Volume 19 (2009-2010)
Annals of Health Law
The Health Policy and Law Review of Loyola University Chicago School of Law
Volume 19 (2009-2010)
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Editor-in-Chief: |
Publications Editor: |
Technical Publications Editor: |
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Correspondence Editor: |
Symposium Editor: |
Advance Directive Editor: |
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Senior Editors: Advance Directive Senior Editor: |
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Members: *Margaret Begalle was also a contributing member to Volume 19 Issue 2.
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Issue 1, 25th Anniversary Special Edition
Issue 2, Winter 2010
Articles
Access to Medicine in an Era of Fractal Inequality
Author: Frank Pasquale
This article evaluates the legitimacy and degree of inevitability of unequal access to medicine. The author introduces ‘fractal inequality’ to the access issue by using the term to describe skewed patterns in distributions of income and wealth that lead to reallocative effects of higher spending on health care by the wealthiest that can cascade down the distributive ladder. ‘Fractal inequality’ is transposed to the U.S. health care sector to explain the trend away from medical need toward ability to pay. The author cautions U.S. policymakers to consider international access problems instead of exacerbating those issues when domestic access to care policies is debated in a vacuum. The author also analyzes some policy proposals designed to reduce inequities in the global trade of medicine.
Pharmaceutical Pricing: A Review of Proposals to Improve Access and Affordability of Prescription Drugs
Author: Paula Tironi
This article discusses how pharmaceutical innovation achieves remarkable improvements in human health but a significant portion of the U.S. population cannot afford prescription drugs. The author examines ways that patent protection, generics, supply chain complexity, and the cost of innovation and promotion affect access and affordability. The author then looks at the influences of marketing strategies and industry trends such as the patent cliff and pipeline for new drugs, innovations in biotechnology and genomics, comparative effectiveness analysis, and payor and employer strategies on drug prices. An analysis of reform proposals in the context of industry trends suggests that promoting generic drug use and availability through education, prohibiting authorized generics, and restricting the practice of developing follow-on drugs and discontinuing the original formulations upon patent expiration could improve access and affordability most quickly and significantly.
An Economic Assessment of Patent Settlements in the Pharmaceutical Industry
Authors: Bret Dickey, Jonathan Orszag, and Laura Tyson
This article demonstrates that in recent years, patent settlements between branded and generic manufacturers involving “reverse payments” from branded manufacturers to generic manufacturers have received close antitrust scrutiny, driven by concerns that such settlements harm consumers by delaying the entry of lower-priced generic drugs. The authors note that such settlements will be a focus of the Obama Administration’s antitrust enforcement policy, yet there is a growing consensus among the courts that such settlements are anticompetitive only under narrow sets of circumstances. in this article, the authors present an analytical framework for evaluating the competitive effects of patent settlements, including those involving reverse payments, and demonstrate that these settlements can benefit consumers. Thus, the authors conclude that while continued scrutiny of such settlements is important, broad brush treatments are inappropriate and only a more individualized evaluation can correctly determine the competitive effects of a particular settlement agreement.
Post-Mortem Pregnancy: A Proposed Methodology for the Resolution of Conflicts Over Whether a Brain Dead Pregnant Woman Should be Maintained on Life-Sustaining Treatment
Author: Alexis Gregorian
In this article, the author examines conflicts over whether to maintain a brain dead pregnant woman on life-sustaining treatment. The author cautions that on the rare occasions when courts are confronted with such a conflict, they should employ a consistent methodology for resolution of the conflict and attempt to honor the wishes of the post-mortem mother and her family. The author draws on relevant areas of law to demonstrate the existence of a legal fiction that protects the interests of post-mortem pregnant women in refusing medical treatment. This article then proceeds to propose a methodology that enables courts to account for a post-mortem pregnant woman’s interests, her family’s interests, and the state’s interests in resolving conflicts over whether to remove a post-mortem pregnant woman from life-sustaining treatment.
A Call for Minds: The Unknown Extent of Societal Influence on the Legal Rights of Involuntarily and Voluntarily Committed Mental Health Patients
Author: Teresa Cannistraro
This article begins and ends with a call for more empirical research to understand the connection between societal views of mental illness and the legal system. The author asserts that changing social perceptions of mental illness certainly affect legal outcomes and commitment levels, but the degree remains unknown. This article explores the above two topics through the framework of the Circuit Court ‘split’ regarding the Constitutional rights of persons committed to state mental health institutions. A main facet of the ‘split’ is centered on the Circuits’ disagreement about whether or not all mentally ill patients committed to institutions deserve the same Constitutional protections.
