer syndromes as a test case, we explore the contours of the Public Health Exception to the HIPAA Privacy Rule to assess whether it is a viable pathway for implementing a Traceback program. After examining the Privacy Rule as well as state laws and regulations for reportable conditions and genetic privacy, we conclude that this is not currently a viable approach for Traceback programs. We conclude by reflecting on ethical considerations of leveraging HIPAA's public health exception to disclose PHI directly to at-risk relatives and offering insights for how legal hurdles to such a Traceback program could be overcome, if desired.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"9 2","pages":"lsac034"},"PeriodicalIF":3.4,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9740515/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10605033","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

Deconstructing age(s): an analysis of the different conceptions of age as a legal criterion for access to assisted reproductive technologies. 解构年龄:分析将年龄作为获得辅助生殖技术的法律标准的不同概念。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac036

Andrea Martani, Eva De Clercq, Christian De Geyter, Guido Pennings, Tenzin Wangmo, Bernice Simone Elger

{"title":"Deconstructing age(s): an analysis of the different conceptions of age as a legal criterion for access to assisted reproductive technologies.","authors":"Andrea Martani, Eva De Clercq, Christian De Geyter, Guido Pennings, Tenzin Wangmo, Bernice Simone Elger","doi":"10.1093/jlb/lsac036","DOIUrl":"https://doi.org/10.1093/jlb/lsac036","url":null,"abstract":"Whether there should be restrictions for access to Assisted Reproductive Technologies (ART) is a matter of continuous medical, societal, and ethico-legal debate. One of the most controversial topics in this context is the use of parental age as a criterion to limit access to ART. Views are divided on whether there should be an upper age limit for one or both parents and on where such limits should be. Although this debate is centered around the issue of 'age' and although age-related limits are present in many legislations, the intrinsic ambiguity of the term `age' is largely overlooked. In this article, we build on gerontological, medical, and sociological literature on the concepts of 'age' and 'aging' to distinguish three conceptions of age that are relevant for ART regulation: the chronological, the biological, and the social-cultural one. Beyond mapping out these conceptions of age, we describe how they relate to ART and reproduction, and illustrate the advantages and disadvantages of relying on each of them as a basis for limiting ART access. Finally, we propose a template for defining legal age limits for ART access in the law, based on the refined understanding of the different conceptions of age that we outline and we discuss two potential objections to our proposal.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"9 2","pages":"lsac036"},"PeriodicalIF":3.4,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9754082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10441918","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

Mifepristone, preemption, and public health federalism. 米非司酮，优先权和公共卫生联邦制。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-07-01 DOI: 10.1093/jlb/lsac037

Patricia J Zettler, Annamarie Beckmeyer, Beatrice L Brown, Ameet Sarpatwari

{"title":"Mifepristone, preemption, and public health federalism.","authors":"Patricia J Zettler, Annamarie Beckmeyer, Beatrice L Brown, Ameet Sarpatwari","doi":"10.1093/jlb/lsac037","DOIUrl":"https://doi.org/10.1093/jlb/lsac037","url":null,"abstract":"On June 24, 2022, the Supreme Court issued an opinion in which five justices voted to overturn Roe v Wade. Even before the final opinion issued, scholars and advocates had begun to consider legal strategies that might mitigate the decision's anticipated harmful consequences. One such strategy involves challenging state restrictions on Food and Drug Administration (FDA)-approved pregnancy termination drugs on preemption grounds. This article begins by exploring how these challenges might fare-considering both drug-specific restrictions and complete bans on abortion-arguing that there are compelling legal grounds on which courts should conclude that many state restrictions are preempted. Importantly, although these state restrictions have arisen within a larger debate about reproductive health care, this is far from the only area in which states seek to regulate prescription drugs. States have long regulated drugs in ways that diverge from FDA, arguably increasingly so in recent years. Accordingly, the article investigates the implications that preemption challenges in the abortion context may have for other areas of state drug regulation, making the case that the benefits of public health federalism need not be undermined by successful preemption challenges in the abortion arena.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"9 2","pages":"lsac037"},"PeriodicalIF":3.4,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9774452/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10436436","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: 2

