Court of Justice of the European Communities (including Court of First Instance Decisions)

OPINION OF ADVOCATE GENERAL

Mazák

delivered on 20 November 2008 (1)

Case C-489/06

Commission of the European Communities

v

Hellenic Republic

(Failure of a Member State to fulfil obligations Free movement of goods Directives 93/36/EEC and 93/42/EEC Hospital purchase of medical devices bearing the CE marking Protective measures Public supply contract)

1. By this action the Commission asks the Court to declare that, by rejecting tenders in respect of medical devices bearing the CE certification marking, without, in any event, the competent contracting authorities of Greek hospitals having followed the procedure set out in Council Directive 93/42/EEC (the Medical Devices Directive), (2) Greece has failed to fulfil its obligations under Article 8(2) of Council Directive 93/36/EEC (the Public Supply Contracts Directive) (3) and Articles 17 and 18 of Directive 93/42.

I The legal framework

A Community law

2. With regard to Directive 93/42, as I explain in point 33 of this Opinion, in Medipac-Kazantzidis (4) delivered after the closure of the written procedure in the present case the Court, in my view, has now settled the issue concerning the obligations of the contracting authorities, and the procedure to be followed by them, in cases such as those complained of in the present proceedings. I therefore do not consider it necessary to set out the whole legal framework of Directive 93/42, as this has been done exhaustively in Medipac-Kazantzidis.
3. Paragraphs 1 to 4 of Article 8 of Directive 93/36 respectively provide:

'1. The technical specifications defined in Annex III shall be given in the general or contractual documents relating to each contract.

2. Without prejudice to the legally binding national technical rules, in so far as these are compatible with Community law, the technical specifications mentioned in paragraph 1 shall be defined by the contracting authorities by reference to national standards implementing European standards, or by reference to European technical approvals or by reference to common technical specifications.

3. A contracting authority may depart from paragraph 2 if:

(a) the standards, European technical approvals or common technical specifications do not include any provision for establishing conformity or technical means do not exist for establishing satisfactorily the conformity of a product to these standards, European technical approvals or common technical specifications;

(b) the application of paragraph 2 would prejudice the application of Council Directive 86/361/EEC [(5)] ... or Council Decision 87/95/EEC [(6)] ... or other Community instruments in specific service or product areas;

(c) use of these standards, European technical approvals or common technical specifications would oblige the contracting authority to acquire supplies incompatible with equipment already in use or would entail disproportionate costs or disproportionate technical difficulties, but only as part of a clearly defined and recorded strategy with a view to change-over, within a given period, to European standards, European technical approvals or common technical specifications;

(d) the project concerned is of a genuinely innovative nature for which use of existing European standards, European technical approvals or common technical specifications would not be appropriate.

4. Contracting authorities invoking paragraph 3 shall record, wherever possible, the reasons for doing so in the tender notice published in the Official Journal of the European Communities or in the contract documents and in all cases shall record these reasons in their internal documentation and shall supply such information on request to Member States and to the Commission.'

4. Annex III to Directive 93/36, entitled 'Definition of certain technical specifications', provides:

'For the purposes of this Directive the following terms shall be defined as follows:

1. Technical specifications: the totality of the technical prescriptions contained in particular in the tender documents, defining the characteristics required of a material, product or supply, which permits a material, a product or a supply to be described in a manner such that it fulfils the use for which it is intended by the contracting authority. These technical prescriptions shall include levels of quality, performance, safety or dimensions, including the requirements applicable to the material, the product or the supply as regards quality assurance, terminology, symbols, testing and test methods, packaging, marking or labelling.

2. Standard: a technical specification approved by a recognised standardising body for repeated and continuous application, compliance with which is in principle not compulsory.

3. European standard: a standard approved by the European Committee for standardisation (CEN) or by the European Committee for Electrotechnical Standardisation (Cenelec) as 'European standard (EN)' or 'Harmonisation documents (HD)' according to the common rules of these organisations.

4. European technical approval: a favourable technical assessment of the fitness for use of a product, based on fulfilment of the essential requirements for building works, by means of the inherent characteristics of the product and the defined conditions of application and use. The European agreement shall be issued by an approval body designated for this purpose by the Member State.

5. Common technical specification: a technical specification laid down in accordance with a procedure recognised by the Member States to ensure uniform application in all Member States which has been published in the Official Journal of the European Communities.'

B National law

5. Directive 93/36 was transposed into Greek law, principally, by way of Presidential Decree No 370 (FEK A' 199/1995). Article 16 of that decree essentially reproduces the wording of Article 8 of Directive 93/36.
6. Joint Ministerial Decree No DY7/oik.2480 of 19 August 1994 (FEK B' 679), bringing Greek legislation into line with Directive 93/42, transposed that directive into Greek law.
7. In addition, the Ethnikos Organismos Farmakon (the Greek authority responsible for ensuring the implementation of the Community directives on medical devices, under the Ministry of Health, 'ΕΟF'), was designated under Article 19 of Law No 2889/2001 as the competent authority in respect of medical devices.

