62008CC0393_EN
Opinion of the Advocate-General
Opinion of the Advocate-General
I – Introduction
1. Proceedings were brought before the Tribunale amministrativo regionale per il Lazio (Lazio Regional Administrative Court) (Italy) (‘the Tribunale’) in a dispute between Ms Sbarigia, a pharmacist, and the administration of the Municipality of Rome regarding the regional legislation governing the opening times of pharmacies and, in particular, the exclusion of any possibility of declining to close for an annual holiday. It is in this context that the referring court decided to stay the proceedings and to refer to the Court of Justice for a preliminary ruling two questions, the first concerning the interpretation of Articles 49 EC, 81 EC, 82 EC, 83 EC, 84 EC, 85 EC and 86 EC, and the second concerning the interpretation of Articles 152 EC and 153 EC. (2)
2. The order for reference indicates that the referring court has doubts as to whether the regional legislation in question is compatible in particular with the principles underlying the policy of free competition. However, a link between the European Union legislation cited in the reference for a preliminary ruling and the debate regarding competition conducted at national or regional levels has not been clearly established. This raises questions as to the admissibility of the questions referred by the national court, and as to the possible need to reformulate them.
II – The legal framework
3. In Italy, pharmacy services are organised essentially as public service concessions, subject to the issue of an authorisation.
4. In order to guarantee continuity of pharmacy services, which are a key to protecting public health, the opening times, duty rotas and holidays for pharmacies are regulated by regional laws. In the case of Lazio, this is Regional Law No 26 of 30 July 2002 (Legge regionale Lazio n. 26/2002, ‘Regional Law No 26/2002’). (3)
5. Articles 2 to 8 of Regional Law No 26/2002 determine the opening times, voluntary duty-pharmacy service, weekly closing and annual holidays for pharmacies. These provisions impose in particular maximum opening hours, the obligation to close on Sundays, a half-day per week and on public holidays, and a minimum period of annual holidays. The application of a number of articles of Regional Law No 26/2002 is subject to conditions relating to the geographical particularities of the municipalities concerned or the location of the pharmacy.
6. Article 10 of Regional Law No 26/2002 reads as follows:
‘1. For the municipality of Rome, each local health office (“USL”) shall adopt the measures provided for in this Law falling within its competence, with the agreement of the other USLs concerned.
2. For outlets situated in specific municipal areas, the weekly public opening times, holidays for urban pharmacies and the weekly half-day rest period ... may be modified by decision of the USL responsible for the area in question, in agreement with the mayor of the municipality concerned, the provincial order of pharmacists and the provincial professional organisations most representative of public and private pharmacies.’
III – The dispute in the main proceedings and the questions referred for a preliminary ruling
7. Ms Sbarigia is the owner of a pharmacy of long standing, located in a ‘specific area’ known as ‘del Tridente’, in the historical centre of Rome. This neighbourhood, entirely pedestrianised, is situated in the heart of the capital’s tourist area.
8. Because of this location and the significant increase in the number of consumers in the neighbourhood during the summer season of July and August, on 31 May 2006 Ms Sbarigia applied to the Azienda USL RM/A (the local health office for Rome A) which is responsible for that area, for exemption from the holiday closure period for summer 2006.
9. That application, made on the basis of Article 10(2) of Regional Law No 26/2002, was later extended to a request to be exempted from closure in respect of all annual holidays, to be allowed to extend her weekly opening hours throughout the year and not to have to close on public holidays. In that regard, Ms Sbarigia argues that such authorisation had been granted, on 8 September 2006, to another pharmacy situated near the Termini railway station, which has the same specific type of clientele as her own pharmacy.
10. Ms Sbarigia’s applications were rejected on a number of occasions by the Azienda USL RM/A, pursuant to Article 10(2) of Regional Law No 26/2002, on the basis of unfavourable opinions from the municipality of Rome, the Ordine dei Farmacisti della Provincia di Roma (Order of Pharmacists of the Province of Rome) as well as the professional associations Assiprofar (Associazione Sindicale Proprietari Farmacia) and Confservizi.
11. The Tribunale noted that the opening times of pharmacies, duty rotas for Sundays, closing on public holidays and annual holiday periods are not matters of free choice or organisational decisions taken by individual pharmacists. The possibility of derogation is limited and always subject to the discretion of the administrative authorities, and refusals are difficult to challenge.
12. According to the Tribunale, the classification of pharmacy services as a public service intended to protect the health of their consumers does not suffice to justify those restrictive provisions relating to the opening times of pharmacies. A liberalisation of the timetables and opening periods for all outlets would make it possible to broaden supply as a whole, with the rules on location guaranteeing a balanced geographical spread of pharmacies, for the benefit of consumers. Such a reform was suggested, in fact, in a report issued on 1 February 2007 by the national authority responsible for upholding competition and the market.
