C-264/01

AOK-BUNDESVERBAND AND OTHERS

OPINION OF ADVOCATE GENERAL JACOBS delivered on 22 May 2003 1

1. These four joined cases raise a number 81 EC; and, if so, whether those decisions of questions concerning the compatibility might be defended by reference to Article with the Community competition rules of 86(2) EC. the arrangement, provided for by statute, whereby the leading associations of sickness funds in Germany collectively determine the maximum amounts (known as 'fixed amounts') paid by sickness funds towards the cost of various types of medicinal product. Insured patients are left to pay the excess cost of any prescribed product 3. Article 81(1) EC prohibits decisions by which is priced above the amount thus associations of undertakings which may fixed. affect trade between MemberStates and which have as their object or effect the prevention, restriction or distortion of competition within the common market, and in particular, under Article 81(1)(a), those which directly or indirectly fix pur- chase or selling prices or any other trading conditions.

2. Cases C-264/01 and C-306/01 are refer- ences from the Competition Chamber of the Oberlandesgericht Düsseldorf. Cases C-354/01 and C-355/01 are references from the Bundesgerichtshof. The questions referred by each of the national courts 4. Article 86(2) EC provides: differ somewhat in formulation and scope. When taken together, the issues which they raise include in particular whether sickness funds are undertakings and therefore subject to the Community competition rules; whether the decisions of their leading associations to set fixed amounts are capable of breaching Article 'Undertakings entrusted with the operation of services of general economic interest or having the character of a revenue-produ- cing monopoly shall be subject to the rules 1 — Original language: English. contained in this Treaty, in particular to the

7. Statutory health insurance is provided by the sickness funds, most of which are bodies governed by public law (Paragraph 4 (1) SGB V). The sickness funds are orga- nised together regionally and sectorally into associations. The appellants in the main proceedings operate at the federal level, and are identified by Paragraph 213(1) SGB V National legal framework as the leading associations of sickness funds. Most of the appellants represent a number of sickness funds. However, the Bundesknappschaft (the miners' sickness fund) and the See-Krankenkasse (the sea- 5. The great majority of employees in men's sickness fund) are themselves direct Germany are required to belong to the providers of statutory health insurance. statutory health insurance system, which is governed by the fifth book of the Sozialge- setzbuch (the social security code), (herein- after the 'SGB V). Employees are subject to statutory health insurance unless their income exceeds a certain level or unless they receive sufficient cover from another statutory source, as in the case of civil 8. Provision was made for the setting of servants. Employees' insurance extends also fixed amounts by the Gesetz zur Strukturre- to unemployed family members. Other per- form im Gesundheitswesen (the law on sons may insure themselves on a voluntary structural reform in the health sector) of basis provided certain conditions are met. 1988. Its object was to reduce the costs of the health insurance system by giving the sickness funds a means of influencing doctors' and patients' choice of medicines and by developing awareness of the cost of medicines on the part of insured persons. To that end, the appellants are, 6. The system is funded by compulsory contributions from insured persons and their employers, the levels of which are fixed according to the insured person's 2 — For the principle of solidarity, see paragraph 32 below.

12. At the second stage of the procedure, the appellants then determine a fixed amount for each category of medicinal products. Under Paragraph 35(3) SGB V 10. In principle, therefore, pharmaceutical the appellants jointly determine uniform companies remain free to set a price for fixed amounts on the basis of average daily their products above any applicable fixed or single dosages or other suitable compar- amount. In practice, however, it appears able quantities determined by the that only around 7% of medicinal products Bundesausschuss. Under Paragraph 35(5) on the German market to which a fixed SGB V, amounts must be set: amount applies are sold at a price exceeding that amount.

11. The procedure for determining fixed 'so that they ensure generally an adequate, amounts is laid down by Paragraph 35 SGB effective and economically efficient treat- V, and has two stages. The first stage serves ment of assured quality. They must exploit

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all reserves in terms of economy and account. The fixed amounts, once set, are produce effective price competition and subject to annual review by the appellants therefore take as a basis the most inexpen- and must at appropriate intervals be sive supply possibilities; so far as is possible, adapted to changes in the market. Once a range of medicinal products which is determined, they are to be published in the adequate for therapeutic purposes must be Bundesanzeiger (Federal Gazette), and are ensured.' open to challenge before the courts.

