OPINION OF ADVOCATE GENERAL

BOT

delivered on 14 June 2016 ( 1 )

Case C‑268/15

Fernand Ullens de Schooten

v

Ministre des Affaires sociales et de la Santé publique,

Ministre de la Justice

(Request for a preliminary ruling

from the cour d’appel de Bruxelles (Court of Appeal, Brussels, Belgium))

‛Reference for a preliminary ruling — State liability for infringement of EU law — Purely internal situation — Article 43 EC (now Article 49 TFEU) — National legislation under which clinical biology laboratories may be operated only by persons authorised to perform clinical biology services — Compatibility’

This request for a preliminary ruling is concerned with the interpretation of Articles 43, 49 and 56 EC (now Articles 49, 56 and 63 TFEU resp

1. ectively), Article 4(3) TEU and the principles of effectiveness and the primacy of EU law, as well as with the scope of the obligation incumbent on courts adjudicating at last instance to make a reference for a preliminary ruling under the third subparagraph of Article 267 TFEU.

2. The request was made in the course of an action for damages brought by Mr Fernand Ullens de Schooten against the Belgian State for an infringement of EU law by the Belgian legislative and judicial authorities.

3. In that action, Mr Ullens de Schooten accuses the Belgian legislature, principally, of having infringed Article 43 EC by adopting Article 3(1)(3) and (4) of Royal Decree No 143 of 30 December 1982 laying down the conditions which a laboratory must satisfy in order for clinical biology services to qualify for reimbursement from the sickness insurance scheme, ( 2 ) as amended by Article 17 of the Programme Law of 30 December 1988 (‘Royal Decree No 143’).

4. Article 3(1)(3) and (4) of Royal Decree No 143 laid down, with respect to clinical biology services, the conditions that must be satisfied by medical analysis laboratories in order for customers to qualify for reimbursement by the sickness insurance scheme for the services received. In the version in force prior to the adoption of the Law of 24 May 2005 amending Royal Decree No 143, that provision stated that only laboratories operated by persons authorised to perform clinical biology services, namely doctors, pharmacists or chemical science graduates, could perform reimbursable services. ( 3 )

5. Furthermore, Mr Ullens de Schooten complains that the Belgian courts also infringed EU law. He thus claims that the Cour de cassation (Court of Cassation, Belgium) refused to make a reference for a preliminary ruling, that the cour d’appel de Bruxelles (Court of Appeal, Brussels, Belgium) infringed Article 43 EC and that the Cour de cassation (Court of Cassation) and the cour d’appel de Mons (Court of Appeal, Mons, Belgium) infringed EU law by relying on an erroneous interpretation of the scope of the principle of the authority of res judicata.

6. In order to define in full the parameters of, and issues raised by, the present case, it is necessary, first and foremost, to describe the episodes that make up the judicial saga which gave rise to it.

I – The procedural background to the present case

7. Mr Ullens de Schooten operated the BIORIM clinical biology laboratory, which was declared bankrupt on 3 November 2000. The services provided by that laboratory were financed by the Institut national d’assurance maladie-invalidité (National Institute for Sickness and Invalidity Insurance) (INAMI). The laboratory used the ‘paying agent’ system.

8. Following a complaint lodged by Mr Ullens de Schooten with the European Commission, that institution, on 20 June 1985, brought an action before the Court of Justice for a declaration that the Kingdom of Belgium had failed to fulfil its obligations under Article 52 of the EEC Treaty (subsequently Article 43 of the EC Treaty and then Article 43 EC) by excluding from reimbursement under the social security scheme clinical biology services provided in laboratories operated by a legal person governed by private law whose members, partners and directors are not all natural persons authorised to carry out medical analyses.

9. By its judgment of 12 February 1987 in Commission v Belgium (221/85, EU:C:1987:81), the Court dismissed that action. In particular, as regards freedom of establishment, it stated that, provided that equality of treatment is respected, each Member State is, in the absence of EU rules in this area, free to lay down rules for its own territory governing the activities of laboratories providing clinical biology services. ( 4 ) It further held that the Belgian legislation at issue did not prevent doctors or pharmacists who are nationals of other Member States from establishing themselves in Belgium and operating there a laboratory to carry out clinical analyses qualifying for reimbursement under the social security system. The legislation in question therefore applied without distinction to Belgian nationals and those of other Member States and was not discriminatory in that regard. ( 5 )

10. In 1989, the BIORIM laboratory was the subject of a criminal investigation into suspected tax evasion. Following that investigation, Mr Ullens de Schooten, along with a number of other individuals, was committed to stand trial before the tribunal correctionnel de Bruxelles (Criminal Court, Brussels, Belgium). Before that court, he was prosecuted for a series of offences committed, in particular, with a view to concealing the illegal operation of medical analysis laboratories in breach of Article 3 of Royal Decree No 143.

11. By judgment of 30 October 1998, the tribunal de première instance de Bruxelles (Court of First Instance, Brussels, Belgium) sentenced Mr Ullens de Schooten to five years’ imprisonment and a fine. In addition, that court upheld the claims of the mutual insurance companies which had joined a civil action to those proceedings and ordered Mr Ullens de Schooten to pay them the token sum of one euro.

12. That judgment was set aside by judgment of the cour d’appel de Bruxelles (Court of Appeal, Brussels), of 7 September 2000. However, that court imposed on Mr Ullens de Schooten, in respect of the same offences, a sentence of five years’ imprisonment, suspended in so far as that sentence exceeded four years, and a fine. The claims of the parties seeking damages were declared inadmissible or unfounded.

13. So far as concerns the offences committed after the entry into force of Article 3 of Royal Decree No 143, the cour d’appel de Bruxelles (Court of Appeal, Brussels), rejected Mr Ullens de Schooten’s complaint that that provision did not comply with EU law and refused to refer a question to the Court of Justice for a preliminary ruling.

14. By judgment of 14 February 2001, the Cour de cassation (Court of Cassation) dismissed the appeals brought against the criminal conviction arising from the judgment of the cour d’appel de Bruxelles (Court of Appeal, Brussels), upheld the appeals brought by the parties claiming damages and referred the case back to the cour d’appel de Mons (Court of Appeal, Mons).

15. By judgment of 23 November 2005, the cour d’appel de Mons (Court of Appeal, Mons), declared the request for payment which six mutual insurance companies had submitted to Mr Ullens de Schooten in connection with the amounts paid in error to the BIORIM laboratory during the period from 1 August 1989 to 16 April 1992 to be in part well founded.

