C-496/01

OPINION OF MR MISCHO — CASE C-496/01

OPINION OF ADVOCATE GENERAL MISCHO delivered on 26 June 2003 1

1. In the present case, the Commission only exercise their activities under the seeks a declaration that the French Republic responsibility of their directors or deputy has failed to fulfil its obligations under directors. Articles 43 EC and 49 EC by requiring bio- medical analysis laboratories established in other Member States to have their place of business on French territory as a condition for obtaining the requisite operating authorisation and by precluding any reim- 3. Under Article L. 6221-1, laboratory bursement of the cost of bio-medical directors and deputy directors must hold a analyses carried out by bio-medical analysis State diploma for the profession of medical laboratories established in another Member doctor, pharmacist or veterinary surgeon, State. be on the roll of the relevant professional association and have received specialised training which may be evidenced by cer- tificates in specialised studies, exemptions or equivalent qualifications or diplomas in specialised bio-medical studies. Foreigners may also be authorised to fulfil the position I — French law of director following a specific procedure referred to in Articles L. 4221-1 and L. 4221-2 of the Code de la santé publique.

A — National public health rules

4. Under Article L. 6211-2 of the Code de 2. Article L. 6211-1 of the Code de la santé la santé publique: publique provides that bio-medical analyses are biological examinations which assist in the diagnosis, treatment or prevention of human diseases or which reveal any other physiological change. Laboratories may 'No bio-medical analysis laboratory may operate without administrative authorisa- 1 — Original language: French. tion.

5. The procedure for obtaining such authorisation is laid down in Articles 15 a list of the directors, deputy directors and to 17 of Decree No 76-1004 of 4 November technicians, including their qualifications and diplomas; 1976 2 layingdown the requirements for authorisation of bio-medical analysis laboratories.

2 — JORF of 6 November 1976, p. 6449. where appropriate, the company statutes.

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When the operator is not owner of the 11. The GBEA consists of a series of equipment or the premises, he shall state the technical rules which define all the stages grounds on which he has the right to use of the relevant procedure, from the taking thereof... .' of samples to the return of validated results.

7. Where the requisite conditions are satis- fied, the operating authorisation is granted to the applicant as of right. Moreover, provision is made for an on-the-spot inspection by a public health inspector 12. The GBEA is in the nature of a who is a doctor or pharmacist. regulation and, consequently, is binding on laboratories. It is therefore applicable to biologists. Failure to comply with its provi- sions may thus lead to withdrawal of operating authorisation.

15. Inspections are carried out by public anomalies as regards their medical use, the health inspectors who are doctors or case of that laboratory shall be submitted pharmacists and by the General Inspecto- anonymously to the Commission du con- rate of Social Affairs (Article L. 6213-1 of trôle de qualité (Quality Assurance Com- the Code de la santé publique). mission), which shall make a determination on the seriousness of those anomalies. Where they are deemed to be serious, the laboratory shall be reported by the Direc- tor-General of the Agence du médicament (Medicinal Products Agency) to the Minis- ter responsible for health, to whom the 16. Those inspections are essentially aimed Director-General shall communicate the at monitoring compliance with the operat- results for the purposes of a control ing conditions for laboratories: premises, pursuant to Article L. 761-13 [now Article equipment, the number of directors and L. 6213-1] of the Code de la santé publique deputy directors, the qualifications and designed, in particular, to ascertain the number of technicians, the organisation of measures taken by the laboratory to the laboratory, the conduct of the analyses improve the quality of its analyses.' and quality assurance; and, generally, compliance with all the provisions laid down by law and regulation, in particular the GBEA.

