C-301/82

JUDGMENT OF 26. 1. 1984 — CASE 301/82 CLIN-MIDY v BELGIUM

CELEX: 61982CJ0301
Datum: 1984-01-26
Källa: eur-lex.europa.eu

In Case 301/82 REFERENCE to the Court under Article 177 of the EEC Treaty by the Conseil d'État [State Council] of Belgium for a preliminary ruling in the proceedings pending before that court between

THE COURT (Third Chamber) composed of: Y. Galmot, President of Chamber, Lord Mackenzie Stuart and U. Everling, Judges, Advocate General : G. F. Mancini Registrar: J. Biancarelli, Legal Secretary

gives the following

JUDGMENT

Facts and Issues

I — Facts and procedure

This reference to the Court for a preliminary ruling arises in an action brought in April 1976 by several pharmaceutical companies for a declaration that a ministerial order of 10 February 1976 (Moniteur Belge of 12.2. 1976) is void. The ministerial order provides that proprietary medicinal products and certain other drugs may not be sold to wholesalers, dispensing chemists and hospital establishments at prices higher than those charged on 11 August 1975; the ministerial order also fixes the maximum profit margins of wholesalers, dispensing chemists and hospital establishments.

As regards the fixing of the prices of new products, the producer, importer or packer must send a proposal to the minister, who may fix another price. Increases in existing and new prices must also be authorized by the minister.

The plaintiffs submitted inter alia that that system is contrary to Council Directive 65/65 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 1965-1966, p. 20).

The preamble to the directive states that trade in proprietary medicinal products is hindered by disparities between certain naţional provisions, in particular provisions relating to medicinal products, and that such hindrances must be removed by progressive approximation of the provisions in question and that priority must be given to eliminating the disparities liable to have the greatest effect on the functioning of the common market.

The directive contains provisions relating to authorization to place proprietary medicinal products on the market and provisions for the suspension and revocation of such authorization.

Article 21 of the directive provides that authorization to market a product may not be refused, suspended or revoked except on the grounds set out in the directive.

Considering that it was obliged to request the Court of Justice to give a ruling on the interpretation of that directive, the Conseil d'Etat stayed the proceedings by judgment of 22 October 1982, registered at the Court on 3 December 1982, and referred the following questions:

1. Does 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 have direct effect in relations between Member States and those subject to their jurisdiction and may the latter plead a breach thereof before a national court?

2. Is Directive 65/65 of 26 January 1965 concerned solely with the approximation of provisions which are intended to protect public health or is it also concerned with the approximation of other provisions relating to proprietary medicinal products, in particular those which are enacted for the purpose of controlling prices?

3. Should Article 21 of Directive 65/65 be interpreted as meaning that an authorization to market a proprietarymedicinal product may be refused, suspended or revoked on the ground that rules on prices have not been complied with?

Pursuant to Article 20 of the Statute of the Court of Justice, written observations were lodged by the plaintiffs in the main action, represented by Professor Raymond Vander Elst, of the Brussels Bar, the Belgian State, represented by the Minister for Economic Affairs, himself represented by Cyr Cambier and Robert Andersen, of the Brussels Bar, the Italian Government, represented by Ivo Braguglia, Avvocato dello Stato, acting as Agent, and the Commission, represented by its Legal Adviser, Michel van Ackere.

Upon hearing the report of the Judge-Rapporteur and the views of the Advocate General, the Court decided to open the oral procedure without any preparatory inquiry and to assign the case to the Third Chamber.

II — Observations of the parties

Second question

In the view of the plaintiffs in the main action, the directive must be reconciled with the ultimate aim of Articles 30 and 34 of the Treaty, namely a system of unimpeded trade. The measures adopted in the directive prohibit all other measures, whatever their nature, whose object or effect, direct or indirect, is to hinder the pursuit of that aim. Even if it is assumed that Directive 65/65 is not directly concerned with the approximation of national provisions on authorizations for marketing on grounds of price, it nevertheless excludes the provisions from being frustrated or stultified by refusals of authorization to market on grounds of price.

In the view of the Belgian State, Directive 65/65 has a very precise objective, namely to eliminate certain obstacles to the free movement of goods. After considering the terms of the preamble and the provisions of the directive, it concludes that the aim to the directive is solely to eliminate disparities in national rules which are dictated by a concern to protect public health and which make the marketing of proprietary medicinal products dependent on the fulfilment of certain conditions. On the other hand, the directive is not intended to abolish disparities which may result from different national rules in relation to the prices of medicinal products in the various Member States or from different national systems of social security in relation to reimbursement for medicinal products.

