The Italian healthcare system, the Servizio Sanitario Nazionale (SSN) is similar in form to the

UK NHS, providing universal coverage free of charge at the point of service. However, it is
significantly more decentralised and characterised by regional inequalities.
SCALE
The SSN employs over 650,000 people and Italy benefits from one of the highest levels of
physicians per 100,000 residents in Europe at 380. There are 1.19 GPs per 1,000 residents,
but nursing levels are low in comparison to neighbouring countries (and below the EU
average). Indeed, Italy suffers from a dearth of nurses and despite schemes aimed at
redressing the balance, the number of trainee nurses remains too low to meet demand.
In terms of physical infrastructure, in 2012 there were over 1,250 hospitals (with some
275,000 hospital beds). Of these, just over half are public, with 43% being private hospitals
accredited by the state system. The remaining 5% are in private ownership offering services
only for out-of-pocket patient payment.
STRUCTURE
The health system effectively has three tiers; national, regional and local.
At the national level it is governed by the Ministry of Health, which has responsibility for
health planning and in particular setting livelli essenziali di assistenza (LEAs) which are the
essential levels of care that Italian citizens can expect to receive. The Ministry also
administers funding and oversees the regulation of drugs and medical equipment.
Below the Ministry of Health there are 20 regions. These have direct responsibility for the
delivery of healthcare in line with the funding and LEAs that the Ministry has set. They are
entirely autonomous when it comes to deciding how healthcare services are delivered and
free to deliver care over and above the LEAs if budgets permit.
The regions deliver healthcare through azienda sanitaria locale (ASLs); local healthcare units
that are based around population sizes. There are around 200 ASLs, each financed by its
region. In addition to ASLs, healthcare services are delivered by hospital trusts (aziende
ospedaliere). These have similar administrative responsibilities to ASLs but can only be
formed where hospitals adhere to certain minimum standards such as the presence of three
high speciality units and an A&E department.
In terms of primary care, individuals are assigned a GP who is responsible for taking care of
his/her global health and for referring him/her to a specialist as and when the need arises.
GPs also issue prescriptions for reimbursed drugs and secondary care services. GPs work as
independent practitioners and are paid a capitation fee based on the number of patients
registered on their list. Each GP is allowed to register a maximum of 1,500 patients. Until
very recently Italy suffered from a glut of qualified doctors and as such many GPs have lists
somewhat smaller than the maximum and therefore tend to earn less than GPs elsewhere in
Europe.
Secondary care is provided by both public and private hospitals and patients can choose to
be treated either by hospitals within their own ASL or by a hospital elsewhere (leading to a
transfer of money between ASLs and even regions depending on where the patient chooses
to go). Services are dispensed on presentation of a prescription written by a GP.
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An alternative secondary care offering is provided by clinicians working on a freelance basis

outside their normal working hours but within the hospital setting (known as Intramoenia).
Patients have to pay a fee which is set by the hospital or ASL. This gives patients the chance
to choose a specific specialist and receive treatment in a more-timely manner. Finally,
patients can also choose to access care from specialists working a private clinic, again
paying for their services.
Interestingly, care largely stops at the point the patient leaves secondary care. There are no
community/district nurses or health visitors and once a patient leaves hospital they are
effectively responsible for their own care. Aside from using the services of a freelance nurse
(usually a hospital nurse working in their spare time), the only form of care provided in the
home is for those that are immobile (e.g. the elderly or infirm). In these instances the
patient or their family can book a visit from a hospital specialist. A further peculiarity of the
Italian system relates to the administration of injections in the primary care setting. GPs do
not administer injections and instead patients are required to purchase syringes/needles
from a pharmacy using their prescription and then either use a freelance nurse or ask a
family member/friend etc to give the injection.
FUNDING
Healthcare expenditure Italy is amounted to 135 billion. This equates to 8.7% of GDP,
placing Italy seventeenth of the OECD countries and below the OECD average (8.8% of
GDP). Despite this, and despite relatively low patient satisfaction levels, the World Health
Organisation ranked the Italian healthcare system as the second best in the world in its most
recent rankings (2000).
Both primary and secondary care account for 46% of total expenditure each with the
remaining 8% split between public health promotion and administration (the latter taking up
slightly more budget than the former). Expenditure on primary care has increased in recent
years and Italy has seen a significant rise in expenditure on drugs.
The healthcare system is funded both through central and regional taxation systems. These
include income tax at a national level and then regional taxes on businesses added value, a
public sector workers tax and piggy-back taxes on income tax and fuel excise duty.
The annual health budget is set by the Ministry of Health on the basis of the total amount
per person needed to cover the essential healthcare levels. Regions are funded according to
a formula that takes into account past spending and weighted capitation. There has
historically been a significant budget deficit and a clear north south divide, largely as a
result of this system.
Whilst inpatient and primary care are free, the ASL are able to generate additional funding
through services that are partially paid for by the patient (dependent on the type of service
and patient income level/age etc. Around 40% of the population is exempt from these
copayments, but depending on the service or drug, copayments can reach 30%.
SELLING TO THE ITALIAN MARKET
All medical devices must be certified with the CE mark to ensure that they meet European
directives. Whilst this is the only compulsory element in the process of selling into Italy, it by
no means equates to SSN reimbursement.
To qualify for reimbursement devices need to appear on specific formulary lists. The
Nomenclature Tariffario delle Prestazioni Ambulatoriali (NTPA) relates to out-patient
procedures that qualify for SSN funding, whilst Nomenclatore Tariffario delle Prestazioni
Ospedaliere (NTPO) is the in-patient equivalent.
The access routes for medical devices depend on whether the specific device relates to a
new or existing procedure. New procedures are added to the National Formulary List every
two years and then only if a suitable codification analogue can be found. ISPOR suggests
that the uptake of devices for existing procedures depends on pricing levels, particularly in
the context of diagnosis related group (DRG) or ambulatory tariffs.