13. The provisions in question also seem to the Tribunale to be excessive and unjustified. The public interest and the needs relating to pharmacy services would be better protected by competitive measures liberalising opening times.
14. Thus, the Tribunale is uncertain as to the compatibility of the restrictions at issue with certain principles of Community law.
15. In those circumstances, the Tribunale decided to refer the following questions to the Court for a preliminary ruling:
‘1. Is it compatible with the Community principles upholding freedom of competition and freedom to provide services, laid down inter alia in Articles 49 [EC], 81 [EC], 82 [EC], 83 [EC], 84 [EC], 85 [EC] and 86 EC, to impose on pharmacies the abovementioned prohibitions – whereby they are not allowed either to decline to take an annual holiday or to remain open whenever they so desire, beyond the maximum limits at present allowed under the abovementioned provisions of Regional Law No 26/2002 – and the concomitant additional requirement, under Article 10(2) of [that law], of a prior discretionary assessment by the Administration (carried out in agreement with the bodies and organisations specified in that article) as to the special nature of the municipal area in which the applicant pharmacies are located, as a precondition for obtaining a derogation from those prohibitions within the Municipality of Rome?
2. Is it compatible with Articles 152 [EC] and 153 [EC] to impose on the public pharmacy service, albeit with the aim of protecting the health of consumers, conditions – such as those laid down in Regional Law No 26/2002 – limiting or precluding the possibility of extending the daily, weekly or annual opening times of individual pharmacies?’ (4)
IV – Procedure before the Court
16. The reference for a preliminary ruling was lodged at the Court Registry on 11 September 2008.
17. Written observations were lodged by Ms Sbarigia, the Municipality of Rome, the Greek, Italian, Netherlands and Austrian Governments, as well as by the Commission of the European Communities.
18. In an annex to the notice to attend the hearing, the parties to the hearing were requested to address, in their oral pleadings in relation to admissibility, the link with Community law and, in relation to substance, the interpretation of Articles 28 EC, 29 EC, 30 EC, 31 EC and 86(2) EC.
19. Ms Sbarigia, Assiprofar, the Ordine dei Farmacisti della Provincia di Roma, the Greek, Italian and Austrian Governments, as well as the Commission, were represented at the hearing, which was held on 17 December 2009.
V – Analysis
A – Introduction
20. It should be noted from the outset that the reference for a preliminary ruling does not contain any information on why the nine articles of the EC Treaty and the two principles of European Union law which are cited should require an interpretation. The parties which submitted written observations seem also to have doubts in this regard.
21. As a preliminary point, I would like to recall that the order for reference must give the precise reasons which prompted the national court to raise the question of the interpretation of European Union law and to consider it necessary to refer questions to the Court for a preliminary ruling. (5) Against that background, it is essential that the national court provide at the very least some explanation of the reasons for the choice of the provisions in European Union law which it requires to be interpreted and of the link it establishes between those provisions and the national legislation applicable to the dispute in the main proceedings. (6)
22. I propose to analyse the reference for a preliminary ruling in the following order: after having examined the admissibility of the questions, I will address the second question, relating to Articles 152 EC and 153 EC, before going on to discuss the first question, which relates to competition law (Articles 81 EC to 86 EC) and the freedom to provide services (Article 49 EC).
B – Admissibility
23. Two grounds for inadmissibility have been raised in this case.
24. First, in its written observations, the Italian Government maintains that the reference for a preliminary ruling is inadmissible since it does contain the factual and legal material that is essential to understanding how the provisions cited are relevant in this case.
25. In that regard it suffices to note that, according to settled case‑law, the Court may refuse to rule on a question referred for a preliminary ruling from a national court only where it is quite obvious that the interpretation of European Union law that is sought bears no relation to the actual facts of the main action or its purpose, where the problem is hypothetical, or where the Court does not have before it the factual or legal material necessary to give a useful answer to the questions submitted to it. (7)
26. However, given the legal and factual material provided by the referring court, this Court has before it, in my view, sufficient material to rule on the reference for a preliminary ruling.
27. Secondly, the question of admissibility was also addressed at the hearing, at the Court’s request, from the perspective of the lack of any cross‑border element in the case.
28. It seems clear to me that the facts at issue in the main proceedings do not include any transborder element. Nevertheless, the case‑law of the Court indicates that the absence of a cross-border element cannot lead the Court to declare a reference for a preliminary ruling inadmissible in such a situation. As regards particularly the questions relating to the interpretation of Article 49 EC, although it is common ground that all aspects of the case before the referring court are confined within a single Member State, in this case a region thereof, a reply might none the less be useful to the referring court, in particular if its national law were to require that an Italian national must be allowed to enjoy the same rights as those which a national of a Member State other than the Italian Republic would derive from European Union law in the same situation. (8)
29. In pass ing, I note that in preliminary ruling cases whose scope is purely national, the Court has adopted a variety of approaches.
