| Ways of Regulating: Therapeutic Agents between Plants, Shops, and Consulting Rooms
Where is the Pharmacy to the World? Pharmaceutical Industry Location and International Regulatory Variation
A consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based organizations have assumed greater roles in defining disease categories than in the past and now influence clinical trials and participate in regulatory decision-making. Yet these developments are far from universal and are taking very different forms around the world. Building on data showing that pharmaceutical firms headquartered in the United States have performed well since 1980 when compared to firms in Europe or Asia (measured both by sales and by numbers of new product introductions), this essay explores the interplay of regulation, definitions of "patient" and "consumer," and centers of power for the pharmaceutical industry. A comparison of the United States and Germany in particular, and the United States and European Union more generally, suggests that how countries resolve tensions between protecting patients and empowering consumers will impact the international competitive standing of their domestic pharmaceutical industries.
Keywords: Geographic Location;
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Demand and Consumers;