Consolidated Act on Pharmaceutical Legislation

At the instigation of the Undersecretary of State for Health Marcello Gemmato, the Government has launched a reform process that has been awaited for decades: a Consolidated Act on Pharmaceutical Legislation. This initiative aims to reorder a legislation that is currently fragmented into hundreds of acts stratified over time, with the goal of building a consistent, modern system matching the needs of citizens, institutions and sector operators alike.

The objectives are:

• ensuring fairness and timeliness in access to medicines
• strengthening the efficiency and sustainability of the pharmaceutical supply chain
• ensuring a clear, coordinated and stable regulatory framework.

The stages of the procedure

08/05/2025
Announcement of the reform project 

With the event "The new EU pharmaceutical legislation and Italian governance: impacts and prospects", organized at the Chamber of Deputies by the Undersecretary for Health Marcello Gemmato, the project of a Consolidated Act on Pharmaceutical Legislation was presented for the first time. The discussion, which was attended by ministers, representatives of Italian and European institutions, AIFA, trade associations and stakeholders in the sector, laid the foundations of the reform process, identifying the main objectives: fairer and more timely access to medicines, the fight against global phenomena such as shortages and antibiotic resistance, regulatory simplification and a strengthening of national production of active ingredients.

31/07/2025
Presentation of the draft empowerment bill

At the Sala della Regina of the Chamber of Deputies, Undersecretary Gemmato officially presented the draft bill empowering the Government to draft the Consolidated Act. This gathering represented a crucial step: the principles announced in May were translated into legislative guidelines, with a focus on access to medicines, governance of spending, and a strengthening of the country’s care network. The dialogue session with stakeholders made it possible to collect observations and concrete proposals, confirming the working method based on the participation and involvement of the actors of the system.

18/09/2025
Approval in the Council of Ministers of the bill empowering the Government to draft the Consolidated Act

The Council of Ministers approved the draft empowerment bill for the reform of pharmaceutical legislation, formally launching the process that will allow the Government to prepare the Consolidated Act. This approval represents the official step that authorizes the executive to draw up the implementing rules and coordinate the subsequent phases of the reform.

Next steps

A study commission will finalize the draft of the empowerment bill and initiate the implementation decrees. The process will continue in Parliament, involving the Regions in the planned steps.

In keeping with the principles of participation and transparency, pharmaceutical sector stakeholders may express any views that would help to define a modern, shared, and citizen-friendly Consolidated Act, fully integrated with the European and international context. The e-mail address is testounicofarmaceutico@sanita.it.

To learn more:

• Government empowerment bill approved in the Council of Ministers