In order to protect patients suffering from rare diseases and to allow the development of adequate therapies, various laws, decrees, resolutions and regulations have been promulgated. These issues were addressed both at the level of the European Community, at the National level and in the Piedmont Region.
Currently in Italy, the legislative substrate for Rare Diseases is represented by Ministerial Decree n. 279 of May 2001 , which determines: " Regulations for the establishment of the National Network of rare diseases and exemption from participation in the cost of the relative health services ".
The regulation also provides for the construction of a clinical-epidemiological network, consisting of accredited principals identified by the regions. The National Network for Rare Diseases aims to improve the quality of care and to collect data useful for the planning, implementation and evaluation of public health interventions. With this decree, the National Registry of Rare Diseases has also begun (see Ministerial Decree n.279 of 2001 in pdf format).
The dm 279 - 2001, was born as an integration between the contents of the National Health Plan (PSN) of 1998-2000 and of the Legislative Decree n. 124 of 1998 . The Legislative Decree n. 124 of 1998 revised the regulation of exemptions to the cost of health services. The criteria adopted by the Ministry take into account the clinical severity, degree of disability and the economic burden of treatment. The legislative decree in question also started a National Monitoring Network for Rare Diseases, with accredited facilities within the Italian regions.
Subsequently, the Ministerial Decree of 05/28/1999 n.329 identified the chronic and invalidating disease conditions that give the right to exemption from the cost of related health care services.
REGIONAL LEGISLATION (Piedmont Region)
The Piedmontese regional council has implemented national legislation with two subsequent resolutions:
1) Resolution of the Regional Council of 2 March 2004, n.22 - 11870 establishing the Regional Network for the prevention, surveillance, diagnosis and therapy of Rare Diseases, composed of regional health centers, and is established at the ASL 4 of Turin the Regional Coordination Center of this network. Our Region differently from others, wanted to involve all the ASLs and the ASOs present in the territory, thus giving all the specialists the possibility to take care of the MR and allowing a widespread and homogeneous assistance throughout the Piedmont Region to patients suffering from the disease rare.
2) Deliberation of the Regional Council of 12 April 2005, n.38 - 15326 established a technical-specialist table, formed by the representatives of the Hospitals, to support the Regional Coordination Center in the monitoring of Rare Diseases in the Piedmont area, for a correct and updated development of the Regional Registry. In addition, the same resolution extended the benefit of the exemption to 40 new rare diseases of considerable clinical severity identified by a working group of regional experts. (see the regional list of rare diseases in pdf format).