II Facts, pre-litigation procedure and forms of order sought

8. The Commission received a complaint relating to the phenomenon of rejection of medical devices in particular, surgical sutures in the context of calls for tenders for supplies to public hospitals in Greece, on grounds relating to the 'general sufficiency and safety of use' of such devices, notwithstanding their certification with the CE marking, (7) and without, in any event, the safeguard procedure provided for in Directive 93/42 being followed.
9. On 20 April 2004, in the context of the Commission's investigation, the Greek authorities forwarded the Commission the EOF's circular, No 19384, of 2 April 2004 ('Circular No 19384'). According to the circular, it was recognised that 'certain committees responsible for procurement in hospitals have ... rejected on grounds of non-conformity offers presented by companies and concerning numerous medical devices certified with the CE marking, without the necessary prior examination by the EOF' and that 'in certain cases the non-conformity concerned specifications arbitrarily fixed by the hospitals'. It went on to state that 'the companies concerned had therefore brought the matter before the Greek courts and the competent European institutions which had decided in the companies' favour'. According to the Greek authorities, Circular No 19384 thus served as a reminder of the legal procedure which the committees were bound to follow and the details of that procedure.
10. In the light of the above developments, the Commission services informed the complainant that they intended to close the case. However, by letter of 8 November 2004, the complainant furnished further information indicating that, in spite of distributing the circular, the competent committees of certain hospitals (including, the general hospitals of Komotini, Messolonghi, Agios Nikolaos in Crete and Venizelio-Pananio of Heraklion in Crete) continued to be in breach of the rules.
11. By way of example, in one particular call for tenders, the general hospital of Komotini rejected a large part of the complainant's tender, on the ground that the devices were inappropriate in spite of bearing the CE marking and of the fact that they were produced in accordance with the European Pharmacopoeia. Despite having received the EOF circular, the hospital refused to comply with its directions to send the devices for checking by the EOF.
12. Similarly, the general hospital of Messolonghi rejected the complainant's tender and closed the call for tender without informing the EOF or sending samples for control. A similar pattern of events arose in a tendering procedure conducted by the general hospital of Agios Nikolaos in Crete.
13. Finally, in a case concerning a call for tenders by the general hospital of Heraklion in Crete, although it informed the EOF beforehand, in compliance with the circular, it failed to comply with the EOF's decision, which considered the medical devices to be safe.
14. On the basis of this information, the Commission sent the Hellenic Republic a letter of formal notice on 21 March 2005, and opened formal proceedings under Article 226 EC against that Member State for failure to fulfil obligations.
15. In their response of 24 May 2005, the Greek authorities did not contest the fact that certain Greek hospitals were not acting in conformity with relevant Community provisions, but merely stressed the exceptional character of the cases referred to by the Commission. In their view, those cases did not attest to the existence of a large-scale, horizontal infringement of Community law.
16. On 19 December 2005, the Commission issued a reasoned opinion in which it stated that the Hellenic Republic had failed to fulfil its obligations under Article 8(2) of Directive 93/36 and Articles 17 and 18 of Directive 93/42 in relation to the award of public supply contracts of medical devices and called on that Member State to comply with the reasoned opinion within two months of its notification.
17. In its response of 9 February 2006, Greece argued that it had taken the necessary measures to ensure proper application of Community law and that the cases enumerated in the Commission's reasoned opinion were merely exceptions to the general practice. It also pointed out that Greek legislation as such was consistent with Community law. In addition to Circular No 19384 and the reminder of 19 January 2006, Greece also referred to the fact that, at the hospitals' request, the EOF carried out systematic controls of the quality of supplies. Finally, Greece underlined the fact that compliance by the national hospitals of the EOF's instructions was becoming increasingly systematic.
18. However, on the basis of new information, the Commission learned that the infringement at issue was in fact still continuing. The information suggested that the incidents were anything but isolated and exceptional and, what is more, the contracting authorities were not sanctioned for their unlawful conduct in any way. According to the complainant, instances of compliance by the hospitals were in fact rather rare. Moreover, it became clear from the information made available to the Commission that the EOF was neither competent to exercise any administrative control over the hospitals nor to impose any sanction on them, and that so far no other body (judicial or otherwise) in the Greek legal order had exercised any powers in this area. In support of its claims, the Commission cites a number of decisions by the supreme administrative court, namely the Symvoulio tis Epikrateias (the Council of State), more particularly its 'suspension committee', as examples of a general tendency on the part of the court to reject appeals against the decisions of the contracting authorities which were in breach of the directives and of the circulars applicable in this area.
19. Accordingly, the Commission took the view that the infringement, the facts of which the Greek authorities never contested, persisted, and that the measures taken by the national authorities to end it were neither sufficient nor effective. The Commission thus brought the present action before the Court.
20. Having submitted written pleadings, neither party requested a hearing.
21. The Commission claims that the Court should:

' declare that, by rejecting tenders in respect of medical devices bearing the CE certification marking, without, in any event, the competent contracting authorities of Greek hospitals having followed the procedure set out in Directive 93/42, the Hellenic Republic has failed to fulfil its obligations under Article 8(2) of Directive 93/36 and Articles 17 and 18 of Directive 93/42;

order the Hellenic Republic to pay the costs.'

