C-215/87
ECLI:EU:C:1989:37
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SCHUMACHER v HAUPTZOLLAMT FRANKFURT AM MAIN-OST
OPINION OF MR ADVOCATE GENERAL TESAURO delivered on 26 January 1989*
Mr President, France ... I therefore refer the Court to the Members of the Court, Report for the Hearing and shall confine myself to reciting the question submitted by the Hessische Finanzgericht:
1. The facts giving rise to the proceedings for a preliminary ruling with which the Court is concerned today relate to a trip 'Is Paragraph 73(1) of the Gesetz zur made by Mr Schumacher, a German Neuordnung des Arzneimittelrechts of 24 national, as a tourist in France in 1983. At August 1976 (Bundesgesetzblatt I, 1976, that time, the 'unfortunate' (or 'deliberate'?) p. 2445 et seq.) compatible with Article 30 idea occurred to him of having mailed to his of the EEC Treaty in so far as it generally address in the Federal Republic of Germany prohibits the importation by private indi a package containing a pharmaceutical viduals of medicines from Member States?' product purchased in a pharmacy in Strasbourg, essentially comprising an extract of artichoke. If instead of choosing that method of despatch he had followed the example of thousands of tourists and simply imported the product directly by putting it into his pocket, he would not have fallen foul of the German customs authorities. In fact, since that day Mr Schumacher has 2. Needless to say, a question in those been locked in a struggle with the customs terms must be reformulated since, in authorities of his country which, relying on proceedings for a preliminary ruling, the the law amending the law on medicines (the Court has no jurisdiction to rule as to the 'AMG'), rejected his application to have the compatibility of national provisions with medicinal preparation released into free Community law. On the basis of a circulation, on the ground that to do so consistent line of decisions of the Court, would infringe the prohibition of imports from which it follows that, where questions laid down in that law. To save time I shall are improperly formulated, the Court's not recount the other episodes of this decision may set out criteria enabling the amusing tale, in which I suspect that, as national court to decide the case before it, I often happens in proceedings in which propose that the national court be deemed questions are referred to this Court, the to have asked essentially whether Articles 30 protagonist's role is played by the god and 36 of the EEC Treaty must be inter Mercury rather than by the goddess preted as preventing a Member State from Hygeia: it appears from the file on the case prohibiting private individuals from that the product is sold in Germany at importing for their own consumption around four times the price charged in medicinal preparations which are authorized
* Original language Italian
OPINION OF MR TESAURO — CASE 215/87
and sold without a medical prescription on distribution system for pharmaceutical its own territory, where those products have products; as such, it is the only suitable way been purchased in a pharmacy in another of meeting the requirements of protection of Member State. health and could not be changed or replaced by alternative means of control; indeed, notwithstanding the need to safeguard the unity of the Community internal market, it is inconceivable that the 3. One thing appears to me to be beyond German rules should be changed. doubt: the prohibition of imports of medicinal preparations by a private indi vidual is a measure having an effect equi valent to a restriction of imports and as such is caught by Article 30 (the Dassonville That argument is without foundation. case). That fact is not contested by the German and Danish Governments which, like the French Government and the Commission, have submitted observations to the Court. 7. To demonstrate that fact, let us return, in the first place, to the facts of the case pending before the national court. It is common ground that the medicinal prepa ration in question is on open sale in phar 4. The whole problem boils down to macies in Germany, that is to say without deciding whether the prohibition in question the need for a prescription. It is also uncon may be allowed under Article 36, in tested that the product was sold by a phar particular on the ground that it is justified macist in France. It is similarly clear that if for reasons of protection of health. Mr Schumacher had himself carried the medicinal preparation from Strasbourg to his place of residence he would not have been browbeaten by the German rules, since the seventh indent of Paragraph 73(2) of the 5. Two radically different views have been AMG expressly provides that the prohibition advanced on that point: on the one hand, laid down in Paragraph 73(1) 'does not the German and Danish Governments apply where the products are carried in maintain that Article 36 is applicable to this vehicles and are intended exclusively for use case and, on the other, the French or consumption by persons carried in such Government and the Commission forcefully vehicles'. deny this.