30. There is one series of decisions in which the Court has declared, by way of judgment, that the Treaty provisions invoked cannot be applied to activities which are confined in all relevant respects within a single Member State (9) and the question whether that is the case depends on a determination of fact that is for the national court to make. (10)
31. In a second series of decisions, it is declared, by way of order, that the relevant European Union law does not preclude the national legislation in question. (11)
32. A third approach consists in noting that the national legislation in question is outside the scope of European Union law and that the subject-matter of the dispute is not connected in any way with any of the situations contemplated by the provisions of the Treaties. In such cases, the Court has ruled by way of order, declaring that it clearly has no jurisdiction to answer the question referred. (12)
33. Finally, in a fourth series of decisions, the Court undertakes substantive examination of the provisions of European Union law of which an interpretation is sought, in so far as the national law at issue in the main proceedings would be applied in a cross-border situation, even if all elements of the case in the main proceedings are confined within a single Member State. (13)
34. In the light of these approaches, I note that the choice between a judgment and an order is made by the Court according to the practices defined by Article 92(1) of the Rules of Procedure. As to the question whether or not a situation is national, the answer to that question should in no way affect the jurisdiction of the Court for the purpose of ruling on the criteria for the applicability of the provisions of European Union law and, where appropriate, on their interpretation.
35. It seems to me that, in case of doubt, the Court should fundamentally proceed on the assumption that, as a general rule, questions referred for a preliminary ruling should be examined as to their substance rather than declared inadmissible. Merely stating that the question is inadmissible might be perceived by the national courts as contrary to the principle of good cooperation with those courts, which is a fundamental principle governing that relationship. Moreover, there is a significant difference between an examination of inadmissibility in the context of a direct action or an appeal, on the one hand, and of a question referred for a preliminary ruling, on the other. In a direct action, the examination of admissibility seeks to protect in particular the interests of the defendant. In an appeal, a strict application of the admissibility criteria is important so that the allocation of competences between the different levels of court is respected. Those reasons are not present in the same way in a reference for a preliminary ruling.
36. As regards the present case, I note that the requirement that it be cross‑border in nature does not have the same importance with regard to the various fundamental freedoms. (14) It follows that the applicability of the Treaty provisions depends on their interpretation. Given that the Court may also be asked to adjudicate on the same issues in the context of proceedings for failure to fulfil obligations, where the absence of a cross-border dimension has no effect whatsoever on the admissibility of the action, it seems to me that the problem raised by the ‘purely national’ nature of a situation ought to be resolved by addressing its substance, in the context of the interpretation of the provisions at issue, rather than as a question of the Court’s jurisdiction, examined in terms of the admissibility of the questions referred.
37. Finally, as we shall see further on, the criteria for assessing the admissibility of a reference for a preliminary ruling are not necessarily identical to those used for a substantive analysis of the adequacy of the factual and legislative material as presented by the referring court.
38. I therefore suggest to the Court that it declare the reference for a preliminary ruling to be admissible.
C – Preliminary comments on the regional legislation
39. In Italy, competence to issue rules governing the timetables and opening and closing times of pharmacies is vested in a regional authority. At the hearing, the parties explained that the solutions adopted varied from one region to another.
40. The application to pharmacies of the principle of free competition appears to be disputed in Italy. In any event, the provision of non-prescription medicines has been liberalised in Italy. Even though pharmacies are economic operators, they are none the less required to provide services in the public interest. (15)
41. However, it should be emphasised that the latter aspect is also apparent from Regional Law No 26/2002. That law must be considered an act of the public authority that clearly establishes the specific tasks, corresponding to public service obligations, that are entrusted to all the pharmacies covered by that Law. Articles 2 to 8 of Regional Law No 26/2002 define in detail the public service obligations relating to opening times, the daytime and night-time duty of pharmacies on Sundays and public holidays, that is, the mandatory service that pharmacies must provide outside the regular opening times in effect for working days, the voluntary duty-pharmacy service, the weekly day of rest, as well as annual holidays. The obligations aimed at guaranteeing a continuous, broad and regular supply of medicines to patients restrict the commercial freedom of pharmacies to an extent which goes well beyond ordinary conditions for authorisation to pursue an activity in a particular sector.
42. The regional legislature seems to have considered that the continuity and efficiency of the supply of medicines demands that pharmacies follow certain rules as far as opening times and annual holidays are concerned.
43. Furthermore, the geographical distribution of pharmacies, which carry an equivalent range of medicines and are regularly accessible during opening times that are uniformly determined at regional level, is intended to guarantee a local supply in isolated areas, something that is recognised as a matter of overriding public interest by the Court’s case-law. (16) The regulation of opening times may, however, present a double‑edged disadvantage: a well situated pharmacy could consider it an obstacle if it wished to extend the opening periods of an outlet that is particularly profitable, while a pharmacy that is less well situated could, by contrast, consider it a constraint if it wished to shorten the aforesaid periods in order to limit its operating costs.
