Report for the Hearing delivered in Case 215/87
I — Facts
On 28 December 1983, Heinz Schumacher applied to the Zollamt Post Domplatz for customs clearance of a consignment of Chophytol a medicinal preparation which had been sent to him by Pharmacie du Dôme, Strasbourg, where he had purchased it.
His application was rejected on 3 January 1984 on the ground that the import was prohibited by Paragraph 73(1) of the Gesetz zur Neuordnung des Arzneimittelrechts (AMG') (Law of 24 August 1976 amending the law on medicines, Bundesgesetzblatt I, 1976, pp. 2445 et seq.) which allows the importation of such products, where they come from a Member State of the European Communities, only if the consignee is a pharmaceutical undertaking or wholesaler or veterinary surgeon or operates a pharmacy.
Mr Schumacher's administrative appeal against that decision was rejected by the Oberfinanzdirektion Frankfurt am Main on 25 January 1984, and he therefore brought proceedings before the Hessische Finanzgericht (Finance Court, Hesse) for the annulment of those two decisions.
Before that court, Mr Schumacher claimed that Chophytol is manufactured in France but is also authorized in the Federal Republic of Germany, where, moreover, it is available without prescription. He pointed out, however, that in German pharmacies the price of the product is about four times as high as in France. He also claimed that the general prohibition of importation applicable to all private persons under Paragraph 73(1) of the AMG was contrary to Article 30 of the EEC Treaty.
The Hessische Finanzgericht notes that Paragraph 73(1) of the AMG generally prohibits private individuals from importing medicinal preparations, irrespective of whether or not a prescription is required for the medicinal preparation in question or whether it is authorized or registered in Germany and regardless of its availability in a pharmacy in another Member State.
Having regard to the case-law of the Court of Justice on Article 30 et seq. of the EEC Treaty, the Hessische Finanzgericht can see no reason based on the interests of the protection of health or consumers for prohibiting private individuals from importing from other Member States drugs which do not require prescriptions and are authorized for domestic sale.
In those circumstances, the Hessische Finanzgericht referred the following question to the Court of Justice by order of 25 May 1987:
The order for reference was received at the Court Registry on 14 July 1987.
Pursuant to Article 20 of the Protocol on the Statute of the Court of Justice written observations were lodged on behalf of the Government of the Federal Republic of Germany, by Martin Seidel, Ministerialrat at the Federal Ministry of Economic Affairs, assisted by Dietrich Ehle, Rechtsanwalt, Cologne, acting as Agents;
Upon hearing the report of the Judge-Rapporteur and the views of the Advocate General, the Court decided to open the oral procedure without any preparatory inquiry.
By order of 23 November 1988, the Court assigned the case to the Third Chamber pursuant to Article 95(1) and (2) of the Rules of Procedure.
II — Summary of the written observations submitted to the Court
A — The Federal Republic of Germany and Denmark lodged written observations indicating in both cases that they consider legislation of the type at issue in the main proceedings to be compatible with Article 30 et seq. of the EEC Treaty.
1. The German legislation
2. The German Government draws attention to the features of the system for the distribution of medicinal preparations in the Federal Republic of Germany.
3. According to the Government of the Federal Republic of Germany, such a system, of which Paragraph 73 is an essential feature, makes it possible to achieve various purposes, such as the provision of advice for purchasers when the medicinal preparations are supplied, proper labelling of products and adequate information for consumers, guaranteed quality of medicinal preparations and compliance with the provisions relating to their supply and, in particular, the requirement of a medical prescription in certain cases.
4. The Government of the Federal Republic of Germany finally points out that it is not possible to replace the contested Paragraph 73(1) of the AMG by less restrictive rules. The Commission of the European Communities has moreover implicitly recognized that fact, since it has not disputed the compatibility of Paragraph 73(1) with the EEC Treaty, even though it has been regularly kept informed of developments in German legislation.
B — The observations of the Danish Government are to the same effect.
1. The Danish Government first describes the legislation in force in Denmark, under which, in compliance with Directive 65/65 of the Council of 26 January 1965, a pharmaceutical product may not be marketed unless the competent authorities have issued a marketing authorization (Paragraph 13 of the Lov om lægemidler — Law on Pharmaceutical Products).
2. The Danish Government states that in all the Member States the marketing of medicinal preparations is subject to authorization and that such authorization is granted only after the competent national authorities have evaluated the product in question. It must also be remembered that practices in the Member States are different, that Community harmonization is limited at the moment and, moreover, that certain products are deliberately marketed by the producers in only one or two Member States.
C — The Commission of the European Communities and the French Republic consider, on the other hand, that the legislation in question is incompatible with the EEC Treaty.
1 Language of the case: German.