1. 

By its request for a preliminary ruling, the Consiglio di giustizia amministrativa per la Regione siciliana (Italy) is essentially asking the Court whether European Union law precludes regional legislation such as that at issue in the main proceedings, which makes the establishment of new opticians’ practices subject to criteria based on population density and on distance between practices.

2. 

The questions referred were raised in proceedings between Ottica New Line di Accardi Vincenzo (‘Ottica New Line’) and the Comune di Campobello di Mazara concerning a decision by which the Comune di Campobello di Mazara authorised Fotottica Media Vision di Luppino Natale Fabrizio e C. Snc (‘Fotottica’) to set up, on a permanent basis, an optician’s practice in premises located in the territory of that municipality.

3. 

This case must be seen in the context of the case-law concerning national measures making the exercise of freedom of establishment, for professions linked to public health, subject to an authorisation scheme which constitutes a restriction. ( 2 ) It should be observed that the specific features of the activity of opticians have already been examined in the case-law, from which it is clear that those features distinguish it from services which relate entirely to the protection of public health. ( 3 ) In the present case, the Court will have to clarify whether and, if relevant, to what extent the principles established in Blanco Pérez and Chao Gómez, ( 4 ) regarding the establishment of pharmacies, may be applied to opticians’ practices.

4.

Recital 22 in the preamble to Directive 2006/123/EC ( 5 ) is worded as follows:

‘The exclusion of healthcare from the scope of this Directive should cover healthcare and pharmaceutical services provided by health professionals to patients to assess, maintain or restore their state of health where those activities are reserved to a regulated health profession in the Member State in which the services are provided.’

5.

Article 1(1) of that directive provides as follows:

‘This Directive establishes general provisions facilitating the exercise of the freedom of establishment for service providers and the free movement of services, while maintaining a high quality of services.’

6.

Article 2(2)(f) of Directive 2006/123 provides:

‘This Directive shall not apply to the following activities:

...

7.

Under Article 1 of Sicilian Regional Law No 12 of 9 July 2004 (‘Rules governing the activity of optician and amendment to Regional Law No 28 of 22 February 1999’) (‘Regional Law No 12/2004’):

‘1.   For the purposes of the grant of authorisation by the relevant municipal authority to exercise the activity of optician, in addition to entry in the appropriate special register provided for under Article 71 of Regional Law No 25 of 1 September 1993, account shall be taken of the ratio of inhabitants to opticians’ practices, in order to secure a rational distribution of supply throughout the territory. That ratio shall be established on the basis of one optician’s practice per 8000 residents. The distance between one optician’s practice and another may be no shorter than 300 metres. The above limits shall not apply to practices which transfer from rented to owner-occupied premises or which are compelled to transfer as a result of eviction or other reasons of force majeure. Authorisations granted before the entry into force of this law shall not be affected.

2.   Where the existence of territorial needs has been substantiated, the competent municipal authority shall, in derogation from paragraph 1, issue the relevant authorisation or transfer an existing authorisation, after obtaining the mandatory opinion of the provincial committee of the Chamber of Commerce, referred to in Article 8 of the regulation implementing Article 71 of Regional Law No 25 of 1 September 1993, enacted by Presidential Decree No 64 of 1 June 1995.

3.   In municipalities in which the number of inhabitants does not exceed 8000, the competent municipal authority may, without obtaining the opinion of the committee referred to in paragraph 2, grant a maximum of two authorisations. Applications processed prior to the entry into force of this law shall not be affected.’

8.

By decision of 18 December 2009, the Comune di Campobello di Mazara authorised Fotottica to set up an optician’s practice in the municipality’s territory. The order for reference shows that the decision of 18 December 2009 was issued in breach of Article 1(1) of Regional Law No 12/2004, since the establishment of that practice did not observe the conditions relating to population density and on distance between opticians’ practices which were laid down by that provision.

9.

Ottica New Line contested the decision of 18 December 2009 before the Tribunale Amministrativo Regionale per la Sicilia. By decision of 18 March 2010, that court ruled out the application of Article 1(1) of Regional Law No 12/2004, holding that it was incompatible with European Union law, and dismissed Ottica New Line’s action.

