C-227/82

VAN BENNEKOM

with the authorities constitutes such a to the interests referred to in Article measure, since such legislation is 36 of the Treaty and, in particular, to liable to hinder trade between show that the marketing of the Member States. product in question creates a serious 5. It is only when Community directives, risk to public health. in pursuance of Article 100 of the Treaty, make provision for the full 7. Where certain vitamin or multi- harmonization of all the measures vitamin preparations imported from needed to ensure the protection of another 'Member State may be human and animal life and institute regarded as medicinal products within Community procedures to monitor the meaning of Directive 65/65 on compliance therewith that recourse to proprietary medicinal products, but Article 36 ceases to be justified. are not covered by the legislation on medicinal products of one or more 6. In so far as uncertainties persist in the Member States, or are not covered present state of scientific research, it by the Community definition of a is for the Member States, in the medicinal product contained in that absence of harmonization, to decide directive, the law of a Member State what degree of protection of the may prohibit the sale or holding in health and life of humans they intend stock thereof for the purpose of to assure, having regard however supply, in particular when such to the requirements of the free preparations are presented in a phar- movement of goods within the maceutical form or when they are Community. highly concentrated. However, such In that connection it is for the rules are justified only if author- national authorities to demonstrate in izations for marketing are granted each case that their rules are when they are compatible with the necessary to give effective protection requirements of health protection.

T H E C O U R T (Fifth Chamber)

c o m p o s e d of: Y. G a l m o t , President of C h a m b e r , Lord M a c k e n z i e Stuart, O . D u e , U . Everling, a n d C. Kakouris, J u d g e s ,

A d v o c a t e G e n e r a l : S. R o z è s Registrar: P. Heim

gives the following

JUDGMENT

Facts and Issues

The Wet op de Geneesmiddelenvoor- On the other hand, Article 19 of the ziening assigns the following meaning to Besluit Registratie Geneesmiddelen [De- "medicinal product": cree on the Registration of Medicinal Products] provides for the issue of an "Any substance or combination of sub- authorization to deal in pharmaceutical stances which is intended to be used or products throughout the territory of the which is in any way indicated or EEC (in accordance with the provisions recommended as being suitable for: of the Second Council Directive, 75/319/EEC, published in Official 1. healing, treating or preventing any Journal L 147 of 9 June 1975, p. 13, as infection, disease, symptom, pain, amended on 2 May 1978 by Directive 78/420/EEC, published in Official wound or illness in human beings; Journal L 123 of 11 May 1978, p. 26). Manufacturers, importers and whole- 2. restoring, correcting or modifying the salers of medicinal products must there- function of bodily organs in human fore hold manufacturing, importing and beings; wholesale licences respectively. Van Bennekom did not hold such licences. 3. making a medical diagnosis by its administration to or use upon human beings." The Kantonrechter [Cantonal Court], Amsterdam, decided that highly con- Council Directive 65/65 assigns the centrated vitamin preparations, such as following meaning to medicinal product: those which had been seized in the present case, were medicinal products within . the meaning of the Wet op "Any substance or combination of sub- Geneesmiddelen voorziening because, by stances presented for treating or reason of their composition (highly preventing disease in human beings or concentrated), they were intended to be animals. used for healing, treating or preventing any infection, disease or illness in human Any substance or combination of sub- beings, in particular an existing or stances which may be administered to potential deficiency of vitamins in the human beings or animals with a view to body. making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings The Arrondissementsrechtbank [District or in animals is likewise considered a Court] Amsterdam, dealing with the case medicinal product." on appeal, decided that a ruling by the Court of Justice on the interpretation of It should be noted, however, that the the Community provisions was necessary directive is applicable only to "pro- and, staying the proceedings, asked the prietary medicinal products", that is to Court to answer the following questions: say ready-prepared medicinal products placed on the market under a special name and in a special pack. According to 1. Is it possible for substances or Article 3 of the directive, no proprietary combinations of substances, such as medicinal product may be placed on the vitamin preparations in certain con- market in a Member State unless an centrations and doses and in the form authorization has been issued by the (tablets, pills and capsules) referred to competent authority of that Member in the present case, which are not State. indicated or recommended as being

