Opinion of Advocate General
Mr President,
Members of the Court,
1. In this case the Court is asked to interpret Articles 13 and 20 of the free-trade Agreement between the Community and the Republic of Austria, which substantially follow the wording of Articles 30 and 36 of the EEC Treaty.
2. The facts which gave rise to these proceedings are relatively straightforward and may be summarized as follows.
3. After making an unsuccessful administrative objection, Eurim-Pharm brought an action before the Verwaltungsgericht (Administrative Court) Berlin, arguing that the national rules in question infringed the prohibition on measures having equivalent effect to quantitative restrictions laid down by Articles 13 and 20 of the Agreement between the Community and Austria. In particular, the requirement that an importer of a medicine from Austria produce documentation for that medicine, when the authority of the importing Member State had already authorized the marketing thereof by the manufacturer's designated distributor and already had all the necessary documents, constituted a measure having equivalent effect prohibited by those articles. That was especially so where, as in the present case, the documentation in question was unobtainable in practice without the consent of the manufacturer or its authorized distributors.
4. Eurim-Pharm maintains that its arguments are confirmed by the judgment in the De Peijper case, concerning the parallel importation of medicines between Member States. In the applicant's view, the ruling in that judgment, even though it relates to intra-Community trade, applies equally to a product imported from Austria, since Articles 13 and 20 of the above Agreement and Articles 30 and 36 of the EEC Treaty are similar in content and pursue the same objective, namely the elimination of obstacles to trade.
5. The national court, having ascertained for a fact that the product intended to be imported in parallel from Austria is identical with the product already marketed in Germany, is inclined to hold that, if it were to apply De Peijper to the case before it, the refusal by the German health authorities would be found incompatible with Community law. Since, however, the court is unsure whether that judgment is applicable in its entirety and in any event in the context of a free-trade agreement, it asks the Court to clarify whether, as regards the parallel importation of medicines, Articles 13 and 20 of the Agreement between the Community and Austria are to be interpreted in the light of the same principles as Articles 30 and 36 of the EEC Treaty. If that were so, it would follow that authorization to market a medicine imported into Germany from Austria, which was absolutely identical to a nonparallel product already authorized in Germany, could not be made subject to the condition that the importer provide the competent health authority with documents or information already in its possession.
6. Before considering the merits of that question, it will be useful to consider a number of preliminary issues.
7. Let me say straight away that I find such a restrictive reading of the Agreement devoid of substance and, in the final analysis, unconvincing.
8. Secondly, it seems to me that to read an agreement such as this one in a manner calculated significantly to limit its scope is incompatible with its aims and its context.
9. Moreover, as stated in the preamble to the Agreement, the Contracting Parties' decision progressively to eliminate the obstacles to substantially all their trade should be seen in the general context of the provisions of the General Agreement on Tariffs and Trade (GATT) concerning the establishment of free-trade areas. Under Article XXIV (8), a free-trade area is to be understood to mean a group of two or more customs territories in which the duties and other restrictive regulations of commerce ... are eliminated on substantially all the trade between the constituent territories in products originating in such territories.
10. If, therefore, the Agreement was intended primarily to promote the export of products originating in one Contracting State to the other, it follows that there is nothing in it which calls for a restrictive interpretation. On the contrary, the absence of any precise wording along those lines and the general context referred to above suggest that it would be arbitrary to adopt an interpretation which, by completely excluding the possibility of the reimportation of products from the scope of the Agreement, may considerably impede the flow of trade and thereby reduce the benefits that an agreement of this kind is intended to achieve.
11. The Italian Government argues that the national court was wrong to refer to Articles 13 and 20 of the Agreement, and that the relevant provision in this case is Article 15(2), which is narrower in scope and provides that the Contracting Parties shall apply their agricultural rules in veterinary, health and plant health matters in a nondiscriminatory fashion and shall not introduce any new measures that have the effect of unduly obstructing trade.
12. Before turning to the merits of the question referred, the further issue arises as to whether the relevant provisions of the Agreement may be pleaded before the national court.
13. Moreover, in Case 104/81 Kupferberg 1, when faced with the question of the direct applicability of Article 21 of the free-trade agreement between the Community and Portugal, the Court stated, having dismissed a number of objections based in particular on potential lack of reciprocity and on the existence of a special institutional framework for consultations and negotiations in relation to the implementation of the agreement, that its purpose was to create a system of free trade in which rules restricting commerce are eliminated in respect of virtually all trade in products originating in the territory of the parties, in particular by abolishing customs duties and charges having equivalent effect and eliminating quantitative restrictions and measures having equivalent effect. The Court therefore concluded that the first paragraph of Article 21 of that agreement, drafted in similar terms to the first paragraph of Article 95 of the EEC Treaty, imposes on the Contracting Parties an unconditional rule against discrimination in matters of taxation, which is dependent only on a finding that the products affected by a particular system of taxation are of like nature, and the limits of which are the direct consequence of the purpose of the agreement. As such, this provision may be applied by a court and thus produce direct effects throughout the Community.
14. Since the structure of the agreement examined by the Court in the Kupferberg I judgment was similar to that of the agreement in this case, and since Articles 13 and 20 of the Agreement with Austria substantially restate the prohibition on measures having equivalent effect contained in Articles 30 and 36 of the Treaty, it seems to me that the Court's reasoning in Kupferberg I can easily be applied to this case. Furthermore, although it did not deal with the question expressly, the Court seems to have impliedly recognized the direct applicability of a provision contained in the free-trade agreement between the Community and Switzerland, and drafted in the same terms as Article 13 of the Agreement in this case.
