Opinion of Mr Advocate General Jacobs delivered on 13 March 1992. - Commission of the European Communities v Federal Republic of Germany. - Free movement of goods - Derogations - Protection of public health - Importation of medicinal products y private individuals - Limits. - Case C-62/90.



European Court reports 1992 Page I-02575

Swedish special edition Page I-00029

Finnish special edition Page I-00059



Opinion of the Advocate-General

++++

My Lords,

1. In this case the Commission seeks a declaration, under Article 169 of the EEC Treaty, that Germany has failed to fulfil its obligations under Article 30 of the Treaty by prohibiting individuals from importing for their personal use medicinal products available only on prescription in Germany, when the products in question have been purchased at a pharmacy in another Member State in accordance with a prescription issued by a doctor established in the same Member State.

The background to the case

2. The contested German legislation came to the Commission' s attention as a result of a reference to the Court for a preliminary ruling from the Hessische Finanzgericht, (Case 215/87 Schumacher v Hauptzollamt Frankfurt am Main-Ost [1989] ECR 617). That case, which was referred to the Court in July 1987, arose out of an attempt by a person resident in Frankfurt am Main to import, by post, a medicinal preparation supplied by a pharmacist established in Strasbourg. The product in question was authorized in Germany and was sold there by pharmacists without a doctor' s prescription. Mr Schumacher was prevented from importing the product into Germany by a decision based on Paragraph 73(1) of the Gesetz zur Neuordnung des Arzneimittelrechts (Law making new provision with respect to medicinal products) of 24 August 1976 (hereafter "the AMG"). Under those provisions, subject to certain exceptions, medicinal products could be imported only by pharmaceutical undertakings, wholesalers, veterinary surgeons or pharmacists. By judgment of 7 March 1989 the Court ruled that:

"National provisions which prohibit the importation by a private individual for his personal needs of medicinal preparations which are authorized in the Member State of importation, are available in that State without a medical prescription and were purchased in a pharmacy in another Member State are incompatible with Articles 30 and 36 of the Treaty."

It will be noted that the Schumacher ruling was confined to medicines available in the importing State without a doctor' s prescription, while the present proceedings concern medicines available in Germany only on prescription.

3. While that case was pending the Commission had, by letter of 22 February 1988, invited the German Government to comment on the compatibility of the legislation in question with the Treaty. In a letter of 17 June 1988 the German Government contended that its legislation was justified on grounds of the protection of human health, in accordance with Article 36 of the Treaty. On 23 November 1988 the Commission issued a reasoned opinion stating that Germany had failed to fulfil its obligations under Article 30 of the Treaty by prohibiting the importation of medicinal products by individuals intended for their personal use. Germany was invited to take the steps needed to comply with the opinion within two months. The Commission did not, however, lodge its application until 12 March 1990. In the meantime, the Court had given judgment in the Schumacher case, which induced Germany to amend its legislation. As a result of the amendments, which were adopted on 11 April 1990, the Commission modified the scope of its application slightly. It made a further modification in its replies to certain written questions put to it by the Court.

4. Paragraph 73 of the AMG originally provided as follows:

"(1) Medicinal products subject to approval or registration may be imported into the territory covered by this Law ° except in duty-free areas other than the island of Heligoland ° only if they are approved or registered for marketing within that territory or they are exempt from approval or registration, and:

1. where the product is imported from a Member State of the European Communities, the recipient is a pharmaceutical undertaking, a wholesaler, a veterinary surgeon or a pharmacist;

2. where the product is imported from a country that is not a Member State of the European Communities, the recipient holds a permit under Paragraph 72;

(2) Subparagraph (1) shall not apply to medicinal products which

1. are intended in specific cases for use in small quantities for the treatment of certain animals in connection with animal shows, competitions or similar occasions;

2. are intended to meet the needs of scientific and research establishments and are necessary for scientific purposes;

3. are transported across the territory covered by this Law under customs supervision or are re-exported after passing through a customs warehouse or a warehouse under customs control;

4. are intended for the use of a foreign head of State or his entourage when staying in the territory covered by this Law;

5. are intended for the personal use or consumption of members of diplomatic missions or consular representatives established in the territory covered by this Law or for officials of international organizations which have their seat within that territory and for members of their families, provided such persons are neither German nationals nor permanently resident within the territory covered by this Law;

6. are imported by travellers in quantities which do not exceed such use or consumption as is normally appropriate during travel;

7. are imported in vehicles and intended for use or consumption exclusively by the persons carried in those vehicles;

8. are intended for use or consumption on sea-going vessels and are consumed on board such vessels;

9. are sent as samples to the competent federal authorities for approval or inspection of consignments;

10. are acquired by the federal or Land authorities in the course of international trade.

