Italy has moved its pharmaceutical reform bill out of Senate committee, taking a broad delegation on medicine access, expenditure control and payback into the next parliamentary stage. The Senate of the Republic (Senato della Repubblica) completed committee examination on 14 July and authorised rapporteur Ignazio Zullo to report favourably to the Assembly on the modified text.
The Government Delegation Bill on Pharmaceutical Reform (Delega al Governo per la riforma e il riordino della legislazione farmaceutica, A.S. 1786) would allow the Government to adopt one or more legislative decrees by 31 December 2026. The delegation covers medicine distribution and access, pharmaceutical expenditure ceilings and payback, health-data systems and the role of community pharmacies.
Payback remains the most commercially consequential element. Implementing rules on payback would require agreement through the Unified Conference (Conferenza unificata) between central government, regions and local authorities. Government information supplied during April budget scrutiny said reform could follow principles of graduality, selectivity and financial neutrality.
Possible approaches included progressively reducing company exposure as expenditure ceilings are adjusted, selectively recognising qualifying Italian investment in clinical research, development and production, and differentiating payback according to therapeutic area, innovativeness and the availability of lower-cost alternatives. The Government also said any additional public costs would need to be quantified and funded when the implementing decrees are adopted.
The committee text leaves those choices for the delegated legislation. More prescriptive proposals to phase out payback did not enter the bill, although the Government accepted an order calling for consideration of more predictable, value-based governance and recognition of clinical-research investment.
The next stage therefore concerns a broad legislative mandate rather than a settled replacement for payback. Its eventual commercial effect will depend on the implementing decrees, the fiscal constraints applied to them and the agreement reached with the regions.
Source: Senate of the Republic
Link: Relazione n. 1786-A (Report no. 1786-A)
Date: 14 July 2026