suitable for treating, relieving or form of a criminal penalty to, the sale preventing any infection, disease or or holding in stock for the purpose symptom, pain, wound or infirmity of supply of vitamins and vitamin in human beings, to constitute sub- preparations by the use of a definition stances or combinations of substances of medicinal product which, like that "presented for treating or preventing contained in the Wet op de Genees- disease in human beings or animals"? middelenvoorziening, is so wide as to include such preparations if they are not, either alone or in combination, medicinal products within the meaning of the directive? 2. Is it possible for a substance or combination of substances, such as a vitamin or multi-vitamin preparation similar to those referred to in the 5. If vitamins or multi-vitamin prep- present case, which may be suitable arations may be regarded as medicinal for treating or preventing disease in products within the meaning of the human beings or animals but which directive but the latter or the national is not presented as such and cannot legislation based thereon is drafted, be administered to human beings or interpreted or applied in one or more animals with a view to making a of the Member States in such a way medical diagnosis or to restoring, that those preparations do not fall correcting or modifying physiological within the legislation governing functions in human beings or in medicinal products which is in force animals, to be a "medicinal product" there, may Netherlands law prevent within the meaning of the directive? the sale or the holding in stock for the purpose of supply of such preparations imported from one of those Member States in reliance on 3. (a) On the assumption that vitamins the Wet op de Geneesmidde- in certain low concentrations are lenvoorziening or its implementing intended for use in foodstuffs and decrees, or would that be in conflict not as medicinal products, even with the Treaty, in particular with though they are marketed in the Article 30 thereof, and with the form of tablets, pills or capsules, prohibition of restrictions on trade can a high(er) concentration of between the Member States? those vitamins, whether or not they are in that form, be sufficient for the substance to be classified as a medicinal product within the 6. If the answer to the preceding meaning of the directive? questions leads to the conclusion that the definition of medicinal products in Netherlands law, in contrast to the definition contained in the EEC directive, includes the vitamin prep- (b) If so, on the basis of what critera arations referred to in this case, with may that be established? the result that they must be registered as indicated above in the same way äs proprietary medicinal products and medicinal preparations, must the 4. Is it permissible for Netherlands law Netherlands statutory provisions be to prohibit, or to be applied in the regarded as constituting to that extent

1. The accused, Mr van Bennekom, Pursuant to Article 20 of the Protocol on remarks that in Germany, the United the Statute of the Court of Justice of the Kingdom and in Belgium the great EEC written observations were submitted majority of vitamins are regarded as on 4 December 1982 by the accused in foodstuffs. According to him only the main case, Leendert van Bennekom, Vitamins A and D are capable of having represented by H. A. Bouman of the any toxic effect and then only if they are Amsterdam Bar and by C. T. Barbas of consumed in excessive quantities. The the Brussels Bar, on 15 November 1982 toxic effect is, however, no greater than by the Commission of the European that of many foodstuffs if they are Communities, represented by its Agent, consumed in excessive quantities. Auke Haagsma, a member of the Commission's Legal Department, on 3 December 1982 by the Government of the Netherlands, represented by the Vitamins are organic compounds which Secretary General for Foreign Affairs, are necessary for the normal functioning F. Italianer, and the Government of of the human body in its entirety and not the Federal Republic of Germany, for that of each individual bodily organ. represented by its Agents, Martin Seidel and Ernst Roder, and on 10 December 1982 by the Danish Government, represented by L. Mikaelsen, Legal Scientific research has hitherto been Adviser on Foreign Affairs, and by the unable to establish whether there is an Italian Government, represented by I. M. optimum or maximum quantity which Braguglia, Avvocato dello Stato. corresponds to the needs of the body; it has however been established that water- soluble vitamins (Vitamin C among others) are eliminated by the kidneys to Upon hearing the report of the Judge- the extent to which the body does not Rapporteur and the views of the need them; lipo-soluble vitamins (A and Advocate General, the Court decided to D) are accumulated in the body and, open the oral procedure without any when absorbed in large quantities, they preparatory inquiry. However, it invited may have a certain toxic effect which is, the parties to submit their observations however, no greater than that of many on three specific questions in writing foodstuffs absorbed in large quantities.

