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Contents - JLME - 2009 Volume 37: 2
Table of Contents
  1. Table of Contents
Letter From The Editor
  1. Letter From The Editor
Symposium Articles
  1. Introduction Pharmaceutical Innovation: Law & the Public's Health
  2. Using Patent Data to Assess the Value of Pharmaceutical Innovation
  3. An Economic Justification for Open Access to Essential Medicine Patents in Developing Countries
  4. Developing Nations and the Compulsory License: Maximizing Access to Essential Medicines While Minimizing Investment Side Effects
  5. Compulsory Licensing in Canada and Thailand: Comparing Regimes to Ensure Legitimate Use of the WTO Rules
  6. Wild-Card Patent Extensions as a Means to Incentivize Research and Development of Antibiotics
  7. Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options
  8. Commentary: Innovation Policy for a New Era
  9. Right to Experimental Treatment: FDA New Drug Approval, Constitutional Rights, and the Public's Health
  10. Just a Spoonful of Sugar: Drug Safety for Pediatric Populations
  11. Prizes and Parasites: Incentive Models for Addressing Chagas Disease
  12. Riegel v. Medtronic, Inc.: Revisiting Pre-emption for Medical Devices
Independent Articles
  1. Collaborated Death: An Exploration of the Swiss Model of Assisted Suicide for Its Potential to Enhance Oversight and Demedicalize the Dying Process
  2. Pushing the Dead into the Next Reproductive Frontier: Post Mortem Gamete Retrieval under the Uniform Anatomical Gift Act
  3. When Scientists Deceive: Applying the Federal Regulations
  4. Differences in Regulatory Frameworks Governing Genetic Laboratories in Four Countries
  5. The Pharmacist's Obligations to Patients: Dependent or Independent of the Physician's Obligations?
Columns
  1. Currents in Contemporary Ethics
  2. Teaching Health Law
  3. Recent Case Developments in Health Law
Table of Contents
Table of Contents
ASLME - [PDF] (Free Download)
Table of Contents
Letter From the Editor
Letter From The Editor
ASLME - [PDF]

Pharmaceutical Innovation: Law & the Public's Health
Symposium Articles
Introduction Pharmaceutical Innovation: Law & the Public's Health
Kevin Outterson - [PDF]

Pharmaceutical Innovation: Law & the Public's Health
Using Patent Data to Assess the Value of Pharmaceutical Innovation
Aaron S. Kesselheim, Jerry Avorn - [PDF]

Though many more patents emerge from industry sources, drug-related patents generated in the non-profit setting appear to have greater importance than patents arising from the commercial sector, which helps demonstrate the value non-profit research institutions can have in driving drug development.
An Economic Justification for Open Access to Essential Medicine Patents in Developing Countries
Sean Flynn, Aidan Hollis, Mike Palmedo - [PDF]

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the "deadweight losses" caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which can be corrected through compulsory licensing. Open licenses that permit any qualified firm to supply the market on the same terms, such as may be available under licenses of right or essential facility legal standards, can be used to mitigate the negative effects of government-granted patents, thereby increasing overall social welfare.
Developing Nations and the Compulsory License: Maximizing Access to Essential Medicines While Minimizing Investment Side Effects
Robert C. Bird - [PDF]

This manuscript addresses how developing countries can maximize access to essential medicines and minimize unwanted side-effects within the legal environment of a compulsory license regime. While compulsory licensing can play a role in improving public health, external social and political conditions must be considered in order to make licensing an effective practice.
Compulsory Licensing in Canada and Thailand: Comparing Regimes to Ensure Legitimate Use of the WTO Rules
Kristina M. Lybecker, Elisabeth Fowler - [PDF]

