ECJ Judgements concerning cross border Health Care Summaries

Transcription

1 ECJ Judgements concerning cross border Health Care Summaries By Roos van der Velde Based on: "EuGH-Urteile zur grenzüberschreitenden Inanspruchnahme von Gesundheitsdienstleistungen" by Anna Englaender

2 Table of Contents Introduction page 3 Molenaar C-160/ page 5 Decker C-120/ page 5 Raymond Kohll C-158/ page 6 Vanbraekel & others C-368/ page 7 Geraets-Smits & Peerbooms C-157/ page 8 Ioannidis C-326/ page 10 Müller-Faure & van Riet C-385/ page 11 Inizan C-56/ page 12 Leichtle C-8/ page 13 Watts C-372/ page 15 Herrera C-466/ page 17 Annex I Important Articles involved page 19 2

3 Introduction In the last years the European Court of Justice has passed some decisive judgements in cases relating to cross border health care for EU citizens. Those cases established important case law and are permanently interfering in national healthcare systems. The cases at stake are in essence dealing with the scope of Treaty articles on the free movement of goods, services and persons, the application of regulation 1408/71, and the compatibility of national regulations with those articles. The fact that the national rules fall within the sphere of social security cannot exclude the application of Articles on free movement of goods, services and persons. The Court has held that measures adopted by Member States in social security matters which may affect the marketing of medical products and indirectly influence the possibilities of importing those products are subject to the Treaty rules on the free movement of goods. Also according to settled case-law, medical services fall within the scope of the provisions on the freedom to provide services there being no need to distinguish between care provided in a hospital environment and care provided outside such an environment. Regulation 1408/71 on "the application of social security schemes to employed persons and their families moving within the Community", is of great practical meaning for cross border health care and is intended to help facilitating the free movement of patients and cross-border provision of medical services. In the Annex of this summary you can find important Treaty Articles and Articles of Regulation 1408/71 which form the basis of the court cases treated here. In the following table you first find a short summary of the main conclusion of those cases. Case/Date C-160/96 ("Molenaar") C-120/95 ("Decker") C-158/96 ("Kohll") C-368/98 ("Vanbraekel") C-157/99 ("Geraets- Smits & Peerbooms") C-326/00 ("Ioannidis") Important Conclusions An allowance such as the care allowance, which constitutes a sickness benefit in cash, can not be made subject to the condition that the insured person resides in the territory of the Member State where he is insured. Requiring prior permission for getting medical treatment abroad is in principle not admissible. It can only be justified: - If a substantial endangerment of the financial balance of the social security system is at stake - On the ground of the protection of public health, guaranteeing the quality of medical services. Requiring prior authorisation can also be justified to maintain a balanced medical and hospital service open to all, on grounds of public health protection. Right to get most advantageous refunding tariff Hospital services provided n a benefits in kind system fall within the scope of the freedom to provide services: The requirement of prior authorisation for hospital treatment abroad can be a necessary and appropriate means to enable planning in relation to waiting lists. The criteria for giving authorisation must however be non discriminatory and objective. Meaning of: 'normal in the professional circles concerned', 'medical necessity' Medical treatment of pensioners abroad: - Obligation to get permission - and condition that illness suddenly arises for reimbursement are inadmissible 3

4 C-385/99 ("Müller-Faure & van Riet") C-56/01 ("Inizan") C-8/02 ("Leichtle") C-372/04 ("Watts") C-466/04 ("Herrera") Requiring prior authorisation for treatment abroad outside a hospital is not applicable with the freedom to provide services. If hospital treatment abroad belongs to the service catalogue and if the same/equivalent treatment in time is not possible in the own country, permission can not be refused. It is inadmissibly to make reimbursement of expenditures in connection with medical treatment abroad dependent on: - increased prospects of success in that other Member State - or on awaiting the conclusion of court proceedings. The obligation of reimbursement of costs of treatment in an other member state, applies in principle also to systems where treatment is provided free of charge. Maintaining a balanced system, can however in a system with waiting lists be a justification of requiring prior authorisation for medical treatment. This prior authorisation can not be refused if treatment in the own country is not available within an acceptable time having regard to the medical circumstances. Travel costs do not fall under the category of medical services strictly defined, or under the concept of cash benefits within the meaning of Article 22(1) of Regulation 1408/71 and do not therefore need to be refunded under this Article. 4

5 Molenaar C-160/ This case concerns proceedings between Mr and Mrs Molenaar, who live in France an are of Dutch and German nationality respectively, and the Allgemeine Ortskrankenkasse Baden-Württemberg ('the AOK ), concerning the couple's right to German social care insurance benefits. - Under the German Code of Social Law (SGB), any person insured, either voluntarily or compulsorily, against sickness must contribute to the care insurance scheme. Pursuant to Paragraph 34(1)(1) of Volume XI of the SGB, insurance care benefits may be paid only to insured persons residing on German territory. Question The Sozialgericht Karlsruhe referred the following question to the Court of Justice for a preliminary ruling: 'Are Articles 6 and 48(2) of the EC Treaty to be interpreted as restricting the right of a Member State to set up a social security system covering the risk of reliance on care as part of statutory compulsory insurance arrangements under which persons residing in another Member State are liable to pay compulsory contributions, even though their entitlement to benefits is simultaneously excluded or suspended because of their place of residence? Argumentation - The care insurance benefits considered in this case must, even if they have their own characteristics, be regarded as 'sickness benefits within the meaning of Article 4(1)(a) of Regulation No 1408/71, which was designed in order to safeguard the effective exercise of the right to freedom of movement enshrined in Article 48 of the EC Treaty. - It follows from Article 19(1)(b) of Regulation No 1408/71 that a worker is to receive cash benefits such as the care allowance in the Member State in which he resides. The benefits in question are paid by the competent institution of the Member State of employment under the conditions provided for by the legislation of that State. - There is no rule of Community law which requires the competent institution to ascertain whether an employed person is likely to be able to take advantage of all the benefits of a sickness insurance scheme before registering that person and collecting the appropriate contributions. Conclusion - The answer to the question submitted must therefore be that Articles 6 and 48(2) of the EC Treaty do not preclude a Member State from requiring persons working in its territory but residing in another Member State to contribute to a social security scheme covering the risk of reliance on care, although Articles 19(1), 25(1) and 28(1) of Council Regulation (EEC) No 1408/71 do prevent entitlement to an allowance such as the care allowance, which constitutes a sickness benefit in cash, from being subject to the condition that the insured person resides in the territory of the Member State where he is insured. - A provision such as Paragraph 34(1)(1) of Volume XI of the SGB, which prohibits 'cash payment of care insurance benefits in the Member State in which the migrant worker resides, accordingly conflicts with Article 19(1)(b) of Regulation No 1408/71. Decker C-120/ This case concerns proceedings between Mr Decker, a Luxembourg national, and the Caisse de Maladie des Employés Privés (the Fund) concerning a request for reimbursement of the cost of a pair of spectacles with corrective lenses purchased from an optician established in Arlon, Belgium, on a prescription from an ophthalmologist established in Luxembourg. - Article 60 of the Luxembourg Code des Assurances Sociales (Social Insurance Code), in the version in force at the material time, provided in particular:... insured persons may obtain treatment abroad only with 5

