The role of European HTA agencies in relation to the governance of medical technologies: a discourse analysis of academic literature

How the role of health technology assessment (HTA) agencies in relation to medical technologies (MedTech) is framed in the literature reflects and influences governance, shaping perceptions and guiding decisions. We identify different academic discourses to advance MedTech policy debates, in light of several factors potentially influencing this role. This is the first time that discourse on the role of HTA agencies in relation to MedTech has been reviewed. We conducted a comprehensive search, screened for eligibility, and synthesised findings using discourse analysis. 119 articles were included, from which 5 discourses were constructed. The first discourse describes the HTA agency as an independent evaluator of appropriate evidence for all health technologies. The second discourse explicitly categorises MedTech as separate from pharmaceuticals and expands the role of evaluator to include encouraging evidence generation for MedTech. The third discourse moves away from the role of independent evaluator and describes the HTA agency as a convenor of all stakeholder perspectives, using an experimental approach. The fourth and fifth discourses critically reflect on the role of HTA agencies, the fourth on their level of normative reflection and the fifth on their level of nuanced, clinical expertise. We conclude with recommendations for policy and research.