This paper examines two recent examples of compulsory licensing legislation: one globally embraced regime and one internationally controversial regime operating under the same WTO rules. In particular, we consider Canadian legislation and the use of compulsory licensing for HIV/AIDS drugs destined for a developing country. This is then contrasted with the conditions under which Thai authorities are pursuing compulsory licenses, the outcomes of their compulsory licenses, as well as the likely impact of the Thai policy. Finally, we construct a rubric to evaluate characteristics of a successful regime. This is used to analyze the Canadian and Thai regimes and frame the expected implications of each national policy. It is hoped that the assessment will guide changes to compulsory licensing design to ensure that legitimate regimes are embraced while illegitimate ones are disallowed.
Wild-Card Patent Extensions as a Means to Incentivize Research and Development of Antibiotics
Jorn Sonderholm - [PDF]

Antibiotic resistance is a serious public health problem on a global scale. In both developed and developing countries, the unpleasant consequences of the phenomenon are being felt. This paper discusses wild-card patent extensions as a means to incentivize research and development of new antibiotics. The thesis defended in the paper is that the implementation of such patent extensions is an appropriate legislative response to the problem of antibiotic resistance. The general idea of wild-card patent extensions is presented in the first part of the paper. A number of objections to the idea are thereafter discussed and rejected.
Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options
Jerome H. Reichman - [PDF]

In this Comment, the author traces the relevant legislative history pertaining to compulsory licensing of patented pharmaceuticals from the TRIPS Agreement of 1994 to the 2003 waiver to, and later proposed amendment of, article 31, which enables poor countries to obtain needed medicines from other countries that possess manufacturing capacity. The Comment then evaluates recent, controversial uses of the relevant legislative machinery as viewed from different critical perspectives. The Comment shows how developing countries seeking access to essential medicines can collaborate in ways that would avoid undermining incentives to innovation and other social costs attributed to compulsory licensing. It ends by defending the legality of recent measures taken to promote public health in developing countries, and by reminding developed countries that unilateral retaliation against such measures is demonstratably illegal under WTO foundational law and jurisprudence.
Commentary: Innovation Policy for a New Era
Amy Kapczynski - [PDF]

This commentary offers a response to the Sonderholm, Bird, and Flynn et al. articles, and argues that the current innovation crisis requires more ambitious approaches, as well as a serious consideration of alternative mechanisms for R&D such as prizes.
Right to Experimental Treatment: FDA New Drug Approval, Constitutional Rights, and the Public's Health
Elizabeth Weeks Leonard - [PDF]

On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.
Just a Spoonful of Sugar: Drug Safety for Pediatric Populations
Barbara A. Noah - [PDF]

Children deserve optimal medical care. Although prescription drugs play a prominent and essential role in pediatric health care delivery, health care providers often must make prescribing decisions for their young patients based on imperfect or absent safety and efficacy data for pediatric populations. The safe and effective use of prescription drugs in children depends on a thorough understanding of the physiologic differences between children and adults. Currently, only one-third of drugs prescribed to children have been studied for safety and efficacy in pediatric populations. Until relatively recently, the Food and Drug Administration (FDA) made surprisingly little effort to improve the quality or quantity of clinical research data for this patient group. Recent agency efforts to encourage pediatric drug research have generated mixed results and created unintended consequences. The development, prescribing, and safety evaluation of prescription drugs for children will require that the FDA and health care providers examine current practices, acknowledge their shortcomings, and consider creative solutions to the challenges associated with gathering additional data through pediatric drug research.
Prizes and Parasites: Incentive Models for Addressing Chagas Disease
Sara E. Crager and Matt Price - [PDF]

Recent advances in immunology have provided a foundation of knowledge to understand many of the intricacies involved in manipulating the human response to fight parasitic infections, and a great deal has been learned from malaria vaccine efforts regarding strategies for developing parasite vaccines. There has been some encouraging progress in the development of a Chagas vaccine in animal models. A prize fund for Chagas could be instrumental in ensuring that these efforts are translated into products that benefit patients.
Riegel v. Medtronic, Inc.: Revisiting Pre-emption for Medical Devices
Bruce Patsner - [PDF]