The Netherlands authorities cannot take The accused maintains that since the measures restricting trade between preparations include neither indications Member States and justify them on the nor recommendations they are not grounds set out in Article 36 of the EEC "presented" within the meaning of the Treaty when rules for the protection of directive and that the directive does not public health have already been made at admit of an interpretation according to Community level. which a substance becomes a "medicinal product" by reason either of its pres- entation (as a pill, for example), or of its degree of concentration. 2. The Commission of the European Communities states first that the term "presented" which appears in the Com- munity definition does not refer solely to Furthermore, a national rule which is not an instruction on the label of the product consistent with the directive, may not be concerned. A product is also "presented" used against him. Since the directive only within the terms of that definition when deals with medicinal products which curative or preventive properties are are proprietary medicinal products (by attributed to it by other means, such as reason of their special packaging and publicity, the press, prospectuses, their individual names), while the Wet brochures and so forth, or even by verbal op de Geneesmiddelenvoorziening is recommendation of the seller. The form applicable to all medicinal products, the of the products in question, namely that Netherlands definition cannot, in any of tablets, pills or capsules, without being case, be wider than that of the directive conclusive none the less raises a as fár as medicinal products which are presumption that it was intended to proprietary medicinal products within present them as substances possessing the the meaning of the directive are properties set out in the Community concerned. definition.

Other (material) circumstances may also vitamin thus being used as a true suggest that they are presented in that medicament". way; that is true, for example, of products containing leatrile which, The only criterion which may be applied according to Dr Hannema who was in this respect is that in the case of a quoted in the judgment of the trial (very) low concentration a foodstuff is judge, are "recommended for treating or concerned and in the case of a (very) healing cancer or cancerous symptoms". high concentration a medicinal product

of that definition. If a substance wider than the Community definition. possesses properties "for treating or Clearly, in such cases it is necessary preventing disease in human beings or to observe the other provisions of animals, but . . . is not presented as Community law and, in particular, such", then, according to the Com- Articles 30 to 36 of the EEC Treaty. mission, it falls into the second part of the definition precisely because it In so far as it is able to form an opinion possesses those properties and is from the documents on the file, the therefore to be regarded as a medicinal Commission believes that the measures

However, where constitute an essential element of daily a product is not regarded as a medicinal nutrition and cannot be considered product in one Member State, the medicinal products. On the other hand, competent authority of another Member in high or very high concentrations State may arrive at a different conclusion vitamins should be considered medicinal (namely that the substance does products. Thus, for example, the constitute a medicinal product) unless it Larousse de la Médecine States that has good reasons for doing so and, vitamins may be used "generally in very generally, submit the question to the high doses as therapeutic agents against Committee for Proprietary Medical various diseases in which the deficiency Products established by Article 8 of of vitamins is not the morbid cause, the Directive 75/319/EEC.

In conclusion, the Commission does not in which the medicinal product is exclude the possibility that some of the marketed may also provide an indication, products in issue might not fall within in particular when the product under the Community definition. However, on examination is presented in the form of the basis of the facts as shown in the file, tablets, powders, capsules or pills. The it believes that the application of the quantity or the concentration of the rules laid down in the Community product must also be taken into account. directives to the products referred to it An important role may also be played by by the national court which do not fall the recommended daily dose of the within the definition of the directive are substance (that is to say the quantity justified on the ground of the protection corresponding to the daily needs of of health under Article 36 of the Treaty. a normal person) as scientifically established and recorded in agreements or in resolutions of international organ- izations such as the World Health Organization or foreign institutions such 3. The Government of the Netherlands as the National Academy of Science — states that the terms used in the National Research Council (United Netherlands definition ("intended", States of America). Beyond that daily "indicated" and "recommended") in dose, the product becomes dangerous for substance coincide with the definition public health or at least is no longer a used in the directive. A number of normal foodstuff. criteria which are equally relevant, such as publicity details, the form and the quantity or concentration, may be used to complement the three legal con- cepts mentioned above ("intended", The Government of the Netherlands "indicated" and "recommended"). For states that even though the definition of that reason substances which are not "medicinal product" in the Netherlands indicated or recommended as being Law is no wider than that which appears suitable for healing may perfectly well be in the directive, there is in fact nothing substances or combinations of substances to prevent it from being so. The fact that presented for treating or preventing the legislation on the subject does not disease in human beings or animals. necessarily correspond to that of other Member States does not mean that it is contrary to Community law. In the present case, if the products in question do not fall within the definition of the On the other hand, products which do expression "medicinal product" in the not fall within one of the two elements directive, the Netherlands rules are of the definition of the expression justified by Article 36 of the Treaty. "medicinal product" in the directive cannot be "medicinal products" within the meaning of the directive.