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in particular with pharmaceutical compan- 2. If the answer to the first question is in the ies' right to pursue a profession. By its affirmative: judgment of 17 December 2002, 3 the Bundesverfassungsgericht upheld the con- stitutionality of Paragraph 35 SGB V. It is therefore clear that the questions referred to the Court remain necessary to enable the referring courts to reach judgment in the (a) are determinations of fixed amounts as main proceedings. described in [question] 1 above to be regarded as agreements (or decisions) of the leading associations of statutory sickness funds which restrict competi- tion, in particular within the meaning of Article 81(1 )(a) EC, and are pro- hibited by Article 81(1) EC? 18. The two orders for reference made by the Oberlandesgericht in Cases C-264/01 and C-306/01 address the following ques- tions to the Court: (b) is question 2(a) to be answered in the affirmative at least where the object of the regulation concerning fixed amounts is, inter alia, to exploit all reserves of medicinal product manu- facturers in terms of economy as '1. Is Article 81(1) EC to be interpreted as regards sale price, and the application meaning that the leading associations of the regulation concerning fixed of statutory sickness funds of a Mem- amounts in the Member State so fai- ber State are to be regarded as associ- has had the effect that, of the finished ations of undertakings or, where a medicinal product packages offered on leading association is also a direct the market that fall within the regula- provider of statutory sickness insur- tions concerning fixed amounts, ance, as undertakings within the mean- approximately 93% do not now ing of Article 81(1) EC when they exceed the amount fixed for them? jointly determine the applicable level of uniform fixed amounts for medicinal products in the Member State, where such amounts constitute the highest price at which the statutory sickness funds, who are required to provide 3. If the answer to either or both of the benefits in kind to insured persons, will questions in [question] 2 above is in purchase and pay for medicinal prod- the affirmative: ucts and thereby limit their liability to insured persons?

'1. Are Articles 81 and 82 EC to be interpreted as precluding national rules under which national leading associ- ations of statutory sickness insurance determine binding maximum amounts (a) what conditions must be set forth and for all statutory sickness funds and proved by the leading associations of compensatory sickness funds up to statutory sickness funds so that they which the funds bear the costs of may be exempted under Article 86(2) medicines, where the legislature defines EC, first sentence, in relation to deter- the criteria by which the maximum minations of fixed amounts? or amounts are to be calculated, provid- ing in particular that the fixed amounts must ensure comprehensive and qual- ity-assured treatment of insured per- sons as well as an adequate range of therapeutic alternatives, and the deter- mination is subject to comprehensive review by the courts, which may be (b) is the grant of an exemption under initiated by both insured persons and Article 86(2) EC, first sentence, pre- affected product manufacturers?

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21. The following five issues can therefore be distilled from the various orders for reference. The first relates to the applic- 3. If question 1 is answered in the ability of the Community competition rules affirmative and question 2 in the to the sickness funds and their leading negative: associations. The answer to that issue lies in a consideration of the case-law relating to the meaning of an undertaking and an association of undertakings. The second issue concerns whether the setting of fixed amounts would, in the absence of any available defence, put the leading associ- ations of sickness funds in breach of Article 81 EC. Despite the Bundesgerichtshofs mention of Article 82 EC in its first Are leading associations such as the question, given that the parties' submissions defendants liable to claims under do not elaborate upon the applicability of Community law for damages and an that article to the setting of fixed amounts, I injunction even where in determining consider it appropriate to confine the maximum amounts they follow a second issue to a consideration of Article statutory direction, notwithstanding 81. The third issue is whether, if Article 81 that national law does not impose EC were in principle applicable to the any penalty for refusal to assist in the setting of fixed amounts, the leading making of such a determination?' associations of sickness funds might defend

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Assessment

The classification of the appellants as an Do the sickness fonds act as undertakings in association of undertakings when setting providing health insurance services? fixed amounts

