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	Číslo (Kód CELEX): Number (CELEX Code):		61992J0328

	Název: Title:		Judgment of the Court of 3 May 1994. Commission of the European Communities v Kingdom of Spain. Failure to fulfil obligations - Public supply contracts - Pharmaceutical products and specialities. Case C-328/92.

	Publikace: Publication:		European Court Reports 1994 page I-1569

	Předmět (klíčová slova): Keywords

	Související předpisy: Corresponding acts:

	Odkaz na souvisejicí judikáty: Corresponding Judgements:		Case 71/92 Commission v Spain [1993] ECR I-5923 · [685] Evans Medical Case 324/93 The Queen v Secretary of State [1995] ECR I-563 · Case 199/85 Commission v Italy [1987] ECR 1039 · Case 24/91 Commission v Spain [1992] ECR I-1989


	Plný text: Fulltext:		Ne

Fakta:
In Spain, the award of public contracts is governed by the Ley de Contratos del Estado (Law on State Contracts, LCE) and the Reglamento General de Contratación del Estado (General Regulations concerning State Contracts, RGCE). These provisions are intended to transpose Council Directive 77/62/EEC
Of 21 December 1976 coordinating procedures for the award of public supply contracts (OJ 1977 L 13, p. 1).
. Contracts for the purchase of pharmaceutical products and specialities by hospitals within the social security system are, however, exempted from the LCE and the RGCE. Such contracts are governed by a special regulation pursuant to which the social security authority shall purchase the products directly from the producer in a single-tender procedure on the basis of the lowest price.
The Commission, contending that this exemption from the general laws of public procurement which were intended to transpose Directive 77/62 was incompatible with Community law, under Article 169 of the Treaty brought an action against the Kingdom of Spain before the Court of Justice.

Názor soudu a komentář:
The Kingdom of Spain in its defence submitted (i) that Directive 77/62 did not apply in the sector of pharmaceutical products; (ii) even if it applied, the exceptions provided for by Spanish law were covered by the exception clauses contained in Article 6 of the directive.
The Spanish Government first contended that public procurement of medicinal products did not fall within the scope of Directive 77/62. It argued that the medicinal products market was highly regulated by Community law, in particular by Council Directive 89/105/EEC
Of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems (OJ 1989 L 40, p. 8).
, and that the Spanish legislation ultimately complied with those special rules. The Court rejects this contention. Relying on its established case-law, it points out that “the only permissible exceptions to the application of Directive 77/62 are those which are expressly and exhaustively mentioned in it” ( Case 71/92). Articles 2(2) and 3 of Directive 77/62, which list the public supply contracts to which the directive does not apply, does not refer to contracts relating to pharmaceutical products and specialities.
The Court neither accepts the argument that the single-tender procedure could be justified under Article 6 of Directive 77/62. As a general matter, the Court points out that “Article 6 of Directive 77/62, which authorizes derogations from rules intended to ensure the effectiveness of rights conferred by the Treaty in the public supply contracts sector must be interpreted strictly” ( Case C-71/92; see also [685]
Evans Medical
). “[T]he burden of proving the actual existence of exceptional circumstances justifying a derogation lies on the person seeking to rely on those circumstances” ( Case 199/85).
According to Article 6(1)(b) of the Directive, the contracting authorities may award their supply contracts without applying the open or restricted procedures “when … for reasons connected with protection of exclusive rights, the good supplied may be manufactured or delivered only by a particular supplier”. This exception does not apply simply because of the fact that the product to be purchased is protected by exclusive rights. Secondly, it is necessary that as a consequence the product must be available from a particular supplier only. “Article 6(1)(b) cannot in any way justify general and indiscriminate recourse to the single tender procedure for all supplies of all pharmaceutical products and specialities”.
Article 6(1)(d) on the other hand applies “in so far as is strictly necessary when, for reasons of extreme urgency brought about by events unforeseeable by the contracting authorities, the time limit laid down in the procedures covered by Article 4(1) and (2) cannot be kept”. While the Court accepts that the “urgent need” required by the provision may well arise in a hospital pharmacy, “the freedom to prescribe pharmaceutical products cannot justify
a priori
systematic recourse to the single-tender procedure for all supplies of pharmaceutical products and specialities to hospitals”. Indeed, as is apparent from the wording of the provision, the “urgent need” must be such that - unforeseeably - arisen in a concrete case. Furthermore, the Court expresses doubt as to whether the other requirements of Article 6(1)(d), which must be satisfied cumulatively ( Case C-24/91), are met in the present case.

Shrnutí (Summary of the Judgment):

Plný text judikátu (Entire text of the Judgment):