44. It is in the light of the abovementioned aspects that we will now proceed to analyse the questions submitted by the referring court.
D – Articles 152 EC and 153 EC
45. I intend first to address Articles 152 EC (public health) and 153 EC (consumer protection), although these are the subjects of the second question.
46. Ms Sbarigia is of the opinion that those articles preclude the application of requirements relating to the daily, weekly and annual opening times of pharmacies, such as those provided for in Regional Law No 26/2002. The defendant in the main proceedings maintains, conversely, that the provisions in question do not preclude the regional law at issue.
47. The Commission and the Governments which submitted written observations, with the exception of the Greek Government, argue in essence that Articles 152 EC and 153 EC are merely rules of competence addressed in particular to the Community legislature and that it would thus be appropriate to interpret them as not precluding national legislation that imposes on pharmacies limitations in respect of their timetables and opening hours. The Greek Government, for its part, considers that establishing an operating timetable for pharmacies is not contrary to the provisions of Articles 152 EC and 153 EC.
48. First of all, I admit to having some difficulty in detecting the relevance of the interpretation of Article 153 EC for resolving the dispute brought before the referring court. This article, cited only in the question referred, relates to consumer protection and provides, in particular, the framework for the contribution of the European Union to attaining the objectives in this area. The referring court gives no explanation at all of the extent to which consumer protection was at issue, and thus I consider that the question in fact relates only to Article 152 EC.
49. As far as Article 152 EC is concerned, I agree with the interpretation proposed by the Commission and the Member States, with the exception of the Hellenic Republic, according to which Article 152 EC in essence contains a rule of competence addressed in particular to the Community legislature. Article 152(1) EC provides that a high level of human health protection is to be ensured in the definition and implementation of all European Community policies and activities. However, in the present case, no implementation of Community policies or activities is involved.
50. Moreover, Article 152(5) EC does not come directly into play. The Court has already ruled on this point that European Union law does not detract from the power of Member States to organise their social security systems and to adopt, in particular, provisions intended to govern the organisation of health services such as pharmacies. In exercising that power, however, Member States must comply with European Union law, in particular the Treaty provisions on the freedoms of movement, including freedom of establishment, which will be analysed below. (17)
51. Article 152 EC is therefore not applicable to the present case.
E – Articles 81 EC to 86 EC
52. Ms Sbarigia maintains that the regional legislation at issue is not compatible with Articles 81 EC to 86 EC. The defendant in the main proceedings considers, instead, that the regional provisions are consistent with European Union law. The Netherlands and Austrian Governments consider, for their part, that the articles cited are not applicable, whereas the Greek Government notes that the reference to Articles 81 EC to 86 EC is imprecise, in so far as the national court did not explain the relevance of those various provisions. The Commission, in turn, wonders about the relevance of all the provisions cited, but none the less proposes that Articles 10 EC and 81 EC be interpreted as not precluding national legislation that provides for consultative participation by the provincial union organisations most representative of public and private pharmacies, as well as by the provincial order of pharmacists, in the decision-making process for setting the timetables and opening times of pharmacies.
53. Like the Commission, I consider that this part of the first question referred is scarcely relevant for resolving the dispute in the main proceedings.
54. Il should be noted from the outset that Articles 83 EC, 84 EC and 85 EC have no relevance in the case before the referring court, since these are either provisions that are purely procedural (as is true of Articles 83 EC and 85 EC), or transitional provisions (as is true of Article 84 EC).
55. Next, the applicability of Article 81 EC should be verified. It seems to me that the question from the referring court seeks, in actual fact, to establish whether provisions such as those of Regional Law No 26/2002 are compatible with Article 81 EC read in conjunction with Article 10 EC.
56. According to settled case-law, although it is true that Article 81 EC is concerned solely with the conduct of undertakings and not with laws or regulations emanating from Member States, that article, read in conjunction with Article 10 EC, which lays down a duty to cooperate, none the less requires Member States not to introduce or maintain in force measures, even of a legislative or regulatory nature, which may render ineffective the competition rules applicable to undertakings. (18)
57. The Court has thus held that Articles 10 EC and 81 EC are infringed where a Member State requires or encourages the adoption of agreements, decisions or concerted practices contrary to Article 81 EC or reinforces their effects, or where it divests its own rules of the character of legislation by delegating to private economic operators responsibility for taking decisions affecting the economic sphere. (19)
58. Nevertheless, it should be noted that a law such as Regional Law No 26/2002, in so far as it provides for the procedure to determine opening times for pharmacies and that allowing derogation from them, does not fall within any of the situations for the combined application of Articles 10 EC and 81 EC.
