1. By order of 23 November 2000, received at the Court on 9 February 2001, the Tribunal des affaires de sécurité sociale (Social Security Court), Nanterre, referred to the Court of Justice for a preliminary ruling under Article 234 EC, a question on the validity and interpretation of Article 22 of Regulation (EEC) No 1408/71 of the Council of 14 June 1971 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community, as amended and updated by Council Regulation (EC) No 118/97 of 2 December 1996 (OJ 1997 L 28, p. 1; hereinafter "Regulation No 1408/71" ), and on the interpretation of Articles 49 EC and 50 EC.
2. That question was raised in the context of proceedings between Ms Inizan and the Caisse primaire d'assurance maladie des Hauts-de-Seine ( "the CPAM" ) regarding the refusal by the CPAM to reimburse the cost of hospital treatment that the claimant in the main proceedings intends to undergo in Germany. Legal background Community law
3. Under the heading "Stay outside the competent State ─ Return to or transfer of residence to another Member State during sickness or maternity ─ Need to go to another Member State in order to receive appropriate treatment" , Article 22 of Regulation No 1408/71 states in paragraphs 1 and 2: "1. An employed or self-employed person who satisfies the conditions of the legislation of the competent State for entitlement to benefits, taking account where appropriate of the provisions of Article 18, and: ... (c) who is authorised by the competent institution to go to the territory of another Member State to receive there the treatment appropriate to his condition, shall be entitled: (i) to benefits in kind provided on behalf of the competent institution by the institution of the place of stay or residence in accordance with the provisions of the legislation which it administers, as though he were insured with it; the length of the period during which benefits are provided shall be governed, however, by the legislation of the competent State; ... 2. ... The authorisation required under paragraph 1(c) may not be refused where the treatment in question is among the benefits provided for by the legislation of the Member State on whose territory the person concerned resides and where he cannot be given such treatment within the time normally necessary for obtaining the treatment in question in the Member State of residence taking account of his current state of health and the probable course of the disease. " National law
4. The first paragraph of Article L.332-3 of the French Social Security Code states: "Without prejudice to agreements and international rules, or to Article L.766-1, where medical treatment is given outside France to insured persons and their dependants, the corresponding benefits under the sickness and maternity insurance scheme shall not be provided."
5. By way of derogation from that rule, Article R.332-2 of that code provides: "Sickness insurance funds may reimburse, at a flat rate, the costs of treatment given outside France to insured persons, and members of their families, who are taken ill unexpectedly, provided that the amount does not exceed the total sum which would have been paid to them had they been treated in France. Where it is not possible for an insured person or his dependants to receive in France the treatment appropriate to their condition, the agreements between the French competent bodies and certain hospitals abroad may, with the joint authorisation of the Minister for Social Security and the Minister for Health, lay down the conditions on which patients may stay in those hospitals and the methods of reimbursing the costs of the treatment received. Notwithstanding the cases referred to in the previous paragraph, in exceptional circumstances and subject to a favourable opinion from the medical supervisory body, sickness insurance funds may reimburse, at a flat rate, the cost of treatment provided outside France to an insured person or his dependants, where the person concerned establishes that he could not receive in French territory the treatment appropriate to his condition. "
6. It is moreover apparent from the order for reference that, under French law, the authority competent to authorise the reimbursement of costs for treatment received during a stay at an establishment in a Member State of the European Union other than the French Republic is the Médecin Conseil national (National Medical Officer). The main proceedings and the question submitted for a preliminary ruling
7. Ms Inizan, who is resident in France and is covered for medical insurance by the CPAM, asked the latter to reimburse the cost of multidisciplinary pain treatment which she intended to undergo at the Berlin Moabit hospital (Germany).
8. That request was refused by the CPAM by decision of 6 July 1999, confirmed by decision of the Commission de Recours Amiable (Arbitration Committee) of the CPAM of 7 October 1999, on the ground that the requirements of the second subparagraph of Article 22(2) of Regulation No 1408/71 had not been satisfied.
