Protecting the people?: risk communication and the chequered history and performance of bureaucracy.

The history and characteristics of bureaucracy(1) are examined with a view to understanding the impact of the bureaucratic mindset on medicines' regulation, the pharmaceutical industry and healthcare delivery with a focus on risk communication, pharmacovigilance and patient safety. Controversies and allegations relating to common, negative effects of bureaucratic regulatory and management systems are reviewed and examples of creative and effective practice provided. Strategic directions and specific actions for reform are proposed.(2)