59. In my view, there is no evidence to show that Regional Law No 26/2002 encourages, reinforces or codifies concerted practices or decisions by undertakings. It seems to me, instead, that the consultation of the associations of pharmacies provided for in the Regional Law responds to the need to organise duty services among pharmacies. Nor is there anything in the order for reference to suggest that the legislative provision at issue has been divested of the character of legislation in that the Member State in question has delegated to private economic operators responsibility for taking decisions affecting the economic sphere.
60. Lastly, it does not follow from the order for reference that what is at issue here is any kind of agreement between undertakings, decision by an association of undertakings or concerted practice which may affect trade between Member States and which has as its object or effect the prevention, restriction or distortion of competition within the common market within the meaning of Article 81 EC.
61. As to the first paragraph of Article 82 EC, it reads as follows: ‘Any abuse by one or more undertakings of a dominant position within the common market or in a substantial part of it shall be prohibited as incompatible with the common market in so far as it may affect trade between Member States’.
62. The reference to Article 82 EC, which prohibits the abuse of a dominant position, is thus seen to be irrelevant since it is not apparent from the case-file that Ms Sbarigia’s pharmacy or any other establishment competing with that pharmacy is in such a situation.
63. According to Article 86(1) EC, ‘[i]n the case of public undertakings and undertakings to which Member States grant special or exclusive rights, Member States shall neither enact nor maintain in force any measure contrary to the rules contained in this Treaty, in particular to those rules provided for in Article 12 and Articles 81 to 89’. Pursuant to the Court’s case-law, a Member State will be in breach of the prohibitions thus laid down where the undertaking in question, merely by exercising the special or exclusive rights conferred upon it, is led to abuse its dominant position or where such rights are liable to create a situation in which that undertaking is led to commit such abuses. (20)
64. The order for reference, however, contains no information concerning, in particular, the definition of the relevant market, the calculation of the market shares held by the various undertakings operating on the market, or the alleged abuse of a dominant position. The reference for a preliminary ruling does not set out the national or regional rules relating to the establishment of pharmacies. It provides no information on whether there are one or more in a specific area, such as that called ‘del Tridente’ or that of the Termini railway station. Nor does it specify whether there are any rules concerning minimum distances between pharmacy outlets.
65. As regards Article 86(2) EC, it should be recalled first of all that, according to that provision, ‘[u]ndertakings entrusted with the operation of services of general economic interest or having the character of a revenue-producing monopoly shall be subject to the rules contained in this Treaty, in particular to the rules on competition, in so far as the application of such rules does not obstruct the performance, in law or in fact, of the particular tasks assigned to them. The development of trade must not be affected to such an extent as would be contrary to the interests of the Community’.
66. Article 86(2) EC makes subject to the rules contained in the Treaty those undertakings entrusted with the operation of services of general economic interest or having the character of a revenue‑producing monopoly, (21) but allows certain derogations in favour of those undertakings. (22) However, since no incompatibility with the Treaty has been demonstrated, the provisions of Article 86(2) EC do not apply. The same conclusion may be drawn as regards the applicability of Article 86(1) EC.
67. On the basis of the information provided by the referring court, it seems to me possible to conclude that this is a case of the inapplicability in substance of the provisions cited rather than the partial inadmissibility of the first question referred. As I explained above, in such situations the Court should not declare a question referred to be inadmissible, but should instead examine it as to substance to determine whether or not the provisions in question are applicable. (23)
68. I therefore propose that the Court reply that Articles 10 EC and 81 EC must be interpreted as not precluding regional legislation that provides for consultative participation by the provincial union organisations most representative of public and private pharmacies, as well as by the provincial order of pharmacists, in the decision-making process for setting the timetables and opening times of pharmacies. The other provisions cited by the referring court are not applicable.
F – The freedom to provide services (Article 49 EC)
69. As regards fundamental freedoms, the referring court sought an interpretation only of Article 49 EC.
70. Article 49 EC prohibits restrictions on freedom to provide services within the Community in respect of nationals of Member States who are established in a State of the Community other than that of the person for whom the services are intended.
71. Ms Sbarigia considers that Regional Law No 26/2002 and its application are incompatible with Article 49 EC. By contrast, the Greek and Austrian Governments maintain that that article does not apply, in the absence of any cross‑border aspect.
72. The Commission, for its part, considers that the reference to Article 49 EC is manifestly mistaken. It refers to settled case-law according to which a national of a Member State who, on a stable and continuous basis, pursues a professional activity in another Member State falls within the chapter of the Treaty on the right of establishment and not the one on services. (24) The latter chapter – unlike the former – therefore relates not to the situation of the national of a Member State who participates in a stable manner in the economic life of another Member State, but solely to that of the service provider who pursues his or her activity on the territory of another Member State on a temporary basis.
