Mary A. Burke, Riley Sullivan, K. Carman, H. Wen, J. Wharam, Hao Yu
This paper uses the all-payer claims database (APCD) for Rhode Island to study three questions about the use of medication-assisted treatment (MAT) for opioid use disorder (OUD): (1) Does MAT reduce the risk of opioid overdose; (2) are there systematic differences in the uptake of MAT by observable patient-level characteristics; and (3) how successful were federal policy changes implemented in 2016 that sought to promote increased use of buprenorphine, one of three medication options within MAT? Regarding the first question, we find that MAT as practiced in Rhode Island is associated with a reduced risk of repeated opioid overdose among patients who had an initial nonfatal opioid overdose, consistent with the strong endorsement of MAT by public health officials. Concerning the second, we find that factors such as age, gender, health insurance payer, and the poverty rate in one’s residential Zip code are associated with significant differences in the chance of receiving methadone and/or buprenorphine, suggesting that certain groups may face unwarranted disparities in access to MAT. About the third question, we find that a 2016 federal rule change enabled at least some experienced Rhode Island buprenorphine prescribers to reach more patients, and a separate 2016 policy aimed at recruiting new buprenorphine prescribers was also found to be effective. However, the data also suggest that many more patients in the state could be treated with buprenorphine if prescribers took full advantage of their prescribing limits.
{"title":"Who Gets Medication-assisted Treatment for Opioid Use Disorder, and Does It Reduce Overdose Risk? Evidence from the Rhode Island All-payer Claims Database","authors":"Mary A. Burke, Riley Sullivan, K. Carman, H. Wen, J. Wharam, Hao Yu","doi":"10.29412/RES.WP.2021.03","DOIUrl":"https://doi.org/10.29412/RES.WP.2021.03","url":null,"abstract":"This paper uses the all-payer claims database (APCD) for Rhode Island to study three questions about the use of medication-assisted treatment (MAT) for opioid use disorder (OUD): (1) Does MAT reduce the risk of opioid overdose; (2) are there systematic differences in the uptake of MAT by observable patient-level characteristics; and (3) how successful were federal policy changes implemented in 2016 that sought to promote increased use of buprenorphine, one of three medication options within MAT? Regarding the first question, we find that MAT as practiced in Rhode Island is associated with a reduced risk of repeated opioid overdose among patients who had an initial nonfatal opioid overdose, consistent with the strong endorsement of MAT by public health officials. Concerning the second, we find that factors such as age, gender, health insurance payer, and the poverty rate in one’s residential Zip code are associated with significant differences in the chance of receiving methadone and/or buprenorphine, suggesting that certain groups may face unwarranted disparities in access to MAT. About the third question, we find that a 2016 federal rule change enabled at least some experienced Rhode Island buprenorphine prescribers to reach more patients, and a separate 2016 policy aimed at recruiting new buprenorphine prescribers was also found to be effective. However, the data also suggest that many more patients in the state could be treated with buprenorphine if prescribers took full advantage of their prescribing limits.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"37 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128440500","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The right to life is a goal written in many written and unwritten norms, and alongside it, we can align the responsibility and, at the same time, the liability of those who have the duty to perform the medical act with holiness and dedication. Starting from common law, imperative norms and devices and going beyond the universal right, like for example, the one built up by the European Convention on Human Rights, we can unequivocally affirm that the right to life, health and the integrity of the individual is the most important human right, which not only the state has to protect, but every one of us. Thus, through this study, we will try to substantiate the pillars of ethics that medical art has woven its way through the passage of time, pointing to another essential goal - to prevent malpractice.
{"title":"The Architecture Behind the Malpractice Concept Guidelines","authors":"Safa Singrid Adriana Canbolant","doi":"10.2139/ssrn.3387942","DOIUrl":"https://doi.org/10.2139/ssrn.3387942","url":null,"abstract":"The right to life is a goal written in many written and unwritten norms, and alongside it, we can align the responsibility and, at the same time, the liability of those who have the duty to perform the medical act with holiness and dedication. Starting from common law, imperative norms and devices and going beyond the universal right, like for example, the one built up by the European Convention on Human Rights, we can unequivocally affirm that the right to life, health and the integrity of the individual is the most important human right, which not only the state has to protect, but every one of us. Thus, through this study, we will try to substantiate the pillars of ethics that medical art has woven its way through the passage of time, pointing to another essential goal - to prevent malpractice.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"33 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132392802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Data from a novel online survey of 5,000 English-speaking adult cigarette smokers in California in advance of a recent increase in the state’s cigarette excise tax indicate that slightly more than one-quarter of that population engaged in some legal tax-avoiding behavior in the previous month, while nearly one-fifth illegally evaded taxes. (The two behaviors overlapped substantially.) Candor-inducing indirect questioning via the item count technique substantially increased those figures. Smokers who roll their own cigarettes, e-cigarette users, younger smokers, and those with more income and education are all more likely to engage in at least some of the suspect market behaviors examined. There is a much lower incidence of counterfeit product and sales of single cigarettes. This suggests that the tax increase may lead to significant amounts of adaptive behavior by smokers that will tend to reduce the intended health benefits of that policy change.
