C-317/92

* Original language: French. 1 — Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal prod­ ucts (OJ, English Special Edition 1965-1966, p . 20). 2 — Law of 24 August 1976 ( Bundesgesetzblatt /, 1976, p . 2445, 2448) amended on 16 August 1986 ( Bundesgesetzblatt I, 4. It is necessary, before tackling those two 1986, p . 1296), on 20 July 1988 ( Bundesgesetzblatt I, 1988, questions on substance, to examine the p . 1050) and 11 April 1990 ( Bundesgesetzblatt I, 1990, p . objection of inadmissibility raised by the 3 — Bundesgesetzblatt I,1985, p. 546. defendant State, according to which the 4 — Bundesgesetzblatt I, 1988, p . 480. 5 — Article 2(2)(1)(a) of the Law of 24 August 1976, cited above Commission has no legal interest in bringing in footnote 2. proceedings.

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5. In that connection, the Commission is in Commission v Belgium, explicitly stating criticized, on the one hand, for failing to that: bring its action within a reasonable period from that stated in the reasoned opinion, and, on the other hand, for failing to proceed with the default proceedings during consul­ tations leading up to the adoption of Council Directive 92/27/EEC of 31 March 1992 on '(...) the rules contained in Article 169 of the the labelling of medicinal products for Treaty must be applied and the Commission human use and on package leaflets, which is not obliged to act within a specific harmonizes the subject of expiry dates and 9 period'. which the Federal Republic of Germany is preparing to transpose.

OPINION OF MR DARMON — CASE C-317/92

opinion, and even when the default has been 13. Article 13 of the directive provides: remedied subsequently to the time-limit pre­ scribed by paragraph 2 of the same Article, 10 pursuit of the action still has an object'.

'The following particulars shall appear on containers and outer packages of proprietary medicinal products:

11. The objection of inadmissibility must therefore be dismissed and the two claims set out by the Commission in support of its action must be considered.

1 7. Expiry date in plain language.' 1

I — The barrier to intra-Community trade

2. Medicinal product: 16. That obligation and its potential conse­ quences as far as the increased cost of prod­ ucts and the reduction in their marketing periods are concerned led the Commission to commence the present proceedings.

Any substance or combination of sub­ stances presented for treating or pre­ venting disease in human beings or ani­ mals. 17. The explanations given by the Federal Republic of Germany in order to justify that obligation did not satisfy the Commission, which sees it as a measure having equivalent effect to a quantitative restriction on imports.

Any substance or combination of sub­ stances which may be administered to human beings or animals with a view to making a medical diagnosis or to restor­ 18. The question which arises is therefore ing, correcting or modifying physiolo­ the following: should restricting to two a gical functions in human beings or in ani­ year the expiry dates which can be used, be mals is likewise considered a medicinal deemed to be a measure having equivalent product.' effect to the quantitative restrictions prohib­ ited under Article 30 of the Treaty in so far as it entails an increase in the cost of the products originating in other Member States and a reduction in their marketing period?

15. In transposing the provisions of the aforementioned Article 13, the German legis­ lation imposed, for all medicinal products within the meaning of the directive, for vet­ 19. The Court's case-law warrants an affir­ erinary medical products within the meaning mative reply to that question. 12 of Directive 81/851/EEC and for non- reusable sterile medical instruments, a duty to show, as the expiry date, either 30 June 1 or 31 December. 3

21. The Court's judgment in Keck and 24. Moreover, the duty to comply with the 16 Mithouard seems to me to have no bearing contested measure entails mandatory amend­ on this case. The Court simply excluded ment of product labelling and accordingly from the scope of the Dassonville judgment involves an additional cost which may make national provisions which restrict or prohibit sales in the German market more difficult. certain rules governing sale provided that they apply to all operators concerned and that they affect domestic products and those originating in other Member States similarly. The Court held that, in such circumstances, the implementation of those provisions is 25. In its judgment in Merci convenzionali not, for those products, 'such as to prevent 19 porto di Genova, the Court stated that a their access to the market or to impede domestic measure is contrary to Article 30 access any more than it impedes the access of 17 where it is capable of having a restrictive domestic products'. effect on trade between the Member States, and in particular where the imports of prod­ ucts originating in other Member States are rendered more costly and more difficult.

operators in general, and, more particularly, by several months the marketing period for by a producer or distributor of proprietary the products concerned. medicinal products acting furthermore, it should be recalled, within the scope of a Community regulation which aims, whilst ensuring that public health is safeguarded, to prevent hindrances to the development of the pharmaceutical industry or trade in medicinal products within the Commun­ 31. Here again there is an undoubted impact 20 ity. on marketing, which, together with the increase in the cost of the products described above, must be taken into consideration in deciding whether the prohibition in Article 30 applies to the contested measures. 28. However, in addition to the hindrance resulting from the increased cost of imported products, the hindrance arising from the reduction in their marketing period must be noted. Clearly, any change of date, under the conditions imposed by the German legisla­ 32. The size of that impact is not important. tion, reduces the marketing period for the relevant medicinal products whose validity It follows from the judgment in the Prantl 21 for a longer period, in so far as their thera­ case that: peutic value is concerned, is not in dispute.

29. Were it not for an obligation of the kind 'it is sufficient that the measures in question imposed by the German legislation, import­ are liable to impede, directly or indirectly, ers would have the right to sell their medic­ actually or potentially, trade between the inal products until expiry of the period of Member States. It is not necessary that they stability determined in the State of origin on should have an appreciable effect on intra- the grant of authorization for placing the Community trade', product on the market, and could import others whose remaining period of stability, at the time of the request for importation, was short.