22. The Greek Government contends that the Court should dismiss the application.

III Assessment

A Arguments of the parties

23. The Commission submits that Directive 93/36 coordinating procedures for the award of public supply contracts establishes a precise framework concerning any contracting authority's definition of technical requirements imposed on devices included in an offer. According to Article 8(2) of that directive, the reference to national standards implementing European standards, to European technical approvals or to common technical specifications is obligatory both in the tender notice and in the evaluation of compliance of the products which are the subject of the tender. The Commission underlines the fact that derogations from the principle enshrined in Article 8(2) are set out exhaustively in Article 8(3).
24. The Commission further maintains that the calls for tenders issued by the Greek hospitals refer to the requirement under Article 8(2) of Directive 93/36 for a European technical approval particular to medical devices, that is, the CE certification marking, which is also laid down in Directive 93/42. None the less, the contracting authorities proceeded to exclude tenders of medical devices bearing the CE marking, even though exclusion on this basis is clearly not one of the derogations provided for by Article 8(3) of Directive 93/36.
25. As regards Directive 93/42 concerning medical devices, the Commission submits that the specific and exclusive procedures for certifying such devices and placing them on the market, as well as for contesting their suitability are laid down in such detail that there can be no doubt as to the certified qualitative characteristics nor is there any discretion on the part of the national authorities beyond the framework established by the directive.
26. The Commission argues that the essential requirements of compliance and safety which apply to medical devices are enumerated in Annex I to Directive 93/42 and that products bearing the CE marking meet all those requirements. Article 3, in conjunction with Article 17 of Directive 93/42, sets out the basis for recognising that the devices in question are compliant, and may circulate freely in the internal market.
27. The Commission argues that it may be that certain medical devices, despite bearing the CE marking, are considered by the doctors to endanger the health and safety of patients. In such cases, however, the Commission makes clear that such devices may only be rejected by the contracting authorities in the context of the safeguard procedure provided for in Articles 8 and 18 of Directive 93/42 and described in Circular No 19384.
28. The Commission submits that instead of applying the safeguard procedure the Greek contracting authorities proceeded directly to rejecting the tenders of medical devices bearing the CE marking.
29. However, according to the Commission, it follows from settled case-law that the existence of a directive approximating the laws of the Member States, such as Directives 93/36 and 93/42, and stating that the compliance of the products included in the tenders with all the technical provisions of the directive is necessarily certified with the CE marking, gives rise to the obligation of a Member State to respect the special procedures of the directive concerning disputation of the validity of certification. (8)
30. The Commission maintains that, despite the adoption of Circular No 19384 and the sending of a reminder two years later, the unlawful conduct of the contracting authorities, as well as the Greek authorities' failure to control or sanction it, persists.
31. The Greek Government submits that hospitals, in their role as contracting authorities, do comply with the relevant provisions of Community law and of national law in the area of public procurement. It takes the view that the fact that certain hospitals were not acting in accordance with relevant Community provisions merely constitutes an exception to the general rule, from which, however, one should not deduce the existence of a large-scale horizontal infringement of Community law in the area at issue.
32. Moreover, the Greek Government maintains that, in any event, the EOF distributed Circular No 19384 and, on 19 January 2006, Circular No 4051, which both served as a reminder as to how properly to assess devices for the purposes of their supply. Therefore, the EOF took the necessary measures to ensure proper application of Community law. In addition, the Greek Government explains that the reason why it has not yet determined the sanctions to be imposed on hospitals which do not act in accordance with relevant Community provisions is that the inspectors of the Soma Epitheoriton Ipiresion Igias kai Pronias (Health and Welfare Services Inspection Body) are still in the process of carrying out an investigation.

