C-145/82

J U D G M E N T OF T H E C O U R T 15 MARCH 1983 '

Commission of the European Communities v Italian Republic

(Failure of a State to fulfil its obligations — Directive on proprietary medicinal products)

Case 145/82

Measures adopted by institutions — Directives — Implementation by the Member States (EEC Treaty, third paragraph ofArt. 189)

Mere administrative practices, which by valid fulfilment of the obligation imposed their nature may be altered at the whim by Article 189 of the Treaty on Member of the authorities and lack the appro- States to which the directives are priate publicity, cannot be regarded as a addressed.

composed of: P. Pescatore, President of the Second Chamber, acting as President, A. O'Keeffe and U. Everling (Presidents of Chambers), G. Bosco, T. Koopmans, O. Due and K. Bahlmann, Judges,

Advocate General: G. Reischl Registrar: P. Heim

gives the following

JUDGMENT

Facts and Issues

The facts of the case, the course of the down by law, regulation or adminis- procedure and the conclusions, sub- trative action relating to proprietary missions and arguments of the parties medicinal products. In Articles 22, 3 and may be summarized as follows: 38 respectively the directives stipulate that the Member States must within 18 months of their notification bring into I — Facts and written procedure force the measures needed to comply with them. 1. The purpose of Council Directives No 65/65/EEC of 26 January 1965 That period expired on 31 December (Official Journal, English Special Edition 1966 for Directive No 65/65, as 1965-1966, p. 20), No 75/318/EEC of amended by Council Directive No 20 May 1975 (Official Journal 1975, 66/454 of 28 July 1966 (Official Journal, L 147, p. 1) and No 75/319/EEC of 20 English. Special Edition 1965-1966, May 1975 (Official Journal 1975, L 147, p. 168), and on 22 November 1976 for p. 13) is to approximate provisions laid the other two.

By a letter of 23 September 1977 the that the Minister of Health had Permanent Representation of Italy sent consequently decided to review the draft, the Commission a copy of a draft law to bring it up to date and to supplement prepared by the Italian Ministry of it and that this was now virtually done. Health concerning the implementation of Whilst acknowledging that it was Directives Nos 65/65, 75/318 and expedient to introduce new rules on 75/319. After studying that draft the proprietary medicinal products the Commission, by letter of 31 May 1978, Italian Government pointed out that by drew the attention of the Italian and large it was already complying with Government to the fact that the the directives in question by means inter directives of 20 May 1975 as well as all alia of ministerial circulars. the provisions of the directive of 26 January 1965 ought to have been implemented in the national legal system On 25 November 1981 the Commission, by 22 November 1976. finding that the rules notified to it had still not been adopted and considering that administrative practices could not In reply the Permanent Representation constitute a sufficient means of per- of Italy informed the Commission in a forming the obligation imposed on telex message of 11 July 1978 that the Member States under Article 189 of the draft in question was before the Senate EEC Treaty as addressees of directives, for scrutiny and that the Italian auth- delivered the reasoned opinion provided orities were endeavouring to have it for by Article 169 of the Treaty passed with all due speed. Then, by letter requesting the Italian Government to of 7 December 1978, the Permanent comply with it within two months. Representation informed the Com- mission that the draft law to implement the directives had been approved by the By a letter of 2 March 1982 the Italian Senate and that the Italian Government Government informed the Commission was hopeful that it would complete the that it intended to make every effort to parliamentary adoption procedure in a expediate the implementation of 45 very short while. directives the dates for the implemen- tation of which had expired and which included the three directives in question, When it received no word that the draft but that it was unable to commit itself to law had been finally passed the a precise date. Commission sent the Italian Republic a letter on 9 April 1980 giving it notice that it considered that the Italian Republic had failed to fulfil its 2. Having received no further word obligations under the directives and from the Italian Government the requesting it, in accordance with Article Commission, acting pursuant to the 169 of the EEC Treaty, to submit its second paragraph of Article 169 of the observations within two months. Treaty, referred to the Court the alleged failure of the Italian Republic to fulfil its obligations under Article 189 of the By a letter dated 17 June 1980 the Italian Treaty. Government informed the Commission that it had not been possible for the par- liamentary procedure to adopt the bill, which had already been approved by the 3. The Commission's application was Senate, to be completed owing to the registered at the Court on 11 March premature dissolution of the Chambers, 1982.

Referring to the reasons set out in the reasoned opinion of 25 November 1981 II — C o n c l u s i o n s of t h e p a r t i e s the Commission contends that the ministerial circulars on which the Italian Government relies are not capable of The Commission claims that the Court guaranteeing compliance with Article should: 189 of the Treaty because they may be altered at the whim of the relevant 1. Declare that, by failing to implement ministry and lack the appropriate within the prescribed period the publicity. Hitherto the sphere of provisions needed to comply with proprietary medicinal products has been Council Directives Nos 6 5 / 6 5 / E E C governed by statute. That is why the of 26 January 1965, 75/318/EEC of directives in issue are meant to be 20 May 1975 and 75/319/EEC of converted into provisions of domestic 20 May 1975 on the approximation of law having the same legal force as those provisions laid down by law, regu- which apply to the sphere of proprietary lation or administrative action relating, medicinal products in the Member State to proprietary medicinal products, the in question. Italian Republic has failed to fulfil its obligations under the Treaty; The Commission then goes on to point out that the provisions notified in the 2. Order the defendant to pay the costs. appendix to the Italian Government's letter of 17 June 1980 do not appear to take any account of Article 7 and 10 of Directive No 65/65 or of Articles 16 (2), The Italian Republic contends that the and (3), 20 and 22 of Directive No Court should dismiss the application. 75/319.

