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

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

Reforming the countermeasures injury compensation program for COVID-19 and beyond: An economic perspective 改革新冠肺炎及以后的对策伤害赔偿制度:经济学视角

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-04-04 DOI: 10.1093/jlb/lsac008

Junying Zhao, Firat Demir, Pallab K. Ghosh, Austin Earley, Myongjin Kim

{"title":"Reforming the countermeasures injury compensation program for COVID-19 and beyond: An economic perspective","authors":"Junying Zhao, Firat Demir, Pallab K. Ghosh, Austin Earley, Myongjin Kim","doi":"10.1093/jlb/lsac008","DOIUrl":"https://doi.org/10.1093/jlb/lsac008","url":null,"abstract":"Abstract As of Aug. 2, 2021, 1693 injury claims associated with COVID-19 medical countermeasures have been filed in the Countermeasures Injury Compensation Program (CICP), of which 686 claims were related to COVID-19 vaccines and urgently needed compensation decisions. However, from an economic and public policy perspective, we find that the CICP design has unintended consequences: locating CICP in the executive agency DHHS potentially creates a conflict of interest, and not permitting judicial review generates a lack of checks and balances, both of which could jeopardize justice. These fundamental problems would subsequently weaken four key performance indicators of CICP compared with its judicial counterpart in the Court of Federal Claims. CICP lacks accountability, transparency, and cost-effectiveness efficiency, with 94% of its total costs spent on administration rather than compensation. CICP’s ability to compensate is also questionable. If COVID-19 claims were compensated at its historical rate, CICP would face around $21.16 million in compensation outlays and $317.94 million in total outlays, 72.1 times its current balance. To ensure just compensation for injured petitioners during COVID-19 and future public health emergencies, we recommend Congress (1) initiate a major reform by relocating CICP from DHHS to the Claims Court or (2) keep CICP within DHHS and make incremental changes by permitting judicial review of DHHS administrative adjudication of CICP claims. We further recommend Congress audit and adjust budgets for CICP and DHHS promptly propose an injury table for COVID-19 claims. This is the first study that contributes an economic perspective to the limited literature on CICP and also provides unique and rich economic data.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":"9 1","pages":""},"PeriodicalIF":3.4,"publicationDate":"2022-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"61110320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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: 3

Pain that only she must bear: on the invisibility of women in judicial abortion rhetoric. 只有她必须承受的痛苦:论堕胎司法修辞中女性的不可见性。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-03-16 eCollection Date: 2022-01-01 DOI: 10.1093/jlb/lsac003

F Laguardia

{"title":"Pain that only she must bear: on the invisibility of women in judicial abortion rhetoric.","authors":"F Laguardia","doi":"10.1093/jlb/lsac003","DOIUrl":"https://doi.org/10.1093/jlb/lsac003","url":null,"abstract":"The graphic and bodily facts of a legal question of rights are relevant to the courts, particularly in questions that directly implicate physical bodies and pain, such as right to die cases, or what level of search may be allowable and when. However, in the case of abortion, or more specifically the bodily ramifications of pregnancy and childbirth, this detail is conspicuously absent. This article, relying on a content analysis of over 220 legal opinions on abortion rights, documents this absence of rhetoric. Particularly in the context of other discussions of pain and physical health risks in these very same cases, the complete absence of an acknowledgement of the bodily ramifications of pregnancy and childbirth appears purposeful, if perhaps not conscious. Reviewing prior literature on abortion rights and abortion rhetoric, it is likely that this lack of language both reflects and reinforces an assumption of women's roles as mothers, a general reluctance to acknowledge the totality of the sacrifices women make in giving birth, and the refusal to acknowledge women's individual interests as whole persons.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsac003"},"PeriodicalIF":3.4,"publicationDate":"2022-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/35/5a/lsac003.PMC8924427.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40309111","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

Vaccine suspension, risk, and precaution in a pandemic. 大流行中的疫苗暂停、风险和预防措施。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-03-16 eCollection Date: 2022-01-01 DOI: 10.1093/jlb/lsab036

Jonathan Pugh, Dominic Wilkinson, Ian Kerridge, Julian Savulescu

{"title":"Vaccine suspension, risk, and precaution in a pandemic.","authors":"Jonathan Pugh, Dominic Wilkinson, Ian Kerridge, Julian Savulescu","doi":"10.1093/jlb/lsab036","DOIUrl":"https://doi.org/10.1093/jlb/lsab036","url":null,"abstract":"In early 2021, cases of rare adverse events were observed in individuals who had received the Astra Zeneca COVID-19 vaccine. Countries around the world differed radically in their policy responses to these observations. In this paper, we outline the ethical justification for different policy approaches for managing the emerging risks of novel vaccines in a pandemic. We begin by detailing the precautionary approach that some countries adopted, and distinguishing ethical questions regarding the management of known and unknown risks. We go on to outline the harms of adopting a highly precautionary approach in a pandemic context, and explain why an appropriate policy approach should accommodate the benefits as well as the risks of vaccination. In the final section, we outline three policy approaches that can accommodate the different benefits of vaccination, whilst taking into account the harms of precaution. Whilst we do not set out to defend one particular policy approach, we explain how different moral theories lend different degrees of support to each of these different approaches. Our analysis elucidates how fundamental value conflicts in public health ethics played out on the global stage of vaccine policy.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsab036"},"PeriodicalIF":3.4,"publicationDate":"2022-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8928173/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40309113","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

Competition law and pricing among biologic drugs: the case of VEGF therapy for retinal diseases. 生物药物的竞争法与定价:以VEGF治疗视网膜疾病为例。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-02-22 eCollection Date: 2022-01-01 DOI: 10.1093/jlb/lsac001

