Legal and Political Competitiveness for Pharmaceuticals

The pharmaceutical industry operates both as an important business sector and a vital contributor to the delivery of health services worldwide. In 2012, the total world market for pharmaceutical products amounted to nearly US$1 trillion (see Table 1). Although global in scope, some 60 percent of sales were in North America and Europe, which comprise only 15 percent of the world’s population. The industry plays an important economic role in many countries by contributing to national income and employing hundreds of thousands of educated workers. Studies in the United States and Germany have found that for each direct employee, the pharmaceutical industry also generates between 1.6 and 3.5 jobs in supporting industries [7, 9]. While Germany long boasted of its role as the “world’s apothecary,” firms in Switzerland, France, the United Kingdom, and the United States also have underwritten decades of research into new medicines and brought several thousand new medicines to market since the late 19th century [1]. However, since the early 2000s, a steady decline in global prescription drug sales has accompanied an international deterioration in the underlying conditions critical to pharmaceutical in novation [6]. Troubles can be found also in a declining number of new chemical or biological medicines approved for markets despite a steady rise in research spending [8]. Policy discussions in some countries reveal a shift against industry arguments that high profit margins on current drug sales are necessary to finance research into future pharmaceuticals. Countries across the OECD instead are looking for ways to reduce health spending and national pharmaceutical budgets have been held constant or even reduced. Policies including reference pricing and demands that the industry demonstrate the cost effectiveness of its products are now widespread, especially in Europe [4]. Articles in this special issue of Pharmaceuticals Policy and Law analyse factors governing the legal and competitive environment for the pharmaceutical sector. Key issues are explored across the full pharmaceutical value chain, including drug discovery, development, authorization, and marketing. The articles demonstrate widespread, typically longstanding, tensions between policies that on the one hand