Volume 18 (2008-2009)
Annals of Health Law
The Health Policy and Law Review of Loyola University Chicago School of Law
Volume 18 (2008-09)
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Editor-in-Chief: |
Publications Editor: |
Technical Publications Editor: |
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Correspondence Editor: |
Symposium Editor: |
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Senior Editors: Advance Directive Senior Editors: |
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Members: |
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Issue 1, Winter 2009
Articles
Re-Shaping the Common Good in Times of Public Health Emergencies: Validating Medical Triage
Author: George P. Smith, II
This article discusses the utilitarian principle of triage in the context of governmental response to national disasters, while analyzing the delicate balance between individual liberties and the government actions necessary to promote the common good. The author examines competing conceptions of the common good, and posits that a new philosophy is required for public health emergencies in order to promote balanced and normative standards of conduct necessary for consensus-based decision-making in times of national emergency. The author then demonstrates that the principal of medical triage is a valid construct for the distribution of scarce resources during national emergencies, tests this construct by applying it to model legislative proposals, and finds that distributive justice can be achieved during national emergencies by incorporating the triage principle into federal policy-making instruments and state legislative proposals.
Public Health Law & Military Medical Assets: Legal Issues in Federalizing National Guard Personnel
Authors: Bryan A. Liang and James Balcius
This article examines the role of the National Guard in enforcing public health mandates in emergency situations. The authors analyze the activation of the National Guard through Title 10 of the U.S. Code, which prohibits the National Guard from engaging in law enforcement activities under the Posse Comitatus Act (PCA). The authors then discuss the potential role of the National Guard in emergency and disaster response such as quarantine and compulsory vaccination as well as legal liability issues. The authors conclude by proposing revisions to the PCA to clarify the law and to allow for the effective use of military medical assets in emergency and disaster response initiatives.
EMR Metadata Uses and E-Discovery
Author: Thomas R. McLean, M.D., J.D., F.A.C.S., Esq.
In this article, the author discusses how the metadata found in an Electronic Medical Record (EMR) can be used as evidence in litigation under the 2006 amended Rules of Civil Procedure and the Federal Rules of Evidence. The article first reviews how EMR metadata can profile the actions a physician takes when caring for a patient. The author then looks at the relevant changes to the Rules and analyzes case law concerning both electronic discovery (e-discovery) and metadata. Finally, the author examines how EMR metadata specifically impacts physicians who are involved in litigation, as metadata may be used as the standard for authentication of the EMR and can give insight into a patient’s clinical outcome.
The Promises and Pitfalls of Health Savings Accounts
Author: Adam Larson
This comment examines the drawbacks and potential efficiencies associated with Health Savings Accounts (HSAs), and discusses whether HSAs will deliver the purported benefits of reducing aggregate healthcare costs by encouraging value-conscious decisions and increasing cost transparency; thereby reducing the number of Americans without healthcare coverage. The author then discusses several initiatives by state, federal, and private organizations that could ensure wider availability of the tax benefits associated with HSAs, which would broaden the appeal of such accounts for lower-income Americans. After analyzing the background of HSAs, recent developments, and potential improvements, the author describes the current political environment surrounding healthcare coverage and the uncertain future of tax-favored accounts.
Issue 2, Summer 2009
Introduction
By Cynthia M. Ho, J.D. and Ann Weilbaecher, Psy.D
Articles
Prizes for Innovation of New Medicines and Vaccines
Authors: James Love, M.P.A. and Tim Hubbard, Ph.D
This article argues that prizes can help stimulate medical innovation, control costs and ensure greater access to new medicines and vaccines. The authors explore four increasingly ambitious prize options to reward medical innovation, each addressing flaws in the current patent system. The first option promotes innovation through a large prize fund linked to the impact on health outcomes; the second option rewards the sharing of knowledge, data, and technology with open source dividends; the third option awards prizes for interim benchmarks and discrete technical problems; and the final option removes the exclusive right to use patented inventions in upstream research in favor of prizes. The authors conclude that a system of prizes to reward drug development would break the link between R & D incentives and product prices, and that such a reform is needed to improve innovation and access to new medicines and vaccines.
Patents & The Progress of Personalized Medicine: Biomarkers Research as Lens
Author: Matthew Herder, L.L.B., L.L.M., J.S.M
This article addresses the barriers to personalized medicine, focusing on the burgeoning field of biomarkers research. The author begins by framing intellectual property issues as more than a product of industry incentives and suggests that these issues are deeply entangled with other barriers facing personalized medicine such as regulatory framework deficiencies. The author proposes a set of future research questions to more fully define the barriers to biomarkers research and to uncover which corrective measures may be effective. The author concludes by recommending an integration of regulatory and patent reforms, with a call to action by scholars, scientists, representatives of the biopharmaceutical industry, and policy-makers.
