Keywords
Summary

Keywords

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1. Approximation of laws - Proprietary medicinal products - Directive 65/65 - Concept of disease or illness - No definition

(Council Directive 65/65)

2. Approximation of laws - Proprietary medicinal products - Product fulfilling both the definition of medicinal product given in Directive 65/65 and that of cosmetic product given in Directive 76/768 - Covered by Directive 65/65

(Council Directive 65/65, Art. 1(2), and Council Directive 76/768, Art. 1(1))

3. Approximation of laws - Proprietary medicinal products - Definition of medicinal products given in Directive 65/65 - Medicinal products by virtue of their function and medicinal products by virtue of their presentation - Application by the national authorities to a product presented for dealing with certain sensations or states - Criteria

(Council Directive 65/65, Art. 1(2))

4. Free movement of goods - Quantitative restrictions - Measures having equivalent effect - Pharmacists' monopoly - Extent - Medicinal products within the meaning of Directive 65/65 - Presumption of justification - Other products - Justification - Protection of public health or of consumers - Examination by national court

(EEC Treaty, Arts 30 and 36; Council Directive 65/65)

5. Approximation of laws - Emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs - Directive 74/329 - Scope - Inclusion in the pharmacists' monopoly of a product listed in Annex I but used for a purpose not covered by the directive - Excluded - Application of Articles 30 and 36 of the Treaty

(EEC Treaty, Arts 30 and 36; Council Directives 65/65 and 74/329)

Summary

1. Council Directive 65/65 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products gives no definition of illness or disease. The only possible definitions for those terms are those most commonly accepted on the basis of scientific knowledge.

2. A given product, even if it falls within the definition of cosmetic products given in Article 1(1) of Directive 76/768, must nevertheless be treated as a "medicinal product" referred to in Article 1(2) of Directive 65/65 on proprietary medicinal products and be made subject to the corresponding rules if it is presented as possessing properties for the treatment or prevention of illness or disease or if it is intended to be administered with a view to restoring, correcting or modifying physiological functions.

That classification is necessary in view of the aim of protecting public health pursued by both directives, since the legal rules applicable to proprietary medicinal products are more rigorous than those applicable to cosmetic products, in view of the particular dangers which the former may present to public health and cosmetic products generally do not.

3. A product presented as being intended to facilitate certain physiological functions falls within the scope of the Community definition of medicinal product in the second subparagraph of Article 1(2) of Council Directive 65/65/EEC as a medicinal product by virtue of its function. In order to decide whether that product is to be categorized as a medicinal product or as a foodstuff, it is necessary to have regard to its pharmacological properties. The fact that such a product is classified as a foodstuff in one Member State does not preclude its being treated as a medicinal product in the State concerned if it possesses the relevant characteristics. The specific features of the legislation concerning natural mineral waters have no relevance to the definition of medicinal product within the meaning of Directive 65/65/EEC.

A product may be regarded as being a medicinal product "by virtue of its presentation" for the purposes of the first subparagraph of Article 1(2) of Directive 65/65 if its form and the manner in which it is packaged render it sufficiently similar to a medicinal product and, in particular, if on its packing and in the information provided with it reference is made to research by pharmaceutical laboratories, to methods or substances developed by medical practitioners or even to testimonials from medical practitioners commending the qualities of the product. A statement that the product is not medicinal is persuasive evidence which the national court may take into consideration but is not in itself conclusive.

It is for the national authorities to determine, subject to judicial review, whether or not, having regard to its composition, the risks which its prolonged consumption may entail or its side-effects and, more generally, all of its characteristics, a product presented as counteracting certain conditions or sensations, such as hunger, heaviness in the legs, tiredness or itching constitutes a medicinal product.

There is no provision obliging Member States to consult the consultative committees specialized in medicinal products attached to the Community institutions before taking the steps dictated in internal law by the definitions of medicinal product given in Directive 65/65/EEC.

4. Under Community law as it now stands, the determination of the rules governing the distribution of pharmaceutical products remains a matter for the Member States, provided that the provisions of the Treaty, and in particular those relating to the free movement of goods, are respected.

A monopoly of the right to distribute medicinal or other products, granted to dispensing pharmacists, may constitute a barrier to importation.

If a Member State chooses to restrict to pharmacists the right to distribute products of that kind, such a barrier is, in principle and in the absence of any evidence to the contrary, justified in so far as it concerns medicinal products within the meaning of Council Directive 65/65/EEC on proprietary medicinal products.

Where other products are concerned, however they may be classified in national law, it is for the national court to determine whether a monopoly of the right to market such products granted to pharmacists is necessary for the protection of public health or of consumers and whether those two aims cannot be achieved by measures less restrictive of intra-Community trade.

5. Directive 74/329 on the approximation of the laws of the Member States on emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (Official Journal 1974 L 189, p. 1) and Articles 30 and 36 of the EEC Treaty must be interpreted as meaning that a measure whereby a Member State makes a product listed in Annex I to the directive, such as guar gum, subject to marketing authorization and to the sales monopoly of pharmacists when it is used as part of a method intended to facilitate weight loss, however that product may be classified in any other sphere of national law, does not fall within the scope of that directive, but may constitute a barrier to importation. When the product in issue is not a medicinal product within the meaning of Directive 65/65/EEC on proprietary medicinal products, such a measure is not permissible under Community law unless it is necessary in order to protect public health or consumers and is proportionate to those aims.