C-83/92

O P I N I O N O F MR LENZ — CASE C-83/92

OPINION OF ADVOCATE GENERAL LENZ delivered on 15 July 1993

Mr Preńdent, when the competent authority of that State Members of the Court, has issued an authorization.

3. Pursuant to Article 10 of Directive 65/65, A — Introduction this authorization is valid for five years. It may be renewed for five-year periods on application by the holder. 1. In the area of the law relating to medici­ nal products there has been considerable activity by the Community with the aim of 4. The question of the circumstances under the gradual attainment of the free movement which such authorization may be suspended of medicinal products while at the same time or revoked is regulated in Article 11 of safeguarding public health. Of fundamental Directive 65/65 and Article 11 of Directive importance in this area are Council Directive 92/27/EEC of 31 March 1992 on the label­ 65/65/EEC of 26 January 1965 on the ling of medicinal products for human use approximation of provisions laid down by and on package leaflets. 4 law, regulation or administrative action relat­ ing to proprietary medicinal products ' and the Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of According to the last-mentioned provision, provisions laid down by law, regulation or an authorization may be suspended under administrative action relating to proprietary certain conditions if the labelling provisions medicinal products. 2 Some of the most of the directive are not complied with. This important further directives in this area are possibility is not relevant to the present case. listed in the Report for the Hearing. 3

where its qualitative and quantitative compo- 9. On the basis of this provision the Italian sition is not as declared.' Minister of Health adopted a number of decrees declaring that the authorizations for marketing several products of Pierrcl SpA and other undertakings had lapsed. The Other cases in which an authorization may undertakings concerned challenged these be 'suspended or revoked' are set out in the decrees before the Tribunale Amministrativo second paragraph of Article 11 of the direc- per il Lazio, which however dismissed the tive. applications for a stay of execution of the decrees. The undertakings then lodged an appeal against this decision with the Con- 6. It is clear from the provision cited above siglio di Stato. that an authorization may also be annulled in cases where it was unlawful, i. e. where the conditions laid down by the directive for issuing the authorization were not fulfilled. 10. The Consiglio di Stato referred the fol- According to the customary terminology in lowing questions to the Court for a prelimi- Germany, the annulment of unlawful admin- nary ruling pursuant to Article 177 of the istrative measures is referred to as 'Rück- EEC Treaty: nahme' ('withdrawal'). However, as the directive uses the term 'Widerruf' ('revoca- tion'), this is the word I shall use below, in the wider sense for the purposes of the Directive as covering cases of the withdrawal '1. Must Article 11 in conjunction with of illegal authorizations. Article 21 of Council Directive 65/65/EEC of 26 January 1965, as amended, be interpreted as meaning that the grounds for suspension or revoca- 7. Article 21 of Directive 65/65 provides as tion are definitive and that the national follows: authorities are therefore precluded from introducing additional grounds for sus- pension or revocation? 'An authorization to market a proprietary medicinal product shall not be refused, sus- pended or revoked except on the grounds set out in this directive.' 2. If so, must the abovementioned provi- sions be understood as prohibiting the national authorities not only from introducing additional grounds for sus- 8. On 11 March 1988 the Italian legislature pension and revocation, but also from passed Law No 67. 5 Article 19(11) of this providing for the lapse of an authoriza- Law provides that an authorization for mar- tion, which is a very different matter keting medicinal products shall lapse if it is from revocation, in so far as, unlike not used within 18 months of issue. revocation, it does not involve a reas- sessment of the benefits of the product but is the automatic consequence of fail- S - The text of this Law is reproduced in the Supplemento Ordi- ure to make use of the authorization for nario of the Official Journal of the Italian Republic (GURI) 61, 14.3.88. a certain period (in the present case,

13. There is much to be said in favour of the B — Analysis Portuguese Government's argument. The Community law provisions leave it to the Member States to determine the competent First question authorities for the issue of authorizations in the individual Member States and also, to a large extent, the detailed organization of the administrative procedure. Therefore it seems 11. The wording of Article 21 itself shows only consistent in principle to leave the law that this provision aimed to regulate exhaus- of the Member State concerned to decide on tively the grounds on which an authorization the consequences of contravening the rele- for marketing a proprietary medicinal prod- vant provisions concerning competence or uct may be refused, suspended or revoked. procedure. In the judgment of 26 January 1984 in Case 301/82, Clin-Midy v Belgium, the Court confirmed that the Council 'intended to restrict the grounds for the refusal, suspen- If, for example, under the law of a Member sion or revocation of authorization to mar- State an authority or body has to be con- ket proprietary medicinal products solely to sulted before such authorization is issued the considerations of public health expressly and if failure to consult renders the authori- mentioned in the directive'. 6 zation illegal under the law of that State, annulment of the authorization on that ground would in principle undoubtedly be compatible with the rules of Community 12. Italy and the Commission concur in this law, which makes exhaustive provision for interpretation. The Portuguese Government annulment on grounds relating to public also considers that the relevant provisions of health. Community law constituted an exhaustive rule so far as the substantive requirements for the refusal, suspension or revocation of authorization are concerned. However, rely- 14. Of course, it might be pointed out that ing on the principle that administrative mea- this could result in making it more difficult sures must be based on law, the Portuguese or impossible to attain the objectives of the Government takes the view that unlawful Community measures. As we have already authorizations may be withdrawn if their seen, one of these is to bring about the free illegality arises from the infringement of pro- movement of medicinal products. If the visions or principles applying to administra- authorities of a Member State could tempo- tive measures, i. e. on formal grounds. Here rarily prevent the marketing of such a prod- the Portuguese Government refers in partic- uct by annulling a marketing authorization, ular to the provisions concerning compe- which fulfils all the requirements of Com- munity law, on grounds relating to lack of competence or to procedural defects, the 6 — [1984] ECR 251, paragraph 10. attainment of this objective might be jeopar-