Legal, Ethical, and Conceptual Bottlenecks to the Development of Useful Genomic Tests
Author: Michael Tomasson, M.D
This article discusses advances in genomic research in the context of the debate surrounding gene patent rights and the limited rights of patient-participants in translational research. In addition, the author explores statutory and regulatory hurdles to advances in disease diagnosis, such the Bayh-Dole Act, Medicare Legislation, and the Health Insurance Portability and Accountability Act. The author questions the effectiveness of increasingly commercialized academic research and the limited success of the private sector in genomic research. The author concludes that future genomic research will require significantly increased patient participation, which may necessitate a reshaping of the pharmaceutical approach to medicine and the limited stake that patients have in the breakthroughs developed through their participation in the process.
Patents with an “I” = Patients
Authors: Alice O. Martin, J.D., Ph.D. and Sendil K. Devadas, J.D., Ph.D.
The authors address how patent protection in the United States is often quite narrow in scope, difficult to obtain, and insufficient in duration; thus stifling research and development of potential breakthrough pharmaceuticals. The authors further posit that countries that have enacted stronger intellectual property rights and research incentives have seen tremendous increases in foreign direct investment. In addressing critics of the current patent system, the authors show that alternatives to biotechnology patents would not demonstrably improve innovation and development of beneficial medicines. The authors conclude that given the substantial evidence of the patent system's benefits, and the mere speculation that patents have a deleterious effect on patients, no suggestions currently proposed to replace or improve the patent system will have the same beneficial effects for patients.
Diseases Endemic in Developing Countries: How to Incentivize Innovation
Author: Ann Weilbaecher, Psy.D.
This comment addresses the inadequacies of research and development for diseases endemic in developing countries and explores how the patent system can inhibit innovation for new drugs for neglected diseases. The author analyzes four strategies to encourage innovation, including open source initiatives, patent pools, prizes, and wild card patent extensions, and examines how these alternative systems may spur innovation while balancing cost concerns held by drug manufacturers and purchasers. The author concludes that a combination of solutions may provide the best framework for the creation of essential medicines for neglected diseases.
Annals of Health Law
The Health Policy and Law Review of Loyola University Chicago School of Law
Volume 18 (2008-09)
|
Editor-in-Chief: |
Publications Editor: |
Technical Publications Editor: |
|
Correspondence Editor: |
Symposium Editor: |
|
|
Senior Editors: Advance Directive Senior Editors: |
|
|
|
Members: |
|
|
Issue 1, Winter 2009
Articles
Re-Shaping the Common Good in Times of Public Health Emergencies: Validating Medical Triage
Author: George P. Smith, II
This article discusses the utilitarian principle of triage in the context of governmental response to national disasters, while analyzing the delicate balance between individual liberties and the government actions necessary to promote the common good. The author examines competing conceptions of the common good, and posits that a new philosophy is required for public health emergencies in order to promote balanced and normative standards of conduct necessary for consensus-based decision-making in times of national emergency. The author then demonstrates that the principal of medical triage is a valid construct for the distribution of scarce resources during national emergencies, tests this construct by applying it to model legislative proposals, and finds that distributive justice can be achieved during national emergencies by incorporating the triage principle into federal policy-making instruments and state legislative proposals.
Public Health Law & Military Medical Assets: Legal Issues in Federalizing National Guard Personnel
Authors: Bryan A. Liang and James Balcius
This article examines the role of the National Guard in enforcing public health mandates in emergency situations. The authors analyze the activation of the National Guard through Title 10 of the U.S. Code, which prohibits the National Guard from engaging in law enforcement activities under the Posse Comitatus Act (PCA). The authors then discuss the potential role of the National Guard in emergency and disaster response such as quarantine and compulsory vaccination as well as legal liability issues. The authors conclude by proposing revisions to the PCA to clarify the law and to allow for the effective use of military medical assets in emergency and disaster response initiatives.
EMR Metadata Uses and E-Discovery
Author: Thomas R. McLean, M.D., J.D., F.A.C.S., Esq.
In this article, the author discusses how the metadata found in an Electronic Medical Record (EMR) can be used as evidence in litigation under the 2006 amended Rules of Civil Procedure and the Federal Rules of Evidence. The article first reviews how EMR metadata can profile the actions a physician takes when caring for a patient. The author then looks at the relevant changes to the Rules and analyzes case law concerning both electronic discovery (e-discovery) and metadata. Finally, the author examines how EMR metadata specifically impacts physicians who are involved in litigation, as metadata may be used as the standard for authentication of the EMR and can give insight into a patient’s clinical outcome.