4. On the first question the Govern- "modify physiological functions in ment of the Federal Republic of Germany human beings". maintains (as appears from a document submitted by the German Government in response to questions put by the Court) that a product may be "presented" as a According to the German Government, medicinal product within the meaning of vitamins doubtless serve nutritional pur- the first branch of the Community poses to a large extent. Even to the definition even if it is not expressly so extent to which vitamins contained in described, but for example — according vitamin preparations are administered to to the circumstances of each individual compensate for seasonal fluctuations in case — if it is put on sale in the form of the natural vitamin content of foodstuffs, a medicinal product or according to such preparations constitute a dietary information published on the packaging. additive. The same applies when vitamin The fact that a product is in the form of preparations are consumed because a a capsule or tablet cannot however be need has arisen which cannot be satisfied considered conclusive in all cases. by the natural vitamin content of foodstuffs, as is the case for example following a particular physical effort required of a sportsman, of a pregnant woman or of a growing child.

The latter but on general opinion, that is to say on condition is essential because otherwise the opinion of a majority of consumers. all foodstuffs containing vitamins would be medicinal products to the extent to which, without them, diseases might arise. Moreover, the German Law on medicinal products (Arzneimittelgesetz) explicitly excludes foodstuffs from the definition of medicinal products. The Federal Government believes that, according to the use to which they are put, vitamin preparations may amount either to foodstuffs or to medicinal products within the meaning of Directive In the opinion of the Federal Govern-

JUDGMENT OF 30. 11. 1983 — CASE 227/82

VAN BENNEKOM

According to Mr van Bennekom, the first part of the definition should be strictly construed. It is true that a product may fall within the first part of I I I — R e p l i e s to t h e questions the definition if it is presented as a p u t by t h e C o u r t medicinal product, whether expressly or by implication, whether orally or in writing. However, in that respect, neither In reply to the questions put by the the form, nor the concentration nor the Court, the Commission of the European dose can play any part, in connection

JUDGMENT OF 30. 11. 1983 — CASE 227/82

either with the first or with the second represented by H.A. Bouman of the part of the definition. It can only be Amsterdam Bar, the Netherlands assumed that, beyond a certain degree of Government, represented by its Agent, concentration, vitamin preparations A. Bos, the Italian Government, rep- become medicinal products. Finally, resented by I. M. Braguglia, Avvocato certain vitamins (but not vitamins B and dello Stato, and the Commission of the C) have a toxic effect in high European Communities, represented by concentrations, but that is also true of its Agent, A. Haagsma, a member of its many foodstuffs. Legal Department, presented oral argument and replied to the questions put to them by the Court. IV — Oral procedure At the sitting on 18 May 1983, the The Advocate General delivered her accused in the main proceedings, opinion at the sitting on 5 October 1983.

Decision

1 By judgment of 12 May 1982, received by the Court on 1 September 1982, the Arrondissementsrechtbank [District Court] Amsterdam referred for a preliminary ruling under Article 177 of the EEC Treaty a number of questions concerning the interpretation of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regu- lation or administrative action relating to proprietary medicinal products (Official Journal, English Special Edition 1965-66, p. 20) and also of Articles 30 to 36 of the EEC Treaty, with a view to appraising the compatibility with Community law of the Netherlands Law on the Supply of Medicinal Products (Wet op de Geneesmiddelenvoorziening).

