Artegodan GmbH v European Commission.
Date: 2012-04-19
80. It should be borne in mind that where the unlawfulness of a legal act is in issue, the non-contractual liability of the European Union depends on the fulfilment of a set of conditions, including the existence of a sufficiently serious breach of a rule of law that is intended to confer rights on individuals (see Case C‑352/98 P Bergaderm and Goupil  v Commission [2000] ECR I‑5291, paragraphs 41 and 42; Case C‑282/05 P Holcim (Deutschland)  v Commission  [2007] ECR I‑2941, paragraph 47; and Joined Cases C‑120/06 P and C‑121/06 P FIAMM and Others  v Council and Commission  [2008] ECR I‑6513, paragraphs 172 and 173).
86. The Court of Justice has already drawn attention to the importance, both in the European Union legal order and in the national legal orders, of the principle of res judicata . In order to ensure stability of the law and legal relations, as well as the sound administration of justice, it is important that judicial decisions which have become definitive after all rights of appeal have been exhausted, or after expiry of the time-limits provided to exercise those rights, can no longer be called into question (Case C‑234/04 Kapferer [2006] ECR I‑2585, paragraph 20; Case C‑526/08 Commission  v Luxembourg [2010] ECR I‑6151, paragraph 26; and Case C‑352/09 P ThyssenKrupp Nirosta  v Commission [2011] ECR I‑2359, paragraph 123).
87. In that regard, the Court has held, firstly, that res judicata  extends only to the matters of fact and law actually or necessarily settled by the judicial decision in question ( Commission  v Luxembourg  paragraph 27; and Thyssenkrupp Nirosta  v Commission  paragraph 123) and, secondly, that the force of res judicata  attaches not only to the operative part of that decision, but also to the ratio decidendi  of that decision which is inseparable from it (Joined Cases C‑442/03 P and C‑471/03 P P & O European Ferries (Vizcaya) and Diputación Foral de Vizcaya  v Commission  [2006] ECR I‑4845, paragraph 44).
90. In that respect, it must be noted that, although the Court of Justice dismissed that appeal, it was, as the Court of Justice states in paragraph 52 of its judgment in Commission  v Artegodan and Others , on the ground that, without it being necessary to rule on the other pleas and arguments put forward by the Commission, the Commission lacked the competence to adopt the contested decision and, accordingly, that decision had to be annulled.
94. Although it follows from paragraphs 82 and 93 of the present judgment that the General Court erred in law, it is settled case‑law that, if the grounds of a judgment of the General Court disclose an infringement of European Union law but its operative part is shown to be well founded on other legal grounds, the appeal must be dismissed ( FIAMM and Others  v Council and Commission  paragraph 187).
99. Those substantive criteria for the suspension or withdrawal of a marketing authorisation must be interpreted in accordance with the general principle, set out in the case‑law, that the protection of public health must unquestionably take precedence over economic considerations (Case C‑183/95 Affish [1997] ECR I‑4315, paragraph 43).
102. However, the adoption of a decision to withdraw a marketing authorisation is only justified if, following that assessment, concrete and objective factors make it possible to hold that there is a negative benefit/risk assessment for the medicinal product concerned.
103. In that respect, the existence of a consensus within the medical community regarding a development of the assessment criteria of the therapeutic efficacy of a medicinal product and the questioning, within that community and following that development, of the therapeutic efficacy of that medicinal product constitute — in the same way as the identification of scientific data or new information — concrete and objective factors capable of acting as a basis for the finding of a negative benefit/risk assessment of that medicinal product.
104. In the present case, the Commission’s decision to use the criterion of long-term efficacy in order to assess the therapeutic efficacy of amfepramone in the treatment of obesity and to withdraw the marketing authorisation concerning the medicinal products containing that substance is based on the existence of a consensus within the medical community regarding a new assessment criterion of that therapeutic efficacy, according to which an effective therapy in the treatment of obesity must be for the long-term, on the questioning of the therapeutic efficacy of that substance, and also on the finding, in the light of that new assessment criterion, of a negative benefit/risk assessment of that substance.
110. It follows that, in so far as the rejection by the General Court of the action for damages brought by Artegodan is based on other grounds, the errors of law referred to in paragraphs 82 and 93 of the present judgment are not such as to invalidate the contested judgment (see, to that effect, Case C‑412/05 P Alcon  v OHIM [2007] ECR I‑3569, paragraph 41).