9. Ms Inizan challenged those decisions before the Tribunal des affaires de sécurité sociale, Nanterre, where she stated that she now wished to follow that treatment in Essen Hospital (Germany).
10. By interlocutory judgment of 6 July 2000, that court, first, requested Ms Inizan to provide evidence that the treatment in question is reimbursed by the German social security scheme and, secondly, sought the opinion of the National Medical Officer as to whether the CPAM should reimburse the cost of treatment.
11. On 17 August 2000, the National Medical Officer gave an adverse opinion regarding reimbursement of costs finding that a wide range of treatments was available in France which could be considered equivalent to that offered by Essen Hospital, without involving undue delay. Furthermore, pain treatment implies long-term, regular treatment which could not therefore be provided by a hospital far from the patient's home.
12. For her part, Ms Inizan proved, to the satisfaction of the national court, that the treatment in question is reimbursed by the German social security scheme. She claims that her state of health requires her to follow such treatment and that it is not available in France.
13. The national court, noting the wording of Article 22(1)(c)(i) and the second subparagraph of Article 22(2) of Regulation No 1408/71 and pointing out that the opinion of the National Medical Officer was that the prior authorisation referred to in those provisions should not be granted, wonders none the less whether, by thus making reimbursement of the costs of health services provided in another Member State subject to a prior authorisation, the aforementioned provisions constitute a restriction on freedom to provide services, contrary to Articles 49 EC and 50 EC.
14. In those circumstances, the Tribunal des affaires de sécurité sociale de Nanterre decided to stay proceedings and to refer the following question to the Court for a preliminary ruling: "Is Article 22 of Regulation (EEC) No 1408/71 compatible with Articles [49 EC] and [50 EC?] Consequently, is the CPAM of the Hauts de Seine entitled to refuse Ms Inizan reimbursement of the costs of psychosomatic pain treatment in Essen (Germany), following an adverse opinion from the National Medical Officer[?] " The first part of the question
15. By the first part of its question, the national court raises the question of the validity of Article 22(1)(c)(i) of Regulation No 1408/71. In particular, the court wonders whether, in so far as that provision makes the grant of the benefits in kind to which it guarantees entitlement subject to prior authorisation, it is consistent with Articles 49 EC and 50 EC on the freedom to provide services.
16. First, according to settled case-law, medical activities fall within the scope of Article 50 EC, there being no need to distinguish in that regard between care provided in a hospital environment and care provided outside such an environment (see, among others, Case C-368/98 Vanbraekel and Others [2001] ECR I-5363, paragraph 41; Case C-157/99 Smits and Peerbooms [2001] ECR I-5473, paragraph 53, and Case C-385/99 Müller-Fauré and Van Riet [2003] ECR I-4509, paragraph 38).
17. Moreover, although it is not disputed that Community law does not detract from the power of the Member States to organise their social security systems and that, in the absence of harmonisation at Community level, it is for the legislation of each Member State to determine the conditions on which social security benefits are granted, it is nevertheless the case that, when exercising that power, the Member States must comply with Community law (see, among others, Smits and Peerbooms , paragraphs 44 to 46, and Müller-Fauré and Van Riet , paragraph 100, and the case-law cited therein).
18. Accordingly, the Court has ruled in particular that Article 49 EC precludes the application of national rules making reimbursement of medical costs incurred in another Member State subject to a system of prior authorisation where it is apparent that such a system deters, or prevents, insured persons from approaching providers of medical services established in Member States other than the State of insurance, save where the barrier to the freedom to provide services to which it gives rise is justifiable under one of the derogations allowed by the EC Treaty (see, in particular, Case C-158/96 Kohll [1998] ECR I-1931, paragraphs 35 and 36, and Smits and Peerbooms , paragraphs 69 to 75, and Müller-Fauré and Van Riet , paragraphs 44, 67 and 68).
19. So far as concerns Article 22 of Regulation No 1408/71, it should nevertheless be borne in mind that that provision is in no way intended to regulate, and hence does not in any way prevent, the reimbursement by Member States, at the tariffs in force in the competent Member State, of costs incurred in connection with treatment provided in another Member State, even without prior authorisation (Kohll , paragraph 27, and Vanbraekel and Others , paragraph 36).