(3) By derogation from subparagraph (1), finished medicinal products which are not approved or registered for marketing within the territory covered by this Law or which have not been exempted from approval or registration may be imported into that territory if they are intended for pharmacies. Such products may be obtained by pharmacies only in small quantities, if specially ordered by individuals and solely in the ordinary course of business."

5. The amending Law of 11 April 1990 added Nos 2a and 6a to Paragraph 73(2) of the AMG and amended the wording of No 6. It follows from those provisions that Paragraph 73(1) does not apply to medicinal products which:

"2a. are required in small quantities by a pharmaceutical undertaking as samples for experimental or analytical purposes,

6. are imported upon entry into the territory covered by this Law in a quantity corresponding to normal personal needs,

6a. are available without a medical prescription, may be put on the market in the country of origin and are obtained in a Member State of the European Communities in a quantity corresponding to normal personal needs... ."

The scope of the application

6. It is not clear from the wording of Paragraph 73(2) of the AMG whether those provisions permit the importation of products which have not been approved or registered for marketing in Germany. However, in answer to a written question from the Court the German Government has stated that Paragraph 73(2) does indeed have that effect. It may in any event be noted that the Commission has stated, in reply to questions put by the Court, that medicinal products not authorized in Germany lie outside the scope of the application. The Commission is not therefore contesting Germany' s right to restrict personal imports of medicinal products the marketing of which is authorized in the exporting Member State but not in Germany. It is in fact clear from the form of order sought by the Commission, as set out in its reply to the written questions from the Court, that the scope of the application is now rather narrow. The Commission is asking the Court to declare that:

"The Federal Republic of Germany has infringed its obligations under Article 30 of the EEC Treaty inasmuch as ° apart from the cases covered by Paragraph 73(2) Nos 6 and 6a [of the AMG] ° it prohibits individuals from importing for their personal use medicinal products purchased at a pharmacy in another Member State and available in Germany only on prescription, notwithstanding that the products in question have been prescribed by a doctor established in the exporting Member State."

The application is thus concerned solely with restrictions on the importation into Germany, for personal use, of medicinal products prescribed by a doctor established in the exporting Member State, where the products in question are available in Germany only on prescription. The Court will not therefore have to consider whether Member States are required to permit personal imports of medicinal products issued without a prescription in the exporting State but available only on prescription in the importing State.

7. Moreover, the German Government contends that, since the amendment of the German legislation which followed the Schumacher judgment, the present proceedings must relate solely to the importation by post of medicinal products that are available in Germany only on prescription. In response to a written question from the Court, the Commission stated that its application now relates only to the dispatch of medicinal products, but that it is not limited to dispatch by post.

8. It appears that, since the amendment of Paragraph 73(2) No 6 of the AMG, German law does not restrict personal imports of medicines that cross the frontier at the same time as the person for whose use they are intended. Paragraph 73(2) No 6 permits the importation of medicines which "are imported upon entry into the territory covered by this Law in a quantity corresponding to normal personal needs". In view of the breadth of that provision, Paragraph 73(2) No 6a, the benefit of which is confined to medicines available (in Germany) without a doctor' s prescription, can only come into operation in relation to medicines that are not physically brought into German territory by the person for whose use they are intended.