B Appraisal

33. First of all, with regard to Directive 93/42, I would like to refer to the recent case of Medipac-Kazantzidis (9) delivered after the closure of the written procedure in this case where the Court held that 'a contracting authority, which has issued an invitation to tender for the supply of medical devices and specified that those devices must comply with the European Pharmacopoeia and bear the CE marking, [is precluded] from rejecting, directly and without following the safeguard procedure provided for in Articles 8 and 18 of Directive 93/42, on grounds of protection of public health, the materials proposed, if they comply with the stated technical requirement. If the contracting authority considers that those materials may jeopardise public health, it is required to inform the competent national authority with a view to setting that safeguard procedure in motion.'
34. That part of the present case being settled, the main issue that remains to be analysed is the question of the burden of proof.
35. In this regard, the Commission is seeking to prove, on the basis of certain individual cases, that the conduct of the Greek hospitals, in their capacity as contracting authorities, evinces a consistent administrative practice which is unlawful and which is neither controlled nor sanctioned by the competent authorities. As a result, the Commission is seeking to obtain a finding that Greece has generally failed to fulfil its obligations under Community law.
36. In Commission v Germany, (10) the Court held that 'a failure to fulfil obligations may arise due to the existence of an administrative practice which infringes Community law, even if the applicable national legislation itself complies with that law'.
37. In that connection, the Court stated in another Commission v Greece case (11) that 'so far as concerns the possibility of finding that there has been a failure to fulfil obligations on the basis of the administrative practice followed in a Member State, the Court has already established the applicable criteria. In those circumstances, the failure to fulfil obligations can be established only by means of sufficiently documented and detailed proof of the alleged practice; that administrative practice must be, to some degree, of a consistent and general nature; and, in order to find that there has been a general and consistent practice, the Commission may not rely on any presumption.'
38. In the present case, the Commission issued the reasoned opinion on 19 December 2005, in which it stated that Greece had failed to fulfil its obligations under Article 8(2) of Directive 93/36 and under Articles 17 and 18 of Directive 93/42 in relation to the award of public supply contracts of medical devices, and called on that Member State to comply with the opinion within two months of its notification.
39. On 9 February 2006, Greece responded to the reasoned opinion and submitted that it had taken the necessary measures to ensure proper application of Community law, inter alia, through the distribution of Circular No 19384 on 2 April 2004 and of the reminder on 19 January 2006, drawing the hospitals' attention to their Community law obligations. In my view, this approach indicates that the Greek Government: (i) accepted the existence of the factual situations underlying the allegations set out in the reasoned opinion; (ii) in seeking to remedy the problem, took further measures (that is, the reminder of 19 January 2006); and (iii) failed to provide any substantive answer to the conduct complained of.
40. In its application, the Commission submits that despite adopting Circular No 19384 and sending the reminder two years later, the unlawful conduct of the contracting authorities, as well as the failure by the Greek authorities to control it, persists. In its view, the cases that were brought to its attention are indicative of what seems to be common practice in Greek hospitals, of the fact that the infringement in question is anything but isolated and exceptional, as maintained by the Greek Government, and that the conduct of the contracting authorities responsible continues to go unchecked.
41. Before considering the merits of the Commission's complaint, I will first deal with the Greek Government's contention that the Commission is not justified in drawing general conclusions as to the existence of a large-scale horizontal infringement of Community law from the examination of specific regarded by that State as 'exceptional' cases by presuming alleged systemic failures by Greece to fulfil its obligations.
42. In the ensuing paragraphs, I will seek to establish why, in my view, the alleged infringement may be considered to be of a general and persistent nature.
43. In this connection, I think it would be helpful to set out at length the relevant parts of the judgment in Commission v Ireland ('Irish Waste case'). (12) In this case, the Court held that whilst it is incumbent upon the Commission to prove the allegation that the obligation has not been fulfilled, (13) 'the Member States are required, under Article 10 EC, to facilitate the achievement of the Commission's tasks, which consist, in particular, pursuant to Article 211 EC, in ensuring that the provisions of the Treaty and the measures taken by the institutions pursuant thereto are applied [(14)] ... In this context, account should be taken of the fact that, where it is a question of checking that the national provisions intended to ensure effective implementation of the directive are applied correctly in practice, the Commission [having no] investigative powers of its own in the matter, is largely reliant on the information provided by any complainants and by the Member State concerned [(15)] ... It follows in particular that, where the Commission has adduced sufficient evidence of certain matters in the territory of the defendant Member State, it is incumbent on the latter to challenge in substance and in detail the information produced and the consequences flowing therefrom [(16)] ... In such circumstances, it is indeed primarily for the national authorities to conduct the necessary on-the-spot investigations, in a spirit of genuine cooperation and mindful of each Member State's duty ... to facilitate the general task of the Commission [(17)] ... Thus, where the Commission relies on detailed complaints revealing repeated failures to comply with the provisions of the directive, it is incumbent on the Member State to contest specifically the facts alleged in those complaints [(18)] ... Likewise, where the Commission has adduced sufficient evidence to show that a Member State's authorities have developed a repeated and persistent practice which is contrary to the provisions of a directive, it is incumbent on that Member State to challenge in substance and in detail the information produced and the consequences flowing therefrom.' (19)
