CJEC, 3rd chamber, March 7, 1989, No 215-87

The court (third chamber)

1 By order of 25 may 1987, which was received at the court registry on 14 july 1987, the hessische finanzgericht (finance court, hesse) referred to the court of justice for a preliminary ruling under article 177 of the eec treaty a question on the interpretation of articles 30 and 36 of that treaty.

2 The question was raised in proceedings brought by heinz Schumacher against the Hauptzollamt (principal customs office) Frankfurt am main. Mr Schumacher, who lives in Frankfurt am main, ordered for his own personal use from the pharmacie du dôme, strasbourg, a medicinal preparation called "chophytol", which is made from an extract of artichoke and is used in particular for the treatment of dyspeptic disorders and as a diuretic. That medicinal preparation, which is manufactured in france, is authorized in the federal republic of germany, and is available in pharmacies there without a prescription. However, its price is higher in germany than in france. The customs authorities refused to grant clearance of the product in question and mr Schumacher appealed against that decision to the hessiche finanzgericht; that court referred a question to the court of justice for a preliminary ruling.

3 The refusal was based on paragraph 73(1) of the gesetz zur neuordnung des arzneimittelsrechts of 24 august 1976, under which the importation from a member state of the european community of medicinal preparations which are subject to authorization or registration is allowed only if they are authorized or registered or are exempted from those formalities and if the consignee of the medicinal preparations is a pharmaceutical undertaking, a wholesaler or a veterinary surgeon or operates a pharmacy so that importation by individuals acting in a private capacity is not permitted. There are a number of exceptions to that prohibition which are not relevant to this case.

4 Having regard, in particular, to the very general character of that provision, the national court entertained doubts as to its compatibility with article 30 et seq. Of the eec treaty and therefore referred the following question to the court of justice:

"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?"

5 Reference is made to the report for the hearing for a fuller account of the facts of the case, the course of the procedure and the observations submitted to the court, which are mentioned or discussed hereinafter only in so far as is necessary for the reasoning of the court.

6 It must first be pointed out that the court is not empowered under article 177 of the treaty to rule on the compatibility with the treaty of provisions of national law. However, it has jurisdiction to provide the national court with all such matters relating to the interpretation of community law as may enable it to decide the issue of compatibility in the case before it.

7 Accordingly, the question submitted by the hessische finanzgericht must be understood as seeking clarification from the court of justice as to whether legislation which prohibits a private individual from importing for his personal use a medicinal preparation which is authorized in the member state of importation, is available there without a prescription and was purchased in a pharmacy in another member state is contrary to articles 30 and 36 of the treaty.

8 The german and danish governments claim that rules of the type contained in the law on medicines, to which, moreover, there are a number of exceptions such as that relating to travellers, are justified, under article 36 of the eec treaty, by the requirements of the protection of public health.

9 They state that the systems for the distribution of medicinal preparations, which in the member states in general allow their sale only by authorized retailers, are designed to provide the consumer with a number of safeguards, such as proper information, advice and guarantees of quality, with regard in particular to the rules on storage. The need for such safeguards is recognized by community law, in particular council directive 65-65 of 26 january 1965 on the approximation of provisons laid down by law, regulation or administrative action relating to proprietary medicinal products (official journal, english special edition 1965-66, p. 20). That directive, moreover, also makes the marketing of medicinal preparations subject to authorization by the member states, empowering them to determine the efficacy of medicines and to decide whether or not they are harmful.

10 That whole system would be endangered, they say, if private individuals were free to import medicinal preparations. That freedom might give rise to abuses which it would be impossible to control and to the misuse of medicinal preparations. It would also facilitate evasion of the rule on national authorization for marketing contained in directive 65-65.

11 The commission and the french government, on the other hand, consider that legislation of the type at issue is incompatible with articles 30 and 36 of the treaty since it is excessively general and is disproportionate in relation to the need to protect public health.

