CJEC, February 7, 1984, No 238-82

The court

1 By order dated 16 september 1982, which was received at the court on 29 september 1982, the president of the arrondissementsrechtbank (district court), the hague, referred to the court for a preliminary ruling under article 177 of the eec treaty several questions on the interpretation of articles 3, 5, 30, 34, 36, 85 and 86 of the treaty and of council directive 65-65-eec of 26 january 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (official journal, english special edition 1965-66, p. 20) and of council directive 75-319-eec of 20 may 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (official journal 1975, l 147, p. 13), to enable it to decide whether certain national rules concerning the supply of medicinal preparations and dressings under a sickness insurance scheme were compatible with those provisions.

2 The questions were raised in an action brought against The Netherlands State by 23 pharmaceutical undertakings for the adoption of an interim decision declaring that articles 2 and 3 of the besluit farmaceutische hulp ziekenfondsverzekering (sickness insurance fund (provision of medicinal preparations) order) 1982 (staatscourant no 139 of 23 july 1982) and the annexes thereto were inoperative since they were incompatible with community law and in particular with articles 3, 5, 30, 34, 36, 85 and 86 of the treaty and directives 65-65 and 75-319, cited above.

3 The order is intended to enhance the quality of pharmaco-therapeutical services and to eliminate the considerable deficit of the Netherlands health-care scheme. To that end, article 2 provides that persons insured under the compulsory health-care scheme are no longer to be entitled to be supplied with the medicinal preparations and health products exhaustively listed in annex 1 and 2 to the order, and article 3 provides that they are not to be entitled to be supplied with the medicinal preparations listed in annex 4 to the order except with the prior authorization of the sickness fund, which is to be granted only if it may reasonably be assumed that if the preparations in question are not supplied this will have an unacceptably harmful effect on the outcome of the treatment.

4 According to the explanatory memorandum to the order in question, the exclusion of products as a result of their being listed in the annexes thereto is justified by considerations relating specifically to each annex. The exclusion of the medical preparations listed in annex 1 is based on their price and the fact that, in the view of the central medico-pharmaceutical committee, there are in each case other medicinal preparations which have the same therapeutic effect but whose price is lower. The products listed in annex 2 are excluded because they are over-the-counter products which can be marketed otherwise than through a pharmacist. The exclusion of the medicinal preparations listed in annex 4 is justified by the fact that, in the view of the abovementioned central medico-pharmaceutical committee they must, for reasons described as being ' ' of a pharmaco-therapeutical nature ' ', be prescribed only in very specific cases.

5 Considering that the decision in the case turned on the interpretation of various rules of community law, the president of the arrondissementsrechtbank referred the following questions to the court for a preliminary ruling:

' ' (a) Must community law, laid down in articles 30, 34 and 36 of the eec treaty, be construed as meaning that those articles prevent a member state from introducing, with a view to making savings in the field of the supply of medicinal preparations to persons insured under sickness insurance schemes, unilateral provisions under which insured persons are deprived of a right to be supplied with specific named medicinal preparations and dressings?

(b) Must community law, laid down in article 5 of the eec treaty, in conjunction with article 21 read with articles 11, 12 and 5 of directive 65-65 and article 32 read with articles 28 and 31 of directive 75-319, be construed as meaning that those provisions have direct effect?

(c) If so, must those provisions be construed as set out in subparagraph (a) above?

(d) Must community law, laid down in article 3 (f) in conjunction with articles 85 and 86 of the eec treaty, be construed as set out in subparagraph (a) above?

' '

I - The first question

6 The first question seeks in substance to ascertain whether the prohibition of measures having an effect equivalent to quantitative restrictions on imports (article 30) and on exports (article 34) applies to measures (of the type described above) whereby a member state, with a view to achieving economies regarding compulsory health-care insurance, prevents specifically named medicinal preparations and dressings from being supplied to persons insured under the scheme. The national court also wishes to know whether, if that part of the question is answered in the affirmative, article 36 of the treaty allows an exception to that prohibition.

7 For the purpose of answering the first question, it is appropriate to consider how articles 30, 34 and 36 of the treaty are to be interpreted in relation to the particular features of the national legislation in question.

