A regulatory governance perspective on health technology assessment (HTA) in France: The contextual mediation of common functional pressures

•Applies a new regulatory governance frame to the study of health technology assessment (HTA).•HTA does not take place within isolated institutions that apply self-selected methods.•Development of national HTA agencies follows an evolutionary pattern under which contextual factors mediate common functional pressures.•European calls for harmonization of HTA methods are likely to be met with diverse national policy responses.•French process for HTA uses multiple stakeholders to contain costs within the system.•French policy makers have been historically wary of strict economic measures of cost-effectiveness.

The new regulatory governance perspective has introduced several insights to the study of health technology assessment (HTA): it has broadened the scope for the analysis of HTA; it has provided a more sophisticated account of national diversity and the potential for cross-border policy learning; and, it has dissolved the distinction between HTA assessment and appraisal processes. In this paper, we undertake a qualitative study of the French process for HTA with a view to introducing a fourth insight: that the emergence and continuing function of national agencies for HTA follows a broadly evolutionary pattern in which contextual factors play an important mediating role. We demonstrate that the French process for HTA is characterised by distinctive institutions, processes and evidential requirements. Consistent with the mediating role of this divergent policy context, we argue that even initiatives for the harmonisation of national approaches to HTA are likely to meet with divergent national policy responses.