Legal, ethical, and conceptual bottlenecks to the development of useful genomic tests.

Abstract

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.