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PARALLEL TEXTS
Il divieto, previsto dalla legge italiana, di vendere in parafarmacia medicinali soggetti a prescrizione è conforme al diritto dell’Unione europea
Inglese tratto da:
http://europa.eu/rapid/press-release_CJE-13-155_en.htm
Italiano tratto da:
http://europa.eu/rapid/press-release_CJE-13-155_it.htm
Data documento: 05-12-2013
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The prohibition, provided for by Italian law, on the sale in para-pharmacies of prescription-only medicinal products is compatible with EU law
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Il divieto, previsto dalla legge italiana, di vendere in parafarmacia medicinali soggetti a prescrizione è conforme al diritto dell’Unione europea
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That prohibition is justified by the objective of ensuring that the supply to the public is reliable and of good quality
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Tale divieto è giustificato dall’obiettivo di garantire alla popolazione un rifornimento di medicinali sicuro e di qualità
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In Italy, the provision of pharmaceutical services can be engaged in only by municipal pharmacies or by private pharmacies operating under government licence.
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In Italia, la prestazione di servizi farmaceutici può essere esercitata solo attraverso farmacie comunali oppure a mezzo di concessione governativa ai privati farmacisti.
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The establishment of pharmacies in Italy is subject to planning rules under which the opening of a new pharmacy is subject to prior authorisation and the pharmacies which are set up there are subject to quotas and are evenly distributed in Italy, in accordance with the ‘grid’.
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Lo stabilimento delle farmacie sul territorio è oggetto di un regime di pianificazione in forza del quale l’apertura di una nuova farmacia è subordinata al rilascio di una previa autorizzazione e le farmacie ivi presenti sono limitate a un numero massimo e ripartite in modo equilibrato sul territorio, conformemente alla «pianta organica».
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The aim of the rules is, first, to avoid the risk that pharmacies become concentrated only in commercially more attractive areas and to ensure that each pharmacy has a market share and, second, to meet the requirements for medicinal products in the whole of Italy.
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Tale regime è diretto – da un lato – ad evitare il rischio che le farmacie si concentrino unicamente nelle zone commercialmente più attraenti e a garantire a ciascuna di loro una quota di mercato e – dall’altro – a soddisfare il fabbisogno di medicinali su tutto il territorio.
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Since 2006 it has been possible to open para-pharmacies that are entitled to sell medicinal products for which a prescription is not required, which can be publicly advertised and the cost of which is borne by the client.
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Dal 2006 è stata consentita l’apertura di parafarmacie, autorizzate a vendere medicinali non soggetti a prescrizione medica con accesso alla pubblicità destinata al pubblico e il cui costo è a carico del cliente.
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Ms Venturini, Ms Gramegna and Ms Muzzio, three qualified pharmacists, registered with the Milan Order of Pharmacists, sought authorisation to sell, in their respective para-pharmacies, prescription-only medicinal products the cost of which is wholly borne by the customer.
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Le sig.re Venturini, Gramegna e Muzzio, tre farmaciste abilitate, iscritte all’ordine professionale dei farmacisti di Milano, hanno chiesto l’autorizzazione a vendere, nelle rispettive parafarmacie, medicinali soggetti a prescrizione medica ma che sono interamente a carico del cliente.
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The local health authorities (ASLs) and the Ministry of Health rejected their requests on the ground that the national legislation authorised the sale of such medicinal products only in pharmacies.
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Le aziende sanitarie locali (ASL) nonché il Ministero della Salute hanno respinto tali domande, in quanto la normativa nazionale autorizza la vendita di simili medicinali solo nelle farmacie.
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They then brought proceedings before the Tribunale amministrativo regionale per la Regione Lombardia (Regional Administrative Court, Lombardy) claiming that that refusal was contrary to EU law.
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Esse hanno quindi adito il Tribunale amministrativo regionale per la Regione Lombardia, affermando che tale rigetto era contrario al diritto dell’Unione.
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That court has asked the Court of Justice whether the FEU Treaty precludes legislation which does not allow a pharmacist, who is qualified and registered with the professional body but does not own a pharmacy in the ‘grid’, to sell, in the para-pharmacy owned by that pharmacist, prescription-only medicinal products the cost of which is borne not by the national health service but wholly by the purchaser.
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Tale giudice ha chiesto alla Corte di giustizia se il Trattato sul funzionamento dell’Unione europea osti ad una normativa che non consente al farmacista, abilitato ed iscritto all’ordine professionale, ma non titolare di una farmacia ricompresa nella «pianta organica», di vendere, nella parafarmacia di cui sia titolare, i farmaci soggetti a prescrizione medica che non sono posti a carico del Servizio sanitario nazionale ma interamente a carico dell’acquirente.
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In today’s judgment, the Court recalls, first, that the geographical distribution of pharmacies and the monopoly for dispensing medicinal products remains a matter for the Member States.
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Nella sua sentenza odierna, la Corte ricorda anzitutto che la ripartizione geografica delle farmacie e il monopolio della dispensa dei medicinali sono di competenza degli Stati membri.
