4.

Let us turn to Article 36. Starting from the premise that the procedures for the surveillance of medicinal preparations placed on the market are not harmonized, the German Government relies on that article in four respects. The presence of a representative of the undertaking on the territory of the Federal Republic is, it claims, indispensable for the protection of health because: (a) it enables the competent authorities to obtain all the information necessary for assessing the product before it is placed on the market; (b) it enables them to subject it to further analyses and, if these show that it is harmful, to order its immediate withdrawal after it has been. placed on the market; (c) it facilitates actions for compensation for. damage caused by harmful medicinal preparations; and (d) it ensures the effectiveness of criminal proceedings in the case of an offence against the legislation. In comparing this case with Case 155/82, I have already made a number of references to the high degree of harmonization in the sector involved in this case and I will return to this point later. For the moment I will confine myself to remarking that, however far apart the national rules remain, the Court regards as justified under Article 36 only those internal measures which are strictly necessary for the protection of public health, for which there are no alternatives less restrictive of intra-Community trade and which do not entail arbitrary discrimination or disguised restrictions on trade between the Member States. The provision which requires the employment of a representative on the territory of the Federal Republic penalizes only foreign undertakings, by discriminating against them as compared with national undertakings. As regards the questions whether that provision is indispensable and whether there are no measures which could achieve the same ends by less restrictive means, I should like to put forward the following considerations. The first argument: The requirement laid down by that provision, it is said, must be met before the product is placed on the market because the direct contact which that requirement renders possible between the national authorities and the representative of the undertaking, makes it easier for the authorities to obtain the information on the basis of which they establish whether it is appropriate to authorize the marketing of the product. This argument would carry'weight were it not for the fact that the rules of Community law deal with this very point in the most detailed way. According to Article 4 of Council Directive 65/65 of 26 January 1965 (Official Journal, English Special Edition, 1965-1966, p. 20) any person wishing to obtain an authorization must provide the competent authority of the Member State with information on the composition of the product, the method of preparation, the therapeutic indications, the contra-indications, the posology, the control methods employed by the manufacturer and the results of the tests (physicochemical, biological, pharmacological, toxological and clinical) to which the medicinal preparation has been subjected. Nor is that all. According to a later directive (75/318 of 20 May 1975, Official Journal L 147, p. 1) the information relating to the method of preparation must include at least a“mention of the various stages of manufacture, so that an assessment can be made of whether the processes employed in producing the pharmaceutical form might have produced an adverse change in the constituents” (Annex, Part 1, B). What more information the national authorities need in order to decide whether the authorization can be granted, I cannot imagine. Assuming, however, that they did need more information, there would be nothing to prevent them from seeking it from the applicant. The latter will, as a rule, be the manufacturer of the medicinal preparation and thus the person who best knows its characteristics. From that point of view, whether or not there is a person responsible for marketing resident in Germany is totally irrelevant. The second argument: Such a person, so the argument continues, is indispensable even after the authorization to place the product on the market has been granted, for example when the competent authorities consider it appropriate to subject the product to new tests or when, having established that it is dangerous, they intend to withdraw it immediately from the market. Let me distinguish between these two situations. In the first, it seems to me, there are no grounds of urgency which prevent the competent authorities from addressing themselves to the foreign manufacturer. In the second, the possibility of being able to contact a person resident in Germany would undoubtedly facilitate their task. However, it seems to me that it is going too far to say that the immediate withdrawal of the dangerous medicinal product is the only means of protecting the health of consumers. As the Commission has pointed out, there are other ways and means of ensuring that consumers do not use it, for example, by warning them of the danger through the mass media (press, radio, television). The third argument: It is further contended that a person who consumes a harmful medicinal product can bring an action for damages more easily against a representative of an undertaking residing in the Federal Republic of Germany. That argument is in itself correct, but it misses the point. I do not believe that the exemption under Article 36 goes so far as to cover measures which protect consumers not against the use of harmful medicinal products, but against having used them. The requirement to which the German Government has expressly drawn attention is covered by other Community texts, such as the Brussels Convention on Jurisdiction and the Enforcement of Judgments in Civil and Commercial Matters. The fourth argument: Finally, it is asserted that the presence in the Federal Republic of a person responsible for marketing renders more effective criminal proceedings instituted for offences against provisions relating to the protection of health. This is also correct, but of no value for our purposes, as this Court itself observed in its judgment of 2 March 1983. when it stated that “questions of criminal liability are relevant to the objective of Article 36 only in so far as the application of criminal provisions may have a preventive effect” and added that “even though criminal penalties may have a deterrent effect as regards the conduct which they sanction, that effect is not guaranteed and, ... is not strengthened, in the case of a manufacturer in another Member State ..., solely by the presence on national territory of a person who may legally represent the manufacturer” (paragraph 15 of the decision). In my opinion there is no reason for the Court now to depart from that approach.