8. We now come to the legal assessment. I 6. Let me say straight away that I fully do not think it is necessary to undertake a share the latter view. I would add with the detailed examination of the previous cases same immediacy that in the present case I of the Court, the only purpose of which consider it superfluous to rebut in detail the would be to show something which, after arguments put forward in defence of the the judgment of 20 May 1976 in Case German rules. Those arguments essentially 104/775 De Pijper [1976] ECR 613, is amount to no more than an assertion that superabundantly evident: as Community law the prohibition in question must be accepted stands at present, pharmaceutical prepa because it forms an integral part of the rations are included among the products to
SCHUMACHER v HAUPTZOLLAMT FRANKFURT AM MAIN-OST
which the principle of free movement of upon a previous decision of the the Court goods applies. Of course, that assertion (the De Pijper judgment) regarding must immediately be tempered by a reser 'proportionality'. In other words, having vation: 'subject to compliance with certain regard to the state of advancement — albeit conditions'. And that is obvious if it is borne incomplete but nevertheless not to be under in mind that a pharmaceutical product for estimated — of the harmonization of the which free movement is considered is national laws on medicinal preparations, I neither a nutcracker nor a corkscrew and am of the opinion that in the present case that ex natura rerum in addition to, or even the powers still available to the Member instead of, producing the desired thera State of importation have been reduced to peutic effects, the supply of a medicinal the minimum. preparation may in fact cause considerable damage to human health.
10. And in fact, although it might appear For those reasons the Community legis justifiable for the authorities of a Member lature has progressively drawn up a system State, relying on doubts as to the innocu- of rules whose purpose, as is apparent from ousness of a medicinal preparation the fifth recital in the preamble to the produced in another Member State whose second Council Directive of 20 May 1975 release into circulation has not, for the sake on the approximation of provisions laid of argument, been authorized in either the down by law, regulation or administrative first or the second State, to invoke reasons action relating to proprietary medicinal of protection of health under Article 36 to products (75/319/EEC, Official Journal control the importation into its own L 147, 9.6.1975, p. 13), is the 'free territory of that preparation, the facts of the movement of proprietary medicinal products'. case pending before the national court are such as to render recourse to Anicie 36 unjustified. And the Hessische Finanzgericht 9. But whilst it is certainly true that, in my opinion reacted correctly when, in the without doubt, the principle of free order for reference, it expressly emphasized movement of medicinal preparations the fact that it had strong doubts as to continues to be subject to certain whether Paragraph 73 of the AMG was exceptions, justified by Article 36 — a compatible with Article 36 of the EEC provision which must incontestably be Treaty. narrowly interpreted — in the present case the facts are such that the contention of the two governments (of Germany and Denmark) that justification for the prohibition of imports is to be found in the 11. The true position is extremely simple: as requirement of the protection of health does Community law stands at the moment in not stand up to an analysis properly based this area, four years before the achievement on the aims pursued by Articles 30 and 36, of the great single market, in the circum which adopts as a criterion of assessment stances described by the national court there not the exception to the rule, that is to say is no scope for the Court to uphold, either the permitted restrictions to freedom of objectively or subjectively, arguments movement, but rather the rule itself, namely relating to the protection of health so as to that of free movement. suspend the operation of the prohibition laid down in Article 30 of the EEC Treaty. The reason for this is simple: since the medicinal And it seems to me that that conclusion may preparation in question is authorized in both be arrived at without even having to rely the Member States involved, all the
OPINION OF MR TESAURO —CASE 215/87
requirements concerning the protection of conditions laid down in Article 9 et seq. of health have already been taken into account the second directive, machinery enabling the in the State of exportation and that must be producer of a medicinal preparation auth sufficient for the State of importation. orized for release on to the market of a Member State to have the Committee on Medicinal Preparations determine whether the product fulfils the requirements laid down for the issue of authorization in other 12. Objectively: the same product is sold in Member States. And at that time those pharmacies without the need for a medical Member States have an opportunity to prescription in the country into which oppose the grant of authorization for their importation is sought. Any person residing territory. there may therefore purchase unlimited quantities of it for himself, for the members of his family, for his neighbours, for his
colleagues. Is that not the best proof of the fact that the Member State in question, by authorizing its sale — what is more without It therefore seems more than a little prescription — has recognized that the hazardous to contend that a medicinal prep medicinal preparation is harmless? In those aration of which the marketing is legally circumstances the defence of the prohibition authorized both in the Member State of of imports of the product appears very exportation and in that of importation and weak.