{"title":"Tax Evasion and Illicit Cigarettes in California: Part I – Survey Evidence on Current Behavior","authors":"J. Prieger, Jonathan Kulick","doi":"10.2139/ssrn.3181586","DOIUrl":"https://doi.org/10.2139/ssrn.3181586","url":null,"abstract":"Data from a novel online survey of 5,000 English-speaking adult cigarette smokers in California in advance of a recent increase in the state’s cigarette excise tax indicate that slightly more than one-quarter of that population engaged in some legal tax-avoiding behavior in the previous month, while nearly one-fifth illegally evaded taxes. (The two behaviors overlapped substantially.) Candor-inducing indirect questioning via the item count technique substantially increased those figures. Smokers who roll their own cigarettes, e-cigarette users, younger smokers, and those with more income and education are all more likely to engage in at least some of the suspect market behaviors examined. There is a much lower incidence of counterfeit product and sales of single cigarettes. This suggests that the tax increase may lead to significant amounts of adaptive behavior by smokers that will tend to reduce the intended health benefits of that policy change.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"19 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2018-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116584340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abstract Rewarding innovation is a part of the regulatory system for drugs, both in terms of patent protection and the granting of regulatory exclusivity. One particular area where there has been a significant amount of innovation is in the development of orphan drugs. However, there has been a persistent issue regarding the significant percentage of approved new drugs that are less innovative than their counterparts. Further, it appears that the level of innovation in approved drugs containing a new molecular entity (NME) has been on the decline. This issue is highlighted by the proliferation of "me-too" or "addition-to-class" drugs. Me-too or addition-to-class drugs include drugs such as Lipitor and Nexium. These are considered less ground-breaking than other NMEs, as they generally function similarly to products that are already on the market. To combat the proliferation of me-too drugs, this Note proposes increasing regulatory exclusivity as a way to incentivize drug companies to create more innovative NMEs. This Note suggests that increasing exclusivity periods for more innovative NMEs, in that they are a drug with an NME that either demonstrates a new way to treat a disease or is designated for priority review by the FDA, will result in a greater number of these drugs being produced.
{"title":"Regulatory Exclusivity Revision: Working to Achieve Greater Innovation in Approved New Molecular Entities","authors":"William Rich","doi":"10.2139/ssrn.3218034","DOIUrl":"https://doi.org/10.2139/ssrn.3218034","url":null,"abstract":"Abstract Rewarding innovation is a part of the regulatory system for drugs, both in terms of patent protection and the granting of regulatory exclusivity. One particular area where there has been a significant amount of innovation is in the development of orphan drugs. However, there has been a persistent issue regarding the significant percentage of approved new drugs that are less innovative than their counterparts. Further, it appears that the level of innovation in approved drugs containing a new molecular entity (NME) has been on the decline. This issue is highlighted by the proliferation of \"me-too\" or \"addition-to-class\" drugs. Me-too or addition-to-class drugs include drugs such as Lipitor and Nexium. These are considered less ground-breaking than other NMEs, as they generally function similarly to products that are already on the market. To combat the proliferation of me-too drugs, this Note proposes increasing regulatory exclusivity as a way to incentivize drug companies to create more innovative NMEs. This Note suggests that increasing exclusivity periods for more innovative NMEs, in that they are a drug with an NME that either demonstrates a new way to treat a disease or is designated for priority review by the FDA, will result in a greater number of these drugs being produced.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2018-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133096588","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2016-09-28DOI: 10.1017/9781316544587.003
J. Contreras
This chapter analyzes the role that the state has played with respect to the generation and management of large repositories of scientific data, situating it within the context of commons theory and the organization of common pool resources. Extending beyond the traditional “big science” conception of the state as creator/provisioner of large-scale scientific data pools, and the literature of state-based innovation incentives, this chapter identifies nine distinct but interdependent roles that the state has played in assembling and maintaining scientific data sets. It uses as a case study the U.S. federal government’s engagement with genomic research projects beginning with the Human Genome Project and encompassing a range of federally-funded, public-private and private sector projects. It then assesses the potential roles that the state may play in the formation and maintenance of new pools of biomedical data, namely data from clinical trials. The analytical framework described in this chapter offers a means by which state engagement with data-intensive research projects may be compared across agencies, fields and national borders. This framework may be used to assess the effectiveness of state engagement in such research programs and to configure state engagement in new data commons in a manner that can enhance the efficiency and effectiveness of data sharing arrangements and improve overall social welfare.