It points out that the Commission's admitted several times, in particular in objection is not that the provisions the ministerial report on the 1977 draft adopted are not capable of putting the law, that it has not entirely complied directives into effect in domestic law. In with the directives in issue, thus its view the Commission is thus ignoring confirming that the application is well the prerogative of a Member State under founded. the third paragraph of Article 189 of the Treaty freely to choose the means which it considers to be the most suitable for incorporating directives into its domestic legal order. The defendant contends that in its application the Commission The Commission next denies having undertakes a review which goes beyond made the unwarrantable assumption that the limits of assessing the suitability of the ministerial circulars on which the the measures taken by a Member State Italian Government relies are mere for the adoption of the required administrative practices. The Com- provisions. mission observes that it had already separately examined both categories in its reasoned opinion of 25 November 1981. When doing so it noticed that there was no provision at all in Italian The Italian Government also disputes the law (statute or circular) corresponding to existence of a rule, expressed in general Articles 7 or 10 of Directive No 65/65. terms by the Commission, to the effect that directives must be adopted by a statute if the subject-matter is governed by statute in domestic law. Such an obligation would constitute in substance The Commission also denies that it the abolition of the right of Member refused from the outset to take into States to make use in addition of regu- consideration the ministerial circulars of lations and administrative provisions. which the texts were notified in the appendix to the Italian Government's letter of 17 June 1980. However, for ministerial circulars to be capable of constituting a suitable means of The Italian Government then goes on implementing Community directives, in to contend that the Commission bases the Commission's opinion the two its application on the unwarrantable fundamental requirements as to assumption that ministerial circulars are uniformity of rules and certainty in legal mere administrative practices. It observes situations must also be fulfilled. that circulars are genuine binding administrative provisions. For that reason it considers that the Commission failed in its duty to consider the action already taken to incorporate the directives in question in national law. The Commission bases that view on the case-law of the Court as contained, in particular, in the judgment of 6 May 1980 in Case 102/79 Commission v Belgium [1980] ECR 1473. In that case In its reply the Commission states that the Court stated that harmonizing the Italian Government has itself directives are meant to be converted into

Decision

1 By application l o d g e d at the C o u r t Registry on 11 M a y 1982 the Commission of the E u r o p e a n Communities b r o u g h t an action before the C o u r t u n d e r Article 169 of the E E C T r e a t y for a declaration that by failing to adopt within the prescribed periods the provisions needed to comply with Council Directives ' N o s 6 5 / 6 5 / E E C , 7 5 / 3 1 8 / E E C and 7 5 / 3 1 9 / E E C o n the approximation of provisions laid d o w n by law, regulation or administrative action relating to proprietary medicinal products, the Italian Republic has failed to fulfil its obligations u n d e r Article 189 of the E E C T r e a t y .

2 T h e purpose of Council Directive N o 65/65. of 26 J a n u a r y 1965 o n the approximation of provisions laid d o w n by law, regulation or administrative

COMMISSION v ITALY

action relating to proprietary medicinal products (Official Journal, English Special Edition 1965-1966, p. 20) is to eliminate the disparities in this sector liable to have the greatest effect on the functioning of the common market. To that end it lays down provisions on authorization to place proprietary medicinal products on the market, the suspension and revocation of such authorization and on the labelling of proprietary medicinal products.

3 Council Directive N o 75/318 of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (Official Journal 1975, L 147, p. 1) continues the approxi- mation initiated by Directive No 65/65 by laying down uniform rules for carrying out tests and trials, compiling dossiers and examining applications for marketing authorization. Those uniform rules are set out in a detailed annex to the directive, Article 2 of which requires Member States to take all appropriate measures to ensure that the competent authorities examine the particulars and documents submitted in support of applications for marketing authorization in accordance with the criteria laid down in that annex.

s Although the recitals in the preamble to the ministerial order of 1979 evince the intention of the Italian authorities to adapt the procedure for granting marketing authorization to the requirements of the three directives, that fact is not sufficient to remedy the alleged failure. First, the ministerial order was adopted after the period prescribed for the implementation of the directives had expired. Secondly, the order is concerned only with the continued registration of proprietary medicinal products already registered before 1 January 1975.

9 As to the circulars relied upon by the Italian Government, they cover the procedure to be followed for authorizing the marketing of proprietary medicinal products. They do not govern either the suspension or revocation of such authorizations, the labelling of proprietary medicinal products or the rules applying to products imported from non-member countries.

io It should be added in this respect that, as the Court has already stressed on other occasions, in particular in its judgment of 6 May 1980 in Case 102/79 Commission v Belgium [1980] ECR 1473, mere administrative practices, which by their nature may be altered at the whim of the authorities and lack the appropriate publicity cannot be regarded as a valid fulfilment of the obligation imposed by Article 189 of the Treaty on Member States to which the directives are addressed.

COMMISSION v ITALY

1 1 It follows from all the considerations set out above that the Italian Government's argument to the effect that it is a matter for the Member States to which a directive is addressed to determine the methods to implement the directive is, though correct, nevertheless irrelevant in the present case. Indeed, apart from the fact that it was based at least in part on mere administrative practice, the implementation of the three directives in issue upon which the Italian Government relies, came too late and was incomplete.

1. Declares that, by failing to adopt within the prescribed periods the provisions needed to ensure the implementation of Council Directives Nos 65/65/EEC of 26 January 1965 and 75/318/EEC 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 Article 189 of the Treaty;

OPINION OF MR REISCHL — CASE 145/82

2. Orders the defendant to pay the costs.

Pescatore O'Keeffe Everling

Bosco Koopmans Due Bahlmann

Delivered in open court in L u x e m b o u r g on 15 M a r c h 1983.

1 — Translated from the German.