10.

Ottica New Line appealed against the decision of 18 March 2010 before the referring court, which considered the possibility of transposing the principles arising from Blanco Pérez and Chao Gómez to the establishment of opticians’ practices. According to the referring court, the profession of optician, even more than that of pharmacist, is indisputably subject to commercial considerations. However, the existence of an analogous healthcare interest in introducing and maintaining a particular system for the territorial distribution of opticians’ practices cannot be entirely excluded.

11.

In those circumstances, the Consiglio di giustizia amministrativa per la Regione siciliana decided to stay proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

12.

This request for a preliminary ruling was lodged at the Registry of the Court of Justice on 21 October 2011. Written observations have been submitted by the Czech, Spanish and Netherlands Governments and the European Commission.

13.

First of all, I note that all the facts of the case at issue in the main proceedings are confined within a single Member State, even a single region. Since it does not have a cross-border aspect, the question referred for a preliminary ruling could therefore be declared inadmissible.

14.

According to settled case-law, the provisions of the Treaty on freedom of establishment do not apply to purely internal situations in a Member State. ( 6 )

15.

According to the case-law of the Court, the Court’s answer to such a question may nevertheless be useful to the referring court, in particular if its national law required it to grant the same rights to a national as those which a national of another Member State in the same situation would derive from European Union law. ( 7 )

16.

In the present case, the inference drawn from that case-law relates, in the context of the main proceedings, to the rights which a national of a Member State other than the Italian Republic could derive from European Union law if he were in the same situation as Fotottica, which wishes to set up an optician’s practice and is faced with action by another optician’s practice on the basis of regional legislation imposing a system of prior authorisation, the grant of which is subject to particularly strict requirements likely to interfere with the rights which Fotottica enjoys under the Treaty.

17.

Consequently, since it is not obvious that the interpretation of European Union law would not be of use in enabling the referring court to proceed to a determination of the case, this request for a preliminary ruling must be regarded as admissible.

18.

This request for a preliminary ruling is essentially asking whether the activities of an optician are sufficiently closely linked with the protection of public health to be capable of justifying national measures which restrict the freedom of establishment guaranteed by the Treaty. Therefore I propose to start by analysing certain general aspects relating to that issue.

19.

In the first place, I would like to highlight the fact that, in my view and notwithstanding differences which exist at national level, ( 8 ) the activity of optician is generally mixed in nature. Consequently, for the purposes of analysing the legislation at issue in the main proceedings, which governs the exercise of opticians’ activities, a distinction should be made between two aspects.

20.

Firstly, it is not in dispute that patients or customers most often come to opticians’ practices with prescriptions from ophthalmologists, in order to buy articles intended to correct sight defects, such as spectacles or contact lenses. In addition, an optician who is authorised to conduct eye tests, to measure visual acuity, to define and check the ocular correction needed, to detect eye problems and to treat defects of vision using corrective optical devices, to advise customers in that regard and to refer them to an ophthalmic specialist is exercising an activity which falls within the definition of healthcare and responds to public health concerns.

21.

Secondly, specialised staff at opticians’ practices carry out a certain number of technical activities, such as assembling frames, repairing spectacles, changing lenses and adjusting the position of spectacles. Moreover, opticians’ shops usually sell a wide range of optical products and accessories, such as sunglasses, spectacle cases and spectacle-care products, and of optical instruments such as binocular magnifiers. That part of the activity of optician, which might be described as ‘paraoptical’, cannot be regarded as falling within the definition of healthcare and therefore is commercial in nature.

22.

Although these two aspects are most often intrinsically linked, the possibility cannot be excluded that the ‘paraoptical’ part will be the predominant one, or even the only one, if that is the option chosen by a national legislature. In order to be able to rule on the treatment of the activity of optician in one Member State in particular, therefore, the scope of his functions should be examined on a case-by-case basis in terms of the applicable national legislation.

23.