7 J n e . N e t n e r l a n d s Law on the Supply of Medicinal Products defines "medicinal product" as:

"Any substance or combination of substances which is intended to be used or which is in any way indicated or recommended as being suitable for:

1. healing, treating or preventing any infection, disease, symptom, pain, wound or illness in human beings;

2. restoring, correcting or modifying the function of bodily organs in human beings;

3. making a medical diagnosis by its administration to or use upon human beings."

s Council Directive 65/65 defines "medicinal product" in the first place as "Any substance or combination of substances presented for treating or preventing disease in human beings or animals", and, in the second place, as "Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a medicinal product."

(b) If so, on the basis of what criteria may that be established?

4. Is it permissible for Netherlands law to prohibit, or to be applied in the form of a criminal penalty to, the sale or holding in stock for the purpose of supply of vitamins and vitamin preparations by the use of a definition of medicinal product which, like that contained in the Wet op de Geneesmiddelenvoorziening, is so wide as to include such preparations if they are not, either alone or in combination, medicinal products within the meaning of the directive?

VAN BENNEKOM

5. If vitamins or multi-vitamin preparations may be regarded as medicinal products within the meaning of the directive but the latter or the national legislation based thereon is drafted, interpreted or applied in one or more of the Member States in such a way that those preparations do not fall within the legislation governing medicinal products which is in force there, may Netherlands law prevent the sale or the holding in stock for the purpose of supply of such preparations imported from one of those Member States in reliance on the Wet op de Geneesmiddelenvoorziening or its implementing decrees, or would that be in conflict with the Treaty, in particular with Article 30 thereof, and with the prohibition of restrictions on trade between the Member States?

6. If the answer to the preceding questions leads to the conclusion that the definition of medicinal products in Netherland law, in contrast to the definition contained in the EEC directive, includes the vitamin preparations referred to in this case, with the result that they must be registered as indicated above in the same way as proprietary medicinal products and medicinal preparations, must the Netherlands statutory provisions be regarded as constituting to that extent a measure having an effect equivalent to a quantitative restriction on trade within the meaning of Article 30 et seq. of the EEC treaty, in view of the fact that the EEC directive only contains rules concerning proprietary medicinal products?"

H Directive 65/65 is designed to eliminate — at least in p a r t — obstacles to trade in proprietary medicinal products within the Community whilst at the same time attaining the essential objective of safeguarding public health. As a result of such harmonization recourse to Article 36 of the EEC Treaty must gradually become unnecessary.

is It is in the light of those considerations that replies should first be given to the first three question of the Arrondissementsrechtbank Amsterdam, concerning the interpretation of the directive, and then, in the alternative, should the vitamin preparations at issue prove not to be covered by the directive, to the questions concerning Articles 30 et seq. of the Treaty.

First question

i6 In the first question the Court is asked, essentially, whether products such as the vitamin preparations at issue, which are not "indicated or recommended" expressly as being suitable for curing, treating or preventing an infection, may none the less be substances "presented for treating or preventing disease in human being or animals" within the meaning of the Community definition of "medicinal product" in Directive 65/65.

i7 In order to answer this question, it should be observed that the directive, by basing itself, in the first Community definition of a medicinal product, on the criterion of the product's "presentation", is designed to cover not only medicinal products having a genuine therapeutic or medical effect but also those which are not sufficiently effective or which do not have the effect which consumers would be entitled to expect in view of their presentation.

Second question

2i The second question seeks to ascertain whether a substance which may have curative or preventive properties in relation to human or animal diseases, but which is not presented as such and cannot be administered to a human being or an animal with a view to making a medical diagnosis or to restoring,

JUDGMENT OF 30. 11. 1983 — CASE 227/82

correcting or modifying physiological functions in human beings or animals, nevertheless falls within the definition of a medicinal product for the purposes of Directive 65/65.

22 It is apparent in this connection that a substance which is endowed with properties "for treating or preventing disease in human beings or animals" within the meaning of the first part of the Community definition, but which is not "presented" as such, falls in principle within the scope of the second part of the Community definition of a medicinal product.

23 On the other hand, a product which is covered by neither the first nor the second part of the Community definition of a medicinal product may not be regarded as a medicinal product within the meaning of Directive 65/65.