73. I agree with the Commission’s analysis. The order of reference does indeed state that Ms Sbarigia is the owner of a pharmacy in Rome, where she pursues the activity of selling pharmaceutical and parapharmaceutical products, and does so on a stable and continuous basis.
74. The situation of the persons for whom the services in question are intended should also be examined. The legislation at issue restricts the possibility for tourists to use the services of Ms Sbarigia’s pharmacy during periods of mandatory closure. This restriction does not, however, constitute discrimination on the basis of nationality and everyone is free to use other pharmacies that are open or on duty. (25)
75. I therefore propose that the Court reply that Article 49 EC must be interpreted as not precluding regional legislation that restricts the arrangements for daily, weekly and annual opening times for pharmacies, in a situation such as that at issue in the case in the main proceedings.
G – Possible change in the legal basis of referred questions
76. After having examined all the questions referred by the national court, I am of the opinion that the Court should not extend its analysis any further.
77. It is true that some of the parties that submitted written observations to the Court also referred to two other articles, namely, Article 43 EC, relating to the freedom of establishment, and Article 28 EC on the free movement of goods, and that the applicability of those articles was raised at the hearing.
78. Nevertheless, it seems to me that the Court should not rule on those two provisions, on which the referring court did not ask any questions. There are two series of reasons for this.
79. First, it is for the referring court to identify the provisions of European Union law of which an interpretation seems to it necessary in order to resolve the case in the main proceedings. In its order for reference, it did so in a way that seems to me to be exhaustive, referring explicitly to the specific principles that underlie a fairly significant number of provisions of European Union law. In such a case, it is not for the Court to seek out all the other provisions of European Union law the interpretation of which might prove useful to the referring court. The power which the Court has taken upon itself to reformulate referred questions is intended, in my view, to allow the Court to assist the referring court in finding the precise expression of a problem of interpretation of European Union law that is relevant for the purposes of the proceedings. On this view, it is for the Court to clarify, and not to expand, the problem raised by the reference for a preliminary ruling. (26)
80. Secondly, this restrictive interpretation is also supported by the Statute of the Court of Justice of the European Union. The order for reference as formulated by the national court is notified, under the Statute of the Court, to the Member States and institutions of the European Union in particular. It is on the basis of this document that the latter determine whether or not it would be useful to submit written observations and to participate in the proceedings before the Court. (27) For the Court as well, this is a document of reference. It is clear that a reformulation would require the Court to have available all the necessary and relevant material, including that relating to the facts and the national legal framework.
81. For the sake of completeness, I will recall in any event that according to settled case-law Article 28 EC does not apply to national rules concerning the closure of shops that are enforceable against all economic operators pursuing activities within the national territory and that affect, in the same way, in law and in fact, the sale of domestic products and of products from other Member States. (28)
82. As regards Article 43 EC, the Court recently noted the compatibility with the Treaty of fairly restrictive Italian legal provisions concerning pharmacies, that had a much more direct link with the freedom of establishment than the provisions at issue in the main proceedings. (29)
83. In addition, I do not consider that regional legislation such as Regional Law No 26/2002, which applies without distinction to all pharmacies in the region in question, is among the measures that prohibit, impede or render less attractive the exercise of the freedom of establishment by undertakings from other Member States. It is therefore not a restriction of the freedom of establishment as defined in the Court’s case-law. (30)
84. In my view, a contrary conclusion would be possible only if the legislation on opening hours and holidays were devoid of all transparency, or if its application depended in a decisive manner on the discretion of the administrative authorities.
85. Ms Sbarigia, as well as the Netherlands Government and the Commission, raised the question of whether the procedure for taking decisions, in respect of the derogations provided for in Article 10(2) of Regional Law No 26/2002, is indeed compatible with Articles 28 EC and/or 43 EC, taking into account, in particular, the consultations provided for and the broad discretion conferred on the administrative authorities.
86. The discretion conferred on the administrative authorities by Regional Law No 26/2002 seems to me to exist, in particular, in respect of the application of the derogations and exemptions referred to in Articles 2(6), 6, 7(3), 8(1) (d) and (e), and 10(2) of Regional Law No 26/2002.
87. Cases in which the administrative authorities are called upon to decide on a derogation or an exemption clearly vary. There may be, first of all, a prohibition or a generally applicable condition in respect of which the administrative authorities may grant derogations or exemptions where the conditions provided for by law are fulfilled. In that case, the grant of the derogation or the exemption is more or less automatic, without the administrative authorities having any discretion. A second scenario is one in which, even where the conditions necessary for obtaining a derogation were fulfilled, its grant is none the less left to the discretion of the competent administration. This is not an exceptional situation. The exercise of a discretionary power of assessment may prove necessary, for example, because it is not possible to meet all requests for derogation. A third scenario is one in which the legislation does not specify the conditions for granting a derogation. In that case, the administration’s power of assessment may be subject to judicial review by reference to the general principles of administrative law such as equal treatment, impartiality, proportionality and the prohibition against any misuse of power.
