CELEX: 62012CJ0159
Freedom of establishment
Article 49 TFEU
Public health
National legislation prohibiting para-pharmacies from selling prescription-only medicinal products the cost of which is borne by the patient

These requests for a preliminary ruling concern the interpretation of Article 49 TFEU.
The requests have been made in proceedings between Ms Venturini (Case C‑159/12), Ms Gramegna (Case C‑160/12) and Ms Muzzio (Case C‑161/12), who are three qualified pharmacists, registered with the Milan Order of Pharmacists and owners of business premises (‘para-pharmacies’), and the Aziende Sanitarie Locali (ASL) (local health authorities), namely the Varese ASL (Case C‑159/12), the Lodi ASL (Case C‑160/12), and the Pavia ASL (Case C‑161/12), the Ministero della Salute, the Regione Lombardia, the Comune di Saronno (Case C‑159/12), the Comune di Sant’Angelo Lodigiano (Case C‑160/12) and the Comune de Bereguardo (Case C‑161/12), and the Agenzia Italiana del Farmaco (AIFA), concerning a prohibition on para‑pharmacies selling prescription-only medicinal products which are not chargeable to the Servizio sanitorio nazionale (SSN) (‘national health service’) and are entirely paid for by the purchaser.
Legal context
European Union law
Recital 26 of the preamble to Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (
OJ 2005 L 255, p. 22
), states:
‘This Directive does not coordinate all the conditions for access to activities in the field of pharmacy and the pursuit of these activities. In particular, the geographical distribution of pharmacies and the monopoly for dispensing medicines should remain a matter for the Member States. This Directive leaves unchanged the legislative, regulatory and administrative provisions of the Member States forbidding companies from pursuing certain pharmacists’ activities or subjecting the pursuit of such activities to certain conditions.’
Italian law
Law No 468 of 22 May 1913 defined the provision of pharmaceutical services as ‘a primary State activity’ which could be engaged in only by municipal pharmacies or by private pharmacies operating under government licence.
In order to ensure a proper distribution of dispensing pharmacies throughout the national territory and to prevent them from becoming concentrated solely in commercially more desirable areas, an administrative instrument for controlling supply was established, the ‘pianta organica’ (‘the grid’) which provides that the distribution of those dispensing pharmacies, in the territory, is to be subject to quotas considered to be suitable to respond to the demand from people concerned in order to ensure each such dispensing pharmacy a market share and to meet the requirements for medicinal products throughout the national territory.
Essentially, subsequent legislative developments have perpetuated that model.
Accordingly, in the words of Article 1(1), (2) and (7) of Law No 475 on rules on the provision of pharmaceutical services (legge n. 475 - Norme concernenti il servizio farmaceutico) of 2 April 1968 (GURI No 107, 27 April 1968, p. 2638), as amended by Law No 362 on rules governing the reorganisation of the pharmaceutical sector (legge n. 362 - Norme di riordino del settore farmaceutico) of 8 November 1991 (GURI No 269, 16 November 1991, p. 3):
‘1.   Authorisation to open and operate a dispensing pharmacy shall be issued by the competent authority for the area concerned.
2.   The number of authorisations to be issued for each municipality shall be determined in such a manner that there is one pharmacy for every 5000 inhabitants in municipalities with a population of up to 12 500 inhabitants and one pharmacy for every 4000 inhabitants in all other municipalities.
...
7.   Any new dispensing pharmacy must be situated at a distance of at least 200 metres from other such pharmacies and must in any case be located in such a manner as to meet the requirements of the local inhabitants.’
Article 122 of a Royal Decree, No 1265 of 27 July 1934, had reserved the sale of medicinal products exclusively to pharmacies.
Law No 537 of 24 December 1993 later re-categorised medicinal products on the basis of the following classes, namely Class A for essential medicinal products and medicinal products for chronic diseases, Class B for medicinal products other than those falling into Class A and of significant therapeutic value, Class C for medicinal products other than those falling within Class A or Class B. Under Article 8(14) of Law No 537 of 24 December 1993, the cost of medicinal products falling within Class A or Class B is wholly to be borne by the national health service, whereas the cost of medicinal products in Class C is wholly to be borne by the customer.
Subsequently, Article 85(1) of Law No 388 of 23 December 2000 abolished Class B, while Article 1 of Law No 311 of 30 December 2004 created a new category of medicinal products – Class C(a) – to cover medicinal products for which a prescription is not required and which, unlike products falling within the other categories, may be publicly advertised. As in the case of Class C medicinal products, the cost of Class C(a) medicinal products is to be borne by the customer.