A - The interpretation of articles 30 and 36 of the treaty

8 The plaintiffs in the main proceedings propose that article 30 should be interpreted as meaning that rules such as those with which this case is concerned constitute a measure having an effect equivalent to a quantitative restriction on imports because they restrict intra-community trade and make it impossible for the suppliers of certain imported medicinal preparations to sell them on the market in question since the proportion of the total consumption of medicinal preparations charged to the sickness funds amounts to 70%.

9 The plaintiffs in the main proceedings argue that such a measure does not escape the prohibition contained in article 30 merely because it applies without distinction to national and imported products. According to previous decisions of the court, even measures which apply without distinction to national products and those imported from other member states but give rise to obstacles to intra-community trade do not escape the prohibition of measures having equivalent effect unless:

(a) No community rules exist;

(b) The obstacles are the result of disparities between national laws regarding the marketing of a product;

(c) Imperative grounds exist relating inter alia to the effectiveness of fiscal controls, the protection of public health, the fairness of commercial transactions or the protection of the consumer; and

(d) Those imperatives render the obstacles necessary.

10 According to the plaintiffs in the main proceedings those conditions are not satisfied in any of the three cases in which medicinal preparations are excluded by the annexes to the contested order. As regards exclusion of medicinal preparations by reason of their price (annex 1) they claim that even if the concern to achieve economies in the costs of health care justifies certain restrictions upon the fundamental rule of the free movement of goods, a national measure which entails such a wide-ranging prohibition is excessive. The desired aim could be attained by measures which did not affect the functioning of the common market and competition to such an extent. As regards the over-the-counter products (annex 2), they deny that any of the imperative reasons accepted by the previous decisions of the court exist, in particular the justification based on the protection of public health. As regards medicinal preparations excluded for reasons described as ' ' pharmaco-therapeutical ' ' (annex 4), they also deny that the conditions mentioned above are satisfied, contending in particular that the obstacle is not the result of any disparity between national laws on the marketing of the products in question.

11 The Netherlands State, the defendant in the main proceedings, submits that the prohibition contained in article 30 cannot extend to measures of the type with which the main proceedings are concerned. It considers in the first place that there is no question of any obstacle to intra-community trade. Where a public authority finances by far the greater part of the consumption of medicinal preparations and other health-care products, it is in the position of an economic operator and accordingly is, like any other such operator, entitled to make a choice and to choose among the preparations on the market, giving preference to one rather than to another. Where, as in this case, the national authority made its decision on the basis of objective considerations inspired by the concern to safeguard the quality of the care, there can be no question of obstacles to trade between member states.

12 The defendant in the main proceedings adds that, even if measures of the type in question could be regarded as capable of hindering trade, they nevertheless do not constitute measures having an effect equivalent to quantitative restrictions prohibited by article 30. Those measures, which apply without distinction to national and imported products, were adopted for imperative reasons - in this case the rationalization, and therefore the continuation, of a national health-care scheme - which, by virtue of the judgment of the court of 20 february 1979 (case 120-79 rewe (1979) ecr 649), justify obstacles of that kind so that they escape the prohibition contained in article 30. Finally, the defendant in the main proceedings claims, in the alternative, that even if the measures in question were to be regarded as measures having an effect equivalent to quantitative restrictions they would fall within the exception provided for in article 36 of the treaty as restrictions justified on the grounds of the protection of health.

13 The commission considers that the order in question constitutes a measure having an effect equivalent to a quantitative restriction. It points out however that, in its judgment of 20 february 1979 (cited above), the court did not give an exhaustive list of the imperative requirements which might justify a national measure affecting the volume of imports. It considers that the order, which is intended to rationalize the financial management of a sickness insurance scheme, could be regarded as compatible with article 30 even if it affected trade. The measure applies objectively to medicinal preparations manufactured in the Netherlands and to imported medicinal preparations. The products are not treated differently according to their origin. Moreover, no measure capable of directly affecting the marketing of the products in the strict sense has been adopted. Such marketing remains wholly unrestricted, so that anyone can obtain the medicinal preparations in question, if necessary on the basis of a prescription. However, if the court should decide that the contested measures are incompatible with article 30 of the treaty, the commission considers that the grounds of justification set out in article 36 do not apply in this case.

