Opinion of Mr Advocate General Capotorti

Mr President,

Members of the Court,

1. This case again brings up for your consideration the issue of the conformity with Community law of national provisions which have or may have a restrictive effect on the importation of pharmaceutical products and in particular on what are know as parallel imports. I would recall that in the judgment delivered on 20 May 1976 in Case 104/75 De Peijper [1976] ECR 613 the Court held that national rules which made permission to market pharmaceutical products dependent on the production of documents not usually available to the national importer were unlawful. On that occasion the Court observed that national rules of that kind have effects equivalent to those of a quantitative restriction on imports since they enable a manufacturer and his exclusive dealers to enjoy a monopoly of importing and marketing the products simply by refusing to produce the documents in question.

2. Although the question is formulated in general terms and thus appears formally to accord with the requirements of Article 177 of the EEC Treaty, it is in fact concerned with whether or not that part of the Netherlands legislation governing trade in medicinal products which deals with the fees payable on the registration of products which have been imported in parallel is in accordance with Community law. It follows that the Court is once again required to resolve within the framework of proceedings for a preliminary ruling a question which could have been considered in greater depth if the Commission had instituted a direct action under Article 169 of the EEC Treaty. There are thus grounds for fearing that it will not be easy to provide the national court, through the reply to a hypothetical question referred to the Court of Justice by the court seised of the main action, with the particular information which it requires and which relates to specific aspects of the relevant Netherlands legislation.

3. The first of the issues raised by the Netherlands court is whether, having regard to Community rules on the free movement of goods, it is lawful for a Member State to require parallel importers of pharmaceutical products to pay a registration fee.

4. I shall now endeavour to establish whether the provisions of the Treaty on the free movement of goods permit Member States to require payment of fees from parallel importers as a condition of their placing pharmaceutical products on the market.

5. I have already noted that the question which has been submitted to the Court of Justice refers specifically to Article 36 of the EEC Treaty. This entails the notion that charging parallel importers fees for the registration of medicinal products may be considered a measure having an effect equivalent to quantitative restrictions which is nevertheless capable of qualifying for the exemption referred to in Article 36 as a restriction intended to protect health.

6. The conclusion which I have just reached remains valid even where certain differences exist between the treatment accorded to importers and that given to domestic producers provided that such differences are not so marked as to preclude their being regarded as features of substantially one single system.

7. Once it has been established that the registration fee for medicinal products must be appraised in the light of Article 95 it remains to ascertain what deductions may be drawn from that provision with regard to the treatment of parallel importers. In seeking to do so, it is necessary also to broach the second issue raised by the national court, namely the standards which should be applied to the amount and frequency of the payments and the system governing the payments. Nevertheless in this connexion I am bound to repeat what I pointed out at the outset: the reply to a question of this nature which is in abstract terms can only be general whilst taking into consideration the details of the specific case goes beyond the function of these proceedings.

8. On the basis of all the considerations which have been set out above I propose that the reply to be given to the question submitted to the Court of Justice by the Arrondissementsrechtbank Roermond, The Netherlands, by judgment of 4 November 1979 should be as follows:

1 Translated from the Italian.