16. That court rejected Mr Ullens de Schooten’s argument that Article 3 of Royal Decree No 143 is incompatible with EU law. Considering itself bound by the authority of res judicata attaching to the judgment of the cour d’appel de Bruxelles (Court of Appeal, Brussels), of 7 September 2000, the cour d’appel de Mons (Court of Appeal, Mons), ordered Mr Ullens de Schooten to pay those mutual insurance companies the token sum of one euro, and asked the mutual insurance companies concerned to recalculate the loss sustained by them in connection with the payments made after 30 April 1990.

17. The appeals brought against that judgment of 23 November 2005 were dismissed by the Cour de cassation (Court of Cassation) by judgment of 14 June 2006.

18. While the aforementioned judicial proceedings for the award of damages against Mr Ullens de Schooten were ongoing, the commission de biologie clinique (Clinical Biology Committee), by decision of 18 March 1999, suspended BIORIM laboratory’s accreditation for a period of 12 months.

19. By ministerial order of 9 July 1999, the ministre de la Santé publique (Minister for Public Health) dismissed the administrative appeal brought against that decision.

20. By decision of 8 June 2000, the Clinical Biology Committee extended the suspension of the accreditation by 12 months.

21. By ministerial order of 24 July 2000, the Minister for Public Health dismissed the administrative appeal brought against that new decision.

22. Having before it two actions for the annulment of those ministerial orders, the Conseil d’État (Council of State, Belgium) referred to the Cour constitutionnelle (Constitutional Court, Belgium) a preliminary question concerning the compatibility of Article 3(1)(3) and (4) of Royal Decree No 143 with the [Belgian] Constitution.

23. By judgment No 160/2007 of 19 December 2007, the Cour constitutionnelle (Constitutional Court) held that that provision, in the version applicable prior to the amendment introduced by the Law of 24 May 2005, was compatible with Articles 10 and 11 of the Constitution.

24. Consequently, by judgments of 10 September and 22 December 2008, the Council of State dismissed the actions for annulment.

25. At the same time, having received a complaint lodged by Mr Ullens de Schooten, among others, the Commission, on 17 July 2002, issued the Kingdom of Belgium with a reasoned opinion in which it took the view that Article 3(1)(3) and (4) of Royal Decree No 143 was contrary to Article 43 EC.

26. Since Article 3 of Royal Decree No 143 had been amended by the Law of 24 May 2005 in order to bring it into line with EU law, the Commission, on 4 April 2006, decided not to take any further action in relation to that complaint.

27. On 10 April 2007, however, Mr Ullens de Schooten lodged with the Commission a second complaint alleging new breaches of EU law on the part of the Kingdom of Belgium, namely judicial breaches arising from the purported infringement of EU law by the Belgian courts and the legislative breach arising from the maintenance in force and retrospective application by the Belgian authorities of the effects of Article 3(1)(3) and (4) of Royal Decree No 143.

28. By two applications of 14 December 2006 and 3 March 2008, Mr Ullens de Schooten also brought before the European Court of Human Rights (ECtHR) an action seeking a declaration that the Belgian State had violated the European Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950. ( 6 )

29. In its judgment of 20 September 2011, Ullens de Schooten and Rezabek v. Belgium, ( 7 ) the ECtHR held that there had been no violation of Article 6(1) ECHR.

30. On 17 July 2007, Mr Ullens de Schooten brought before the tribunal de première instance de Bruxelles (Court of First Instance, Brussels) an application, directed against the Belgian State, by which he sought to be indemnified, first, against all the financial consequences of his conviction by judgment of 23 November 2005 of the cour d’appel de Mons (Court of Appeal, Mons), secondly, against all the consequences of any convictions against him as a result of actions brought by the BIORIM laboratory or its former manager, and, thirdly, against all the consequences of a conviction accruing to him in the course of tax litigation.

31. By that application, Mr Ullens de Schooten also sought an order requiring the Belgian State to pay the sum of EUR 500000 by way of compensation for non-material damage, the token sum of EUR 34500000 in reparation for his having been unable to operate a clinical biology laboratory between 1 January 1990 and 1 December 2005, and the token sum of one euro in repayment of the lawyers’ fees and costs incurred before the ordinary courts and the Commission.

32. In the event that the tribunal de première instance de Bruxelles (Court of First Instance, Brussels), was uncertain as to the applicability of EU law in the case at issue, Mr Ullens de Schooten asked that court to refer a question for a preliminary ruling to the Court of Justice.

33. By judgment of 19 June 2009, the tribunal de première instance de Bruxelles (Court of First Instance, Brussels), declared the application inadmissible because it was time-barred.

34. Mr Ullens de Schooten appealed against that judgment to the referring court, before which it reiterates the claims it had made before the tribunal de première instance de Bruxelles (Court of First Instance, Brussels).

35. In those circumstances, the cour d’appel de Bruxelles (Court of Appeal, Brussels), decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling: ‘(1) Does [EU] law, and in particular the principle of effectiveness, in certain circumstances and, in particular, those described in paragraph 38 [of the present request for a preliminary ruling], require the national limitation period, as [that prescribed by] Article 100 of the Co-ordinated Laws on State Accounting applicable to a claim for compensation made by an individual against the Belgian State for infringement of Article 43 of the EC Treaty [...] by the legislature, not to start to run until that infringement has been ascertained or, on the contrary, is the principle of effectiveness sufficiently well upheld in those circumstances by the opportunity open to that individual to interrupt the limitation period by having process served by a huissier de justice? (2) Must Articles 43, 49 and 56 EC and the concept of a “purely internal situation”, which is liable to limit reliance on those provisions by a litigant in proceedings before a national court, be interpreted as precluding the application of [EU] law in proceedings between a Belgian citizen and the Belgian State in which redress is sought for damage caused by an alleged infringement of [EU] law resulting from the adoption and maintaining in force of Belgian legislation of the same kind as Article 3 of Royal Decree No 143 … which applies without distinction to Belgian nationals and nationals of other Member States? (3) Must the principle of the primacy of [EU] law and Article 4(3) TEU be interpreted as not allowing the principle of res judicata to be disapplied in connection with the re-examination or setting aside of a judicial decision which has become res judicata and which proves to be contrary to [EU] law but, on the contrary, as allowing a national rule establishing res judicata to be disapplied when the latter requires the adoption, on the basis of that judicial decision which has become res judicata but is contrary to [EU] law, of another judicial decision which would perpetuate the infringement of [EU] law by the first judicial decision? (4) Could the Court confirm that the question whether the rule of res judicata must be set aside in the event of a judicial decision which has become res judicata but is contrary to [EU] law in the context of an application for review or setting aside of that decision is not a question materially identical, within the meaning of the judgments [of 27 March 1963, DaCosta and Others (28/62 to 30/62, EU:C:1963:6)] and [of 6 October 1982, Cilfit and Others (283/81, EU:C:1982:335)], to the question whether the rule of the authority of res judicata [must be set aside in the event of a judicial decision which has become res judicata] but is contrary to [EU] law in the context of an application for a (new) decision which would repeat the infringement of [EU] law, so that the court giving judgment at last instance cannot escape its obligation to make a reference for a preliminary ruling?’