6 the consent of their sickness fund, except in the case of initial treatment in the event of accident or illness occurring abroad. Question The Conseil Arbitral des Assurances Sociales referred the following question to the Court for a preliminary ruling: 'Is Article 60 of the Social Insurance Code, compatible with Articles 30 and 36 of the EEC Treaty in so far as it penalises in general the importation by private individuals of medicinal products or, as in this case, spectacles from other Member States? Argumentation - Rules which make reimbursement of the costs incurred in that Member State subject to prior authorisation, must be categorised as a barrier to the free movement of goods, since they encourage insured persons to purchase those products in Luxembourg rather than in other Member States, and are thus liable to curb the import of spectacles assembled in those States - Reimbursement at a flat rate of the cost of spectacles and corrective lenses purchased in other Member States has no effect on the financing or balance of the social security system. The purchase of a pair of spectacles from an optician established in another Member State provides guarantees equivalent to those afforded on the sale of a pair of spectacles by an optician established in the national territory. Consequently, rules such as those applicable in the main proceedings cannot be justified on grounds of stability of financing the social system or on grounds of public health in order to protect the quality of medical services provided in other Member States. Conclusion In those circumstances, the answer must be that Articles 30 and 36 of the Treaty preclude national rules under which a social security institution of a Member State refuses to reimburse to an insured person on a flat-rate basis the cost of a pair of spectacles with corrective lenses purchased from an optician established in another Member State, on the ground that prior authorisation is required for the purchase of any medical product abroad. Raymond Kohll C-158/ It concerns proceedings between Mr Kohll, a Luxembourg national, and the Union des Caisses de Maladie (UCM), with which he is insured, concerning a request by a doctor established in Luxembourg for authorisation for his daughter, who is a minor, to receive treatment from an orthodontist established in Trier (Germany). - It appears from Article 20(1) of the Code des Assurances Sociales, that with the exception of emergency treatment received in the event of illness or accident abroad, insured persons may be treated abroad or approach a treatment centre or centre providing ancillary facilities abroad only after obtaining the prior authorisation of the competent social security institution. Question The Cour de Cassation referred the following two questions to the Court for a preliminary ruling: 1. Are Articles 59 and 60 of the Treaty establishing the EEC to be interpreted as precluding rules under which reimbursement of the cost of benefits is subject to authorisation by the insured person's social security institution if the benefits are provided in a Member State other than the State in which that person resides? 2. Is the answer to Question 1 any different if the aim of the rules is to maintain a balanced medical and hospital service accessible to everyone in a given region? Argumentation - The national rules at issue in the main proceedings make reimbursement of the costs incurred in that Member State subject to prior authorisation, and deny such reimbursement to insured persons who have 6

7 not obtained that authorisation. Costs incurred in the State of insurance are not, however, subject to that authorisation. Such rules deter insured persons from approaching providers of medical services established in another Member State and constitute, for them and their patients, a barrier to freedom to provide services. - It is clear that reimbursement of the costs of dental treatment provided in other Member States in accordance with the tariff of the State of insurance has no significant effect on the financing of the social security system. Doctors and dentists established in other Member States must be afforded all guarantees equivalent to those accorded to doctors and dentists established on national territory, for the purposes of freedom to provide services. Consequently, rules such as those applicable in the main proceedings cannot be justified on grounds of stability of financing the social system or on grounds of public health in order to protect the quality of medical services provided in other Member States. Conclusion In those circumstances, the answer must be that Articles 59 and 60 of the Treaty preclude national rules under which reimbursement, in accordance with the scale of the State of insurance, of the cost of dental treatment provided by an orthodontist established in another Member State is subject to authorisation by the insured person's social security institution. Vanbraekel C-368/ Ms Descamps, a Belgian national residing in Belgium and insured under the ANMC sought authorisation from the ANMC to undergo orthopaedic surgery in France, to be paid for by the ANMC. - In view of the report of the designated expert, which concluded that Mrs Jeanne Descamps's recovery required hospital treatment which could be provided in better medical conditions abroad, the Cour du travail de Mons held that the ANMC would be ordered to pay the costs connected with Ms Descamps's hospital treatment 'in accordance with Article 22 of Regulation [No] 1408/71 and Articles 59 and 60 of the Treaty'. - It held that the only question still to be resolved was the amount of the costs assumed. Question The Cour du travail de Mons decided to refer the following questions to the Court for a preliminary ruling:... (a) Must the costs of hospital treatment be reimbursed in accordance with the scheme of the State of the competent institution or in accordance with that organised by the State on whose territory the hospital treatment has taken place? (b) Is a limitation of the amount reimbursed under the legislation of the State of the competent institution permitted, having regard to Article 36 of Regulation No 1408/71 which refers to reimbursement in full? Argumentation - It follows from the actual wording of paragraph Regulation 1408/71 Article 22 1(i) that the insured person must in principle be entitled to the benefits in kind provided on behalf of the competent institution by the institution of the place where the insured person is staying, in accordance with the provisions of the legislation of the State in which the benefits are provided, as if the covered person were insured in that State. - Although Article 22 of Regulation No 1408/71 does not have the effect of preventing extra reimbursement, additional to that resulting from the application of the system of the Member State where the treatment was provided, when the system applied in the Member State in which the person concerned is insured is more beneficial, that provision does not have the further effect of requiring such additional reimbursement. Consequently, it is necessary to consider whether such an obligation might arise under Article 59 of the Treaty. - In the present case, there is no doubt that the fact that a person has a lower level of cover when he receives hospital treatment in another Member State than when he undergoes the same treatment in the Member State in which he is insured may deter, or even prevent, that person from applying to providers of medical 7