34. Can it therefore be considered, in order to exclude the barrier from the prohibition in Article 30, that the measure it stems from 38. Therefore the question must be exam­ satisfies mandatory requirements within the ined in the context of Article 30 in view of meaning of the Court's judgment in the Cas- the reliance placed on the submission relat­ 23 sis de Dijon case? This submission is put ing to the protection of public health. forward in the alternative, by the Federal Republic of Germany.

39. Has the German Government justified the duty to show biannual expiry dates, in the light of Community law? 35. The protection of health was included among the mandatory requirements listed in that judgment. The defendant State relies on 24 — On that point, see Manfred A. Dauses 'Measures having that imperative. equivalent effect to quantitative restrictions in the light of the case-law of the Court of Justice of the European Com­ munities', RTDE 28 (4), October-December 1992, p . 607, in particular pp. 615 et seq. 25 — See judgments in Case 35/76 Simmenthal [1976] ECR 1871 and Case 28/84 Commission v Germany [1985] ECR 3097, 23 — Judgment in Case 120/78 REWE-Zentral [1979] ECR 649. paragraph 25.

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40. In the absence of harmonization, the and that, Court accepts that it is for the Member States to decide to what extent they intend to safeguard the protection of health. It is cor­ rect to say that the only information 26 required under Community legislation with regard to the duration of validity of 'in those circumstances, (...) it is for the products is a clear indication of the expiry national authorities to determine (...), for date. each product, (...) the way in which it is used (...)',

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45. The Court noted that principle in its 48. The clear indication on the packaging of judgment in Council of the City of Stoke-on- the proprietary medicinal products, of the Trent and Norwich City Council v B&Q: expiry dates of those products, as required by law in the State of origin, by the labora­ tories which produce them, subject to the relevant checks and in particular to market­ ing authorizations seems to me adequately to satisfy the objective of the protection of the 'Appraising the proportionality of national health of users. The essential aim in the rules which pursue a legitimate aim under present case is to prevent users from coming Community law involves weighing the into contact with expired products. national interest in attaining that aim against the Community interest in ensuring the free movement of goods. In that regard, in order to verify that the restrictive effects on intra- Community trade of the rules at issue do not exceed what is necessary to achieve the aim in view, it must be considered whether those effects are direct, indirect or purely specula­ 49. Moreover, all the proprietary medicinal tive and whether those effects do not impede products produced in the Member States fea­ the marketing of imported products more ture an expiry date which satisfies that objec­ than the marketing of national products.' tive and compliance with Community provi­ sions requiring a clear indication of that date on the packaging is manifestly sufficient to protect users.

46. The Court has consistently held that the principle of proportionality requires in par­ ticular that a Member State having a choice between several measures capable of attain­ ing the same objective must 'choose the 50. The additional safeguard which may means which least restrict the free movement possibly result from biannual dating does 30 of goods'. not therefore seem necessary to protect health.

52. The Federal Government does not show beyond what is necessary to attain the objec- why it is necessary to bring forward the tive justified under Community law'. dates in order to increase safety, and this all the more so since the alleged margin of secu­ rity is of a different duration according to whether the initial expiry date shown on the product is closer or further from 30 June or 31 December. 55. It is worth reiterating that whereas it is for national authorities to choose appropri­ ate measures, it is also for them to establish that they are justified. In my view, that has not been proved by the Federal Republic of 53. Furthermore, to add such a margin is Germany which submits merely that it also inconvenient in that the different sought to protect public health. The practical periods of validity of the various proprietary implementation of that aim, undoubtedly a medicinal products are, contrary to what the legitimate one, involved techniques corre­ defendant State maintains, not all of several sponding clearly to national professional years' duration. practices for which, however, no evidence was available to suggest that they were nec­ essary in order to attain the desired objec­ tive.

54. Nor does simplifying the verification of the validity of products appear to me to be capable of affording justification, on grounds of protection of public health, for the obliga­ tion of biannual dating. The Federal Govern­ 56. I conclude, therefore, that the contested ment has not shown how the simplification measure should be held by the Court to have of stock-management for pharmacists, facili­ an equivalent effect to a quantitative restric­ tated by restricting to two expiry dates on tion on imports, within the meaning of packaging, was the only measure capable of Article 30 of the Treaty. guaranteeing safety in the distribution of products. As noted by Mr Advocate General Van Gerven in his Opinion in the Keck and 31 Mithouard cases, II — The failure to notify the Commission

62. The Order clearly provides, de jure, that the packaging of the products concerned must feature an expiry date of 30 June or 31 59. The Commission considered that the December. Federal Republic of Germany, by failing to notify of it of the Order which, it claims, contrary to the view of the defendant State, contains a technical regulation, has contra­ vened Articles 8(1) and 9(1) of Direc­ tive 83/189/EEC. 63. It is therefore a national provision intro­ ducing a new technical rule and it does not constitute merely a transposition by the Fed­ eral Republic of Germany of an obligation arising from an international agreement or a Community directive, since the directive 60. That directive provides, in Article 10, relied upon by the German authorities does that Articles 8 and 9 do not apply where not provide for an indication of an expiry Member States honour their obligations aris­ date for non-reusable sterile medical instru­ ing out of Community directives or commit­ ments. ments arising out of an international agree­ ment where they result in the adoption of uniform technical specifications in the Com­ munity.

64. The failure to fulfil obligations which is 32 — Council Directive 83/189/EEC of 28 March 1983 laying alleged in this head of claim is therefore down a procedure for the provision of information in the field of technical standards and regulations (OJ 1983 L 109, established in so far as it is based on p. 8). Article 8(1) of Directive 83/189/EEC.

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