Italy: Adoption of a national law for Rare Diseases

The Senate Health Commission approved the bill for the treatment of rare diseases and support for research and production of orphan drugs, after approval from the Chamber of Deputies. The national law on rare diseases provides a definition for rare diseases, using the prevalence of less than five individuals per ten thousand criteria.This is the same definition as the one applied at EU level. For rare cancers, the law recalls the European definition as cancers with an incidence rate of less than 6 per 100,000 persons. It also defines orphan drugs in accordance with the criteria laid down in Article 3 of the Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products. The national law contains 16 articles which affirm the protection of right to health for people suffering from rare diseases. In this regard, the law provides for the creation of a Solidarity Fund that will finance measures aimed at enhancing their access to care and assistance while ensuring their inclusion into society and in the workplace. The national law also implements the coordination of the levels of care for rare diseases in Italy and the regular update of the list of rare diseases. On orphan drugs, the bill provides provisions to ensure their immediate availability as well as the uniformity of their provision throughout the territory, while regulating their production and import. The bill also supports research in the rare disease field, notably through the National Centre for Rare Diseases.

The law also provides for the establishment of a National Committee for Rare Diseases within the Ministry of Health, which will be responsible for defining the strategic guidelines of national and regional policies on rare diseases. Finally, it indicates that the Ministry of Health shall promote useful actions to provide timely and accurate information to patients and their families and to raise public awareness on rare diseases.