15. Turning now to the interpretation of the provisions which form the subject-matter of the reference, the first point to be made is that, according to a settled line of authority, the interpretation of provisions in the EEC Treaty cannot be applied by way of simple analogy to the corresponding provisions of a free-trade agreement.
16. Whilst, therefore, it is true in principle that an interpretation given by the Court in the context of the EEC Treaty is not automatically applicable in the context of an agreement with a nonmember country, it is equally true that, when faced With provisions drafted in substantially identical terms and laying down rules of fundamental importance in the context either of the EEC Treaty or of a free-trade agreement, it is still necessary to determine the specific reasons which may lead to a divergent interpretation.
17. That, in my view, is the more correct reading of the Polydor judgment which also appears to be confirmed by the most recent case-law.
18. In that case, the Court first pointed out that national rules or practices which result in imports being channelled in such a way that only certain traders can effect them, whilst others are prevented from doing so, constitute measures having an effect equivalent to quantitative restrictions prohibited by Article 30 of the Treaty.
19. The Court made a distinction between, on the one hand, the documents relating to a medicinal preparation in general, in that case the file prescribed by the Netherlands legislation, and, on the other, those relating to a specific batch of that preparation imported by a particular trader, in that case the records prescribed by the same legislation.
20. The Court came to essentially the same conclusion with regard to the documents relating to specific batches of the imported medicinal preparation, since, whilst recognizing that the supervisory authorities must be able to check with absolute certainty and at any time whether a particular batch of the product complies with the particulars on the file, the Court found, first, that national authorities do not lack legislative and administrative methods capable of compelling the manufacturer or its sole importer to supply particulars making it possible to ascertain that the medicinal preparation imported in parallel in the particular case is identical with the medicinal preparation in respect of which the file has already been lodged, and, secondly, that simple cooperation between such authorities would enable them to obtain on a reciprocal basis the documents necessary for checking certain largely standardized and widely distributed products.
21. Finally, basing its reasoning once again on the ability of the competent authority of the importing Member State to obtain data and information from the manufacturer or its sole importer, the Court emphasized that the same answer applies to the case where the imported medicinal preparation constitutes a variant of the product already authorized, provided the differences are insignificant and do not have therapeutic effects.
22. The Commission and the two governments which have intervened in this case argue that the Court's approach in the De Peijper judgment was made possible by the progress which had already been made at that time in harmonizing legislation on medicines and by the cooperation existing between the administrations of the Member States in that sector.
23. Although I might be able to subscribe to those arguments in general terms, they do not seem to me to be relevant to the specific case referred by the national court.
24. Nor am I swayed by the objections made in the course of the proceedings concerning the risk that the provisions of the Agreement might be read differently by the other party and that the Agreement itself might thus be applied differently, in a manner capable of affecting conditions of competition in commercial relations between the Community and Austria.
25. Before concluding, however, I would like to allay the fear raised by the United Kingdom concerning the possibility that, if the Agreement were to be interpreted in such a way as to encourage parallel imports of medicinal products, European undertakings would be encouraged to increase the prices of medicinal products marketed in those developing countries towards which the Community has undertaken unilaterally to abolish obstacles to imports.
26. In the light of the above considerations, I therefore propose that the Court give the following answer to the question submitted by the Verwaltungsgericht Berlin:
1 Original language: Italian.
2 OJ, English Special Edition 1972 (31 December), p. 4.
3 Case 104/75 [1976] ECR 613.
4 Case C-18/90 Kziber [1991] ECR I-199, paragraph 15; Case 12/86 Demirel [1987] ECR 3719, paragraph 14.
5 [1982] ECR 3641.
6 Case 65/79 Châtain [1980] ECR 1345.
7 Kupferberg ƒ, cited above, paragraph 30; Case 270/80 Polydor [1982] ECR 329, paragraphs 15 and 16.
8 Case 225/78 Bouhelier [1979] ECR 3151, paragraph 6.
9 See Article 31(1), whereby a treaty shall be interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose.
10 I recall here the ancient rule of interpretation, attributed to Celsus, whereby: Incivile est, nisi tota lege perspecta, una aliqua particula eius proposita, iudicare vel respondere.
11 In the recent judgment in Case C-163/90 Legros [1992] ECR I-4625, paragraph 26, the Court, referring to the free-trade agreement with Sweden, considered that the agreement would be deprived of much of its effectiveness if the term charge having equivalent effect contained in Article 6 of the agreement were to be interpreted as having a more limited scope than the same term appearing in the EEC Treaty.
12 Paragraph 4.
13 See 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 products (OJ, English Special Edition 1965-1966, p. 20); Council Directive 75/318/EEC 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 (OJ 1975 L 147, p. 1); Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietarv medicinal products (OJ 1975 L 147, p. 13).
14 Sec, in particular, Articles 8 to 15 of Directive 75/319/EEC and Council Decision 75/320/EEC of 20 May 1975 setting up a pharmaceutical committee (OJ 1975 L 147, p. 23).
15 OJ 1982 C 115, p. 5.