Volume 9 (2003) / Issue 4
The imposition of a 'fourth hurdle' of cost-effectiveness is becoming a common feature of the regulation of pharmaceuticals in several European countries. The National Institute for Clinical Excellence (NICE), which operates in England and Wales, is one of the most visible examples of this phenomenon and represents an influential model for reform elsewhere. This paper considers the lessons which may be drawn from NICE, focusing in particular upon the issue of legitimacy. It will be argued that regulatory legitimacy may be enhanced by giving institutional effect to procedural values which are of central importance to public law.
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