{"title":"Leviathan in the Commons: Biomedical Data and the State","authors":"J. Contreras","doi":"10.1017/9781316544587.003","DOIUrl":"https://doi.org/10.1017/9781316544587.003","url":null,"abstract":"This chapter analyzes the role that the state has played with respect to the generation and management of large repositories of scientific data, situating it within the context of commons theory and the organization of common pool resources. Extending beyond the traditional “big science” conception of the state as creator/provisioner of large-scale scientific data pools, and the literature of state-based innovation incentives, this chapter identifies nine distinct but interdependent roles that the state has played in assembling and maintaining scientific data sets. It uses as a case study the U.S. federal government’s engagement with genomic research projects beginning with the Human Genome Project and encompassing a range of federally-funded, public-private and private sector projects. It then assesses the potential roles that the state may play in the formation and maintenance of new pools of biomedical data, namely data from clinical trials. The analytical framework described in this chapter offers a means by which state engagement with data-intensive research projects may be compared across agencies, fields and national borders. This framework may be used to assess the effectiveness of state engagement in such research programs and to configure state engagement in new data commons in a manner that can enhance the efficiency and effectiveness of data sharing arrangements and improve overall social welfare.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128261695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Interprofessional collaboration in healthcare describes a model of practice where multiple health professionals work together in a team-based approach to patient care. A growing body of literature demonstrates that interprofessional collaboration advances healthcare quality and safety, improves patient outcomes and experiences of care, and promotes job satisfaction among health professionals. Governments and health organisations across Canada are working to advance interprofessional healthcare delivery. This paper examines the importance of law in supporting a shift to interprofessional collaboration in Canadian healthcare and discusses two key aspects of the legal context in which health practitioners work. First, the paper discusses trends in the legal regulation of health professions in Canada, including law reform initiatives aimed at promoting collaborative practice and expanding scopes of practice to break down the historically siloed approach to healthcare delivery. Second, the papers examines civil liability rules that courts apply when allegations of negligence are made against health care providers working in team-based situations. New legislative models that provide for expanded and overlapping scopes of practice, and which introduce new professional roles into the health workforce, may raise legal concerns regarding responsibility for patient care and outcomes. The paper illustrates how legal innovations, such as new models of health profession regulation, and legal adaptability, through judicial understanding of the modern context of health service delivery, are important to the advancement of interprofessional collaboration in Canadian healthcare.
