Medicines, forecasting tools and right prescriptions to contain expenditure

"There is no favourable wind for the sailor who does not know where he is going," wrote Seneca. It is a principle that also applies to health and industrial policies: without clear direction, without planning and without government and regulatory stability, there can be neither sustainability of public spending nor attractiveness for investment.

The pharmaceutical sector is, by its very nature, one of the most sensitive to regulatory uncertainty. It is a sector that requires long horizons, predictable rules and reliable data. The stability of government action today makes it possible to address this structural issue not with spot measures, but with system-oriented reforms. It is in this framework that the choices on the reorganisation of the distribution of medicines and the reform of pharmaceutical legislation that I intended to initiate with the Consolidated Text are to be placed. Pharmaceutical expenditure in Italia is subject to continuous and certified monitoring. By law, the only authority competent to validate the data is the Agenzia Italiana del Farmaco. This system allows not only the final control, but also the construction of forecast scenarios useful for the planning of health and industrial policies. The transfer of certain classes of drugs from direct hospital and account distribution to contracted pharmacies is part of a medium-term strategy that aims to simplify access to care for citizens, improve the organisational efficiency of the system, strengthen territorial care and bring hospital functions back to the clinical dimension.

From an accounting point of view, there is no increase in public expenditure attributable either to the change of distribution channel for certain classes of antidiabetics initiated with the Budget Law 2024 or to the new remuneration of pharmacies. The resources earmarked for the medicines affected by the reclassification were already fully allocated to the ceiling of direct purchases; the shift to the contracted pharmacy allocates the same expenditure to another ceiling, not the introduction of new burdens for public finance. In the case of glyflozines, the reclassification process was accompanied by a downward price renegotiation that the manufacturers responsibly agreed to, aware of the scope of the reform. This resulted in a saving of EUR 9.2 million for the National Health Service in a single quarter, or approximately EUR 36 million on an annual basis.

Now, constructing estimates based on individual products and projecting them onto the entire therapeutic class of glyphozines - consisting of 29 molecules with heterogeneous price conditions - produces results that are methodologically unrepresentative and not useful for planning purposes. The increase in contracted expenditure observed in the first nine months of 2025 is mainly attributable to the spread of more innovative and effective therapies. This dynamic is consistent with a healthcare system that directs resources towards solutions with greater clinical value. The crux of the matter is not to stifle innovation, but to govern its economic impact through forecasting tools and appropriate prescribing. This is also the background to the issue of pharmaceutical payback, which is regulated by current legislation as an instrument for compensating for deviations from expenditure ceilings. A mechanism introduced in an emergency phase and progressively becoming structural, with significant effects on the predictability of financial flows and on industrial planning capacity, now also the subject of attention by the Competition and Market Authority.

This confirms the need to overcome a purely compensatory logic and to build a system that is more consistent with health programming and with the need for stability in the production sector, while maintaining a balance between financial sustainability and access to innovation. Access to medicines is not protected by stiffening classifications born in different contexts, nor by fuelling contrasts between actors in the supply chain. It is protected by recomposing the planning, clinical and organisational levels in a unified vision, based on certified data, stable rules and shared responsibilities. This is the step we are called upon to take today: from the ex post management of deviations to the ex ante construction of the conditions for balance, to make the right to care, competitiveness and sustainability compatible.