The legislative issue in Italy

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The Italian policy in the sector of scientific research development is inadequate. The legislative decree n. 124/April 29th 1998 establishes the rare diseases' network creation, their free-of-charge detection, investigation and care, and promotes a survey of rare diseases' Registers/Recruitment that already exists at a local, regional, interregional and national level.

According to the peculiarity of the problems connected to such pathologies, it is expected a co-ordination of the different initiatives implemented, promoting those directed to guarantee:

Currently in our country there is not an exhaustive and systematic legislation on rare diseases and, above all, a specific one for orphan drugs. 

In Italy, drugs industry gives in average 8-12% of its sales to research expenses. Considering that research and development expenses for rare diseases piled to approximately 50 million dollars in ten years, the Italian drug companies invested 700 million dollars for the research in 1987, this amount would have been theoretically sufficient to assure the development of 14 drugs with strongly innovative characteristics in the same year. 

Among the whole Italian drug companies it exists a remarkable cultural and technological background, nevertheless nobody could sustain that in Italy, in last 10 years, it has been developed 140 drugs with strongly innovative characteristics. 

Actually, as a matter of fact, the problem can not be solved at a national level, but it is necessary to work on a single law for the whole European Union.

In 1993, in London it was founded the European agency for the appraisal of the medical products (EMEA). In 1995 a new European system for authorisation of drug recording became effective.

The necessity of a European law regards not only the field of development and research, but also information and cost distribution’s fields.

Nowadays, the research and development of a new drug implies 250-500.000$ and in average takes 10 to 14 years from the discovery to its commercialisation. When it is on the market, the aim is to recover expenses, therefore the drug commercialisation aims at a-lot-of-money-for-a-long-time “feedback”, as attested in the definition, the purchasers will be a small number (orphan drugs for orphan or rare pathologies and/or populations with limited economic resources). Many researchers don't choose to study rare diseases because of the insufficient probabilities of funding flow, so the treatments are nipped in the bud. Those diseases, although rare, are at least 5.000, and they constitute a heavy burden for the European Community and a large group of health resources' consumers; that's the reason why their treatment may represent a good investment for the community. 

Among the activities provided in the "Redefinition of the system of participation to the cost of the sanitary performances and the regimen of the exemptions" (legislative Decree n.124 of April 29th 1998), the Italian Health Council has recently approved a regulation’s scheme dealing with the "Institution of the national network of rare diseases and of exemption from the participation to the cost of the relative sanitary performances", currently still in preliminary proceeding.

In such regulation, the expectancy is to add elements to contribute in inverting the current Italian tendency, both in terms of attendance and research.



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