II – Analysis

36. I shall begin by examining the second question, on which the parties that took part in the hearing were asked to focus their oral arguments. Next, I shall propose a rewording of the other questions, which are all based on the erroneous premiss that Article 3(1)(3) and (4) of Royal Decree No 143 is incompatible with Article 43 EC, and, finally, I shall suggest that that premiss be corrected with a view to ensuring the correct application of EU law, as indicated, in my view, in the Court’s case-law relating to the holding of capital in pharmacies and biomedical analysis laboratories.

A – The second question, relating to the consequences of the existence of a purely internal situation from the point of view of whether Article 43 EC can be relied on in an action for damages against a Member State for infringement of EU law

37. Mr Ullens de Schooten’s position is, in essence, as follows. In his view, the national courts that were called upon to hear and determine the contentious proceedings relating to him gave no weight to his argument that Article 3 of Royal Decree No 143 was incompatible with Article 43 EC. Despite the primacy of EU law, Article 3 continued to be applied. Manifest infringements of EU law were therefore repeated by a number of national courts, notwithstanding the action taken by the Commission. Those infringements were reinforced by virtue of the rule of national law relating to the authority of res judicata.

38. Like the Belgian Government, I consider that, in the second question, Articles 49 and 56 EC are relied on purely for the sake of form. After all, the appellant in the main proceedings bases his claims essentially on Article 43 EC. ( 8 ) The examination of that question must therefore be carried out exclusively in the light of the freedom of establishment, referred to only in the first question.

39. By its second question, the referring court asks, in essence, whether, notwithstanding that the facts of the dispute in the main proceedings are confined within a single Member State, Article 43 EC may be relied on by an applicant in an action for damages for infringement of EU law brought against that very same State.

40. There might be a temptation to give that question a terse response based on the strict application of the Court’s case-law relating to the non-application of the Treaty rules governing the free movement of persons in purely internal situations.

41. Purely internal situations may be described as situations which have ‘no factor connecting them to any of the situations envisaged by [EU] law’, ( 9 ) and which, therefore ‘[fall] outside the scope of the rules contained in the Treaty’ ( 10 )‘[in the absence of a] sufficient link with trade between Member States’. ( 11 )

42. According to the Court, ‘the Treaty rules governing freedom of movement for persons and the measures adopted to implement them cannot be applied to activities which have no factor linking them with any of the situations governed by EU law and which are confined in all relevant respects within a single Member State’. ( 12 )

43. It is common ground that the appellant in the main proceedings, who is a Belgian national, is in dispute with the Belgian State in relation to the soundness of the convictions secured against him in connection with the operation of a biomedical laboratory located in Belgium. Unless the referring court is able to verify that the evidence relied on by the appellant in the main proceedings is capable of establishing the existence of international factors, ( 13 ) this does appear to be a purely internal situation.

44. Having regard to the position taken by the Cour constitutionnelle (Constitutional Court) in its judgment of 19 December 2007, it is not possible to apply here the case-law of the Court of Justice to the effect that, even in a purely internal situation, the answer provided by the Court may be useful to the referring court, if its national law required it to grant the same rights to a national of a given Member State as those which a national of another Member State in the same situation would derive from EU law in the same conditions. ( 14 )

45. In the case which gave rise to its judgment of 19 December 2007, the Cour constitutionnelle (Constitutional Court) was presented with a preliminary question from the Council of State concerning whether Article 3(1)(3) and (4) of Royal Decree No 143 was contrary to the principles of equality and non-discrimination established in Articles 10 and 11 of the Constitution, in that it creates a difference in treatment between doctors, pharmacists and chemical science graduates, on the one hand, and other economic operators, on the other, to the extent that only the services provided by the former qualify for sickness and invalidity insurance cover. In that judgment, the Cour constitutionnelle (Constitutional Court) stated that ‘“BIORIM” is a private limited liability company governed by Belgian law and established in Belgium and the first intervener before the Council of State is a Belgian national; they complain that they are able to operate a clinical biology laboratory only under the conditions laid down in the provisions to which the question put to the Court relates. Given that those legal relationships operate entirely within the internal sphere of one Member State, the applicants cannot rely on Articles 43, 49 and 56 [EC]’. ( 15 )

46. As the Belgian Government submits, it is therefore clear from the judgment of the Cour constitutionnelle (Constitutional Court) that Belgian national law does not require the appellant in the main proceedings to be granted the same rights as those which a national of another Member State would, in the same circumstances, derive from EU law in relation to the conditions set out in Article 3(1)(3) and (4) of Royal Decree No 143.

47. The Belgian Government rightly draws a parallel with the case which gave rise to the judgment of 22 December 2010 in Omalet (C‑245/09, EU:C:2010:808), which concerned a dispute between the Belgian National Office of Social Security and a principal contractor established in Belgium who was held jointly and severally liable under Belgian law for the debts of his subcontractor, also established in Belgium. In those proceedings, the Cour constitutionnelle (Constitutional Court) had already ruled on the issue of the inapplicability of Article 49 EC to the purely internal dispute before it. In those circumstances, the Court of Justice held that it did not have jurisdiction to answer the questions which had been referred to it for a preliminary ruling, as EU law was not applicable.

48. I am of the opinion, however, that, in the specific context of the present case, a strict application of the case-law relating to purely internal situations such as to support the conclusion that the appellant in the main proceedings cannot rely on EU law in the action for damages between him and the Belgian State is not advisable or appropriate, for the following reasons.

49. First, the Court cannot disregard the fact that the contentious proceedings which have been brought against Mr Ullens de Schooten or which he has initiated over the last 20 years revolve for the most part around the central argument that Article 3(1)(3) and (4) of Royal Decree No 143 is incompatible with Article 43 EC. The ordinary courts, in particular the cour d’appel de Bruxelles (Court of Appeal, Brussels), in its judgment of 7 September 2000, applied Article 43 EC.

