Chapter 2

CEIS Health Report 2006
nence; infusion; laparoscopy.
Data of billing 2004, related to the in partnership firms Assobiomedica, point out that the
Italian market of the biomedicale has realized a billing equal to € 3.428 mlds., that of the
diagnostic ones in vitro € 1.762 mlds. and that of the products from laboratory € 525 mil.
As already said, the commercial balance in 2002 is negative for € 1,4 mlds. (1,4 mlds. of
€ for the exports and € 2,9 mlds. for the importations).
The firms of the Italian sector are mainly based on Italian capital (54%), whereas the multinationals
are located outside the national territory. 67% of the firms of the association
of category are of commercial character, whereas the ones that develops activity of production
of medical technologies, 85% is formed by national manufacturing. It is formed
by a considerable number of firms of small dimensions (73,9% don’t overcome t20 mils.
€ of annual sales), mainly located in the Center North Italy, with a greater concentration
in Lombardia, Emilia Romagna and Lazio.
At level of Italian SSN it is recently been faced the problem of the monitoraggio of the
expenditure for medical devices, that it is second only to the pharmaceutics one.
This has determined an abundant regulation that is worth describing. With the aim to
make monitorable the attributable expenditure to the medical devices, with the law of
December 27 2002 ns. 289 arts. 57 has been founded the Committee Unica of the
Devices (CUD), to which following competences have been attributed:
• to make transparent the market of medical devices through the publication and the
updating of a repertoire;
• to elaborate evaluations of technology assessment on the relationship cost benefit and
risk benefit of the new medical devices;
• to improve the system of vigilance on the accidents;
• to effect an overseeing of the market of the consumptions and of the prices applied to
the structures of the SSN;
• to favour a research on the innovative medical devices and of quality.
The CUD in 2004 undertook the layout of the National Classification of the medical
Devices (CND). It has an alpha numerical structure developed at hierarchical tree multilevel,
that gathers the medical devices in Categories (Box 2), Groups and Typologies.
In this first layout the medical devices of diagnostic in vitro have not been included yet.
The financial law 2006, paragraph 409, introduces a series of obligations for the manufacturing
firms of the medical devices modelled on the bases of the existing regulation
for the pharmaceutical industry; the most meaningful elements of such regulation are:
• the classification of the devices is approved with decree of the Minister of the health,
previous agreement with the Regions and the autonomous Provinces;
• it is established, with the institution of the general repertoire of the medical devices, the
date elapsing from which they can be purchased within the national sanitary Service,
used or entirely distributed the enrolled devices in the same repertoire;
• the firms that produce or introduce medical devices in commerce in Italy are kept to
declare through direct self-certification to the Office of the health within 30th April of
every year, the general amount of expenditure sustained in the preceding year for the
activities of promotion by the physicians, the health care professionals, including the exe-
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