8 services established in other Member States and constitutes, both for insured persons and for service providers, a barrier to freedom to provide services. - It follows from the actual wording of Article 36 of Regulation No 1408/71 that the full refund between institutions to which that provision refers concerns only benefits in kind provided by the institution of a Member State of stay on behalf of the competent institution Conclusion - It follows from Article 22(1)(c) and (i) of Council Regulation (EEC) No 1408/71, that concerning the reimbursement of medical costs the legislation of the Member State in which the treatment is given is to be applied, while the competent institution remains responsible for subsequently reimbursing the institution of the place of stay. - It follows from Article 59 of the EC treaty that if the reimbursement of costs incurred on hospital services provided in a Member State of stay, calculated under the rules in force in that State, is less than the amount which application of the legislation in force in the Member State of registration would afford to a person receiving hospital treatment in that State, additional reimbursement covering that difference must be granted to the insured person by the competent institution. - The answer to be given to the second part of the question referred to the Court must be that Article 36 of Regulation No 1408/71 cannot be interpreted as meaning that it follows from that provision that a covered person is entitled to reimbursement of all the medical costs which he incurred in the Member State in which he received treatment. Geraets-Smits & Peerbooms C-157/ Proceedings between Mrs Geraets-Smits, a Dutch national, and Stichting Ziekenfonds VGZ ('Stichting VGZ') and between Mr Peerbooms, a Dutch national, and Stichting CZ Groep Zorgverzekeringen ('Stichting CZ') concerning the reimbursement of hospital treatment costs incurred in Germany and Austria respectively. Questions The Arrondissementsrechtbank te Roermond decided to refer the following questions to the Court for a preliminary ruling: 1. (a) Must Articles 59 and 60 of the EC Treaty be interpreted as meaning that a provision such as Article 9(4) of the ZFW in conjunction with Article 1 of the Rhbz is inconsistent with those Treaty provisions where the national rules cited provide that a person insured under the sickness insurance fund requires prior authorisation from the sickness insurance fund in order to claim his entitlement to benefits from a person or establishment outside the Netherlands? (b) What is the answer to Question 1(a) where the authorisation referred to therein is refused or does not apply, because the relevant treatment in the other Member State is not regarded as normal in professional circles and thus is deemed not to constitute a benefit within the meaning of Article 8 of the ZFW? Does it make any difference in that connection whether regard is had solely to the conceptions of Netherlands professional circles and whether national or international scientific yardsticks are applied and, if so, in what respect? Is it also relevant whether the relevant treatment is reimbursed under the social security system provided for under the law of that other Member State? (c) What is the answer to Question 1(a) where the treatment abroad is deemed to be normal and therefore to constitute a benefit but the requisite authorisation is refused on the ground that timely and adequate care can be obtained from a contracted Netherlands care provider and treatment abroad is therefore not necessary for the health care of the person concerned? 2. If the requirement to obtain authorisation constitutes a barrier to the freedom to provide services enshrined in Articles 59 and 60 of the EC Treaty, are the overriding reasons in the general interest relied on by the defendants... sufficient in order for the barrier to be regarded as justified?' Argumentation 8

