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Other Issues:	Contents: Summer 2009, Volume 37, Issue 2   [Index by author]  Symposium Articles   I. PATENTS, INNOVATION [amp ] PUBLIC HEALTH   II. INVITED REVIEWS   III. PHARMACEUTICAL INNOVATION [amp ] SPECIAL POPULATIONS Independent Articles Columns
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Symposium Articles

I. PATENTS, INNOVATION [amp ] PUBLIC HEALTH

Using Patent Data to Assess the Value of Pharmaceutical Innovation Aaron S. Kesselheim and Jerry Avorn J Law Med Ethics 2009 37: 176–183. [PDF] [References]   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, and Mike Palmedo J Law Med Ethics 2009 37: 184–208. [PDF] [References]   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 J Law Med Ethics 2009 37: 209–221. [PDF] [References]   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 and Elisabeth Fowler J Law Med Ethics 2009 37: 222–239. [PDF] [References]   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 J Law Med Ethics 2009 37: 240–246. [PDF] [References]   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.

II. INVITED REVIEWS

Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options Jerome H. Reichman J Law Med Ethics 2009 37: 247–263. [PDF] [References]   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 J Law Med Ethics 2009 37: 264–268. [PDF] [References]   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.

III. PHARMACEUTICAL INNOVATION [amp ] SPECIAL POPULATIONS

Right to Experimental Treatment: FDA New Drug Approval, Constitutional Rights, and the Public's Health Elizabeth Weeks Leonard J Law Med Ethics 2009 37: 269–279. [PDF] [References]   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 J Law Med Ethics 2009 37: 280–291. [PDF] [References]   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 J Law Med Ethics 2009 37: 292–304. [PDF] [References]   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 J Law Med Ethics 2009 37: 305–317. [PDF] [References]   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

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