50. Secondly, I would recall that the Commission issued a reasoned opinion, notified to the Kingdom of Belgium on 17 July 2002, in which it considered that Article 3(1)(3) and (4) of Royal Decree No 143 was contrary to Article 43 EC. I would draw attention to the paradox that would lie in a position to the effect that, in the present reference for a preliminary ruling, EU law cannot be relied on by the appellant in the main proceedings in support of his action for damages against the Belgian State, even though the Commission has officially taken the view that the provision in question is incompatible with EU law.

51. A reasoned opinion has only limited legal effects, of course, and, in particular, does not establish the existence of a failure to fulfil obligations. It does, however, highlight the potential existence of infringements of EU law and individuals are justified in seeking to ascertain the consequences of such infringements before their national courts in order to obtain compensation for the damage suffered.

52. Moreover, let us imagine that the Kingdom of Belgium had refused to amend its national legislation following the Commission’s reasoned opinion, that an action had been brought before the Court of Justice and that the latter had held that Belgium had failed to fulfil its obligations under Article 43 EC by adopting Article 3(1)(3) and (4) of Royal Decree No 143. Would the Court then have been able, in the context of a reference for a preliminary ruling, to find, in response to a question identical to the second question raised in the present case, that the argument as to the incompatibility of that national provision with EU law cannot be relied on by an applicant before the national court in support of an action for damages against the Belgian State for infringement of EU law on the sole ground that the situation is purely internal, in other words, for the sole reason that that applicant is a national of the Member State that adopted the contested measure? I do not believe so and I see no reason why the position should be otherwise where the contentious proceedings ended at the stage of the reasoned opinion.

53. Thirdly, as the action which the Commission took with a view to ensuring that the Kingdom of Belgium amend its national legislation shows, and as I shall explain in more detail in the submissions that follow, Article 3(1)(3) and (4) of Royal Decree No 143 is a measure liable to hinder access for economic operators established in other Member States to the Belgian market in medical analysis laboratories.

54. When faced with such legislation producing cross-border effects, the Court has on a number of occasions agreed to interpret EU law even though the facts of the disputes in the main proceedings which had given rise to the references for a preliminary ruling were confined within a single Member State. ( 16 )

55. In those decisions, the Court begins by noting that the legislation of a Member State which, according to its wording, applies without distinction to the nationals of that State and to the nationals of other Member States is as a rule capable of falling within the scope of the provisions on the fundamental freedoms guaranteed by the Treaty only to the extent that it applies to situations linked to trade between Member States. The Court goes on to point out, for the purpose of substantiating its jurisdiction, that it is by no means inconceivable that economic operators established in other Member States had or have an interest in pursuing an economic activity in the Member State whose legislation is contested.

56. In the light of all of the foregoing, it is my view that the best way for the Court to reply to the referring court is not to declare, on the basis of a strict application of its case-law relating to purely internal situations, that the reference for a preliminary ruling is inadmissible, but rather, in accordance with the spirit of cooperation which characterises this procedure, to declare the reference admissible, and then to reword the questions raised in order to give the referring court a reply that enables it to settle the dispute in the main proceedings unambiguously.

57. It is true that the facts of the dispute in the main proceedings are confined within a single Member State. That said, a reply from the Court serves to meet a need inherent in the resolution of the dispute in the main proceedings. In other words, it is part and parcel of the Court’s role to assist in the administration of justice in the Member States, in the spirit of cooperation which must prevail in the preliminary ruling procedure. ( 17 )

58. I would recall that, according to settled case-law, ‘Article 43 EC precludes any national measure which, even though it is applicable without discrimination on grounds of nationality, is liable to hinder or render less attractive the exercise by [EU] nationals of the freedom of establishment that is guaranteed by the Treaty’. ( 18 )

59. The line of case-law favourable to the notion that the questions referred for a preliminary ruling are admissible by reason of the potential effects of a national measure on the ability of undertakings established in other Member States to exercise their freedom to establish themselves in the Member State which has adopted such a measure serves to bring to an end the inconsistency that would characterise the proposition to the effect that the compatibility of that measure with EU law can be examined in the context of an action for failure to fulfil obligations but, because of the features specific to the situation in question, in which there are no international factors, not in a reference for a preliminary ruling.

60. From that point of view, I propose that the Court declare the present reference for a preliminary ruling to be admissible and that its answer to the second question referred should be that, in circumstances such as those in the dispute in the main proceedings, Article 43 EC may be relied on in an action for damages against a Member State for infringement of EU law.

B – The compatibility of Article 3(1)(3) and (4) of Royal Decree No 143 with EU law

61. It is important, first and foremost, to note that, while it is true that the referring court has not raised a question relating expressly to the compatibility of Article 3(1)(3) and (4) of Royal Decree No 143 with the Treaty rules on freedom of establishment, it nonetheless intends to apply those rules in the dispute in the main proceedings in the event that the obstacle linked to the existence of a purely internal situation is removed by the Court in reply to its second question.

62. In order to ascertain whether or not the action for damages against the Belgian State is well founded, the referring court will necessarily have to rule on whether or not EU law has been infringed by the national legislature and the national courts that were successively called upon to hear and determine that dispute.

63. I would make the point here that the line of argument put forward by Mr Ullens de Schooten is based, in essence, on the premiss that the national courts erred in ruling that Article 3(1)(3) and (4) of Royal Decree No 143 was compatible with Article 43 EC. In his submission, that misapplication of EU law was perpetuated over the course of the successive actions brought owing to the authority of res judicata recognised in the judgment of the cour d’appel de Bruxelles (Court of Appeal, Brussels), of 7 September 2000.

64. It goes without saying that, if the premiss that EU law has been infringed were to be refuted, which, as I shall explain in the submissions that follow, I think it should be, the resolution of the present case, which, to my mind, has been presented to the Court in an unnecessarily complex way, would be simplified as a result.

65. Which is why the Court must, in my view, rule on whether Article 43 EC is to be interpreted as meaning that it precludes a national provision such as Article 3(1)(3) and (4) of Royal Decree No 143.

66. I am very aware that the Court’s role is not to seek to settle issues other than those identified by the referring court in its request for a preliminary ruling.

67. In my view, however, the Court is not in danger of succumbing to such a pitfall here.

68. I would submit, in that regard, that it follows expressly from paragraph 24 of the order for reference that, in support of his action for damages against the Belgian State, Mr Ullens de Schooten accuses both the legislature and the judiciary of having infringed Article 43 EC.

