Judgment_paragraph 35 · Artegodan GmbH v European Commission (C-221/10 P)

35As regards the issue of whether, by infringing the rules of competence to adopt the contested decision, the Commission committed a sufficiently serious breach of the rules of law intended to confer rights on individuals, the General Court held in paragraphs 71 to 78 of the contested judgment that:71 In order to determine whether the Commission’s lack of competence to adopt the [contested decision], established in the judgment in Artegodan and Others v Commission is of such a kind as to cause the Community to incur liability, the Court considers it appropriate to ascertain first of all whether, as the case-law requires …, the rules of law infringed are intended to confer rights on individuals.72 Contrary to the applicant’s assertions, the abovementioned case-law laid down the requirement that the rule of law infringed must be protective in nature, regardless of the nature and scope of the act alleged to be unlawful, and in particular, of the question whether the act affects a closed group or a limited number of persons.73 In this case, in must be stated that the relevant provisions of Directive 75/319 delimiting the areas of competence of the Commission and the Member States are not intended to confer rights on individuals.74 Those provisions are specifically intended to organise the division of powers between the national authorities and the Commission, as regards the procedure for the mutual recognition of national marketing authorisations, together with Community arbitration procedures put in place by Directive 75/319 in the context of the gradual harmonisation of the national rules relating to marketing authorisations for medicinal products.75 In that context, the fact that the principle of the distribution of competences enshrined in Article 5 EC and the principle of subsidiarity have particular importance, as the applicant submits, does not mean that the rules on the division of powers between the Community and the Member States may be regarded as rules which are intended to confer rights on individuals, for the purposes of the case-law. In particular, contrary to the applicant’s submission at the hearing, the fact that the [contested decision] has no legal basis on account of the Commission’s lack of competence, and the fact that the applicant has obtained, on that ground in particular, its annulment, is not sufficient for a finding that the rules of competence infringed are intended to confer rights on individuals so that an infringement of those rules is of such a kind as to cause the Community to incur liability.76 Furthermore, [the judgment in Joined Cases 5/66, 7/66 and 13/66 to 24/66 Kampffmeyer and Others v Commission [1967] ECR 317], relied on by the applicant, is irrelevant for the assessment of the protective nature of the rules of competence breached in this case. The rule of law whose infringement was examined in that case was intended, inter alia, to facilitate the development of the free movement of goods. The Court of Justice therefore held that the fact that the interests related to the protection of the free movement of goods were of a general nature did not prevent their including the interests of individual undertakings such as the applicants, which, in their capacity as importers of cereals, were involved in intra-Community commerce. However, in the present case, the rules relating to the delimitation of competences between the Community and the Member States in the context of the procedure for the mutual recognition of national marketing authorisations and the arbitration procedures established by Directive 75/319 cannot be understood as also intending to ensure the protection of individual interests. In that connection, the applicant does not put forward any specific argument to show that the rules of competence infringed were also intended to confer rights on individuals.77 Furthermore, the applicant’s argument, based on an allegation that its right to establish and operate an undertaking has been undermined, has no bearing on the determination of whether the rules of competence examined are also intended to confer rights on individuals. As the Commission submits, the allegation that fundamental rights have been undermined is entirely distinct from the question whether the rules relating to the division of powers, the infringement of which has been established, are intended to confer rights on individuals.78 In those circumstances, the plea alleging that the fact that the Commission exceeded its powers is of such a kind as to cause the Community to incur liability must be rejected as unfounded on the ground that the rules of competence infringed are not intended to confer rights on individuals, so that it is therefore unnecessary to examine whether the infringement of those rules constitutes a sufficiently serious breach of Community law.’