Life Sciences and Healthcare

2022 Finance Act increases State investment in Italian national health system

Published on 25th Jan 2022

Pharmaceutical spending ceilings are increased and reforms to technical standards are expected 

The Covid-19 pandemic has triggered a strong response by the Italian government with the approval of the 2022 Finance Act (Law no. 234 of 30 December 2021).

In addition to a number of measures to address the emergency, including the allocation of dedicated funds and the recruitment of additional healthcare professionals (HCPs), the Finance Act provides for an overall increase of existing national health funds, including those relating to pharmaceutical spending ceilings with the intent to reduce the payback due by pharmaceutical companies and, hopefully, any related court litigation. 

The implementation of new technological standards, including telemedicine, IT tools and artificial intelligence, also signals an intention to strengthen the assistance to patients.

Increase in the National Health Fund

Each year the Finance Act sets the overall level of resources to cover the costs of the National Health System (NHS) to which the State contributes.

The 2022 Finance Act has increased overall national health funding by allocating an additional €2 billion in each of the next three years to the National Health Fund (NHF), which will grow from €122 billion to €124 billion in 2022, to €126 billion in 2023 and to €128 billion in 2024.

The fund for the purchase of innovative drugs has also been increased by €100 million in 2022, €200 million in 2023 and €300 million in 2024.

Pharmaceutical spending ceiling

The overall ceiling of public pharmaceutical spending will increase from 14.85% to 15% of the NHF in 2022, to 15.15% in 2023 and to 15.3% from 2024 onwards. 

In particular, the ceiling for the purchases of retail drugs (spesa convenzionata) will remain unchanged (7%), while the spending ceiling for direct purchases of drugs by hospitals (acquisti diretti) will increase from the current 7.65% of the NHF to 8% in 2022, 8.15% in 2023 and 8.3% from 2024 onwards.

The increase is subject to the following conditions: 

  • the annual revision by AIFA (the Italian Medicines Agency) of the list of drugs reimbursable by the NHS; and
  • the issue of a ministerial decree, by 2 March 2022, setting out  the procedures authorising the application of the higher spending ceiling only to those pharmaceutical companies that have paid in full the payback for the years 2019 and 2020 without any reserve.

The Finance Act also clarifies that the companies that have not paid in full their 2019-2020 payback will risk losing their right to reimbursement by the NHS of their drugs, if AIFA has previously ascertained the existence of a substitutable drug having similar efficacy.

Improvement in assistance to patients

New funds to ensure the implementation of organisational, quantitative, qualitative and technological standards, in addition to those envisaged by the National Recovery and Resilience Plan (PNRR), have been allocated.

The State is promoting a reform of the organisational model of territorial health assistance, carried out at regional level, through the implementation of a regulatory framework that identifies structural, technological and organisational standards. The reform is also aimed at establishing criteria for the prevention in the area of health, environment and climate, in line with an integrated approach ("One Health") and according to  a holistic view ("Planetary Health ").

The legislature intends to define the standards of existing healthcare facilities and services and the operational procedures for innovative services – such as telemedicine, IT tools and those based on artificial intelligence – as well as the information flows of the NHS, first and foremost those relating to electronic health records.

If you would like to discuss any of these issues further, please do not hesitate to contact the authors or your usual Osborne Clarke contact.
 

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* This article is current as of the date of its publication and does not necessarily reflect the present state of the law or relevant regulation.

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