C-62/90

COMMISSION v GERMANY

OPINION OF ADVOCATE GENERAL JACOBS delivered on 8 April 1992 *

My Lords, 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 Aizncimit- telrechts (Law making new provision with respect to medicinal products) of 24 August 1. In this case the Commission seeks a 1976 (hereafter 'the AMG'). Under those declaration, under Article 169 of the EEC provisions, subject to certain exceptions, Treaty, that Germany has failed to fulfil its medicinal products could be imported only obligations under Article 30 of the Treaty by pharmaceutical undertakings, whol- by prohibiting individuals from importing esalers, veterinary surgeons or pharmacists. for their personal use medicinal products By judgment of 7 March 1989 the Court available only on prescription in Germany, ruled that: 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. '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 thai State without a medical prescription and were The background to the case purchased in a pharmacy in another Member State are incompatible with Articles 30 and 36 of the Treaty.'

lation in question with the Treaty. In a 2. where the product is imported from a letter of 17 June 1988 the German country that is not a Member State of Government contended that its legislation the European Communities, the recipient was justified on grounds of the protection holds a permit under Paragraph 72; 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 (2) Subparagraph (1) shall not apply to obligations under Article 30 of the Treaty medicinal products which 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 1. are intended in specific cases for use in not, however, lodge its application until 12 small quantities for the treatment of March 1990. In the meantime, the Court certain animals in connection with had given judgment in the Schumacher case, animal shows, competitions or similar which induced Germany to amend its legis- occasions; lation. 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 modi- 2. are intended to meet the needs of fication in its replies to certain written scientific and research establishments questions put to it by the Court. and are necessary for scientific purposes;

4. Paragraph 73 of the AMG originally 3. are transported across the territory provided as follows: covered by this Law under customs supervision or are re-exported after passing through a customs warehouse or a warehouse under customs control; '(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 4. are intended for the use of a foreign Heligoland — only if they are approved or head of State or his entourage when registered for marketing within that staying in the territory covered by this territory or they are exempt from approval Law; or registration, and:

9. are sent as samples to the competent federal authorities for approval or inspection of consignments; 6. are imported upon entry into the territory covered by this Law in a quantity corresponding to normal personal needs, 10. are acquired by the federal or Land authorities in the course of international trade.

6a. are available without a medical prescription, may be put on the market (3) By derogation from subparagraph (1), in the country of origin and are finished medicinal products which are not obtained in a Member State of the approved or registered for marketing within European Communities in a quantity the territory covered by this Law or which corresponding to normal personal have not been exempted from approval or needs . . . .'

I - 2593

OPINION OF MR JACOBS — CASE C-62/90

'The Federal Republic of Germany has 8. It appears that, since the amendment of infringed its obligations under Article 30 of Paragraph 73(2) No 6 of the AMG, the EEC Treaty inasmuch as — apart from German law does not restrict personal the cases covered by Paragraph 73(2) Nos 6 imports of medicines that cross the frontier and 6a [of the AMG] — it prohibits indi- at the same time as the person for whose viduals from importing for their personal use they are intended. Paragraph 73(2) use medicinal products purchased at a No 6 permits the importation of medicines pharmacy in another Member State and which 'are imported upon entry into the available in Germany only on prescription, territory covered by this Law in a quantity notwithstanding that the products in corresponding to normal personal needs'. In question have been prescribed by a doctor view of the breadth of that provision, established in the exporting Member State.' Paragraph 73(2) No 6a, the benefit of

I - 2594

COMMISSION v GERMANY

Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member The relevant Community legislation States relating to analytical, pharmacoiox- icological 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. 9. It may be useful at this point to summarize briefly the relevant Community legislation.

Member State. Articles 4 to 12 of the laid down by law, regulation or adminis- directive harmonize the conditions under trative action in respect of certain activities which such authorizations are to be granted. in the field of pharmacy (OJ 1985 L 253, Article 4 lists the information that must be p. 34) harmonizes national legislation contained in an application for author- governing the training of pharmacists. ization to place a medicinal product on the Council Directive 85/433/EEC of 16

was adopted. Article 1 of the Second requires Member States to recognize certain Directive requires Member States to ensure formal qualifications granted by other that a properly qualified person is involved Member States in the field of pharmacy. in preparing applications for authorization. The Council has also adopted directives Article 8 of the Second Directive sets up a harmonizing access to the medical Committee for Proprietary Medicinal profession and providing for the mutual Products. One of the Committee's tasks is recognition of doctors' qualifications: see

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 12. The Commission contests all the above Article 36 of the Treaty. Germany points arguments. The supervisory function of the out that national legislation governing the doctor is performed at the time when he sale of medicines has not yet been prescribes the medicine in question. If the completely harmonized, with the result that patient requires further advice from the Member States are still entitled to invoke doctor he may obtain it by arranging an Article 36. Germany maintains that if it appointment with the doctor or by tele- were required to permit postal imports of phoning him in urgent cases. The advisory medicines for personal use the protection function of the pharmacist is superfluous in that it seeks to guarantee for the health of the case of medicines prescribed by a its citizens would be undermined. That doctor; in such a case the pharmacist's task protection consists of three elements: (a) the is to ensure that the medicine selected by supervisory function of the doctor, (b) the the doctor is supplied to the patient in the advisory function of the pharmacist and (c) appropriate form. As regards labelling and the provision of information by means of explanatory leaflets, the Commission states proper labelling and explanatory leaflets. that these are normally adequate, even According to the German Government, the though the relevant legislation has not been doctor's supervisory function would be completely harmonized. The Commission impaired if he were not in continuous minimizes the linguistic obstacles by contact with the patient; if medicines were pointing out that persons who obtain prescribed by a doctor established in medicines from abroad will normally possess another Member State there would be no the necessary linguistic knowledge or be in guarantee that the doctor would be able to contact with other persons who can help perform his supervisory function throughout them in that respect.