18. As regards quality control of analyses, Article L. 6213-3 of the Code de la santé publique provides that such controls are to 17. The inspections are also designed to be carried out by the Agence française de ensure that corrective measures have been sécurité sanitaire des produits de santé taken where the results of the quality (French Agency for Health Product Safety) control of a laboratory have revealed in accordance with the procedure deter- repeated or significant anomalies as regards mined by decree. their medical use. Article 9 of Decree No 94-1049 of 2 December 1994 on the quality control of bio-medical analyses 4 states:

22. Under Article L. 162-14 of the Code de 25. However, Article L. 332-2 of the Code la sécurité sociale, the total cost of labora- de la sécurité sociale prohibits payment of tory analyses and examinations to be sickness and maternity insurance benefits reimbursed by sickness insurance funds where the insured party and his dependants and the insured person's contribution are receive treatment outside France. to be fixed by a national agreement between, on the one hand, the Caisse nationale de l'assurance maladie de travail- leurs salariés (National Workers' Sickness Insurance Fund) and at least one other national sickness insurance fund and, on the other, the bio-medical laboratory direct- 26. Article R. 332-2 of that code makes ors' trade unions which are recognised as provision for a number of derogations from the most representative at national level. that principle. It does not permit agree- I - 2358

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OPINION OF MR MISCHO — CASE C-496/01

3. In the case of the medical and allied and requested information by letter of 18 pharmaceutical professions, the progressive March 1999 to the French authorities. abolition of restrictions shall be dependent The French authorities replied by letter of upon coordination of the conditions for 21 September 1999. their exercise in the various Member States.'

32. By letter of formal notice of 1 February 2000, the Commission indicated to the French Government that, in its view, a 30. The third paragraph of Article 50 EC number of provisions of the French legisla- reads as follows: tion concerning bio-medical analysis laboratories raised problems of compatibil- ity with the right of establishment and the freedom to provide services laid down in Articles 43 EC and 49 EC.

'Without prejudice to the provisions of the Chapter relating to the right of establish- ment, the person providing a service may, 33. As the French authorities did not reply in order to do so, temporarily pursue his to that letter, the Commission sent the activity in the State where the service is French Republic a reasoned opinion on 24 provided, under the same conditions as are January 2001. imposed by that State on its own nationals.'

34. The French authorities replied to the reasoned opinion by letter of 6 June 2001, rejecting the Commission's objections. III— Procedure

35. The Commission considered that the response was not satisfactory and, by 31. Following a complaint by a German application of 17 December 2001, com- laboratory regarding the French rules in menced an action under Article 226 EC question, the Commission services against the French Republic. I - 2360

(b) order the French Republic to pay the costs. 39. The Commission submits that the French Republic denies a laboratory which has its place of business in another Member State the opportunity to set up a secondary place of business in France in accordance 37. The French Republic claims that the with the second paragraph of Article 43 Court should: EC. I - 2361

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40. I have some difficulty in understanding activity in itself. However, that would what the Commission means by that. The imply that the 'place of business' of the Commission does not appear to claim and, 'blood test laboratory' in question was, by in any event, does not show that French definition, in France, so that the above- legislation prohibits a foreign laboratory mentioned complaint would be irrelevant. from establishing a branch or subsidiary in France in which to undertake all the operations traditionally carried out by a laboratory.

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48. The Court held in Gebhard 6 that 'the State the opportunity to respond to the fact that a provision of services is tempor- requests of persons insured in France from ary does not mean that the provider of its place of business abroad. services within the meaning of the Treaty may not equip himself with some form of infrastructure in the host Member State (including an office, chambers or consulting rooms) in so far as such infrastructure is necessary for the purposes of performing 51. Without disputing that a Member State the services in question'. may lay down rules governing authorisa- tion for operating laboratories, the Com- mission considers that such rules must take account of the requirements and safeguards already complied with in the Member State of establishment. Otherwise, the situation 49. I consider therefore that the French would run counter to the principle of requirement to have a place of business on proportionality. French territory does not have the effect of excluding an entire economic sector from application of the principle of freedom of establishment (Article 43 EC), as the Com- mission claims, but that the requirement must be examined in the light of the principle of freedom to provide services 52. The Commission considers that the (Articles 49 EC and 50 EC). requirement to have a place of business in France cannot be justified. To the extent that there is discrimination, Article 46(1) EC together with Article 55 EC on the freedom to provide services cannot allow application of the principles of right of establishment and freedom to provide services to be excluded from an entire B — Breach of the principle of freedom to economic sector such as the one at issue. 7 provide services If the requirement must be seen as a non- discriminatory restriction, according to the Commission, all the grounds for justifica- tion invoked by the French authorities must be rejected. 1. The arguments submitted to the Court