12 Although the member states are certainly responsible for regulating trade in medicinal preparations and for taking the measures necessary to ensure that they are distributed only through pharmacies, a general prohibition of imports is not justified in the case of private individuals if they have purchased the medicinal preparations in question in a pharmacy in another member state. Purchase on that basis is in itself sufficient to ensure that all the safeguards pursued by the closed system for the distribution of medicinal preparations are guaranteed. It would be sufficient to limit the authorization to import such preparations to the quantity necessary for the personal use of the person concerned, a restriction which could be enforced by means of appropriate rules.

13 The commission points out that the medicinal preparation with which the present case is concerned is authorized in germany and is available there without prescription. It does not, however, consider those two facts decisive since, in its view, the decision whether to purchase in another member state a medicinal preparation which is not authorized in the member state where the person concerned resides is a matter for that person. Should the court not share its view, it goes on to say that there is nothing to prevent private individuals from being required to prove that the imported medicinal preparation was authorized and that a prescription was not required or else that the preparation was prescribed for him.

14 It must be observed in the first place - and indeed it has not been disputed - that legislation of the type at issue constitutes, as as the court has consistently held, a measure having an effect equivalent to a quantitative restriction on imports.

15 In the second place, as the court has already had occasion to point out, directive 65-65, as amended by council directives 75-319 of 20 march 1975 (official journal 1975, l 147, p. 13), 83-570 of 20 october 1983 (official journal 1983, l 332, p. 1) and 87-21 of 22 december 1986 (official journal 1987, l 15, p. 36), is intended only to achieve progressive harmonization of the national legislation on the manufacture and marketing of proprietary medicinal products. As community law now stands, that harmonization has not been fully achieved, since, for example, a medicinal preparation may be authorized in one member state but not in one or more others, with or without prescription. It is only when community directives provide for complete harmonization of all the measures necessary for the protection of human and animal health that recourse to article 36 will cease to be justified. It is therefore necessary to consider whether measures of the type at issue may be justified under article 36 of the treaty.

16 According to article 36 of the eec treaty "articles 30 to 34 shall not preclude prohibitions or restrictions of imports... Justifed on grounds of... The protection of health and life of humans" provided that they do not constitute "a means of arbitrary discrimination or a disguised restriction on trade between member states ".

17 As the court has consistently held, health and the life of humans rank foremost among the property or interests protected by article 36 and it is for the member states, within the limits imposed by the treaty, to decide what degree of protection they intend to assure and in particular how strict the checks to be carried out are to be.

18 The court has also held, however, that it emerges from article 36 that national rules or practices which restrict imports of pharmaceutical products or are capable of doing so are compatible with the treaty only to the extent to which they are necessary for the effective protection of the health and life of humans.

19 Where a private individual purchases in a pharmacy in another member state a medicinal preparation which is authorized and dispensed without a medical prescription in the member state into which he is importing it for his own personal use, a provision such as paragraph 73(1) of the law on medicines, which applies in this case, clearly constitutes a measure restricting intra-community trade which is not justified by the protection of public health.

20 The purchase of a medicinal preparation in a pharmacy in another member state provides a guarantee equivalent to that referred to by the german and danish governments, that is to say 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 of 16 september 1985 (official journal 1985, l 253, pp. 34 and 37).

21 It must also be pointed out that in the sixth and seventh indents of paragraph 73(2) of the law on medicines, the german legislature allowed exceptions to the prohibition on imports of medicinal preparations where they are brought into germany in the course of travel in quantities not exceeding that necessary for normal consumption or use during the travel in question and where they are carried in vehicles and are intended to be used or consumed exclusively by the people carried in such vehicles. It is apparent from those provisions that the german legislature itself does not consider controls of the kind at issue here to be necessary for the protection of public health, since no such controls exist for certain non-postal import procedures which provide no greater safeguards for the protection of public health than imports by post.

22 In answer to the question referred by the national court, it must therefore be stated 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.

Costs

23 The costs incurred by the governments of the federal republic of germany, the kingdom of denmark and the french republic and by the commission of the european communities, which have submitted observations to the court, are not recoverable. Since these proceedings are, in so far as the parties to the main proceedings are concerned, in the nature of a step in the action pending before the national court, the decision on costs is a matter for that court.

On those grounds,

The court (third chamber),

In reply to the question referred to it by the hessische finanzgericht, by order of 25 may 1987, hereby rules:

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.