After more than 3 years of discussion, the first Italian law on rare diseases has been approved and came into force on 12 December 2021 (Law 10.11.2021 no. 175 – “Provisions for the treatment of rare diseases and for the support of research and production of orphan drugs“).
The state and the different regions have until 12 June 2022 to implement numerous measures (decrees, regulations, and agreements) to fully implement this law. Despite the hope that these measures will be issued by the competent bodies within the deadlines provided, Italy will now have to wait until at least the end of 2022 before making its first assessments on the real scope of the new legislation.
The new law on rare diseases has brought several new provisions, particularly regarding the funding for research and tax incentives. These two are of particular interest to pharmaceutical companies.
Funding for research: according to article 11, the contribution by pharmaceutical companies to the national fund for orphan drugs will increase by 2%. Payment will be due on 30 April of every year.
Tax incentives: Public and private entities that carry out or finance research on rare diseases or orphan drugs will receive a tax incentive of up to €200,000 (within the overall annual expenditure limit of €10 million) in the form of a tax credit equal to 65% of the expenses incurred by the entity for research projects. The criteria and methods for implementing the incentive will be issued by 12 June 2022.
With this new law, the prioritization of orphan drugs and funding for rare diseases research is expected, which will have a positive impact on paediatric research, considering that 80% of rare diseases present in childhood.
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