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.

Physician-vendor marketing and financial relationships under attack.

The appropriateness of gifts, payments, and other remuneration paid to those in a position to influence the purchase or distribution of pharmaceuticals, medical devices, and other goods and services--or those who sell and distribute those goods and services--has come under increased government scrutiny. While providers and vendors scramble to respond to growing concern over potential conflicts of interest and undue influence, federal and state legislators have introduced legislation targeting provider/vendor relationships and regulators have launched significant enforcement actions. This article describes common industry practices, potential legal implications, physician and industry responses, federal and state legislative initiatives, and compliance planning.

Examining the impact of the new Stark rules on joint ventures.

The new Stark rules will affect joint ventures involving physicians and hospitals in four primary areas: Services provided "under arrangement". "Per click" lease arrangements. Percentage-based compensation. "Stand-in-the-shoes" provisions.