Rare diseases, 65 percent tax credit for research

The Ministry of Health has implemented the tax credit for research on rare diseases and orphan drugs with the decree of August 5, 2026, n. 198, published in the Official Gazette of the Italian Republic, General Series n. 252 of October 29, 2026, reference 26G00215. The regulation recognizes a contribution equal to 65 percent of eligible expenses, up to a maximum of 200,000 euros per year for each beneficiary and within an overall limit of 10 million euros per year. The measure defines expenses, requirements, admission procedures, controls, and grounds for revocation.

The decree implements Article 12, paragraphs 1 to 4, of the law of November 10, 2021, n. 175, which had provided for the tax credit starting from 2022 and entrusted the definition of criteria to a regulation within six months. The text is signed by the Minister of Health Orazio Schillaci, in agreement with the Minister of University and Research and the Minister of Economy and Finance; it obtained opinion n. 1365/2024 from the Advisory Section for Regulatory Acts of the Council of State (meeting of November 5, 2024) and was registered by the Court of Auditors on September 28, 2026, Control Office for acts of the Ministry of Health and the Ministry of Labour and Social Policies, under n. 872, with the visa of the Minister of Justice Carlo Nordio.

Who can apply: IRCCS, universities, and research bodies

The incentive is reserved for those who carry out research aimed at the development of therapeutic protocols for rare diseases or the production of orphan drugs, or who finance projects on these topics. Three recipients have been identified:

• Scientific Institutes for Research, Hospitalization and Healthcare (IRCCS) and other entities of the National Health Service;
• public or private universities;
• public and private research and knowledge dissemination bodies.

To qualify, the activity must be almost exclusively of a non-economic nature, with economic use being purely ancillary: the capacity allocated each year to economic activity cannot exceed 20 percent of the total annual capacity, and the relative costs and revenues must have separate accounting. Excluded are entities in voluntary, judicial, or compulsory administrative liquidation, in composition with creditors (except those with business continuity), in other insolvency proceedings, and recipients of disqualifying sanctions pursuant to Article 9, paragraph 2, of the legislative decree of June 8, 2001, n. 231.

Three expense items and two internal caps

Expenses incurred to start and implement the projects, made by December 31 of the year preceding the year of granting, are eligible; for the first tax period, expenses from January 1, 2022, are also valid. The recognized items are:

• intangible investments: software, systems and system integration, platforms and applications;
• tangible investments: purchase, rental and leasing of tools and equipment, with consumables allowed up to 10 percent of the costs for tangible investments;
• wage costs of employees or personnel with collaboration contracts, staffing, or research grants, up to 40 percent of the eligible project costs.

Receipted invoices must report, under penalty of inadmissibility, the Unique Project Code (CUP); expenses must be accounted for separately and cannot benefit from other state, regional or European public grants.

From March 31 to F24 offsetting

The application must be submitted to the Ministry of Health by March 31 of each year, exclusively electronically, through the procedure made available on the institutional website by February, when the call for expressions of interest is also published. For the first year of application, the deadline will be set by a notice published in the Official Gazette within ninety days of the publication of the regulation.

The attached protocol must be coordinated by a researcher with a declared H-index of at least 18 and as first, last or corresponding author in at least 15 indexed publications. The Ministry grants or denies the incentive within sixty days from the receipt deadline; if requests exceed the 10 million available, the credit is reduced proportionally. The benefit is used only via offsetting with the electronic F24 form, ten days after the communication, without the limits of article 1, paragraph 53, of the law of December 24, 2007, n. 244 and article 34 of the law of December 23, 2000, n. 388.

Controls, revocation and prohibition of accumulation

Beneficiaries shall keep the documentation for ten years and must obtain certification from the board of auditors, the board of statutory auditors or a legal auditor regarding the requirements, effectiveness and regularity of the expenses. The Ministry carries out controls and inspections, including random checks, proportionate to the risk and the amount of the benefit; in the event of missing requirements or untruthful declarations, it revokes the grant and recovers the unduly used credit with interest and penalties, pursuant to article 1, paragraph 6, of the decree-law of March 25, 2010, n. 40. The credit does not contribute to income or the IRAP taxable base and cannot be accumulated, for the same expenses, with that of article 1, paragraphs 198 to 207, of the law of December 27, 2019, n. 160.

For universities, IRCCS (Scientific Institutes for Research, Hospitalization and Healthcare), and public health facilities, the measure serves as the first operational guideline after four years of waiting: expenses incurred since 2022 finally become reportable, but the annual cap of 10 million and the proportional allocation make the speed of submitting applications decisive. For biotech companies, access remains possible only within the European definition of a research organization, with separate accounting and without forms of privileged access to results.

Source: Official Gazette of the Italian Republic, General Series no. 252 of October 29, 2026 — Ministry of Health, decree August 5, 2026, no. 198, “Regulation implementing article 12 of law November 10, 2021, no. 175” (26G00215).