C-319/05, Commission v Germany

By classifying as a medicinal product a garlic preparation in capsule form, Germany infringed Art. 28 and Art. 30 EC. The capsule from did not satisfy the definition of a medicinal product within the meaning of Art. 1(2) of Directive 2001/83.

The Commission sought a declaration from the Court that, by classifying a garlic preparation in capsule form, which did not fall under the definition of a medicinal product by virtue of its designation, as a medicinal product, Germany had failed to fulfil its obligations under Articles 28 and 30 EC.

The Court held if a product produced industrially came within the definition of medicinal product in Art. 1(2) of Directive 2001/83, the obligation on the importer of that product to obtain a marketing authorisation in accordance with that directive prior to marketing it in the Member State of importation could not in any event constitute a restriction on trade between Member States prohibited by Art. 28 EC.

The fact that a product was classified as a foodstuff in another Member State could not prevent it from being classified as a medicinal product in the Member State of importation, if it displayed the characteristics of such a product.

A product which satisfied the definition of “medicinal product” within the meaning of Directive 2001/83 must be held to be a medicinal product and be made subject to the corresponding rules even if it came within the scope of other, less stringent Community rules (see
C-219/91, Ter Voort).

The Court reiterated Art. 1(2)(1) of Directive 2001/83 gave two definitions of medicinal product, one “by presentation” and one “by function’. A product was a medicinal product if it fell within either of those definitions (see
Joined Cases C and-211/03, C-299/03 and C-316/03 to C-318/03 HLH Warenvertrieb and Orthica).

The first definition was to be interpreted broadly, covering not only medicinal products having a genuine therapeutic or medical effect, but also those which were not sufficiently effective or did not have the effect which consumers would be entitled to expect from the way in which they were presented.

With regards to the second definition, the Court that 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 could be established in the present state of scientific knowledge, the manner in which it was used , the extent of its distribution, its familiarity to consumers and the risks which its used might entail.

The Court concluded that the capsule form could not be classified as a medicinal product either by presentation or function.

Germany's decision to classify the capsule form as a medicinal product created an obstacle to intra-Community trade in so far as the products concerned, legally marketed in other Member State as a foodstuff, could be marketed in Germany only after having been subjected to the authorisation procedure for the placing on the market of a medicinal product.

With regard to a possible justification under Art. 30 EC, the Court held that it was for the Member States, in the absence of harmonisation and to the extent that uncertainties continued to existed 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 Court reiterated that in exercising their discretion relating to the protection of public health, the Member States must comply with the principle of proportionality. Germany had failed to prove that the legislation at issue was necessary in order to protect consumer health and that it went no further than was necessary in order to achieve that aim. The decision did not therefore satisfy the principle of proportionality.

Text of Judgment