What the harm principle says about vaccination and healthcare rationing. 伤害原则对疫苗接种和医疗配给的看法。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-06-25 eCollection Date: 2022-01-01 DOI: 10.1093/jlb/lsac017

Christopher Robertson

{"title":"What the harm principle says about vaccination and healthcare rationing.","authors":"Christopher Robertson","doi":"10.1093/jlb/lsac017","DOIUrl":"https://doi.org/10.1093/jlb/lsac017","url":null,"abstract":"Clinical ethicists hold near consensus on the view that healthcare should be provided regardless of patients' past behaviors. In classic cases, the consensus can be explained by two key rationales-a lack of acute scarcity and the intractability of the facts around those behaviors, which make discrimination on past behavior gratuitous and infeasible to do fairly. Healthcare providers have a duty to help those who can be helped. In contrast, the COVID-19 pandemic suggests the possible recurrence of a very different situation, where a foreseeable acute shortage of healthcare resources means that some cannot be helped. And that shortage is exacerbated by the discrete decision of some to decline a free, safe, and highly effective vaccine, where the facts are clear. In such a future case, if healthcare must be denied to some patients, rationers who ignore vaccination status will become complicit in externalizing the consequences of refusing vaccination onto those who did not refuse. I argue that giving the unvaccinated person healthcare resources that would have otherwise gone to other patients is to wrongfully set back the interests of, or harm, those patients. The article considers rejoinders around the voluntariness of the vaccination choice, which impinges both access and information, and how to scale this criterion proportionally with other rationing criteria that serve utility. Ultimately, the article speculates on why there will be some cognitive dissonance under this approach, while upholding a more general solidarity with and concern for all those seeking healthcare.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsac017"},"PeriodicalIF":3.4,"publicationDate":"2022-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/66/d3/lsac017.PMC9235116.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40410577","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: 1

Framing vaccine mandates: messenger and message effects. 制定疫苗授权:信使和信息效应。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-06-23 eCollection Date: 2022-01-01 DOI: 10.1093/jlb/lsac016

Christopher Buccafusco, Daniel J Hemel

{"title":"Framing vaccine mandates: messenger and message effects.","authors":"Christopher Buccafusco, Daniel J Hemel","doi":"10.1093/jlb/lsac016","DOIUrl":"https://doi.org/10.1093/jlb/lsac016","url":null,"abstract":"In September 2021, President Biden announced that the Occupational Safety and Health Administration (OSHA) would require large employers to ensure workers are vaccinated against Covid-19 or tested weekly. Although widely characterized as 'Biden's vaccine mandate', the policy could be described with equal accuracy as 'OSHA's testing mandate'. Some commentators speculated that reframing the policy as a testing mandate would boost support. This study investigates how framing effects shape attitudes toward vaccination policies. Before the Supreme Court struck down the vaccinate-or-test rule, we presented 1500 US adults with different descriptions of the same requirement. Reframing 'Biden's vaccine mandate' as 'OSHA's testing mandate' significantly increased support, boosting net approval by 13 percentage points. The effect was driven by changing the 'messenger frame' (replacing 'Biden' with 'OSHA') rather than changing the 'message frame' (replacing 'vaccine mandate' with 'testing mandate'). Our results suggest that messenger framing can meaningfully affect public opinion even after a policy is widely known. Our study also reveals a potential cost of presidential administration when partisan divisions are deep. Framing a regulatory policy as an extension of the president can elicit strong-here, negative-reactions that may be avoidable if the policy is framed as the work of a bureaucratic agency.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsac016"},"PeriodicalIF":3.4,"publicationDate":"2022-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/cc/b0/lsac016.PMC9231693.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40409924","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 international data governance landscape. 国际数据管理格局。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-04-04 eCollection Date: 2022-01-01 DOI: 10.1093/jlb/lsac005

Alexander Bernier, Fruzsina Molnár-Gábor, Bartha Maria Knoppers

引用次数: 0