69. It strikes me as paradoxical at the very least that, in the context of a reference for a preliminary ruling intended to enable the referring court to resolve the dispute in the main proceedings, the Court should refrain from addressing that issue when it lies at the very the heart of that dispute.

70. In those circumstances, the fact that an interpretation of Article 43 EC in relation to Article 3(1)(3) and (4) of Royal Decree No 143 has not been expressly requested by the referring court does not in my opinion preclude the Court from addressing that issue. It is, moreover, in line with the current practice of the Court to consider that, in the procedure laid down by Article 267 TFEU, providing for cooperation between national courts and the Court of Justice, it is for the latter to provide the national court with an answer which will be of use to it and enable it to determine the case before it. The Court also regularly demonstrates its concern to give the referring court a full answer. ( 19 ) To that end, the Court may have to reformulate the questions referred to it. The fact that a national court has, formally speaking, worded a question referred for a preliminary ruling with reference to certain provisions of EU law does not prevent the Court from providing that court with all the guidance on points of interpretation which may be of assistance in adjudicating on the case pending before it, whether or not it has referred to those points in its questions. In that regard, it is for the Court to extract from all the information provided by the national court, in particular from the grounds of the decision referring the questions, the points of EU law which require interpretation, having regard to the subject matter of the dispute. ( 20 )

71. In the light of the foregoing, I propose that the Court, in keeping with the spirit of cooperation that governs preliminary ruling procedures and with a view to providing the referring court with all the elements of interpretation of EU law which may be of assistance to it in resolving the dispute in the main proceedings, supply that court with guidance such as to enable it to examine the soundness of the premiss of an infringement of EU law on which the present reference for a preliminary ruling is based.

72. That key aspect of the present case was referred to at the hearing. Thus, the Commission stated that it maintained the position which it had expressed in its reasoned opinion of 17 July 2002. Mr Ullens de Schooten, for his part, reiterated the position adopted by the Commission in that reasoned opinion. Lastly, the Kingdom of Belgium stated that, in 2005, it had amended the contested national provision so as to comply with that reasoned opinion on a voluntary and precautionary basis and thus prevent the matter from being referred to the Court, but that that amendment did not amount to an acknowledgement on its part that that provision was not compatible with EU law.

73. It is clear from the documents before the Court that, in the national proceedings which culminated in the judgment of the cour d’appel de Bruxelles (Court of Appeal, Brussels), of 7 September 2000, the appellants submitted that Article 3(1)(3) and (4) of Royal Decree No 143 was incompatible with Article 43 EC.

74. In that judgment, that court found against the appellants in that regard. It recalled that national measures which are liable to hinder or render less attractive the exercise of the fundamental freedoms guaranteed by the Treaty must meet the following four conditions: they must be applied in a non-discriminatory manner, they must be justified by imperative requirements in the general interest, they must be suitable for securing the attainment of the objective which they pursue and they must not go beyond that which is necessary to achieve it.

75. According to the cour d’appel de Bruxelles (Court of Appeal, Brussels), the contested national provision met those four conditions. It stated that the condition that laboratories must be operated by persons authorised to perform clinical biology services could not be considered discriminatory, as the authorisation requirement was applicable to both Belgian nationals and nationals of other Member States.

76. The cour d’appel de Bruxelles (Court of Appeal, Brussels), also stated that the objective pursued by the legislation at issue was to combat the overconsumption of clinical biology services, which was such as to destabilise the social security budget. According to that court, the authorisation which operators of any kind were required to have provided a means, both effective and proportionate to the objective pursued, of limiting the number of laboratories, ensuring that laboratories were not subject to commercial interests, pre-empting an excess supply of clinical biology services and combating overconsumption.

77. The analysis thus arrived at by the cour d’appel de Bruxelles (Court of Appeal, Brussels), in its judgment of 7 September 2000 seems to me to be fully consistent with the principles set out by the Court of Justice in its case-law relating to the holding of capital in pharmacies and biomedical analysis laboratories.

78. I would submit, in that regard, that the stance taken by the Commission in its reasoned opinion relating to the incompatibility of Article 3(1)(3) and (4) of Royal Decree No 143 with Article 43 EC was contradicted by that very same case-law of the Court. ( 21 )

79. Mr Ullens de Schooten relies on the judgment of 21 April 2005 in Commission v Greece (C‑140/03, EU:C:2005:242), relating to optician’s shops. In that judgment, the Court held that the measures laid down in the Greek legislation at issue, which did not permit an optician to operate more than one optician’s shop and limited to a maximum of 50% the share of capital that could be held by persons other than the optician operating the shop, were contrary to Articles 43 and 48 EC. According to Mr Ullens de Schooten, there is a parallel to be drawn between, on the one hand, the legislation that led to that judgment and, on the other hand, the Belgian provision at issue in the present case.

80. It is important to note, however, that the Court adopted a different approach in its judgments concerning restrictions on the ownership of capital in pharmacies. ( 22 ) In those judgments, the Court thus held that freedom of establishment does not preclude national rules, such as those laid down in the Italian and German legislation [at issue there], which allow only pharmacists to own and operate pharmacies.

81. In the case which gave rise to the judgment of 16 December 2010 in Commission v France (C‑89/09, EU:C:2010:772), the Commission submitted, under its first head of claim, that the French regulations concerning biomedical analysis laboratories infringed Article 43 EC inasmuch as they provided that a non-biologist could not hold more than 25% of the shares, hence of the voting rights, in a société d’exercice libéral à responsabilité limitée (limited liability company formed by persons carrying on a professional activity) (Selarl) operating biomedical analysis laboratories.

82. In that case, the Commission submitted that the explanation for the approach adopted by the Court in relation to pharmacies lay in the highly specific nature of medicinal products. ( 23 ) In its view, biomedical activities, on the other hand, are carried out solely on the basis of a medical prescription, thus offering a better safeguard, both in terms of the protection of public health and in terms of containing the costs for the health system. The fact of being confined within the terms of medical prescription is justified by both the nature and the number of the tests to be carried out. ( 24 )

83. The Commission also maintained that the biomedical sector has substantial financing needs, a characteristic which distinguishes it in particular from the pharmacies sector. However, the contested provisions prevented amalgamations that would make it possible to achieve the investment needed in order to provide a quality service. ( 25 )

84. The objective cited by the French Republic at that time was the protection of public health. In its submission, the contested provisions sought to ensure the independence of biologists by preventing the decisions they take from being motivated by economic considerations rather than by public health considerations. ( 26 )

85. In its judgment, the Court noted that both its case-law and Article 152(5) EC make it clear that EU law does not detract from the power of the Member States to organise their social security systems and to adopt, in particular, provisions governing the organisation and provision of health services and medical care. ( 27 )

