An approved medicine is not necessarily an accessible medicine. Between European authorization and patient access lie rules, resources, and organizational structures governed at different levels that are not always aligned.

Integration, overlap, or conflict?

This was the question at the heart of the Privileged Talk promoted by the Pharmaceutical Observatory at CERGAS, SDA Bocconi School of Management, which brought together representatives from European, national, and regional institutions to exchange perspectives and discuss how to make the governance of pharmaceutical care more effective.

The first critical issue is time. A reform that takes years to develop risks coming into force only after technological innovation has already transformed the context in which it is intended to operate. As Pietro Erba, Policy Officer, DG SANTE, European Commission, explained, the new European pharmaceutical legislation therefore also relies on flexible regulatory tools. These include regulatory sandboxes, controlled environments in which companies and regulators can test innovative approaches, and Adapted Frameworks, designed for therapies that do not fit existing standards.

More agile rules, however, are not enough if the system is not ready to embrace innovation. Ugo Trama, Directorate General for Health Protection, Campania Region, and Marzia Mensurati, Head of the Pharmaceuticals and Medical Devices Unit, Lazio Region, clearly emphasized the need to invest in networks, capabilities, and care pathways. Above all, what is needed is a shift in perspective that moves the focus from costs to outcomes and recognizes the value a medicine delivers in clinical practice, beyond the evidence generated by registrational trials.

This is also the foundation of the vision outlined by Robert Nisticò, President of the Italian Medicines Agency, AIFA, who sees planning as the key driver of system modernization. This means moving beyond a constant emergency response and using horizon scanning to prepare treatment centers, diagnostic services, and care pathways before new therapies become available. It also means defining shared outcomes that account for quality of life and indirect costs, while giving renewed momentum to research, including basic research.

This is a direction that SDA Bocconi has long supported. Francesco Costa, Associate Professor of Practice and Coordinator of the Pharmaceutical Observatory, Government, Health and Not for Profit Division, SDA Bocconi; Patrizio Armeni, Associate Professor of Practice, Government, Health and Not for Profit Division, and Coordinator of the Digital Transformation Hub, SDA Bocconi; and Monica Otto, Director for Executive Education, Government, Health and Not for Profit Division, SDA Bocconi, and Scientific Director of the Pharmaceutical Observatory, highlighted that linking funding to outcomes is complex, but can no longer be postponed.

The necessary data already exist. The challenge is to connect them at the individual patient level while ensuring security and confidentiality, leveraging tools such as the Electronic Health Record and the European Health Data Space.

Italy has capabilities, networks, and innovative tools that are also recognized at the European level. The task now facing institutions, academia, and industry is to work together to turn these assets into practical, sustainable solutions.