The relevant Community legislation

9. It may be useful at this point to summarize briefly the relevant Community legislation. 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 1965-66, p. 20) provides, in Article 3, that no proprietary medicinal product may be placed on the market in a Member State unless an authorization has been issued by the competent authority of that Member State. Articles 4 to 12 of the directive harmonize the conditions under which such authorizations are to be granted. Article 4 lists the information that must be contained in an application for authorization to place a medicinal product on the market. Articles 13 to 20 introduce harmonized rules governing the labelling of medicinal products. In 1975 a Second Council Directive (Directive 75/319/EEC ° OJ 1975 L 147, p. 13) on the approximation of provisions laid down by laws governing proprietary medicinal products was adopted. Article 1 of the Second Directive requires Member States to ensure that a properly qualified person is involved in preparing applications for authorization. Article 8 of the Second Directive sets up a Committee for Proprietary Medicinal Products. One of the Committee' s tasks is to deliver a reasoned opinion where authorization to market a medicinal product is granted in one Member State and refused in another. Such opinions are not, however, binding. Under Article 16 of the Second Directive only the holders of an authorization may manufacture proprietary medicinal products. The succeeding articles harmonize the conditions governing the grant of such authorizations. Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products (OJ 1975 L 147, p. 1) lays down extremely detailed rules concerning the testing of medicinal products.

10. In addition, there have been two directives concerning access to the profession of pharmacist. Council Directive 85/432/EEC of 16 September 1985 concerning the coordination of provisions laid down by law, regulation or administrative action in respect of certain activities in the field of pharmacy (OJ 1985 L 253, p. 34) harmonizes national legislation governing the training of pharmacists. Council Directive 85/433/EEC of 16 September 1985 concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in pharmacy, including measures to facilitate the effective exercise of the right of establishment relating to certain activities in the field of pharmacy (OJ 1985 L 253, p. 37) requires Member States to recognize certain formal qualifications granted by other Member States in the field of pharmacy. The Council has also adopted directives harmonizing access to the medical profession and providing for the mutual recognition of doctors' qualifications: see Council Directive 75/363/EEC of 16 June 1975 concerning the coordination of provisions laid down by law, regulation or administrative action in respect of activities of doctors (OJ 1975 L 167, p. 14) and Council Directive 75/362/EEC of 16 June 1975 concerning the mutual recognition of diplomas, certificates and other evidence of formal qualifications in medicine, including measures to facilitate the effective exercise of the right of establishment and freedom to provide services (OJ 1975 L 167, p. 1).

The arguments of the parties

11. Germany contends that the restrictions placed by Paragraph 73 of the AMG on the importation of medicines for personal use are justified on grounds of the protection of the health of humans in accordance with Article 36 of the Treaty. Germany points out that national legislation governing the sale of medicines has not yet been completely harmonized, with the result that Member States are still entitled to invoke Article 36. Germany maintains that if it were required to permit postal imports of medicines for personal use the protection that it seeks to guarantee for the health of its citizens would be undermined. That protection consists of three elements: (a) the supervisory function of the doctor, (b) the advisory function of the pharmacist and (c) the provision of information by means of proper labelling and explanatory leaflets. According to the German Government, the doctor' s supervisory function would be impaired if he were not in continuous contact with the patient; if medicines were prescribed by a doctor established in another Member State there would be no guarantee that the doctor would be able to perform his supervisory function throughout the period in which the medicines were being taken. The advisory function of the pharmacist would also be impaired if medicines were sent by post because the pharmacist would not be in direct contact with the patient. Nor would there be any guarantee that the patient could obtain information about the use of medicines from the labelling on the containers and the enclosed leaflets because the information might be in a foreign language. Finally, Germany argues that there is a danger that the same prescription might be used twice, either because the pharmacist failed to realize that it had been used already or because the law of the country in question, unlike German law, might permit the multiple use of prescriptions.

12. The Commission contests all the above arguments. The supervisory function of the doctor is performed at the time when he prescribes the medicine in question. If the patient requires further advice from the doctor he may obtain it by arranging an appointment with the doctor or by telephoning him in urgent cases. The advisory function of the pharmacist is superfluous in the case of medicines prescribed by a doctor; in such a case the pharmacist' s task is to ensure that the medicine selected by the doctor is supplied to the patient in the appropriate form. As regards labelling and explanatory leaflets, the Commission states that these are normally adequate, even though the relevant legislation has not been completely harmonized. The Commission minimizes the linguistic obstacles by pointing out that persons who obtain medicines from abroad will normally possess the necessary linguistic knowledge or be in contact with other persons who can help them in that respect.

