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:

‘Is Paragraph 73(1) of the Gesetz zur Neuordnung des Arzneimittelrechts of 24 August 1976 (Bundesgesetzblatt I, 1976, p. 2445 et seq.) compatible with Article 30 of the EEC Treaty in so far as it generally prohibits the importation by private individuals of medicines from Member States?’

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;

the Government of the Kingdom of Denmark, represented by Laurids Mikaelsen, legal adviser, acting as Agent;

the Government of the French Republic, represented by Régis de Goutte, of the Legal Affairs Directorate of the Ministry of Foreign Affairs, acting as Agent;

the Commission of the European Communities, represented by its Legal

Adviser Jörn Sack, assisted by Reinhard Wagner, a German civil servant seconded to the Commission's Legal Department under the system for exchanges with national civil servants, 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.

a) The Government of the Federal Republic of Germany claims that Articles 30 and 36 of the EEC Treaty must not be interpreted as prohibiting a provision such as Paragraph 73(1) of the AMG which for reasons of the protection of the health and life of humans and animals prohibits the importation of medicinal preparations by private persons within a system for the distribution of medicines.

1. The German legislation Paragraph 73(1) of the AMG reads as follows:

‘Paragraph 73 Prohibition of imports

(1). Medicinal preparations subject to authorization or registration may not be brought into the territory to which the present law applies — with the exception of duty-free areas other than the island of Helgoland — unless they are authorized or registered for circulation within the territory or are exempt from such authorization or registration, and:

1) if the product is imported from a Member State of the European Communities, the consignee is a pharmaceutical undertaking, wholesaler, veterinary surgeon or operates a pharmacy;

2) if the product is imported from another country, the consignee has a permit under Paragraph 72.

(2). Subparagraph 1 shall not apply to medicinal preparations which:

1) in special cases and in small quantities are intended for the requirements of specific animals in connection with exhibitions, competitions or similar events,

2) are intended for the requirements of scientific and research establishments and are necessary for scientific purposes,

3) cross the territory to which this law applies under customs supervision or are re-exported after storage in a customs warehouse or warehouse under customs control,

4) are imported for the use of a foreign Head of State or persons accompanying him during a stay in the territory to which the present law applies,

5) are intended for the personal use or consumption of members of diplomatic missions or consular offices established on the territory to which this law applies or officials of international organizations whose seat is in that territory or for the members of their families, provided that those persons are not German nationals and are not permanent residents of the territory to which this law applies,

6) are imported by travellers in quantities not exceeding those normally appropriate for consumption or use in the course of the travel concerned,

7) are carried in vehicles and are intended exclusively for use or consumption by the persons carried in such vehicles,

8) are intended to be consumed or used on seagoing vessels and are consumed on such vessels,

9) are sent as samples to the competent Federal authority for the purposes of authorization or batch inspection,

10) are acquired by Federal or Land authorities in international trade.

(3). Notwithstanding subparagraph 1, medicinal preparations which are not authorized or registered for circulation in the territory to which this law applies or exempted from such authorization or registration may be imported into the said territory if they are ordered by pharmacies. Pharmacies may acquire such medicinal preparations only in limited quantities on the basis of a prescription from a doctor, dentist or veterinary surgeon and by special order from an individual, and only in the course of the normal operation of the pharmacy; detailed provisions in that connection are laid down in the regulation on the operation of pharmacies. The first sentence shall not apply to medicinal preparations intended to be used on animals used for the production of food.

(4). With the exception of paragraphs 5 and 8, and, in the cases referred to in subparagraph 2, indent 2, and subparagraph 3, first and second sentences, paragraphs 40, 41, 48, 49, 95(1), indent 1, and (2) to (4), 96(2), (3), (10) and (11) and 97(1), (2), indents 1 and 9, and (3), the provisions of the present law shall not apply to medicinal preparations referred to in subparagraphs 2 and 3, first and second sentences.

(5). In the exercise of their profession on a cross-frontier basis doctors and veterinary surgeons may carry with them only medicinal preparations which are authorized or registered for circulation within the territory to which the present law applies, or are exempted from such authorization or registration.

(6). For the purpose of customs clearance for home use, in the cases referred to in subparagraph 1, a certificate from the competent authority for the consignee must be produced, indicating the quantity and nature of the medicinal preparations and attesting that the conditions of subparagraph 1 are fulfilled. The competent customs department shall forward the certificate, at the expense of the declarant, to the administration which prepared it.