The Promises and Pitfalls of Health Savings Accounts
Author: Adam Larson
This comment examines the drawbacks and potential efficiencies associated with Health Savings Accounts (HSAs), and discusses whether HSAs will deliver the purported benefits of reducing aggregate healthcare costs by encouraging value-conscious decisions and increasing cost transparency; thereby reducing the number of Americans without healthcare coverage. The author then discusses several initiatives by state, federal, and private organizations that could ensure wider availability of the tax benefits associated with HSAs, which would broaden the appeal of such accounts for lower-income Americans. After analyzing the background of HSAs, recent developments, and potential improvements, the author describes the current political environment surrounding healthcare coverage and the uncertain future of tax-favored accounts.
Issue 2, Summer 2009
Introduction
By Cynthia M. Ho, J.D. and Ann Weilbaecher, Psy.D
Articles
Prizes for Innovation of New Medicines and Vaccines
Authors: James Love, M.P.A. and Tim Hubbard, Ph.D
This article argues that prizes can help stimulate medical innovation, control costs and ensure greater access to new medicines and vaccines. The authors explore four increasingly ambitious prize options to reward medical innovation, each addressing flaws in the current patent system. The first option promotes innovation through a large prize fund linked to the impact on health outcomes; the second option rewards the sharing of knowledge, data, and technology with open source dividends; the third option awards prizes for interim benchmarks and discrete technical problems; and the final option removes the exclusive right to use patented inventions in upstream research in favor of prizes. The authors conclude that a system of prizes to reward drug development would break the link between R & D incentives and product prices, and that such a reform is needed to improve innovation and access to new medicines and vaccines.
Patents & The Progress of Personalized Medicine: Biomarkers Research as Lens
Author: Matthew Herder, L.L.B., L.L.M., J.S.M
This article addresses the barriers to personalized medicine, focusing on the burgeoning field of biomarkers research. The author begins by framing intellectual property issues as more than a product of industry incentives and suggests that these issues are deeply entangled with other barriers facing personalized medicine such as regulatory framework deficiencies. The author proposes a set of future research questions to more fully define the barriers to biomarkers research and to uncover which corrective measures may be effective. The author concludes by recommending an integration of regulatory and patent reforms, with a call to action by scholars, scientists, representatives of the biopharmaceutical industry, and policy-makers.
Legal, Ethical, and Conceptual Bottlenecks to the Development of Useful Genomic Tests
Author: Michael Tomasson, M.D
This article discusses advances in genomic research in the context of the debate surrounding gene patent rights and the limited rights of patient-participants in translational research. In addition, the author explores statutory and regulatory hurdles to advances in disease diagnosis, such the Bayh-Dole Act, Medicare Legislation, and the Health Insurance Portability and Accountability Act. The author questions the effectiveness of increasingly commercialized academic research and the limited success of the private sector in genomic research. The author concludes that future genomic research will require significantly increased patient participation, which may necessitate a reshaping of the pharmaceutical approach to medicine and the limited stake that patients have in the breakthroughs developed through their participation in the process.
Patents with an “I” = Patients
Authors: Alice O. Martin, J.D., Ph.D. and Sendil K. Devadas, J.D., Ph.D.
The authors address how patent protection in the United States is often quite narrow in scope, difficult to obtain, and insufficient in duration; thus stifling research and development of potential breakthrough pharmaceuticals. The authors further posit that countries that have enacted stronger intellectual property rights and research incentives have seen tremendous increases in foreign direct investment. In addressing critics of the current patent system, the authors show that alternatives to biotechnology patents would not demonstrably improve innovation and development of beneficial medicines. The authors conclude that given the substantial evidence of the patent system's benefits, and the mere speculation that patents have a deleterious effect on patients, no suggestions currently proposed to replace or improve the patent system will have the same beneficial effects for patients.
Diseases Endemic in Developing Countries: How to Incentivize Innovation
Author: Ann Weilbaecher, Psy.D.
This comment addresses the inadequacies of research and development for diseases endemic in developing countries and explores how the patent system can inhibit innovation for new drugs for neglected diseases. The author analyzes four strategies to encourage innovation, including open source initiatives, patent pools, prizes, and wild card patent extensions, and examines how these alternative systems may spur innovation while balancing cost concerns held by drug manufacturers and purchasers. The author concludes that a combination of solutions may provide the best framework for the creation of essential medicines for neglected diseases.