5.

Let me repeat that the Luxembourg rules concerning the distribution of medicinal products require wholesalers residing in another Member State who wish to supply Luxembourg pharmacies directly to comply with two separate requirements: (a) they must have at their disposal in the Grand Duchy suitable storage facilities for such products and adequate technical equipment; and (b) they must arrange for their premises to be accessible to the health authorities at all times. The Luxembourg Government contends that such an obligation does not constitute a measure having equivalent effect within the meaning of Article 30 because it applies to all wholesalers, whether they reside in Luxembourg or abroad, who supply pharmacies in Luxembourg. Furthermore, it does not imply that foreign suppliers must have their registered office in Luxembourg or maintain a representative there. The present case therefore cannot be assimilated to the one on which the Court ruled in Case 247/81, cited above. However, in putting forward this argument, the Luxembourg Government is confusing two different situations: wholesale trading in medicinal products and exportation of such products to Luxembourg by a wholesaler residing in another Member State. It is clear that Member States are entitled to require any person who wishes to pursue the first of those activities on its territory to obtain an administrative authorization in order to meet public interests. However, the foreign supplier in this case is not in fact seeking to trade as a wholesaler in the Grand Duchy. He merely wishes to supply local pharmacies directly. Indeed, if he sells the same consignment of goods to a Luxembourg wholesaler, he does not need either a licence or storage facilities in the Grand Duchy. Thus to extend to him the rules governing wholesale trading and to require him to maintain premises in Luxembourg even though he already has such premises at his disposal in the State in which his headquarters are situated imposes on him additional costs and so obstructs his access to the market in the importing State, or even renders such access impossible. Since such a measure is certainly contrary to the prohibition contained in Article 30 of the EEC Treaty, it is then necessary to ascertain whether the measure can be justified on the basis of Article 36 and, in particular, of the rule concerning the protection of health. On this question, the Luxembourg Government points out that the medicinal products sold in Luxembourg are nearly all imported and that, in the absence of the contested obligation, the local health authorities would have no opportunity of exercising effective control of the market. Such control is essential for reasons of public order to meet the following requirements: (a) to check whether the products are in a good condition; (b) to withdraw from the market consignments which do not comply with the legal requirements; (c) to ensure regular supplies to the market; (d) to detect unlawful sales of toxic substances; and, (e) to supervise the granting of any discounts or other advantages on wholesale transactions. Let me say at once that the last three requirements are of very little weight. The fifth appears to be motivated by concerns of a protectionist nature rather than by the need to protect health. The fourth (preventing the sale of narcotic drugs) can be achieved by other methods which are both more effective and more consistent with Community law, such as customs controls or inspections carried out in the individual pharmacies. With regard to the third (the regular supply of the Luxembourg market), it seems to me that it is mainly up to local suppliers and wholesalers to ensure such supplies. However, the other two requirements, concerning the quality of medicinal products placed on the market and their conformity with national requirements, deserve more detailed examination. As the representative of the Luxembourg Government observed on this point, there are medicinal products on the European markets which have identical names and packaging but have slightly different constituents. It is precisely in regard to such products, which appear identical to consumers but are substantially dissimilar, that periodical inspections must be carried out in the places from which pharmacies are directly supplied. Such inspections are possible only if those places are located on the national territory. What can be said in regard to that argument? It seems to me that the problem to which it relates has already been largely resolved by Community law. Thus, according to Article 11 of Directive 65/65, the Member States may suspend or revoke an authorization to place a proprietary medicinal product on the market where that product proves to be harmful under normal conditions of use or where its qualitative and quantitative composition is not as declared. Furthermore, Article 13 provides that the outer packages of medicinal products must indicate the name of the product, the name and permanent address of the person responsible for placing it on the market and, where applicable, of the manufacturer, and the ‘expiry date for proprietary products with a shelf-life of less than three years’. Finally, Article 30 of Directive 75/319 requires the Member States to take all appropriate measures to ensure that the competent authorities concerned communicate to each other such information as is appropriate to guarantee that the requirements for the marketing of proprietary medicinal products are fulfilled. However, that is not all. The Luxembourg legislature itself does not share its Government's concern, since it has recently amended the rules governing the marketing of medicinal products, which no longer require foreign suppliers to have storage facilities in Luxembourg and provide for inspections to be carried out prior to wholesale distribution and sale to the public. For example, Articles 4 and 13 of the Law of 11 April 1983 prohibit the sale and importation of medicinal products which are not covered by a marketing authorization issued by the Luxembourg authorities. Under Article 7, the holder of such an authorization, and hence also foreign suppliers who market their products in Luxembourg, must immediately transmit to the Minister for Health any new information which they obtain concerning the medicinal product and, in particular, any prohibitions and restrictions imposed by the authorities in the country of origin and in the countries in which the product is marketed. Furthermore, the authorization may be withdrawn, not only on the grounds laid down in the directives, but also when the name of the medicinal product: (a) coincides with that of another product of different composition which is already on the market; or (b) is likely to give rise to error or, because of the similarity of name, cause confusion as to its therapeutic effect (Article 11). In my view, that is sufficient reason for the Court to decide that the dangers alleged by the Luxembourg Government are not substantial or, at least, are not such as to justify recourse to measures which obstruct intra-Community trade. That conclusion appears all the more reasonable because it is supported by a final and, as it were, practical argument: it is not clear for what purpose foreign suppliers should be required to have storage facilities in Luxembourg when the Luxembourg authorities are unable to require them to store a certain quantity of samples of each proprietary medicinal product there.