{"title":"Innovation in Healthcare, Innovation in Law: Does the Law Support Interprofessional Collaboration in Canadian Health Systems?","authors":"N. Ries","doi":"10.2139/SSRN.2820057","DOIUrl":"https://doi.org/10.2139/SSRN.2820057","url":null,"abstract":"Interprofessional collaboration in healthcare describes a model of practice where multiple health professionals work together in a team-based approach to patient care. A growing body of literature demonstrates that interprofessional collaboration advances healthcare quality and safety, improves patient outcomes and experiences of care, and promotes job satisfaction among health professionals. Governments and health organisations across Canada are working to advance interprofessional healthcare delivery. This paper examines the importance of law in supporting a shift to interprofessional collaboration in Canadian healthcare and discusses two key aspects of the legal context in which health practitioners work. First, the paper discusses trends in the legal regulation of health professions in Canada, including law reform initiatives aimed at promoting collaborative practice and expanding scopes of practice to break down the historically siloed approach to healthcare delivery. Second, the papers examines civil liability rules that courts apply when allegations of negligence are made against health care providers working in team-based situations. New legislative models that provide for expanded and overlapping scopes of practice, and which introduce new professional roles into the health workforce, may raise legal concerns regarding responsibility for patient care and outcomes. The paper illustrates how legal innovations, such as new models of health profession regulation, and legal adaptability, through judicial understanding of the modern context of health service delivery, are important to the advancement of interprofessional collaboration in Canadian healthcare.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"34 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121209671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The pharmaceutical industry may be losing the battle of public opinion, but it has won important victories in the war over First Amendment commercial speech. In December 2012, the Second Circuit held in United States v. Caronia that the misbranding provisions of the Food, Drug, and Cosmetic Act could not prohibit a sales representative’s truthful statements promoting off-label uses of his company’s products. At the same time, a parallel area of pharmaceutical litigation has curiously remained almost untouched: Civil False Claims Act (FCA) settlements based on allegations that manufacturers caused false claims to be submitted by promoting their drugs off-label. Yet logic suggests that if manufacturers have a First Amendment right to discuss off-label drug uses, claims submitted when drugs are prescribed for those uses should not be considered false. This inconsistency is problematic and likely unsustainable. If manufacturers are emboldened by Caronia to challenge off-label FCA suits, the focus likely will be on the truth of the company’s statements. Despite its name, however, FCA is unsuited to addressing disputes over medical and scientific data. To maintain the integrity of this key anti-fraud enforcement tool, it is crucial to separate the truth of the claims for payment from the truth of the manufacturer’s underlying scientific statements. Because Medicare and Medicaid coverage determinations rely heavily on FDA approval, however, those issues are inextricably intertwined. This article explores why off-label promotion has been treated inconsistently in these contexts, and how this trend highlights the limitations of the FCA as a panacea for health care fraud.
制药业可能正在输掉舆论之战，但它在反对第一修正案商业言论的战争中赢得了重要胜利。2012年12月，第二巡回法院在《美国诉卡罗尼亚案》(United States v. Caronia)中裁定，《食品、药品和化妆品法》(Food, Drug, and Cosmetic Act)的虚假商标条款不能禁止销售代表在推销其公司产品的标签外用途时做出真实陈述。与此同时，令人奇怪的是，制药诉讼的一个平行领域几乎没有受到影响:民事虚假申报法(FCA)基于制造商通过推销其药品标签外导致虚假声明提交的指控达成和解。然而，从逻辑上讲，如果制造商根据第一修正案有权讨论标签外药物的用途，那么在处方药物用于这些用途时提交的声明不应被视为虚假。这种不一致是有问题的，而且可能是不可持续的。如果制造商们因为Caronia而敢于挑战FCA的标签外诉讼，那么焦点可能会集中在该公司声明的真实性上。尽管名为FCA，但它并不适合解决有关医疗和科学数据的争议。为了保持这一关键的反欺诈执法工具的完整性，将付款索赔的真实性与制造商基础科学陈述的真实性分开是至关重要的。然而，由于医疗保险和医疗补助覆盖范围的决定严重依赖于FDA的批准，这些问题是不可避免地交织在一起的。本文探讨了为什么标签外促销在这些情况下被不一致地对待，以及这一趋势如何突出了FCA作为医疗保健欺诈灵丹妙药的局限性。
{"title":"Truth, Falsity, and Fraud: Off-Label Drug Settlements and the Future of the Civil False Claims Act","authors":"J. Krause","doi":"10.2139/SSRN.2648354","DOIUrl":"https://doi.org/10.2139/SSRN.2648354","url":null,"abstract":"The pharmaceutical industry may be losing the battle of public opinion, but it has won important victories in the war over First Amendment commercial speech. In December 2012, the Second Circuit held in United States v. Caronia that the misbranding provisions of the Food, Drug, and Cosmetic Act could not prohibit a sales representative’s truthful statements promoting off-label uses of his company’s products. At the same time, a parallel area of pharmaceutical litigation has curiously remained almost untouched: Civil False Claims Act (FCA) settlements based on allegations that manufacturers caused false claims to be submitted by promoting their drugs off-label. Yet logic suggests that if manufacturers have a First Amendment right to discuss off-label drug uses, claims submitted when drugs are prescribed for those uses should not be considered false. This inconsistency is problematic and likely unsustainable. If manufacturers are emboldened by Caronia to challenge off-label FCA suits, the focus likely will be on the truth of the company’s statements. Despite its name, however, FCA is unsuited to addressing disputes over medical and scientific data. To maintain the integrity of this key anti-fraud enforcement tool, it is crucial to separate the truth of the claims for payment from the truth of the manufacturer’s underlying scientific statements. Because Medicare and Medicaid coverage determinations rely heavily on FDA approval, however, those issues are inextricably intertwined. This article explores why off-label promotion has been treated inconsistently in these contexts, and how this trend highlights the limitations of the FCA as a panacea for health care fraud.