Patient-tailored medicine, part two: personalized medicine and the legal landscape.

In Part One, the authors addressed the relevance of genetic information, and how race and genetics have affected and may impact the development of medicines, pharmacogenomics, and personalized medicine in the United States. Part Two examines current and proposed federal and state laws and regulations intended to protect individuals from the misuse of genetic information, including uses that discriminate based on genetic predispositions. This Part next explores the potential for litigation against both manufacturers and providers,as well as potential defenses. The authors also discuss legal issues relating to research that relies on the use of genetic information.

Patient-tailored medicine, Part one: the impact of race and genetics on medicine.

One of the more controversial elements of advancing technology is the use of race and genetics to help create more specific types of medicines that will help combat diseases and conditions that appear to be more prevalent within certain races or ethnic groups than in others. Considering the history of discrimination and inadequate treatment of individuals on the bases of race and gender in the United States, there is justifiable concern that race or gender-based treatment could be used to legitimate discrimination. On the other hand, there is substantial proof that the current method of creating medicines for the general public is problematic and could prevent effective treatments from reaching the marketplace. Part One of this series addresses the relevance of genetic information, and how race and genetics have affected and may impact the development of medicines, pharmacogenomics, and personalized medicine in the United States. Part Two, which will appear in the next issue of the Journal of Health and Life Sciences Law, will focus on how personalized medicine may affect the American legal, regulatory, and legislative environment.