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The Court next makes clear that it is apparent from the national legal background that a pharmacist who wishes to become established in Italy as the owner of a para-pharmacy will be excluded from the economic benefits accruing from the market for prescription-only medicinal products which are wholly paid for by the purchaser, their sale being reserved to pharmacies.
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Essa rileva inoltre che dal contesto giuridico nazionale risulta che un farmacista che intenda stabilirsi in Italia come titolare di una parafarmacia sarà escluso dai benefici economici derivanti dal mercato dei medicinali soggetti a prescrizione medica e che vengono pagati interamente dall’acquirente, la cui vendita è riservata alle farmacie.
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That legislation constitutes a restriction on freedom of establishment, since it is liable to hinder or render less attractive the establishment on Italian territory of a pharmacist who is a national of another Member State and has the intention of operating a para-pharmacy there.
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Tale normativa, che può ostacolare e scoraggiare lo stabilimento sul territorio italiano di un farmacista, cittadino di un altro Stato membro, che intenda ivi gestire una parafarmacia, costituisce una restrizione alla libertà di stabilimento.
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Nevertheless, it may be justified by overriding reasons in the public interest.
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Tuttavia, essa può essere giustificata da ragioni imperative di interesse generale.
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The Italian legislation pursues the objective, which falls within a more general objective of protecting public health, of ensuring that the supply to the public of medicinal products is reliable and of good quality.
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La normativa italiana persegue l’obiettivo di garantire alla popolazione un rifornimento di medicinali sicuro e di qualità, il quale rientra nell’obiettivo più generale di tutela della salute.
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In that connection, the Court recalls that planning rules may be indispensable for filling in possible gaps in access to public health services and for avoiding the duplication of structures, so as to ensure the provision of public health care which is adapted to the needs of the population, covers the entire territory, and takes account of geographically isolated or otherwise disadvantaged regions.
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Al riguardo, la Corte ricorda che un regime di pianificazione può rivelarsi indispensabile per colmare eventuali lacune nell’accesso alle prestazioni sanitarie e per evitare una duplicazione nell’apertura delle strutture, in modo che sia garantita un’assistenza sanitaria adeguata alle necessità della popolazione, che copra tutto il territorio e tenga conto delle regioni geograficamente isolate o altrimenti svantaggiate.
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If the sale of some prescription-only medicinal products were to be allowed in para-pharmacies, that would amount to those medicinal products being sold without being subject to the requirements of territorial planning, with the risk of causing a concentration of para-pharmacies in areas deemed to be the most profitable and bringing about, in those areas, a reduction in the number of customers and a loss of income for pharmacies.
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Se fosse consentito vendere nelle parafarmacie determinati medicinali soggetti a prescrizione medica, ciò equivarrebbe a commercializzare tali medicinali senza osservare il requisito della pianificazione territoriale, con il rischio che le parafarmacie si concentrino nelle località considerate più redditizie e che le farmacie situate in tali località vedano diminuire la propria clientela e subiscano una perdita di reddito.
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That situation might then bring about a lower quality of service provided by pharmacies to the public and also result in the definitive closure of some of them:
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Questa situazione potrebbe quindi causare una diminuzione della qualità del servizio che le farmacie forniscono al pubblico e comportare perfino la chiusura definitiva di alcune di esse:
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a shortage of pharmacies in some parts of Italy could cause the supply of medicinal products to be unreliable and not of good quality.
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una penuria di farmacie in determinate parti del territorio condurrebbe allora ad un approvvigionamento di medicinali inadeguato quanto a sicurezza e a qualità.
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The Court states, furthermore, that it is for each Member State to determine the level of protection which it wishes to afford to public health and the way in which that level is to be achieved.
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La Corte sottolinea, inoltre, che ogni Stato membro può decidere il livello al quale intende garantire la tutela della sanità pubblica e il modo in cui questo livello deve essere raggiunto.
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The Italian system, as it does not allow the sale in para-pharmacies of prescription-only medicinal products the cost of which is borne not by the national health service but wholly by the purchaser, reduces the risk of a shortage of pharmacies in a manner which is proportionate to the objective of ensuring that the supply of medicinal products to the public is reliable and of good quality.
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Il sistema italiano, che non consente alle parafarmacie di vendere farmaci soggetti a prescrizione medica che non sono a carico del Servizio sanitario nazionale, bensì vengono pagati interamente dall’acquirente, riduce il rischio di una penuria di farmacie in modo proporzionato all’obiettivo di garantire un rifornimento di medicinali alla popolazione sicuro e di qualità.
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NOTE:
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IMPORTANTE:
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A reference for a preliminary ruling allows the courts and tribunals of the Member States, in disputes which have been brought before them, to refer questions to the Court of Justice about the interpretation of European Union law or the validity of a European Union act.
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Il rinvio pregiudiziale consente ai giudici degli Stati membri, nell'ambito di una controversia della quale sono investiti, di interpellare la Corte in merito all’interpretazione del diritto dell’Unione o alla validità di un atto dell’Unione.