86. In exercising that power, however, the Member States must comply with EU law, in particular with the provisions of primary law relating to the freedoms of movement, including the freedom of establishment for the purposes of Article 43 EC. Those provisions prohibit the Member States from introducing or maintaining unjustified restrictions on the exercise of those freedoms in the healthcare sector. ( 28 )

87. That being so, for the purposes of assessing whether that obligation has been complied with, account must be taken of the fact that the health and life of humans rank foremost among the assets and interests protected by the EC 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. Since the level may vary from one Member State to another, Member States should be allowed a measure of discretion. ( 29 )

88. According to settled case-law, Article 43 EC precludes any national measure which, even though it is applicable without discrimination on grounds of nationality, is liable to hinder or render less attractive the exercise by EU citizens of the freedom of establishment guaranteed by the Treaty. ( 30 )

89. In that context, it is important to recall that the concept of ‘restriction’ within the meaning of Article 43 EC covers measures taken by a Member State which, although applicable without distinction, affect access to the market for undertakings from other Member States and thus hinder trade within the European Union.

90. In particular, according to the Court, legislation which makes the establishment in the host Member State of an economic operator from another Member State subject to the issue of a prior authorisation and allows self-employed activity to be pursued only by certain economic operators who satisfy predetermined requirements, compliance with which is a condition for the issue of that authorisation, constitutes a restriction within the meaning of Article 43 EC. ( 31 )

91. It is clear that, as the Court held in its judgment of 16 December 2010 in Commission v France (C‑89/09, EU:C:2010:772), the condition, set out in Article 3(1)(3) and (4) of Royal Decree No 143, to the effect that, in order to qualify for INAMI cover, biomedical laboratories may be operated only by persons authorised to perform clinical biology services, is such as to limit the opportunity for natural or legal persons who do not meet that condition and are established in other Member States to establish themselves in Belgium. The prospect of not being able to provide analysis services that are eligible for reimbursement by INAMI is liable to deter economic operators who do not meet the condition laid down in Article 3(1)(3) and (4) of Royal Decree No 143 from establishing themselves in Belgium. That national provision therefore has the effect of hindering and rendering less attractive the exercise by those economic operators of their activities on Belgian territory through a permanent establishment, and of impairing their access to the Belgian market in biomedical analyses.

92. It is now necessary to examine whether such a restriction can be justified.

93. According to well-established case-law, restrictions on freedom of establishment that are applicable without discrimination on grounds of nationality may be justified by overriding reasons relating to the general interest, provided that the restrictions are appropriate for securing attainment of the objective pursued and do not go beyond what is necessary for attaining it. ( 32 )

94. It should be noted that Article 3(1)(3) and (4) of Royal Decree No 143 is applicable without discrimination on grounds of nationality.

95. As the Court has recognised, the protection of public health is one of the reasons which can justify restrictions on the freedoms of movement guaranteed by the Treaty, such as the freedom of establishment. ( 33 )

96. In that context, it is apparent from case-law that the aim of maintaining the quality of medical services may be covered by one of the exceptions provided for in Article 46 EC, in so far as it contributes to the attainment of a high level of health protection. ( 34 )

97. The national provision at issue must still be able to guarantee the achievement of such an objective.

98. In that regard, the Court noted, in its judgment of 16 December 2010 in Commission v France (C‑89/09, EU:C:2010:772), that the medical biology sector is special and is at the forefront of healthcare. ( 35 )

99. Endorsing the analysis which had been proposed by Advocate General Mengozzi, ( 36 ) the Court thus noted that ‘just as the supply of the wrong medication to a customer by a pharmacist may have serious consequences, so a biomedical analysis that is performed in an inappropriate manner, or too late, or incorrectly, may result inter alia in wrong diagnosis or treatment’. ( 37 ) It also pointed out that, ‘in the same way as excess consumption or incorrect use of medication, the incorrect or inappropriate performance of biomedical analyses, from either the quantitative or qualitative point of view, may generate unnecessary costs for the social security system and, as a consequence, for the State’. ( 38 )

100. The Court inferred from this that ‘it is apparent, therefore, that the incorrect or inappropriate performance of biomedical analyses poses a risk to public health comparable with the risk resulting from the inappropriate dispensing of medicinal products, which the Court had occasion to consider in the judgments of 19 May 2009, Commission v Italy [C‑531/06, EU:C:2009:315], and Apothekerkammer des Saarlandes and Others [C‑171/07 and C‑172/07, EU:C:2009:316]. On the other hand, the risk presented by the incorrect or inappropriate dispensing of optical products, which was at issue in the judgment of 21 April 2005, Commission v Greece [C‑140/03, EU:C:2005:242] does not appear to be comparable. Although that may undoubtedly have adverse consequences for the patient, the Commission has not demonstrated that those are as serious as the effects liable to be brought about by the incorrect or inappropriate performance of biomedical analyses’. ( 39 )

101. According to the Court, ‘given the similarities, from the point of view of the risks to public health, between the pharmacy sector and the biomedical analysis sector and the fact that, contrary to the assertions made by the Commission, those two sectors cannot really be distinguished from one another, either from the point of view of the findings with regard to medical prescriptions or in terms of financing needs, the principles laid down in Commission v Italy [C‑531/06, EU:C:2009:315], and in Apothekerkammer des Saarlandes and Others [C‑171/07 and C‑172/07, EU:C:2009:316], concerning restrictions on the holding of capital in pharmacies, would appear to be fully transposable to the present case’. ( 40 ) Consequently, ‘given the power afforded to the Member States to determine the level of protection that they wish to give to public health, it must be accepted that Member States may require that biomedical analyses be carried out by biologists enjoying genuine professional independence. They may also take measures for eliminating or reducing a risk that that independence might be compromised, because that in turn would be liable to have an adverse effect on public health and the quality of medical services’. ( 41 ) The Court also pointed out that, ‘by definition, non-biologists have no training, experience or responsibility equivalent to that of biologists. Accordingly, they do not provide the same safeguards as those provided by biologists’. ( 42 )