23. It is first necessary to consider whether 25. As to the status of the sickness fonds, Community competition law is applicable the Court's general approach to whether a

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given entity is an undertaking within the Article 86(2) EC for arrangements which meaning of the Community competition would otherwise infringe Community com- rules can be described as functional, in that petition law. 5 it focuses on the type of activity performed rather than on the characteristics of the actors which perform it, the social object- ives associated with it, or the regulatory or funding arrangements to which it is subject in a particular Member State. 4Provided that an activity is of an economic character, those engaged in it will be subject to Community competition law. 27. In assessing whether an activity is economic in character, the basic test appears to me to be whether it could, at least in principle, be carried on by a private undertaking in order to make profits. 6If there were no possibility of a private undertaking carrying on a given activity, there would be no purpose in applying the competition rules to it. 7

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29. Some such schemes have been held by 32. It seems to me clear that compulsory the Court not to involve economic activities state social security schemes such as those and therefore to fall outside the scope of the at issue in Cisal and Poucet and Pistre are Community competition rules. not classified as economic activities because they are incompatible, even in principle, with the possibility of a private undertaking carrying them on. Such schemes entail such an element of redistribution in the interests of social solidarity that little or no scope remains for the various actuarial, invest- ment and intermediary services which private pensions and insurance providers can and do supply on the market. 10 30. In Poucet and Pistre, 8 the Court considered the status of an old-age pension scheme and a sickness and maternity insurance scheme. It held that neither scheme involved an economic activity in circumstances where affiliation was com- pulsory, where there was no link between the level of contributions made and benefits received, where the level of contributions and benefits was fixed by law, and where (in the case of the pension scheme) current benefits were paid directly out of current contributions rather than on the basis of income from a capital fund.

36. The appellants, the German Govern- 34. By contrast, pension schemes which are ment and the Commission argue on the funded through the administration of a basis of Poucet and Pisire and Cisal 15 that capital fund, into which contributions are sickness funds are not involved in economic paid, and in which benefits are directly activities and are therefore not undertak- related to contributions, have been held in ings for the purposes of EC competition FFSA 13and Albany 14 to be subject to the law. The sickness funds are founded on the Community competition rules, despite the principle of social solidarity. All Germans existence of certain elements of are guaranteed the same basic level of solidarity. In such schemes, the redistribu- benefits regardless of their income, state of tive element is not such as to entail a health or the level of risk which they suppression of the types of activity habi- represent. Contributions are unrelated tually provided by private insurance and to benefits on an individual level. In order pension companies, such as actuarial assess- to sustain such solidarity, membership of ment and the management of investments. funds is compulsory for most German employees.

35. It is of course difficult to arrive at any precise statement of the point at which the 37. Certainly, the German statutory health redistributive component of a pension or insurance system does have a number of insurance scheme will be so pronounced as points in common with the schemes at issue to eclipse the economic activities which in Poucet and Pistre and Cisal. However, it private pension and insurance providers appears to me also to possess various compete to supply. Schemes come in a wide features which distinguish it by introducing variety of forms, ranging from State social a degree of competition between the sick- ness funds, as well as between the sickness

38. First, as the Bundesgerichtshof states in its order for reference, and as the appellants themselves acknowledged at the hearing, sickness funds are engaged in a degree of price competition with one another. Employees have a choice as to which fund they join. The funds determine for themselves the level of contribution which they require from insured 40. Secondly, according to the respon- persons. In consequence, the levels of dents, there is also some potential for the contribution do show some variation from funds to compete in terms of the services fund to fund. Solidarity is apparently which they offer. Although the basic level of guaranteed by means of a mechanism (the benefits is statutorily defined, the respond- Risikostrukturausgleich) designed to cor- ents claim that the funds possess some rect any difference in the degree of risk discretion as to how to meet their borne by the various funds, thereby allow- obligations. For example, they may decide ing them to compete without in the process whether to offer certain complementary undermining the redistributive aspect of the and preventive treatments. Insofar as the system. If some funds have a population of respondents' contention is correct, the insured persons which requires dispropor- funds are therefore able to differentiate tionately expensive medical care, the other themselves in an effort to render themselves funds must make a contribution towards more attractive to insured persons. those higher costs.

