C-207/91

Mr President, 3. After making an unsuccessful administra- Members of the Court, tive objection, Eurim-Pharm brought an action before the Verwaltungsgericht (Administrative Court) Berlin, arguing that the national rules in question infringed the 1. In this case the Court is asked to interpret prohibition on measures having equivalent Articles 13 and 20 of the free-trade Agree- effect to quantitative restrictions laid down ment between the Community and the by Articles 13 and 20 of the Agreement Republic of Austria, ' which substantially between the Community and Austria. In follow the wording of Articles 30 and 36 of particular, the requirement that an importer the EEC Treaty. of a medicine from Austria produce docu- mentation for that medicine, when the auth- ority of the importing Member State had 2. The facts which gave rise to these pro- already authorized the marketing thereof by ceedings are relatively straightforward and the manufacturer's designated distributor may be summarized as follows. 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, Eurim-Pharm, a company whose registered the documentation in question was unob- office is in Germany, wished to offer for sale tainable in practice without the consent of on the German market a drug called 'Adalat', the manufacturer or its authorized distribu- manufactured in France by Bayer and dis- tors. tributed by the latter under the same name in Austria and Germany. For that purpose, Eurim-Pharm bought Adalat on the Austrian market intending to resell it in Germany, in parallel with Bayer's distribution network, after attaching a label with its own company 4. Eurim-Pharm maintains that its argu- name. ments are confirmed by the judgment in the De Peijper case, 2 concerning the parallel importation of medicines between Member However, the German health authorities States. In the applicant's view, the ruling in rejected the application for marketing autho- that judgment, even though it relates to rization because it lacked the information intra-Community trade, applies equally to a which national rules required to be commu- product imported from Austria, since Arti- nicated to the supervisory authority. cles 13 and 20 of the above Agreement and Articles 30 and 36 of the EEC Treaty are

similar in content and pursue the same In their opinion, the purpose of the Agree- objective, namely the elimination of obsta- ment, which is to foster the development of cles to trade. the economic activities of the Contracting Parties through a liberalization of trade, implies that, in order to benefit from the free-trade regime provided for, the product must necessarily have undergone some pro- 5. The national court, having ascertained for cessing in the exporting country. In other a fact that the product intended to be words, the Agreement applies to products imported in parallel from Austria is identical originating in Austria which are imported with the product already marketed in Ger- into the Community, and vice versa, but not many, is inclined to hold that, if it were to to products originating in a Community apply De Peijper to the case before it, the country which, after merely passing through refusal by the German health authorities Austria, are reimported into the Community. would be found incompatible with Commu- nity 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 impor- tation of medicines, Articles 13 and 20 of the 7. Let me say straight away that I find such Agreement between the Community and a restrictive reading of the Agreement devoid Austria are to be interpreted in the light of of substance and, in the final analysis, the same principles as Articles 30 and 36 of unconvincing. the E E C Treaty. If that were so, it would fol- low that authorization to market a medicine imported into Germany from Austria, which was absolutely identical to a non-parallel product already authorized in Germany, could not be made subject to the condition that the importer provide the competent health authority with documents or infor- First, as regards the wording, although Arti- mation already in its possession. cle 2, which defines the scope of the Agree- ment, stipulates that it is to apply to prod- ucts originating in the Community or in Austria, it makes no reference to any requirement that the Community products should be exported to Austria or vice versa. 6. Before considering the merits of that question, it will be useful to consider a num- ber of preliminary issues.

Under Article 1, the aim of the Agreement is regulations of commerce ... are eliminated on to promote through the expansion of recip- substantially all the trade between the con- rocal trade the harmonious development of stituent territories in products originating in economic relations between the Contracting such territories'. Parties, and thus to foster the advance of economic activity, the improvement of living and employment conditions, and increased productivity and financial stability, while at 10. If, therefore, the Agreement was the same time providing fair conditions of intended primarily to promote the export of competition for trade between the Contract- products originating in one Contracting ing Parties. 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 inter- pretation which, by completely excluding the The Agreement therefore provides for the possibility of the reimportation of products abolition of customs duties and charges hav- from the scope of the Agreement, may con- ing equivalent effect in trade between the siderably impede the flow of trade and Community and Austria (Articles 3 to 7). thereby reduce the benefits that an agree- The same principle is applied to quantitative ment of this kind is intended to achieve. restrictions and measures having equivalent effect (Article 13). Those provisions are com- plemented by the prohibition of discrimina- tory fiscal measures and practices (Article 11. The Italian Government argues that the 18) and by the abolition of all restrictions on national court was wrong to refer to Articles payments relating to trade in goods (Article 13 and 20 of the Agreement, and that the rel- 19). The Agreement also contains a number evant provision in this case is Article 15(2), of provisions concerning competition, public which is narrower in scope and provides that aid and dumping practices (Articles 23 and 'the Contracting Parties shall apply their 25). agricultural rules in veterinary, health and plant health matters in a non-discriminatory fashion and shall not introduce any new measures that have the effect of unduly obstructing trade.'