In this connection, I would like to draw attention to some considerations arising from Ker‑Optika, which, in my opinion, favour the mixed approach suggested. Asked to give a ruling on the lawfulness of prohibiting the on-line sale of contact lenses, the Court held that establishing a link between a customer and a qualified optician and the services provided by such an optician were likely to reduce risks to public health. Thus, while finding that the legislation at issue did not satisfy the need for proportionality in pursuing the objective of protecting public health, the Court nevertheless accepted that, by reserving the supply of contact lenses to opticians’ shops, the national legislation was at least appropriate for securing the attainment of that objective. ( 9 )

24.

In the same vein, it seems to me that the rule made clear by the Court in the case-law resulting from LPO, ( 10 ) according to which a Member State may impose a requirement that contact lenses are to be supplied by qualified staff, could be extended, in compliance with the principle of proportionality, to any optical goods whose use could pose risks to patients’ health. The same rule, moreover, appears to have subsequently arisen from Mac Quen and Others, ( 11 ) according to which, under certain conditions, it is legal to reserve, for public health reasons, examination for the correction of purely optical defects to a category of professionals such as ophthalmologists, to the exclusion of opticians who are not qualified medical doctors.

25.

On the other hand, the Court clearly acknowledged in Ker-Optika that it is possible to separate the obtaining of prior medical advice requiring the physical examination of a patient from the actual selling of contact lenses. Since they can be sold by, or possibly under the supervision of, a non-specialist, the Court confirmed that, from this point of view, the activity of opticians’ practices can be clearly distinguished from features concerning the protection of public health.

26.

That position is a continuation of earlier case-law relating to the single‑practice rule for the exercise of the professions of general medical practitioner, dentist or veterinary surgeon, which, according to the Court, constitutes a restriction on the freedom of establishment incapable of any justification by public health requirements, since it is not essential for a practitioner to be close to the patient or client all the time. ( 12 ) In his Opinion in the Commission v Greece case, ( 13 ) Advocate General Ruiz‑Jarabo Colomer was right to propose that this approach should also be extended to opticians. ( 14 ) In addition, it is worth mentioning the analysis, in the same Opinion, of the two spheres of legal relationships in opticians’ practices. ( 15 )

27.

Consequently, it seems to me that the case-law of the Court in relation to the activity of optician accepts that this profession does not, in its entirety, concern the protection of public health in the strict sense.

28.

Finally, even though Directive 2006/123 is not expressly mentioned in the questions referred for a preliminary ruling, the actual text of the order for reference refers to it. Without going into an exhaustive analysis of the applicability of that directive to the present case, I shall observe that, in any event, the directive applies to any form of service, as defined in Article 4(1) of the directive, subject to the exceptions set out in Articles 1 to 4. However, in accordance with Article 2(2)(f) of Directive 2006/123, read in conjunction with recital 22 in the preamble to the directive, healthcare services are excluded from the scope of the directive, subject to certain conditions. Firstly, the exclusion covers services provided to patients to assess, maintain or restore their state of health. Secondly, the excluded healthcare must be provided by members of a health profession regulated in the Member State.

29.

I would further observe that, in Italy, the profession of optician is a regulated profession within the meaning of Directive 2005/36/EC. ( 16 ) The profession of optician comes under point 1 of Annex II, concerning paramedical and childcare training courses, and therefore constitutes a profession for which training is necessary, as provided for in Article 11(c)(ii) of that directive.

30.

I propose to analyse the questions referred to the Court for a preliminary ruling in the light of all the foregoing considerations.

31.

It should be noted at the outset that, even though the referring court has asked the Court three separate questions in turn, the issues on which it is seeking an interpretation focus on whether European Union law precludes legislation such as the regional legislation at issue. Consequently, I suggest reformulating the questions to that effect and giving a general answer to them.

32.

In addition, the main proceedings relate to the permanent exercise of the activity of optician, which implies stability and continuity of an economic activity being carried on in a Member State for an indefinite period. Therefore, notwithstanding the relatively broad wording of the questions referred for a preliminary ruling, which relate to both freedom of establishment and freedom to provide services, I consider that the answer given should be limited to the issues of freedom of establishment.

33.

By its questions, the referring court asks, in essence, whether European Union law precludes legislation, such as the Sicilian regional legislation, which makes the establishment of opticians’ practices subject to conditions based on population density and on distance between practices.