Legal appraisal

13. There is no doubt ° and the point is not contested ° that the legislation at issue constitutes a measure equivalent in effect to a quantitative restriction on trade between Member States, within the meaning of Article 30 of the Treaty. It has the effect that in certain circumstances individuals resident in Germany who might otherwise buy medicines from pharmacists in other Member States are forced to obtain their supplies from German pharmacists. The effect on intra-Community trade is admittedly slight, particularly since the amendment of the AMG, but that is not sufficient to take a measure outside the scope of Article 30: Joined Cases 177 and 178/82 Van de Haar and Kaveka de Meern [1984] ECR 1797.

14. The only question that arises is whether the measure is justified on grounds of the protection of health under Article 36 of the Treaty. There are of course circumstances in which Article 36 may be invoked in order to prevent personal imports. If, for example, a Member State prohibits the importation of live animals or plants in order to prevent the spread of disease (such as rabies or Dutch elm disease), there is no doubt that such a prohibition may in principle be applied to personal imports; otherwise the very purpose of the prohibition might be defeated because the occasional import of an infected animal or plant might lead to a generalized outbreak of disease.

15. However, I do not think that Article 36 may be invoked in order to justify prohibiting individuals from importing medicines by post for their personal needs, even where the medicine in question is available only on prescription in the country of importation. At any rate, such a prohibition cannot be justified in the case of medicines purchased at a pharmacy in another Member State with a doctor' s prescription.

16. In paragraph 20 of the Schumacher judgment the Court said:

"The purchase of a medicinal preparation in a pharmacy in another Member State provides a guarantee equivalent to ... that which arises from the fact that the medicinal preparation is sold through a pharmacy in the Member State into which the medicinal preparation is imported by a private individual. That conclusion is all the more compelling inasmuch as the conditions for access to the profession of pharmacist and the conditions for the exercise of that profession are regulated in Council Directives 85/432 and 85/433... ."

17. The Schumacher case concerned medicines that were available in Germany without a prescription. However, the logic on which the judgment was based is equally applicable to medicines that can be obtained only with a doctor' s prescription in the country of importation, at least when the medicines have been obtained with a doctor' s prescription in another Member State. In such a case the guarantee that arises from the fact that the medicines have been prescribed by a doctor and dispensed by a pharmacist in another Member State is equivalent to the guarantee that would be provided if they were prescribed by a German doctor and dispensed by a German pharmacist. In Schumacher the Court attached some importance to the fact that the conditions for access to the profession of pharmacist had been harmonized; in the present case, it may be noted that the medical profession has undergone similar harmonization by virtue of Council Directives 75/362 and 75/363.

18. It is true that complete harmonization has not yet been achieved in the pharmaceutical field. That does not, however, mean that Member States retain complete freedom to impose whatever restrictions they choose on imports of medicines. It would surely be a mistake to imagine that Member States may have unlimited recourse to Article 36 until the final step on the path to complete harmonization is taken. When harmonization is pursued gradually, each step in the process may reduce the extent to which recourse to Article 36 is justified. That, in my opinion, is what has happened in relation to the pharmaceutical trade.

19. Following the adoption of directives harmonizing access to the professions of doctor and pharmacist and providing for the mutual recognition of qualifications for doctors and pharmacists, it may be assumed that doctors and pharmacists established in other Member States are as unlikely to furnish patients with harmful or inappropriate medicines as their colleagues in Germany. Moreover, following the partial harmonization of provisions relating to the marketing of pharmaceutical products it is clear that all medicines lawfully marketed in a Member State will have been authorized after a procedure which is broadly similar and which includes similar tests. Although Member States remain free to prohibit the marketing of a medicinal preparation authorized in another Member State, if they are not satisfied that it is safe, I do not think that they may prohibit individuals from importing such a preparation for their own use. The individual is entitled to decide that the guarantee offered by medicines purchased with a doctor' s prescription from a pharmacy in another Member State is equivalent to the guarantee offered by medicines purchased in similar circumstances in Germany.