Victor L Van de Wiele, Maximilian Hammer, Ravi Parikh, William B Feldman, Ameet Sarpatwari, Aaron S Kesselheim

{"title":"Competition law and pricing among biologic drugs: the case of VEGF therapy for retinal diseases.","authors":"Victor L Van de Wiele, Maximilian Hammer, Ravi Parikh, William B Feldman, Ameet Sarpatwari, Aaron S Kesselheim","doi":"10.1093/jlb/lsac001","DOIUrl":"https://doi.org/10.1093/jlb/lsac001","url":null,"abstract":"Neovascular age-related macular degeneration (AMD) is a progressive eye disease and is a leading cause of vision loss in the Western world. Vascular endothelial growth factor inhibitors have become a mainstay of treatment for this disease. Currently, treatment options include three originator biologics with approvals for neovascular AMD (aflibercept, ranibizumab, and brolucizumab-dbll) and one biologic that is commonly used off-label for the condition (bevacizumab). In the USA, Medicare spending on these drugs consistently surpassed $4 billion per year between 2015 and 2019, driven by high prices and varying off-label use of bevacizumab, which is substantially cheaper than the other biologics used to treat neovascular AMD. In this article, we discuss how legal reform can improve market competition for biologic drugs, using AMD therapies as a case study. We chose this group of drugs for their significant contribution to Medicare spending, the price difference between approved therapies and intravitreal bevacizumab, and because there currently exists a large biosimilar pipeline with many drug candidates in the final stage of development. We propose mechanisms for anticipating and facilitating the market introduction of biosimilars, as well as changes to the pricing model in Medicare that can promote use of cost-effective therapies. Reforms such as empowering Medicare to negotiate drug prices may help ensure that introduction of new biologics and biosimilars for AMD will lower spending and increase patient access.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsac001"},"PeriodicalIF":3.4,"publicationDate":"2022-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/87/a8/lsac001.PMC8863367.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39670856","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: 5

Heritable genome editing and cognitive biases: why broad societal consensus is the wrong standard for moving forward. 可遗传的基因组编辑和认知偏见:为什么广泛的社会共识是前进的错误标准。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-02-07 eCollection Date: 2022-01-01 DOI: 10.1093/jlb/lsac002

Kerry Lynn Macintosh

{"title":"Heritable genome editing and cognitive biases: why broad societal consensus is the wrong standard for moving forward.","authors":"Kerry Lynn Macintosh","doi":"10.1093/jlb/lsac002","DOIUrl":"https://doi.org/10.1093/jlb/lsac002","url":null,"abstract":"Heritable genome editing (HGE) may one day safely correct mutations that cause serious monogenic diseases. Nevertheless, some scientists and bioethicists argue that HGE should be subject to a moratorium. In their view, no nation should proceed with clinical use absent broad societal consensus in favor of moving forward with HGE and a specific use. This article critiques this plan in light of two cognitive biases. First, human beings favor the status quo. We are primed to favor human reproduction and the human genome in their current forms and resist HGE. Second, human beings also dwell on negative information. Dr He Jiankui's unethical and premature experiment encourages us to judge HGE and its offspring harshly. By reinforcing these biases, the proposed moratorium would make it difficult to achieve broad societal consensus in support of using HGE even to correct dangerous mutations. As an alternative, this article recommends HGE be regulated for safety and efficacy. This approach will keep scientists from using HGE prematurely, while giving society time to discuss this new technology and enact further legislation if necessary.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsac002"},"PeriodicalIF":3.4,"publicationDate":"2022-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d1/15/lsac002.PMC8826381.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39908695","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

Are genome-edited micro-organisms covered by Directive 2009/41/EC?-implications of the CJEU's judgment in the case C-528/16 for the contained use of genome-edited micro-organisms. 指令2009/41/EC是否涵盖基因组编辑微生物?-欧洲高等法院在C-528/16案中对基因组编辑微生物的限制使用的判决的影响。

IF 3.4 2区哲学

Journal of Law and the Biosciences Pub Date : 2022-01-31 eCollection Date: 2022-01-01 DOI: 10.1093/jlb/lsab033

Hans-Georg Dederer, David Hamburger

{"title":"Are genome-edited micro-organisms covered by Directive 2009/41/EC?-implications of the CJEU's judgment in the case C-528/16 for the contained use of genome-edited micro-organisms.","authors":"Hans-Georg Dederer, David Hamburger","doi":"10.1093/jlb/lsab033","DOIUrl":"https://doi.org/10.1093/jlb/lsab033","url":null,"abstract":"In its judgement of July 25, 2018, the Court of Justice of the European Union (CJEU) in the case C-528/16, Confédération paysanne and Others, held that organisms obtained by techniques of mutagenesis are 'genetically modified organisms' (GMOs). It follows from the Court's reasoning that genome-edited organisms, ie organisms resulting from techniques of directed mutagenesis, are GMOs as well and are fully regulated by Directive 2001/18/EC. However, Directive 2001/18/EC only stipulates rules for the deliberate release and placing on the market of GMOs. By contrast, the European Union (EU) has adopted a separate set of rules laid down in Directive 2009/41/EC, which apply to the so-called 'contained use' of 'genetically modified micro-organisms' (GMMs). Whether also genome-edited micro-organisms are GMMs and, thus, subject to Directive 2009/41/EC is of crucial importance since contained use activities with genome-edited micro-organisms are currently carried out extensively, eg in laboratories and research facilities. An in-depth legal analysis shows that the CJEU's interpretation of Directive 2001/18/EC can be extended to Directive 2009/41/EC which means that, in the end, genome-edited micro-organisms are GMMs invariably subject to Directive 2009/41/EC.","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":" ","pages":"lsab033"},"PeriodicalIF":3.4,"publicationDate":"2022-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/42/93/lsab033.PMC8801222.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39576987","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