The recent United States Supreme Court decision in Riegel v. Medtronic, Inc. affirmed the doctrine of pre-emption protection only for those medical devices reaching U.S. markets via the PMA (premarketing approval) process and preserved the previous Lohr v. Medtronic decision's lack of preemption protection for those medical devices marketed via the generally more abbreviated 510(k) clearance mechanism. This paper reviews the logic and faults of the Riegel decision and discusses the implications of the Riegel decision for pre-emption protection for other classes of FDA-approved medical products.
Independent Articles
Collaborated Death: An Exploration of the Swiss Model of Assisted Suicide for Its Potential to Enhance Oversight and Demedicalize the Dying Process
Stephen J. Ziegler - [PDF]

Death, like many social problems, has become medicalized. In response to this medicalization, physician-assisted suicide (PAS) has emerged as one alternative among many at the end of life. And although the practice is currently legal in the states of Oregon and Washington, opponents still argue that PAS is unethical, is inconsistent with a physician's role, and cannot be effectively regulated. In comparison, Switzerland, like Oregon, permits PAS, but unlike Oregon, non-physicians and private organizations play a significant role in assisted death. Could the Swiss model be the answer? The following essay explores the Swiss model of assisted suicide for its potential to enhance the regulation of PAS, reduce physician involvement, and perhaps demedicalize the way we die.
Pushing the Dead into the Next Reproductive Frontier: Post Mortem Gamete Retrieval under the Uniform Anatomical Gift Act
Bethany Spielman - [PDF]

In re Matter of Daniel Thomas Christy authorized post mortem gamete retrieval under the most recent revision of the Uniform Anatomical Gift Act. This article recommends that the National Conference of Commissioners on Uniform State Laws explicitly address the issue of post mortem gamete retrieval for reproductive purposes; that legislators specify whether their states will follow the Christy ruling; and that ethics committees and consultants prepare for the questions about human identity and self determination that post mortem gamete retrieval raises.
When Scientists Deceive: Applying the Federal Regulations
Collin C. O'Neil, Franklin G. Miller - [PDF]

Deception is a useful methodological device for studying attitudes and behavior, but deceptive studies fail to fulfill the informed consent requirements in the U.S. federal regulations. This means that before they can be approved by Institutional Review Boards, they must satisfy the four regulatory conditions for a waiver or alteration of these requirements. To illustrate our interpretation, we apply the conditions to a recent study that used deception to show that subjects judged the same wine as more enjoyable when they believed it had a higher price.
Differences in Regulatory Frameworks Governing Genetic Laboratories in Four Countries
Anne Marie Tasse, lodie Petit, Beatrice Godard - [PDF]

The purpose of this article is to determine how the heterogeneity of the different regulatory frameworks governing genetic laboratories in Australia, France, the United Kingdom, and the United States hinder the international availability of genetic tests. We conclude that a better understanding of the various national standards governing genetic laboratories may help health professionals choose laboratories for referral in an evidence based manner in order to protect the patient's best interests.
The Pharmacist's Obligations to Patients: Dependent or Independent of the Physician's Obligations?
Jason V. Altilio - [PDF]

It has been 40 years since the seminal papers on pharmacy's status as a profession sparked debate about the pharmacist's role in health care, yet the questions they raised are just as poignant today as they were then. Questions about whether pharmacists are the experts when it comes to drug therapy information can be answered practically by assessing the perception of pharmacists' obligations to patients as being dependent on or independent of physicians' responsibilities. Both options have important implications for pharmacy's status as a profession, the value that pharmacists can add to health care, and a pharmacist's right to deny a patient emergency contraception.
Columns
Currents in Contemporary Ethics
Amy L. McGuire - [PDF]

Currents in Contemporary Ethics
Teaching Health Law
Jonathan Todres - [PDF]

Teaching Health Law
Recent Case Developments in Health Law
Brett Hartman, Faina Shalts, and Caitlyn Ross - [PDF]

Recent Case Developments in Health Law