57. The Commission complains that the French Republic has not explained whether and why its own system ensures a higher level of quality assurance and why it is not possible to carry out blind controls on 54. As for monitoring, the Commission samples coming from laboratories estab- states that the requirement of a permanent lished in other Member States. establishment can only exceptionally be justified, if the authorities show that their supervisory tasks cannot otherwise be carried out. That is not the case here. The condition that the place of business must be situated on French territory would not be necessary if the foreign laboratory in 58. The Commission explains in justifica- question could obtain the administrative tion that the effectiveness of penalties operating authorisation on condition that it against laboratories and the maintenance agreed that all the controls necessary for the of an essential treatment facility may also French authorities to accomplish their tasks be guaranteed by less restrictive means than be carried out on its premises. The purpose the condition of having a place of business of the controls could be fulfilled by appro- priate organisational measures, including temporary authorisation. 8 — OJ 1998 L 331, p. 1.

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on French territory. The Commission notes, 62. The French Republic states that it in respect of the maintenance of an essential cannot judge the levels of control in other treatment facility on national territory, that Member States. It is for the Commission to the French Republic has not proven, in show that the quality criteria and monitor- accordance with the judgment in Kohll, ing procedures are equivalent to the criteria that a balanced medical service, open to all, and controls in force in France. It also could not otherwise be guaranteed. points out that it is not possible to compare the system for in vitro diagnostic medical devices, as laid down by Directive 98/79, and the situation of bio-medical analysis laboratories.

10 — Case 205/84 [1986] ECR 3755, paragraph 52. 9 — Cited in footnote 7, paragraph 51. 11 — Case C-355/98 [2000] ECR I-1221, paragraph 27.

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acknowledge as equivalent the controls 67. It is clear from Article 47(3) EC that carried out in other Member States. '[i]n the case of the medical and allied and pharmaceutical professions, the progressive abolition of restrictions shall be dependent upon coordination of the conditions for their exercise in the various Member States'. 64. The French Republic describes in detail the scope and procedures of the controls carried out by its authorities and notes that they are strictly linked to the practising restrictions imposed by French legislation for the protection of public health. For certain analyses, specific methods and an interpretation of results are required. If 68. Under Article 55 EC, that provision analyses were carried out in another Mem- also applies as regards the provision of ber State, there would be a higher risk of a services. false interpretation of results, which would bring about a real risk for the patients' health.

69. To my mind, medical analysis labora- tories fall within the field of paramedical 2. Analysis professions.

65. It cannot be denied that the disputed provisions prevent any foreign laboratory from providing its services in France, which is not, in any case, challenged by the French 70. In my Opinion of 13 December 2001 in Government. Gräbner, 12 I argued that the abovemen- tioned sectors were thus subjected to a condition which is not laid down for any other sphere of professional activity. For other sectors, the prohibition of restrictions on the freedom to provide services inside 66. It is also established that no directive the Community, set out in Article 49 EC, has been adopted by the Community must be considered as 'an obligation to institutions with a view to coordinating the establishment and operating conditions for bio-medical laboratories. 12 — Case C-294/00 [2002] ECR I-6515, points 29 and 30.

