Italy’s Undersecretary of Health Marcello Gemmato presented a framework bill to Parliament today aiming to simplify, rationalize, and enhance the effectiveness of the nation’s complex pharmaceutical regulations. The bill delegates authority to the government to draft a Consolidated Act for Pharmaceutical Legislation.
“With pragmatism and responsibility, we are advancing the plan announced last May,” Gemmato stated during a conference. “We are building a unified, modern regulatory framework capable of addressing the needs of both citizens and the sector. The new Consolidated Act will be founded on core principles: ensuring drug access, monitoring and controlling pharmaceutical expenditure, and strengthening community healthcare services.”
The proposed reform involves multiple key ministries—Health, Economy and Finance, Enterprise and Made in Italy, Environment, and Justice. The implementing decrees will require approval by Parliament and the State-Regions Conference.
“The objective,” explained Gemmato, “is to overcome the fragmented legislation accumulated over time, ranging from Royal Decrees dating back to 1934 to amendments in recent budget laws. This government intends to provide the country with a clear, updated, and coherent regulatory framework for a sector vital to public health and the national economy.”
Key provisions of the measure include:
Improved patient access to medicines, particularly for those with rare, chronic, or disabling conditions;
Revision of spending caps and drug rebate (payback) mechanisms;
Enhancement of health information systems and full interoperability with the Electronic Health Record;
Digitalization of prescriptions.
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