34.

According to settled case-law, Article 49 TFEU requires the elimination of restrictions on the freedom of establishment. All measures which prohibit, impede or render less attractive the exercise of such freedom must be regarded as constituting such restrictions. ( 17 )

35.

A national rule under which the establishment of an undertaking from another Member State is subject to the issue of a prior authorisation falls within that category, since it is capable of hindering the exercise by such an undertaking of freedom of establishment by preventing it from freely carrying on its activities through a fixed place of business. First, that undertaking may have to bear the additional administrative and financial costs involved in any grant of such an authorisation. Second, the system of prior authorisation excludes from the pursuit of self-employed activity any economic operators who do not satisfy predetermined requirements, compliance with which is a condition for the issue of that authorisation. ( 18 )

36.

Moreover, national legislation under which the pursuit of an activity is subject to a condition linked to the economic or social need for that activity constitutes a restriction in that it tends to limit the number of providers of services. ( 19 )

37.

As regards the main proceedings, it should be noted first that the national legislation makes the setting up of an optician’s practice conditional upon the issue of a prior authorisation by the competent municipal authority. Secondly, that legislation allows one optician’s practice to be set up per 8000 residents of the region. Thirdly, that legislation precludes opticians being able to pursue an independent economic activity in the premises of their choice, since they are required, in general, to observe a minimum distance of 300 metres in relation to existing practices.

38.

In addition, that legislation deters or even prevents opticians’ businesses from other Member States from carrying on their activities in Sicily through a fixed place of business.

39.

Moreover, I would like to point out that, despite its ostensibly non‑discriminatory nature, the regional legislation at issue in the main proceedings seems to me liable to involve indirectly discriminatory effects in relation to the nationality of the businesses involved.

40.

According to Regional Law No 12/2004, the limits on the establishment of opticians’ practices do not apply in cases of transfer from rented to owner‑occupied premises or where the practice is compelled to transfer as a result inter alia of eviction. It is highly probable that any such derogation operates more in favour of residents of Sicily than of people who originate elsewhere, inter alia nationals of other Member States.

41.

Consequently, regional legislation such as that at issue in the main proceedings constitutes a restriction on the freedom of establishment within the meaning of Article 49 TFEU.

42.

As the referring court suggests, this is a question of whether, in the context of the regional legislation at issue, which limits the establishment of opticians’ practices, an overriding reason relating to the public interest, linked to the protection of human health, might apply.

43.

According to the case-law of the Court, a national measure which, even though it is applicable without discrimination on grounds of nationality, is liable to hamper or to render less attractive the exercise by European Union nationals of fundamental freedoms guaranteed by the Treaty may be justified by pressing reasons of public interest, provided that the measure in question is appropriate for ensuring attainment of the objective pursued and does not go beyond what is necessary for that purpose. ( 20 )

44.

It is established that the protection of public health is one of the overriding reasons in the general interest which can, under Article 46(1) EC, justify restrictions of freedom of establishment. More specifically, restrictions on the 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. The importance of that general objective is confirmed, inter alia, by Article 168(1) TFEU, under which a high level of human health protection is to be ensured in the definition and implementation of all European Union policies and activities. ( 21 )

45.

In that regard, the referring court acknowledges that there is a connection between the activity of optician and the general interest in the protection of public health, so that in the present case there is an overriding reason capable of justifying the abovementioned restriction on the freedom of establishment.

46.

The order for reference explains, in this connection, that, under the Italian legislation, opticians practise an auxiliary healthcare profession in that they supply, check and adjust devices to correct sight defects: lenses, spectacle frames, contact lenses and visual aids for the visually impaired. According to that legislation, an optician may carry out simple tests to measure vision. Further, an optician who holds a degree may also treat defects of vision using corrective optical devices. The optician/optometrist then uses special apparatus to measure the quality of vision and identify defects; thus, he selects, prescribes and supplies the most appropriate corrective device, adjusting it to the patient’s needs. In addition, opticians are entrusted with preventing eye problems. Finally, the main activity of opticians’ practices consists of selling spectacles and contact lenses on the basis of a medical prescription.

47.

