PBMs obtain pharmacy discounts and rebates from drug manufacturers that have helped to stem the rise in prescription drug prices. At the same time, PBMs implement drug utilization management and also are involved increasingly in disease management. This paper describes the evolution of PBMs and assesses the ways in which PBMs could facilitate the process of adding a Medicare prescription drug benefit. Not surprisingly, the settlements have been attacked under the antitrust laws, and there have been calls for reform of the Hatch-Waxman Act provisions that create a greater incentive for these settlements. This article explains how these settlements should be analyzed under the antitrust laws and when competitive problems are posed.
Human tissues play a critical role in modern medicine.
Both living donors and cadavers serve as sources of human tissue. But whether procured from a living or deceased donor, subjected to sophisticated tissue engineering or used in transplantation in its unprocessed, basic form, multifaceted human tissue is no longer limited by national borders. In this era of globalization, the increasingly international scope of human tissue use presents new challenges in cross-border disease control. In response, the regulatory authorities of several industrialized countries, along with consumer and industry leaders in the biomedical field, are now developing a globally accepted set of standards governing human tissue use and tissue banking. This article examines the ethical considerations associated with human tissue use, human tissue regulation in several countries, as well as regionally by the European Union, and the current multi-country effort toward international harmonization of human tissue use and tissue banking.