The national rules on prices must be considered in the light of Article 30 et seq. of the Treaty.

The Belgian State suggests that the Court should answer the second question as follows:

The directive has a limited objective, which is to eliminate certain disparities which may most affect the functioning of the common market, namely those resulting from national rules on health which, with the intention of protecting public health, make the access of proprietary medicinal products to the domestic market and their continued presence thereon dependent on various conditions. The directive is not intended to eliminate other disparities, such as those resulting from different national rules on the fixing of prices for proprietaiy medicinal products.

The Italian Government's observations are similar to those of the Belgian Government. The directive in question concerns only national rules appertaining to health, whereas other rules, in particular those relating to the prices of proprietary medicinal products, remain outside its scope. Harmonization directives adopted pursuant to Article 100 have never been concerned with national provisions in relation to prices.

The Commission also considers that the directive is intended to harmonize national rules the aim of which is to protect public health in order to prevent recourse to Article 36 on grounds of the protection of health and human life. It is clear from the provisions of the directive that they are concerned only with rules governing access to the market which are intended to ensure that no dangerous or ineffective drugs are marketed. On the other hand, national measures concerned for example with trade marks, social security or economic policy (such as price controls) are not covered by the directive.

The Commission accordingly suggests the following answer to the second question:

Directive 65/65 relates solely to the approximation of the provisions of the Member States which seek to ensure the protection of public health and is not concerned with other provisions relating to proprietary medicinal products, such as provisions enacted for the purpose of controlling prices.

Third question

In the view of the plaintiffs, Article 21 has a general scope falling within the objectives of the EEC and of Article 30 et seq. of the Treaty of Rome.

In the view of the Belgian State, that article prohibits Member States from making the marketing of proprietary medicinal products subject to conditions based on health considerations, save as provided in the directive, but does not prevent Member States from imposing other conditions, such as price controls.

The Belgian Government nevertheless points out that the legislation in question contains no provision making authorization for marketing dependent on observance of a particular price.

It suggests the following answer:

Article 21 of the directive must be understood as meaning that, although authorization for marketing may not be refused, suspended or withdrawn for reasons connected with health other than those exhaustively listed in the directive, on the other hand there is nothing to prevent authorization from being refused (which has not, however, occurred in this case) for reasons not connected with health, for example on grounds of an economic or social nature.

The Italian Government considers that Article 21 is not relevant since the rules in question are outside the scope of the directive. Article 21 may not be relied upon against a refusal of authorization based on grounds other than those relating to public health.

The Commission considers that the only reasons which may justify the refusal or revocation of authorization to market are those listed in the directive, to the exclusion of any other reason such as observance of rules on prices. The Commission also points out that the Belgian rules do not provide for the revocation of authorization to market in the event of a breach of the price rules.

The Commission suggests the following answer to the third question :

Article 21 of Directive 65/65 must be interpreted as meaning that the authorization to market provided for in Article 3 of the directive may not be refused, suspended or revoked on the ground that rules relating to prices are not observed.

First question

In the light of their answers to the other questions, the Italian Government and the Commission consider that it is not necessary to answer the first question.

The Belgian State and the Commission nevertheless state that, in their view, the provisions of the directive, in particular Article 21 thereof, are on the whole unconditional and sufficiently precise for them to be relied upon by individuals before the national courts.

The Belgian State suggests the following answer:

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 contains provisions the majority of which appear to be, from the point of view of their content, unconditional and sufficiently precise for individuals to be able to rely on them before their national courts against any incompatible provision of national law.

The Commission suggests the following answer:

Council Directive 65/65 of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products imposes unconditional and sufficiently precise obligations on Member States for them to be relied upon before the national courts by the persons concerned; that is true, in particular, of the provisions laying down the conditions for the grant, suspension or revocation of the authorization, provided for in Article 3, of the marketing of proprietary medicinal products (Articles 5, 7, 10, 11 and 12).

III — Oral procedure

At the sitting on 15 September 1983 oral argument was presented by the following: R. Anderson, for the defendant in the main action, M. van Ackere, for the Commission; and I. Braguglia for the Italian Government.

The Advocate General delivered his opinion at the sitting on 24 November 1983.

Decision

1. By a judgment of 22 October 1982, which was received at the Court on 3 December 1982, the Belgian Conseil d'Etat [State Council] referred to the Court for a preliminary ruling under Article 177 of the EEC Treaty several questions on the interpretation 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 1965-1966, p. 20), in order to enable it to assess the conformity with that directive of a ministerial order of 10 Februaiy 1976 which provides for a price freeze on proprietary medicinal products and fixes the maximum profit margins of wholesalers, dispensing chemists and hospital establishments in respect of those products.