39. As I stated in my Opinion in Cisal, 16 the fact that, as here, the level of benefits 41. Finally, as the appellants acknow- provided under a scheme is determined by ledged at the hearing, sickness funds and law cannot in itself rule out the application private health insurers are clearly in com- petition with one another for the business of those employees who are not obliged to 16 — At paragraph 73. take out statutory health insurance.

44. In my view, there is no merit to the argument, advanced by the appellants, that 17— See, for example, the Amministrazioni' Auto/uima dci the setting of fixed amounts can somehow Monopoli di Stato in Case 118/85 Commission v Italy be separated from the sickness funds' main [1987] ECR 2599, at paragraph 7 of the ludgment and the Bundesanstalt fur Arbeu in Hofner and Elser, cited in note activity of providing health insurance, so 4.

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purchases is itself active on another market assert that, at the first stage of the for which the goods or services purchased procedure, 19 decisions are taken by the constitute an input. The Commission, the appellants in conjunction with the Bunde- appellants and the German Government all sausschuss, a body which is itself partly contend otherwise. The question does not composed of the appellants' representa- arise, however, given that the sickness funds tives, whilst at the second stage of the are active on another market, and contrib- procedure, fixed amounts are set exclu- ute towards the purchase of pharmaceut- sively by the appellants. If sickness funds icals as part of their activity on that are undertakings, their leading associations market. 18 are just as clearly associations of under- takings, and the decisions reached by those associations constitute decisions by an association of undertakings.

Do the appellants act as an association of undertakings when setting fixed amounts? 49. The appellants submit that, even if their member funds are undertakings, they themselves operate within a statutory frame- work when setting fixed amounts which ensures that they act independently and in 47. The final stage involved in assessing the the general interest. As such, their determin- status of the appellants under Community ations cannot be classed as decisions of an competition law is to consider whether they association of undertakings. act as an association of undertakings when they set the uniform fixed amounts which are then applied by the sickness funds.

determining the categories to which fixed undertakings, or in an independent manner amounts are to apply, and at the subse- in the public interest. 20 quent stage where the fixed amounts are actually set. Medical experts representing pharmaceutical companies and the pharma- cists' profession are given the opportun- ity to make representations and their views must be taken into account. Thirdly, they emphasise the various supervisory controls applicable to them. Decisions reached at the first stage require the approval of the 53. One important factor in performing Federal Ministry of Health. At the latter that assessment will be the criteria for stage, they are subject to judicial review. selecting members of the body in question. If members are chosen for their independent expertise, their determinations can ordinar- ily be presumed not to constitute decisions under Article 81 EC. Another important factor to consider is the substantive and procedural obligations to which the body in question is subject in reaching its determin- ations. If it is required to take account of general interest considerations, and to consult with various interested parties, it 51. I am not convinced by the appellants' will generally not be held to constitute an submissions. association of undertakings. 21

57. The reference in Paragraph 35(3) SGB 55. As regards the second stage of the V to the need to set fixed amounts on the procedure, however, I am much less per- basis of the average daily or single dosages suaded of the appellants' case that they are or other suitable comparative quantities is a acting independently and in the general purely practical aspect of the calculation of interest. The decision-making body consists fixed amounts and will, in any event, have exclusively of the appellants. Their deci- been specified at the first stage of the sions become immediately effective, with- procedure. out any prior approval procedure by the Ministry of Health. The sickness funds which the leading associations represent compete with one another in a variety of ways, and have a clear interest as under- takings in setting fixed amounts at as low as possible a level. The lower the fixed amount, the less their resources will be tied up in assuring the supply of medicinal 58. As to the criteria specified in Paragraph products, and the more will be available 35(5) SGB V, 23 the emphasis is upon to fund their ability to compete with one securing prices for medicinal products another in other regards. which are as low as possible consistent with the appellants' overriding mission of maintaining treatment for all at an ad- equate, effective and quality-assured level. That goal is to be achieved by exhausting all reserves in terms of economy and securing the most inexpensive supply possibilities. At the time to which the present proceedings relate, Paragraph 35 (5) SGB V further emphasised the need for 56. It is true that Paragraph 35 SGB V does the fixed amounts to be based on the lowest specify criteria pursuant to which the pharmacy sale prices of the comparator appellants must act when setting fixed group. In its more recent formulation, the amounts, so that any discretion which they paragraph still requires that the fixed may possess is bounded. However, the amounts should not exceed the highest sale applicable criteria are in my view not sufficiently differentiated from the appel- lants' own interests to prevent the determin- ations applying those criteria from consti- 23 — See paragraph 12 above.