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The Court of Justice does not decide the dispute itself.
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La Corte non risolve la controversia nazionale.
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It is for the national court or tribunal to dispose of the case in accordance with the Court’s decision, which is similarly binding on other national courts or tribunals before which a similar issue is raised. |
Spetta al giudice nazionale risolvere la causa conformemente alla decisione della Corte.Tale decisione vincola egualmente gli altri giudici nazionali ai quali venga sottoposto un problema simile. |
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LISTEN WITH READSPEAKER
The prohibition, provided for by Italian law, on the sale in
para-pharmacies of prescription-only medicinal products is compatible with EU
law
That prohibition is justified by the objective of ensuring that the
supply to the public is reliable and of good quality
In Italy, the provision of pharmaceutical services can be engaged in only by
municipal pharmacies or by private pharmacies operating under government
licence.
The establishment of pharmacies in Italy is subject to planning rules under
which the opening of a new pharmacy is subject to prior authorisation and the
pharmacies which are set up there are subject to quotas and are evenly
distributed in Italy, in accordance with the ‘grid’.
The aim of the rules is, first, to avoid the risk that pharmacies become
concentrated only in commercially more attractive areas and to ensure that each
pharmacy has a market share and, second, to meet the requirements for medicinal
products in the whole of Italy.
Since 2006 it has been possible to open para-pharmacies that are entitled to
sell medicinal products for which a prescription is not required, which can be
publicly advertised and the cost of which is borne by the client.
Ms Venturini, Ms Gramegna and Ms Muzzio, three qualified pharmacists,
registered with the Milan Order of Pharmacists, sought authorisation to sell, in
their respective para-pharmacies, prescription-only medicinal products the cost
of which is wholly borne by the customer.
The local health authorities (ASLs) and the Ministry of Health rejected their
requests on the ground that the national legislation authorised the sale of such
medicinal products only in pharmacies.
They then brought proceedings before the Tribunale amministrativo regionale
per la Regione Lombardia (Regional Administrative Court, Lombardy) claiming that
that refusal was contrary to EU law.
That court has asked the Court of Justice whether the FEU Treaty precludes
legislation which does not allow a pharmacist, who is qualified and registered
with the professional body but does not own a pharmacy in the ‘grid’, to sell,
in the para-pharmacy owned by that pharmacist, prescription-only medicinal
products the cost of which is borne not by the national health service but
wholly by the purchaser.
In today’s judgment, the Court recalls, first, that the geographical
distribution of pharmacies and the monopoly for dispensing medicinal products
remains a matter for the Member States.
The Court next makes clear that it is apparent from the national legal
background that a pharmacist who wishes to become established in Italy as the
owner of a para-pharmacy will be excluded from the economic benefits accruing
from the market for prescription-only medicinal products which are wholly paid
for by the purchaser, their sale being reserved to pharmacies.
That legislation constitutes a restriction on freedom of establishment, since
it is liable to hinder or render less attractive the establishment on Italian
territory of a pharmacist who is a national of another Member State and has the
intention of operating a para-pharmacy there.
Nevertheless, it may be justified by overriding reasons in the public
interest.
The Italian legislation pursues the objective, which falls within a more
general objective of protecting public health, of ensuring that the supply to
the public of medicinal products is reliable and of good quality.
In that connection, the Court recalls that planning rules may be
indispensable for filling in possible gaps in access to public health services
and for avoiding the duplication of structures, so as to ensure the provision of
public health care which is adapted to the needs of the population, covers the
entire territory, and takes account of geographically isolated or otherwise
disadvantaged regions.
If the sale of some prescription-only medicinal products were to be allowed
in para-pharmacies, that would amount to those medicinal products being sold
without being subject to the requirements of territorial planning, with the risk
of causing a concentration of para-pharmacies in areas deemed to be the most
profitable and bringing about, in those areas, a reduction in the number of
customers and a loss of income for pharmacies.
That situation might then bring about a lower quality of service provided by
pharmacies to the public and also result in the definitive closure of some of
them:
a shortage of pharmacies in some parts of Italy could cause the supply of
medicinal products to be unreliable and not of good quality.
The Court states, furthermore, that it is for each Member State to determine
the level of protection which it wishes to afford to public health and the way
in which that level is to be achieved.
The Italian system, as it does not allow the sale in para-pharmacies of
prescription-only medicinal products the cost of which is borne not by the
national health service but wholly by the purchaser, reduces the risk of a
shortage of pharmacies in a manner which is proportionate to the objective of
ensuring that the supply of medicinal products to the public is reliable and of
good quality.
NOTE:
A reference for a preliminary ruling allows the courts and tribunals of the
Member States, in disputes which have been brought before them, to refer
questions to the Court of Justice about the interpretation of European Union law
or the validity of a European Union act.
The Court of Justice does not decide the dispute itself.
It is for the national court or tribunal to dispose of the case in accordance
with the Court’s decision, which is similarly binding on other national courts
or tribunals before which a similar issue is raised.
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