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"56 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129695126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In 2014, the European Commission announced the launch of a study of knowledge transfer by public research organizations and other institutes of higher learning “to determine which additional measures might be needed to ensure an optimal flow of knowledge between the public research organisations and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the EU needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies.” This article builds on our earlier work on structuring efficient pharmaceutical public-private partnerships (PPPPs) but focuses on the regulatory infrastructure necessary to support the efficient commercialization of publicly funded university medical research in both the European Union and the United States. Our comparative analysis of the EU and U.S. approaches to translational medicine shows that there are lessons to be shared. The EU can apply the experiences from the U.S. Bayh-Dole Act and PPPPs in the United States, and the United States can emulate aspects of the open innovation aspects of the European Innovative Medicines Initiative and the tighter patenting standards imposed by the European Patent Office. Thus, a secondary purpose of this article is to suggest amendments to the U.S. laws governing the patenting and licensing of government-funded technology to prevent undue burdens on the sharing of certain upstream medical discoveries and research tools.
{"title":"Promoting 'Academic Entrepreneurship' in Europe and the United States: Creating an Intellectual Property Regime to Facilitate the Efficient Transfer of Knowledge from the Lab to the Patient","authors":"C. Bagley, Christina D. Tvarnoe","doi":"10.2139/SSRN.2571103","DOIUrl":"https://doi.org/10.2139/SSRN.2571103","url":null,"abstract":"In 2014, the European Commission announced the launch of a study of knowledge transfer by public research organizations and other institutes of higher learning “to determine which additional measures might be needed to ensure an optimal flow of knowledge between the public research organisations and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the EU needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies.” This article builds on our earlier work on structuring efficient pharmaceutical public-private partnerships (PPPPs) but focuses on the regulatory infrastructure necessary to support the efficient commercialization of publicly funded university medical research in both the European Union and the United States. Our comparative analysis of the EU and U.S. approaches to translational medicine shows that there are lessons to be shared. The EU can apply the experiences from the U.S. Bayh-Dole Act and PPPPs in the United States, and the United States can emulate aspects of the open innovation aspects of the European Innovative Medicines Initiative and the tighter patenting standards imposed by the European Patent Office. Thus, a secondary purpose of this article is to suggest amendments to the U.S. laws governing the patenting and licensing of government-funded technology to prevent undue burdens on the sharing of certain upstream medical discoveries and research tools.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"92 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124217386","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In Roe v. Wade the Supreme Court identified the abortion right as “inherently, and primarily, a medical decision” to be decided between doctors and their patients. Early abortion case law closely linked the right to the doctor-patient relationship and situated abortion within the context of healthcare. Over the last forty years, however, the abortion right has come to be viewed almost exclusively as a constitutional right of decision-making or “choice.” Under the Court’s current analysis, the abortion right is cabined exclusively as a constitutional right to decide to terminate a pregnancy and, as a result, the Court has upheld significant restrictions on access to abortion-related healthcare. The aid in dying (AID) movement has experienced the opposite trajectory between framings of healthcare and a constitutional right of decsionmaking. Originally identified as a “right to die” by advocates such as Dr. Jack Kevorkian, the movement has since transitioned to a right framed as healthcare. Dr. Timothy Quill’s call for “death with dignity” helped to reframe the AID movement from a narrow focus on decision-making at death to transforming the process of dying more generally. The transition to death with dignity coincided with an expanded public discourse about how poverty, disability, social and family support, and healthcare access impact end-of-life decision-making. At the same time, the goals of the movement expanded from court-won rights to changing healthcare practices, and increasing healthcare access, legal rights and social support for people facing the end of life. It is a critical time to study and draw lessons from these two movements as they are accelerating in opposite directions: Last year pro-AID legislation was passed in California and was pending in twenty-five states, and cases were filed in California and New York. The Supreme Court will hear oral arguments this term in a Texas case on regulatory restrictions of abortion