On July 31, 2025, the draft enabling bill for the Consolidated Act on Pharmaceutical Legislation was presented to the Italian Chamber of Deputies. The reform aims to simplify and streamline the current regulatory framework, which is fragmented and the result of overlapping legislative interventions over time. The new Consolidated Act seeks to establish a coherent and modern set of rules, capable of responding more effectively to the present and future needs of the pharmaceutical sector.

 Among the key elements of the draft bill are the updating of pharmaceutical spending caps and the revision of the payback mechanisms, with the goal of ensuring greater financial sustainability and enhancing the attractiveness of the system. A further priority is to strengthen the right to fair and continuous access to medicines, with particular attention to patients affected by rare, chronic, or debilitating diseases. This will involve revising distribution rules and promoting domestic production of active ingredients and excipients.

The bill also provides for the enhancement and integration of national and regional health information systems, which are to become fully interoperable with the Electronic Health Record and the Pharmaceutical Dossier. This integration aims to enable real-time monitoring of prescriptions, consumption, and stock levels, as well as the timely detection of drug shortages, supported by collaboration among companies, local authorities, and healthcare stakeholders.

Additionally, the reform calls for the strengthening of the Health Card system through full digitalization of the entire prescription and dispensing process, thereby reducing administrative burdens.

Lastly, community pharmacies are recognized as key points of care, to be structurally integrated into the broader territorial healthcare network.