(7). In the case referred to in subparagraph 1 indent 1, a consignee who is a wholesaler or runs a pharmacy must prove the existence of liability cover pursuant to paragraph 94.’

2. The German Government draws attention to the features of the system for the distribution of medicinal preparations in the Federal Republic of Germany. In order to protect public health and ensure safety with respect to pharmaceutical products, certain medicinal preparations can be purchased only in pharmacies. Other medicinal preparations may be sold only by dealers with special skills. Moreover, undertakings and wholesalers may not deliver to individuals. The necessity for such a distribution system was confirmed by the Bundesverfassungsgericht in a decision of 7 January 1959 in which it was stated that the purpose of the pharmacies' monopoly on the sale of medicinal preparations was, primarily, to obviate the risk of abuse of medicinal preparations. The need for such a system is also borne out by the existence of similar rules in the other Member States. There are similar rules, for example, in Denmark, Greece, Italy and Spain.

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. Such a system also prevents uncontrolled parallel imports of medicinal preparations and the uncontrolled use of medicinal preparations on animals which may be used for the production of food. The prohibition contained in Paragraph 73(1) of the AMG must be seen against this background. In the first place, the prohibition of imports makes it possible to prevent circumvention of the distribution system which would undermine the safeguards it is designed to provide. Freedom of imports, breaking the distribution monopoly, would promote the wider distribution of medicinal preparations and therefore their abuse. Unrestricted importation would also run counter to the pharmacist's duty to give advice, which is embodied in the regulations for pharmaceutical protection and in particular the rules of the profession. The role of the pharmacist is important since in general he knows his customers and is in a position to advise against excessively frequent recourse to medicinal preparations. Unrestricted imports would defeat the duty to give advice as regards both the importer himself and those persons to whom he might subsequently pass on the products imported by him. Unrestricted importation might also make the rules on the labelling of pharmaceutical products and the information to be provided to the consumer ineffective. With that in view, and in accordance with the requirements of the directives of 26 January 1965 and 20 May 1975 (Directive 65/65, Official Journal, English Special Edition 1965-66, p. 20, and Directive 75/319, Official Journal L 147, 9.6.1975, p. 13), German legislation requires certain information to appear on pharmaceutical products, relating in particular to their use, therapeutic indications and storage conditions, which must appear in the German langauge. That is an essential safeguard which would no longer be satisfied if imports were unrestricted. The Federal Regulation on the operation of pharmacies (Bundesapothekenbetriebsordnung) contains provisions concerning the quality of medicinal preparations which would be defeated if there were unrestricted imports; that might endanger not only the importer himself but also third parties to whom he might later pass on the medicinal preparations in question. Unrestricted imports would also frustrate the rules on medicinal preparations for which a prescription is required. Since the matter has not yet been harmonized at Community level there is no way of guaranteeing that a medicinal preparation purchased abroad has in fact been issued on the basis of a prescription. The German Government also claims that totally unrestricted imports would create problems regarding control of parallel imports. It points out in that connection that although the Court of Justice, in its judgment of 20 May 1976 in Case 104/75 De Peijper [1976] ECR 613, recognized the permissibility of parallel imports of pharmaceutical products, it nevertheless took the view that such freedom could apply only to products which were identical in every respect to products in respect of which the health authorities in the Member State of importation already have information. The national authorities are entitled to carry out the necessary checks. Moreover, that possibility is recognized in the Communication on parallel imports of proprietary medicinal products for which marketing authorizations have already been granted, issued by the Commission of the European Communities (Official Journal C 115, 6.5.1982, p. 5). The German Government claims that this supervision, which is recognized to be justified, presupposes that imports of medicinal preparations should be concentrated ‘at a limited number of points known to the authorities’. The same arguments apply to medicinal preparations that are to be administered to animals which may be used for the production of food. In that connection, the German Government points out that the national legislation provides for a further limitation on channels of distribution and prohibits despatches of medicinal preparations of that type.

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. In those circumstances, the Federal Republic of Germany asks the Court to rule that Articles 30 and 36 of the EEC Treaty do not prohibit rules such as the German provisions which, for reasons of the protection of health and in the framework of a distribution system for medicinal preparations, prohibit the import of such preparations by private individuals.