9 It is settled case-law that medical activities fall within the scope of Article 60 of the Treaty irrespective of whether they are provided in or outside a hospital environment. Also hospital services provided in the context of a sickness insurance scheme providing benefits in kind are classified as services within the meaning of Article 60 of the Treaty (now Article 50) as this Article does not require that the service be paid for by those for whom it is performed. It constitutes a restriction on freedom to provide services where the costs of treatment provided in a hospital in another Member State is assumed under the sickness insurance scheme only on condition that the person receiving the treatment obtains prior authorisation. The Court has held out that such a barrier to the principle of freedom to provide services may be justified by the following overriding reason in the general interest: possible risk of seriously undermining a social security system's financial balance maintaining a balanced medical and hospital service open to all, in so far as it contributes to the attainment of a high level of health protection. Article 56 of the Treaty permits Member States to restrict the freedom to provide medical and hospital services in so far as the maintenance of treatment capacity or medical competence on national territory is essential for the public health, and even the survival of, the population. The Court accepts that medical services provided in a hospital take place within an infrastructure with certain very distinct characteristics. The number of hospitals, their geographical distribution, the mode of their organisation and the equipment with which they are provided, and even the nature of the medical services which they are able to offer, are all matters for which planning must be possible. Planning seeks to achieve the aim of ensuring that there is sufficient and permanent access to a balanced range of highquality hospital treatment in the State concerned. It also assists in meeting a desire to control costs and to prevent any wastage of financial, technical and human resources. Therefore a requirement that the assumption of costs of hospital treatment provided in another Member State must be subject to prior authorisation appears to be a measure which is both necessary and reasonable. The conditions attached to the grant of such authorisation must none the less be justified with regard to the overriding considerations examined and must satisfy the requirement of proportionality. Such a prior administrative authorisation scheme must likewise be based on a procedural system which is easily accessible and capable of ensuring that a request for authorisation will be dealt with objectively and impartially within a reasonable time and refusals to grant authorisation must also be capable of being challenged in judicial or quasi-judicial proceedings. If the grant of authorisation is subjected to the condition that the proposed medical or surgical treatment can be regarded as 'normal in the professional circles concerned', this condition must be interpreted in such a way that the treatment is sufficiently tried and tested by international medical science. Furthermore, in order to determine whether medical service provided abroad is required or whether equally effective treatment can be obtained without undue delay from an establishment having contractual arrangements with the insured person's fund, the national authorities are required to have regard to all the circumstances of each specific case. They have to take due account not only of the patient's medical condition at the time when authorisation is sought but also of his past record. Judgement - Article 59 of the EC Treaty (now, after amendment, Article 49 EC) and Article 60 of the EC Treaty (now Article 50 EC) do not preclude legislation of a Member State, such as that at issue in the main proceedings, which makes the assumption of the costs of treatment provided in a hospital located in another Member State subject to prior authorisation from the insured person's sickness insurance fund and the grant of such authorisation subject to the condition that (i) the treatment must be regarded as 'normal in the professional circles concerned', a criterion also applied in determining whether hospital treatment provided on national territory is covered, and (ii) the insured person's medical treatment must require that treatment. However, that applies only in so far as - the requirement that the treatment must be regarded as 'normal' is construed to the effect that authorisation cannot be refused on that ground where it appears that the treatment concerned is sufficiently tried and tested by international medical science, and 9

10 - authorisation can be refused on the ground of lack of medical necessity only if the same or equally effective treatment can be obtained without undue delay at an establishment having a contractual arrangement with the insured person's sickness insurance fund. Ioannidis C-326/ Proceedings between Mr Ioannidis and Idryma Koinonikon Asfaliseon (Greek Social Insurance Institute, the IKA) concerning the IKA's refusal to fund hospital treatment for Mr Ioannidis during a stay in Germany. - Decree No 33651/E of the Minister of Labour of 2 June 1956 laying down the IKA Hospital Care Regulations (FEK B' 126/ ), includes an Article 3a, in which it is provided that bearing the cost of hospital treatment, under defined circumstances, received abroad is subject to a prior authorisation system. As an exception, Article 3a(4)(g) of the IKA Regulations provides, however: In very exceptional cases, the director of the competent regional branch may, authorise hospital treatment which has already taken place abroad, provided that prior authorisation was not feasible. Questions - By its first question, the national court is asking, essentially, whether Articles 31 and 36 of Regulation No 1408/71 and Articles 31 and 93 of Regulation No 574/72 preclude national legislation under which reimbursement by the institution of a pensioner's place of residence of hospital treatment received by him during a stay in another Member State is subject to ex post facto authorisation which is granted only in so far as the prior authorisation normally required by that national legislation was impossible to obtain because the illness in question manifested itself suddenly during that stay, making the provision of treatment immediately necessary. - The second, third, fourth and fifth questions referred are treating the application of article 60 EC, article 56 EC and article 1 of the protocol. They have to be answered only in case the answer to the thirst question is denying. Argumentation - Article 31 of regulation 1408/71, lays down a similar entitlement adopted to pensioners, like Article 22(1)(a) of that regulation, which confers an entitlement to benefits in kind on employed or self-employed persons whose condition necessitates immediate benefits during a stay in the territory of another Member State. The system established by Article 31 of Regulation No 1408/71 must nevertheless, be distinguished from that laid down by Article 22(1)(a) of that regulation. - In particular, Article 31 of Regulation No 1408/71 cannot be interpreted as meaning that the enjoyment of the benefits in kind it guarantees is reserved solely to pensioners whose condition requires immediate benefits during a stay in another Member State. Nor can that provision be interpreted as meaning that those benefits are limited solely to cases where the treatment provided has become necessary because of a sudden illness. - Moreover, it should be noted that, unlike for example Article 22(1)(c) of Regulation No 1408/71, Article 31 of that regulation does not provide for a system of authorisation with respect to the provision of the benefits in kind which it guarantees to pensioners and members of their families staying in a Member State other than the State in which they reside. - It follows from all the foregoing that it is not permissible for a Member State to make provision of the benefits in kind guaranteed by Article 31 of Regulation No 1408/71 to pensioners staying in a Member State other than the State in which they reside subject either to any authorisation procedure whatever or to the requirement that the illness which necessitated the treatment in question manifested itself suddenly during that stay, making that treatment immediately necessary. - Article 36 of Regulation No 1408/71 and Articles 31 and 93 of Regulation No 574/72 are relating to the application of Article 31 of Regulation No 1408/71, and should make sure that the rights conferred on pensioners and members of their families by Article 31 of Regulation No 1408/71 with a view to 10