44. Furthermore, in Commission v Italy (20) the Court held that 'that obligation rests on the Member States under the duty of genuine cooperation, enshrined in Article 10 EC, throughout the procedure provided for by Article 226 EC'.
45. It is in this context that I shall consider the merits of this case.
46. First of all, as the Court held in Commission v Ireland, (21) 'the Commission may seek a finding that provisions of a directive have not been complied with because a general practice contrary thereto has been adopted by the authorities of a Member State, using particular situations to shed light on that practice'.
47. In this case, I consider that it is apparent from the documents before the Court that there have been at least 14 instances known to the Commission of hospitals acting as contracting authorities in the incorrect and unlawful manner described above.
48. Those 14 cases of alleged infringement of Community law concern the following hospitals: Attica, Athens Agios Savvas, Elpis, Argos, Korgialenio-Benakio Red Cross Hospital of Athens, General Hospital of Kalamata (in the Peloponnese peninsula), the General Hospital of Nafplio, Athens General Children's Hospital P. & A. Kiriakou, Siros (in the Cyclades), the General Hospital of Sparta, General Hospital Panarkadiko of Tripolis, the Elena Venizelou General and Maternity Hospital, the Asklipio General Hospital of Voula Attiki and Kos.
49. It would appear from the documents before the Court that some of the largest hospitals in Greece are included in that list, namely: Attica, Agios Savvas (a well-known cancer hospital), Korgialenio-Benakio, Kiriakou and Elena Venizelou.
50. In addition, I consider that those instances would appear to reflect both a wide geographic coverage and a number of areas of specialisation, including general hospitals, a children's hospital, a cancer treatment hospital and a maternity hospital. (22)
51. In this respect, I agree with the views of Advocate General Geelhoed in his Opinion in Commission v Ireland (23) that 'although isolated cases may in themselves be sufficient to establish an infringement ... a structural infringement suggests that there is a more general practice or a pattern of non-compliance which is also likely to keep recurring. In the case of a directive it implies that the substantive content of the directive, for whatever reason, is not brought into practice and that the result of the directive is not attained within the Member State. An indication of this might be that the practice is not restricted to a particular locality in a Member State, but is more widespread in that more situations which are contrary to the terms of the directive occur simultaneously within the territory of the Member State.' That, indeed, appears to be the case here.
52. Finally, it should be borne in mind, in this respect, that the relevant product in the present proceedings is a product that hospitals need to purchase on a recurrent and regular basis. Therefore, given the nature of the product at issue in the present proceedings as opposed to one that is purchased on a one-off basis the general practice complained of by the Commission is, in my view, likely to keep recurring.
53. I therefore consider that, on the basis of the considerations set out in points 45 to 51 above, and the similarity and recurrent nature of the situations in question, there seems to be a generalised and systemic failure on the part of the contracting authorities to comply with Directives 93/36 and 93/42 and on the part of the Hellenic Republic. (24)
54. In the light of the above, it should be noted that once the Commission has adduced sufficient evidence to show that a Member State's authorities have developed a repeated and persistent practice contrary to the provisions of Directives 93/36 and 93/42, it is for that Member State to challenge, in substance and in detail, the information produced and the consequences flowing therefrom.
55. However, the crux of the present case is that the Greek Government has failed to contest any of the claims in relation to any of these hospitals. (25) Moreover, Greece has presented neither arguments nor specific evidence to contradict or to challenge, in substance and in detail, the Commission's allegations.
56. In fact, in Circular No 19384, in the pre-litigation phase and, in particular, in its defence in the present proceedings, the Greek Government recognises the fact that 'certain hospitals acted in breach of relevant Community provisions'.
57. Therefore, in the light of the Greek Government's failure to contest the Commission's allegations and to provide sufficient evidence in rebuttal, those allegations must be regarded as substantiated. (26)
58. I consider that the Commission has provided sufficient proof of Greece's infringement of Community law. That proof is only reinforced by the fact, apparent from the documents before the Court and not contested by the Greek Government, that the contracting authorities' unlawful conduct is neither controlled nor sanctioned by that Member State.
59. It follows from the case-law cited in point 43 of this Opinion that Greece was required, under Article 10 EC, to facilitate the achievement of the Commission's tasks in proceedings under Article 226 EC.
60. Therefore, instead of simply denying (27) that it is possible, on the basis of the individual cases (which in any event it did not contest), to find a general failure to fulfil obligations, pursuant to its duty under Article 10 EC, Greece should have rather furnished evidence of instances where the two directives at issue were correctly applied. To this end, it should have provided an estimate of the average number of calls for tenders issued annually by a hospital in order to show that the instances known to the Commission were, on the basis of their number, geographical spread and nature of specialisation, indeed exceptional, and that, in relation to all the other cases, no general deficiencies underpinned them. However, in both the pre-litigation phase and its written submissions in these proceedings, the Greek Government manifestly failed to do either.
61. The only and one argument advanced by the Greek Government is that the Commission has failed to prove that the instances known to it are not isolated and exceptional incidents.
62. In my view, having regard to, on the one hand, the number, the geographical spread and the range of specialisation of the hospitals, and, on the other, the fact that they include some of the largest hospitals in Greece, it would appear that the Greek hospitals' conduct amounts to a generalised breach and thus may not be considered to be confined to those 14 instances known to the Commission.