2. Those questions arose in the course of an action before the Conseil d'État in which 14 pharmaceutical companies, including SA Clin-Midy, sought a declaration that the abovementioned ministerial order was void. In support of their claim the plaintiffs submitted that the contested rules were contrary to Community law, in particular Directive 65/65. The national court therefore referred the following questions to the Court of Justice:

“1. Does 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 have direct effect in relations between Member States and those subject to their jurisdiction and may the latter plead a breach thereof before a national court?

3. Should Article 21 of Directive 65/65 be interpreted as meaning that an authorization to market a proprietary medicinal product may be refused, suspended or revoked on the ground that rules on prices have not been complied with?”

First question

3. By this question the national court asks in substance whether Directive 65/65 has direct effect in the national legal order of the Member States and whether individuals may therefore rely upon it before a national court.

4. That question would arise in particular if a Member State were to refuse authorization to market a product on grounds other than those provided for in the directive, such as the desire to ensure compliance with its legislation on prices. In that regard, it must be noted that the provisions of the directive laying down the conditions for the grant, suspension or revocation of an authorization to market, in particular Article 21, are unconditional and sufficiently precise for them to be relied upon before a national court by the persons concerned in order to challenge any national provision laid down by law, regulation or administrative action which is incompatible with the directive.

Second question

5. According to the preamble to the directive, the primary purpose of any rules concerning the production and distribution of proprietary medicinal products must be to safeguard public health. The approximation of national provisions adopted for that purpose, which the directive seeks to achieve, is intended to eliminate the existing disparities in so far as they hinder trade in proprietary medicinal products. However, the directive is only the first stage of harmonization and it deals chiefly with the disparities which have the greatest effect on the functioning of the common market. For that purpose it lays down common conditions for the grant, suspension and revocation of authorization to place proprietary medicinal products on the market and makes common rules governing the labelling of the products concerned.

6. It is therefore clear that the directive seeks to approximate provisions laid down by law, regulation or administrative action in Member States relating to proprietary medicinal products only in so far as such provisions are connected with public health. It does not contain any provision aimed at limiting the power of the Member States to regulate the prices of those products. In the absence of any provision to that effect, such a limitation cannot be inferred.

7. Consequently, the answer to the second question must be that 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 must be interpreted as concerning solely national provisions which are intended to protect public health.

Third question

8. The Conseil d'État asks in substance whether Article 21 of Directive 65/65 must be interpreted as preventing Member States from refusing, suspending or revoking an authorization to market a proprietary medicinal product on the ground that rules on prices have not been complied with.

9. In that regard, it should be stressed that the words “authorization to market” in the directive relate solely to an authorization concerned with the protection of public health and that the existence of such an authorization does not imply that the other requirements which a product must meet in order to be lawfully marketed are satisfied.

10. Article 21 of the directive provides that authorization may not be refused, suspended or revoked except on the grounds set out in the directive. It is clear from Articles 3 to 10 of the directive, which deal with the granting of authorization, and from Articles 11 and 12, which deal with the suspension and revocation of authorization, that the Council intended to restrict the grounds for the refusal, suspension or revocation of authorization to market proprietary medicinal products solely to the considerations of public health expressly mentioned in the directive.

11. The answer to the third question should therefore be that Article 21 of the directive must be interpreted as meaning that authorization to market a proprietary medicinal product may not be refused, suspended or revoked save on the ground of the protection of public health as referred to by the directive.

12. That does not prevent Member States which introduce a price control system for proprietary medicinal products from ensuring that it is complied with by means which are appropriate to that system and compatible with the Treaty, in particular Article 30 thereof.

Costs

13. The costs incurred by the Kingdom of Belgium, the Italian Government and the Commission of the European Communities, which have submitted observations to the Court, are not recoverable. As these proceedings are, in so far as the parties to the main proceedings are concerned, in the nature of a step in the action before the national court, costs are a matter for that court.

On those grounds, THE COURT (Third Chamber), in answer to the questions submitted to it by the Belgian Conseil d'État by judgment of 22 October 1982, hereby rules:

1 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 must be interpreted as concerning solely national provisions which are intended to protect public health.

2 Article 21 of the directive must be interpreted as meaning that authorization to market a proprietary medicinal product may not be refused, suspended or revoked save on the ground of the protection of public health as referred to in the directive.