However, it should be noted that this description by the referring court is based on the text of Royal Decree No 1265 of 27 July 1934, and not on the Sicilian legislation at issue. Yet the referring court does not explain the relationship that may exist between these two sources.

48.

In the light of my preliminary considerations, I am nevertheless inclined to think that the view of the profession of optician which underpins the national legislation makes it possible to accept that the regional legislation at issue in the main proceedings may, theoretically, reflect an overriding reason relating to public health.

49.

However, it is also necessary for the legislation at issue to genuinely pursue that objective, which should be clear from the provisions applicable to the exercise of the profession of optician in Sicily. Since the general objective of protecting public health is expressed in various ways, the justification for a restriction requires, in my view, the existence of a strong, appropriate link between the aims pursued by the disputed legislation and the overriding reason relating to the public interest at issue.

50.

In that regard, I must express my regret at the outset that the Italian Government has not submitted observations which might usefully clarify the intention and aims of the Sicilian legislation. It is the task of the Member State concerned to establish that the measure – whether national or local – which may constitute a restriction is fully justified.

51.

In addition, taking into account, firstly, the mixed nature of opticians’ activities outlined in my preliminary considerations and, secondly, the fact that in some circumstances measures for planning infrastructure provision of optical services are particularly restrictive, I consider that the threshold at which a national measure governing the opening of opticians’ practices can be regarded as likely to be justified by the objective of protecting public health must be set higher than in cases where a regulated activity clearly concerns, in its entirety or predominantly, the delivery of healthcare (medical and hospital services, pharmacies).

52.

In the present case, according to Regional Law No 12/2004, the restriction on the freedom of establishment results, firstly, from a population-based limitation and, secondly, from a geographical one.

53.

As regards the restriction based on population, I accept that such a measure may be pursuing the objective of protecting public health, in that it is intended to achieve, inter alia, the equitable provision of optical products to the population and the balanced distribution of opticians’ shops throughout Sicily. As the Court has already found, Member States may decide that public health establishments and infrastructures should be subject to planning with a view to ensuring accessibility of public health services in less attractive areas, setting a minimum threshold for the number of residents to be served by such an establishment. ( 22 ) For that reason, such a distribution of optical services could help to ensure that each optician’s shop has enough customers.

54.

On the other hand, as regards the geographical restriction, even though theoretically it could be supplementary to the restriction linked to population, ( 23 ) I cannot find, in the present case, any connection with the objective of protecting public health. Such a limitation merely has a restrictive effect on competition, preventing too great a concentration of opticians’ shops in a given area (in a neighbourhood or even in a shopping centre). Such an objective seems to me to be unrelated to the protection of public health.

55.

However, I consider that such a geographical limitation could fall within the scope of that objective provided that it is designed broadly enough to reflect the same purpose as the population-related limitation. ( 24 ) More generally, a geographical limitation can form part of an objective to protect public health only if it is based on relevant criteria. Thus, a geographical limitation may contribute, in an urban environment, to ensuring balanced provision of medical or optical products, whereas, in contrast, in a rural or peri-urban environment, it may merely have an anti-competitive effect.

56.

In the light of the documents before the Court, it does not appear to me to be established prima facie that the Sicilian legislation falls, in its entirety, within the scope of the objective of protecting public health. I note that the case-law of the Court does not place the profession of optician on the same footing as health professions in the strict sense.

57.

However, since the activity of optician may cover both public health and ‘paraoptical’ services, it is important to examine, on a case-by-case basis, the relative balance between those two aspects which has led to the adoption of national legislation constituting a restriction on the freedom of establishment. It is imperative that the referring court should establish, in the light of the factors referred to above, the real intention of the Sicilian legislation, in order to be able to respond with certainty to the question of whether it is justified.

58.

Nevertheless, if the Court considers, in the light of the documents in the case, that, in imposing restrictions relating to population density and to the distance to be observed between opticians’ practices, the Sicilian legislature has been guided by the objective of protecting public health, it should, in the alternative, examine the supplementary justifying criteria set out in the case-law.

59.