88. The possibility of a derogation as provided for in Article 10(2) of Regional Law No 26/2002 seems to be midway between the last two scenarios. It is subject to certain geographical and procedural conditions. As I have already noted, the case-file does not contain any precise information on the rules that may apply with regard to the geographical location of pharmacy outlets in the Lazio region. The same remark should be made with regard to the question of how the concept of ‘specific municipal area’ has been interpreted in regional administrative practice and in national case-law. In any event, it seems to me that this provision should not be examined in isolation but in the light of all the provisions of Regional Law No 26/2002. The provision in question seems, from that point of view, to provide for particular arrangements, in one specific case, amongst others, implying that opening times may be rearranged depending on the circumstances.
89. Taken in isolation, Article 10(2) of Regional Law No 26/2002 could admittedly be criticised for its lack of clarity and precision, but, examined in the light of all the provisions of the regional law in question, this provision seems to me reasonable and comprehensible. In any event, I would be wary of adopting the criticism made of the single example of the application of this provision mentioned in the file, namely, the exemption granted to a pharmacy near the Termini railway station, and of analysing this decision as an indication of discretionary, non-objective or discriminatory treatment. The reasons for granting a specific status to a pharmacy situated at the hub of local, national and international railway traffic in a European metropolis cannot necessarily be transposed to a tourist area such as the one at issue in the main proceedings. (31)
90. The rules governing opening and closing times must be considered in their entirety. At the hearing, the representative of Assiprofar gave a useful example concerning the voluntary night duty that begins at about 8.00 p.m. The period between 8.00 p.m. and 10.00 p.m. is the peak time for night pharmacies, since in that region a considerable part of the active population returns home when other pharmacies are already closed. A possible extension of the daytime hours would encroach on the most profitable time slot in the night pharmacy’s opening times. This might discourage candidates who agree to take on voluntary night duty, inasmuch as the constraints involved in it would no longer be compensated for by the profit gained from the privilege of opening during the aforesaid time slot. The resulting decline in private initiative would mean having to return to a system of mandatory duty service.
91. Lastly, as regards the procedure provided for in Regional Law No 26/2002, and in particular the required consultations, it is clear that these fall within the administration’s exercise of discretion. The participation of the other parties does not in itself render the procedure incompatible with European Union law. It is important, however, for the decision to be subject to judicial review, and this indeed appears to be the case here.
92. In the light of the wording of the reference for a preliminary ruling, I therefore propose that the Court reply to the questions referred, to the extent that they are relevant and, in any event, that it does not extend them beyond the reference for a preliminary ruling that was submitted to it.
VI – Conclusion
93. Having regard to the foregoing, I consider that the questions referred by the Tribunale amministrativo regionale per il Lazio should be answered as follows:
1. Article 49 EC must be interpreted as not precluding regional legislation that restricts the daily, weekly and annual opening times of pharmacies in a situation such as that at issue in the main proceedings.
2. Articles 10 EC and 81 EC must be interpreted as not precluding regional legislation that provides for the consultative participation of the provincial union organisations most representative of public and private pharmacies, as well as of the provincial order of pharmacists, in the decision-making process regarding the setting of timetables and opening times for pharmacies.
3. The other provisions of the EC Treaty referred to by the national court do not apply to a situation such as that at issue in the main proceedings.
(1) .
(2)
–	Since the request for a preliminary ruling dates from 21 May 2008, reference will be made to the provisions of the EC Treaty according to the numbering applicable prior to the entry into force of the Treaty on the Functioning of the European Union.
(3)
–	GURI no. 24, Serie speciale no. 3 of 14 June 2003, and Boll. Uff. Lazio no. 23, Supplemento ordinario no. 5, of 20 August 2002.
(4)
– The question does indeed relate to the EC Treaty, even though the question refers to the EU Treaty. This was clearly a clerical error.
(5)
–	See the information note on references from national courts for a preliminary ruling (OJ 2005 C 143, p. 1), in its most recent version (OJ 2009 C 297, p. 1).
(6)
–	See inter alia, order in Case C‑167/94 Grau Gomis and Others
[1995] ECR I‑1023, paragraph 9; Joined Cases C‑453/03, C‑11/04, C‑12/04 and C‑194/04 ABNA and Others
[2005] ECR I‑10423, paragraph 46, Case C‑380/05 Centro Europa 7
[2008] ECR I‑349, paragraph 54, and Case C‑116/08 Meerts
[2009] ECR I‑0000, paragraph 27).
(7)
–	See Case C‑314/08 Filipiak
[2009] ECR I‑0000, paragraph 42 and case-law cited.