Decree-Law No 223 of 4 July 2006, converted into Law No 248 of 4 August 2006, allowed the opening of para-pharmacies, by means of which their owners were authorised to sell medicinal products falling within the scope of Class C(a). More recently, Decree-Law No 201 of 6 December 2011, converted into Law No 214 of 22 December 2011, further extended the number of medicinal products that can be sold by para-pharmacies, so that they can now offer to the public some of the Class C medicinal products for which no prescription is required.
The disputes in the main proceedings and the question referred
The applicants in the main proceedings each submitted a request to the competent ASL, as well as to the municipalities concerned, the Ministero della Salute and the Agenzia Italiana del Farmaco, for authorisation to sell to the public prescription‑only medicinal products for human use but the cost of which is wholly borne by the customer, as well medicinal products for veterinary use for which a prescription is also required and the cost of which is also wholly borne by the customer.
On 17 August 2011 the competent ASLs rejected the requests of the applicants in the main proceedings on the ground that, on the basis of the domestic legislation in force, such medicinal products could be sold only in pharmacies. Similar refusals were given by the Ministry of Health on 16 and 18 August 2011.
The applicants in the main proceedings brought an action against those decisions before the Tribunale amministrativo regionale per la Lombardia, claiming that the legislation on which those decisions were based was incompatible with European Union law (‘EU law’), in that it provides that the sale in para-pharmacies of prescription-only Class C medicinal products, the cost of which is however not borne by the national health service, is prohibited.
In those circumstances, the Tribunale amministrativo regionale per la Lombardia decided to stay the proceedings and to refer the following question, which is identically worded in Cases C‑159/12 to C‑161/12, to the Court of Justice for a preliminary ruling:
‘Do the principles of freedom of establishment, non-discrimination and the preservation of competition under Article 49 et seq TFEU preclude national legislation which does not allow a pharmacist, who is qualified and registered with the appropriate professional body but does not own a pharmacy in the grid, also to offer for retail sale, in the para‑pharmacy owned by that pharmacist, medicinal products for which a prescription in the form of a ‘ricetta bianca’ is required – that is to say, medicinal products the cost of which is borne not by the national health service but wholly by the purchaser – and which also establishes in that sector a prohibition on the sale of certain categories of pharmaceutical products, as well as a quota in relation to the number of commercial outlets which may be established in the national territory?’
By order of the President of the Court of 27 April 2012, Cases C‑159/12 to C‑161/12 were joined for the purposes of the written and oral procedures and of the judgment.
Consideration of the question referred for a preliminary ruling
Preliminary observations
It should be noted that in the question submitted by it for a preliminary ruling the national court referred not only to freedom of establishment, but also to the principle of non-discrimination and to the preservation of competition.
In that regard, in relation to, first, the principle of non‑discrimination, it must be borne in mind that the Court has consistently held that that principle is intended to apply independently only to situations governed by EU law for which the FEU Treaty lays down no specific prohibition of discrimination. In the field of freedom of establishment, the principle of the prohibition of discrimination is given specific expression in Article 49 TFEU (see, in particular, Case
C-193/94
Skanavi and Chryssanthakopoulos
[1996] ECR I-929
, paragraphs 20 and 21; Case
C-251/98
Baars
[2000] ECR I-2787
, paragraphs 23 and 24; and Case
C-384/08
Attanasio Group
[2010] ECR I-2055
, paragraph 37).
Therefore, in the present case, it is necessary to take account of the principle of non-discrimination in the context of Article 49 TFEU.
Secondly, it should be recalled that the need to provide an interpretation of EU law which will be of use to the national court requires that the national court define the factual and legal context of its questions or, at the very least, that it explain the factual circumstances on which those questions are based. Those requirements are of particular importance in the area of competition, where the factual and legal situations are often complex (see, inter alia,
Attanasio Group
, paragraph 32, and Joined Cases C‑357/10 to C‑359/10
Duomo Gpa and Others
[2012] ECR, paragraph 22).
In the present case, the orders for reference do not provide the Court with the factual and legal information necessary for it to determine the conditions under which State measures such as those at issue in the main proceedings might fall within the scope of the Treaty provisions on competition. In particular, those orders do not provide any indication of the specific rules of competition which require interpretation nor do they provide an explanation of the connection made between those rules and the disputes in the main proceedings or their subject‑matter.
In those circumstances, there is no need to examine the question referred in the light of preservation of competition.