28 It is, however, apparent from the file and from the observations submitted to the Court, taken as a whole, that it is impossible in the present state of scientific knowledge to state whether the criterion of concentration alone is always sufficient in order to be able to determine whether a vitamin preparation constitutes a medicinal product; still less therefore is it possible to specify the level of concentration above which such a vitamin preparation would fall within the Community definition of a medicinal product.

29 The answer to be given to the national court should therefore be that the classification of a vitamin as a medicinal product within the meaning of the second part of the definition in Directive 65/65 must be carried out case by case, having regard to the pharmacological properties of each such vitamin to the extent to which they have been established in the present state of scientific knowledge.

F o u r t h , fifth a n d sixth q u e s t i o n s

30 The fourth, fifth and sixth questions ask, in substance, whether, where the certain vitamin or multi-vitamin preparations may

(a) be regarded as medicinal products within the meaning of Directive 65/65, but are not covered by the legislation on medicinal products of one or more Member States, or

(b) are not covered by the Community definition of medicinal product,

34 Under Article 36 of the Treaty, however, "The provisions of Articles 30 to 34 shall not preclude prohibitions or restrictions on imports . . . justified on grounds of . . . the protection of health and life of humans . . .", unless they constitute "a means of arbitrary discrimination or a disguised restriction on trade between Member States."

35 It is only when Community directives, in pursuance of Article 100 of the Treaty, make provision for the full harmonization of all the measures needed to ensure the protection of human and animal life and institute Community procedures to monitor compliance therewith that recourse to Article 36 ceases to be justified. It is, however not in dispute that such is not the case with the directives dealing with pharmaceutical products. It is therefore necessary to consider whether measures which restrict the marketing of vitamins may be justified by Article 36 of the Treaty.

36 As the Court has had occasion to affirm in its judgment of 14 July 1983 (Officier van Justitie w Sandoz, Case 174/82, [1983] ECR 2445), the excessive consumption of vitamins over a prolonged period may have harmful effects, the extent of which varies according to the type of vitamin, there being generally a greater risk with vitamins soluble in fat than with those soluble in water. It is further apparent that it is principally in high concentrations that

VAN BENNEKOM

vitamins constitute a serious risk to health. According to the observations submitted to the Court, however, scientific research does not appear to be sufficiently advanced to be able to determine with certainty the critical quantities and the precise effects.

JUDGMENT OF 30. 11. 1983 — CASE 227/82

4i The answer to be given to the national court should therefore be that where certain vitamin or multi-vitamin preparations may

(a) be regarded as medicinal products within the meaning of Directive 65/65, but are not covered by the legislation on medicinal products of one or more Member States, or

(b) are not covered by the Community definition of medicinal products,

the law of a Member State may prohibit the sale, or the holding in stock for the purpose of supply, of such preparations imported from another Member State, in particular when they are presented in a pharmaceutical form or when they are highly concentrated. However, such rules are justified only if authorizations for marketing are granted when they are compatible with the requirements of health protection.

Costs

stances "presented for treating or preventing disease in human beings or animals" within the meaning of the Community definition of "medicinal product" contained in Directive 65/65.

2. A product which falls neither under the first nor the second part of the Community definition of "medicinal product" cannot be considered a medicinal product within the meaning of Directive 65/65.

3. The classification of a vitamin as a medicinal product within the meaning of the second part of the definition in Directive 65/65 must be carried out case by case, having regard to the pharmacological properties of each of them, to the extent to which they have been established in the present state of scientific knowledge.

4. Where certain vitamin or multi-vitamin preparations may (a) be regarded as medicinal products within the meaning of Directive 65/65, but are not covered by the legislation on medicinal products of one or more Member States, or (b) are not covered by the Community definition of medicinal products, the law of a Member State may prohibit the sale, or the holding in stock for the purpose of supply, of such preparations imported from another Member State, in particular when they are presented in phar- maceutical form or when they are highly concentrated. However, such rules are justified only if authorizations for marketing are granted when they are compatible with the requirements of health protection.

Galmot Mackenzie Stuart

Due Everling Kakouris