71. However, the Court paid no attention 73. It follows from this reasoning that, to this argument in its judgment in Gräb- according to the interpretation of the ner. Court, even in the medical, paramedical and veterinary fields, the directives are aimed solely at facilitating the freedom to provide services. Therefore, once the transi- tional period expired, the free movement of doctors would be usual practice, even without the adoption of relevant directives. I do not think that this was the view of the 72. Indeed, the Court declared: 1 4'it should authors of the Treaty but I will not dwell on be stated at the outset that consistent case- this point further. law shows that, in the absence of harmo- nisation of a profession, Member States remain, in principle, competent to define the exercise of that profession but must, when exercising their powers in this area, respect the basic freedoms guaranteed by the Treaty (see, in particular, Case C-58/98 Corsieri [2000] ECR I-7919, paragraph 31, and Case C-108/96 Mac Quen and Others [2001] ECR I-837, paragraph 24)'. The Court added: '[i]n order to answer the first 74. I will therefore take the consistent case- question, therefore, it is necessary to estab- law that the Court has developed regarding lish, first, whether in a situation such as that all sectors of activity and which the Court in the main proceedings the exercise of the has applied also to the paramedical sector activity of a Heilpraktiker within the mean- in Mac Quen and Others 16 and Grtilmer, 17 ing of the German legislation is regulated as a basis for my analysis. by harmonisation at Community level and,

77. It is undisputed that legislation imply- ing that authorisation to operate a labora- tory can be granted only to laboratories having a place of business in France constitutes a restriction on the exercise of the freedom to provide services. It is appropriate, therefore, to consider whether 80. That is not the case. It must be such legislation may be justified in the light remembered that the protection of public of the four conditions derived from the health is one of the reasons which may, case-law of the Court. under Article 46(1) EC, justify restrictions on freedom of establishment resulting from the application of provisions laying down special treatment for foreign nationals. Protection of public health is therefore, in principle, also capable of justifying meas- ures which constitute indirect discrimin- 78. In that respect, it should be noted that, ation or which apply indiscriminately. 19 although the provision in question does not The provisions of this paragraph apply to include any reference to the nationality of the provision of services pursuant to Article 55 EC.

18 — See Grabner, cited in footnote 12, paragraph 39; Gebhard, cited in footnote 6, paragraph 3; Case C-424/97 Haim [2000] ECR I-5123, paragraph 57; and Mac Quen and 19 — See, for example, paragraph 28 of Mac Quen and Others, Others, cited above, paragraph 26. cited above.

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83. It should be borne in mind in this regard that the fact that other Member States impose possibly less strict rules than those applicable in France does not mean in 87. It is however apparent from this judg- itself that the latter's rules are dispropor- ment that the Court adopted a more tionate and hence incompatible with Com- moderate position than stated by the munity law. 20 defendant.

20 — See Gräbner, cited in footnote 12, paragraph 46; Case 21 — Gräbner, cited i nfootnote 12, paragraph 47; Mac Quen C-3/95 Reiseburo Broede [1996] ECR I-6511, para- and Others, cited above, paragraph 34; and Case C-67/98 graph 42; Mac Quen and Others, cited above, para- graph 33; and Case C-309/99 Wouters and Others [2002] Zenatti [1999] ECR I-7289, paragraph 34. ECR I-1577, paragraph 108. 22 — Cited in footnote 10, paragraph 55.

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91. That said, I would like once again to consider the judgment in Commission v 89. Next, the Court pointed out that it was Germany, concerning the insurance sector, for the competent authorities to show 'that which I have just mentioned, as it includes those authorities cannot, even under an other details which can be transposed to authorisation procedure, carry out their this case. supervisory tasks effectively unless the undertaking has in the aforesaid State a permanent establishment at which all the necessary documents are kept' (end of paragraph 54). The Court however con- sidered that this had not been proved in relation to balance sheets, accounts and commercial documents, including insurance 92. As I have already pointed out, the conditions and schemes of operation. Commission accepts that the French Copies of these documents could be sent Republic may also apply its authorisation from the State of establishment and duly procedure to foreign laboratories, and I certified by the authorities of that Member fully agree with the Commission in that State. The Court concluded that 'it is respect. possible under an authorisation procedure to subject the undertaking to such condi- tions of supervision by means of a provision 23 — Cited in footnote 11.