It follows from all the foregoing that the question referred by the national court should be understood as asking, in essence, whether Article 49 TFEU must be interpreted as precluding legislation, such as that at issue in the main proceedings, which does not allow a pharmacist, who is qualified and registered with the professional body but does not own a pharmacy in the grid, also to offer for retail sale, 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.
Admissibility
Federpharma – Federazione Nazionale Unitaria dei Titolari di Farmacia Italiani disputes the admissibility of the requests for a preliminary ruling on the ground that the disputes in the main proceedings contain no cross-border elements. The present case is, in essence, identical to that which gave rise to the judgment in Case
C-393/08
Sbarigia
[2010] ECR I-6337
, in which the Court considered that the exercise of the right of establishment was clearly not at issue, and, therefore, dismissed the request for a preliminary ruling as being inadmissible.
In that regard, the Court has consistently held that, while national legislation such as that at issue in the main proceedings – which applies indiscriminately to Italian nationals and to nationals of other Member States – is, generally, capable of falling within the scope of the provisions relating to the fundamental freedoms established by the Treaty only to the extent that it applies to situations connected with trade between the Member States, it is far from inconceivable that nationals established in Member States other than the Italian Republic have been or are interested in operating para-pharmacies in that latter Member State (see, to that effect, Joined Cases
C-570/07 and C-571/07
Blanco Pérez and Chao Gómez
[2010] ECR I-4629
, paragraph 40 and the case‑law cited).
Admittedly, although it is apparent from the orders for reference that the applicants in the main proceedings are of Italian nationality and that all the factual aspects of the main proceedings are limited to one Member State, nevertheless the legislation at issue in the main proceedings is capable of producing effects which are not confined to that Member State.
Moreover, the cases in the main proceedings differ from that which gave rise to the judgment in
Sbarigia
, which concerned a decision on the possible grant of an exemption in relation to the opening hours of a particular pharmacy, and, as a result, there was nothing to indicate how such a decision might affect economic operators coming from other Member States.
Moreover, even in a purely internal situation such as that at issue in the main proceedings, where all the factors are confined within a single Member State, a response could nevertheless be useful for the referring court, in particular if its national law were to require it to grant to an Italian national the same rights as those which a national of another Member State would derive from EU law in the same situation (see
Blanco Pérez and Chao Gómez
, paragraph 39 and the case‑law cited).
In those circumstances, the requests for a preliminary ruling must be held to be admissible.
Substance
Whether there is a restriction on freedom of establishment
It is settled case‑law that any national measure which, albeit applicable without discrimination on grounds of nationality, is liable to hinder or render less attractive the exercise by European Union nationals of the freedom of establishment guaranteed by the Treaty constitutes a restriction within the meaning of Article 49 TFEU (see, to that effect, Case
C-299/02
Commission
v
Netherlands
[2004] ECR I-9761
, paragraph 15, and Case
C-140/03
Commission
v
Greece
[2005] ECR I-3177
, paragraph 27).
As is apparent from the national legal background described above, a pharmacist who wishes to become established in Italy has the option of choosing between, on the one hand, requesting and, if appropriate, obtaining prior authorisation enabling him to become an owner of a pharmacy and, on the other, setting up a para‑pharmacy, without being dependent, in that case, on such authorisation.
As regards the first option, the Court has previously stated that the requirement of prior authorisation constituted, in principle, a restriction on freedom of establishment under Article 49 TFEU (see orders of 17 December 2010 in Case C‑217/09
Polisseni
, paragraph 16 and of the President of the Court of 29 September 2011 in Case C‑315/08
Grisoli
, paragraph 23).
However, in the main proceedings, it is the second option which applies. In that regard, it must be determined whether national legislation which does not allow a pharmacist, who is a national of another Member State, and is an owner of a para‑pharmacy, also to sell prescription-only medicinal products, in particular those the cost of which is borne not by the national health service but wholly by the purchaser, constitutes a restriction on freedom of establishment.
It is clear that, in so far as the owner of a para‑pharmacy, unlike an owner of a pharmacy, cannot sell that class of medicinal products, he is excluded from certain parts of the medicinal products market in Italy and, as a result, from the accruing economic benefits.
Accordingly, such national legislation 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.
Consequently, national legislation such as that at issue in the main proceedings constitutes a restriction on freedom of establishment within the meaning of Article 49 TFEU.