11 facilitating the freedom of movement of those insured persons are fully respected. They are not in any way lessening the working of article 31 of regulation 1408/71. Conclusion - Article 31 of Regulation No 1408/71 must be interpreted as meaning that enjoyment of the benefits in kind guaranteed by that provision to pensioners staying in a Member State other than their State of residence is not subject to the condition that the illness which necessitated the treatment in question manifested itself suddenly during such a stay, making that treatment immediately necessary. That provision therefore precludes a Member State from subjecting that enjoyment to such a condition. - Article 31 of Regulation No 1408/71 precludes a Member State from subjecting the enjoyment of the benefits in kind guaranteed by that provision to any authorisation procedure. Müller-Faure & van Riet C-385/ Proceedings between Ms Müller-Fauré and Onderlinge Waarborgmaatschappij OZ Zorgverzekeringen UA (mutual sickness insurance fund; the Zwijndrecht Fund), established in Zwijndrecht (Netherlands), and between Ms Van Riet and Onderlinge Waarborgmaatschappij ZAO Zorgverzekeringen (the Amsterdam Fund), established in Amsterdam (Netherlands), concerning the reimbursement of medical costs incurred in Germany and Belgium respectively. Questions The Centrale Raad van Beroep decided to refer the following questions to the Court for a preliminary ruling: 1. Are Articles 59 and 60 of the EC Treaty... to be interpreted as meaning that in principle a provision such as Article 9(4) of the Ziekenfondswet, read in conjunction with Article 1 of the Regeling hulp in het buitenland ziekenfondsverzekerig, is incompatible therewith in so far as it stipulates that in order to assert his entitlement to benefits a person insured with a sickness insurance fund requires the prior authorisation of that fund to seek treatment from a person or establishment outside the Netherlands with whom or which the sickness insurance fund has not concluded an agreement? 2. If so, do the objectives of the Netherlands system of benefits in kind referred to above constitute an overriding reason in the general interest capable of justifying a restriction on the fundamental principle of freedom to provide services? 3. Does the question whether the treatment as a whole or only a proportion thereof involved hospital care affect the answers to these questions? Argumentation - The Court approved its case law, particularly in the Geraets-Smits and Peerbooms case. - Regarding the question whether a restriction on the freedom to provide services by the requirement of a prior authorisation for the purchase of hospital treatment abroad, the Court took a closer look on the meaning of the term undue delay : - In order to determine whether hospital treatment which is equally effective for the patient can be obtained without undue delay in an establishment having an agreement with the insured person's fund, the national authorities are required to have regard to all the circumstances of each specific case. They have 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. - However, a refusal to grant prior authorisation which is based solely on the ground that there are waiting lists on national territory for the hospital treatment concerned, without account being taken of the specific 11

12 circumstances attaching to the patient's medical condition, cannot amount to a properly justified restriction on freedom to provide services. It is not clear from the arguments submitted to the Court that such waiting times are necessary, apart from considerations of a purely economic nature which cannot as such justify a restriction on the fundamental principle of freedom to provide services, for the purpose of safeguarding the protection of public health. On the contrary, a waiting time which is too long or abnormal would be more likely to restrict access to balanced, high-quality hospital care. - The removal of the requirement for sickness insurance funds to grant prior authorisation for non-hospital health care provided in another Member State does not call in question the essential characteristics (benefits in kind system) of the system of access to health care in the Netherlands: - First, when applying Regulation No 1408/71, those Member States which have established a system providing benefits in kind, or even a national health service, must provide mechanisms for ex post facto reimbursement in respect of care provided in a Member State other than the competent State. - Second, insured persons who go without prior authorisation to a Member State other than the one in which their sickness fund is established to receive treatment there can claim reimbursement of the cost of the treatment received only within the limits of the cover provided by the sickness insurance scheme of the Member State of affiliation. - Third, nothing precludes a competent Member State with a benefits in kind system from fixing the amounts of reimbursement which patients who have received care in another Member State can claim, provided that those amounts are based on objective, non-discriminatory and transparent criteria. Judgement - Article 59 of the EC Treaty (now, after amendment, Article 49 EC) and Article 60 of the EC Treaty (now Article 50 EC) must be interpreted as not precluding legislation of a Member State, such as that at issue in the main proceedings, which (i) makes the assumption of the costs of hospital care provided in a Member State other than that in which the insured person's sickness fund is established, by a provider with which that fund has not concluded an agreement, conditional upon prior authorisation by the fund and (ii) makes the grant of that authorisation subject to the condition that such action is necessary for the insured person's health care. 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 an establishment which has concluded an agreement with the fund; - by contrast, Articles 59 and 60 of the Treaty do preclude the same legislation in so far as it makes the assumption of the costs of non-hospital care provided in another Member State by a person or establishment with whom or which the insured person's sickness fund has not concluded an agreement conditional upon prior authorisation by the fund, even when the national legislation concerned sets up a system of benefits in kind under which insured persons are entitled not to reimbursement of costs incurred for medical treatment, but to the treatment itself which is provided free of charge. Inizan C-56/ This case concerns proceedings between Ms Inizan resident in France 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. - Article R of the French Social Security Code makes reimbursement of the cost of treatment, where it is provided in a Member State other than the State of residence of the insured person, subject to a system of prior authorisation, granted on certain conditions. Question The Tribunal des affaires de sécurité sociale de Nanterre decided to refer the following question to the Court for a preliminary ruling: 1) Is Article 22 of Regulation (EEC) No 1408/71 compatible with Articles 49 EC and 50 EC and 2) Consequently, is the CPAM of the Hauts de Seine entitled to refuse Ms Inizan 12

13 reimbursement of the costs of hospital treatment in Germany, following an adverse opinion from the National Medical Officer? Argumentation and Conclusions - Article 22 of Regulation No 1408/71 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. It helps to facilitate the free movement of patients and cross-border provision of medical services. 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. - 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 of the Social Security Code. - 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. It is for the national court to ascertain whether that second condition is satisfied in the case before it. - So far as concerns Article R 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, a restriction on freedom to provide services. - In the present case, account must however be taken of the fact that the treatment which the claimant in the main proceedings envisages undergoing involves her hospitalisation. 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. - Articles 49 EC and 50 EC must also be interpreted as not precluding legislation of a Member State, such as that at issue in the main proceedings. 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. Leichtle C-8/ It are proceedings between Mr Leichtle, an official of the Bundesanstalt für Arbeit (Federal Labour Office; the Bundesanstalt ), and the Bundesanstalt concerning the latter s refusal to reimburse expenditure to be incurred in connection with a health cure which Mr Leichtle proposed to take in Italy. - Under section 13 of the Allgemeine Verwaltungsvorschrift für Beihilfen in Krankheits-, Pflege-, Geburtsund Todesfällen (BhV) the reimbursement of expenditure incurred on board, lodging, travel, visitors tax and the making of a final medical report in connection with a health cure taken in another Member State is conditional, first, on the obtaining of prior recognition of eligibility, which is given only provided that it is established, in a report drawn up by a medical officer or a medical consultant, that the proposed cure is 13

