DELIVERED ON 2 FEBRUARY 1983 (1)

Mr President

Members of the Court,

In these proceedings concerning infringement of the Treaty the Commission accuses the Italian Republic of failing to incorporate into national law in proper time Council Directives Nos 65/65/EEC of 26 January 1965 (Official Journal, English Special Edition 1965-1966, p. 20), 75/318/EEC of 20 May 1975 (Official Journal L 147 of 9 June 1975, p. 1) and 75/319/EEC of 20 May 1975 (Official Journal L 147 of 9 June 1975, p. 13) intended to approximate provisions laid down by the laws, regulations or administrative action of the Member States relating to proprietary medicinal products.

The directives stipulate that the Member States must bring into force the measures needed to comply with them within 18 months of their notification and must forthwith inform the Commission thereof. Those periods expired on 31 December 1966 for the first directive and on 22 November 1976 for the other two.

By a letter of 23 September 1977 the Permanent Representation of Italy notified the Commission of a draft law prepared by the Italian Ministry of Health, which was meant to incorporate into national law the directives mentioned. The Commission pointed out that the directives had not been implemented in proper time and Italy's Permanent Representation then gave an assurance on 11 July 1978 that the draft law in question was before the Senate for scrutiny and that the Italian authorities were endeavouring to have it passed with all due speed. By a letter of 7 December 1978 Italy's Permanent Representation finally stated that the draft had been approved by the Senate and was expected to receive final parliamentary approval in a very short while.

On 9 April 1980 the Commission gave Italy the opportunity, in accordance with the first paragraph of Article 169 of the EEC treaty, to submit its observations within a period of two months on the charge that it had failed to fulfil its obligations under the Treaty. In reply the Italian Permanent Representation informed the Commission in a letter of 17 June 1980 that owing to the premature dissolution of the Chambers the draft law had not been passed in time and that the Ministry of Health was reviewing the draft. It contended that there was no question of a breach of obligations under the Treaty, however, since in practice the aims of the directives, or most of them, had been put into effect internally by Article 29 of Law No 833 of 23 December 1978, by a ministerial order of 18 December 1979 and by six ministerial circulars.

The Commission was not satisfied with that answer and after a reasoned opinion of 27 November 1981 addressed to the Italian Republic had also failed to achieve any result, the Commission finally brought this action for a declaration that:

“By failing to adopt within the prescribed periods the measures needed to implement Council Directives Nos 65/65/EEC of 26 January 1965, 75/318/EEC of 20 May 1975 and 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, the Italian Republic has failed to fulfil its obligations under the EEC treaty.”

The Italian Government does admit that the enactment of a statute, as planned, would be the most suitable means of approximating provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. In view, obviously, of the Court's well-established case-law according to which a Member State may not plead provisions, practices or circumstances existing in its internal legal system in order to justify a failure to comply with obligations arising from directives, the Italian Government does not attempt to use the internal legislative difficulties as justification for its conduct thus far. Instead, it takes the view that the directives in question have been implemented, for the most part at any rate, by the measures described. It argues that such a method of incorporating them is unobjectionable since it is clear from the mere wording of the third paragraph of Article 189 of the EEC Treaty that Member States are left to decide for themselves the form and methods to be used to implement a directive internally; that is why the relevant provisions of the directives state essentially merely that the Member States are to put into force the measures needed in order to comply with the directives.

1.Even if we assume for a moment that this argument is correct, which will have to be investigated later, the fact remains that by its own admission the Italian Government has not fully implemented the directives by means of the internal measures even to this day. Thus the Italian Government does not in the last resort deny that the texts notified to the Commission do not take account of either Article 7 and 10 of Directive No 65/65, dealing with authorization to place proprietary medicinal products on the market, or Articles 16 (2) and (3), 20 and 22 of Directive No 75/319, dealing with the manufacture and importation of proprietary medicinal products from nonmember countries. Nor, finally, does the Italian Government appear to wish to deny that, according to the well-established case-law of the Court, (2) a mere administrative practice is not by itself sufficient to comply with the requirements of directives. Therefore since the directives have not been fully implemented but at best implemented only in part that fact alone must be said to constitute a breach of the Treaty.