20. The purpose of Article 22(1)(c)(i) is to confer on the insured persons concerned an entitlement to benefits in kind provided on behalf of the competent institution by the institution of the place of stay, in accordance with the legislation of the Member State in which the benefits are provided, as though the covered person were insured in that State, the length of the period during which benefits are provided alone remaining to be governed by the legislation of the competent Member State (see, in particular, Vanbraekel and Others , paragraph 32). The competent institution is then required to reimburse, directly, the institution of the place of stay in compliance with the conditions laid down in Article 36 of Regulation No 1408/71.
21. It follows that, by guaranteeing in paragraph 1(c)(i) that insured persons covered by the legislation of one Member State and granted authorisation have access to treatment in the other Member States on conditions of reimbursement as favourable as those enjoyed by insured persons covered by the legislation of those other States and by stating, in the second subparagraph of paragraph 2, that the competent national institution may not refuse such authorisation where the two conditions laid down therein are satisfied, Article 22 of Regulation No 1408/71, as mentioned in particular by the Council and the Commission, helps to facilitate the free movement of insured persons (see, to that effect, Vanbraekel and Others , paragraph 32) and, to the same extent, the cross-border provision of medical services between Member States.
22. Insured persons are thus granted rights which they would not otherwise have since, as they involve reimbursement by the institution of the place of stay in accordance with the legislation administered by it, those rights cannot by definition be guaranteed to those persons under the legislation of the competent Member State alone (see, by analogy, Case C-62/91 Gray [1992] ECR I-2737, paragraph 10).
23. However, it should be borne in mind that, as the Court has previously held, Article 51 of the EC Treaty (now, after amendment, Article 42 EC), does not prohibit the Community legislature from attaching conditions to the rights and advantages which it accords in order to ensure freedom of movement for workers or from determining the limits thereto (Joined Cases 41/79, 121/79 and 796/79 Testa and Others [1980] ECR 1979, paragraph 14, and Gray , paragraph 11).
24. In those circumstances, it cannot be complained that the Community legislature made entitlement to the abovementioned rights subject to obtaining prior authorisation from the competent institution. It must furthermore be pointed out in that regard, first, that it is for that latter institution to bear, in accordance with the conditions laid down by Article 36 of Regulation No 1408/71, the cost of the services thus provided and, secondly, that the proper application of Article 22(1)(c)(i) and of Article 36 of Regulation No 1408/71 is such as to require a level of administrative cooperation between the abovementioned institution and that of the place of stay.
25. It follows from all the foregoing that, contrary to the arguments put forward by the claimant in the main proceedings, Article 22(1)(c)(i) and (2) of Regulation No 1408/71 help to facilitate the free movement of patients and cross-border provision of medical services.
26. The answer to the first part of the question must therefore be that consideration thereof has disclosed no factor of such a kind as to affect the validity of Article 22(1)(c)(i) of Regulation No 1408/71. The second part of the question The purpose of the second part of the question
27. By the second part of its question the national court is essentially asking whether, in view of the answer given to the first part of the question, the CPAM was right to refuse to reimburse the cost of the treatment at issue in the main proceedings, in light of the adverse opinion issued by the National Medical Officer.
28. As the observations submitted to the Court show, the wording of this part of the question gives rise to a number of difficulties of interpretation.
29. The CPAM contends that this part of the question is inadmissible on the ground that it concerns exclusively the application of domestic law to the present case, which falls outwith the jurisdiction of the Court.
30. Ms Inizan, on the other hand, submits that the principle of procedural economy requires that the points of Community law which require interpretation be extracted from the order for reference, so that the Court should in this instance give a ruling not only on the validity of Article 22 of Regulation No 1408/71 but also on the interpretation of that provision having regard to the facts of the case in the main proceedings.