20. Certainly, I do not think that the specific grounds invoked by the German Government can justify the restrictions in question. Germany, it will be recalled, has referred to three considerations: namely, the supervisory function of the doctor, the advisory function of the pharmacist and the information function performed by labelling and explanatory leaflets. As regards the first point, Germany argues that if medicines were prescribed by a doctor in another Member State the doctor would be unable to perform his supervisory function throughout the period in which the medicines were consumed. But that argument amounts to denying persons resident in Germany the right to consult a doctor established in another Member State and is manifestly contrary to the case-law of the Court: see Joined Cases 286/82 and 26/83 Luisi and Carbone v Ministero del Tesoro [1984] ECR 377, at paragraph 16. Moreover, if persons resident in Germany are entitled to consult a doctor established in another Member State, it would be illogical to deny them the right to use a prescription issued by such a doctor in order to buy medicines from a pharmacist in the same Member State. And if for some reason it is not possible to obtain the prescribed medicines immediately, it is perfectly natural to arrange for them to be sent by post.

21. As regards the advisory function of the pharmacist two points may be made. First, in so far as the pharmacist performs an advisory function when he dispenses medicines prescribed by a doctor, he can do so in writing as well as orally; there is no need for face-to-face contact between the pharmacist and the patient. Secondly, if such contact were necessary, then surely the German Government should subject postal supplies within Germany to the same restrictions as postal supplies from abroad; and yet, as we learnt at the hearing, there is no restriction on the internal supply of medicines by post.

22. As regards the information function performed by labelling and explanatory leaflets, the German Government argues that there is a danger that patients who receive medicines from abroad might suffer injury if the instructions concerning the correct use of the medicines were written in a foreign language. In my view, that argument must be rejected for a number of reasons. First, the danger is less serious than the German Government contends because pharmaceutical companies frequently print instructions regarding the use of their products in several languages. Secondly, the patient may well have some knowledge of the language of the country from which the medicines are supplied. He may even be a native of that country who has taken advantage of the Treaty provisions on the free movement of workers and who obtains medicines from his native country. To refuse to allow him to import such medicines on the ground that the instructions might not be in German would be absurd. It is perfectly reasonable for Germany to insist that medicines sold in Germany should be labelled in the German language; it is less reasonable for Germany to insist that medicines imported by an individual for his own use should be labelled in German. Thirdly, the German legislation is illogical in so far as it treats postal imports differently from imports effected by the patient in person; for whatever dangers may exist, on account of linguistic complications, they must be equally great in both types of operation.

23. One further point may be noted with regard to the language problem. If, for example, a German patient consults a doctor in France and receives a prescription written in French, it seems far more practical that he should obtain the prescribed medicines from a French pharmacist rather than from a German pharmacist who might have difficulty in understanding the prescription. If the German Government is really concerned about the dangers of linguistic incomprehension, I cannot see why it insists on maintaining a rule that may result in German pharmacists having to dispense medicines against prescriptions written in a foreign language.

24. The German Government argues finally that medicines might be issued more than once against the same prescription. It points out that in Germany a prescription may be used once only, whereas in other Member States it may be possible to use the same prescription repeatedly. At the hearing the Commission confirmed that in some Member States the repeated use of a prescription is possible where the doctor has expressly authorized it. The Commission points out that a chronically sick patient may occasionally visit a doctor outside Germany and then have periodic supplies of medicines dispatched to him by a pharmacist in accordance with a single prescription issued by the doctor. The Commission maintains that there can be no harm in such a practice, where it is approved by the doctor.

25. Once again I do not find the German Government' s argument convincing. When the repeated use of a prescription is authorized by a doctor, there is no reason to assume that the patient is in greater danger of being administered harmful or inappropriate medicine than when the prescription is used once only. The German Government has not shown why the guarantee arising from the professional expertise of the doctor and pharmacist should not continue to operate in such circumstances.

Conclusion

26. Accordingly, I am of the opinion that the Court should:

(1) declare that the Federal Republic of Germany has infringed its obligations under Article 30 of the EEC Treaty by restricting the right of individuals to import for their personal use medicinal products available in Germany only on prescription, where the products in question were purchased at a pharmacy in another Member State in accordance with a prescription issued by a doctor established in that other Member State;

(2) order the Federal Republic of Germany to pay the costs.

(*) Original language: English.