Legal appraisal 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 13. There is no doubt — and the point is prohibition cannot be justified in the case of not contested — that the legislation at issue medicines purchased at a pharmacy in constitutes a measure equivalent in effect to another Member State with a doctor's a quantitative restriction on trade between prescription. 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 16. In paragraph 20 of the Schumacher buy medicines from pharmacists in other judgment the Court said: 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 'The purchase of a medicinal preparation in sufficient to take a measure outside the a pharmacy in another Member State scope of Article 30: Joined Cases 177 and provides a guarantee equivalent to . . . that 178/82 Van de Haar aud Kaveka de Meeni which arises from the fact that the medicinal [1984] ECR 1797. preparation is sold through a pharmacy in the Member State into which the medicinal preparation is imported by a private indi- vidual. That conclusion is all the more compelling inasmuch as the conditions for access to the profession of pharmacist and 14. The only question that arises is whether the conditions for the exercise of that the measure is justified on grounds of the profession arc regulated in Council protection of health under Article 36 of the Directives 85/432 and 85/433 ' 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 17. The Schumacher case concerned spread of disease (such as rabies or Dutch medicines that were available in Germany elm disease), there is no doubt that such a without a prescription. However, the logic prohibition may in principle be applied to on which the judgment was based is equally personal imports; otherwise the very applicable to medicines that can be obtained purpose of the prohibition might be only with a doctor's prescription in the defeated because the occasional import of country of importation, at least when the an infected animal or plant might lead to a medicines have been obtained with a generalized outbreak of disease. 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 15. However, I do not think that Article 36 provided if they were 'prescribed by a may be invoked in order to justify German doctor and dispensed by a German

18. It is true that complete harmonization has not yet been achieved in the pharma- ceutical 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 harmon- ization is pursued gradually, each step in the 20. Certainly, I do not think that the process may reduce the extent to which specific grounds invoked by the German recourse to Article 36 is justified. That, in Government can justify the restrictions in my opinion, is what has happened in question. Germany, it will be recalled, has relation to the pharmaceutical trade. 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 19. Following the adoption of directives Member State the doctor would be unable harmonizing access to the professions of to perform his supervisory function doctor and pharmacist and providing for the throughout the period in which the mutual recognition of qualifications for medicines were consumed. But that doctors and pharmacists, it may be assumed argument amounts to denying persons that doctors and pharmacists established in resident in Germany the right to consult a other Member States are as unlikely to doctor established in another Member State furnish patients with harmful or inappro- and is manifestly contrary to the case-law of priate medicines as their colleagues in the Court: see Joined Cases 286/82 and Germany. Moreover, following the partial 26/83 Luisi and Carbone v Ministero del harmonization of provisions relating to the Tesoro [1984] ECR 377, at paragraph 16. marketing of pharmaceutical products it is Moreover, if persons resident in Germany clear that all medicines lawfully marketed in are entitled to consult a doctor established a Member State will have been authorized in another Member State, it would be after a procedure which is broadly similar illogical to deny them the right to use a and which includes similar tests. Although prescription issued by such a doctor in order

to buy medicines from a pharmacist in the the language of the country from which the same Member State. And if for some reason medicines are supplied. He may even be a it is not possible to obtain the prescribed native of that country who has taken medicines immediately, it is perfectly natural advantage of the Treaty provisions on the to arrange for them to be sent by post. 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 21. As regards the advisory function of the to insist that medicines imported by an indi- pharmacist two points may be made. First, vidual for his own use should be labelled in in so far as the pharmacist performs an German. Thirdly, the German legislation is advisory function when he dispenses illogical in so far as it treats postal imports medicines prescribed by a doctor, he can do differently from imports effected by the so in writing as well as orally; there is no patient in person; for whatever dangers may need for face-to-face contact between the exist, on account of linguistic complications, pharmacist and the patient. Secondly, if they must be equally great in both types of such contact were necessary, then surely the operation. 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. 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 phar- macist rather than from a German phar- 22. As regards the information function macist who might have difficulty in under- performed by labelling and explanatory standing the prescription. If the German leaflets, the German Government argues Government is really concerned about the that there is a danger that patients who dangers of linguistic incomprehension, I receive medicines from abroad might suffer cannot see why it insists on maintaining a injury if the instructions concerning the rule that may result in German pharmacists correct use of the medicines were written in having to dispense medicines against a foreign language. In my view, that prescriptions written in a foreign language. 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 24. The German Government argues finally patient may well have some knowledge of that medicines might be issued more than

(2) order the Federal Republic of G e r m a n y to p a y the costs.

I - 2600