31. The Commission and a number of the governments which lodged observations before the Court submit that the answer to be given to the national court could involve an examination of whether Article R. 332-2 of the Social Security Code is consistent with Articles 49 EC and 50 EC.
32. In that regard, it is appropriate to recall, as a preliminary point, the consistent case-law regarding the division of functions provided for by Article 234 EC, according to which it is for the national court to apply the rules of Community law, as interpreted by the Court, to the case before it (see, inter alia, Case C-320/88 Shipping and Forwarding Enterprise Safe [1990] ECR I-285, paragraph 11, Case C-342/97 Lloyd Schuhfabrik Meyer [1999] ECR I-3819, paragraph 11; and Joined Cases C-223/99 and C-260/99 Agorà and Excelsior [2001] ECR I-3605, paragraph 23).
33. It follows that it is for the national court to determine whether, by rejecting the request for reimbursement submitted by the claimant in the main proceedings, the CPAM has acted in conformity with the rules of Community law.
34. However, it is for the Court to extract from all the information provided to it by the national court, in particular the grounds of the order for reference, the points of Community law which require interpretation, having regard to the subject-matter of the proceedings (see, inter alia, Case 35/85 Tissier [1986] ECR 1207, paragraph 9, and Agorà and Excelsior , paragraph 24).
35. First, it must be noted that the opinion issued by the National Medical Officer to which the second part of the question refers concluded that the cost of the treatment at issue in the main proceedings should not be reimbursed on the ground that there was a wide choice of treatment available in France which could be considered to be equivalent and without involving undue delay.
36. It should be observed that the reasons thus relied upon by the National Medical Officer seem to be able to be covered by Article 22(2) of Regulation No 1408/71 as much as by Article R. 332-2 of the Social Security Code.
37. Article 22(2) of Regulation No 1408/71 lays down two conditions which, if satisfied, render mandatory the prior authorisation to which it refers. However, one of those conditions is that the treatment in question cannot be given to the person concerned within the time normally necessary for obtaining the treatment in question in the Member State of residence, taking account of his current state of health and the probable course of the disease. For its part, Article R. 332-2 of the Social Security Code provides that, in exceptional circumstances, sickness insurance funds may reimburse, at a flat rate, the cost of treatment given outside France where it is proved that the insured person could not receive the treatment appropriate to his condition in French territory.
38. Secondly, it must be noted that neither the order for reference nor the case-file before the national court makes it possible to determine with certainty the nature of the "reimbursement" which is at the heart of the dispute in the main proceedings and to which the second part of the question refers. In particular, it is difficult to determine whether that "reimbursement" is that provided for by Article 22(1)(c)(i) of Regulation No 1408/71, namely the provision of benefits in kind by the institution of the place of stay in accordance with the legislation which it administers, to be reimbursed subsequently by the competent institution, or whether it is a question of the claimant in the main proceedings obtaining directly from the CPAM the flat-rate reimbursement provided for in Article R. 332-2 of the Social Security Code, or one of those forms of reimbursement if the other cannot be obtained.
39. In those circumstances, it must be held that the second part of the question must be understood to be asking essentially, first, whether Article 22(2) of Regulation No 1408/71 is to be construed as precluding a sickness insurance fund from being able, in circumstances such as those of the main proceedings, to refuse to grant an insured person the prior authorisation referred to in Article 22(1)(c)(i) thereof and, secondly, whether Articles 49 EC and 50 EC must be interpreted as precluding national legislation such as Article R. 332-2 of the Social Security Code, which makes subject to a system of prior authorisation, granted on certain conditions, reimbursement of the cost of treatment such as that in issue in the main proceedings where it is provided in a Member State other than the State of residence of the insured person.
40. In order to give an answer to the second part of the question thus reformulated, it is therefore necessary to examine in turn Article 22 of Regulation No 1408/71 and the provisions of the Treaty relating to freedom to provide services. Article 22(1)(c)(i) and (2) of Regulation No 1408/71
41. First of all, it should be borne in mind that the purpose of the second subparagraph of Article 22(2) of Regulation No 1408/71 is to identify two conditions which, where they are cumulatively satisfied, mean that the competent national institution cannot refuse the authorisation sought on the basis of Article 22(1)(c)(i) thereof (Vanbraekel and Others , cited above, paragraph 31).