Perceiving Others as Different: A Discussion on the Stigmatization of the Mentally Ill
Authors: Marchell Goins, Kyneitres Good, and Cori Harley
This commentary on the stigmatization of people with mental illness explores social perceptions of them as dangerous and uncivilized. The authors discuss how the legal system suggests that these are people who should be ousted from the community while mental health professionals attempt to reiterate the fact that these individuals are simply human. The authors describe ways people with mental illness have been subjected to discrimination, ridicule, and humiliation. This commentary discusses multiple perspectives of mental illness, from past to present, and how those perspectives influenced social, legal and psychological frameworks.
Issue 3, Summer 2010
Articles
Rationing Health Care: It’s a Matter of the Health Care System’s Structure
Author: David Orentlicher
The article examines two primary policy proposals for how the U.S. should allocate its limited health care dollars: a centralized model in which a commission establishes rationing guidelines, and a decentralized model in which rationing decisions are made by health care providers on a case by case basis. The author finds significant advantages with each position, leading the author to assert that a combination of each is key to an effective rationing policy: a centralized control of structure coupled with decentralized physician-level decision making. While mindful that formal rationing guidelines alone are unfeasible to effectuate cost-effective care, the author introduces two decentralized policies to control costs: the limitation of resources at physicians’ disposal and elimination of physicians’ personal incentive to provide high-cost care.
Government-Sponsored Reinsurance
Author: Mark A. Hall
Many measures to reform health insurance markets include various types of government-sponsored reinsurance. This article explains the purposes and types of private and public reinsurance, and reviews available evidence about their performance. The author concludes that government-sponsored reinsurance inherently cannot reduce total costs, but it can shift costs from the private to the public sector. Also, reinsurance can help transition to a new government program or market structure that creates uncertain risks. Whether reinsurance is the best way to accomplish these goals depends greatly on the details.
Charter Rights & Health Care Funding: A Typology of Canadian Health Rights Litigation
Authors: Colleen M. Flood and Y. Y. Brandon Chen
Canadian health consumers have increasingly relied on the Charter of Rights and Freedoms to demand certain therapies and reasonably timely access to care. Organizing these cases into a 5-part typology, we examine how a rights-based discourse affects allocation of health care resources. First, successful Charter challenges can, in theory, lead to courts granting and enforcing positive rights to therapies or to timely care. Second, courts may grant a right to certain health services; however, subsequently government fails to deliver on this right. Third, successful litigation may create negative rights, i.e. rights to access care or private health insurance without government interference. Fourth, consumers can fail in their legal pursuit of a right but galvanize public support in the process, ultimately effecting the desired policy changes. Lastly, a failed lawsuit can stifle an entire advocacy campaign for the sought-after therapies. The typology illustrates the need to examine both legal and policy outcomes of health right litigation. This broader analysis reveals that the pursuit of health rights seems to have caused largely a regressive rather than progressive impact on Canadian Medicare.
Retail Medical Clinics: Increasing Access to Low Medical Care Amongst a Developing Legal Environment
Author: Kristin E. Schleiter
Retail medical clinics are an innovation in health care with the potential to increase access to low-cost basic health care services while changing the delivery model for routine, non-urgent medical care. However, the few states that attempted to directly regulate retail medical clinics have been met with criticism by the FTC due to the proposed legislations’ anticompetitive undertones. The relationship between retail medical clinics and the host stores or pharmacies that house them has the potential to spark fraud and abuse concerns. Retail medical clinics must abide by state-specific regulation on scope of practice of the various mid-level practitioners who work for the clinics, particularly to minimize exposure to litigation and keep within the clinics’ intended purpose of a supplement to primary care physician offices. The author concludes that the consumer benefits of cost and convenience, combined with the potential for growth and expanded consumer base from a retailers’ perspective, make the legal challenge inherent in running a retail medical clinic well worth the effort.
Mental Health Courts: Serving Justice and Promoting Recovery
Author: Hon. Ginger Lerner-Wren
This article begins and ends with a call for more empirical research to understand the connection between societal views of mental illness and the legal system. The author asserts that changing social perceptions of mental illness certainly affect legal outcomes and commitment levels, but the degree remains unknown. This article explores the above two topics through the framework of the Circuit Court ‘split’ regarding the Constitutional rights of persons committed to state mental health institutions. A main facet of the ‘split’ is centered on the Circuits’ disagreement about whether or not all mentally ill patients committed to institutions deserve the same Constitutional protections.
