The approval of amendments to Italy’s Budget Law marks a critical step forward in shaping the nation’s healthcare landscape. This blog explores the public health-related measures included in the 2025 Budget Law, their potential implications, and provides a commentary on the reforms.

From a technical perspective, the Budget Law’s focus on innovative medicines, patient involvement, and regional equity reflects a strategic shift towards an inclusive and modernized public health model. The refinancing of the SSN is a commendable step toward addressing inflationary pressures and the increasing demands for healthcare. However, numerous organizations have expressed disappointment with the allocated funds, arguing that the reform falls short of resolving critical public health challenges, such as workforce shortages and insufficient funding. Additionally, the focus on regional benchmarks underscores enduring disparities in healthcare access, which call for continuous monitoring and more targeted corrective actions.

The inclusion of patient associations in decision-making is a progressive step, but ensuring their meaningful participation without overburdening the regulatory framework will be critical. Similarly, the allocations for pandemic preparedness and rare diseases underscore a forward-looking approach but hinge on efficient fund utilization and implementation timelines.

Politically, the 2025 Budget Law underscores a pragmatic approach to healthcare funding amidst fiscal constraints. The increased allocations signal the government’s commitment in attempting to address systemic gaps, yet the law’s reliance on projected growth raises questions about long-term sustainability.

Contentious issues, such as the redistribution of pharmaceutical sector revenues and regional compliance with HTA requirements, could lead and have already led to political friction between stakeholders. Additionally, the delayed implementation of critical reforms, like telehealth reimbursement adjustments, reflects ongoing challenges in balancing innovation with fiscal prudence.

The Assembly voted on the law on 20 December 2024, and its approval laid the groundwork for reforms slated to take effect on 1 January 2025. Overall, the Budget Law represents a cautious yet ambitious step towards a more healthcare system, and amidst criticisms and complaints, is set to innovate key areas of public health governance. Its success will hinge on meaningful stakeholder engagement and collaboration, along with the government’s ability to manage political and economic pressures in the years ahead.

Take a look at our detailed review of the most relevant aspects included in the Budget Law.

The 2025 Budget Law: Key Healthcare Measures

Enhancing AIFA Activities

The Italian Medicines Agency (AIFA) will align with Ministry of Health regulations, provided these are legally and financially feasible. This measure aims to streamline operations and enhance decision-making efficiency within AIFA.

Refinancing the National Health Service (SSN)

The Budget Law significantly increases national healthcare funding, with a progressive rise over the next five years:

• 2025: +€1.302 billion
• 2026-2030: Annual increases ranging from €5.0154 billion to €8.8407 billion.

These funds prioritize:

• €831.5 million in 2026 for critical healthcare goals.
• Benchmarking healthcare funding for five key regions in 2024-2025 to address regional disparities.

Measures for Innovative Medicines and Antibiotics

The Budget introduces enhanced oversight and funding for innovative medicines and antibiotics:

• Annual allocations include €900 million for innovative medicines, €300 million for conditional innovations, and €100 million for listed antibiotics.
• Criteria for funding are tied to safety, efficacy, and quality-of-life improvements, with AIFA set to finalize evaluation metrics by 31 March 2025.

Patient Associations in Health Decision-Making

For the first time, patient associations will have a structured role in public health decisions:

• A registry and guidelines for participation will be established.
• Representatives will join health committees, adhering to conflict-of-interest regulations.

National Breast Unit Registry

A centralized Breast Unit Registry launched on 1 January 2025 at the ISS (Italian National Institute of Health), centralizing data on breast cancer diagnosis and treatment to improve care consistency nationwide.

Funding for Next-Generation Sequencing (NGS) Tests

The fund for NGS tests to diagnose rare diseases is refinanced with €1 million for 2025, emphasizing the importance of precision medicine.

National Pandemic Plan (2025–2029)

Authorized spending for pandemic preparedness includes €50 million in 2025, escalating to €300 million annually by 2027.

Cancer Registry Funding

Increased support for cancer data collection, with an additional €0.5 million annually for 2025 and 2026, and €1 million for 2027.

Governance of Medical Devices

Starting in 2025, medical device governance adheres to a new National Health Technology Assessment (HTA) Program, requiring regional compliance for funding access.

Palliative Care and Lung Cancer Screening

• Palliative care funding rises by €10 million annually from 2025.
• Increased funding for lung cancer screening through the Italian Lung Screening Network.

Prevention and Control of HIV, HPV, and Other STIs

The Budget allocates €5 million annually from 2026 for initiatives targeting sexually transmitted infections.