Gender medicine responds to the need for a reassessment of the medical-scientific approach in a gender perspective, to increase knowledge of the different aspects underlying gender differences and the appropriateness/ effectiveness of health interventions.

A policy review of documents prepared by the Italian Ministry of Health on gender medicine was carried out, to investigate the possible areas of intervention of health technology assessment in the development of this interdisciplinary dimension. The areas of highest priority for action have been identified.

In Italy, the Ministry of Health, with the support of the National Institute of Health, issued a Plan for Application and Dissemination of Gender Medicine in June 2019. Our review shows that for the development of research on the mechanisms of pathogenesis the Italian Plan gives indications on the identification of diagnostic markers, prognostic and predictive response in a gender perspective, but there are no formalized rules that constitute a constraint or an obligation to do so. In Horizon Europe calls, for example, “Pragmatic trials on minimally invasive diagnostics” (HORIZON-MISS-2023-CANCER-01-03) on the other hand, it is required that gender and gender issues should be taken into account in all projects and all data should be disaggregated by gender, socio-economic status and ethnicity. Separating subjects into two groups in the analysis leads to greater complexity. This is even more true when considering the different types of gender. The total number of subjects to be included must likely increase to maintain statistical power in evaluating effects in subgroups. This increase leads to an increase in time and cost, if one needs to provide separate data by sex and even more so by gender. Different statistical tests to be used, according to the type of variables of the primary endpoint, should be considered in the study protocols.

It seems appropriate to suggest reviewing upcoming health technology assessments with an eye to gender medicine. Gender medicine should become a strategic goal of prevention in public health and will strengthen the concept of the patient centrality until the personalization of therapies is achieved.