which, following the example of Article 13. Moreover, in Case 104/81 Kupferberg 36 of the EEC Treaty, permits restrictions 1,4 when faced with the question of the and prohibitions which are justified on direct applicability of Article 21 of the free- grounds of human health provided they do trade agreement between the Community not constitute a means of arbitrary discrimi- and Portugal, the Court stated, having dis- nation or a disguised restriction on trade missed a number of objections based in par- between the Contracting Parties. ticular on potential lack of reciprocity and on the existence of a special institutional framework for consultations and negotia- tions 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 virtu- 12. Before turning to the merits of the ques- ally all trade in products originating in the tion referred, the further issue arises as to territory of the parties, in particular by abol- whether the relevant provisions of the ishing customs duties and charges having Agreement may be pleaded before the equivalent effect and eliminating quantitative national court. 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 The Court's case-law on that point seems to in matters of taxation, which is dependent me to be sufficiently abundant and clear as to only on a finding that the products affected enable an appropriate solution to be found in by a particular system of taxation are of like a case such as this without too much diffi- nature, and the limits of which are the direct culty. consequence of the purpose of the agree- ment. As such, this provision may be applied by a court and thus produce direct effects throughout the Community.'

easily be applied to this case. Furthermore, Vienna Convention on the Law of Treaties, 8 although it did not deal with the question whereby a rule is to be interpreted having expressly, the Court seems to have impliedly regard to the most general context in which recognized the direct applicability of a provi- it appears. 9 sion 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. 5 16. Whilst, therefore, it is true in principle that an interpretation given by the Court in the context of the EEC Treaty is not auto- matically applicable in the context of an agreement with a non-member country, it is 15. Turning now to the interpretation of the equally true that, when faced With provisions provisions which form the subject-matter of drafted in substantially identical terms and the reference, the first point to be made is laying down rules of fundamental impor- that, according to a settled line of authority, tance in the context either of the EEC Treaty the interpretation of provisions in the EEC or of a free-trade agreement, it is still neces- Treaty cannot be applied by way of simple sary to determine the specific reasons which analogy to the corresponding provisions of a may lead to a divergent interpretation. free-trade agreement. 6

17. That, in my view, is the more correct reading of the Polydor judgment which also However, whilst that statement of principle appears to be confirmed by the most recent is perfectly acceptable in itself, it must be case-law. 10 seen in its proper perspective and is certainly not intended to encourage or justify in gen- eral terms divergent interpretations of the EEC Treaty and the corresponding rules in free-trade agreements to which the Commu- In any event, I believe that the De Peijper nity is a party. judgment cited above, ' ' in which the Court answered two questions raised in criminal proceedings brought by the Rotterdam

district prosecutor against a trader accused of on a previous occasion, all the pharmaceuti- supplying medicines imported from the cal particulars relating to the medicinal prep- United Kingdom to Netherlands pharmacies aration in question and considered to be without the authorization of the competent absolutely necessary for the purpose of authorities, has to be seen in that perspective. checking that the medicinal preparation is effective and not harmful, it is clearly unnec- essary, in order to protect the health and life of humans, for the said authorities to require 18. In that case, the Court first pointed out a second trader who has imported a medici- that national rules or practices which result nal preparation which is in every respect the in imports being channelled in such a way same, to produce the abovementioned partic- that only certain traders can effect them, ulars to them again. Therefore national rules whilst others are prevented from doing so, or practices which lay down such a require- constitute measures having an effect equiva- ment are not justified on grounds of the pro- lent to quantitative restrictions prohibited by tection of health and life of humans within Article 30 of the Treaty. the meaning of Article 36 of the Treaty' (paragraphs 21 and 22 of the judgment).

As regards the documents concerning a given pharmaceutical product, the Court pointed out that 'if the public health authorities of 21. Finally, basing its reasoning once again the importing Member State already have in on the ability of the competent authority of their possession, as a result of importation the importing Member State to obtain data

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EURIM-PHARM V BUNDESGESUNDHEITSAMT

and information from the manufacturer or It is on the basis of considerations such as its sole importer, the Court emphasized that these that the Commission and the interven- the same answer applies to the case where ing governments argue that it is not possible the imported medicinal preparation consti- to apply that case-law in the context of a tutes a variant of the product already autho- free-trade agreement which does not provide rized, provided the differences are insignifi- for any harmonization of legislation or even cant and do not have therapeutic effects. any specific obligation on the part of the administrations of the Contracting Parties to cooperate in that sector.

I - 3739

OPINION OF MR TESAURO — CASE C-207/91

24. N o r am I swayed by the objections 25. Before concluding, however, I would made in the course of the proceedings con- like to allay the fear raised by the United cerning the risk that the provisions of the Kingdom concerning the possibility that, if Agreement might be read differently by the the Agreement were to be interpreted in other party and that the Agreement itself such a way as to encourage parallel might thus be applied differently, in a man- imports of medicinal products, European ner capable of affecting conditions of compe- undertakings would be encouraged to tition in commercial relations between the increase the prices of medicinal products Community and Austria. marketed in those developing countries towards which the Community has undertaken unilaterally to abolish obstacles Given that such a possibility always exists to imports. when a court or tribunal of one of the Con- tracting Parties is called upon to apply the rules of an international treaty, I do not con- sider that anything has emerged in the course of the present proceedings to suggest that the other contracting party might be entitled to regard as compatible with the Agreement Apart from anything else, the aforesaid crite- measures which encourage the channelling of ria laid down by the Court for interpreting imports and which do not have any justifica- provisions in international agreements, tion in terms of protecting human health. which are based in particular on the nature Moreover, any potential divergence in the and purpose of the agreement, do not in any application of the Agreement could be ade- event allow an interpretation given in the quately resolved using the procedure for the context of a free-trade agreement to be auto- settlement of disputes laid down by the matically applied in the context of an agree- Agreement itself. ment with developing countries.