That applies a fortiori in view of the for which, moreover, no prescription is fact that, on the basis of the first and second necessary, might give rise in the latter State Council directives approximating the to such a danger to public health as to provisions laid down by law, regulation or justify a prohibition of imports. And that administrative action relating to proprietary applies, I repeat, regardless of any consider medicinal products (65/65/EEC and ations— which frankly appear to me to be 75/319/EEC), the release on to the market superfluous in this case — regarding failure of a Member State of a medicinal prepa to observe the principle of proportionality. ration must be preceded by a prior authori zation issued by the competent authorities, which highlights ad abundiantam the differing treatment accorded to the sale of a medicinal preparation on the one hand and a corkscrew on the other. Furthermore, as I pointed out earlier and as also became clear at today's hearing, the German legislature itself permits imports of medicinal preparations by private individuals in the course of a journey where the quantity does not exceed that required for The issue of authorization for release on to personal use (sixth indent of Paragraph the market presupposes compliance with 73(2)) and, where passage through customs extremely rigorous procedural requirements is by vehicle, without limit as to quantity if and every Member State is required, under the medicinal preparations are intended for Article 3 of the first directive to which I the consumption of the passengers (ibid., have just referred, to withhold such authori seventh indent). In those circumstances, the zation where it is found that the proprietary question remains unanswered whether there medicinal preparation is harmful under is a difference between imports of that kind normal conditions of use.
Moreover, the and the situation with which these Community legislature included, among the proceedings are concerned where a product
SCHUMACHER v HAUPTZOLLAMT FRANKFURT AM MAIN-OST
is imponed by post for personal use, in directives, I must nevertheless emphasize in which the possibilities of verifying the essence that the Member States gave a quantity, origin and consignee are certainly commitment to recognize the qualifications greater. of pharmacists in other Member States and to allow them to participate in the 'supply of 13. Subjectively: the Commission is in my medicinal products in pharmacies open to opinion quite right to draw attention to the the public'. It follows that the argument importance to this case of the Council based on the alleged need to ensure that the directive concerning the coordination of sale of medicinal preparations should be provisions laid down by law, regulation or controlled on the national market by phar administrative action in respect of certain macists of the Member State of importation activities in the field of pharmacy is manifestly unfounded. Once the Member (85/432/EEC, Official Journal L 253, States recognize the professional qualifi 24.9.1985, p. 34) and the Council directive cations of pharmacists of other Member concerning mutual recognition of diplomas, States, they no longer have any basis for certificates and other qualifications in claiming, without contradicting themselves, pharmacy (84/433, ibid., p. 37). Without that the health of their population must be burdening the Court with a detailed protected by ensuring that pharmaceutical description of the provisions of those products are sold by their own pharmacists.
14. In conclusion, I propose that the Court state in reply to the question from the national court that Articles 30 and 36 of the EEC Treaty prevent a Member State from prohibiting private individuals from importing for their own consumption medicinal preparations authorized and sold without a prescription on its own territory , where such medicinal preparations have been purchased in a pharmacy in another Member State.