clinics. Further, more state abortion restrictions were enacted between 2011 and 2013 than in the entire previous decade. While other scholarship has compared AID and the abortion right to consider their doctrinal, moral and ethical similarities, this Article is the first to identify that these two movements arc in opposite directions between framings of healthcare and rights, with vastly different efficacy for the rights holder. I draw upon this comparison to consider how the history and discursive development of these two movements offers the possibility of framing healthcare more broadly within the context of dignity to achieve social justice goals beyond narrow constitutional rights status. The transformation of AID from a constitutional rights frame to a healthcare frame highlights the importance of developing a healthcare model related to dignity that is undergirded by social support, legal rights and healthcare access. However, the history of the abortion right cautions against narrowly identifying healthcare
{"title":"From Rights to Dignity: Drawing Lessons from Aid in Dying and Reproductive Rights","authors":"Y. Lindgren","doi":"10.2139/SSRN.2495647","DOIUrl":"https://doi.org/10.2139/SSRN.2495647","url":null,"abstract":"In Roe v. Wade the Supreme Court identified the abortion right as “inherently, and primarily, a medical decision” to be decided between doctors and their patients. Early abortion case law closely linked the right to the doctor-patient relationship and situated abortion within the context of healthcare. Over the last forty years, however, the abortion right has come to be viewed almost exclusively as a constitutional right of decision-making or “choice.” Under the Court’s current analysis, the abortion right is cabined exclusively as a constitutional right to decide to terminate a pregnancy and, as a result, the Court has upheld significant restrictions on access to abortion-related healthcare. The aid in dying (AID) movement has experienced the opposite trajectory between framings of healthcare and a constitutional right of decsionmaking. Originally identified as a “right to die” by advocates such as Dr. Jack Kevorkian, the movement has since transitioned to a right framed as healthcare. Dr. Timothy Quill’s call for “death with dignity” helped to reframe the AID movement from a narrow focus on decision-making at death to transforming the process of dying more generally. The transition to death with dignity coincided with an expanded public discourse about how poverty, disability, social and family support, and healthcare access impact end-of-life decision-making. At the same time, the goals of the movement expanded from court-won rights to changing healthcare practices, and increasing healthcare access, legal rights and social support for people facing the end of life. It is a critical time to study and draw lessons from these two movements as they are accelerating in opposite directions: Last year pro-AID legislation was passed in California and was pending in twenty-five states, and cases were filed in California and New York. The Supreme Court will hear oral arguments this term in a Texas case on regulatory restrictions of abortion clinics. Further, more state abortion restrictions were enacted between 2011 and 2013 than in the entire previous decade. While other scholarship has compared AID and the abortion right to consider their doctrinal, moral and ethical similarities, this Article is the first to identify that these two movements arc in opposite directions between framings of healthcare and rights, with vastly different efficacy for the rights holder. I draw upon this comparison to consider how the history and discursive development of these two movements offers the possibility of framing healthcare more broadly within the context of dignity to achieve social justice goals beyond narrow constitutional rights status. The transformation of AID from a constitutional rights frame to a healthcare frame highlights the importance of developing a healthcare model related to dignity that is undergirded by social support, legal rights and healthcare access. However, the history of the abortion right cautions against narrowly identifying healthcare","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"8 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116492192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Is it reasonable for a physician to condition treatment upon the patient’s execution of an arbitration agreement? Is such an agreement enforceable? Is such an agreement medically ethical? This paper will address these topics (and others) in an effort to determine whether a treatment conditioned upon the execution of an arbitration agreement covering medical liability claims is consistent with, and should be a defensible component part of, the physician-patient relationship.
{"title":"The Execution of an Arbitration Provision as a Condition Precedent of Medical Treatment: Legally Enforceable? Medically Ethical?","authors":"M. Ginsberg","doi":"10.2139/SSRN.2631323","DOIUrl":"https://doi.org/10.2139/SSRN.2631323","url":null,"abstract":"Is it reasonable for a physician to condition treatment upon the patient’s execution of an arbitration agreement? Is such an agreement enforceable? Is such an agreement medically ethical? This paper will address these topics (and others) in an effort to determine whether a treatment conditioned upon the execution of an arbitration agreement covering medical liability claims is consistent with, and should be a defensible component part of, the physician-patient relationship.","PeriodicalId":410798,"journal":{"name":"Medical-Legal Studies eJournal","volume":"2 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123975720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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