102. In the course of examining whether the restriction on freedom of establishment for the purposes of Article 43 EC did not go beyond what is necessary for attaining the objective of protecting public health relied upon, the Commission maintained, in particular, that that objective could be attained by less restrictive measures, such as the requirement that biomedical analyses be carried out by competent staff who have the necessary qualifications and who, by virtue of their code of professional ethics, are bound by the principle of independence of healthcare professionals. However, given the discretion which the Member States are allowed, the Court, applying the reasoning which it had adopted in relation to the holding of capital in pharmacies, held that ‘a Member State may take the view that there is a risk that rules designed to ensure the professional independence of biologists would not be observed in practice, given that the interest of a non-biologist in making a profit would not be tempered in the same way as that of self-employed biologists and that, if biologists, as employees, were in a subordinate position with respect to a Selarl operating biomedical analysis laboratories in which non-biologists held the majority of shares, that could make it difficult for them to oppose instructions given by those non-biologists’. ( 43 ) According to the Court, ‘it cannot be excluded, inter alia, that such non-biologists would be tempted to refuse to carry out tests that were less profitable or more complicated to perform, or to cut down on the advice given with regard to patients at the pre-analysis and post-analysis stages, the existence of which is a feature of the organisation of medical biology in France’. ( 44 )

103. It is my opinion that, even though the Belgian legislation at issue in the present case is not identical to that which was examined by the Court in its judgment of 16 December 2010 in Commission v France (C‑89/09, EU:C:2010:772), the guiding principles that emerge both from that judgment and from the judgments relating to the holding of capital in pharmacies support the view that Article 3(1)(3) and (4) of Royal Decree No 143 is compatible with Article 43 EC in so far as the restriction on the freedom of establishment which it entails is justified by the objective of protecting public health and does not go beyond what is necessary to attain that objective.

104. In that regard, it is clear from the documents before the Court, and in particular from the judgment of the Cour constitutionnelle (Constitutional Court) of 19 December 2007, that the objective of Article 3 of Royal Decree No 143 was to combat the increasing overconsumption within the clinical biology sector and the abuse found to be present in that sector.

105. Like the Belgian Government, I take the view that, by ensuring that laboratories are operated not by persons who, in terms of their qualifications, are external to the health sector, but by professional providers of clinical biology services who, precisely because of their status as such, cannot pursue their activity for strictly commercial purposes but must, on the contrary, act with due regard for the objectives associated with public health and, therefore, have as their primary concern to safeguard patients’ health and ensure the quality of the services provided, the Belgian legislature adopted a measure capable of attaining the objective of combating the increasing overconsumption within the clinical biology sector and the abuse found to be present in that sector.

106. It is common ground, I would reiterate, that the protection of public health is one of the overriding reasons in the public interest which may, under Article 46(1) EC, justify restrictions on the freedom of establishment. It follows, furthermore, from the Court’s case-law that the objective of preventing the risk of serious harm to the financial balance of the social security system is covered by that derogation. ( 45 ) The objective of combating the increasing overconsumption within the clinical biology sector and the abuse found to be present in that sector is directly linked to that latter objective.

107. In that connection, it must be recalled that the Court has held, in its judgments relating to the holding of capital in pharmacies, that ‘overconsumption or incorrect use of medicinal products leads … to a waste of financial resources which is all the more damaging because the pharmaceutical sector generates considerable costs and must satisfy increasing needs, while the financial resources which may be made available for healthcare are not unlimited, whatever the mode of funding applied’. ( 46 ) In that regard, the Court stated that ‘there is a direct link between those financial resources and the profits of businesses operating in the pharmaceutical sector because in most Member States the prescription of medicinal products is borne financially by the health insurance bodies concerned’. ( 47 )

108. The Court inferred from this that, in the light of the risks to public health and to the financial balance of social security systems, ‘the Member States may make persons entrusted with the retail supply of medicinal products subject to strict requirements, including as regards the way in which the products are marketed and the pursuit of profit. In particular, the Member States may restrict the retail sale of medicinal products, in principle, to pharmacists alone, because of the safeguards which pharmacists must provide and the information which they must be in a position to furnish to consumers’. ( 48 )

109. It is my view, moreover, that Article 3(1)(3) and (4) of Royal Decree No 143 does not go beyond what is necessary to attain the objective of combating the increasing overconsumption within the clinical biology sector and the abuse found to be present in that sector. I would recall, in that regard, that that provision is not intended to prohibit the existence and operation of laboratories which do not meet the conditions laid down in that provision, but only to make the reimbursement of analysis services by INAMI conditional upon compliance with specific requirements in relation to the professional qualifications of the persons operating those laboratories. In the light of the Court’s abovementioned case-law relating to the holding of capital in pharmacies and biomedical analysis laboratories, such requirements seem to me to be proportionate.

110. It follows from the forgoing considerations that Article 3(1)(3) and (4) of Royal Decree No 143 must be considered to be compatible with Article 43 EC.

111. It is now necessary to draw the appropriate conclusions from that finding with respect to the action for damages for infringement of EU law brought by Mr Ullens de Schooten against the Belgian State.

112. According to settled case-law, EU law confers a right to reparation where three conditions are met: the rule of law infringed must be intended to confer rights on individuals, the infringement must be sufficiently serious, and there must be a direct causal link between the breach of the obligation resting on the State and the damage sustained by the injured parties. ( 49 )

113. In so far as the premiss to the effect that there is an infringement of EU law in the incompatibility of Article 3(1)(3) and (4) of Royal Decree No 143 with Article 43 EC has been shown to be erroneous, Mr Ullens de Schooten cannot secure a right to reparation under EU law in the action for damages which he has brought against the Belgian State.

114. It follows that such an action certainly cannot be upheld by the cour d’appel de Bruxelles (Court of Appeal, Brussels). Consequently, a reply from the Court to the first, third and fourth questions, which are all founded on the premise, erroneous in my view, that EU law has been infringed by the Belgian State, would be of no use for the purposes of resolving the dispute in the main proceedings. I therefore propose that the Court confine its reply to the points analysed above in the present Opinion.

III – Conclusion

115. In the light of all of the foregoing considerations, I propose that the Court’s reply to the cour d’appel de Bruxelles (Court of Appeal, Brussels, Belgium), should be as follows:

In circumstances such as those in the dispute in the main proceedings, Article 43 EC may be relied on in an action for damages against a Member State for infringement of EU law.

Article 43 EC must be interpreted as meaning that it does not preclude legislation of a Member State under which only clinical biology laboratories operated by persons authorised to perform clinical biology services, that is to say doctors, pharmacists or chemical science graduates, may perform analysis services that are reimbursable by the social security scheme of that Member State.

( 1 ) Original language: French.

( 2 ) Moniteur belge of 12 January 1983.

( 3 ) Article 3(1) of Royal Decree No 143 is worded as follows:

‘The laboratory must be operated:

...

