The Political Sociology of NICE: Investigating Pharmaceutical Cost-Effectiveness Regulation in the UK.

The National Institute for Health and Care Excellence (NICE) was established a quarter of a century ago in 1999 to regulate the cost-effectiveness of pharmaceuticals (and other health technologies) for the NHS. Drawing on medical sociology theories of corporate bias, neoliberalism, pluralism/polycentricity and regulatory capture, the purpose of this article is to examine the applicability of those theories to NICE as a key regulatory agency in the UK health system. Based on approximately 7 years of documentary research, interviews with expert informants and observations of NICE-related meetings, this paper focuses particularly on NICE's relationship with the interests of the pharmaceutical industry compared with other stakeholder interests at the meso-organisational level. Consideration of the interaction between the UK Government and the pharmaceutical industry in relation to NICE is presented together with the analysis of revolving doors and conflicts of interest of NICE experts/advisors. The nature of policy changes over time (e.g. accelerated assessment pathways and industry fees for regulatory appraisals) and how they relate to the relevant stakeholder interests is also investigated. It is concluded that NICE is largely characterised by neoliberal corporate bias, though some elements of its organisation are also consistent with theories of capture, pluralism and polycentricity.