62. Once it is accepted that the appellants 60. The obligation upon the appellants reach decisions of an association of under- when setting fixed amounts to consult takings when they set fixed amounts, the medical and pharmacological experts and application of Article 81 to such decisions to take account of their views does not alter then depends on whether it can be shown, my opinion. Medical and pharmacological first, that they have as their object or effect expertise is only one of the factors on the to prevent, restrict, or distort competition; basis of which the appellants discharge their secondly that they may affect trade between responsibility to set fixed amounts at the Member States; and thirdly that their effects lowest possible level, and a duty to take on c o m p e t i t i o n and t r a d e are account of such expertise therefore does not appreciable. The disagreement between the remove the possibility of the appellants parties regarding the application of Article acting as representatives of their member 81(1) is focused on the first of those three funds. elements.

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66. The appellants also contend that, prior to the introduction of fixed amounts, the market for medicinal products in Germany was prone to structural distortions which 64. The respondents note that an agree- prevented the operation of price ment among suppliers to fix the price at competition. Because neither patients nor which goods or services are sold has been doctors had to pay for medicines pre- held by the Court to have as its object to scribed, there was no incentive for either restrict competition, without there being group to purchase the most affordable any need to consider its actual effects. 24 available products, and pharmaceutical The same approach should be taken, they companies were under no pressure to submit, to an agreement among buyers to compete on price. Hence, it is claimed, the fix their purchasing price on a given setting of fixed amounts cannot be said to market. have had a negative effect on competition.

65. The appellants deny that the decisions at issue amount to the fixing of purchase 67. It seems clear to me that, whether or prices for medicinal products. As a matter not the funds are, as a matter of national of German law, such products are pur- law, the purchasers of medicinal products, chased by patients and their doctors, not by they are engaged in a fixing of trading conditions within the meaning of Article 81 (1)(a) when they coordinate, by setting fixed amounts, the maximum level of 24 — Case 123/83 BNIC v Clair [1985] ECR 391, at paragraph 22 of the judgment. contribution which they will make towards

the cost of those products. The respondents purchased products to below the competi- are also correct, in my opinion, to char- tive level, with negative consequences for acterise such a practice as fixing the the supply side of the relevant market. In purchase price for medicinal products. my view, therefore, they should be subject to the same strict control applied by Community competition law to supply cartels. 68. Contrary to the Commission's observa- tions, that conclusion does not appear to me to depend on how the contractual relations underlying the purchase of medi- cinal products are analysed as a matter of national law. To my mind, the status of the sickness funds as purchasers turns instead on whether as a matter of fact it is they who provide the funds with which, and deter- mine the price at which, those products are to be acquired. It seems clear that for most of the products in question, the sickness funds perform both of those functions. A contribution towards the cost of a medi- cinal product by the insured person is only required where the fixed amount is exceeded. Given the understandable reluc- tance of insured persons to incur cost on their own account, the demand for medi- 70. I am in any event of the view that the cinal products is heavily determined by the setting of fixed amounts has the effect of fixed amount set by the leading associations restricting competition on the market for of sickness funds. That economic reality is medicinal products within the meaning of borne out by the small percentage of Article 81(1) EC. From the information medicinal products sold in Germany the contained in the orders for reference, fixed price of which exceeds the applicable fixed amounts have had a very clear impact on amount. the prices charged by pharmaceutical com- panies in Germany. Nor am I convinced by the appellants' argument that no anti- competitive effect can be shown given that 69. I am likewise persuaded that an agree- prior to the introduction of fixed amounts, ment or decision on the part of buyers to fix structural distortions prevented price com- the purchase price on a given market must petition on the market for medicinal prod- be understood to have as its object to ucts in Germany. Even assuming the restrict competition, without the need, at existence of such structural distortions, the that stage of the analysis, for any investiga- setting of fixed amounts does not remove tion of its competitive effects. Purchasing those distortions by introducing price cartels are expressly identified in Article 81 competition. Instead, it introduces another (1)(a) as falling within the mischief of type of anti-competitive effect not pre- Article 81. The special attention which they viously seen on the German market for receive can be understood in the light of medicinal products, by coordinating a large their potential to suppress the price of part of demand on that market.