Irrespective of the existence of a legitimate objective under European Union law, a restriction on the fundamental freedoms established by the Treaty may be justified only if the relevant measure is appropriate for ensuring attainment of the objective in question and does not go beyond what is necessary to attain that objective. ( 25 ) Furthermore, national legislation is appropriate for ensuring attainment of the objective pursued only if it genuinely reflects a concern to attain it in a consistent and systematic manner. ( 26 )

60.

In its order for reference, the national court considered, in this connection, whether it was possible to transpose the solution arising from Blanco Pérez and Chao Gómez into the present case; in that judgment, the Court concluded that European Union law does not preclude, in principle, national legislation that makes the establishment of new pharmacies conditional upon limits based on population density and on distance between pharmacies, in so far as such limits are likely to result in an even distribution of pharmacies throughout the national territory, in that way to ensure that the population as a whole has adequate access to pharmaceutical services, and, as a consequence, to improve the reliability and the quality of the provision of medicinal products to the public.

61.

That conclusion was based on case-law which accepted that public health establishments and infrastructures may be subject to planning. That may include prior authorisation for the establishment of new service providers, where that proves 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 healthcare 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. ( 27 )

62.

However, I am not convinced that the Court’s conclusion can be directly transposed in full to the services provided by opticians.

63.

It is true that the referring court has pointed out that the existence of a healthcare interest in introducing and maintaining a particular system for the territorial distribution of opticians’ practices cannot be entirely excluded. According to that court, it could be argued that, without any form of regulation, opticians’ practices would end up converging on localities regarded as profitable from a commercial point of view, with the result that other, less attractive localities would suffer a shortfall in numbers of opticians.

64.

Nevertheless, it seems to me that there is a significant difference, in terms of public health, between tasks which can be entrusted to pharmacies, on the one hand, and those which are the responsibility of opticians’ practices, on the other hand.

65.

In the first place, that difference is emphasised above all by the criterion of urgency which distinguishes access to pharmaceutical products from access to optical products.

66.

As the Court has already made clear, it is imperative, in creating a regulatory framework applicable to pharmacies, to guarantee that the population has adequate access to pharmaceutical services and, as a consequence, to improve the reliability and the quality of the provision of medicinal products to the public. ( 28 )

67.

For that reason, national laws often not only lay down rules for population‑based or geographical distribution, but also impose obligations on pharmacists which aim to guarantee that medicinal products are permanently accessible. For example, those obligations might involve out-of-hours duties or supplying medicinal products on a doctor’s prescription within a given period.

68.

By contrast, the service provided by opticians, even when it is responding to public health concerns, is never as urgent in nature.

69.

In the second place, the case-law of the Court has already tackled certain aspects of the distinction that should be made between pharmacies, opticians’ shops and biomedical laboratories, from the point of view of the risk to patients if a medicinal product is dispensed incorrectly or inappropriately as against the risk posed if an error is made when dispensing optical products. Thus, ‘unlike optical products, medicinal products prescribed or used for therapeutic reasons may none the less prove seriously harmful to health if they are consumed unnecessarily or incorrectly, without the consumer being in a position to realise that when they are administered. Furthermore, a medically unjustified sale of medicinal products leads to a waste of public financial resources which is not comparable to that resulting from unjustified sales of optical products.’ ( 29 )

70.

The Court has also explained that the risk resulting from inappropriate dispensing of optical products is not comparable with the risk resulting from incorrect performance of biomedical analyses, even though it may have adverse consequences for the patient. ( 30 )

71.

Finally, irrespective of the question whether the activities of opticians might be placed on the same footing as the activities of pharmacists, for the purposes of the analysis of restrictions on the freedom of establishment, it is in any event necessary to examine whether the Sicilian regional legislation is appropriate for ensuring attainment of the objective of protecting public health and does not go beyond what is necessary to attain it.

72.

In view of the lack of precision of the order for reference in that regard, it will be for the national court to establish whether there is, in Sicily, a real planning policy applicable to opticians’ practices, based on considerations relating to the protection of public health. In particular, the drafting history of the legislation at issue should have included a comparative examination of the criteria on which Regional Law No 12/2004 is based and reasons for the choice of those criteria.

73.