63. Indeed, as the Commission has shown, the number of instances of infringement by the contracting authorities and the failure to control and sanction such conduct at administrative and judicial levels both generally and in individual cases lead to a different conclusion from that advocated by Greece. I consider therefore that both the action of the contracting authorities and the practice of the relevant supervisory authorities render the infringement of the lawful procedure systemic in nature.
64. The Commission has demonstrated that the existence of the factual situations which are the subject of the various instances complained of, given their number and nature, can only be explained by a pattern of non-observance of Community law obligations on a larger scale. In such a situation, taken together and seen in context, the instances of conduct complained of cannot be regarded as mere isolated incidents but rather symptomatic of a policy of administrative practice contrary to that Member State's obligations. (28)
65. Indeed, the conduct of public tendering procedures in breach of Directive 93/36 by a large number of hospitals is contrary to the obligations of the Greek authorities under Article 8(2) thereof.
66. The Commission correctly points out that the measures taken by the Greek Government to remedy those infringements, after it had been advised of them by the Commission, merely consist of the EOF's adoption of a regulatory act, namely Circular No 19384, and of the sending of a reminder two years later. It should be noted that the latter was sent on 19 January 2006, one month after the Commission had sent its reasoned opinion to the Greek authorities.
67. However, it is apparent from the documents before the Court that the contracting authorities' unlawful conduct, as well as the failure by the Greek authorities to control and sanction it, persists.
68. In view of the above considerations, I agree with the Commission that the cases brought to its attention constitute examples which are indicative of a common practice in Greek hospitals as regards the supply of medical devices.
69. The Greek authorities' argument based on the existence of national (appeal) procedures, which are designed to deal with every infringement relating to public procurement does not justify breach of the relevant Community rules by the Member State.
70. As the Court stated in Brasserie du Pêcheur and Factortame, (29) it 'has consistently held that the right of individuals to rely on the directly effective provisions of the Treaty before national courts is only a minimum guarantee and is not sufficient in itself to ensure the full and complete implementation of the Treaty'.
71. Indeed, a failure to fulfil an obligation ensuing from an administrative practice of a Member State assumes that a particular pattern of behaviour can be discerned on the part of the authorities of the defendant Member State. (30)
72. I am of the view that this is the case here. As appears from the documents before the Court, the administrative practice complained of, illustrated by numerous examples, is clearly, to some degree, of a consistent and general nature and is coupled, at the same time, with a lack of control, enforcement and sanctions. (31) In addition, according to the Commission's submissions, as set out in point 18 of this Opinion, it would appear as is evident from the general tendency to reject the appeals against the contracting authorities' decisions that, far from disagreeing with the incorrect and unlawful construction of the applicable provisions by the contracting authorities, the Council of State has rather confirmed it. (32)
73. On this basis, I consider that the administrative practice complained of by the Commission as described above is likely to persist. Moreover, it would appear that such an infringement by the Hellenic Republic is not only liable to have adverse effects on specific interests protected by Directives 93/36 and 93/42 but also, more generally, on the objectives promoted by those directives.
74. Indeed, in the present case the remedy for the situation lies not merely in taking action to resolve a number of individual cases which do not comply with the Community law obligation in question, but in a revision of the general policy and administrative practice of the Member State at issue. (33)
75. In addition, the conclusion that the administrative practice complained of is clearly, to some degree, of a consistent and general nature, and is coupled with a lack of control, enforcement and sanction would appear to be paradoxically confirmed by the Greek Government's argument that the sanctions could not (yet) have been imposed, since, at the time of lodging its rejoinder, the investigation by its Health and Welfare Services Inspection Body was still ongoing. In fact, prima facie, that investigation would appear unduly protracted, not least because the information that came to light during the administrative procedure under Article 226 EC could have enabled the Greek authorities to further their own investigation. In particular, from the documents before the Court the Commission first informed Greece of the contracting authorities' conduct on 26 September 2003 and Greece lodged its rejoinder on 19 April 2007. Therefore at least three and a half years had elapsed since the date on which Greece was first advised of the conduct at issue.
76. In my view, it should be noted here that the present case manifestly meets the criteria of time (the fact that the situation of non-compliance has existed over a long period of time) and of seriousness (the degree to which the actual situation in the Member State deviates from the result intended to be achieved by the Community obligation). (34)
77. Finally, the action for failure to fulfil obligations is objective and the protracted nature of the authorities' investigation cannot serve to expunge Greece's failure to fulfil its obligations. In Commission v Belgium (35) the Court stated that it 'has consistently held that a Member State may not plead provisions, practices or circumstances in its internal legal order to justify a failure to comply with obligations under Community directives'.
78. Therefore, it follows from the case-law referred to above that in the absence of evidence to the contrary produced by the Greek Government, the Commission must be held to have demonstrated to the requisite legal standard that by rejecting tenders in respect of medical devices bearing the CE marking, without, in any event, the competent contracting authorities of Greek hospitals having followed the procedure set out in Directive 93/42, Greece has failed to fulfil its obligations under Directives 93/36 and 93/42. (36)

