Redefining the Italian HTA framework?

Is there a need for a stronger, more centralized HTA agency in Italy? This is a question that lies at the nexus of health and governance, with the regionalization of Italy enshrined in the Constitution of the…young country (Italy as a united country dates back 1861 only). The subsequent devolution of powers allocated a wide scope of competence to regional health authorities in particular.


While health stewardship sketchily falls under the jurisdiction of decentralized bodies, Italy also allocated co-ordination responsibilities in the field of HTA to the Italian Agency for Regional Services (AGENAS). As reported by lawyers Baker McKenzie:


As part of the debate on the need to identify a national agency for the health technology assessment to promote the sustainability, universality and efficiency of the National Health System, the Italian Agency for Regional Health Services (Agenas) emphasized the importance of its role in the cooperation between the central and regional level for the evaluation of health technologies named National Program for the Health Technology Assessment (HTA).


More specifically, the AGENAS published a report in July this year underlining the need to increase its scope of responsibilities in view of the pandemic: COVID-19 illustrates the need to push for faster and more streamlined procedures. In this regard, the AGENAS clearly positions itself as the focal point in support to the Coordination Office for HTA activities and calls for more responsibilities, which include already:


The setting up of a notification system of assessment needs, the drawing up of the list of technologies to be submitted for priority evaluation by the Coordination Office, as well as the managing and coordination of national reports on HTA requested by the Coordination Office.


It looks as though the AGENAS calls for lawmakers to help channel the HTA activities carried out at regional level (11 Italian regions have enacted specific regulations to manage HTA processes) and perhaps increase the efficiency and timeliness of the HTA mechanisms.


Decide would welcome comments, analyses or further information from its many Italian experts who are part of its community. Cordiali Saluti a tutti!



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