C-301/82

T H E BELGIAN STATE

on the interpretation of Council Directive 65/65/EEC concerning proprietary medicinal products,

T H E C O U R T (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

Considering that it was obliged to As regards the fixing of the prices of new request the Court of Justice to give a products, the producer, importer or ruling on the interpretation of that packer must send a proposal to the directive, the Conseil d'Etat stayed the minister, who may fix another price. proceedings by judgment of 22 October Increases in existing and new prices must 1982, registered at the Court on also be authorized by the minister. 3 December 1982, and referred the following questions: The plaintiffs submitted inter alia that that system is contrary to Council 1. Does Council Directive 65/65/EEC Directive 65/65 of 26 January 1965 on of 26 January 1965 on the approxi­ the approximation of provisions laid mation of provisions laid down by down by law, regulation or adminis­ law, regulation or administrative trative action relating to proprietary action relating to proprietary med­ medicinal products (Official Journal, icinal products have direct effect in English Special Edition 1965-1966, relations between Member States and p. 20). those subject to their jurisdiction and may the latter plead a breach thereof The preamble to the directive states that before a national court? trade in proprietary medicinal products is hindered by disparities between certain 2. Is Directive 65/65 of 26 January 1965 nažional provisions, in particular pro­ concerned solely with the approxi­ visions relating to medicinal products, mation of provisions which are and that such hindrances must be intended to protect public health or is

JUDGMENT OF 26. 1. 1984 — CASE 301/82

In the view of the Belgian State, Pursuant to Article 20 of the Statute of Directive 65/65 has a very precise the Court of Justice, written observations objective, namely to eliminate certain were lodged by the plaintiffs in the obstacles to the free movement of goods. main action, represented by Professor After considering the terms of the Raymond Vander Elst, of the Brussels preamble and the provisions of the Bar, the Belgian State, represented by the directive, it concludes that the aim to the Minister for Economic Affairs, himself directive is solely to eliminate disparities represented by Cyr Cambier and Robert in national rules which are dictated by a Andersen, of the Brussels Bar, the concern to protect public health and Italian Government, represented by Ivo which make the marketing of proprietary Braguglia, Avvocato dello Stato, acting medicinal products dependent on the as Agent, and the Commission, rep- fulfilment of certain conditions. On the resented by its Legal Adviser, Michel van other hand, the directive is not intended Ackere. to abolish disparities which may result from different national rules in relation to the prices of medicinal products in the Upon hearing the report of the Judge- various Member States or from different Rapporteur and the views of the national systems of social security in Advocate General, the Court decided to relation to reimbursement for medicinal open the oral procedure without any products. preparatory inquiry and to assign the case to the Third Chamber. The national rules on prices must be considered in the light of Article 30 et seq. of the Treaty. II — O b s e r v a t i o n s of t h e p a r t i e s The Belgian State suggests that the Court should answer the second question Second question as follows:

The Italian Government's observations In the view of the plaintiffs, Article 21 are similar to those of the Belgian has a general scope falling within the Government. The directive in question objectives of the EEC and of Article 30 concerns only national rules appertaining et seq. of the Treaty of Rome. to health, whereas other rules, in particular those relating to the prices of proprietary medicinal products, remain outside its scope. Harmonization In the view of the Belgian State, that directives adopted pursuant to Article article prohibits Member States from 100 have never been concerned with making the marketing of proprietary national provisions in relation to prices. 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 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 The Belgian Government nevertheless recourse to Article 36 on grounds of the points out that the legislation in question protection of health and human life. It is contains no provision making authori- clear from the provisions of the directive zation for marketing dependent on that they are concerned only with rules observance of a particular price. governing access to the market which are intended to ensure that no dangerous or ineffective drugs are marketed. On the It suggests the following answer: other hand, national measures concerned for example with trade marks, social security or economic policy (such as price controls) are not covered by the Article 21 of the directive must be directive. 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, The Commission accordingly suggests on the other hand there is nothing to the following answer to the second prevent authorization from being refused question: (which has not, however, occurred in

First question III — Oral p r o c e d u r e In the light of their answers to the other questions, the Italian Government and the Commission consider that it is not At the sitting on 15 September 1983 oral necessary to answer the first question. argument was presented by the follow- ing: R. Anderson, for the defendant in the main action, M. van Ackere, for the The Belgian State and the Commission Commission; and I. Braguglia for the nevertheless state that, in their view, the Italian Government. provisions of the directive, in particular Article 21 thereof, are on the whole unconditional and sufficiently precise for The Advocate General delivered his them to be relied upon by individuals opinion at the sitting on 24 November before the national courts. 1983.

CLIN-MIDY v BELGIUM

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, regu- lation 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.

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 har- monization 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 auth- orization to place proprietary medicinal products on the market and makes common rules governing the labelling of the products concerned.

io 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.

1 1 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.

i2 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.

JUDGMENT Of 26. 1. 1984 — CASE 301/82

Costs

1 3 The costs incurred by the Kingdom of Belgium, the Italian Government and the Commission of the European Communities, which have submitted obser­ vations 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.

Delivered in open court in Luxembourg on 26 January 1984.

P. Heim Y. Galmot Registrar President of the Third Chamber