Health Regulation
Several laws, decrees, resolutions and regulations have been passed in order to safeguard patients with Rare Diseases and to allow for suitable therapies to be developed. These issues have been dealt with by the European Community, as well as by the Italian Parliament and by the Piemonte and Valle d’Aosta Governments.
NATIONAL LEGISLATION (every link refers to italian laws)
Currently in Italy, the basic legislation related to Rare Disease is expressed in Ministerial Decree n. 279, May 2001, which deals with :"Regulations regarding the establishment of the National Rare Diseases Network and exemption from payment of expenses for health-care related services".
This regulation includes the establishment of a clinical- epidemiological network made up of accredited regional health facilities.
The goals of the National Rare Diseases Network are to improve the quality of medical care and to collect data that would be useful to the Public Health Services for planning, carrying out and evaluating interventions.
The same decree ( Ministerial Decree n.279) was applied to set up the Italian National Registry of Rare Diseases (Ministerial Decree n. 279, 2001), pdf.
M.D. n. 279, 2001, integrates some parts of the 1998-2000 National Health Plan (N.H.P.) with Legislative Decree n. 124, 1998, which explicitly changed the regulations regarding exemption of payment for health-care related services.
The criteria that were adopted by the Ministry take into account several factors, such as : clinical severity, degree of disability, and financial burden of the treatment. This Legislative Decree also included the foundation of a National Network to monitor Rare Diseases, which is supported by accredited regional medical facilities.
Ministerial Decree n. 329 dated 28th May, 1999 identified and stated which chronic, invalidating diseases give patients the right to obtain exemption from payment of heath care related expenses.
REGIONAL LEGISLATION
The Piemonte Regional Committee acknowledged the national legislation and approved two subsequent resolutions:
- Regional Committee Resolution, March 2nd , 2004. n.22 - 11870, which institutes the Regional Network for the prevention, monitoring, diagnosis and follow up of Rare Diseases. This Network is composed of regional medical facilities and its Co-ordinating Centre is located in Torino at the ASL TO 2 . Unlike most other Italian regions, we decided to involve each of the medical facilities within the regions, thus giving all specialists the opportunity to be involved in treating patients with Rare Diseases. This choice allows us to provide widespread, homogeneous care to people with Rare Diseases throughout the Piemonte and Valle d’ Aosta regions.
- Regional Committee Resolution, n. 38- 15326, April 12th , 2005, instituted a technical-specialty board made up of representatives from Public Hospitals. Its aims were to support the Regional Co-ordinating Centre in monitoring Rare Diseases within the Piemonte territory and to provide appropriate, up-to-date development of the Regional Registry. This resolution also extended the exemption benefits to 40 other especially severe rare diseases, chosen by a working group of regional experts. (Rare Disease regional list, pdf).