42. The first of those conditions is that the treatment in question be among the benefits provided for by the legislation of the Member State on whose territory the insured person resides. In that regard, it is none the less sufficient to note that there is nothing in the order for reference nor in the case-file relating to the main proceedings to show that the CPAM refused to reimburse the treatment in question on the ground that that condition had not been satisfied.
43. On the other hand, as is clear from the order for reference and from the wording of the opinion of the National Medical Officer, the second condition laid down in the second subparagraph of Article 22(2) of Regulation No 1408/71 is manifestly at issue in the context of the main proceedings, and thus it is appropriate to clarify its scope to the extent necessary for the resolution of the abovementioned dispute.
44. That second condition requires, as noted in paragraph 37 of the present judgment, that the treatment which the patient intends to undergo in a Member State other than that in which he resides cannot be given to the patient within the time normally necessary for obtaining the treatment in question in the Member State of residence taking account of his current state of health and the probable course of the disease.
45. It follows that such a condition is not satisfied whenever it is apparent that treatment which is the same or equally effective for the patient can be obtained without undue delay in the Member State of residence (see, to similar effect, Smits and Peerbooms , paragraph 103, and Müller-Fauré and Van Riet , paragraph 89).
46. In that connection, in order to determine whether treatment which is equally effective for the patient can be obtained without undue delay in the Member State of residence, the competent institution is required to have regard to all the circumstances of each specific case and to take due account not only of the patient's medical condition at the time when authorisation is sought and, where appropriate, of the degree of pain or the nature of the patient's disability which might, for example, make it impossible or extremely difficult for him to carry out a professional activity, but also of his medical history (see Smits and Peerbooms , paragraph 104, and Müller-Fauré and Van Riet , paragraph 90).
47. As follows from the case-law referred to in paragraph 32 of this judgment, it is for the national court to ascertain whether that second condition is satisfied in the case before it.
48. In that respect, it should also be made clear that the prior authorisation scheme which the Member States are called upon to implement pursuant to Article 22(1)(c)(i) and (2) of Regulation No 1408/71 must in particular be based on a procedural system which is easily accessible and capable of ensuring that a request for authorisation will be dealt with objectively and impartially within a reasonable time and refusals to grant authorisation must also be capable of being challenged in judicial or quasi-judicial proceedings (see, to similar effect, Smits and Peerbooms , paragraph 90, and Müller-Fauré and Van Riet , paragraph 85).
49. It follows in particular that refusals to grant authorisation, or the opinions on which such refusals may be based, must refer to the specific provisions on which they are based and be properly reasoned in accordance with them. Likewise, courts or tribunals hearing and determining actions against such refusals must be able, if they consider it necessary for the purpose of carrying out the review which is incumbent on them, to gather the advice of fully objective and impartial independent experts.
50. It should moreover be borne in mind that Article 22(2) of Regulation No 1408/71 is not in any way intended to limit the situations in which authorisation to receive the benefits in kind may be obtained under the conditions laid down in Article 22(1)(c)(i) thereof (see Vanbraekel and Others , paragraph 31). It follows that the Member States are free to provide for such authorisation to be granted also in situations where the two conditions laid down in the second subparagraph of Article 22(2) are not satisfied. Articles 49 EC and 50 EC
51. As to whether Article R. 332-2 of the Social Security Code is consistent with the provisions of the Treaty relating to freedom to provide services, the first point to note is that, although the Court has no jurisdiction in proceedings brought under Article 234 EC to rule on the question whether a provision of national legislation is compatible with the Treaty, it may provide the national court with all such criteria for the interpretation of Community law as may enable it to answer that question (see, among others, Case 45/75 REWE Zentrale [1976] ECR 181, paragraph 11, and Case C-228/98 Dounias [2000] ECR I-577, paragraph 36).
