3.

I shall now examine the three questions on which the Court is requested to give a ruling. At the heart of the case is the second question, which concerns the scope of Directive 65/65: the national court wishes to know whether it covers only rules which are concerned with the protection of health or whether it also applies to rules relating to prices. Logically, that question must be answered before Question 3, which concerns the interpretation of a single provision of the directive, and before Question 1, which asks what effect the various provisions of the directive have. In fact if Question 2 is answered in the negative, a similar answer will have to be given to Question 3, while Question 1 will become irrelevant. I will say at once that, in my opinion, the directive at issue is concerned solely with the approximation of rules relating to pharmaceutical products which are intended to protect public health; it therefore does not cover rules relating to price controls. A number of factors lead me to that conclusion. In the first place, there is the aim of the directive, defined in the preamble. The first recital lays down the basic principle on which any rule concerning the production and distribution of proprietary medicinal products must be based: its “primary purpose ... must be to safeguard public health”. That principle is then developed. In particular, the directive states that: (a) that objective must be attained by means which will not hinder the development of the pharmaceutical industry of trade in medicinal products within the Community (second recital); (b) “trade ... is hindered by disparities between certain national provisions ... relating to medicinal products” (third recital) and “such hindrances must accordingly be removed” (fourth recital); (c) this entails approximation of the national rules (fourth recital), to be achieved “progressively”; and (d) priority must be given to eliminating the disparities liable “to have the greatest effect on the functioning of the common market” (fifth and final recital). Thus the declared aim of the Community legislature is to approximate the national rules from the standpoint of the protection of public health. More important still is the fact that the rules which it has laid down are clearly drafted from the same perspective: those relating to authorization to market (Chapter II) no less than those which deal with the revocation of such authorization (Chapter III) and those which regulate labelling (Chapter IV). It is sufficient for me to cite in detail Articles 4 and 5. Article 4 defines the procedure for obtaining authorization and requires the persons concerned to supply the competent national authorities with particulars of the constituents of the product, the method of preparation, therapeutic indications, contraindications, posology, control methods used by the manufacturer and the results of various tests (physicochemical, biological, pharmacological, toxicological and clinical) to which the medicinal products must be submitted. Article 5 provides that the authorization is to be refused if, after verification of the particulars given, it proves “that the proprietary medicinal product is harmful ... or that its therapeutic efficacy is lacking or is insufficiently substantiated ... or that its ... composition is not as declared”. The same is true of the provisions governing the revocation of authorization: the cases in which revocation is provided for all involve a finding that the product is harmful or dangerous. The provisions on labelling are likewise directed towards the protection of the consumer: the packages must contain particulars such as the “method of administration”, “expiry date”, “special storage precautions”, and so on. Furthermore, the rules on labelling may also be relied on for the sake of a separate argument — which could be described as a contrario — in support of my view. Article 19 provides that the rules on labelling “shall not prevent the particulars required by rules other than those to which this directive relates from being given on outer packages or containers”. It seems to me that it may be inferred from that that the directive does not deal exhaustively with the subject of proprietary medicinal products. Some aspects remain outside it; and I do not think that it would be far from the truth to state that one of those aspects concerns the prices of such products.