Although the conditions laid down by Regional Law No 12/2004 appear very rigorous, I do not exclude the possibility that, subject to adjustment measures of the type provided for in the case-law, ( 31 ) the legislation on opticians’ practices at issue may prove appropriate.

74.

The Court has ruled that the health and life of humans rank foremost among the assets and the interests protected by the Treaty and that it is for the Member States to determine the level of protection which they wish to afford to public health and the way in which that level is to be achieved. ( 32 )

75.

Regional Law No 12/2004 provides for an opportunity to adapt the abovementioned authorisation criteria ‘[w]here the existence of territorial needs has been substantiated’ and ‘after obtaining the mandatory opinion of the provincial committee of the Chamber of Commerce ...’. In addition, Regional Law No 12/2004 permits the grant, without consultation with that committee, of a maximum of two authorisations in municipalities with fewer than 8000 residents.

76.

In the present case, that method of adjustment does not seem to me to satisfy the requirements arising from the Court’s case-law, according to which, ‘in order for a prior administrative authorisation scheme to be justified even though it derogates from such a fundamental freedom, it must, in any event, be based on objective, non-discriminatory criteria which are known in advance, in such a way as to circumscribe the exercise of the national authorities’ discretion, so that it is not used arbitrarily … Such a prior administrative authorisation scheme must likewise be based on a procedural system which is easily accessible and capable of ensuring that a request for authorisation will be dealt with objectively and impartially within a reasonable time and refusals to grant authorisation must also be capable of being challenged in judicial or quasi-judicial proceedings.’ ( 33 )

77.

I do not consider the expression ‘[w]here the existence of territorial needs has been substantiated’, used in Regional Law No 12/2004, sufficiently precise to be capable of circumscribing the discretion of the regional administration.

78.

Moreover, as the Commission has correctly pointed out, the composition of the provincial committee whose mandatory opinion must be taken into account for the purposes of authorising the establishment of an optician’s practice in derogation from the general rules is open to discussion. ( 34 ) Since the committee consists of four representatives of the opticians’ professional association, it appears to infringe the principle established by the case-law, pursuant to which the involvement, in the authorisation procedure, of bodies made up of competing operators already in the territory concerned constitutes a restriction on the freedom to provide services or freedom of establishment. ( 35 )

79.

Finally, I note that, in Blanco Pérez and Chao Gómez, the regional legislation provided for incentive measures for pharmacies to set up in disadvantaged or less profitable areas, a factor which is clearly absent from this case. ( 36 )

80.

In the light of all the arguments set out above, I harbour serious doubts as to the appropriateness of the criteria governing the establishment of opticians’ practices provided for by Regional Law No 12/2004.

81.

In the further alternative, it remains to be considered whether the restriction laid down by Regional Law No 12/2004 goes beyond what is necessary for attaining the objective pursued.

82.

As the order for reference shows, many Sicilian municipalities have populations of between 8000 and 16000, but the regional legislation appears to be less restrictive for municipalities where the number of residents does not exceed 8000. It therefore appears to me that, in those demographic conditions, the Sicilian legislation has an excessively restrictive effect on access to the service provided by opticians in cases where there are intermediate numbers of residents, between the population levels laid down by Regional Law No 12/2004.

83.

Accordingly, in the light of all the foregoing observations, I deem the Sicilian legislation at issue in the main proceedings to be excessive, inconsistent and inappropriate for achieving the objective pursued.

84.

I propose that the Court reply as follows to the questions referred by the Consiglio di giustizia amministrativa per la Regione siciliana for a preliminary ruling:

Article 49 TFEU is to be interpreted as meaning that national legislation, such as that at issue in the main proceedings, which lays down restrictions based on population density and on a mandatory minimum distance between opticians’ practices constitutes a restriction on the freedom of establishment. In circumstances such as those in the main proceedings, that restriction does not appear to be justified by the objective of protecting public health, unless the legislation at issue is based on a coherent policy intended to ensure balanced provision of healthcare, which is a matter for the national court to ascertain. In any event, in the present case, the requirement for a minimum distance between opticians’ practices cannot be justified for the purposes of an overriding reason relating to the public interest based on the protection of public health.