Whether the restriction on freedom of establishment is justified
In accordance with settled case‑law, restrictions on freedom of establishment which are applicable without discrimination on grounds of nationality may be justified by overriding reasons in the public interest, provided that the restrictions are appropriate for securing attainment of the objective pursued and do not go beyond what is necessary for attaining that objective (Case
C-169/07
Hartlauer
[2009] ECR I-1721
, paragraph 44, and Joined Cases
C-171/07 and C-172/07
Apothekerkammer des Saarlandes and Others
[2009] ECR I-4171
, paragraph 25).
It should be noted, first, as regards the cases in the main proceedings, that the rules at issue apply without discrimination on grounds of nationality.
As regards, secondly, the objectives which are in fact pursued by that legislation, and which may justify restrictions on freedom of establishment, it must be noted that identification of those objectives is, in the context of a case referred to the Court under Article 267 TFEU, within the jurisdiction of the national court (see, to that effect, Case
C-347/09
Dickinger and Ömer
[2011] ECR I-8185
, paragraph 51, and Joined Cases C‑186/11 and C‑209/11
Stanleybet International and Others
[2013] ECR, paragraph 26).
As is apparent from the orders for reference, the legislation at issue in the main proceedings is supposed to pursue the objective, which falls within a more general objective of protecting public health, of ensuring that the public has a supply of medicinal products which is reliable and of good quality.
It is apparent from Article 52(1) TFEU that the protection of public health can justify restrictions on freedom of establishment. The importance of that objective is confirmed by Article 168(1) TFEU and Article 35 of the Charter of Fundamental Rights of the European Union, under which, inter alia, a high level of human health protection is to be ensured in the definition and implementation of all the Union’s policies and activities (see
Blanco Pérez and Chao Gómez
, paragraphs 63 and 65).
Moreover, the Court has, more specifically, held that restrictions on freedom of establishment may be justified by the objective of ensuring that the provision of medicinal products to the public is reliable and of good quality (see
Blanco Pérez and Chao Gómez
, paragraph 64 and the case‑law cited).
It follows that the objective of ensuring such provision of medicinal products may justify national legislation such as that at issue in the main proceedings.
Thirdly, it is necessary to determine whether such legislation is appropriate to attaining that objective.
In that regard, it must be borne in mind, first, that the setting up of pharmacies on Italian territory is subject to planning rules under which, first, the number of pharmacies which are set up there is limited and they are to be evenly distributed and, second, the establishment of a new pharmacy is subject to prior authorisation being granted to the owner of that pharmacy.
The Court has held that national legislation which provides for such planning rules is, as a general rule, appropriate to attaining the objective of ensuring that the provision of medicinal products to the public is reliable and of good quality (see, to that effect,
Blanco Pérez and Chao Gómez
, paragraph 94, and orders in
Polisseni
, paragraph 25, and
Grisoli
, paragraph 31).
In fact, such rules may prove 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, which covers the entire territory and which takes account of geographically isolated or otherwise disadvantaged regions (see, to that effect,
Hartlauer
, paragraph 52, and
Blanco Pérez and Chao Gómez
, paragraph 70).
As the Court has stated, if this field were wholly unregulated, pharmacies could become concentrated in the areas considered to be attractive, so that certain other less attractive areas might suffer from a shortfall in the number of pharmacies needed to ensure a pharmaceutical service which is reliable and of good quality (
Blanco Pérez and Chao Gómez
, paragraph 73).
In those circumstances, a Member State may consider that there is a risk of a shortage of pharmacies in some parts of its territory and that, as a consequence, the provision of medicinal products might not be reliable and of good quality, and it may therefore adopt rules for the planning of pharmacies (see, to that effect,
Blanco Pérez and Chao Gómez
, paragraph 75).
Next, it must be borne in mind that the national legislation at issue in the main proceedings provides that the sale of any prescription-only medicinal products is reserved exclusively to pharmacies.
To accept the situation sought by the applicants in the main proceedings, in which the sale of some prescription-only medicinal products would be allowed in para‑pharmacies, would amount to being able to sell those medicinal products without being subject to the requirements of territorial planning. Therefore, interested parties could set up business anywhere and of their own choosing.
Accordingly, it is not inconceivable that such an option would lead to a concentration of para-pharmacies in areas deemed to be the most profitable, and therefore the most attractive, at the risk of reducing the number of customers of pharmacies in those areas and, therefore, of depriving them of a large part of their income, all the more so as pharmacies are subject to a number of particular obligations in the way that they manage their business.
Such a loss of revenue would not only be liable to bring about a lower quality of service provided by pharmacies to the public, but, depending on the circumstances, it could also result in the definitive closure of some pharmacies, thus leading to a shortage of pharmacies in some parts of the territory and therefore to a supply of medicinal products which is unreliable and not of good quality.