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93. In Commission v Germany, a proced- 96. If an authorisation procedure is justi- ure of this kind, called 'authorisation', was fied in the field of insurance, it is a fortiori also called into question and the explan- justified as regards laboratories, whose ations which the Court gave on the subject possible poor operation may bring about are relevant to this case. negative consequences for the health of the persons concerned. However, such a system must also meet the conditions set out above.

95. The Court added that it 'should how- ever be emphasised that the authorisation must be granted on request to any under- taking established in another Member State which meets the conditions laid down by the legislation of the State in which the service is provided, that those conditions may not duplicate equivalent statutory conditions which have already been satis- fied in the State in which the undertaking is 98. This means that laboratories located in established and that the supervisory author- other Member States cannot claim the right ity of the State in which the service is to exercise their activities with regard to provided must take into account super- persons resident in France merely on the vision and verifications which have already basis of the fact that they meet the been carried out in the Member State of conditions in force in the country in which establishment' (paragraph 47). they are established.

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101. Furthermore, I do not think that it is possible to oblige the French Government to commence negotiations with neighbour- ing States with the aim of having those controls authorised or to have them carried 104. It is also for those laboratories to out by the competent local authorities, in ensure that their report of analysis results accordance with French criteria. can be understood by French doctors. That especially applies to the interpretation of the results by the biologist which is, in certain instances, required by the French 24 —See, inter alia, Joined Cases C-369/96 and C-376/96 rules in order to assist the consultant in his Arblade and Others [1999] ECR I-8453, paragraph 34, and the judgments cited therein. diagnosis. I - 2372

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108. On the basis of paragraph 41 of the judgment in Kohll, the Commission con- tends that the risk of seriously undermining A — Arguments submitted to the Court the financial balance of the social security system is the only reason capable of justifying a restriction to the principle of the free movement of services, but that it is not established that reimbursement of the costs of bio-medical analyses carried out in another Member State in accordance with 106. The Commission complains that the French social security tariffs has a signifi- French Republic de facto precludes reim- cant effect on the financing of the social bursement of the cost of medical analyses security system. In this context, the Com- carried out in laboratories established in mission points out in particular that sick- another Member State. This exclusion is an ness insurance funds are authorised to indirect consequence of Article R. 332-2 of refuse to reimburse additional costs result- the Code de la sécurité sociale, because ing from the choice of a laboratory other there are no analyses which French labora- than one located in the area where the tories cannot carry out. For the Commis- insured person lives. If this principle is also sion, this constitutes a barrier and is accepted with regard to laboratories estab- discriminatory. lished abroad, this measure, according to

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113. It also shows that having contractual arrangements with sickness insurance funds 111. Considering that, by this argument, is not really a problem. Not even all French the Commission is not entirely rejecting the laboratories are expressly contracted. The system set up by French legislation, the Commission has pointed out, without being I - 2374

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challenged, that, unless expressly notified 116. Since, at present, no such authorisa- by the director of a laboratory that he does tion can be obtained whatsoever, the not wish to be placed under the scheme of second of the Commission's pleas should the agreement, French laboratories satisfy- be upheld. ing the French conditions of the public health rules are considered to have con- tracted with the national sickness insurance fund and the costs of the analyses carried out are reimbursed on the basis of the tariffs fixed by the agreement. It would therefore be sufficient for the sickness insurance funds to treat bills coming from foreign 117. I should add that, when the French laboratories in the same way. They are, of authorisation system is opened up to course, entitled to refuse to reimburse laboratories established in other Member additional costs resulting from the choice States, that cannot seriously undermine the of a laboratory other than one located in financial balance of the French social the area where the insured person lives. security scheme. The services of those laboratories would be reimbursed only within the limits provided for by the abovementioned agreement.

(1) declare that the French Republic has failed to fulfil its obligations under Articles 49 EC and 50 EC,

— by requiring bio-medical analysis laboratories established in other Member States to have their place of business on French territory as a condition for admission to the French authorisation procedure,

— and by precluding any reimbursement of the cost of bio-medical analyses carried out by laboratories established in another Member State;

(2) order the French Republic to pay the costs.

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