14 absolutely necessary because of the greatly increased prospects of success in that other Member State, and, secondly, on the spa concerned being listed in the Register of Health Spas. First question, argumentation and conclusion - Expenditure in connection with board and lodging can be regarded as forming an integral part of the health cure itself. The medical report drawn up at the end of the cure falls squarely within the scope of medical activity, too. Although travel costs and any visitors tax are not medical in character, and are not as a rule paid to health care providers, they none the less appear to be inextricably linked to the cure itself, since, as previously stated, the patient is required to travel to and stay at the spa. - By its first question, the national court is asking, in essence, whether Articles 49 EC and 50 EC are to be interpreted as meaning that they preclude rules of a Member State, such as those under section 13 of the BhV. - The first condition discussed above, that it is established that the proposed cure is absolutely necessary because of the greatly increased prospects of success in that other Member State, applies only to expenditure occasioned in respect of a health cure taken in a Member State other than Germany. Such a condition, which, by its very nature, has the effect of deterring officials covered by the BhV from approaching health cure centres established in other Member States, cannot be accepted unless the barrier to freedom to provide services resulting therefore is justifiable in the light of the Treaty. - As regards the justification based on the need to avoid a risk of serious harm to the financial equilibrium of the social security system, no clear argument has been put before the Court in support of the assertion that Paragraph 13(3)(1) of the BhV is necessary for such purposes. Moreover, it should be borne in mind that it is for the Member States alone to determine the extent of the sickness cover available to insured persons. A limitation of this extent, which, as the Commission submitted, can be justified by the consideration that the costs to be borne by the State must be limited to what is necessary for medical purposes, if it is based on an objective, non-discriminatory and transparent criterion. - Articles 49 EC and 50 EC are also to be interpreted as meaning that they preclude rules of a Member State, such as those at issue in the main proceedings, under which reimbursement of expenditure incurred on board, lodging, travel, visitors tax and the making of a final medical report in connection with a health cure taken in another Member State is conditional on obtaining prior recognition of eligibility, which is given only where it is established that the proposed cure is absolutely necessary owing to the greatly increased prospects of success in that other Member State. - As regards, the second condition discussed above, that the health spa concerned must be listed in the Register of Health Spas, it must be observed that such a requirement which is probably intended to ensure that the spas concerned are in a position to provide the treatment deemed necessary, is also laid down as regards reimbursement of expenditure incurred in respect of health cures taken in Germany. It follows that such a requirement does not appear, a priori and in principle, to be such as to have the effect of making the provision of services between Member States more difficult than the provision of services purely within one Member State. - It is, however, for the national court to determine, particularly in the light of the conditions to which the registration of health spas in such a Register of Health Spas may be subject, whether that registration requirement is or is not such as to making the provision of services between Member States more difficult than the provision of services purely within one Member State, and to satisfy itself that those conditions are objective. - It depends on the judgement of these abovementioned criteria, whether the condition that the health spa concerned must be listed in the Register of Health Spas is applicable with articles 49 EC and 50 EC. Second question, argumentation & conclusion - By its second question, the national court is asking whether Articles 49 EC and 50 EC are to be interpreted as meaning that they preclude the application of national rules under which reimbursement of expenditure incurred on board, lodging, travel, visitors tax and the making of a final medical report in connection with a health cure taken in another Member State is precluded where the person concerned has not awaited the conclusion of the procedure for obtaining prior recognition of eligibility for assistance provided for in those rules or of any subsequent court proceedings before commencing the cure in question. 14

15 - In the absence of acceptance that the judicial finding of infringement of Articles 49 EC and 50 EC by the contested decision of the Bundesanstalt may retroactively justify the assumption of responsibility for the expenditure in question, the practical effect of those Community provisions would be jeopardised, since in most cases patients cannot await the result of court proceedings before receiving the treatment which their state of health requires - The answer to the second question must therefore be that Articles 49 EC and 50 EC are to be interpreted as meaning that they preclude the application of national rules under which the reimbursement of the concerned expenditure in connection with a health cure taken in another Member State is precluded where the person concerned has not awaited the conclusion of the court proceedings brought against the decision refusing to recognise that expenditure as eligible for assistance before commencing the cure in question. Watts C-372/ It concern proceedings arising from the refusal of Bedford Primary Care Trust ( Bedford PCT ) to reimburse the cost of hospital treatment received in France by Mrs Watts, who resides in the United Kingdom and suffered from arthritis of the hips. The Bedford PCT refused to issue Mrs Watts with an E 112 form. Nevertheless Mrs Watts underwent a hip replacement operation in France for which she paid 3,900 and claimed reimbursement. The application was dismissed on the ground that Mrs Watts had not had to face undue delay. - The National Health Service Act 1977 ( the NHS Act ) states that the Secretary of State for Health is required to provide a National Health Service in England and Wales. Hospital care is provided free of charge by the relevant NHS bodies to all persons ordinarily resident in the United Kingdom, on a nonprofit-making basis. - As the budget allocated by the government to the NHS is not sufficient to allow for the swift provision of treatment to all patients, regardless of urgency, the NHS makes use of the available resources by setting priorities, which results in some quite lengthy waiting lists for less urgent treatment. Questions - By its questions, the referring court seeks clarification of the scope both of the EC Treaty provisions on the freedom to provide services and of Article 22 of Regulation No 1408/71. - The fifth question has been treated first. By this question, the referring court asks essentially whether the criteria for the interpretation of the phrase within the time normally necessary for obtaining the treatment in question in the second subparagraph of Article 22(2) of Regulation No 1408/71 are the same as those used to define the term without undue delay in the context of Article 49 EC. And whether, in interpreting the time referred to in the second subparagraph of Article 22(2) of Regulation No 1408/71, it is necessary or permissible to take account of the factors set out in the fourth question, namely the existence of waiting times, the clinical priorities defined by the competent NHS body, the management of the supply of hospital care in accordance with priorities intended to give best effect to finite resources, the fact that treatment under the NHS is provided free of charge and the individual medical condition of the patient and the history and probable course of his illness. - By the first four questions, which it is convenient to consider together, the referring court asks essentially whether and in what circumstances an NHS patient is entitled under Article 49 EC to receive hospital treatment in another Member State at the expense of that national service. - The sixth question concerns the amount of the amount of the costs to be reimbursed. Argumentation - The second subparagraph of Article 22(2) of Regulation No 1408/71 lays down two conditions which, if both satisfied, render mandatory grant by the competent institution, of the prior authorisation for medical treatment abroad, to which that provision refers. - The first condition is that the treatment in question must be among the benefits provided for by the legislation of the Member State on whose territory the person resides. 15

