Report of the Judge-Rapporteur in Case C-373/92

I — Facts and legal backrground

(a) The national rules

In Belgium the manufacture and marketing of medicinal products is governed by the Royal Decree of 6 June 1960 on the manufacture, preparation and wholesale distribution of medicinal products and the dispensing thereof (Moniteur Belge of 22 June 1960, p. 4684).

That legislation provides that any person who wishes to prepare or manufacture medicinal products in that country must obtain prior authorization. Authorization is granted subject to certain requirements, inter alia the testing of the medicinal products by an industrial pharmacist. That condition is laid down in Article 15(1) of the Royal Decree:

The Royal Decree provides in addition that the importation into Belgium of medicinal products manufactured abroad (inter alia in another Member State) is also subject to prior authorization. One of the conditions under which authorization may be obtained is the same obligation to carry out an examination of the imported medicinal products. That obligation is expressed in Article 15(2) of the Royal Decree:

The obligation of prior monitoring applies to all the medicinal products listed in Article 1 of the Royal Decree, in particular to the sterile medical supplies referred to in Point l(B)(d) to (g) of that provision:

The definition of industrial pharmacist is given in Point 7 of Article 1 of the Royal Decree as follows:

(b) Pre-litigation procedure

On 1 March 1989 the Commission informed the Belgian Government that the rules set out above were contrary to Articles 30 and 36 of the EEC Treaty inasmuch as they constituted an obstacle to Community trade disproportionate to the objective of protecting health; in that letter the Commission also called upon the Belgian Government to submit its observations within a period of two months.

On 8 May and again on 31 October 1989 the Belgian Government forwarded to the Commission a draft amendment to the Royal Decree on the lines indicated by the Commission. The draft added to Article 15(2) the following subparagraph:

By letters of 11 April 1990 and 21 March 1991 the Commission expressed its agreement with the draft which had been submitted to it and requested the Belgian Government to forward to it the definitive version of the Royal Decree as soon as it had been published in the Moniteur Belge.

It subsequently appeared that the Royal Decree had not yet been adopted by the competent authorities. The Commission

accordingly sent a reasoned opinion to the Belgian Government by letter of 30 September 1991 in which it repeated the complaint set out above against the rules in question.

Since there was no reply to the reasoned opinion, the Commission initiated these proceedings on 21 September 1992; the application was lodged at the Court Registry on 28 September 1992.

(c) Forms of order sought by the parties

The Commission claims that the Court should:

The Belgian Government confined itself to pointing out that a draft Royal Decree was at hat time before the competent authorities for signature, that the text thereof would be published very shortly and that a copy would be forwarded to the Court as soon as possible.

II — Arguments of the parties

(a) Commission's observations

The Commission's action does not concern all the medicinal products referred to in Article 1 of the Royal Decree but relates only to the sterile medical supplies referred to in the first part of this report.

Moreover, the action is not directed against the obligation to obtain an authorization to import medicinal products but only against the need to submit those medicinal products to an examination; according to the Commission that examination constitutes an obstacle justified by the need to protect public health (Article 36 of the EEC Treaty) but disproportionate to the objective pursued, inasmuch as some medicinal products have already been subjected, in the Member State of origin, to analyses providing the same guarantees as the tests undergone by products manufactured in Belgium.

On this point the Commission refers to the judgment in Case C-272/80 Frans-Nederlandse Maatschapij voor Biologische Producten [1981] ECR 3277, paragraph 14 of which is in the following terms:

The Commission points out further that a test carried out by the State of origin must be recognized by the importing State when it has been officially certified by the first State or when it has been carried out by an approved analysis laboratory: the latter system would imply, however, that each Member State should designate a body responsible for evaluating laboratories within its territory on the basis of their technical performance.

(b) Observations of the Belgian Government

The Belgian Government states that draft legislation to amend the Royal Decree on the lines indicated by the Commission is at present being prepared.

1 Language of the case: French.

2 Authorization to manufacture or prepare medicinal products.