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Law no. 175 of 10 November 2021, including the provisions for the treatment of rare diseases and for the support of the research and development of orphan medicinal products, has been approved. It officially entered into force in December 2021.

This is the first law addressing solely rare diseases, that approximately affect 2 million people in Italy. An ad hoc law is crucial for a real organisation at national level.

In particular, the law aims to ensure uniformity in order to take in charge diagnostic, therapeutic and care provisions for rare diseases, and to regulate in a systematic and organic way the actions dedicated to supporting research, both on rare diseases and orphan medicines. The law also provides for a solidarity fund, aimed at enhancing the assistance and the social inclusion of patients with rare diseases, as well as the timely update of Livelli Essenziali di Assistenza (LEA), which establish the services and facilities that the National Health System is required to provide to all citizens free of charge or upon a co-payment. This should facilitate the update of the list of exempted rare diseases.

Concerning the support to research, tax incentives are foreseen, in the form of tax credit, equal to 65% of the expenses incurred to start and implement research projects, in favour of public or private entities that carry out or fund research activities aimed to develop therapeutic protocols on rare diseases or orphan medicines.

The law also provides for the establishment, at the Ministry of Health, of the National Committee for Rare Diseases, which will act as coordinator, defining the strategic lines of national and regional policies on rare diseases.

For additional details, consult the full text of the law (in Italian language only) here!

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