16 - The second condition is satisfied only where the treatment which the patient plans to undergo in a Member State other than that in the territory of which he resides cannot be given 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 his disease. - The Court finds that it cannot be denied that the national authorities responsible for managing the supply of hospital treatment are entitled to institute a system of waiting lists in order to manage the supply of that treatment and to set priorities on the basis of the available resources and capacities. - In order to be entitled to refuse to grant authorisation on the ground of waiting time, the competent institution must establish that the waiting time, arising from objectives relating to the planning and management of the supply of hospital care, does not exceed the period which is acceptable in the light of an objective medical assessment of the clinical needs of the person concerned in the light of his medical condition and the history and probable course of his illness, the degree of pain he is in and/or the nature of his disability at the time when the authorisation is sought. - Furthermore, the setting of waiting times should be done flexibly and dynamically, so that the period initially notified to the person concerned may be reconsidered in the light of any deterioration in his state of health occurring after the first request for authorisation. - It is for the referring court to determine whether the waiting time invoked by the competent body of the NHS, in order to refuse the initial application for authorisation and the renewed request exceeded a medically acceptable period. - Article 49 EC applies where a patient such as Mrs Watts receives medical services in a hospital environment for consideration in a Member State other than her State of residence, regardless of the way in which the national system with which that person is registered and from which reimbursement of the cost of those services is subsequently sought operates. - Concerning the first four questions it must be stated that, according to well-established case-law, Article 49 EC precludes the application of any national rules, such as the rule that prior authorisation is needed for foreign treatment, which have the effect of making the provision of services between Member States more difficult than the provision of services purely within a Member State. Exceptions can be made when the balance of the national health care financing is at risk. Reasonable measures can than be taken to diminish this risk. - The regulations on the NHS do not set out the criteria for the grant or refusal of the prior authorisation necessary for reimbursement of the cost of hospital treatment provided in another Member State, and therefore do not circumscribe the exercise of the national competent authorities discretionary power in that context. The lack of a legal framework in that regard also makes it difficult to exercise judicial review of decisions refusing to grant authorisation. - A refusal to grant prior authorisation cannot be based merely on the existence of waiting lists. Refusals to grant authorisation, or the advice 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. - Where the cost charged in the State of treatment is higher than the cost of comparable treatment in the Member State of residence, the competent institution is only required to cover the difference between the cost of the hospital treatment in the two Member States up to the cost of the same treatment in the State of residence. - As regards the travel and accommodation costs, since the obligation on the competent institution exclusively concerns the expenditure connected with the healthcare received by the patient in the Member State of treatment, they are reimbursed only to the extent that the legislation of the Member State of residence imposes a corresponding duty on its national system where the treatment is provided in a local hospital covered by that system. Conclusion - The requirement that the assumption of costs by the national system of hospital treatment provided in another Member State be subject to prior authorisation appears in this case to be a measure which is both necessary and reasonable. - However, where the delay arising from such waiting lists appears to exceed an acceptable time having regard to an objective medical assessment of the abovementioned circumstances, the competent institution may not refuse the authorisation sought on the grounds of the existence of waiting lists, an alleged distortion of the normal order of priorities linked to the relative urgency of 16

17 the cases to be treated, the fact that the hospital treatment provided under the national system in question is free of charge, the obligation to make available specific funds to reimburse the cost of treatment to be provided in another Member State and/or a comparison between the cost of that treatment and that of equivalent treatment in the competent Member State. - It follows from Article 22(1)(c)(i) of Regulation No 1408/71, that where the legislation of the competent Member State provides that hospital treatment provided under the national health service is to be free of charge, and where the legislation of the Member State in which a patient registered with that service was or should have been authorised to receive hospital treatment at the expense of that service does not provide for the reimbursement in full of the cost of that treatment, the competent institution must reimburse that patient the difference (if any) between the cost, objectively quantified, of equivalent treatment in a hospital covered by the service in question up to the total amount invoiced for the treatment provided in the host Member State and the amount which the institution of the latter Member State is required to reimburse under on behalf of the competent institution pursuant to the legislation of that Member State. Herrera C-466/ It concerns proceedings stemming from the refusal of the Servicio Cántabro de Salud (the public health service of the Autonomous Community of Cantabria, the CHS ) to pay the travel, accommodation and subsistence costs incurred by Mr Acereda Herrera, a Spanish resident, for hospital treatment received in France, and the costs incurred by a member of his family who accompanied him. - Under Article 5(3) of the Spanish Royal Decree No 63/1995, meeting the costs of expenses linked to medical treatment administered outside the framework of the national health service was only possible in cases where immediate, urgent, life-saving treatment was provided outside the national health service and in so far as it could be proven that it was not possible to use the services of that system in sufficient time and this exception had not been used inappropriately or abusively. Questions The Tribunal Superior de Justicia de Cantabria decided to refer the following questions to the Court for a preliminary ruling: 1. Must Article 22(1)(c) and (2) and Article 36 of Regulation [No 1408/71] be interpreted as meaning that the authorisation, granted by the competent institution, to go to the territory of another Member State to receive there the appropriate medical treatment also confers the right to be reimbursed, for the costs of travel to, and accommodation and/or subsistence on, the territory of the Member State in question? 2. In the event that the reply to the first question is in the affirmative: is there a provision or rule of Community law in accordance with which the costs to be refunded, and their amount, must be set? 3. By its third question, the national court seeks in essence to ascertain whether Community law, in particular Articles 10 EC and 249 EC and Article 22 of Regulation No 1408/71, precludes national legislation under which provision is made for entitlement to benefits additional to those provided for in Article 22 of Regulation No 1408/71 in the situation covered by paragraph (1)(a) of that article, but not in that covered by paragraph (1)(c) thereof. 4. By its fourth question, the national court essentially seeks to establish whether Articles 12 EC, 49 EC, 81 EC, 82 EC and 87 EC preclude Article 5(3) of the Royal Decree No 63/1995 under which an insured person who has a medical condition for which the national health service cannot provide the necessary treatment within a reasonable period cannot claim direct payment of the costs associated with the medical treatment received from professionals established in Spain but not included in that service, notwithstanding that the Spanish authorities are obliged to authorise the insured person to go to another Member State for the purpose of receiving treatment there at their expense under the conditions laid down in Article 22 of Regulation No 1408/71. 17