Annals of Health Law
The Health Policy and Law Review of Loyola University Chicago School of Law
Volume 19 (2009-2010)
|
Editor-in-Chief: |
Publications Editor: |
Technical Publications Editor: |
|
Correspondence Editor: |
Symposium Editor: |
Advance Directive Editor: |
|
Senior Editors: Advance Directive Senior Editor: |
|
|
|
Members: *Margaret Begalle was also a contributing member to Volume 19 Issue 2.
|
|
|
Issue 1, 25th Anniversary Special Edition
Issue 2, Winter 2010
Articles
Access to Medicine in an Era of Fractal Inequality
Author: Frank Pasquale
This article evaluates the legitimacy and degree of inevitability of unequal access to medicine. The author introduces ‘fractal inequality’ to the access issue by using the term to describe skewed patterns in distributions of income and wealth that lead to reallocative effects of higher spending on health care by the wealthiest that can cascade down the distributive ladder. ‘Fractal inequality’ is transposed to the U.S. health care sector to explain the trend away from medical need toward ability to pay. The author cautions U.S. policymakers to consider international access problems instead of exacerbating those issues when domestic access to care policies is debated in a vacuum. The author also analyzes some policy proposals designed to reduce inequities in the global trade of medicine.
Pharmaceutical Pricing: A Review of Proposals to Improve Access and Affordability of Prescription Drugs
Author: Paula Tironi
This article discusses how pharmaceutical innovation achieves remarkable improvements in human health but a significant portion of the U.S. population cannot afford prescription drugs. The author examines ways that patent protection, generics, supply chain complexity, and the cost of innovation and promotion affect access and affordability. The author then looks at the influences of marketing strategies and industry trends such as the patent cliff and pipeline for new drugs, innovations in biotechnology and genomics, comparative effectiveness analysis, and payor and employer strategies on drug prices. An analysis of reform proposals in the context of industry trends suggests that promoting generic drug use and availability through education, prohibiting authorized generics, and restricting the practice of developing follow-on drugs and discontinuing the original formulations upon patent expiration could improve access and affordability most quickly and significantly.
An Economic Assessment of Patent Settlements in the Pharmaceutical Industry
Authors: Bret Dickey, Jonathan Orszag, and Laura Tyson
This article demonstrates that in recent years, patent settlements between branded and generic manufacturers involving “reverse payments” from branded manufacturers to generic manufacturers have received close antitrust scrutiny, driven by concerns that such settlements harm consumers by delaying the entry of lower-priced generic drugs. The authors note that such settlements will be a focus of the Obama Administration’s antitrust enforcement policy, yet there is a growing consensus among the courts that such settlements are anticompetitive only under narrow sets of circumstances. in this article, the authors present an analytical framework for evaluating the competitive effects of patent settlements, including those involving reverse payments, and demonstrate that these settlements can benefit consumers. Thus, the authors conclude that while continued scrutiny of such settlements is important, broad brush treatments are inappropriate and only a more individualized evaluation can correctly determine the competitive effects of a particular settlement agreement.
Post-Mortem Pregnancy: A Proposed Methodology for the Resolution of Conflicts Over Whether a Brain Dead Pregnant Woman Should be Maintained on Life-Sustaining Treatment
Author: Alexis Gregorian
In this article, the author examines conflicts over whether to maintain a brain dead pregnant woman on life-sustaining treatment. The author cautions that on the rare occasions when courts are confronted with such a conflict, they should employ a consistent methodology for resolution of the conflict and attempt to honor the wishes of the post-mortem mother and her family. The author draws on relevant areas of law to demonstrate the existence of a legal fiction that protects the interests of post-mortem pregnant women in refusing medical treatment. This article then proceeds to propose a methodology that enables courts to account for a post-mortem pregnant woman’s interests, her family’s interests, and the state’s interests in resolving conflicts over whether to remove a post-mortem pregnant woman from life-sustaining treatment.
A Call for Minds: The Unknown Extent of Societal Influence on the Legal Rights of Involuntarily and Voluntarily Committed Mental Health Patients
Author: Teresa Cannistraro
This article begins and ends with a call for more empirical research to understand the connection between societal views of mental illness and the legal system. The author asserts that changing social perceptions of mental illness certainly affect legal outcomes and commitment levels, but the degree remains unknown. This article explores the above two topics through the framework of the Circuit Court ‘split’ regarding the Constitutional rights of persons committed to state mental health institutions. A main facet of the ‘split’ is centered on the Circuits’ disagreement about whether or not all mentally ill patients committed to institutions deserve the same Constitutional protections.