It follows from the foregoing that the option referred to in paragraph 51 of this judgment could have negative repercussions on the effectiveness of the entire planning system in respect of pharmacies, and therefore on its stability.
In those circumstances, the legislation at issue in the main proceedings, which reserves the sale of prescription-only medicinal products, including those the cost of which is borne not by the national health service but wholly by the purchaser, exclusively to pharmacies, the establishment of which is subject to planning rules, is appropriate to guarantee attainment of the objective of ensuring that the supply of medicinal products to the public is reliable and of good quality and, therefore, of ensuring the protection of public health.
The Italian Government fears that the absence of national legislation such as that at issue in the main proceedings would lead to an overconsumption of medicinal products. However, that fear is not well founded.
In that regard, the number of establishments which sell prescription-only medicinal products, including those the cost of which is borne not by the national health service but wholly by the purchaser, is of little importance Since only doctors are authorised to prescribe those medicinal products, neither owners of pharmacies nor owners of para-pharmacies have, in any event, any direct influence on the volume of sales of those medicinal products and cannot therefore contribute to their possible overconsumption.
It remains to be examined, fourthly, whether the restriction on freedom of establishment goes beyond what is necessary to attain the objective pursued, that is to say, whether there are less restrictive measures by means of which that objective could be achieved.
In that regard, it should, first, be borne in mind that, according to the Court’s settled case‑law, when assessing whether the principle of proportionality has been observed in the field of public health, account must be taken of the fact that it is for the 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. Since the level of protection may vary from one Member State to the other, Member States must be allowed discretion (see Case
C-141/07
Commission
v
Germany
[2008] ECR I-6935
, paragraph 51;
Apothekerkammer des Saarlandes and Others
, paragraph 19, and
Blanco Pérez and Chao Gómez
, paragraph 44).
Furthermore, it is important that, where there is uncertainty as to the existence or extent of risks to human health, a Member State should be able to take protective measures without having to wait until the reality of those risks becomes fully apparent. In particular, a Member State may take measures that reduce, as far as possible, a health risk, including, more specifically, a risk to the reliability and quality of the provision of medicinal products to the public (see
Apothekerkammer des Saarlandes and Others
, paragraph 30, and
Blanco Pérez and Chao Gómez
, paragraph 74).
Pursuant to the national legislation at issue in the main proceedings, the sale of prescription-only medicinal products is reserved exclusively to pharmacies. That class of medicinal products, the obtaining and consumption of which by a patient is subject to continuous review by a doctor and which generally have significant effects on health, must be able to be rapidly, easily and reliably accessible.
Accordingly, the risk, referred to in paragraph 53 of this judgment, linked to a possible shortage of pharmacies and leading to the lack of rapid and easy access to prescription-only medicinal products in some parts of the territory, is high. The extent of such a risk would not be reduced, were the measure liberalising the planning rules for pharmacies to be confined solely to those prescribed medicinal products the cost of which is borne not by the national health service but wholly by the purchaser.
In those circumstances, the system established in the Member State at issue in the main proceedings, as it also does not allow the sale in para‑pharmacies of prescription‑only medicinal products, including those the cost of which is borne not by the national health service but wholly by the purchaser, in so far as it substantially reduces the risk referred to in the preceding paragraph of this judgment, does not appear to go beyond what is necessary in order to attain the objective of ensuring that the supply of medicinal products to the public is reliable and of good quality.
Moreover, nothing in the file before the Court points to any possible alternative system capable of reducing that risk as effectively.
It follows from all the foregoing that the system set up by the national legislation at issue in the main proceedings is justified in the light of the objective of ensuring that the supply of medicinal products to the public is reliable and of good quality and does not appear to go beyond what is necessary to attain it.
Having regard to all the foregoing, the answer to the question referred is that Article 49 TFEU must be interpreted as not precluding national legislation, such as that at issue in the main proceedings, which does not allow a pharmacist, who is qualified and registered with the professional body but does not own a pharmacy in the grid, also to offer for retail sale, 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.
Costs
Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.

On those grounds, the Court (Fourth Chamber) hereby rules:

Article 49 TFEU must be interpreted as not precluding national legislation, such as that at issue in the main proceedings, which does not allow a pharmacist, who is qualified and registered with the professional body but does not own a pharmacy in the grid, also to offer for retail sale, 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.

[Signatures]
(
*1
)   Language of the case: Italian.