Current Issue
The current issue of the Annals of Health Law is Volume 18, Issue 2 (Summer 2009).
Issue 2, Summer 2009
Introduction
Articles
Prizes for Innovation of New Medicines and Vaccines
Authors:
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:
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:
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:
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:
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.
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