14 The danish government observes that it does not consider national rules which, for social reasons and on the basis of objective criteria, provide for a public scheme for assistance with the provision of pharmaceutical preparations is contrary to article 30 et seq. Of the treaty, provided that, in the selection of the proprietary medicinal preparations in respect of which assistance may be granted, account is taken exclusively, on the basis of an objective and fair assessment, of their therapeutic value and of the expenses incurred for normal and necessary medical treatment.

15 In order to determine the scope of the prohibition contained in article 30 of the treaty in relation to national measures of the type in question, it should, in the first place, be noted that the rules whose compatibility with national law is to be considered by the national court display the particular feature that, in principle, they provide for reimbursement, to a substantial percentage of the population, of the price paid for all medicinal preparations which may be prescribed to patients by an approved doctor. In that respect they are different from the legislation of other member states which draw up a restrictive list of the medicinal preparations or like products in respect of which reimbursement is permitted. That is why the Netherlands rules, with a view to attaining their objective of reducing costs, set out limitative lists excluding preparations.

16 Although it is not possible, contrary to the contention of the defendant in the main proceedings, to equate the competent authority of a member state which, within the framework of a health-care insurance scheme financed by contributions from the insured persons and by financing from the public authorities, draws up rules governing and limiting reimbursement of the costs of health care, with an economic operator who in each case freely chooses the goods which he acquires on the market, it must be recognized that community law does not detract from the powers of member states to organize their social security systems and to adopt, in particular, provisions intended to govern the consumption of pharmaceutical preparations in order to promote the financial stability of their health-care insurance schemes.

17 Likewise, it must be recognized that in a scheme which - like that in force in the Netherlands - is based on the principle of reimbursement in respect of all medicinal preparations which may be prescribed, it is not in principle incompatible with community law for the member state concerned, with a view to achieving its aim of limiting costs, to prepare limitative lists excluding certain products from the reimbursement scheme.

18 Even if measures such as the provisions in question do not relate directly to the importation of medicinal preparations from other member states, the fact cannot be overlooked that, depending on the manner of their application and the use made of them, they may affect the possibilities of marketing the preparations and, to that extent, they may indirectly influence the possibilities of importation.

19 In that connection it should be borne in mind that 80% of the medicinal preparations consumed in the Netherlands are imported and that the proportion thereof charged to the public insurance schemes amounts in all to 70%. It follows that, where reimbursement by the insurance authority is excluded in respect of a medicinal preparation, purchases of that preparation fall and consequently there is a risk that the preparation in question will be totally eliminated from the national market.

20 However, in view of the special nature, in that respect, of the trade in pharmaceutical products, namely the fact that social security institutions are substituted for consumers as regards responsibility for the payment of medical expenses, legislation of the type in question cannot in itself be regarded as constituting a restriction on the freedom to import guaranteed by article 30 of the treaty if certain conditions are satisfied.

21 In that regard it must be stressed that for such legislation to be in conformity with the treaty the choice of the medicinal preparations to be excluded must be free of any discrimination to the detriment of imported medicinal preparations. To that end, the exclusionary lists must be drawn up in accordance with objective criteria, without reference to the origin of the products, and must be verifiable by any importer. If those conditions are fulfilled, an importer may secure access to the Netherlands market provided that he is in a position to market a product which, whilst having the same therapeutic value, offers a price advantage over some other product available on the market. Such rules would in no way detract from the freedom to market any product meeting that requirement, which relates not to the nature of the product but only to its price.

22 The answer to the first question should therefore be that provisions adopted within the framework of a compulsory national health-care scheme with the object of refusing insured persons the right to be supplied, at the expense of the insurance institution, with specifically named preparations are compatible with article 30 of the treaty if the determination of the excluded medicinal preparations involves no discrimination regarding the origin of the products and is carried out on the basis of objective and verifiable criteria, such as the existence on the market of other, less expensive products having the same therapeutic effect, the fact that the preparations in question are freely marketed without the need for any medical prescription, or are products excluded from reimbursement for reasons of a pharmaco-therapeutic nature justified by the protection of public health, and provided that it is possible to amend the lists whenever compliance with the specified criteria so requires.