According to ISPOR, the funding of medical devices is largely unregulated and purchase
decisions are made by hospital Committees and managers. Indeed, although the DRG tariff
is set at a national level and there are a number of national organisations that bear
influence, it is the regions that have final say in applying reimbursement levels (and so
different levels of reimbursement may apply in different regions). At a regional level the
regional health agency is joined by Commissioni Regionali Dispositivi Medici (specific
regional technical committees dealing with the evaluation of medical devices) and
Commissione Prontuario Terapeutico Ospedaliero (hospital drug committees) in influencing
reimbursement levels.
In cases where devices arent included within the DRG funding system, regions may choose
to apply reimbursement through their own budgets. This particularly applies to new or
innovative devices.
When it comes to the purchasing process itself, medical devices are always purchased via
tender based around EU rules. Often ASLs will form buying groups with the aim of reducing
costs through economies of scale.
Unlike many countries elsewhere in Europe, Italy has a very limited alternate site market
and medical device usage in out-patient settings is particularly low. As mentioned
previously, in cases where devices are required (most usually to administer drugs through
injection) the patient purchases them from a pharmacy. Over 90% of these are public
pharmacies owned by pharmacists working as contractors to the SSN.
MARKET SIZE
Conflicting estimates on the expenditure on medical devices in Italy suggest that it sits
somewhere between 3.5bn and 4.5bn. The US Commercial Service places this as the
fourth largest market in Europe and the sixth largest in the World. However, potential
remains with the Healthcare Economist suggesting that there is a shortage of medical
technology in Italy (citing the example of the US having twice as many MRI units per million
head of population than Italy).
There are clear regional disparities in the amount spent on medical devices, with the north
south divide very much in evidence. According to the Centre for Economic and International
Studies, public expenditure on medical devices ranges from 23 per person in Calabria to
146 in Friuli Venezia Giulia (against an Italian average of 65 per person.
CONCLUSION
Although like much of the EU, Italy is suffering from a significant public deficit and a clear
north south divide, the Italian market retains potential for medical device manufacturers.
Indeed, whilst the regionalised nature of reimbursement makes for a relatively fragmented
market, limited requirement for regulation and a sizeable hospital sector make it an
attractive proposition.

Riguardo Medi-Pragma:
Fondata nel 1984, Medi-Pragma una societ indipendente, leader nel proprio settore,
specializzata nelle ricerche di mercato nellarea farmaceutica, diagnostico-medicale,
cosmetica e in generale nellarea Healthcare. Circa il 60 % del fatturato Medi-Pragma
consiste in ricerche ad hoc e consulenze a livello Nazionale, il restante 40% Internazionale
e per la quasi totalit originato da progetti multicountry e studi di fieldwork.

Lambizione di Medi-Pragma di offrire sempre ai suoi clienti un servizio eccellente per

aiutarli a migliorare le proprie performance, per questo che negli ultimi anni MediPragma ha sviluppato una molteplicit di servizi innovativi in grado di poter soddisfare ed
andare incontro ai bisogni dei suoi clienti. Linnovazione Medi-Pragma consiste nella
coniugazione di successo tra lerogazione di uneccellente qualit di raccolta ed analisi dei
dati, in tempi molto rapidi ed al miglio prezzo possibile.

Lo staff Medi-Pragma costituito da diversi team di esperti ricercatori ed analisti, sia

nellarea delle ricerche qualitative sia quantitative e da un area produzione costantemente
dedicata allofferta della migliore qualit possibile. Medi-Pragma, con i suoi uffici a Roma e

Milano (per il 2013 in programma lapertura di un ufficio a Londra), opera al fianco dei
propri clienti in ogni fase del processo di ricerca: dall'identificazione del problema allo studio
sul campo, all' interpretazione dei dati e alla presentazione dei risultati. Medi-Pragma si
avvale inoltre della collaborazione continuativa di consulenti esperti in marketing, sales,
medica e psicologia industriale in grado di offrire ai propri clienti soluzioni
strategico/operative ad elevato impatto sul business. Per garantire, inoltre, ai propri clienti
standard qualitativi sempre eccellenti, la raccolta delle informazioni sul campo, condotta
esclusivamente da personale appositamente preparato e qualificato. Oltre 150 intervistatori
distribuiti sul territorio italiano costituiti da: medici, psicologi, biologi, professionisti nelle
ricerche di mercato; in aggiunta ad un innovativo sistema C.A.T.I. home based in grado di
garantire postazioni teoricamente illimitate. Oltre alle tradizionali figure di riferimento per le
ricerche nellarea della salute (Medici, Farmacisti, Pazienti, etc), la Medi-Pragma ha
acquisito negli anni una notevole esperienza nelle indagini che coinvolgono Payers
Istituzionali, KOLs e Specialisti con ricerche Ad Hoc e servizi di rilevazione mirata per
questi target. In linea con la propria filosofia aziendale Specialists tailored on market
measure, tutti gli studi sono realizzati ad hoc per le specifiche esigenza del Cliente nel
rispetto del codice E.SO.MAR. e della legge sulla privacy; Medi-Pragma, azienda certificata
ISO 9001/Vision 2000, membro Confindustria e ASSIRM.