On 27 November 2021, Law No. 175/2021 (“Consolidated Law“) was published in the Official Journal. The Consolidated Law’s main objective is the protection of the right to health of those suffering from rare diseases through measures aimed at ensuring the uniform distribution of services and medicines, including orphan drugs, throughout the Italian territory, the surveillance, diagnosis and treatment of rare diseases as well as the support to research activities.
The main changes introduced by the Consolidated Law include those relating to the establishment of the National Committee for Rare Diseases, which will carry out management and coordination functions and define the strategic guidelines of national and regional policies on rare diseases; the establishment of the Solidarity Fund for persons affected by rare diseases; and the adoption of the National Plan for Rare Diseases, which will define the objectives of, and relevant interventions in, this field.
In addition, the Consolidation Law provides for the granting of a contribution, in favor of public or private entities carrying out research activities aimed at developing therapeutic protocols on rare diseases, manufacturing orphan medicines, or financing research projects in this area, in the form of tax credit, equal to 65% of the expenses incurred for the development and implementation of these projects, up to a maximum annual amount of EUR 200,000 per beneficiary and within the overall expenditure limit of EUR 10 million per year.