23 If the national court should find that the measure whose compatibility with community law it is called upon to consider does not meet the conditions to which such conformity is subject, it should be borne in mind with regard to the application of article 36 of the treaty, as the court has held on many occasions (for example the judgment of 19 december 1961 in case 7-61 commission v italy (1961) ecr 317), that article 36 relates to measures of a non-economic nature. That provision cannot therefore justify a measure whose primary objective is budgetary inasmuch as it is intended to reduce the operating costs of a sickness insurance scheme.

B - The interpretation of article 34 of the treaty

24 The first question also seeks to ascertain whether article 34 of the treaty must be interpreted as meaning that it precludes national rules of the type in question. The plaintiffs in the main proceedings maintain that the contested order constitutes a measure having an effect equivalent to a quantitative restriction on exports within the meaning of that article.

25 As the court has already stated in its judgment of 8 november 1979 (case 15-79 groenveld (1979) ecr 3409), article 34 concerns national measures which have as their specific object or effect the restriction of patterns of exports and thereby the establishment of a difference in treatment between the domestic trade of a member state and its export trade in such a way as to provide a particular advantage for national production or for the domestic market of the state in question.

26 That part of the first question must therefore be answered in the negative.

II - The second and third questions

27 The second and third questions submitted by the president of the arrondissementsrechtbank seek essentially to ascertain whether the provisions of article 5 of the treaty in conjunction with the provisions of articles 5, 11, 12 and 21 of council directive 65-65 of 26 january 1965 and the provisions of article 32 in conjunction with the provisions of articles 28 and 31 of council directive 75-319 of 20 may 1975 have direct effect (second question) and, if so, whether they preclude rules of the kind at issue in this case (third question).

28 As the commission has rightly contended, the order in question does not concern access to the market within the meaning of the two directives cited, since the validity of the authorizations granted by application of those directives is not called in question. New products brought onto the Netherlands market may be granted authorization as soon as they satisfy the prescribed conditions. The third question must therefore be answered in the negative. In view of those considerations, the second question becomes devoid of purpose.

III - The fourth and fifth questions

29 In his fourth and fifth questions, the president of the arrondissementsrechtbank asks whether the provisions of article 3 (f), combined with those of articles 85 and 86 of the treaty, have direct effect and preclude rules of the kind at issue in this case.

30 Articles 85 and 86 of the treaty form part of the competition rules ' ' applicable to undertakings ' ' and therefore are not relevant to an assessment of the question whether the legislation of the type at issue in the main proceedings is in conformity with community law.

Costs

31 The costs incurred by the government of the kingdom of denmark, the government of the italian republic and the commission of the european communities, which have submitted observations to the court, are not recoverable. As these proceedings are, so far as the parties to the main proceedings are concerned, in the nature of a step in the matter for that court, the decision on costs is a matter for that court.

On those grounds,

The court

In reply to the questions submitted to it by the president of the arrondissementsrechtbank, the hague, by order of 16 december 1982, hereby rules:

1. Provisions adopted within the framework of a compulsory national health-care scheme with the object of refusing insured persons the right to be supplied, at the expense of the insurance institution, with specifically named medicinal preparations are compatible with article 30 of the treaty if the determination of the excluded medicinal preparations involves no discrimination regarding the origin of the products and was carried out on the basis of objective and verifiable criteria, such as the existence on the market of other, less expensive products having the same therapeutic effect, the fact that the preparations in question are freely marketed without the need for any medical prescription, or are products excluded from reimbursement for reasons of a pharmaco-therapeutic nature justified by the protection of public health, and provided that it is possible to amend the lists whenever compliance with the specified criteria so requires.

2. Article 36 of the eec treaty cannot justify a measure whose primary objective is budgetary inasmuch as it is intended to reduce operating costs of a sickness insurance scheme.

3. Article 34 of the treaty does not preclude a system of the kind described in the order making the reference.

4. Article 5 of the treaty and the provisions of council directives 65-65 of 26 january 1965 (official journal, english special edition 1965-66, p. 20) and 75-319 of 20 may 1975 (official journal 1975, l 147, p. 1) do not preclude such a system.

5. Articles 85 and 86 of the treaty are not relevant to the question whether legislation of the type at issue in the main proceedings is in conformity with community law.