25 — Joined Cases C-359/95 P and C-379/95 P Ladbroke [1997] ECR I-6265, at paragraph 33 of the judgment. 26 — Ladbroke, cited in note 25, at paragraph 34 of the judgment. 73. Article 81 applies only to anti-compe- 27 — See paragraph 60 of the Court of First Instance's judgment titive conduct engaged in by undertakings in Case T-513/93 Consiglio Nazionale Spedizionieri Doganali v Commission [2000] ECR II-1807, and the on their own initiative. If anti-competitive case-law cited there.

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77. Thirdly, the respondents assert that the State action defence is unavailable to the appellants who in effect seek to define themselves as indirectly forming part of the State administration. If the appellants' objectively anti-competitive conduct is indeed to be considered as a form of State 76. Secondly, the respondents suggest that implementation of the law, they must the State action defence should not apply in according to the respondents accept the situations where a Member State deprives duty of loyal cooperation which Commu- its own rules of the character of legislation nity law attaches to the State. That argu- by delegating to undertakings the responsi- ment is in my view misconceived. Under- takings seeking to rely on the State action defence will always operate within a national legal framework. If for that reason 28 — Cited in note 25. they were held to constitute a part of the 29 — Case C-18/88 [1991] ECR I-5941. 30 — See Case C-198/01 C.I.F, at paragraphs 48 to 50 of my State, the State action defence would never Opinion delivered on 30 January 2003. apply.

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33 — See paragraph 51 or my Opinion in C.I.F., cited in note 30. 34 — See paragraph 54 of the Judgment i n Commission v Italy, 32 — See paragraph 69 or my Opinion in C.I.F., cited in note 30. cited in note 21 and the cases which are cited there.

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The application of Article 86(2) EC whose existence is endangered by a sig- nificant increase in costs.

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economically acceptable conditions 37 or in of assuring the conformity of such a conditions of financial stability. 38 decision or agreement with the Community competition rules. Given that no notifica- tions have been made in respect of determin- ations setting fixed amounts, they submit that Article 86(2) cannot be relied upon by the appellants.

89. There can therefore be no doubt that the appellants could in principle defend the setting of fixed amounts along the lines suggested in the Bundesgerichtshofs second question. It is, of course, the national courts which must determine in the main proceed- ings whether the setting of fixed amounts is indeed necessary to the financial stability of 92. I do not consider that it is necessary for the German sickness funds. a notification to have been made to the Commission for exemption pursuant to Article 81(3) in order to be able to have recourse to Article 86(2) in defence of a decision or agreement which is in breach of Article 81(1). In Almelo, 39 the Court considered Article 86(2) to be applicable to the agreements at issue 40 even though 90. The main disagreement regarding the they were unnotified. 41 application of Article 86(2) arises in rela- tion to the proportionality of the current system for setting fixed amounts.