Perceiving Others as Different: A Discussion on the Stigmatization of the Mentally Ill
Authors: Marchell Goins, Kyneitres Good, and Cori Harley
This commentary on the stigmatization of people with mental illness explores social perceptions of them as dangerous and uncivilized. The authors discuss how the legal system suggests that these are people who should be ousted from the community while mental health professionals attempt to reiterate the fact that these individuals are simply human. The authors describe ways people with mental illness have been subjected to discrimination, ridicule, and humiliation. This commentary discusses multiple perspectives of mental illness, from past to present, and how those perspectives influenced social, legal and psychological frameworks.
Issue 3, Summer 2010
Articles
Rationing Health Care: It’s a Matter of the Health Care System’s Structure
Author: David Orentlicher
The article examines two primary policy proposals for how the U.S. should allocate its limited health care dollars: a centralized model in which a commission establishes rationing guidelines, and a decentralized model in which rationing decisions are made by health care providers on a case by case basis. The author finds significant advantages with each position, leading the author to assert that a combination of each is key to an effective rationing policy: a centralized control of structure coupled with decentralized physician-level decision making. While mindful that formal rationing guidelines alone are unfeasible to effectuate cost-effective care, the author introduces two decentralized policies to control costs: the limitation of resources at physicians’ disposal and elimination of physicians’ personal incentive to provide high-cost care.
Government-Sponsored Reinsurance
Author: Mark A. Hall
Many measures to reform health insurance markets include various types of government-sponsored reinsurance. This article explains the purposes and types of private and public reinsurance, and reviews available evidence about their performance. The author concludes that government-sponsored reinsurance inherently cannot reduce total costs, but it can shift costs from the private to the public sector. Also, reinsurance can help transition to a new government program or market structure that creates uncertain risks. Whether reinsurance is the best way to accomplish these goals depends greatly on the details.
Charter Rights & Health Care Funding: A Typology of Canadian Health Rights Litigation
Authors: Colleen M. Flood and Y. Y. Brandon Chen
Canadian health consumers have increasingly relied on the Charter of Rights and Freedoms to demand certain therapies and reasonably timely access to care. Organizing these cases into a 5-part typology, we examine how a rights-based discourse affects allocation of health care resources. First, successful Charter challenges can, in theory, lead to courts granting and enforcing positive rights to therapies or to timely care. Second, courts may grant a right to certain health services; however, subsequently government fails to deliver on this right. Third, successful litigation may create negative rights, i.e. rights to access care or private health insurance without government interference. Fourth, consumers can fail in their legal pursuit of a right but galvanize public support in the process, ultimately effecting the desired policy changes. Lastly, a failed lawsuit can stifle an entire advocacy campaign for the sought-after therapies. The typology illustrates the need to examine both legal and policy outcomes of health right litigation. This broader analysis reveals that the pursuit of health rights seems to have caused largely a regressive rather than progressive impact on Canadian Medicare.
Retail Medical Clinics: Increasing Access to Low Medical Care Amongst a Developing Legal Environment
Author: Kristin E. Schleiter
Retail medical clinics are an innovation in health care with the potential to increase access to low-cost basic health care services while changing the delivery model for routine, non-urgent medical care. However, the few states that attempted to directly regulate retail medical clinics have been met with criticism by the FTC due to the proposed legislations’ anticompetitive undertones. The relationship between retail medical clinics and the host stores or pharmacies that house them has the potential to spark fraud and abuse concerns. Retail medical clinics must abide by state-specific regulation on scope of practice of the various mid-level practitioners who work for the clinics, particularly to minimize exposure to litigation and keep within the clinics’ intended purpose of a supplement to primary care physician offices. The author concludes that the consumer benefits of cost and convenience, combined with the potential for growth and expanded consumer base from a retailers’ perspective, make the legal challenge inherent in running a retail medical clinic well worth the effort.
Mental Health Courts: Serving Justice and Promoting Recovery
Author: Hon. Ginger Lerner-Wren
This article begins and ends with a call for more empirical research to understand the connection between societal views of mental illness and the legal system. The author asserts that changing social perceptions of mental illness certainly affect legal outcomes and commitment levels, but the degree remains unknown. This article explores the above two topics through the framework of the Circuit Court ‘split’ regarding the Constitutional rights of persons committed to state mental health institutions. A main facet of the ‘split’ is centered on the Circuits’ disagreement about whether or not all mentally ill patients committed to institutions deserve the same Constitutional protections.