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). With a view to protecting patients, the private import of medicinal preparations is prohibited by Paragraph 3 of Order No 542 of 11 December 1979 on private imports of medicinal preparations. Certain exceptions to that prohibition are, however, available. First, travellers are authorized to bring with them into Denmark medicinal preparations in reasonable quantities for personal consumption over a short period, up to a maximum of three months. In addition, under Paragraph 2 of that order, private persons may be authorized to import medicinal preparations where there are exceptional reasons for doing so. That applies for example where the doctor of the person concerned declares that he is prepared to provide treatment and thus undertakes to accept medical responsibility for the treatment and to monitor the patient for its duration. The Danish Government observes that those provisions enable the Community principle of free movement of workers to be upheld.

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. In those circumstances, freedom for private individuals to import medicinal preparations would have adverse consequences on the distribution system for such products, which is based on the principles of authorization and evaluation by the national authorities, principles which are embodied in Directive 65/65. No control would be possible. That argument remains valid where the medicinal preparation in question is authorized in both States, that of importation and that of exportation. The conditions for authorization and use may be different and, moreover, the problem of language arises with respect to information for consumers. Those risks would be even greater if the medicinal preparation could be redistributed in an uncontrolled manner by the importer. The Danish Government considers therefore that the objective of the protection of public health, which requires a system of authorization and a power of assessment vested in the national authorities, can be achieved only by means of a general prohibition of imports subject to a number of exceptions. Moreover, such a system is implicitly provided for in Directive 65/65, since if the marketing of a product may be prohibited a general prohibition of imports must also be allowed for the protection of public health. The same reasoning must apply, in the Danish Government's view, to the private importation of medicinal preparations intended for animals. In conclusion, the Danish Government considers that rules of the kind at issue constitute a barrier to intra-Community trade but are nevertheless justified by Article 36 of the EEC Treaty, which remains applicable in the absence of any harmonization of laws in that area, in view of the fact that it is not possible to adopt a less restrictive system offering the same safeguards.

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.

a)

1) The Commission points out in the first place that the question submitted by the Hessische Finanzgericht must be reformulated in so far as it is not for the Court, as the Court has consistently stated, to assess the compatibility of a provision of national law with the requirements of the Treaty of Rome.

2) The Commission states, secondly, that the measure in question is indeed one having an effect equivalent to a quantitative restriction as defined by the Court in particular in the judgment of 11 July 1974 in Case 8/74 Dassonville [1974] ECR 837. Article 30 relates not only to trade on a business basis but also to transactions between individuals. The Commission also points out that it brought an action for infringement of the Treaty against the French Republic, whose legislation prohibits imports of medicinal preparations by private individuals except where they have been prescribed by a French doctor.

3) According to the Commission, the question submitted by the national court must be examined against the background of Article 36 of the EEC Treaty. That view is based on the hypothesis of the purchase by a national of a Member State of a medicinal preparation for his personal consumption in an approved pharmacy of another Member State. It is true that this case relates to a medicinal preparation supplied in the Federal Republic of Germany, of which the purchaser is a national, without a prescription, and the Court could take that fact into account in defining even more narrowly the question submitted for a preliminary ruling. But the Commission considers that it is impossible to draw an absolute distinction between the two cases and proposes that that element should be left out of account. The Commission points out first that, according to previous decisions of the Court, measures adopted under Article 36 must be necessary and proportionate to the objective pursued. On the other hand, it recognizes that it is for the Member States to regulate trade in medicinal preparations. In so far as the legislation in question is designed to prevent abuse of the rule by virtue of which medicinal preparations may be sold only in pharmacies, it is justified on grounds of public health. However, the prohibition in question seems to the Commission to be too general since it also covers, as in this case, the purchase by a private individual of medicinal preparations in a pharmacy in another Member State for his own personal use. The Commission does not see what reasons based on the protection of public health militate against the importation of medicinal preparations into the Federal Republic of Germany in such a case. In the first place, the medicinal preparation is purchased in a pharmacy and consequently all the safeguards inherent in that method of distribution of medicinal preparations are satisfied. That is true in particular of the advisory role of the pharmacist and the safeguards concerning the storage of medicinal preparations, and in any event the instructions for use are in most cases now given in several languages. That applies whether or not the medicinal preparation is supplied on prescription. The Commission considers that in such circumstances the safeguards are equivalent to those available where the preparation is purchased in a pharmacy in the Federal Republic of Germany, particularly since a degree of harmonization has been achieved in the pharmaceuticals sector by two directives of 16 September 1985 (Directives 85/432 and 85/433, Official Journal 1985, L 253, pp. 34 and 37). The Commission adds that the fact that Paragraph 17(2) of the German regulations governing pharmacies authorizes the sending of medicinal preparations only on a restrictive basis is accounted for by the territorial protection enjoyed by pharmacies. Paragraph 73 of the AMG, the only provision at issue, relates only to imports. The Commission recognizes, however, that authorization must only be given for purchases of medicinal preparations in quantities consistent with personal consumption by the person concerned, since otherwise there would be a risk of creating a parallel market in medicinal preparations which would escape all control. However, it considers that it is perfectly possible to ensure compliance with that condition. That clearly applies where a medicinal preparation is supplied, on prescription, since in such cases only the quantity prescribed can be supplied and the same applies where the preparation is supplied without a prescription, since it is possible to exercise control when taxes are levied upon entry into Germany. The Commission replies in advance to any objections which Germany might put forward on the ground that the customs authorities might not know whether a particular medicinal preparation was authorized in Germany and that it might also be very difficult for them to know whether a preparation was on open sale or was available only on prescription. The Commission states that such objections would be unfounded since, as the products are for personal consumption, their purchase is a matter of personal choice and in those circumstances it is of little importance whether or not the medicinal preparation is authorized in Germany; moreover, clinical tests of unauthorized products are possible in that country. At the present stage of harmonization of the laws, regulations and administrative provisions concerning pharmaceutical products, the purchase of medicinal preparations which are prohibited in one Member State but authorized in others does not present serious risks to public health. Should the Court not be of that opinion, it would, in the Commission's view, be sufficient to require purchasers to prove that the medicinal preparation was authorized and that no medical prescription was necessary.