93. The respondents also contend, as does 91. The respondents argue that Article 86 the Oberlandesgericht, that the appellants' (2) is not available to defend a decision or determinations of fixed amounts cannot be an agreement falling within Article 81(1) justified because of the existence of alter- which has not been notified to the Commis- native institutional arrangements for con- sion for exemption under Article 81 trolling the costs of medicinal products. The (3). They submit that such notification appellants and the Commission disagree. constitutes a more proportionate method

97. Nor can I agree with the Oberlandes- gericht that the possibility of entrusting the setting of fixed amounts to the Federal Government or a Federal Minister is sufficient to show the manifest dispropor- 95. Secondly, in applying Article 86(2) in tionality of the existing arrangements for the present context, it is in my view determining fixed amounts. important also to have regard to the free- dom which Community law accords to the Member States in organising their own social security systems. 43 Given the wide margin of discretion which the national authorities therefore enjoy, 44 I consider that the application of Article 86(2) would be precluded only if the setting of fixed amounts could be shown to be manifestly disproportionate as a method of controlling the cost of medicinal products to the 98. As the Court held in Albany, a national sickness funds. measure in the social security field may be capable of justification under Article 86(2) even where it involves granting a power of decision to an undertaking and thereby 42 — Cited in note 36, at paragraph 58 of the judgment. 43 — See Case 238/82 Duphar [1984] ECR 523, at paragraph 16 of the judgment. 44 — See Albany, cited in note 5, at paragraph 122 of the judgment. 45 — Cited at note 43.

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99. The second factor which influenced the Court in Albany was the complexity of evaluating the effects of particular decisions upon the financial equilibrium of the undertaking. As regards the second factor, there is no doubt that the appellants are well placed to assess both the medical needs of those whom they insure and the impact of pharmaceutical costs on their own 102. As to the Oberlandesgericht's fourth financial equilibrium. question, the limb concerning the condi- tions which the appellants are required to prove so as to obtain an exemption of the setting of fixed amounts under Article 86(2) has already, in my view, been adequately 100. The third was the Member States' addressed in the foregoing analysis. As margin of appreciation in relation to social regards its second limb, concerning the security. That factor is clearly equally applicability of the second sentence of applicable to the present proceedings. Article 86(2), even if it were accepted that that sentence were capable of direct effect, the observations before the Court do not, in my view, supply any grounds for thinking that the setting of fixed amounts has such an effect on the development of trade as 101. The fourth was the existence of an would be contrary to the interests of the adequate level of judicial review to prevent Community. The Oberlandesgericht refers the economic operator exercising its deci- to the scale of savings which have resulted sion-making power in an arbitrary from the setting of fixed amounts, without pointing to any data showing a significant attendant impact on the flow of medicinal 46 — Cited at note 5, at paragraphs 116 to 122. products into or out of Germany or other

103. There only remains to consider the third question posed by the Bundesgerichts- hof, as to whether remedial relief might be obtained against the appellants in respect of a determination setting fixed amounts if 105. However, the question posed by the they acted pursuant to a statutory direction, Bundesgerichtshof would appear to be notwithstanding that national law does not based on the assumption that the appellants impose any penalty for refusal to assist in are required by the applicable statutory the making of such a determination. framework to set fixed amounts in breach of Article 81. If the appellants were so compelled, as I have already made clear in my discussion of the State action defence, they would not themselves be subject to 104. If the appellants could be shown to Article 81, and could not be held liable for have acted autonomously in setting fixed its breach, even in the absence of any amounts, in such a way as to breach Article penalty for a refusal to comply with their 81 EC, and if they did not succeed in national legal obligations. In my opinion, defending their conduct under Article 86 therefore, the Bundesgerichtshofs final (2), I have no doubt that both damages and question is adequately addressed by the injunctive relief would as a matter of second of my proposed answers to the Community law be available to anyone questions referred. suffering loss as a consequence of that conduct, subject to such national proced- ural rules as were compatible with the 47 — Case C-453/99 Courage and Crehan [2001] I - 6 2 9 7 , p r i n c i p l e s of e q u i v a l e n c e and at paragraph 26 of the judgment.

When reaching such a determination, the leading associat1ons will not, however, infringe Article 81 EC in so far as the restriction of competition which results is not attributable to autonomous conduct on their part but is rather required by national law, regardless of whether any penalty is specified for failure to comply with the national law in question.

(3) Such joint determination is by virtue of Article 86(2) EC not subject to the Community competition rules unless it can be shown to be manifestly disproportionate as a method for ensuring the ability of the sickness funds to perform their task of general economic interest in conditions of financial stability. It is for the national courts to determine whether that condition is fulfilled.

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