IV Costs

79. Under Article 69(2) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party's pleadings. The Commission has applied for costs against Greece.

V Conclusion

80. I am therefore of the opinion that the Court should:

declare that, by rejecting tenders in respect of medical devices bearing the CE certification marking, without, in any event, the competent contracting authorities of Greek hospitals having followed the procedure set out in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003, the Hellenic Republic has failed to fulfil its obligations under Article 8(2) of Council Directive 93/36/EEC of 14 June 1993 coordinating procedures for the award of public supply contracts and Articles 17 and 18 of Directive 93/42 concerning medical devices;

order the Hellenic Republic to pay the costs.

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1 Original language: English.

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2 Directive of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 (OJ 2003 L 284, p. 1) ('Directive 93/42').

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3 Directive of 14 June 1993 coordinating procedures for the award of public supply contracts (OJ 1993 L 199, p. 1), as amended by Commission Directive 2001/78/EC of 13 September 2001 (OJ 2001 L 285, p. 1) ('Directive 93/36'). Directive 93/36 was repealed by Directive 2004/18/EC of the European Parliament and of the Council of 31 March 2004 on the coordination of procedures for the award of public works contracts, public supply contracts and public service contracts (OJ 2004 L 134, p. 114). However, it is Directive 93/36 that is pertinent to the facts of the present case.

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4 Case C-6/05 [2007] ECR I-4557.

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5 Directive of 24 July 1986 on the initial stage of the mutual recognition of type approval for telecommunications terminal equipment (OJ 1986 L 217, p. 21).

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6 Decision of 22 December 1986 on standardisation in the field of information technology and telecommunications (OJ 1987 L 36, p. 31).

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7 According to the complaint, the competent committees, usually composed of medical doctors employed by hospitals, claim to be entitled to verify the general sufficiency and safety of use of the medical devices in question, and, taking the view that the CE marking is not a proper and binding guarantee, often discover shortcomings in the standards which, in the committees' opinion, limits or even renders the official CE certificate invalid.

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8 The Commission refers to Case C-14/02 ATRAL [2003] ECR I-4431, paragraphs 50 to 53; Case C-103/01 Commission v Germany [2003] ECR I-5369, paragraphs 28 and 29; Case C-40/04 Yonemoto [2005] ECR I-7755, paragraphs 31 and 32; and the Opinion of Advocate General Sharpston in Medipac-Kazantzidis, case cited in footnote 4, points 83 to 87.

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9 Cited in footnote 4, paragraph 55.

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10 Case C-441/02 [2006] ECR I-3449, paragraph 47, referring to Case C-278/03 Commission v Italy [2005] ECR I-3747, paragraph 13. See also Case C-342/05 Commission v Finland [2007] ECR I-4713, paragraph 22.

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11 Case C-156/04 [2007] ECR I-4129, paragraph 50, referring to Case C-441/02 Commission v Germany, cited in footnote 10, paragraphs 49, 50 and 99, and the case-law cited. For a case where the Commission has not shown the existence in a Member State of an administrative practice with the characteristics required by the Court's case-law, see Case C-287/03 Commission v Belgium [2005] ECR I-3761, paragraph 28.

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12 Case C-494/01 [2005] ECR I-3331, paragraphs 41 to 47. See also Case C-135/05 Commission v Italy [2007] ECR I-3475, paragraphs 26 to 32. Cf. Lenaerts, K., 'The Rule of Law and the Coherence of the Judicial System of the European Union', 44 CML Rev. (2007), 1636, fn. 70, who, in turn, refers to Wennerås, P., 'A New Dawn for Commission Enforcement under Articles 226 and 228 EC: General and Persistent (GAP) Infringements, Lump Sums and Penalty Payments', 43 CML Rev. (2006), 31, and Schrauwen, A., 'Fishery, waste management and persistent and general failure to fulfil control obligations: The role of lump sums and penalty payments in enforcement actions under Community law', 18 Journal of Environmental Law (2006), 289.

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13 See, in particular, Case 96/81 Commission v Netherlands [1982] ECR 1791, paragraph 6, and Case C-408/97 Commission v Netherlands [2000] ECR I-6417, paragraph 15. Cf. also Case 272/86 Commission v Greece [1988] ECR 4875, paragraph 21.

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14 Case 96/81 Commission v Netherlands, cited in footnote 13, paragraph 7, and Case C-408/97 Commission v Netherlands, cited in footnote 13, paragraph 16.

