ABSTRACT

This chapter focuses on the problems of research-based manufacturing companies caused by the legal diversion generally termed parallel trade or unwarranted trade in Europe and describes how companies attempt to minimise the impact of this activity on revenues and profits. The business model operates by the large companies manufacturing and marketing equipment for patient use. Organisations can seek to prevent reimportation by creating a regulatory barrier to the high-priced market. The extent of diversion and other illicit trade in HIV products or similar lifestyle drugs, especially via the Internet, is extraordinary. The United States (US) Food and Drug Administration (FDA) strongly regulates and inspects all manufacturing sites around the world that produce products for the US market. In many developing markets, imported, patented healthcare products represent significant costs and loss of revenue for manufacturers and the local industry.