52. As noted in paragraph 19 of the present judgment, national provisions whose purpose is to make reimbursement by the competent institutions of the Member State of residence subject to the conditions applied by them, in respect of health treatment received in another Member State, do not fall within the scope of Article 22 of Regulation No 1408/71.
53. On the other hand, such national provisions, which, as noted in paragraph 18 of the present judgment, may in certain circumstances constitute a barrier to freedom to provide medical services, must be examined, by the national court, in the light of their consistency with Articles 49 EC and 50 EC.
54. So far as concerns Article R. 332-2 of the Social Security Code, it must be stated that, by providing, in the third paragraph, that treatment provided outside France may give rise to flat-rate reimbursement by sickness insurance funds, subject to the favourable opinion of the medical supervisory body, where the insured person shows that he was not able to receive in France the treatment appropriate to his condition, the consequence of that provision is to deter or prevent insured persons from approaching providers of medical services established in Member States other than the State of residence. It follows that such a national provision constitutes, as is apparent from the case-law referred to in paragraph 19 of this judgment, a restriction on freedom to provide services.
55. In the present case, account must however be taken of the fact that the multidisciplinary treatment of pain which the claimant in the main proceedings envisages undergoing involves her hospitalisation.
56. It should be borne in mind, in that regard, that the Court has previously acknowledged that a requirement that the assumption of costs, under a national social security system, of hospital treatment provided in a Member State other than that of affiliation must be subject to prior authorisation appears to be a measure which is both necessary and reasonable and which may be justified in the light of one of the derogations under the Treaty (see Smits and Peerbooms , paragraphs 76 to 80, and Müller-Fauré and Van Riet , paragraphs 76 to 81).
57. According to the case-law of the Court, in order for such a prior administrative authorisation scheme to be justified even though it derogates from a fundamental freedom such as that in issue in the main proceedings, it is none the less necessary that it be based on objective, non-discriminatory criteria which are known in advance, in such a way as to circumscribe the exercise of the national authorities' discretion, so that it is not used arbitrarily (see Smits and Peerbooms , paragraph 90, and Müller-Fauré and Van Riet , paragraph 85). As stated in paragraph 48 of this judgment, such a prior administrative authorisation scheme must, similarly, be based on a procedural system which is easily accessible and capable of ensuring that a request for authorisation will be dealt with objectively and impartially within a reasonable time and refusals to grant authorisation must also be capable of being challenged in judicial or quasi-judicial proceedings.
58. In the present case, Article R. 332-2 of the Social Security Code provides that the reimbursement to which that provision refers may be granted where it is proved that the person covered by social insurance could not receive in French territory the treatment appropriate to his condition.
59. A condition of that type can be justified under Article 49 EC, provided that the condition is construed to the effect that authorisation to receive treatment in another Member State may be refused on that ground only if treatment which is the same or equally effective for the patient can be obtained without undue delay within the territory of the Member State in which the insured person's sickness fund is established (see, to that effect, Smits and Peerbooms , paragraph 103, and Müller-Fauré and Van Riet , paragraph 89).
60. In view of all the foregoing considerations, the answer to the second part of the question must be that: ─ the second subparagraph of Article 22(2) of Regulation No 1408/71 must be interpreted as meaning that the authorisation to which that provision refers may not be refused where it is apparent, first, that the treatment in question is among the benefits provided for by the legislation of the Member State on whose territory the person concerned resides and, secondly, that treatment which is the same or equally effective cannot be obtained without undue delay in that Member State; ─ Articles 49 EC and 50 EC must be interpreted as not precluding legislation of a Member State, such as that at issue in the main proceedings, which, first, makes reimbursement of the cost of hospital care provided in a Member State other than that in which the insured person's sickness fund is established conditional upon prior authorisation by that fund and, secondly, makes the grant of that authorisation subject to the condition that it be established that the insured person could not receive within the territory of the Member State where the fund is established the treatment appropriate to his condition. However, authorisation may be refused on that ground only if treatment which is the same or equally effective for the patient can be obtained without undue delay in the territory of the Member State in which he resides.