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15 See, by analogy, Case C-408/97 Commission v Netherlands, cited in footnote 13, paragraph 17.

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16 See to this effect Case C-365/97 Commission v Italy [1999] ECR I-7773 ('San Rocco'), paragraphs 84 and 86.

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17 San Rocco, cited in footnote 16, paragraph 85.

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18 See, by analogy, Case 272/86 Commission v Greece, cited in footnote 13, paragraph 19.

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19 See, by analogy, Case 272/86 Commission v Greece, cited in footnote 13, paragraph 21, and San Rocco, cited in footnote 16, paragraphs 84 and 86.

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20 Case C-135/05, cited in footnote 12, paragraph 32.

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21 Case C-248/05 [2007] ECR I-9261, paragraph 64 and the case-law cited.

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22 It is apparent from the documents before the Court that the practice complained of extends to a number of other hospitals, including: Ipokratio Hospital of Thessaloniki ('one of the largest in the country'), Trikala General Hospital, G. Papanikolaou Hospital of Thessaloniki ('one of the largest in the country'), the University Hospital of Patras, the Greek Navy Hospital in Athens, Agia Sofia Hospital of Athens ('the largest hospital for children in the country'), Kifisia Hospital for Accidents (KAT, 'one of the major hospitals in Athens') and Tzanio Hospital ('the major hospital of Piraeus').

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23 Case C-494/01, cited in footnote 12, point 44.

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24 As opposed, for instance, to Case C-229/00 Commission v Finland [2003] ECR I-5727, paragraph 53.

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25 Cf. with Case C-494/01 Commission v Ireland, cited in footnote 12, where Ireland contested the veracity of the majority of the Commission's allegations. Cf. also with Case C-375/90 Commission v Greece [1993] ECR I-2055, paragraph 34, where, since 'the Hellenic Republic provided detailed information in its written pleadings and at the hearing to show that it had in fact complied with the requirements of Annex III and the Commission did not dispute the accuracy of that information', the Court concluded that the Commission had failed to substantiate its allegation that the provisions of the relevant regulation were infringed.

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26 See Case 272/86 Commission v Greece, cited in footnote 13, paragraph 21. See also Case C-508/03 Commission v United Kingdom [2006] ECR I-3969, paragraph 80.

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27 Cf. with what the Court essentially held in Case 272/86 Commission v Greece, cited in footnote 13, that although it is incumbent on the Commission to prove its allegation, the Member State is not entitled, where the Commission has produced sufficient evidence to show the failure to fulfil obligations, merely to deny its existence. The Member State has to contest substantively and in detail the information produced and the consequences thereof. If it does not do so, the allegations must be regarded as substantiated.

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28 See, to that effect, the Opinion of Advocate General Geelhoed in Case C-494/01 Commission v Ireland, cited in footnote 12, point 55.

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29 Joined Cases C-46/93 and C-48/93 [1996] ECR I-1029, paragraph 20.

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30 Lenaerts, K., Arts, D., Maselis, I., Procedural Law of the European Union, 2nd edition, London, 2006, p. 133, section 5-008, citing, for example, Case 21/84 Commission v France [1985] ECR 1355; Case 35/84 Commission v Italy [1986] ECR 545; Case C-150/00 Commission v Austria [2004] ECR I-3887; and Case C-41/02 Commission v Netherlands [2004] ECR I-11375.

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31 Similarly to Case C-494/01 Commission v Ireland, cited in footnote 12, Greece would appear (i) to have failed generally to create and/or enforce the necessary legal and administrative framework for the proper application and enforcement of provisions of Directives 93/36 and 93/42, as well as (ii) to apply and enforce the provisions in casu. Indeed, objectively, there would appear to be a general tendency on the part of the Greek authorities to tolerate situations in which those provisions were not complied with (cf. Case C-494/01 Commission v Ireland, cited in footnote 12, paragraph 132).

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32 As regards the compatibility with Community law of a practice related to a 'neutral' provision of national law, in the context of judicial behaviour, see the judgment in Case C-129/00 Commission v Italy [2003] ECR I-14637. There, the Court set out the circumstances in which a national judicial practice is capable of amounting to a failure by a Member State to fulfil its obligations under Article 226 EC.

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33 See the Opinion of Advocate General Geelhoed in Case C-494/01 Commission v Ireland, cited in footnote 12, point 48, where he goes on to say that: 'restricting the remedial action to identified cases of non-compliance would after all leave other situations of non-compliance intact until they too have been identified and challenged ... by the Commission in new infringement proceedings ... In the meantime a situation contrary to that envisaged by the Community measure persists.'

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34 Ibid., points 45 and 46.

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35 Case 301/81 [1983] ECR 467, paragraph 6.

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36 See, to this effect, SanRocco, cited in footnote 16, paragraph 91.