Managing Uncertainty in Public Health Service Regulation: The Case of Nice Technological Appraisals

This paper examines the ‘technological appraisals’ carried out by NICE (National Institute for Health and Care Excellence) as it regulates the provision of new drugs within the English NHS on cost effectiveness grounds. Regulators must assess and manage risk in order to ensure the effective functioning of the transactions which occur under their jurisdiction. Recent studies have argued that this role is more one of managing uncertainty than managing risk, but few investigations have explored how uncertainty is dealt with at the micro-level. In the context of our study, probabilistic data is derived from existing studies into the effects of a drug and modelled into quality adjusted life years (QALYs) as a means of comparing the cost per QALY of the particular drug for specific patient groups. Ostensibly this is a highly rational process by which the regulatory process absorbs uncertainty. In practice, and as found in a scoping study, things are far more complex and uncertain. This paper draws on ethnographic data – interviews with a range of stakeholders (including clinical and patient experts and representatives of the drug manufacturers) and decision-makers (n=40), observations of public and closed regulator meetings, and documentary analysis – of the decision-making process around three very different pharmaceutical products. The study explores the various ways in which different forms of uncertainty – epistemic, procedural, relational and others – are perceived, considered, presented and tackled within these drug appraisals.  Special attention is paid to various techniques through which uncertainty and complexity are reduced and/or bracketed-off and how these techniques manifest themselves at the micro-interactional level. We also explore how broader organisational pressures and relations are translated into features of decision-making and shape how actors co-construct and cope with uncertainty.