(8)
–	See inter alia Case C‑448/98 Guimont [2000] ECR I‑10663, paragraph 23; Case C‑451/03 Servizi Ausiliari Dottori Commercialisti
[2006] ECR I‑2941, paragraph 29; and Joined Cases C‑94/04 and C‑202/04 Cipolla and Others
[2006] ECR I‑11421, paragraph 30.
(9)
–	See to that effect inter alia Case C‑60/91 Batista Morais
[1992] ECR I‑2085, paragraph 8, and Joined Cases C‑29/94 to C‑35/94 Aubertin and Others
[1995] ECR I‑301, paragraph 9.
(10)
–	See inter alia Case C‑41/90 Höfner and Elser
[1991] ECR I‑1979, paragraph 37, and Case C‑332/90 Steen
[1992] ECR I‑341, paragraph 9.
(11)
–	See inter alia orders of 5 April 2004 in Case C‑3/02 Mosconi et Ordine degli Ingegneri di Verona e Provincia (operative part) and of 19 June 2008 in Case C‑104/08 Kurt
(paragraph 24 and operative part).
(12)
–	See the orders in Case C‑328/04 Vajnai [2008] ECR I‑8577, paragraph 13; of 25 January 2007 in Case C‑302/06 Koval’ský
paragraphs 20 and 22, and of 16 January 2008 in Case C‑361/07 Polier,
paragraph 11 et seq.
(13)
–	See inter alia Case C‑6/01 Anomar and Other s [2003] ECR I‑8621, paragraph 40 et seq.
(14)
–	For example, for the free movement of goods, the cross-border aspect need not be as pronounced as for the freedom to provide services.
(15)
–	See also Case C‑531/06 Commission
v Italy
[2009] ECR I‑0000, paragraph 76.
(16)
–	See Case C‑254/98 TK Heimdienst
[2000] ECR I‑151, paragraph 34.
(17)
–	See to that effect Case C‑372/04 Watts
[2006] ECR I‑4325, paragraphs 92 and 146; Case C‑169/07 Hartlauer
[2009] ECR I‑1721, paragraph 29, and Commission
v Italy, paragraph 35.
(18)
–	See to that effect Cipollla and Others, paragraph 46, and Case C‑446/05 Doulamis
[2008] ECR I‑1377, paragraph 19.
(19)
–	Cipolla and Others,
paragraph 47.
(20)
–	See, inter alia, Joined Cases C‑180/98 to C‑184/98 Pavlov and Others
[2000] ECR I‑6451, paragraph 127; Case C‑475/99 Ambulanz Glöckner
[2001] ECR I‑8089, paragraph 39; and Servizi Ausiliari Dottori Commercialist, paragraph 23.
(21)
–	For examples of services that were considered of general economic interest, see the Opinion of Advocate General Ruiz-Jarabo Colomer, delivered on 20 October 2009 in Case C‑265/08 Federutility and Others
[2010] ECR I‑0000, point 53.
(22)
–	See in particular the Opinion of Advocate General Léger in Case C‑438/02 Hanner [2005] ECR I‑4551, point 135 et seq.
(23)
–	It may be that my approach regarding the examination as to the substance of the reference for a preliminary ruling in such a situation differs somewhat from the solutions adopted by the Court (see in that regard, inter alia Centro Europa 7, paragraph 63).
(24)
–	See inter alia Case C‑2/74 Reyners
[1974] ECR 631, paragraph 21, and Case C‑55/94 Gebhard
[1995] ECR I‑4165, paragraph 28.
(25)
–	This restriction thus applies without distinction to Italian recipients and recipients from other Member States, but complies with European Union law in so far as it does not prohibit, interfere with or render less attractive the activities of a service provider established in another Member State, where he lawfully provides comparable services. See to that effect Joined Cases 286/82 and 26/83 Luisi and Carbone
[1984] ECR 377, paragraph 16; Case C‑76/90 Säger
[1991] ECR I-4221, paragraph 12; and Case C‑58/98 Corsten
[2000] ECR I-7919, paragraph 33.
(26)
–	See, to that effect, Doulamis .
(27)
–	See, to that effect, Case C‑94/07 Raccanelli
[2008] ECR I‑5939, paragraphs 24 and 25.
(28)
–	See Joined Cases C‑418/93 to C‑421/93, C‑460/93 to C‑462/93, C‑464/93, C‑9/94 to C‑11/94, C‑14/94, C‑15/94, C‑23/94, C‑24/94 and C‑332/94 Semeraro Casa Uno and Others
[1996] ECR I‑2975, paragraph 28; and Case C‑110/05 Commission
v Italy
[2009] ECR I‑0000, paragraph 36.
(29)
–	See Commission
v Italy .
(30)
–	See inter alia Case C‑442/02 CaixaBank France
[2004] ECR I‑8961, paragraph 11 and the case‑law cited.
(31)
–	Tourism is mentioned specifically in Regional Law No 26/2002 in Article 6(2), referring to daytime voluntary duty-pharmacy service.