Keywords

Summary



Keywords

1. Approximation of laws – Medicinal products for human use – Directive 2001/83 – Classification of a product as a medicinal product by presentation – Criteria

(European Parliament and Council Directive 2001/83, Art. 1(2), first para.)

2. Approximation of laws – Medicinal products for human use – Directive 2001/83 – Classification of a product as a medicinal product by function – Criteria

(European Parliament and Council Directive 2001/83, Art. 1(2), second para.)

3. Approximation of laws – Medicinal products for human use – Directive 2001/83 – Classification of a product as a medicinal product by function – Criteria

(European Parliament and Council Directive 2001/83, Art. 1(2), second para.)

4. Free movement of goods – Quantitative restrictions – Measures having equivalent effect

(Arts 28 EC and 30 EC)

Summary

1. A product is ‘presented for treating or preventing disease’ within the meaning of Directive 2001/83 on the Community code relating to medicinal products for human use when it is expressly ‘indicated’ or ‘recommended’ as such, possibly by means of labels, leaflets or oral representation, or whenever any averagely well-informed consumer gains the impression, which, provided it is definite, may even result from implication, that the product in question should, having regard to its presentation, have the properties in question.

The criteria laid down in the first paragraph of Article 1(2) of Directive 2001/83 are not satisfied by a garlic preparation in capsule form which is neither indicated nor recommended as a product for treating or preventing disease, whether on the label, the information printed on the external packaging, or otherwise, and whose packaging displays nothing capable of inspiring in a reasonably well-informed consumer confidence like that usually inspired by medicinal products, with the result that presentation in capsule form is the only aspect likely to suggest classification of the product as a medicinal product by presentation. Such a preparation cannot be classified as a medicinal product by presentation for the purposes of that directive.

The external form given to a product, although it may serve as strong evidence of the seller’s or manufacturer’s intention to market that product as a medicinal product, cannot be the sole or conclusive evidence, since otherwise certain food products which are traditionally presented in a similar form to medicinal products would also be covered. The capsule form is not exclusive to medicinal products, given that a large number of foodstuffs are in fact offered for sale in that form in order to facilitate their ingestion by consumers. Consequently, that evidence alone is not sufficient to confer the status of medicinal product by presentation on the product concerned.

(see paras 44-46, 50-54, 78)

2. For the purposes of determining whether a product falls within the definition of a medicinal product by function within the meaning of Directive 2001/83 on the Community code relating to medicinal products for human use, the national authorities, acting under the supervision of the courts, must decide on a case-by-case basis, taking account of all the characteristics of the product, in particular its composition, its pharmacological properties to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail.

The pharmacological properties of a product are the factor on the basis of which it must be ascertained, in the light of the potential capacities of the product, whether it may, for the purposes of the second subparagraph of Article 1(2) of Directive 2001/83, be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings.

However, that criterion must not lead to the classification as a medicinal product by function of substances which, while having an effect on the human body, do not significantly affect the metabolism and thus do not strictly modify the way in which it functions.

Contrary to the definition of medicinal product by presentation, whose broad interpretation is intended to protect consumers from products which do not have the effectiveness they are entitled to expect, the definition of medicinal product by function is designed to cover products whose pharmacological properties have been scientifically observed and which are genuinely designed to make a medical diagnosis or to restore, correct or modify physiological functions.

In those circumstances, and in order to preserve the effectiveness of that criterion, a product must not only have properties beneficial to health in general, but strictly speaking have the function of treating or preventing disease, especially since there are many products generally recognised as foodstuffs which may also serve therapeutic purposes. That fact is not sufficient to confer on them the status of medicinal product within the meaning of Directive 2001/83.

Finally, the fact that ingesting a product could give rise to a health risk is not an indication that it is pharmacologically effective. Whilst the health risk must be taken into consideration in the classification of a product as a medicinal product by function, it is none the less an autonomous factor.

(see paras 55, 59-61, 64-65, 69)

3. A garlic product in capsule form, whose effect on physiological functions is no more than the effects which a foodstuff consumed in a reasonable quantity may have on those functions, does not have a significant effect on the metabolism and cannot, therefore, be classified as a product capable of restoring, correcting or modifying physiological functions within the meaning of the second subparagraph of Article 1(2) of Directive 2001/83. Because the mentioned risks and contra-indications related to taking garlic preparations are limited and, more importantly, are no different from those linked to taking garlic as a foodstuff, and because the criterion of the method of using of the product concerned cannot be decisive, given that capsule form is not unique to medicinal products, such a preparation cannot be classified as a medicinal product by function within the meaning of the second subparagraph of Article 1(2) of Directive 2001/83.

(see paras 68, 76-78)

4. Where a Member State decides to require marketing authorisation as a medicinal product for a garlic preparation in capsule form which does not satisfy the definition of a medicinal product within the meaning of Article 1(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, that requirement constitutes a measure having equivalent effect to a quantitative restriction on imports, prohibited by Article 28 EC.

By so doing, the Member State creates an obstacle to intra-Community trade in so far as such a product, legally marketed in other Member States as a foodstuff, can be marketed in the said State only after having been subjected to the authorisation procedure for placing a medicinal product on the market.

As to whether such a restriction may be justified under Article 30 EC by reasons relating to the protection of public health, it is true that Member States are entitled, in the absence of harmonisation and to the extent that uncertainties continue to exist in the current state of scientific research, to decide on their intended level of protection of human health and life and on whether to require prior authorisation for the marketing of foodstuffs, always taking into account the requirements of the free movement of goods within the Community. However, the means which they choose in that regard must be proportionate to the objective thus pursued. The issuing of a marketing authorisation under Article 8 of Directive 2001/83 is subject to particularly strict requirements, and the obligation to obtain such an authorisation before being able to market the product concerned in the territory of the Member State cannot be regarded as being in accordance with the principle of proportionality unless it is actually necessary to safeguard public health. Such a restriction on the free movement of goods must therefore necessarily be based on a detailed assessment of the risk alleged by the Member State.

A generic reference to the risks that consuming the product may have for health in very specific circumstances is not sufficient to justify a measure such as making the product subject to the particularly strict procedure for a marketing authorisation for a medicinal product.

(see paras 79, 81, 86-87, 89-91, 94, 97, operative part)