AIFA pharmaceutical innovation and evaluation discussions

The Italian Medicines Agency (AIFA) has initiated institutional dialogues focused on the value of pharmaceutical innovation and its impact on the Italian National Health Service. During a conference in Genoa, discussions centered on developing advanced models to evaluate drug innovation, emphasizing that assessments should look beyond clinical efficacy to include patient outcomes and the economic sustainability of healthcare systems.

AIFA President Robert Nisticò has further detailed these themes, noting that scientific research is shifting focus from merely treating symptoms to addressing underlying biological processes. He highlighted advancements in targeted therapies, including gene therapy, genomic editing, and CAR-T cell therapies, which engineer a patient’s own lymphocytes to attack tumor cells. These sophisticated treatments aim to improve both disease progression and patient quality of life.

Regarding the regulatory framework, Nisticò explained that drug authorization begins at the European level through the European Medicines Agency (EMA) based on a benefit-risk assessment. Following EMA approval, individual member states, such as Italy, remain responsible for conducting further evaluations regarding the sustainability of these new medicines within their respective national health frameworks.