4) In those circumstances, the Commission proposes the following answer to the question submitted:

i) ‘Articles 30 and 36 of the EEC Treaty must be interpreted as preventing a Member State from prohibiting private individuals from importing into its territory medicinal preparations intended for their immediate personal consumption where it is established that the purchase took place in an approved pharmacy in another Member State, upon presentation of a medical prescription where one is required’;

ii) in the alternative: ‘Articles 30 and 36 of the Treaty must be interpreted as preventing a Member State from prohibiting private individuals from importing for their own immediate consumption medicinal preparations which are authorized and supplied without prescription on its territory where it is established that the medicinal preparations were purchased in an approved pharmacy in another Member State’.

b) The French Republic also considers that legislation of the type at issue is incompatible with Community law.

1) The French Republic refers first to the judgments of the Court in the judgments of 20 February 1979 in Case 120/78 Rewe Zentral [1979] ECR 649 and of 12 July 1979 in Case 153/78 Commission v Federal Republic of Germany [1979] ECR 2555, in which it is stated that restrictions resulting from disparities in national legislation may be justified provided that they respond to mandatory requirements relating in particular to the effectiveness of fiscal supervision, the protection of public health, fairness of commercial transactions and the defence of consumers. However, such restrictions must be justified; that is true inter alia of health inspections, as is stated in particular in the judgment of 7 April 1981 in Case 132/80 United Foods and Van Den Abeele v Belgium [1981] ECR 995.

2) The French Government considers that the legislation in question is incompatible with Articles 30 and 36 of the EEC Treaty in so far as the general prohibition of imports of medicinal preparations laid down by it is disproportionate having regard to the objective of the protection of public health. It considers that, in order to meet that objective, it would be sufficient to provide for simple inspection of imports; that view lies behind the French rules concerning the importation of medicinal preparations by private individuals, in an order of 22 September 1965 (Journal officiel de la République française, 26.10.1965) adopted pursuant to the relevant provisions of the code de la santé publique (Public Health Code), which provide for prior authorization by the minister responsible for health matters for all imports of medicinal preparations. The authorization is granted when the person concerned provides the necessary information concerning the product and a certificate from the doctor treating him. Such a system allows the importation of medicinal preparations for private use even if they are not authorized on the French market. The only preparations excluded are those whose marketing is prohibited in France because of their toxicity.

3) The French Government therefore proposes that the Court should reply as follows to the question submitted:

‘Paragraph 73(1) of the Federal German Law of 24 August 1976 amending the legislation on medicinal preparations is incompatible with Article 30 of the Treaty of Rome in so far as it imposes a general prohibition on imports by private individuals of medicinal preparations from other Member States.’

F. Grévisse

Judge-Rapporteur

1 Language of the case: German.