It must be added that of the eight measures which the Italian Republic adopted to implement the directives in questions no less than four were promulgated after 22 November 1976, that is after the period stipulated by Directives Nos 75/318 and 75/319 had expired. For that reason alone it is also justifiable to declare that the Italian Republic has not brought into force in time the provisions needed to implement the directives.

2.Finally, apart from those considerations, it is still necessary to consider the basic question whether and to what extent the ministerial circulars in particular were capable as such of effectively incorporating the directives in question into national law. Whereas the Commission's view is that the directives could be incorporated into Italian law only by means of a statute, the defendant adopts the position that in principle Member States are themselves entitled to decide which measures they think are needed to incorporate the directives into national law. In any case the ministerial circulars, which are binding on the administration and are known to the economic interests concerned through the professional or trade associations, take account, it says, of the requirements of the directives in question.

That view must be accepted to the extent to which it is in principle left to the Member States to adopt the measures needed to implement directives within the framework of their own domestic law. However, that freedom of action is restricted by the fact that the measures must be capable of achieving the aim pursued by the directives concerned. In this regard we must remember that the directives in question, based in particular on Article 100 of the EEC Treaty, are meant to approximate the provisions laid down by law, regulation or administrative action in the Member States on proprietary medicinal products. But that aim can only be achieved if, as the Court made clear in Case 102/79, which also concerned a failure to implement harmonizing directives based on Article 100 of the EEC Treaty, the directives adopted under the Treaty are turned into provisions of national law having the same legal force as those governing the same subject-matter in the other Member States. What is more, as the Court also stressed in Case 102/79, each Member State must implement the directives in question in a way which fully meets the requirements of clarity and certainty in legal situations. On the basis of those considerations the Court came to the conclusion that mere administrative practices, which by their nature may be changed as and when the authorities please and which are not publicized widely enough, cannot be regarded as a proper fulfilment of the obligation on Member States arising from Article 189 of the EEC Treaty.

Just the same may be said of the ministerial circulars, although it cannot be denied that they have a different legal quality from a mere administrative practice. One must here bear in mind that the manufacture and marketing in Italy of proprietary medicinal products are governed by the Testo Unico delle Leggi Sanitarie [Consolidated Text of Health Laws, approved by Royal Decree No 1265 of 27 July 1934] which is still in force, that is to say by provisions which have the character of law and which at all events rank above the ministerial circulars, however the latter may be legally classified. For those reasons, and in view of the directives' aim to eliminate obstacles to freedom of trade, their incorporation into national law by means of ministerial circulars does not meet the requirements laid down by Community law of legal certainty and legal clarity.

In the first place, the ministerial circulars, being internal administrative instructions, do not have to be published officially, unlike legislative instruments, and secondly, in so far as they are akin to an administrative practice, they may be altered at any time. The Commission's view must therefore be accepted that the issue of ministerial circulars cannot be regarded as a legally effective fulfilment of the obligation which Article 189 of the EEC Treaty imposes on the Member States.

In conclusion, therefore, and notwithstanding the efforts which, to its credit, the Italian Government has made, there is no alternative but to propose that the Court should grant the Commission's application and declare that by failing to adopt within the prescribed periods the provisions needed to comply with Council Directives No 65/65/EEC of 26 January 1965, No 75/318/EEC of 20 May 1975 and No 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, the Italian Republic has failed to fulfil its obligations under the Treaty. The defendant should also be ordered to pay the costs.

(1) Translated from the German.

(2) Judgment of 6 May 1980 in Case 102/79 Commission v Belgium [1980] ECR 1473;

Judgment of 25 May 1982 in Case 96/81 Commission v The Netherlands [1982] ECR 1791;

Judgment of 15 December 1982 in Case 160/82 Commission v The Netherlands [1982] ECR 4637.