18. The Italian provision has the conse- 16. Article 21 of Directive 65/65 provides quence that a marketing authorization lapses that an authorization may be refused, sus- unless it is used within 18 months of issue. pended or revoked only on the grounds set Therefore the effects of this provision are the out 'in this Directive'. However, there arc same as those of revocation within the mean- now other provisions on which such mea- ing of Directive 65/65. In both cases an exist- sures may be based. For example, as already ing authorization is discontinued. mentioned, under certain circumstances an authorization may be suspended if the label- ling provisions of Directive 92/27/EEC arc not complied with. 9 Therefore the Commis- sion is right to suggest that the reply to the 19. The Italian and Portuguese Governments first question from the national court should claim, however, that lapse ('decadenza') dif- not be limited to Directive 65/65, but should fers from revocation in that, in the frame- work of the revocation procedure, the authorities reassess the benefits of the prod- uct, whereas lapse is the automatic conse- 7 — See the similar problem raised by Advocate General Jacobs in his opinion of 16 June 1993 in Case C 212/91 Angelop- quence of the expiry of the fixed period. I barm (not yet published in ECR), at paragraph 70. There trie am not persuaded by this view, which is con- question was whether a national court could treat as invalid a national provision which was adopted in order to implement fined to the activity of the administrative a directive, if the grounds of invalidity arise from national law. authorities. Directive 65/65, with its prohibi- 8 — Judgment in Case C-106/89 Marleasing v La Comercial tion on annulling an authorization on Internacional de Alimentación [1990] ECR 1-4135, at para- graph 8; settled case-law. grounds other than those stated in the direc- 9 — Sec paragraph 4 above. It should be observed that this dircc tive, is addressed not only to the administra- live replaced the labelling provisions which were originally included in Directive 65/65 (see Articles 13 to 20). tive authorities, but to ail authorities and

In the present case this period is 18 months. However, Article 10 of Directive 65/65 pro- vides that an authorization for marketing 20. The Italian Government points out that proprietary medicinal products is valid for Article 19(11) of Law no 67 has in the mean- five years. The directive does not require the time been repealed and replaced by Article authorization to be used within a particular 11(4) of Legislative Decree No 178 of period. The Commission also correctly 29 May 1991. 11The latter provides that the points out that there are circumstances holder of an authorization must pay a sec- which may delay the marketing of such a ond time the State fee prescribed for the product for which the holder of the authori- issue of the authorization if he does not mar- zation could not be held responsible. The ket the proprietary medicinal product within Italian provision is manifestly incompatible 18 months. On the other hand, there is no with Article 10. mention of the authorization lapsing. It can- not be denied that the reference from the national court was made on the basis of the previous law, so that this new rule cannot be examined in detail here. However, it may be 22. Furthermore, there appear to be no observed that this amendment — which, grounds which would dictate that the Italian according to the submissions of the Italian provision be regarded as nevertheless com- Government, only confirms the 'ratio' of the patible with Community law. In particular, it former provision — does not seem apt to cannot be alleged that this provision is nec- support the Portuguese Government's view essary to safeguard public health. It is not that the Italian provision serves to safeguard clear what risks there may be to public public health. It is more likely that fiscal health from a product which has been autho- considerations also played a part when the rized for marketing, but which has not yet measure was adopted. been placed on the market.

24. I therefore propose that the following replies be given to the questions from the Italian Consiglio di Stato:

(1) Article 21 of Directive 6 5 / 6 5 / E E C must be interpreted as meaning that the suspension or revocation of an authorization to market medicinal products may be effected only on the grounds laid d o w n in that directive or other rel- evant provisions of C o m m u n i t y law.

(2) A national provision to the effect that, if an authorization to market medicinal products is not used within a specified period, it shall lapse is incompatible with the provisions of Directive 6 5 / 6 5 / E E C .

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