3. either by one or more persons authorised to perform clinical biology services who actually carry out analyses in that laboratory and who are not prescribing physicians;

4. or by a civil-law corporation in the form of a private limited liability company, partnership or cooperative all of whose members, partners or directors are persons as listed in subparagraph 3;

...’

( 4 ) Paragraph 9.

( 5 ) Paragraph 11.

( 6 )

( 7 ) EC:ECHR:2011:0920JUD000398907.

( 8 ) See, in that regard, paragraph 24 of the order for reference.

( 9 ) Judgment of 28 March 1979, Saunders (175/78, EU:C:1979:88, paragraph 11).

( 10 ) Judgment of 28 March 1979, Saunders (175/78, EU:C:1979:88, paragraph 12).

( 11 ) Picod, F., ‘Libre circulation et situation interne’, Revue des affaires européennes, 2003-2004/1, p. 47, especially p. 48.

( 12 ) Judgment of 8 May 2013, Libert and Others (C‑197/11 and C‑203/11, EU:C:2013:288, paragraph 33 and the case-law cited).

( 13 ) According to Mr Ullens de Schooten, his situation exhibits numerous factors linking it to EU law. He exercises his freedom of movement in other Member States, the BIORIM laboratory is funded from capital located in those other Member States, in particular Luxembourg, where several bank accounts have been opened in that laboratory’s name. The Belgian State assigned liability for Mr Ullens de Schooten’s tax debts to a number of Luxembourg companies. Furthermore, the services provided by the BIORIM laboratory were available to nationals established in other Member States.

( 14 ) See judgment of 22 December 2010, Omalet (C‑245/09, EU:C:2010:808).

( 15 ) Paragraph B.4.3 of that judgment.

( 16 ) See, in particular, judgments of 11 March 2010, Attanasio Group (C‑384/08, EU:C:2010:133, paragraph 23 and the case-law cited and paragraph 24); 1 June 2010, Blanco Pérez and Chao Gómez (C‑570/07 and C‑571/07, EU:C:2010:300, paragraph 40); 19 July 2012, Garkalns (C‑470/11, EU:C:2012:505, paragraph 21); 8 May 2013, Libert and Others (C‑197/11 and C‑203/11, EU:C:2013:288, paragraph 34); 5 December 2013, Venturini and Others (C‑159/12 to C‑161/12, EU:C:2013:791, paragraph 25); and 15 October 2015, Grupo Itevelesa and Others (C‑168/14, EU:C:2015:685, paragraph 35 and the case-law cited and paragraph 36). See, also, for a summary of that line of case-law, points 33 to 38 of the Opinion of Advocate General Wahl in Venturini and Others (C‑159/12 to C‑161/12, EU:C:2013:529). As Cheynel, B., points out in ‘Les situations purement internes à la lumière de l’arrêt Libert e.a.’, Revue des affaires européennes, 2013/2, p. 405, in connection with the judgment of 8 May 2013, Libert and Others (C‑197/11 and C‑203/11, EU:C:2013:288), ‘the Court appears to have recognised in that judgment that the mere potential for restrictive effects on the part of national legislation is now sufficient to bring that legislation within the scope of Article 21 TFEU (free movement of citizens), Article 45 TFEU (free movement of workers), Article 49 TFEU (freedom of establishment), Article 56 TFEU (free movement of services) and Article 63 TFEU (free movement of capital), irrespective of the situation of the EU national claiming that such legislation is contrary to those provisions’ (p. 407).

( 17 ) See, in particular, order of 14 March 2013, Loreti and Others (C‑555/12, not published, EU:C:2013:174, paragraph 20 and the case-law cited).

( 18 ) See, inter alia, judgment of 21 April 2005, Commission v Greece (C‑140/03, EU:C:2005:242, paragraph 27 and the case-law cited).

( 19 ) See, in particular, judgment of 6 October 2015, Schrems (C‑362/14, EU:C:2015:650, paragraph 67).

( 20 ) See, in particular, judgments of 18 December 2014, Abdida (C‑562/13, EU:C:2014:2453, paragraph 37 and the case-law cited), and 15 October 2015, Biovet (C‑306/14, EU:C:2015:689, paragraph 17 and the case-law cited).

( 21 ) That case-law reflects a ‘trend towards the harmonious reconciliation of the essential requirements of the internal market, in this instance the freedom of establishment and the protection of public health’ (see Michel, V., ‘Laboratoires d’analyses médicales’, Revue Europe No 2, February 2011, comm. 59).

( 22 ) See judgments of 19 May 2009, Commission v Italy (C‑531/06, EU:C:2009:315), and Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316).

( 23 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 23).

( 24 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 24).

( 25 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 25).

( 26 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 31).

( 27 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 40).

( 28 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 41 and the case-law cited).

( 29 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 42 and the case-law cited).

( 30 ) See, in particular, judgment of 19 May 2009, Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316, paragraph 22 and the case-law cited).

( 31 ) See, in particular, judgment of 19 May 2009, Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316, paragraph 23 and the case-law cited).

( 32 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 50 and the case-law cited).

( 33 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 52 and the case-law cited).

( 34 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 53 and the case-law cited).

( 35 ) Paragraph 56.

( 36 ) See points 83 and 84 of the Opinion of Advocate General Mengozzi in Commission v France (C‑89/09, EU:C:2010:305).

( 37 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 57).

( 38 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 57).

( 39 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 58).

( 40 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 65).

( 41 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 66 and the case-law cited).

( 42 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 67 and the case-law cited).

( 43 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 82 and the case-law cited).

( 44 ) See judgment of 16 December 2010, Commission v France (C‑89/09, EU:C:2010:772, paragraph 82 and the case-law cited).

( 45 ) See, in particular, judgment of 10 March 2009, Hartlauer (C‑169/07, EU:C:2009:141, paragraph 47 and the case-law cited).

( 46 ) See judgments of 19 May 2009, Commission v Italy (C‑531/06, EU:C:2009:315, paragraph 57 and the case-law cited), and Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316, paragraph 33).

( 47 ) See judgments of 19 May 2009, Commission v Italy (C‑531/06, EU:C:2009:315, paragraph 57), and Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316, paragraph 33).

( 48 ) See judgments of 19 May 2009, Commission v Italy (C‑531/06, EU:C:2009:315, paragraph 58 and the case-law cited), and Apothekerkammer des Saarlandes and Others (C‑171/07 and C‑172/07, EU:C:2009:316, paragraph 34).

( 49 ) See, in particular, judgment of 10 July 2014, Ogieriakhi (C‑244/13, EU:C:2014:2068, paragraph 50 and the case-law cited).