18 Argumentation - The sole purpose of Article 22(1)(c)(i) of Regulation 1408/71 is to confer on the insured person granted authorisation by the competent institution the right to have access to treatment in another Member State on conditions for reimbursement as favourable as those enjoyed by patients covered by the legislation of that other State. The obligation imposed on the competent institution by this Article therefore relates exclusively to the expenditure connected with the healthcare received by the insured person in the host Member State, the cost of medical services strictly defined and the inextricably linked costs relating to the stay and meals in the hospital - The concept of cash benefits within the meaning of Article 22(1)(c)(ii) of Regulation No 1408/71 refers to benefits of a periodic nature which procure for persons suffering from illness an income substitute or financial support serving to maintain the overall standard of living of the sick person and of members of his family. By contrast, that concept does not refer to the reimbursement of expenditure already incurred, such as the ancillary costs in issue in the main proceedings. - As is apparent from the title of the section under which it is found, Article 36 of Regulation No 1408/71, for its part, is exclusively concerned with the issue of reimbursements between institutions. As the Cypriot Government pointed out in its written observations, it does not confer any entitlement on persons insured. - Concerning the third question it should be noted that the additional benefits at issue are not covered by Article 22. In those circumstances, legislation such as that at issue in the main proceedings cannot be regarded as limiting the entitlement to benefits in kind and cash benefits conferred by Article 22(1)(c) of Regulation No 1408/71 - The fourth question bears no relation to the subject-matter of the main proceedings, which addresses the question whether travel, accommodation and subsistence costs incurred by insured persons and the persons accompanying them to other Member States in order there to receive hospital treatment, with the authorisation of the competent institution, are reimbursable or not. Conclusion - The answer to the first question must be that Article 22(1)(c) and (2) and Article 36 of Regulation No 1408/71 must be interpreted as meaning that authorisation by the competent institution for an insured person to go to another Member State in order there to receive hospital treatment appropriate to his medical condition does not confer on such a person the right to be reimbursed by the competent institution for the costs of travel, accommodation and subsistence which that person and any person accompanying him incurred in the territory of that latter Member State, with the exception of the costs of accommodation and meals in hospital for the insured person himself. - In the light of that answer, there is no need to answer the second question. - The answer to the third question must be that national legislation in which provision is made for entitlement to benefits additional to those provided for in Article 22(1) of Regulation No 1408/71 in the situation covered by paragraph (1)(a) of that article, but not in that covered by paragraph (1)(c) thereof, does not obstruct the direct effect of that provision or infringe the principle of cooperation in good faith stemming from Article 10 EC. - There is no need to reply to the fourth question. 18

19 Annex I Important Articles involved Article 30 EC The provisions of Articles 28 and 29 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. Article 49 EC Within the framework of the provisions set out below, restrictions on freedom to provide services within the Community shall be prohibited in respect of nationals of Member States who are established in a State of the Community other than that of the person for whom the services are intended. The Council may, acting by a qualified majority on a proposal from the Commission, extend the provisions of the Chapter to nationals of a third country who provide services and who are established within the Community. Article 50 EC Services shall be considered to be services within the meaning of this Treaty where they are normally provided for remuneration, in so far as they are not governed by the provisions relating to freedom of movement for goods, capital and persons. Services shall in particular include: (a) activities of an industrial character; (b) activities of a commercial character; (c) activities of craftsmen; (d) activities of the professions. Without prejudice to the provisions of the Chapter relating to the right of establishment, the person providing a service may, in order to do so, temporarily pursue his activity in the State where the service is provided, under the same conditions as are imposed by that State on its own nationals. Article 46 EC 1. The provisions of this Chapter and measures taken in pursuance thereof shall not prejudice the applicability of provisions laid down by law, regulation or administrative action providing for special treatment for foreign nationals on grounds of public policy, public security or public health. 2. The Council shall, acting in accordance with the procedure referred to in Article 251, issue directives for the coordination of the abovementioned provisions. Article 22 of Regulation No 1408/71 provides in particular: '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; (ii) to cash benefits provided by the competent institution in accordance with the provisions of the legislation which it administers. However, by agreement between the competent institution and the institution of the place of stay or residence, such benefits may be provided by the latter institution on behalf of the former, in accordance with the provisions of the legislation of the competent State. 19

20 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. 3. The provisions of paragraphs 1 and 2 shall apply by analogy to members of the family of an employed or self-employed person... 20